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Chengdu Kanghong Pharma buys Israel's IOPtima for $56m
21 Nov, 2017 17:15
Gali Weinreb
The acquisition of the ophthalmology products company will generate $23-27.3 million in cash flow for BioLight, IOPtima's controlling shareholder.
BioLight Israeli Life Sciences Investments Ltd. (TASE:BOLT; Bulletin Board: BLGTY), which develops various ophthalmology products, has announced the completion of a deal to sell its IOPtime subsidiary. BioLight reported in April a memorandum of understanding for an initial investment in the company with an option for acquisition, and the option is now being exercised. IOPtima manufactures and markets a surgical device for treatment of glaucoma. BioLight's share price soared today by over 10%, pushing its market cap up to almost NIS 60 million.
The acquiring company is Chengdu Kanghong Pharmaceutical Group, which is listed on the Shenzhen stock exchange at a $6 billion market cap. The company works in the ophthalmology field, from R&D to marketing. BioLight reported that it would obtain $23.27.3 million in net cash flow from the deal, starting in late 2018. The deal will take place in four stages, with Chengdu Kanghong investing $7 million at a company value of $30 million, before money, in the first stage.
In the next stage, it will buy shares from IOPtima's existing shareholders, including BioLight, which has a 70% stake. If all of the stages are exercised, IOPtima will be sold at a $56 million value, to be paid gradually by 2021.
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Chengdu Kanghong will distribute IOPtima's products in China
Even before the deal is completed, Chengdu Kanghong will become a distributor of IOPtima's products in China. The terms for distributing the products are not known.
IOPtima is responsible for BioLight's only current commercial product. BioLight's revenue in 2016 totaled NIS 2.1 million, mostly from IOPtima's activity, and it lost NIS 21.8 million. The company had only NIS 544,000 in revenue in the first half of 2017, 33% less than in the corresponding period last year. IOPtima had NIS 25 million in cash as of the end of the first half of this year.
BioLight CEO Suzana Nahum-Zilberberg today remarked, "China is an important target market for the product. Cooperation with Chengdu Kanghong, which is active in ophthalmology inside and outside China, is the first step in future cooperation."
IOPtima CEO Ronen Castro said, "This is an important step for IOPtima that will enable it to deepen its penetration of the market in China and throughout the world, and to promote the unique solution that the company offers for glaucoma patients."
Israel Makov acquired BioLight in 2011 in order to realize his vision of assembling a group of companies in medical fields with synergy between them. Makov now owns 14% of BioLight, while Hong Kong investor Lau Ngai Cheung owns 18.8% and Indian investor Dilip Shanghvi owns 14%. IOPtima's product belonged to BioLight before Makov invested in the company, which has since added other products, including an intraocular eye implant for treatment of glaucoma, a product for diagnosing and guiding treatment of dry eye syndrome, and a platform for delivering drugs within the eye. These products are currently in development.
Published by Globes [online], Israel Business News - www.globes-
BioLight Reports Successful Results in Phase 1/2a Clinical Trial for Glaucoma Insert
TEL-AVIV, Israel, July 24, 2017 /PRNewswire/ --
BioLight Life Sciences Ltd. (TASE: BOLT) ("BioLight"), an emerging global ophthalmic company focused on the discovery, development and commercialization of ophthalmic products and product candidates, announced today successful results from its glaucoma insert VS101 ("Eye-D latanoprost insert") Phase 1/2a clinical trial, which demonstrated its ability to lower intraocular pressure ("IOP") for a 12-week period, with a favorable safety profile.
The Eye-D latanoprost insert is designed to provide sustained IOP-lowering for patients who have difficulty taking their prescribed eye drops for the treatment of glaucoma on a continuous daily basis.
BioLight's first-in-human study, this randomized, controlled, exploratory Phase 1/2a clinical trial was designed to compare three doses of its Eye-D latanoprost inserts to once-daily latanoprost eye drops. Following a simple, in-office procedure, the sustained release Eye-D latanoprost inserts were tested for 12 weeks and compared to once-daily latanoprost eye drops for the same period.
The Phase 1/2a results comprise data from 77 glaucoma patients that were collected from 19 clinical centers across the United States. The data demonstrated that a single placement of the Eye-D latanoprost insert of one of the three doses provided the best sustained reduction in IOP throughout the 12 weeks follow up, with a positive safety profile.
Highlights of the clinical trial results include:
Most adverse events were found to be mild and transient. No unanticipated adverse events were observed.
Mean diurnal IOP before treatment of patients that were treated with the effective dosed insert and completed the trial was 23.5 mmHg. A sustained reduction in IOP was observed with average diurnal IOP 17.9 mmHg at the primary endpoint of 12 weeks (5.6 mmHg, 24% reduction).
During the study, the company has gathered additional information about the procedure as well as the insert size, structure and location, which were used to improve retention rates in patient eyes.
"Ophthalmologists today continue to struggle with finding effective solutions to the significant problem of non-adherence to the pharmaceutical treatment of patients with glaucoma," said Dr. Howard Barnebey, MD, who served as a Principle Investigator in the study. "Non-adherence is a complex problem to solve. Several therapeutic approaches that aimed to address the lack of therapy compliance and persistence have either failed or are still in development."
Dr. Barnebey continued, "The Eye-D latanoprost insert has now successfully demonstrated effective intra-ocular pressure lowering for three months after subconjunctival placement of the insert in human eyes, and was well tolerated. This innovative insert presents a promising approach to improving therapeutic compliance, bypassing the issues of patients remembering to take medication as well as instilling it in their eyes. I am excited to participate in further development of Eye-D latanoprost insert."
Suzana Nahum Zilberberg, BioLight's CEO, commented, "We are very happy with the success of this clinical trial which demonstrated that the Eye-D latanoprost insert is safe and efficacious, and intend to continue our discussions with potential strategic partners, aiming to advance the development and approval process for the Eye-D latanoprost insert, while, at the same time, promoting additional steps that will assist in optimizing the treatment for glaucoma patients. This novel technology and its first indication, have the potential of becoming an important advance in the treatment of glaucoma patients".
About BioLight Life Sciences Ltd.
BioLight addresses a number of significant unmet medical needs with a pipeline of ophthalmic products and product candidates, which are in various commercial and clinical stages, including: IOPtiMate™, a laser-based non-invasive surgical treatment for glaucoma; TeaRx™, a diagnostic solution that provides a multi-assay analysis of tear film constituents in order to identify one or more underlying causes of dry eye syndrome, or DES; Eye-D, an in-office insertable platform that provides for controlled release of ophthalmic medications over time; OphRx's lyotropic liquid crystals, or LLC, a non-invasive drug delivery technology administered through eye drops as an alternative to current ocular delivery modalities; and LIPITEAR™, a microemulsion consisting of Phospholipidis and Triglycerides, which forms a tear-like elastic lipid shield which is indicated for use in DES, post-operative ocular surgery (e.g. refractive surgery, cataract surgery and corneal transplant) and corneal erosions. BioLight has also invested, through Micromedic, in innovations in cancer diagnostics.
Leading key investors are Mr. Israel Makov, Chairman of Sun Pharmaceuticals, former CEO and President of Teva Pharmaceuticals and former Chairman of Given Imaging, Mr. Dilip Shanghvi, founder of Sun Pharmaceuticals, India's largest pharmaceutical company, Mr. Dan Oren, founder and CEO of Dexcel Pharma, the second-largest pharmaceutical manufacturer in Israel and Rock-One, a Hong Kong-based investment company.
For more information please visit the Company's website at http://www.bio-light.co.il
Biolight Life Sciences: Raise Up To Nis12m In Rights Offering
By Edison Stock Markets
BioLight Life Sciences Ltd (TA:BOLT) is engaging in a shareholder rights offering of up to NIS12m (if fully subscribed) to strengthen its balance sheet. While BioLight had NIS20.2m net cash at Q117, most was held at subsidiaries, and only NIS4.7m was directly available to the parent firm; hence the imminent funding need. The four largest shareholders (representing 55%) will participate to some degree in the rights offering. If fully subscribed, we estimate the rights offering can provide funding into at least Q417. Our model, which does not yet include the rights offering or the potential IOPtima sale to a Chinese investor, derives an rNPV valuation of NIS92.9-103.4m.
Continuing to work towards completing IOPtima sale
In April 2017, BioLight’s IOPtima subsidiary (of which BioLight holds a 70% ownership stake) signed a non-binding term sheet, calling for it to be sold to Chengdu Kanghong Pharma. Chengdu had a 60-day exclusivity clause restricting IOPtima from entering potential sale discussions with other prospective buyers. While this window should expire imminently (mid-June 2017), BioLight management remains involved with ongoing discussions to finalise a sale transaction with Chengdu, and suggests the expiry of the exclusivity period should not diminish the likelihood of the completion or finalisation of the Chengdu deal.
BioLight will sell its stake in IOPtima in installments at a company value of $30-56 million.
BioLight Israeli Life Sciences Investments Ltd. (TASE:BOLT; Bulletin Board: BLGTY), chaired by Israel Makov and managed by CEO Suzana Nahum-Zilberberg, has signed a memorandum of understanding for the sale of its leading product, the only one directly generating revenue for the company, to a Chinese company. BioLight's share was up 8% today, pushing the company's market cap up to NIS 280 million.
IOPtima, a company that was part of BioLight's historical portfolio before Makov's involvement with the company, developed laser surgery technology for treatment of glaucoma. BioLight holds 70% of IOPtima. Under the memorandum of understanding, which for the present is non-binding, the Chinese company, Chengdu Kanghong Pharma will invest $7 million in IOPtima for 19% of that company's shares at a $30 million company value. The Chinese company will receive an exclusive license to market IOPtima's product in China. After six months, the Chinese company will acquire additional shares in IOPtima from the existing shareholders, including BioLight, thereby increasing Chengdu Kanghong Pharma's IOPtima stake to 60%, for $17.2 million, reflected a $42 million company value.
In two further stages scheduled for 2019 and 2021, the Chinese company will acquire the remaining shares in IOPtima at a price determined by IOPtima's profits, reflected a company value of $40-56 million.
BioLight's system for treatment of glaucoma is approved for marketing in China, Europe, Israel, Mexico, Peru, and Canada. IOPtima already has a Chinese subsidiary founded in order to market its products in this country.
Two months ago BioLight announced that a Chinese company was investing in BioLight itself, but this investment was called off when the Chinese government imposed restrictions on funds leaving the country.
BioLight needs money
BioLight's revenue totaled NIS 2.1 million in 2016, mostly from IOPtima, and the company lost NIS 21.8 million. The company burned NIS 27 million on current activities, leaving it with NIS 25 million.
If and when it receives revenue from the sale, BioLight will invest it in other products it is developing that have yet to reach the sales stage. These include a intra-eye implant for treatment of glaucoma, a product for diagnosing and guiding treatment for dry eye disease, and a product designed as a platform for transporting drugs within the eye. BioLight also owns 35% of Micromedic Technologies Ltd. (TASE:MCTC), a company developing cancer diagnostic tests.
It appears that although BioLight's vision is to found a collection of companies in a specific area enjoying synergy with each other, IOPtima is currently unsuitable for such an ophthalmology group, and will not become the marketing channel for the company's other products. This is probably because the company has not managed to generate substantial revenue, and also because unlike BioLight's other drugs, IOPtima's product is a surgical device, not a drug, test, or tool for guiding drugs. BioLight also needs the money that the IOPtima exit can provide.
Published by Globes [online], Israel Business News - www.globes-online.com - on April 19, 2017
BioLight's TeaRx Multi-Parameter Diagnostic Assays to be Used in Dry Eye Syndrome Drug Trial
TEL-AVIV, Israel, February 23, 2017 /PRNewswire/ --
BioLight Life Sciences Ltd. (BOLT.TA) ("BioLight"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions, announced today that, DiagnosTear Ltd. ("DiagnosTear"), one of BioLight's subsidiaries, has signed a services agreement (the "Agreement") with a pharmaceuticals company, pursuant to which DiagnosTear will provide analysis services through its TeaRx™ multi-parameter diagnostic assays for use in an clinical trial for dry eye syndrome ("DES").
This Agreement marks the first time TeaRx™ will be used in a drug trial. The TeaRx™ assays will be used in order to characterize sub populations of responders and non-responders to the new DES drug treatment. Assuming the TeaRx™ analysis will result with a differentiation between responders and non-responders, the parties will, in good faith, extend their collaboration to a joint-development project of a potential companion diagnostics solution.
"DES is a multifactorial condition and, as such, requires a personalized approach to therapy," commented Suzana Nahum Zilberbeg, BioLight's Chief Executive Officer. "Indeed, the recent launch of a second FDA-approved drug for the treatment of DES clearly demonstrates that significant unmet medical need remains for the personalized treatment of patients suffering from this condition. With that in mind, we are thrilled to be involved in this clinical trial, and are optimistic about the role that TeaRx™ may play in the development of the next generation of DES therapeutics."
About Dry Eye Syndrome
DES is a common disorder of the ocular surface in which the eye produces insufficient tears or tears with abnormal composition. In its mild to moderate forms, DES causes pain and discomfort, and can impact vision quality and the ability to go about daily activities. In its more severe forms, DES can lead to the permanent loss of vision. DES affects approximately 40 million people in the U.S. and 100 million people worldwide. A change in any of the multiple parameters in the tear film could indicate a problem that might cause DES.
About TeaRx™
TeaRx™ is a diagnostic solution that provides a multi-assay analysis of tear film constituents in order to identify one or more underlying causes of DES.
Chinese fund in talks to buy BioLight
29 Dec, 2016 15:09
Gali Weinreb
If a deal takes place, the fund will initially buy the public's 45% holding in ophthalmic company BioLight, resulting in it being delisted.
Ophthalmic company BioLight Israeli Life Sciences Investments Ltd. (TASE:BOLT), run by Suzana Nahum-Zilberberg, announced today that it had signed a non-binding memorandum of understanding with a Chinese investment fund whereby the fund will buy the public's holdings in the company and delist it. If the acquisition goes ahead, it will be at a price of NIS 16.5 per share, representing a premium of 83% on the company's base share price this morning. The share price is currently up 45%, giving BioLight a market cap of NIS 13.6 million.
It should be pointed out that there is no binding agreement. The price, and the entire deal, are subject to due diligence. BioLight said that it estimated that the negotiations could continue for several more weeks.
BioLight has been seeking to commercialize some of its products in the past year, but it was asked to desist from contacts with third parties during the negotiations with the fund, which began in November. The company said today that this condition would shortly expire, perhaps indicating that it is still not certain that the deal with the fund will go ahead, and that it is going back to examining alternatives.
If a deal does take place, the fund will hold 45% of BioLight, for a payment of $5.1 million. The fund will then invest $5-7 million on the same terms and will become the controlling shareholder, but by then BiolIght will be a privately held company and the additional investment will not affect the investing public.
"Product cluster" vision
Former Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) CEO Israel Makov became the controlling shareholder in the stagnating biomed company in 2011. He wanted to use BioLight to realize his vision of "product clusters". According to this vision, Israeli biomed startups can best develop if synergy between them is built in at all stages of the development process: product development, regulation, finance, market research, and marketing. Makov (together with CEO Susana Nahum Zilberberg) assembled two such clusters. He leveraged a glaucoma surgery product, one of BioLight's long-standing technologies, and assembled a cluster of ophthalmology drugs around it. BioLight also acquired a 48% controlling share in Micromedic, a listed diagnostic company, which formerly served as a cluster in cancer diagnosis. The experiment was partly successful. BioLight's products have not yet been commercialized, and have therefore also not attained a value that the shareholders in Tel Aviv could relate to. Perhaps for this reason, the company share has gradually faded in recent years, and lost 72% of its value over the past year. BioLight sought to make an offering to the public last March, but could not complete it at the prices it wanted. That was also one of the reasons why its share price plummeted.
Nahum Zilberberg said, "The stock exchange was good to us for many years, but at the current valuation, it is logical to consider an investment like the one proposed to us. The product cluster vision is working in the company on a day-to-day basis. There is no connection between the vision and its reflection in the share price."
Published by Globes [online], Israel business news - www.globes-online.com - on December 29, 2016
BioLight Reports Successful Feasibility Clinical Study Results for the Detection of Prostate Cancer with CellDetect® Non-Invasive Test
TEL-AVIV, Israel, July 26, 2016 /PRNewswire/ --
BioLight Life Sciences Ltd. (BOLT.TA) ("BioLight" or the "Company"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions and also in innovations in cancer diagnostics, announced promising results from a feasibility clinical study designed to detect prostate cancer cells in urine specimens using its CellDetect® technology. The study successfully demonstrated the feasibility of detecting intact cells originating in the prostate from urine samples following prostate massage.
The CellDetect® technology is being developed by Micromedic Technologies (MCTC.TA), BioLight's cancer diagnostics subsidiary, and allows an accurate diagnosis of cancerous and precancerous cells, based on a unique combination of color and morphology, by utilizing a proprietary kit containing unique extract and dyes. These study results represent a significant milestone in the commercial development of a third diagnostic product based on the CellDetect® platform technology for different cancers, and paves the way for the detection of prostate cancer through a simple urine test.
"We are very pleased with the results from this clinical study, which validates the potential we see in the CellDetect® technology to dramatically improve prostate cancer diagnostics," commented Susana Nahum Zilberberg, BioLight's Chief Executive Officer. "While prostate cancer is the second most common cancer in men worldwide, the currently available diagnostic testing is known to be unreliable or invasive and expensive. With the results that we have announced today, we are confident that CellDetect® has the potential to transform prostate cancer diagnostics, offering patients a non-invasive, accurate and reliable test, and one that could improve the healthcare system through considerable cost savings."
The feasibility clinical study was conducted in the Kaplan Medical Center in Israel. Using the CellDetect® technology, urine samples derived from prostate cancer patients and healthy subjects were examined for the existence of cancerous and precancerous cells using a unique color marker. Of the 18 samples tested, Micromedic's research team correctly diagnosed each case in the study. Assessment of the samples by an external reviewer produced encouraging results, correctly identifying most cases of prostate cancer and most of the healthy subjects as well.
"These results add momentum to what has already been a strong year for BioLight's CellDetect® platform," continued Ms. Zilberberg. "Overall, we believe this technology fills a key void in cancer diagnostics, not only for prostate cancer, but other cancer indications as well."
Last year, BioLight announced that a blinded, multi-center clinical study of CellDetect® had successfully achieved the study's primary endpoint for effectively detecting the recurrence of bladder cancer in subjects with a history of the disease. Since then, BioLight has obtained CE Marking for the use of CellDetect® testing for the detection of bladder cancer in urine, which allows the product to be marketed and sold in Europe and other territories. The Company also recently announced a partnership agreement with Axella Research LLC to advance commercialization of the bladder cancer product in the United States.
About Prostate Cancer
Prostate cancer is the second most common cancer among men worldwide. The incidence of prostate cancer in the U.S. is the highest in the world and it represents the second most common cause of cancer-related death in men. In 2014, 233,000 new cases of prostate cancer were diagnosed in the U.S., and nearly 30,000 patients died of the disease.
About CellDetect®
Micromedic's CellDetect® technology allows an accurate diagnosis of cancerous and precancerous cells, based on unique combination of color and morphology. The technology may be implemented in screening tests and monitoring tests of disease recurrence in cancer patients after being treated. Micromedic has proven the product's efficacy in diagnosing cervical cancer and bladder cancer in the framework of clinical trials, and estimates that the technology underlying the products may be implemented for use in additional cancer indications. Both the cervical cancer detection screening diagnostic test kit and detection of bladder cancer recurrence in urine are in the initial commercial stage.
BioLight Expands Its Product Portfolio With Eye Drops for Dry Eye Syndrome
TEL AVIV, Israel, May 19, 2016 /PRNewswire/ --
BioLight Life Sciences Ltd. (BOLT.TA), ("BioLight" or the "Company"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions, announced today that it has obtained the worldwide rights (excluding Israel and Italy) for the manufacturing, distribution, marketing and sales of a groundbreaking new eye drop product for the treatment of dry eye syndrome (DES) and other ophthalmic indications. The product was in-licensed by BioLight from Fischer Pharmaceuticals Ltd. and RAMOT, the technology transfer arm of the Tel Aviv University. The product has CE Mark marketing approval in Europe, and BioLight is currently evaluating the clinical and regulatory efforts required to commercialize it in other territories around the world.
BioLight was also granted exclusive global rights (excluding Italy) by RAMOT to develop, manufacture and commercialize additional new ophthalmic therapies based on the product's underlying technology. The technology, which protects the ocular surface and enhances the corneal re-epithelization process, was originally developed in the Tel-Aviv University.
"This global in-licensing agreement adds a fifth major ophthalmic product to our pipeline," commented commented BioLight's Chief Executive Officer, Suzana Nahum Zilberberg. "While there have been a number of advances in the understanding and treatment of DES over the past few years, there is no question that significant unmet medical need remains. The potential synergies of pairing the new DES therapeutic product with our TeaRx™ multi-parameter diagnostic test for DES are both obvious and exciting. We look forward to updating our stakeholders as we progress."
About Dry Eye Syndrome
DES is a common disorder of the ocular surface in which the eye produces insufficient tears or tears with abnormal composition. In its mild to moderate forms, DES causes pain and discomfort, and can impact vision quality and the ability to go about daily activities. In its more severe forms, DES can lead to the permanent loss of vision. DES affects approximately 40 million people in the U.S. and 100 million people worldwide.
BioLight Reports 2015 Financial Results
TEL AVIV, Israel, April 4, 2016 /PRNewswire/ --
BioLight Life Sciences (BOLT.TA) ("BioLight" or the "Company"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions, reported operational and financial results for the year ended December 31, 2015. Results were characterized by continued development and commercial progress in multiple markets, and the achievement of all previously announced 2015 milestones.
Operational Highlights:
Completed an upsized private investment and signed a strategic partnership with Rock-One International Holdings Ltd. designed to help BioLight maximize its presence within China, the second largest healthcare market in the world after the United States.
Reported first IOPtiMate™ System sales and procedures for a total of 1.4 million NIS (or approx. $360,000) in selected markets, enhanced worldwide marketing platform, and increased installed based, focusing on KOLs as the basis for expanding product sales going forward.
Completed a joint equity financing agreement pursuant to which two Asia-based venture capital firms invested in BioLight subsidiary, IOPtima, for an aggregate amount of US$6.0 million, representing an approx. US$21 million post-money valuation for IOPtima, primarily to enhance IOPtiMate™ sales and marketing efforts, as well as to initiate a regulatory approval pathway process for the IOPtimate™ system with the U.S. FDA.
Signed a collaboration agreement with Ora, Inc., a world-leading independent, full-service ophthalmic contract research organization and product development firm, pursuant to which the Company and Ora will work together to advance the clinical, regulatory and commercial development of BioLight's novel TeaRx™ multi-assay diagnostic test for dry eye syndrome ("DES").
Completed two positive U.S. clinical studies which assessed the TeaRx™' test's effectiveness in assessing tears of healthy subjects as well as patients with DES, providing the basis for regulatory submissions in the U.S and Europe in 2016.
Progressed with patient enrollment into an ongoing U.S. Phase 1/2a clinical study of Eye-D™ VS-101, BioLight's latanoprost insert product based on its ground-breaking in-office insertable platform that provides for controlled release of ophthalmic medications over time, the results of which are expected to be obtained in the second half of 2016.
Expanded BioLight's balanced and diverse pipeline of ophthalmic products and product candidates with OphRx, a joint-venture that is developing a non-invasive, eye-drop-based ophthalmic drug delivery technology as an alternative to current delivery modalities, such as intravitreal injections.
Reported positive clinical studies results for its CellDetect™ and BRONJ cancer diagnostics, and obtained CE Mark for the CellDetect™ bladder cancer test, enabling the product to be marketed and sold in Europe and other territories.
Financial Results:
All dollar amounts are expressed in New Israeli Shekels ("NIS"), with a convenience U.S. dollar translation of NIS amounts provided using the rate of NIS 3.902 to US$1.00, the representative rate of exchange as of December 31, 2015, and results are reported in accordance with International Financial Reporting Standards.
For the year ended December 31, 2015, BioLight's revenues were NIS 1.4 million (US$ 360,000). The net loss for 2015 was approximately NIS 27.6 million (US$ 7.1 million), or NIS 7.98 loss per share, as compared to a net loss of approximately NIS 36 million (US$ 9.2 million), or NIS 11.96 loss per share, for 2014.
BioLight ended 2015 in a strong financial position. As at December 31, 2015, the Company had approximately NIS 51 million (US$ 13.1 million) in cash and short-term deposits.
About BioLight Life Sciences Ltd.
BioLight address ophthalmic significant unmet medical needs with a pipeline of products and product candidates, which are in various commercial and clinical stages, including: IOPtiMate™, a laser-based non-invasive surgical treatment for glaucoma; TeaRx™, a diagnostic solution that provides a multi-assay analysis of tear film constituents in order to identify one or more underlying causes of DES; Eye-D™, an in-office insertable platform that provides for controlled release of ophthalmic medications over time and OphRx's lyotropic liquid crystals, or LLC, a non-invasive drug delivery technology administered through eye drops as an alternative to current ocular delivery modalities. BioLight has also invested, through Micromedic, in innovations in cancer diagnostics, including proprietary tests that are designated for bladder, cervical, multiple myeloma and other cancers.
Leading key investors are Mr. Israel Makov, Chairman of Sun Pharmaceuticals, former CEO and President of Teva Pharmaceuticals and former Chairman of Given Imaging, Mr. Dilip Shanghvi, founder of Sun Pharmaceuticals, India's largest pharmaceutical company, Mr. Dan Oren, founder and CEO of Dexcel Pharma, the second-largest pharmaceutical manufacturer in Israel and Rock-One, a Hong Kong-based investment company.
For more information please visit the Company's website at http://www.bio-light.co.il
CONTACTS:
Israel Investor Contact:
Itai Bar-Natan, CFO
Email: itai@bio-light.co.il
Tel: +972-73-2753400
U.S. Investor Contact:
Stephen Kilmer, IR
Email: steve@bio-light.co.il
Tel: +1-646-274-3580
Bio Light's IOPtiMate System Receives Regulatory Approval in Canada
PR Newswire Bio Light Israeli Life Sciences Investments Ltd.
TEL AVIV, Israel, December 21, 2015 /PRNewswire/ --
Bio Light Israeli Life Sciences Investments Ltd. (TASE: BOLT, OTCQX: BLGTY) ("Bio Light" or the "Company"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions, announced today that its IOPtiMate™ system for the treatment of glaucoma has been approved by the Canadian Medical Devices Bureau, allowing the Company to commercialize the surgical system in Canada.
The IOPtiMate™ surgical system enables a non-penetrating, CO2 laser-assisted procedure known as CLASS (CO2 Laser-Assisted Sclerotomy Surgery) to reduce elevated intraocular pressure. CLASS is an automated, easy to perform procedure which requires only a short learning curve and provides a safer and more precise alternative to the complex and risky glaucoma surgeries that are currently available.
Bio Light is primarily marketing the IOPtiMate[TM] system to leading physicians and medical centers in Asia and Europe, which has resulted in first sales of the system in Hong Kong, Poland, Hungary, Romania, Peru and Portugal, with distribution agreements under negotiation in additional countries. The Company also recently signed a joint-financing agreement in November 2015 with two Asia-based venture capital firms to further support the global commercialization of the IOPtiMate™ system, as well as to initiate a regulatory approval pathway process for it with the U.S. Food and Drug Administration. With a Canadian license now in place, Bio Light plans to initiate commercial activity in Canada through a local distributer.
"According to CNIB, glaucoma is the second leading cause of vision loss for seniors in Canada, and more than 250,000 Canadians suffer from chronic open-angle glaucoma, the most common form of the disease," explained Biolight's Chief Executive Officer, Suzana Nahum Zilberberg. "The IOPtiMate[TM] system represents a true breakthrough for people who are afflicted by this terrible disease, and we are thrilled to secure the necessary approval to drive the adoption and commercialization of this innovative surgical solution in Canada."
BioLight Announces First IOPtiMate™ System Sale in Portugal
PR Newswire BioLight Life Sciences Investments Ltd.
TEL AVIV, Israel, December 8, 2015 /PRNewswire/ --
BioLight Life Sciences Investments Ltd. (TASE: BOLT, OTCQX: BLGTY) ("BioLight" or the "Company"), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, today announced the first sale of the IOPtiMate™ system to a medical center located in Portugal.
The IOPtiMate™ system is based on CO2 laser technology that enables the performance of a unique filtration surgery to treat glaucoma without penetrating the inner part of the eyeball, thus allowing for substantial reductions in post-operative complications and use of eye drops compared with alternatives.
The IOPtiMate system is currently being marketed primarily to leading physicians and medical centers in Asia and Europe. These marketing efforts have resulted in recent first sales of the IOPtiMate™ system in Hong Kong, Poland, Hungary, Romania and Peru.
Recently, the Company announced that it had entered into a joint financing agreement with two Asia-based venture capital firms (the "New Investors"), pursuant to which BioLight and the New Investors will make a direct equity investment in BioLight's IOPtima Ltd. subsidiary via a private placement. The financing will help IOPtima to continue the global commercialization of its innovative IOPtimate™ system, as well as to initiate a regulatory approval pathway process for the system with the U.S. Food and Drug Administration, commencing 2016.
This press release is being made in accordance with BioLight's policy of announcing a first sale in a new territory.
BioLight Chugging Along Slowly But Steadily
Dec. 4, 2015 3:25 PM ET | About: BioLight Israeli Life Sciences Investments Ltd. ADR (BLGTY)
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)
Summary
On December 1, 2015 BioLight Israeli Life Sciences Ltd. (OTCQX: BLGTY, TASE: BOLT) reported third quarter financial results.
For the third quarter of 2015 BioLight's revenues were $167k, mostly from the sales of IOPtiMate systems.
The company burned roughly $1.4 million in cash from operational activities and exited the third quarter with a cash balance of $9.4 million.
There are several catalysts in the pipeline that have the potential to drive up shareholder value.
Operational Update
During the second quarter of 2015 BioLight signed a strategic partnership with Rock-One International Holdings Ltd. to help maximize its presence within China. Rock-One has a history of successful international collaborations and vast experience and understanding of China's unique regulatory requirements. As China is the second largest healthcare market in the world after the U.S., and since Rock-One has a reliable domestic distribution and service infrastructure within China, the partnership with Rock-One should help BioLight expand their reach within the country.
In July of this year the company announced the changes in American Depository Receipts (ADR) conversion ratio. A 1-for-10 reverse split of its ordinary shares, where one ADR represents ten shares.
Product development pipeline…
…IOPtiMate…
To-date, BioLight has installed the IOPtiMate system in healthcare centers in Thailand, Italy, Eastern Europe (Poland, Hungary, and Romania), Turkey, Hong Kong, and China as they sported favorable market dynamics and insurance reimbursement. In August 2015, one system was sold in Peru, following which the company entered into additional distribution agreements in Argentina and Portugal. BioLight generates revenues for IOPtiMate systems from two channels; from initial sales of the device as well as from the fees customers pay for each procedure they perform using the system.
During the second quarter of this year BioLight announced their first commercial sales of the IOPtiMate system in Hungary as well as in Romania. It was the first sale in Romania using the pay-per-procedure model. Physician adoption is a major driver of revenue for new technologies, and thus far, sales have been nominal as the IOPtiMate systems are still largely in an evaluation stage. As physicians share their clinical experience, we expect adoption and utilization to increase gradually. Since the IOPtiMate system already has a CE Mark, the company is continuing its efforts to accelerate sales in the European Union.
In March 2014, the China Food and Drug Administration (CFDA) approved the marketing and sale of the IOPtiMate system in that country. The devices that were installed in a few medical centers across the country the past year are currently undergoing clinical evaluation. BioLight intends to use the Chinese market as an anchor to enter additional developing Asian territories, such as India, which could be an additional long-term revenue catalyst. BioLight is pursuing regulatory approval in Canada and is in search of a partner in the U.S. to market their device. We see these regions as having potential to meaningfully drive up sales of the IOPtiMate systems.
BioLight, along with venture funds in Taiwan and China invested roughly $7.2 million in its subsidiary IOPtima in November 2015. BioLight will hold approximately 71% of IOPtima's issued and outstanding shares when the deal closes in the coming weeks. As per the agreement the investors will have the right to trigger a "drag along mechanism" if IOPtima fails to reach the forecasted revenue ($13.7 million) and regulatory milestones (FDA approval) within three years of deal closing.
Meanwhile, in September 2015 the IOPtiMate system was granted an Israeli patent that will expire on December 30, 2029.
…EyeD…
Clinical trials in the U.S. (Phase 1/2a) involving the EyeD technology are currently underway. While conducting the trials in humans with the prototype (EyeD) device, the R&D team gathered an initial base of clinical experience. Due to a slower than expected enrollment rate and optimizations of the insert's structure and its insertion procedures the results of the clinical trials are expected during the first half of 2016.
…TeaRx…
In February 2015, the company reported clinical study findings that identified positive statistical correlations between the TeaRx test's diagnostic parameters and widely used benchmark tests for dry eye syndrome (NYSEARCA:DES). BioLight has initiated a second clinical trial in order to assess the effectiveness of the tests in tears of healthy subjects as well as patients with severe DES. Management noted in its third quarter report that the enrollment of subjects for the trial was completed at the beginning of Q3 2015 and the results from this second trial are expected by end of Q4 2015. The process of defining the reliable combination of parameters that are required for the DES diagnostic kit is underway after which BioLight will initiate regulatory approval activities.
In mid-June 2015, BioLight announced their collaboration with Ora Inc., a world-leading independent, full-service ophthalmic contract research organization (CRO) and product development firm, to aid in the commercial development of TeaRx. The two companies have agreed to fund the clinical study and other activities required to obtain U.S. 510K regulatory approval for TeaRx as well as to incorporate the test kit in other clinical trials sponsored by third parties and performed by Ora.
Diagnostear received investment from BioLight as well as from the Office of Chief Scientist in the amount of $550k. BioLight's holdings in Diagnostear will be 74%.
…OphRx…
OphRx offers a unique drug delivery technology that is based on the principle of molecular transport across cell membranes using liquid crystals. The technology creates a basis to load different molecules and release them in a controlled mechanism to the target location. BioLight believes that this technology could be utilized for ophthalmic drug delivery for front and/or back of the eye diseases. The company is currently working on developing a novel formulation for the molecule. It is being designed to deliver the correct dose, follow a predictive route, and release the drug either in a controlled or sustained pattern. Once the formulation is completed, management anticipates commencing pre-clinical trials.
In November 2015, XL Vision and Integra invested the aggregate amount of $0.4 million in OphRx.
…CellDetect…
A large unmet need exists in the U.S. and Europe for non-invasive screening of bladder/cervical cancer. Studies have shown the incidence/mortality rates as well as the costs associated with the disease detection to be high.
Bladder Cancer - Management reported successful results from their blinded, multi-center clinical study using the CellDetect technology. The primary endpoint of effectively detecting the recurrence of bladder cancer in subjects with a history of the disease was achieved. BioLight is pursuing an Israeli AMAR approval, pending which the company hopes to launch in Israel by Q1 2016. The company is now focused on building awareness of the product to facilitate broader roll-out in Europe using distribution agreements in CE Mark territories. In November 2015, BioLight entered into a partnership with Axella Research LLC, to help manage clinical trials and obtain regulatory approval for marketing the CellDetect diagnostic test kit in the U.S. Axella has agreed to contribute over $1 million for this purpose and in exchange will be paid royalties from future U.S.-based sales of CellDetect diagnostic test kits.
Cervical Cancer - Proof of concept has been completed for cervical cancer detection and identification using the CellDetect kit. CE Marking was granted for marketing CellDetect in Europe and Israeli Ministry of Health approved the marketing of CellDetect in Israel. The product also received CFDA approval for marketing in China. BioLight is scouting for possible distribution channels in China and India to commercialize the CellDetect technology for the detection of cervical cancer. The company is also actively pursuing strategies to accelerate sales with their existing distributors in other geographical regions.
In July 2015, the U.S. and European patent office issued a patent for the CellDetect technology, intended to identify cervical cancer cells, which will be in effect until 2030.
In September 2015, the company obtained approval for conducting a clinical trial for diagnosing prostate cancer in urine samples using the CellDetect technology. The trial is expected to conclude by end of Q1 2016.
…BRONJ…
BRONJ is a severe side effect from the use of biophosphonate drugs, prescribed to metastatic cancer patients and osteoporosis patients, causing necrosis of the maxillary bone. This side effect has a prevalence rate of up to 18.6% among multiple myeloma patients, 1.2-12% among breast cancer patients, 6.5-7% among prostate cancer patients and up to 0.1% among osteoporosis patients treated orally. Over 15 million prescriptions for biophosphonates, administered orally or by way of infusion, are issued in the U.S. alone.
At Tel Hashomer Medical Center, Israel, a study was conducted to identify the unique genetic profile that enables the assessment of risk among cancer patients to develop BRONJ and results were reported in May 2014. In order to validate the findings from this study, another trial was performed at the Florida University in the U.S., and at the Tel Hashomer Medical Center, Israel, using diverse patient populations from the U.S., Europe, and Israel. The trial involved 125 subjects who were treated with bisphosphonate drugs, of which 108 were multiple myeloma patients, 13 were breast cancer patients, and four were patients suffering from other cancers. Of the total number of subjects, 69 patients developed BRONJ and the remaining 56 did not. In August 2015, the company announced that they are developing a novel SNP assay (licensed technology from the University of Florida) to detect individuals with a unique genetic profile that are 10 times more susceptible to develop BRONJ. Eventually, the company anticipates developing a test kit that will allow categorizing the risk of developing BRONJ in patients who are treated for cancer.
Valuation
BioLight is currently working towards expanding its distribution network in the global regions by increasing the number of distributors and engaging independent sales representatives. The IOPtiMate systems are currently under clinical evaluations at several leading medical centers in Europe and Asia and therefore are yet to be fully launched. Although this process builds awareness and helps in expanding the device's presence in the respective regions, being in the "try-out" phase by physicians alone does not translate into meaningful revenue numbers. Since the commercial roll-out in Q4 2014, quarterly sales revenues have been incrementally increasing from the beginning of 2015 but have been relatively light. While we remain optimistic that IOPtiMate device uptake may gain traction as awareness builds, we think that revenues could be uneven until demand grows for state-of-the-art technologies in glaucoma surgery. As market adoption increases, we anticipate a significant increase in system/procedure sales beginning late 2016 which would help smooth this unevenness. Therefore, we have modeled sales to be light in the initial years since device uptake may be slow but built in double-digit sales growth in most territories in the out years.
We think that BioLight is likely to gain entry into the U.S. market for the IOPtiMate system around 2018 and if the company is successful in obtaining regulatory approval, it has the potential to steepen the revenue curve. We are looking forward to the results from the clinical trials employing the TeaRx and EyeD technology. OphRx's molecule, a nascent-stage product in the pipeline could be a potential source of revenue in the long term.
The slower than anticipated market adoption of the device has prompted us to make some meaningful downward revisions to our forecasted revenues in the near term. Consequently, this has resulted in a downward revision in the target price from $12.00/share to $10.00/share. However, there are several catalysts in the pipeline that have the potential to drive up shareholder value. We remain optimistic as the company continues to execute its growth strategy. We maintain our Buy rating.
BioLight Announces Partnership With Axella Research For CellDetect® Non-Invasive Test for Monitoring Recurrence of Bladder Cancer
TEL-AVIV, Israel, November 30, 2015 /PRNewswire/ --
BioLight Life Sciences Investments (OTCQX:BLGTY, TASE:BOLT) ("BioLight" or the "Company"), announced today that its cancer diagnostics subsidiary, Micromedic Technologies (MCTC.TA) ("Micromedic"), has entered into a Collaboration Agreement (the "Agreement") with Axella Research LLC ("Axella"), to advance the clinical and regulatory efforts required to commercialize the CellDetect® non-invasive diagnostic test for the monitoring of bladder cancer recurrence in the United States.
Under terms of the Agreement, Axella will contribute over US$1 million in funding and the delivery of key clinical research organization ("CRO") services, including the management and execution of a clinical trial, in order to obtain regulatory approval for the sales and marketing of CellDetect® in the United States. In exchange for financing and CRO services, Axella will be entitled to royalties from future U.S.-based sales of CellDetect®.
"We are thrilled to announce this strategic partnership with Axella, which will yield meaningful progress towards regulatory approval of CellDetect® in the United States, and accelerate the commercialization of this novel technology," commented Suzana Nahum Zilberberg, BioLight's Chief Executive Officer. "With the highest recurrence rate of all cancers worldwide, there is a pressing need for improved diagnostic technologies to combat bladder cancer. CellDetect® bladder cancer fills that void by delivering an accurate and reliable non-invasive test, offering significant commercial potential in the largest cancer diagnostics market in the world."
Micromedic is currently developing the CellDetect® technology, which allows an accurate diagnosis of cancerous cells based on a unique combination of color differentiation and morphology, by utilizing a proprietary kit containing unique extract and dyes.
Earlier this year, BioLight announced that CellDetect® bladder cancer monitoring had obtained CE Mark, enabling the product to be marketed and sold in Europe. This followed the successful completion of a blinded, multi-center clinical study of CellDetect® in February 2015, which achieved the study's primary endpoint for effectively detecting the recurrence of bladder cancer in subjects with a history of the disease. The CellDetect® bladder cancer test successfully identified cancerous cells in urine samples in patients with a history of the disease, with reported sensitivity of 84.4% and specificity of 82.7% for the study's primary endpoint.
Micromedic plans to submit a Pre-IDE for the Product to the U.S. Food and Drug Administration in H1/2016.
About Bladder Cancer
Bladder cancer is the fourth most prevalent cancer among males in the U.S. and the seventh most prevalent among males worldwide, with nearly 430,000 new cases of the disease diagnosed globally in 2012. The rate of recurrence is the highest of all cancers and ranges from 50% to 80%. According to U.S. clinical guidelines, patients with a history of urinary bladder cancer are required to undergo three to four tests per year to monitor disease recurrence in the first two years immediately following treatment, and one test annually in the years that follow. Because of high recurrence rates, the cost of diagnosing and treating bladder cancer is among the highest of all cancers.
About CellDetect®
Micromedic's CellDetect® technology allows an accurate diagnosis of cancerous and precancerous cells, based on unique combination of color and morphology. The technology may be implemented in screening tests and monitoring tests of disease recurrence in cancer patients after being treated. Micromedic has proven the product's efficacy in diagnosing cervical cancer and bladder cancer in the framework of clinical trials, and estimates that the technology underlying the products may be implemented for use in additional cancer indications. The cervical cancer detection screening diagnostic test kit is in the initial commercial stage and Micromedic recently completed a clinical trial to prove its ability to monitor bladder cancer recurrence. Micromedic believes that the underlying technology may be adapted for other types of cancer as well.
BioLight Announces Joint Investment in IOPtima Subsidiary
PR Newswire BioLight Life Sciences Investments Ltd
TEL-AVIV, Israel, November 25, 2015 /PRNewswire/ --
BioLight Life Sciences Investments (OTCQX: BLGTY, TASE: BOLT) ("BioLight" or the "Company"), a company focused primarily on the discovery, development and commercialization of breakthrough ophthalmic diagnostics and therapeutics, announced today that it has entered into a joint financing agreement (the "Agreement") with two Asia-based venture capital firms (the "New Investors"), pursuant to which BioLight and the New Investors will make a direct equity investment in BioLight's IOPtima Ltd. subsidiary ("IOPtima") via a private placement. The financing will help IOPtima to continue the global commercialization of its innovative IOPtimate™ system used in the treatment of glaucoma, as well as to initiate a regulatory approval pathway process for the IOPtimate™ system with the U.S. Food and Drug Administration, commencing 2016.
Under the terms of the agreement, the New Investors and BioLight will invest an aggregate amount of US$6.0 million and US$1.2 million, respectively. The investments are being made on the basis of a US$13.5 million pre-money valuation for IOPtima. Upon completion of the private placement, BioLight will hold approximately 71% of IOPtima's issued and outstanding shares. The Agreement also stipulates that the New Investors will have the right to trigger a "drag along mechanism" and other protective provisions if IOPtima fails to reach certain pre-stipulated revenue and regulatory milestones. The private placement is expected to close within the next few weeks, subject to standard closing terms.
IOPtima is a developer of minimally invasive surgical ophthalmic devices. The company's flagship product, IOPtiMateTM, is based on CO2 laser technology that enables the performance of a unique filtration surgery to treat glaucoma without penetrating the inner part of the eyeball. The IOPtiMate procedure provides high efficacy and allows for substantial reductions in post-operative complications and use of eye drops compared with alternatives. Recent marketing efforts by IOPtima have resulted in first sales of IOPtiMate™ in Hong Kong, Poland, Hungary, Romania and Peru, with distribution agreements also being negotiated in additional countries.
"We are excited to have signed this IOPtima financing deal, which will allow us to secure the financial resources needed to maximize IOPtima™'s commercial potential," commented BioLight's Chief Executive Officer, Suzana Nahum Zilberberg. "Interest in IOPtiMate™ and its clinical benefits continues to spread amongst clinicians, patients and payers around the world, and this investment will allow us to continue to drive global awareness and commercialization of this innovative surgical system."
This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.
About BioLight Life Sciences Ltd.
BioLight's ophthalmic product offering and pipeline of product candidates include IOPtiMate™, a laser-based non-invasive surgical treatment for glaucoma; TeaRx™, a point-of-care multi-parameter diagnostic test for dry eye syndrome; Eye-D®, a controlled release drug-delivery insert platform and OphRx's LLC, a non-invasive topical drug delivery technology administered through eye drops as an alternative to the current ocular delivery modalities; BioLight has also invested in biomedical innovations in cancer diagnostics, including proprietary tests that are designated for bladder, cervical, multiple myeloma and other cancers.
Leading key investors are Mr. Israel Makov, Chairman of Sun Pharmaceuticals, former CEO and President of Teva Pharmaceuticals and former Chairman of Given Imaging, Mr. Dilip Shanghvi, founder of Sun Pharmaceuticals, India's largest pharmaceutical company, and Mr. Dan Oren, founder and CEO of Dexcel Pharma, the second-largest pharmaceutical manufacturer in Israel and Rock-One, an Hong Kong-based investment company.
For more information please visit the Company's website at http://www.bio-light.co.il.
CONTACTS:
BioLight
Itai Bar-Natan, CFO
Email: itai@bio-light.co.il
Tel: +972-73-2753400
BioLight’s Eye-D Technology to be Featured at the 5th Annual Partnership Opportunities in Drug Delivery Conference in Boston
PR Newswire BioLight Life Sciences Investments
TEL-AVIV, Israel, September 24, 2015 /PRNewswire/ --
BioLight Life Sciences Investments (OTCQX: BLGTY, TASE: BOLT) ("BioLight" or the "Company"), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that its Eye-D platform insert will be presented at the 5th Annual Partnership Opportunities in Drug Delivery ("PODD") conference on Monday, October 5, 2015 at 2:00 p.m. Eastern Time at the Boston Intercontinental Hotel in Boston, MA.
The Eye-D is BioLight's platform insert for controlled release ophthalmic medications. The Eye-D is designed to address the known poor compliance of eye drops administration. The first Eye-D indication, the VS-101, contains the market leading glaucoma drug, latanoprost (Pfizer Inc.'s Xalatan®). Utilizing a simple in-office procedure, the VS-101 is intended to release prostaglandin analog (PGA) drug in a controlled manner over time, providing 100% patient compliance to drug therapy.
PODD 2015 seeks to foster a meeting place that inspires innovation and advancement of drug development and delivery as well as providing support for the leaders behind the movement. For more information on the conference, please visit http://theconferenceforum.org/conferences/partners-in-drug-delivery/agenda/.
Valuation
Several catalysts in the pipeline have the potential to drive up shareholder value. IOPtiMate systems have yet to be fully launched in Europe. We anticipate a significant increase in system/procedure sales in 2015 and 2016 as demand grows for state-of-the-art technologies in glaucoma surgery. We are looking forward to the results from the clinical trials employing the TeaRx and EyeD technology. OphRx’s molecule, a nascent-stage product in the pipeline could be a potential source of revenue in the long term.
We believe in BioLight’s strategy of diversifying its portfolio, particularly in ophthalmology. We continue to like the story as the company continues to execute its growth strategy. We maintain our Buy rating.
BLGTY: Update On Second Quarter 2015 Financial Results, BioLight Poised For Growth
Zacks Small Cap Research By Zacks Small Cap Research
By Anita Dushyanth, PhD
OTC:BLGTY
Financial Update
For the three months ended June 30, 2015 BioLight's (BLGTY) revenues were $86k, mostly from the sales of IOPtiMate systems. R&D expenditure amounted to $1.05 million, 40% more than estimated. SG&A expenses, comprising of salaries, PR and IR activity in capital markets in Israel and abroad, marketing and business development, and training sessions in medical centers, came in at around $1 million for the second quarter, which was in-line with our estimates. The net loss for the second quarter of 2015 was approximately $2.3 million vs. $3.4 million in Q2 2014. EPS for Q2 2015 came in at ($0.039).
At the end of the second quarter, BioLight’s cash and short-term deposits amounted to $11.4 million. The strong balance sheet resulted from the company’s capital raise during May 2015.
We continue to look for revenue to show meaningful acceleration in the coming quarters. The company anticipates spending heavily on marketing as they near the launch of the CellDetect diagnostic kit for bladder cancer. We continue to expect that regulatory and clinical trial activities will increase BioLight’s OpEx. We expect the current cash balance of ~$11 million to be sufficient to carry the company through 2017.
Operational Update
During the second quarter of 2015 BioLight signed a strategic partnership with Rock-One International Holdings Ltd. to help maximize its presence within China. Rock-One has a history of successful international collaborations and vast experience and understanding of China’s unique regulatory requirements. As China is the second largest healthcare market in the world after the U.S., and since Rock-One has a reliable domestic distribution and service infrastructure within China, the partnership with Rock-One should help BioLight expand their reach within the country.
In July, with shareholder’s approval, the company announced the changes in ADS conversion ratio. A 1-for-10 reverse split of its ordinary shares, where one ADS represents ten shares.
Product development pipeline…
…IOPtiMate…
To-date, BioLight has installed the IOPtiMate system in healthcare centers in Thailand, Italy, Eastern Europe (Poland, Hungary, and Romania), Turkey, Hong Kong, and China as they sported favorable market dynamics and insurance reimbursement. In August 2015, one system was sold in Peru, following which the company is negotiating additional distribution agreements in South and Central America. BioLight generates revenues for IOPtiMate systems from two channels; from initial sales of the device as well as from the fees customers pay for each procedure they perform using the system.
During the second quarter, BioLight announced their first commercial sales of IOPtiMate system in Hungary as well as in Romania. It was the first sale in Romania using the pay-per-procedure model. Physician adoption is a major driver of revenue for new technologies, and thus far, sales have been nominal as the IOPtiMate systems are still largely in an evaluation stage. As physicians share their clinical experience, we expect adoption and utilization to increase gradually. Since the IOPtiMate system already has a CE Mark, the company is continuing its efforts to accelerate sales in the European Union.
In March 2014, the China Food and Drug Administration (CFDA) approved the marketing and sale of the IOPtiMate system in that country. The devices that were installed in a few medical centers across the country the past year are currently undergoing clinical evaluation. BioLight intends to use the Chinese market as an anchor to enter additional developing Asian territories, such as India, which could be an additional long-term revenue catalyst. BioLight is pursuing regulatory approval in Canada and is in search of a partner in the U.S. to market their device. We see these regions as having potential to meaningfully drive up sales of the IOPtiMate systems.
Clinical trials in the U.S. (Phase I/IIa) involving the EyeD technology are currently underway. While conducting the trials in humans with the prototype (EyeD) device, the R&D team gathered an initial base of clinical experience. Due to a slower than expected enrollment rate and optimizations of the insert’s structure and its insertion procedures the results of the clinical trials are expected during the first half of 2016.
…TeaRx…
In February 2015, the company reported clinical study findings that identified positive statistical correlations between the TeaRx test's diagnostic parameters and widely used benchmark tests for dry eye syndrome (DES). BioLight has initiated a second clinical trial in order to assess the effectiveness of the tests in tears of healthy subjects as well as patients with severe DES. The enrollment of subjects for the trial was completed at beginning of Q3 2015 and the results from this second trial are expected by end of Q3 2015. The process of defining the reliable combination of parameters that are required for the DES diagnostic kit is underway. BioLight will then initiate regulatory approval activities.
In mid-June 2015, BioLight announced their collaboration with Ora Inc., a world-leading independent, full-service ophthalmic contract research organization (CRO) and product development firm, to aid in the commercial development of TeaRx. The two companies have agreed to fund the clinical study and other activities required to obtain U.S. 510K regulatory approval for TeaRx as well as to incorporate the test kit in other clinical trials sponsored by third parties and performed by Ora.
…OphRx…
OphRx offers a unique drug delivery technology that is based on the principle of molecular transport across cell membranes using liquid crystals. The technology creates a basis to load different molecules and release them in a controlled mechanism to the target location. BioLight believes that this technology could be utilized for ophthalmic drug delivery for front and/or back of the eye diseases. The company is currently working on developing a novel formulation for the molecule that is most effective to deliver the correct dose, follows a predictive route, and releases the drug, either in a controlled or sustained pattern, according to the pathophysiology and course of the targeted ophthalmic disease. Once the formulation is completed, management anticipates commencing pre-clinical trials.
…CellDetect…
A large unmet need exists in the U.S. and Europe for non-invasive screening of bladder/cervical cancer. Studies have shown the incidence/mortality rates as well as the costs associated with the disease detection to be high.
Bladder Cancer - Management reported successful results from their blinded, multi-center clinical study using the CellDetect technology. The primary endpoint of effectively detecting the recurrence of bladder cancer in subjects with a history of the disease was achieved. BioLight is pursuing an Israeli AMAR approval, pending which the company hopes to launch in Israel by Q1 2016. The company is now focused on building awareness of the product to facilitate broader roll-out in Europe using distribution agreements in CE Mark territories. Eventually, the long-term goal is to initiate discussions with the FDA for an approval to market the product in the U.S.
Cervical Cancer - Proof of concept has been completed for cervical cancer detection and identification using the CellDetect kit. CE Marking was granted for marketing CellDetect in Europe and Israeli Ministry of Health approved the marketing of CellDetect in Israel. The product also received CFDA approval for marketing in China. BioLight is scouting for possible distribution channels in China and India to commercialize the CellDetect technology for the detection of cervical cancer. The company is also actively pursuing strategies to accelerate sales with their existing distributors in other geographical regions.
In July, the U.S. and European patent office issued patent for the CellDetect technology, intended to identify cervical cancer cells, which will be in effect until 2027.
…BRONJ…
BRONJ is a severe side effect from the use of biophosphonate drugs, prescribed to metastatic cancer patients and osteoporosis patients, causing necrosis of the maxillary bone. This side effect has a prevalence rate of up to 18.6% among multiple myeloma patients, 1.2-12% among breast cancer patients, 6.5-7% among prostate cancer patients and up to 0.1% among osteoporosis patients treated orally. Over 15 million prescriptions for biophosphonates, administered orally or by way of infusion, are issued in the U.S. alone.
At Tel Hashomer Medical Center, Israel, a study was conducted to identify the unique genetic profile that enables the assessment of risk among cancer patients to develop BRONJ and results were reported in May 2014. In order to validate the findings from this study, another trial was performed at the Florida University in the U.S., and at the Tel Hashomer Medical Center, Israel, using diverse patient populations from the U.S., Europe, and Israel. The trial involved 125 subjects who were treated with bisphosphonate drugs, of which 108 were multiple myeloma patients, 13 were breast cancer patients, and four were patients suffering from other cancers. Of the total number of subjects, 69 patients developed BRONJ and the remaining 56 did not. In August 2015, the company announced that they are developing a novel SNP assay (licensed technology from the University of Florida) to detect individuals, with a unique genetic profile, who are 10 times more susceptible to develop BRONJ. Eventually, the company anticipates developing a test kit that will allow categorizing the risk of developing BRONJ in patients who are treated for cancer.
Valuation
Several catalysts in the pipeline have the potential to drive up shareholder value. IOPtiMate systems have yet to be fully launched in Europe. We anticipate a significant increase in system/procedure sales in 2015 and 2016 as demand grows for state-of-the-art technologies in glaucoma surgery. We are looking forward to the results from the clinical trials employing the TeaRx and EyeD technology. OphRx’s molecule, a nascent-stage product in the pipeline could be a potential source of revenue in the long term.
We believe in BioLight’s strategy of diversifying its portfolio, particularly in ophthalmology. We continue to like the story as the company continues to execute its growth strategy. We maintain our Buy rating.
Presentations to Highlight BioLight's IOPtiMate System at Upcoming European Ophthalmology Conferences
TEL-AVIV, Israel, September 2, 2015 /PRNewswire/ --
BioLight Life Sciences Investments (OTCQX: BLGTY, TASE: BOLT) ("BioLight" or the "Company"), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that presentations highlighting its IOPtiMate™ system for the treatment of glaucoma will be delivered at the Ophthalmology Futures European Forum and the XXXIII Congress of the European Society of Cataract & Refractive Surgeons ("ESCRS"), both taking place in the coming days in Barcelona, Spain.
The IOPtiMate[TM] system is based on CO2 laser technology that enables the performance of a unique filtration surgery to treat glaucoma without penetrating the inner part of the eyeball, thus allowing for substantial reductions in post-operative complications and use of eye drops compared with alternatives.
Presentation Details
"Why CLASS Should be the Gold Standard in Glaucoma Surgery"
Mr. Ronen Castro, CEO, IOPtima Ltd.
Ophthalmology Futures European Forum
Fairmont Rey Juan Carlos 1 Hotel, Barcelona
September 3, 2015 at 2:01 p.m.
"Phacoemulsification of CLASS Short-term Results"
Professor E. Wylegala, Head of the Department of Ophthalmology, OSK Hospital Katowice
Congress of the ESCRS
Fira Gran Via, Barcelona
September 5, 2015 at 8:30 a.m.
"Five Years Follow-up of CLASS in Open-angle Glaucoma Patients"
Professor N. Geffen, Department of Ophthalmology, Meir Medical Center
Congress of the ESCRS
Fira Gran Via, Barcelona
September 7, 2015 at 8:00 a.m.
"As interest in the clinical benefits of IOPtiMate[TM] grows, it is important that we continue to drive awareness and acceptance of this unique surgical system amongst researchers, regulators and clinicians through presentations at important meetings like these," commented BioLight's Chief Executive Officer, Suzana Nahum Zilberberg.
BioLight Life Sciences Investments reports operational and financial results for Q2 2015
Published on September 1, 2015 at 8:22 AM ·
BioLight Life Sciences Investments (OTCQX: BLGTY, TASE: BOLT) ("BioLight" or the "Company"), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, today reported operational and financial results for the second quarter ended June 30, 2015.
Operational Highlights:
Completed an upsized private investment and signed a strategic partnership with Rock-One International Holdings Ltd. designed to help BioLight maximize its presence within China, the second largest healthcare market in the world after the U.S.
Signed a collaboration agreement with Ora, Inc., a world-leading independent, full-service ophthalmic contract research organization and product development firm, pursuant to which the companies will work together to advance the clinical, regulatory and commercial development of its TeaRx™ multi-parameter diagnostic test for dry eye syndrome (DES).
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Reported first IOPtiMate™ System sales in new territories as well as the first sale of the IOPtiMate™ system procedures.
Obtained CE Marking for the CellDetect® non-invasive test for detecting bladder cancer in urine, enabling the product to be marketed and sold in Europe and other territories.
Subsequent to the end of Q2, reported positive clinical study results for the identification of new genetic markers to predict risk of developing BRONJ.
Financial Results:
All dollar amounts are expressed in New Israeli Shekels ("NIS"), with a convenience U.S. dollar translation of NIS amounts provided using the rate of NIS 3.769 to US$1.00, the representative rate of exchange as of June 30, 2015, and results are reported in accordance with International Financial Reporting Standards.
For the three months ended June 30, 2015, BioLight's revenues were NIS 325,000 (US$ 86,000). The net loss for the second quarter of 2015 was approximately NIS 8.4 million (US$ 2.2 million), or NIS 0.10 loss per share, as compared to a net loss of approximately NIS 11.3 million (US$ $3.0 million), or NIS 0.12 loss per share, for Q2-2014.
BioLight ended the second quarter in a strong financial position. As of June 30, 2015, the Company had approximately NIS 43 million (US$ 11.4 million) in cash and short-term deposits.
"BioLight realized important progress during the second quarter, including the completion of strategic partnership agreements and commercial projects that will allow us to expand and grow our presence into new markets and territories," commented BioLight's Chief Executive Officer, Suzana Nahum Zilberberg. "We look forward to updating our stakeholders as we continue to execute our growth strategy and carry this momentum into the second half of the year."
Source:
BioLight Life Sciences Investments Ltd.
BioLight Reports Positive Clinical Study Results for Identifying New Genetic Markers to Predict Risk of Developing BRONJ
TEL AVIV, Israel, August 31, 2015 /PRNewswire/ --
BioLight Life Sciences Investments Ltd. (TASE: BOLT, OTCQX: BLGTY) ("BioLight" or the "Company"), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, today announced that its cancer diagnostics subsidiary, Micromedic Technologies (TASE: MCTC), has identified several new genetic markers with high potential to predict necrosis of the jawbone in patients treated with bisphosphonate drugs and was able to repeat findings from a previous study for one significant marker in a larger and more diversified group tested in a second trial.
The findings are based upon a trial that was designed to validate previous findings from a previous study conducted at the Tel Hashomer Medical Center, Israel, and reported in May 2014. The previous study was designed to identify the unique genetic profile that enables the assessment of risk among cancer patients to develop bisphosphonate-related osteonecrosis of the jaw, or BRONJ. The current trial was performed at the Florida University, USA, and at the Tel Hashomer Medical Center, Israel, using diverse patient populations from the U.S., Europe and Israel. The trial involved 125 samples, of which 108 were multiple myeloma patients, 13 were breast cancer patients, and four were patients suffering from other cancers ,that were treated with bisphosphonate drugs. The trial included 69 cancer patients that developed BRONJ and a control group of 56 cancer patients that didn't develop BRONJ. The trial included paving the genes by using full exome sequencing and bioinformatics analysis method was applied for identifying genetic markers.
Statistical model with the use of six gene markers for the 125 trial subjects, provides sensitivity of 93% among cancer patients that developed BRONJ, and 68% specificity among cancer patients that didn't develop BRONJ. It should be noted that the underlying statistical method that was primarily used for these results is based on a threshold value calculated on the basis of a single set of data that contains an element of overestimation. In order to validate these statistical results, an alternative method, (leave-one-out cross validation) was applied and resulted in sensitivity of 84% and specificity of 68%.
"We believe that these study results represent a significant milestone in the ongoing development of Micromedic's assay for identifying risk in patients to develop BRONJ," commented Susana Nahum Zilberberg, BioLight's Chief Executive Officer. "Based on these positive results, Micromedic intends to pursue strategic partnership opportunities for continuing the clinical and commercial development of the BRONJ assay."
"The approach taken in this study is unique," said Dr. Noam Shomron, Head of the Functional Genomics Laboratory at the Faculty of Medicine, Tel Aviv University. "Employing an algorithm based on a small subset of genes allowed reaching a risk predictor for developing BRONJ. Eventually, using a relatively simple genetic test will allow categorizing the risk of cancer treated patients to develop BRONJ and thus lead to personalized cancer treatment."
Dr. Noam Yarom, Director of the Oral Medicine Clinic at the Sheba Medical Center, Tel-Hashomer, commented, "The study results are highly encouraging as no reliable test for predicting BRONJ exists in the market today. BRONJ is a devastating side effect of bisphosphonates, which often leads to both functional and aesthetical problems that may last for many months, or even years. Currently, there is no effective treatment for this condition and, in many cases, it ultimately leads to jaw surgery. Due to the lack of an appropriate predictive test, all cancer patients that need to be treated with bisphosphonates are required to undergo tooth extraction prior to the initiation of therapy. Moreover, there is a contra indication for dental implant placement in cancer patients receiving bisphosphonates during the term of the therapy and for a few years post-treatment. Thus, a test that could stratify the risk for BRONJ is expected to substantially improve the quality of life for patients requiring bisphosphonates therapy."
About BRONJ
The BRONJ side-effect appears in cancer patients who receive intravenous therapy (approximately 500,000 patients each year) with a prevalence rate of up to 18.6% among multiple myeloma patients, 1.2%-12% among breast cancer patients, 6.5%-7% among prostate cancer patients, and up to 0.1% among osteoporosis patients who receive orally administered treatment (approximately 200 million patients worldwide).
BioLight Announces First IOPtiMate™ System Sale in Peru
TEL AVIV, Israel, August 13, 2015 /PRNewswire via COMTEX/ -- TEL AVIV, Israel, August 13, 2015 /PRNewswire/ --
BioLight Life Sciences Investments Ltd. (TASE: BOLT , OTCQX: BLGTY ) ( " BioLight " or the " Company " ), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, today announced the first sale of the IOPtiMate™ system to a medical center located in Peru.
The IOPtiMate™ system is based on CO2 laser technology that enables the performance of a unique filtration surgery to treat glaucoma without penetrating the inner part of the eyeball, thus allowing for substantial reductions in post-operative complications and use of eye drops compared with alternatives.
Up until recently, the IOPtiMate™ system has been marketed primarily to leading physicians and medical centers in Asia and Europe. These marketing efforts have resulted in recent first sales of the IOPtiMate™ system in Hong Kong, Poland, Hungary and Romania. Moving forward, and in keeping with the Company's focus on markets with unmet needs for better solutions to treat glaucoma, BioLight is now also negotiating additional distribution agreements in South and Central America.
This press release is being made in accordance with BioLight policy of announcing a first sale in a new territory.
BioLight Announces Upcoming Change of ADS Conversion Ratio
PR Newswire BioLight Life Sciences Investments Ltd
TEL-AVIV, Israel, July 23, 2015 /PRNewswire/ --
BioLight Life Sciences Investments (OTCQX: BLGTY, TASE: BOLT) ("BioLight" or the "Company"), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that, in accordance with recently obtained shareholder approval for a 1-for-10 reverse split of its ordinary shares ("Shares"), it will change its American Depositary Share ("ADS") to Share ratio from one (1) ADS representing one hundred (100) Shares to one (1) ADS representing ten (10) Shares, effective August 3, 2015. No action with regard to the ratio change is required from the holders of the ADSs.
About BioLight Life Sciences Ltd.
BioLight invests in, manages and commercializes biomedical innovations grouped around defined medical conditions - ophthalmology and cancer diagnostics. The ophthalmic technologies include IOPtiMate™, a laser-based non-invasive surgical treatment for glaucoma; TeaRx™, a point-of-care multi-parameter diagnostic test for dry eye syndrome; Eye-D®, a controlled release drug-delivery insert platform and a new technology a drug-delivery platform for the improvement of ocular molecule transmission; and OphRx, a drug delivery technology platform for ocular uses. The cancer diagnostic technologies include proprietary tests that are designated for bladder, cervical, multiple myeloma and other cancers.
Leading key investors are Mr. Israel Makov, Chairman of Sun Pharmaceuticals, former CEO and President of Teva Pharmaceuticals and former Chairman of Given Imaging, Mr. Dilip Shanghvi, founder of Sun Pharmaceuticals, India's largest pharmaceutical company, and Mr. Dan Oren, founder and CEO of Dexcel Pharma, the second-largest pharmaceutical manufacturer in Israel.
For more information please visit the Company's website at http://www.bio-light.co.il.
CONTACT:
BioLight
Itai Bar-Natan, CFO
Email: itai@bio-light.co.il
Tel: +972-73-2753400
BioLight's CellDetect test gets CE Mark clearance in Europe
Jun 30 2015, 11:42 ET | About: BioLight Israeli Life ... (BLGTY) | By: Douglas W. House, SA News Editor Contact this editor with comments or a news tip
BioLight Life Sciences Investments (OTCQX:BLGTY) announces CE Mark clearance for its CellDetect non-invasive test for detecting bladder cancer cells in urine.
The CellDirect technology is being developed by BioLight's subsidiary Micromedic Technologies.
The regulatory application process will commence in the U.S. in H1 2016.
BioLight Obtains EU CE Mark for CellDetect® Non-Invasive Test for Detecting Recurrence of Bladder Cancer
Core European Patent Granted For CellDetect®
TEL-AVIV, Israel, June 30, 2015 /PRNewswire/ --
BioLight Life Sciences Investments Ltd. (OTC: BLGTY, TASE:BOLT), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that its CellDetect® non-invasive test for detecting bladder cancer in urine has obtained CE Marking, enabling the product to be marketed and sold in Europe and other territories. The CE marking recognizes the conformity of the CellDetect® non-invasive test for detecting recurrence of bladder cancer in urine with the relevant directive of the European Community. BioLight also announced that the European Patent Office has issued a patent related to the core of the CellDetect® technology. The patent will be in effect until March 2027.
The CellDetect® technology is being developed by Micromedic Technologies (TASE: MCTC), BioLight's cancer diagnostics subsidiary, and allows an accurate diagnosis of cancerous and precancerous cells, based on a unique combination of color and morphology, by utilizing a proprietary kit containing unique extract and dyes.
Earlier this year, a blinded, multi-center clinical study of the CellDetect® non-invasive test for detecting recurrence of bladder cancer in urine, successfully achieved the study's primary endpoint for effectively detecting the recurrence of bladder cancer in subjects with a history of the disease. The CellDetect® bladder cancer test successfully identified cancerous cells in urine samples in patients with a history of the disease, with reported sensitivity of 84.4% and specificity of 82.7% for the study's primary endpoint.
Micromedic plans to submit a Pre-IDE for the Product to the U.S. Food and Drug Administration in H1/2016.
"This CE Mark approval for the CellDetect® bladder cancer test represents an important commercial milestone," said BioLight's Chief Executive Officer, Suzana Nahum Zilberberg. "Of the estimated 430,000 new cases of bladder cancer occurring worldwide in 2012, approximately 151,000, or 35%, were in Europe according to Cancer Research UK. There is a clear and urgent need for improved diagnostics in this important market, and we believe the CellDetect® technology answers that call, as well as the potential for diagnosing additional cancer indications."
About Bladder Cancer
Bladder cancer is the fourth most prevalent cancer among males in the U.S. and the seventh most prevalent among males worldwide, with nearly 430,000 new cases of the disease diagnosed globally in 2012. The rate of recurrence is the highest of all cancers and ranges from 50% to 80%. According to U.S. clinical guidelines, patients with a history of urinary bladder cancer are required to undergo three to four tests per year to monitor disease recurrence in the first two years immediately following treatment, and one test annually in the years that follow. Because of high recurrence rates, the cost of diagnosing and treating bladder cancer is among the highest of all cancers.
About CellDetect®
Micromedic's CellDetect® technology allows an accurate diagnosis of cancerous and precancerous cells, based on unique combination of color and morphology. The technology may be implemented in screening tests and monitoring tests of disease recurrence in cancer patients after being treated. Micromedic has proven the product's efficacy in diagnosing cervical cancer and bladder cancer in the framework of clinical trials, and estimates that the technology underlying the products may be implemented for use in additional cancer indications. The cervical cancer detection screening diagnostic test kit is in the initial commercial stage and Micromedic recently completed a clinical trial to prove its ability to monitor bladder cancer recurrence. Micromedic believes that the underlying technology may be adapted for other types of cancer as well.
BioLight Announces Collaboration With Ora, Inc. for TeaRx™ Multi-Parameter Diagnostic Test for Dry Eye Syndrome
TEL-AVIV, Israel, June 15, 2015 /PRNewswire/ --
BioLight Life Sciences Investments (OTCQX: BLGTY, TASE:BOLT) ("BioLight" or the "Company"), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, today announced that it has expanded its relationship with Ora, Inc., a world-leading independent, full-service ophthalmic contract research organization and product development firm, via the signing of a Collaboration Agreement (the "Agreement") pursuant to which the companies will work together to advance the clinical, regulatory and commercial development of BioLight's TeaRx™ multi-parameter diagnostic test for dry eye syndrome ("DES").
While financial terms were not disclosed, BioLight advised that, in accordance with the Agreement, it and Ora will jointly fund the clinical study and other activities required to obtain US 510K regulatory approval for the TeaRx™ multi-parameter diagnostic test for DES. BioLight also granted Ora the right to incorporate the TeaRx™ test in other clinical trials sponsored by third parties and performed by Ora.
"We are proud to be working with a world-leading organization like Ora and are confident that, with their support, we will be able to maximize the TearRX™ opportunity. This collaboration represents a vote of confidence in our TeaRx™ multi-parameter diagnostic test as a novel solution for pharmaceutical companies that will succefuly enble and lead to the development of new therapies to treat the DES, as well as additional companion diagnostic tools," commented BioLight's Chief Executive Officer, Suzana Nahum Zilberberg.
"While there have been a number of advances in our understanding of DES over the past few decades, there is no question that significant unmet medical need remains," said Ora's Vice President, Dry Eye, George Ousler. "TeaRx™ is a simple, accurate and objective test that can not only help identify those suffering from DES, but also the underlying causes of their disease. As such, we believe it has great potential in both the companion diagnostics and research tool markets."
BioLight Reports First Quarter 2015 Financial Results
TEL-AVIV, Israel, June 1, 2015 /PRNewswire/ --
BioLight Life Sciences Investments (OTCQX: BLGTY, TASE: BOLT) ("BioLight" or the "Company"), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, today reported operational and financial results for the first quarter ended March 31, 2015.
Operational Highlights:
Reported clinical study findings that identified positive statistical correlations between the TeaRx™ test's diagnostic parameters and widely used benchmark tests for dry eye syndrome.
Reported that a blinded, multi-center clinical study of the CellDetect® non-invasive test for detecting bladder cancer in urine successfully achieved its primary endpoint for effectively detecting the recurrence of bladder cancer in subjects with a history of the disease.
Completed an investment in OphRx, a newly-formed ophthalmic company that has in-licensed a drug-delivery platform that has the potential to enable more efficient and safer delivery of eye drops.
Announced first IOPtiMate™ System sales in new territories as well as, subsequent to the end of Q1, the first sale of the IOPtiMate™ system procedures.
Subsequent to the end of Q1, signed a strategic partnership with Rock-One International Holdings Ltd., designed to help BioLight maximize its presence within China, the second largest healthcare market in the world after the U.S.
Financial Results:
All dollar amounts are expressed in New Israeli Shekels ("NIS"), with a convenience U.S. dollar translation of NIS amounts provided using the rate of NIS 3.981 to US$1.00, the representative rate of exchange as of March 31, 2015, and results are reported in accordance with International Financial Reporting Standards.
For the three months ended March 31, 2015, BioLight's revenues were NIS 157,000 (US$ 39,000). The net loss for the first quarter of 2015 was approximately NIS 6.6 million (US$ 1.7 million), or NIS 0.01 loss per share, as compared to a net loss of approximately NIS 7.8 million (US$ $2.0 million), or NIS 0.02 loss per share, for Q1-2014.
BioLight ended the first quarter in a strong financial position. As of March 31, 2015, the Company had approximately NIS 23.9 million (US$ 6.0 million) in cash and short-term deposits, which did not include the approximately NIS 26.3 million (US$ 6.6 million) in funds raised through an upsized private placement in May 2015 as part of a new strategic partnership.
"We made progress on multiple fronts in the first quarter toward advancing the clinical and commercial development of both our ophthalmic and cancer diagnostics portfolios," commented BioLight's Chief Executive Officer, Suzana Nahum Zilberberg. "As the execution of our growth strategy continues through the year, we look forward to updating our stakeholders as events unfold."
The Company's financial statements and management's discussion and analysis are available on the Company's website at http://www.bio-light.co.il and on the OTCQX website at http://www.otcmarkets.com/stock/BLGTY/filings.
I have very high hopes for this
company, and it seems i am not
the only one!
BioLight Announces Closing of Upsized US$6.6 Million Private Placement
TEL-AVIV, Israel, May 12, 2015 /PRNewswire/ --
BioLight Life Sciences Investments (OTCQX: BLGTY, TASE: BOLT), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that it has completed an upsized private placement as part of the strategic partnership with Rock-One International Holdings Ltd for aggregate gross proceeds of US$6.6 million.
The strategic partnership along with the private placement was previously announced on April 2, 2015. The offering resulted in the issuance of ordinary shares to Rock-One, which account for approximately 19% of BioLight's issued and outstanding shares. Rock-One's equity investment is approximately $6.25 million, a 12% premium over the average closing price of BioLight shares in the 30-days prior to signing the investment agreement.
BioLight also announced that a new private investor participated in the private placement with the same terms in the amount of $350,000.
This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.
About Rock-One International Holdings Ltd.
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Rock-One is a Hong Kong corporation with offices in Hong Kong and Macau. The company is involved with different investments in Greater China and North America, including real-estate development and construction, internet technology, agriculture, healthcare and bio-med. Patrick Lau is the founder and CEO of Rock-One.
About BioLight Life Sciences Ltd.
BioLight invests in, manages and commercializes biomedical innovations grouped around defined medical conditions - ophthalmology and cancer diagnostics. The ophthalmic technologies include IOPtiMate™, a laser-based non-invasive surgical treatment for glaucoma; TeaRxTM, a point-of-care multi-parameter diagnostic test for dry-eye syndrome; Eye-D®, a controlled release drug-delivery insert platform and a new technology a drug-delivery platform for the improvement of ocular molecule transmission; and OphRx, a drug delivery technology platform for ocular uses. The cancer diagnostic technologies include proprietary tests that are designated for bladder, cervical, multiple myeloma and other cancers.
Leading key investors, holding about 36% of BioLight's issued and outstanding shares, are Mr. Israel Makov, Chairman of Sun Pharmaceuticals, former CEO and President of Teva Pharmaceuticals and former Chairman of Given Imaging, Mr. Dilip Shanghvi, founder of Sun Pharmaceuticals, India's largest pharmaceutical company, and Mr. Dan Oren, founder and CEO of Dexcel Pharma, the second-largest pharmaceutical manufacturer in Israel.
For more information please visit the Company's website at http://www.bio-light.co.il.
CONTACTS:
BioLight
Itai Bar-Natan, CFO
Email: itai@bio-light.co.il
Tel: +972-73-2753400
BioLight Announces First IOPtiMate™ System Sale in Hungary
PR Newswire BioLight Life Sciences Investments Ltd.
TEL AVIV, Israel, April 13, 2015 /PRNewswire/ --
BioLight Life Sciences Investments Ltd. (TASE: BOLT)(OTCQX: BLGTY), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, today announced the first sale of the IOPtiMate™ system to a medical center located in Hungary.
The IOPtiMate™ system is based on CO2 laser technology that enables the performance of a unique filtration surgery to treat glaucoma without penetrating the inner part of the eyeball, thus allowing for substantial reductions in post-operative complications and use of eye drops compared with alternatives.
"We are pleased that a medical center in Hungary has selected the IOPtiMate™ system as its glaucoma surgery solution and believe that this provides further validation of this unique technology from the ophthalmology community," said Suzana Nahum-Zilberberg, BioLight's chief executive officer. "Recent first sales in Hong Kong and Poland, additional distribution agreements in new territories for the IOPtiMate™ system and its launch in China, further demonstrates our ability to become a truly global player in this marketplace."
The sale of the first system in Hungary is a result of a marketing campaign to leading physicians and medical centers mainly in Asia and Europe for the IOPtiMate™ system as part of the company's focus on markets with unmet needs for better solutions to treat glaucoma. These marketing efforts have recently resulted in first sales of the IOPtiMate™ system in Hong Kong and Poland, as well as distribution agreements in Peru and Belarus.
BioLight recently announced a strategic partnership agreement with Rock-One International Holdings Ltd. The agreement will help BioLight maximize its presence in the Chinese market, the second largest healthcare market in the world after the U.S.
Rock-One International of Hong Kong partnered with BioLight Israeli Life Sciences (TASE: BOLT; OTCQX:BLGTY), an Israeli medical device company, to commercialize BioLight devices for ophthalmology and oncology in China (see story). As part of the deal, Rock-One invested $6.2 million in BioLight, buying a 19% stake in the company, paying a 12% premium to the 30-day average closing price. In addition, the two companies will form a manufacturing JV, which will be financially supported entirely by Rock-One, to make BioLight devices in China for the China market.
BioLight: Developments Are Chugging Along Smoothly
Apr. 8, 2015 12:11 PM ET | About: BioLight Israeli Life Sciences Investments Ltd. ADR (BLGTY)
Anita Dushyanth, Zacks (disclaimer) (39 clicks)
Research analyst
Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)
Summary
On April 1, 2015, BioLight reported their financials for the fiscal year ending Dec 31, 2014.
On April 2, 2015, Hong Kong based company, Rock-One International Holdings Ltd., has committed to invest $6.2M in BioLight's products.
BioLight’s development plans are on track and there are several catalysts expected in subsequent quarters of 2015.
We continue to remain highly positive on BioLight and are maintaining our Buy recommendation and $14.00/share price target.
2014 Annual Earnings review
On April 1, 2015, BioLight (OTCQX:BLGTY) reported their financials for the fiscal year ending Dec 31, 2014. The company showed minimal revenues for the year, as expected. The net loss was ~$10M, ($0.02) per share as compared to a loss of $5.8M, ($0.017) per share in 2013. Of the total loss for the year ending 2014, R&D expenses amounted to $4.6M and SG&A amounted to $3M. The company burned ~ $7.0 million in cash from operating activities in 2014. The company exited December 31, 2014, with $10.0 million in total assets, of which $5.5M is in the form of cash and cash equivalents.
Management has provided some guidance on their operations for 2015. To accomplish near-term milestones for the projects under the ophthalmology division, management expects R&D expense of approximately $3.0 million. We think the company's current cash position should be sufficient to fund its operations until 2016. On April 2, 2015, the company announced that Hong Kong-based Rock-One International Holdings Ltd. committed to invest $6.2M to seed the acceleration of BioLight's products in mainland China. The company expects to obtain the funds approximately one month after the standard procedures are completed for closing the deal. We expect this should provide sufficient funding to carry BioLight through 2017. BioLight's development plans are on track and there are several catalysts expected in subsequent quarters of 2015.
Ophthalmology Division
In addition to the existing ophthalmologic companies, which include IOPtima (CO2 laser to treat glaucoma non-invasively), ViSci (sub-conjunctival insert for ophthalmic medications), and DiagnosTear (diagnostic kit to test tear fluid), BioLight obtained a 40% stake in OphRx Ltd. in January 2015, a new company that is involved in developing an ophthalmic drug delivery platform to treat eye diseases. OphRx offers a unique drug delivery technology that is based on the principle of molecular transport across cell membranes using liquid crystals. The technology creates a basis to load different molecules and release them in a controlled release mechanism in the target location. The company believes that this technology could be utilized for ophthalmic drug delivery for front and/or back of the eye diseases. BioLight has committed to invest about $250,000 initially for establishment costs and may invest up to $1.0 million as the new company develops the technology and achieves targeted milestones.
Since commercialization of the laser assisted glaucoma surgery device, the IOPtimate system, was focused on Asian and European markets, BioLight commenced sale of these devices in 2014 in China, Hong Kong and Europe. During the initial roll out period, training and educating physicians on the equipment's usage has been time consuming and has resulted in slower adoption. However, as clinical evidence has already proven the technology's efficiency and superiority to existing procedures, we feel an increase in widespread market adoption will happen over time. Additionally, the current agreement with Rock-One Holdings may help in steepening the revenue curve, as there is a large upward swing in the need for emerging technologies in the Chinese market. In addition to having distributors in China, management has also recruited a local sales person in that country to provide additional support with sales and service. Although the company has postponed product launch in other geographic locations (Mexico, India), the distribution agreements in these countries remain intact. Regulatory approval required to market the system in Canada is expected sometime mid-2015. We estimate revenue from the Canadian market in three years' time of approximately $1.5M. The company installed a pilot system in Thailand, Turkey and Italy and hopes to enter into a distribution agreement by the end of 2015. BioLight is also seeking to form an alliance with a local partner here in the U.S. to obtain regulatory approval for marketing the device.
Phase I/IIa clinical trials on humans employing the EyeD technology are underway in the U.S. In order to test the efficacy of the device, patients need to be medication-free for a 2-week period (known as the wash-out and screen period). During this time, the effect of the prior medication (latanoprost drops) is expected to wear off causing fluctuations in the intra-ocular pressure. At this time if the patient's eye was inserted with the EyeD, then its efficacy would be proven. However, unforeseen delays were encountered during these trials as the wash-out period turned out to be more than 2 weeks. The effect of the latanoprost drops did not appear to wear off even after 6 weeks of discontinuing the medication. As a result, the recruitment of trial participants is now expected to be completed in the second half of 2015. This is about one quarter behind schedule than previously estimated. While the slight delay is disappointing, what is important is that it is unrelated to the technology and management still hopes to complete the trial on time.
Cancer Diagnostics Division
Under the cancer diagnostics division, BioLight is involved in the development and commercialization of the CellDetect technology, a diagnostic technology for staining and identifying cancerous and precancerous cells in several cancer indications. BioLight is also engaged in the recruitment of strategic partners for the continued development of a novel diagnostic kit for identification of carriers of BRCA mutations that increase the risk of developing breast and ovarian cancer as well as for the completion of development and commercialization of a diagnostic kit for early detection of colorectal cancer in blood tests.
CellDetect Cervical Cancer diagnostic kit: Proof of concept has been completed for cervical cancer cell detection and identification kit. CE marking was granted for marketing CellDetect as a supplementary product in Europe. The department of medical devices and accessories at Israeli Ministry of Health approved the marketing of CellDetect as a supplementary product in Israel. The product also received the CFDA approval for marketing in China. The company anticipates to launch the product in China in 2Q 2015.
CellDetect Bladder cancer diagnostic kit - BioLight completed the development of the kit for monitoring the recurrence of bladder cancer in early 2015. The company is considering developing this technology for other cancer indications. Proof of concept for identifying bladder cancer cells in histological urine samples has been established. The multicenter clinical trial for proof of efficacy of the bladder cancer diagnosis using urine samples has been completed. The company expects CE mark, an approval for sales in the European Union, in 2Q 2015. Pending approval, BioLight expects to sign distribution agreements covering the CE Mark territories and commence launch there in the 4Q/15 or 1Q/16 time frame and expects to approach the FDA to file for clearance in the U.S.
BioLight is currently focused on the development of a test to identify the population at increased risk of developing a side effect from the use of bisphosphonate drugs, BRONJ among multiple myeloma patients. The trials are being conducted at Tel Hashomer with results expected in 2Q 2015. Based on the results, BioLight anticipates the possibility of employing the test to other patients affected by cancer and osteoporosis. In addition, BioLight is engaged in the financing of a NOFAR program researching the prediction of the development of brain metastasis by lung cancer patients.
Valuation
We remain positive on BioLight and believe the company's strategy to focus on developing markets where there is a large subset of population with a growing need for cost-effective treatments may help in building a steady revenue stream. BioLight is making a substantial effort to expand market share in China. The sheer size of the population creates an enormous opportunity for BioLight that could help drive the revenue numbers in one years' time. The sales of IOPtimate systems should be the primary revenue driver for 2015. With the currently acquired funds, BioLight is well established to drive revenue, which we think begins to show a greater rate of acceleration going into 2016. BioLight's manufacturing lab units have ISO accreditation which is the gold standard around the world, and emphasizes the technical and manufacturing competencies. We think gross margins expand with higher production volumes and, coupled with the growing top-line, further improve profitability and cash burn. We continue to remain highly positive on BioLight and are maintaining our Buy recommendation and $14.00/share price target.
Editor's Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.
BioLight Announces Strategic Partnership to Significantly Expand Presence in China
Hong Kong-based Rock-One International Holdings Ltd to Invest $6.2M in BioLight
Companies to form China-based Joint Venture
Rock-One to be responsible for manufacturing, and regulatory activities within China
PR Newswire BioLight Life Sciences Investments Ltd.
TEL-AVIV, Israel, April 2, 2015 /PRNewswire/ -- BioLight Life Sciences Investments Ltd. (OTC: BLGTY, TASE: BOLT), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today an agreement to enter into a strategic partnership with Rock-One International Holdings Ltd., a holding company specializing in investment activities, including in the high tech and biomedical industries. The agreement will help BioLight maximize its presence within the Chinese market, the second largest healthcare market in the world after the U.S.
"We are excited to enter into this strategic partnership with Rock-One. They have built an impressive manufacturing, distribution and sales presence in China that will enable BioLight to maximize sales of our products in the world's second largest economy," noted Susana Nahum Zilberberg, BioLight's Chief Executive Officer. "Rock-One has a history of successful international collaborations and vast experience and understanding of China's unique regulatory requirements. This partnership marks an important milestone for BioLight and should increase our global footprint significantly."
Under the terms of the agreement, BioLight will issue a private placement of ordinary shares to Rock-One, which will account for approximately 19% of BioLight's issued and outstanding shares following the private placement. Rock-One's equity investment will total approximately $6.2 million, a 12% premium over the average closing price of BioLight shares in the 30-days prior to signing the investment agreement.
As part of the strategic partnership, the parties will also form a Joint Venture. The newly formed JV will be fully financed by Rock-One and granted exclusive manufacturing rights for BioLight's products distributed within China. The JV will also promote collaboration between Chinese and Israeli academies to develop future products.
"We are pleased to enter into this strategic partnership with BioLight, a company with an established track record of developing and fostering innovation in medical technology. By combining Rock-One's track record of commercial experience with BioLight's portfolio of exciting healthcare products, we believe that our new joint venture is well-positioned for success in the Chinese market," said Patrick Lau, Founder and CEO of Rock-One.
The agreement is expected to close no later than 40 days from the execution of the agreement, subject to closing terms.
Rock-One International Holdings Ltd. is a Hong Kong corporation with offices in Hong Kong and Macau. The company is involved with different investments in Greater China and North America, including real-estate development and construction, internet technology, agriculture, healthcare and bio-med. Patrick Lau is the founder and CEO of the Company.
About BioLight
BioLight Life Sciences Investments invests in, manages and commercializes biomedical innovations grouped around defined medical conditions - ophthalmology and cancer diagnostics. The ophthalmic technologies include IOPtiMate™, a laser-based non-invasive surgical treatment for glaucoma; TeaRxTM, a point-of-care multi-parameter diagnostic test for dry-eye syndrome; Eye-D®, a controlled release drug-delivery insert platform and a new technology a drug-delivery platform for the improvement of ocular molecule transmission; and OphRx, a drug delivery technology platform for ocular uses. The cancer diagnostic activities include tests that are designated for bladder, cervical, multiple myeloma and other cancers.
Leading key investors, holding about 45% of BioLight's shares, are Mr. Israel Makov, Chairman of Sun Pharmaceuticals, former CEO and President of Teva Pharmaceuticals and former Chairman of Given Imaging, Mr. Dilip Shanghvi, founder of Sun Pharmaceuticals, India's largest pharmaceutical company, and Mr. Dan Oren, founder and CEO of Dexcel Pharma, the second-largest pharmaceutical manufacturer in Israel.
For more information please visit the Company's website at www.bio-light.co.il.
CONTACTS:
BioLight
Itai Bar-Natan, CFO
Email: itai@bio-light.co.il
Tel: +972-73-2753400
BioLight Reports Successful Clinical Study Results for Monitoring Bladder Cancer Recurrence with the CellDetect® Non-Invasive Test
CellDetect® Non-Invasive Test
- Plans to Secure CE Mark for a European Launch of the Non-Invasive Test and Submit a Pre-IDE to the U.S. FDA in 2015 -
TEL-AVIV, Israel, Feb. 2, 2015 /PRNewswire/ -- BioLight Life Sciences Investments Ltd. (OTC: BLGTY, TASE: BOLT), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that a blinded, multi-center clinical study of the CellDetect® non-invasive test for detecting bladder cancer in urine, successfully achieved the study's primary endpoint for effectively detecting the recurrence of bladder cancer in subjects with a history of the disease. The CellDetect® urine test successfully identified cancerous cells in urine samples in patients with a history of the disease, with reported sensitivity of 84.4% and specificity of 82.7% for the study's primary endpoint.
The CellDetect® technology is being developed by Micromedic Technologies (MCTC.TA), BioLight's cancer diagnostics subsidiary, and allows an accurate diagnosis of cancerous and precancerous cells, based on a unique combination of color and morphology by utilizing a proprietary kit containing unique extract and dyes. As a result of these successful study results, Micromedic plans to secure CE mark approval for a European launch of the non-invasive test later this year, as well as to submit a Pre-IDE to the U.S. Food and Drug Administration (FDA).
"We are extremely pleased with these clinical results showing CellDetect's high sensitivity and specificity and believe that they provide a foundation upon which regulatory approval can be secured and be a second indication for use of the CellDetect® technology platform," noted Susana Nahum Zilberberg, BioLight's Chief Executive Officer. "There is a clinical need for a better test for the up to 80 percent of patients with bladder cancer whose cancer recurs, since many of the currently available tests are clinically suboptimal, invasive or expensive. Based on these strong clinical results, we believe that CellDetect® is a promising solution for the millions of patients with bladder cancer, and has the potential for diagnosing additional cancer indications."
The blinded clinical study was conducted in nine medical centers in Israel, where urine samples from 217 subjects with a history of bladder cancer were tested. The study population included 121 healthy subjects and 96 patients currently suffering from the disease.
The results of the CellDetect® urine test were compared with results from biopsy or cystoscopy, in cases where biopsies were not taken. The results also indicated that the CellDetect® urine test's negative predictive value (NPV), defined as the probability that a patient having a negative result doesn't suffer from the disease, was 98.5%. In addition to its high sensitivity for advanced stage tumors and high-grade malignancy, the test was also found to exhibit high sensitivity for early stage tumors and low-grade malignancies, which are difficult to identify using other non-invasive tests currently available on the market. These findings indicate that the method is adequately sensitive for the purpose of accurate and early detection of the recurrence of the disease.
Prof. Ofer Yossepowitch. M.D., Head of the Uro-Oncology Service at Rabin Medical Center: "The study results are encouraging. The accuracy of this novel assay appears to be superior over any available non-invasive test, suggesting a potential to supplant some or all of the cystoscopies required for bladder cancer surveillance. This is indeed great news for patients with history of bladder cancer, which may change their management."
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The secondary endpoint showed that the sensitivity of other non-invasive comparator tests, urine cytology, BTA stat and NMP22 BladderCheck, was 50.0%, 68.8% and 17.4%, respectively. These findings further underscore the potential of the CellDetect® test as an accurate, reliable and a non-invasive tool for monitoring the recurrence of bladder cancer.
Micromedic also plans to utilize reimbursement existing codes for monitoring bladder cancer recurrence and will continue to advance the CellDetect® technology for the diagnosis of additional cancer indications.
BioLight Reports Positive Clinical Study Findings for its TeaRx™ Diagnostic Parameters for Dry Eye Syndrome
Positive statistical correlations were identified between TeaRx™ diagnostic parameters and widely used benchmark tests for dry eye syndrome
TEL-AVIV, Israel, Feb. 2, 2015 /PRNewswire/ -- BioLight Life Sciences Investments Ltd. (OTC: BLGTY, TASE: BOLT), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, today announced the completion of a U.S. clinical study, conducted by Ora, Inc. Andover, MA, designed to compare widely used benchmark tests for dry eye with its TeaRx™ diagnostic parameters that test components of tear film. Positive statistical correlations were identified between TeaRx™ diagnostic parameters and widely used benchmark tests for dry eye syndrome
The TeaRx™ diagnostic tests are developed by DiagnosTear Ltd., one of BioLight's subsidiaries.
In this prospective study consisting of approximately 200 subjects, widely-used benchmark tests for dry eye were compared with the TeaRx™ diagnostic parameters, including Schirmer's test, TFBUT (Tear-Film Break-Up Time), staining of corneal and conjunctival epithelial cell damage and patient questionnaires. The study analysis was based on testing the sample extremes, quartiles 1 and 4, representing those enrolled subjects with largest differences for each metric.
This approach resulted in positive statistical correlations that showed many of the predicted trends and correlations between the widely used benchmark tests and the TeaRx™ diagnostic parameters tests which measure tear film components.
The positive correlation that was identified between certain TeaRx™ diagnostic parameters and subjective testing standards that are widely used today indicates a unique ability for improving the dry eye syndrome diagnosis by objective quantification of measures over subjective evaluation.
Ms. Suzana Nahum-Zilberberg, BioLight's CEO said: "Our TeaRx™ technology's unique approach has the potential to solve the unmet needs for hundreds of millions of patients suffering from dry eye syndrome. The ability to diagnose this complex multi-faceted syndrome, using a point-of-care multi-parameter test which is more evidence-based, is a novel approach, which is aimed to improve the diagnosis and treatment of a large and growing patient population world-wide. In addition, this test has the potential to identify sub-groups of dry eye syndrome patients which could lead to the development of new therapies to treat the syndrome, as well as additional companion diagnostic tools."
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George Ousler, Ora Inc. Vice President, Dry Eye said: "Dry eye is a complex, multifactorial disease, and currently available therapeutics are effective in treating only a small portion of the patient population. The variability that characterizes this disease complicates proper diagnosis and has hindered the development of reliable diagnostic tests. The TeaRx™ Diagnostic is a simple, robust test that identifies patients with one or more of the underlying causes of dry eye. The results of the study showed a high correlation between the test parameters and the signs and symptoms of dry eye – this represents a major advancement in the proper diagnosis of dry eye and provides physicians an efficient approach to selecting treatments for individual patients."
The company plans to initiate a second clinical trial in order to assess the effectiveness of the tests in tears of healthy subjects as well as patients with severe dry eye syndrome, based on the FDA definitions as were used in previous FDA regulatory approval processes for other dry eye syndrome diagnostic products. The trial results are expected in Q2 2015 and should enable the company to specifically define the combination of parameters to be part of a commercially available diagnostic kit and then initiate the regulatory processes for the kit. Assuming the completion of a successful development and regulatory process, BioLight expects to obtain regulatory approvals and launch the multi-parameter test kit in 2016.
About Dry Eye Syndrome
Dry Eye Syndrome is a physiological condition that occurs mainly due to changes in the composition of or reduction in the secretion of tears. Although this condition is not life threatening, it causes a great deal of discomfort and has a detrimental effect on quality of life. A change in any of the multiple parameters in the tear film could indicate a problem that might cause the Syndrome. According to Market Scope there are about 100 million people living with the condition worldwide with various degrees of severity, of which 25 million to 30 million are in the U.S. This number rises every year, and is possibly due to environmental factors such as the use of air conditioners, personal computers and contact lenses.
About BioLight
BioLight Life Sciences Investments invests in, manages and commercializes biomedical innovations grouped around defined medical conditions - ophthalmology and cancer diagnostics. The ophthalmic technologies include IOPtiMate™, a laser-based non-invasive surgical treatment for glaucoma; TeaRx™, a point-of-care multi-parameter diagnostic test for dry-eye syndrome; Eye-D®, a controlled release drug-delivery insert platform and a new technology a drug-delivery platform for the improvement of ocular molecule transmission. The cancer diagnostic activities include tests that are designated for bladder, cervical, multiple myeloma and other cancers.
Leading key investors, holding about 45% of BioLight's shares, are Mr. Israel Makov, Chairman of Sun Pharmaceuticals, former CEO and President of Teva Pharmaceuticals and former Chairman of Given Imaging, Mr. Dilip Shanghvi, founder of Sun Pharmaceuticals, India's largest pharmaceutical company, and Mr. Dan Oren, founder and CEO of Dexcel Pharma, the second-largest pharmaceutical manufacturer in Israel.
For more information please visit the Company's website at www.bio-light.co.il.
CONTACTS:
BioLight
Itai Bar-Natan, CFO (itai@bio-light.co.il)
Tel: +972-73-2753400
Why BioLight Life Sciences' India entry is good news for Dilip Shanghvi
The medium-sized Israeli company specialises in cancer and glaucoma diagnostic products
Digbijay Mishra | New Delhi January 19, 2015 Last Updated at 19:32 IST
After a dream run with the Ranbaxy acquisition, Sun Pharma founder Dilip Shanghvi's fortune seems to be on an uptrend. Israel-based BioLight Life Sciences, in which Shanghvi holds a 21.45 per cent stake, is gearing up for its India foray in the next few months, it is learnt. The medium-sized Israeli company specialises in cancer and glaucoma diagnostic products.
BioLight keen on being present in India and is in discussions with Sun for a possible tie-up, sources said. The Israeli firm is yet to get a nod from the Indian regulator for its commercial entry into the country.
Suzana Nahum-Zilberberg, CEO of BioLight, was recently in India. According to sources, distribution gateway in India was one of Zilberberg's agendas during her visit. She has worked for 12 years at Teva Pharma as vice-president Asia and Pacific, driving Teva's business into Japanese and Chinese markets.
An email questionnaire sent to BioLight and Sun Pharma remained un-answered till the time of going to press.
While a possible arrangement between Sun Pharma and BioLight is yet to be finalised, industry sources say Shanghvi's personal investments have been made keeping in mind the long-term dividends those could offer.
BioLight focuses on investments in small, research-oriented biotech companies. The company has controlling stake in Micromedic Technologies, which has developed a range of cancer diagnostic tools. The other portfolio company is IOPtima, an ophthalmology specialty company. Sun has sizable presence in ophthalmology.
BioLight Announces New Investment in Development of Ophthalmic Drugs
TEL AVIV, Israel, January 12, 2015 /PRNewswire/ --
BioLight Life Sciences Investments Ltd. (OTC: BLGTY, TASE: BOLT), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, today announced its investment in a newly-formed ophthalmic company that has licensed-in a world-wide drug-delivery platform from the Hebrew University, Israel, that has the potential to enable more efficient and safer delivery of eye drops.
This drug-delivery platform will help address improve patient compliance with eye disease drug regimens and will form the basis for possible drug development by the new company targeting diseases affecting both the front and back of the eye.
BioLight will co-manage the new company and will hold 40% equity stake.
Suzana Nahum-Zilberberg, BioLight's chief executive officer, said, "This new investment represents a major step in our goal to expand our ophthalmic portfolio that addresses clear unmet needs in the multibillion dollar ophthalmic drug market. Our experience in the ophthalmic space will definitely contribute to the new company efforts to find the best ways to develop this novel drug delivery technology into a portfolio of new drugs with better efficacy and safety profiles."
Tie-up on cards for Biolight & Sun Pharma?
Sources say Sun Pharma could be one of the companies that Biolight is actively talking to. However, Sun Pharma in a statement to CNBC-TV18 says, “We have no immediate plans to work with them on any collaboration project.” ARCHANA SHUKLA Reporter,
India Business Hour 09:00 pm One of Dilip Shangvi's early personal investments seems to be coming of age. Israeli drug maker Biolight Pharma, in which Shangvi holds a significant stake, is preparing to enter the Indian market. So could an alignment between the Israeli company and Sun Pharma be on the cards? Archana Shukla reports. Its a mid-sized Israeli pharma company that specialises in cancer diagnostics and ophthalmology products. But even before it makes its entry in the Indian market, Biolight Lifesciences already has a deep connect with India. Pharma czar Dilip Shanghvi, founder of the country's most valuable pharma company Sun Pharma, holds over 21 percent in Biolight, an investment made in his personal capacity. The Israeli company is now preparing for a commercial entry in India by launching two of its flagship products - a cervical cancer detection device, and a surgery device for glaucoma. As the company waits for approvals from the Indian drug regulator, it is also actively seeking out local partnerships for a smooth passage to the Indian market. Also read: 2014: Blockbuster year for Sun Pharma's Dilip Shanghvi Suzana Nahum Zilberberg, CEO, Biolight Lifesciences Investments says, “It can be a distributor that has their wide sales force that actually can offer these products to the hospitals or to the laboratories and it can also be a pharmaceutical company that has very strong commercial activities in the market. Currently we are working with two distributors in India to launch the product but we are also in discussions with pharmaceutical companies for wider collaboration.” Sources say Sun Pharma could be one of the companies that Biolight is actively talking to. However, Sun Pharma in a statement to CNBC-TV18 says, “We have no immediate plans to work with them on any collaboration project.” Interestingly, Sun Pharma has a strong presence in ophthalmology, and Biolight's glaucoma product could add strength to sun's existing product portfolio. While a near term collaboration may not be on the cards, one must remember that Shanghvi has had a very clear rationale behind all his investments. As the man himself says, most of his personal investments in start-ups have been made with a view to assist Sun Pharma in the long run. Dilip Shanghvi, MD, Sun Pharmaceuticals had last year said that business needs to be strategically linked to the Sun’s future. There may be product sharing. There has to be some potential benefit for Sun but not in the immediate future. As Biolight prepares for its India splash, it already looking at the next step which will include local manufacturing. The market will be keenly watching to see if the Israeli company can get 'sun' to shine on these future plans.
Read more at: http://www.moneycontrol.com/news/cnbc-tv18-comments/tie-upcards-for-biolightsun-pharma_1266185.html?utm_source=ref_article
Israel-based Biolight Lifesciences to introduce cancer-diagnostics products in India
Archana Aroor, Mumbai
Friday, December 12, 2014, 16:30 Hrs [IST]
Israel-based Biolight Lifesciences Investments Ltd, which develops drugs for weight management and for blocked allergies through its subsidiary companies, sees its potential to introduce its cancer-diagnostics products in India. The company is planning to launch its products in the next couple of months.
"We will be happier to shift our focus from the US, to sell our products to India designated in particular to cervical cancer as we see a huge potential in the Indian market. This is mainly because of the increase in the number of deaths of many women in India due to cervical cancer than in the US," says Suzana Nahum Zilberberg, chief executive officer, Biolight Lifesciences Investments Ltd.
According to reports, Cervical cancer is the leading cause of cancer deaths among women in India, with approximately 1.32 lakh new cases of cervical cancer being diagnosed and about 74,000 deaths occurring annually, accounting for nearly one-third of cervical cancer deaths across the world.
India represents 26.4 per cent of all women dying of cervical cancer globally, with China, Bangladesh, Pakistan, Indonesia and Thailand.
Suzana was one of the panelists at the Seventh India-Israel Innovation Colloquium organised by Confederation of Indian Industry (CII), Ananta Centre and Tel-Aviv University (TAU) under the chairmanship of Israel Makov, Chairman, Sun Pharmaceuticals and S Ramadorai, vice chairman, Tata, Consultancy Services in Mumbai.
Suzana stressed that the process may be slow due to already-existing hurdles in the Indian healthcare segment, such as the regulations, patent etc. However, the company is confident to overlook these areas as they possess CE approvals for their products that would pave a smoother way to cover the market.
Further, she added that the company was yet to draw a new paradigm for investments.
The Colloquium encompassing other panelists namely Bart Janssens, director, The Boston Consulting Group, Dr Hardar Ron, managing partner, Israel Healthcare Ventures, Israel Makov, chairman, Sun Pharmaceuticals, Yishai Potack, sales and BD manager, ReWalkk, Dr Adheet Gogate, senior director and India Head, Philips Healthcare Transformation Services and Zeena Johar, president, IKP Centre for Technologies in Public Health discussed the future of healthcare and the joint -potential to invest in the healthcare segment.
"By developing an intrinsic worth to the relationship based on the natural talents of the two peoples, its future appears assured and seeks the right-set of people to see innovations in the healthcare sector," says Dr Hardon Ron.
Dr Ron highlighted that the in such strange area of healthcare segment, today the trend in the developing and the emerging market was that the people going to doctors office directly was increasing due to the cost-affordable medicines than to the hospitals & clinics. People expect to receive cheaper solutions for the problems. Price is seen as a basic hindrance as the Israeli-technology is expensive to buy for the Indian companies.
"This means that we need to bring-in huge solutions with more collaborations and technology to provide different solutions in the healthcare," adds Dr. Ron.
Another significant challenge raised by the panelists was the cultural and psychological factor as Israel was more global and India was struggling to establish- people-people contact, in particular with rural areas.
Mokov stressed that to meet the ongoing challenges, it was important to create more meeting places to tap the knowledge that the two countries had to offer and to look at the opportunities for investments.
Around 200 delegates from different sectors such as the technology, pharmaceuticals, academics, research attended the Colloquium.
BioLight Announces IOPtiMate™ Distribution Agreement in Hong Kong and Macao
Receives commitment to purchase at least 9 systems in first 3 years
TEL AVIV, Israel, December 8, 2014 /PRNewswire/ --
BioLight Life Sciences Investments Ltd. (OTC: BLGTY, TASE: BOLT), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, today announced the signing of an exclusive distribution agreement for the sale and marketing of the IOPtiMate™ system in Hong Kong and Macao, including the purchase of at least 9 systems during the initial term of the agreement.
The IOPtiMate™ system is based on CO2 laser technology that enables the performance of a unique filtration surgery to treat glaucoma without penetrating the inner part of the eyeball, allowing for substantial reductions in post-operative complications and use of eye drops compared with alternatives.
A leading medical center in Hong Kong recently purchased the IOPtiMate™ system and an additional IOPtiMate™ system has been installed on a trial basis at a second medical center in Hong Kong. BioLight recently began marketing to leading physicians and medical centers in China after receiving approval in March 2014 from the China Food and Drug Administration (CFDA) to market and sell the IOPtiMate™ system.
This distribution agreement in Hong Kong and Macao, along with the distributer commitment to purchase at least 9 IOPtiMate[TM] systems, is the result of an intensive marketing campaign by BioLight in Asia for the IOPtiMate™ system as part of the Company's focus on markets with unmet needs for better solutions to treat glaucoma.
Suzana Nahum-Zilberberg, BioLight's chief executive officer, said, "Entering into a strategic distribution agreement in Hong Kong and Macao is an additional significant advancement in our plan to penetrate developing markets in Asia, where there is no available solution for a large population of patients. Our recent first sale in Hong Kong, additional trial basis installation, regulatory approval and distribution agreement entered into earlier this year in China, as well as marketing activity underway in China and additional Asian countries, represent important progress in establishing a presence in Asian markets."
About glaucoma:
Glaucoma, which creates pressure within the eye and causes damage to the optic nerve that may lead to full or partial blindness, is considered the second most common cause of blindness worldwide. According to estimates commonly accepted in the field, there are now about 67 million people worldwide that suffer from the disease. Glaucoma is usually a chronic disease requiring lifelong treatment, and based on assessments, the global market for drug therapy and surgery is estimated at $4 billion annually.
"We are pleased that this medical center selected the IOPtiMate™ system as its glaucoma surgery solution. This milestone conveys further confidence in our unique technology from the ophthalmology community and, along with our recent first sale in Hong Kong and our launch in China, demonstrates our ability to become a truly global player in this marketplace," said Suzana Nahum-Zilberberg, BioLight's chief executive officer.
BioLight Announces First IOPtiMate™ System Sale in Poland
TEL AVIV, Israel, December 1, 2014 /PRNewswire/ --
BioLight Life Sciences Investments Ltd. (TASE: BOLT, OTCQX: BLGTY), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announces the first sale of an IOPtiMate™ system to a medical center located in Poland following a successful product trial.
The sale of this first system in Poland is the result of the an intensive marketing campaign to leading physicians and medical centers mainly in Asia and also in other selected territories for the IOPtiMate™ system as part of the company's focus on markets with unmet needs for better solutions to treat glaucoma.
"We are pleased that this medical center selected the IOPtiMate™ system as its glaucoma surgery solution. This milestone conveys further confidence in our unique technology from the ophthalmology community and, along with our recent first sale in Hong Kong and our launch in China, demonstrates our ability to become a truly global player in this marketplace," said Suzana Nahum-Zilberberg, BioLight's chief executive officer.
The IOPtiMate™ system is based on CO2 laser technology that enables the performance of a unique filtration surgery to treat glaucoma without penetrating the inner part of the eyeball, thus allowing for substantial reductions in post-operative complications and use of eye drops compared with alternatives.
About Glaucoma:
Glaucoma, which created pressure within the eye causes damage to the optic nerve that may lead to full or partial blindness, is considered the second most common cause of blindness worldwide. According to estimates commonly accepted in the field, there are now about 67 million people worldwide that suffer from the disease. Glaucoma is usually a chronic disease requiring lifelong treatment, and based on assessments, the global market for drug therapy and surgery, is estimated at $4 billion annually.
Merriman Capital Initiates on BioLight Life Sciences Investments Ltd. with a Buy Rating
SAN FRANCISCO - October 30, 2014 - Merriman Capital, Inc. ("Merriman"), a wholly owned subsidiary of Merriman Holdings, Inc. (MERR), announced that it has initiated equity research coverage of BioLight Life Sciences Investments Ltd. (BLGTY) with a Buy rating and a $12.00 price target.
BioLight is an early-stage biomed company led by a blue-chip board and seasoned management team. Headquartered in Tel Aviv, Israel, BioLight Life Sciences Investments Ltd. (www.bio-light.co.il) invests in, manages and commercializes biomedical innovations. The company leverages a unique organizational model: investing in early stage companies with technology solutions grouped around specific medical conditions in order to share key resources, facilitate innovation, and speed time to market. The two current portfolio areas are in ophthalmology and in cancer diagnostics. In March, 2014, BioLight`s Level I ADRs began trading over-the-counter in the U.S. (BLGTY). Each ADR equates to 100 underlying shares, which are traded on the Tel-Aviv Stock Exchange (BOLT.TA) which is the primary Stock Market of BioLight`s shares.
BioLight to Present at the Canaccord Genuity 2014 Medical Technology and Diagnostics Forum
TEL AVIV, Israel, October 22, 2014 /PRNewswire/ --
BioLight Life Sciences Investments Ltd. (TASE: BOLT, OTCQX:BLGTY), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that Suzana Nahum-Zilberberg, CEO, and Itai Bar Natan, CFO, will present at the Canaccord Genuity Medical Technology and Diagnostics Forum at the Westin Grand Central in New York, NY.
The BioLight presentation is scheduled to start at 4 p.m. ET on Thursday, November 20, 2014. Mrs. Nahum-Zilberberg and Mr. Bar Natan will also be available to participate in one-on-one meetings with investors who are registered to attend the conference.
BioLight to Present its IOPtiMate™ System at the Ophthalmology Innovation Summit @ the American Academy of Ophthalmology 2014
PR Newswire BioLight Life Sciences Investments Ltd
TEL AVIV, Israel, October 13, 2014 /PRNewswire/ --
BioLight Life Sciences Investments Ltd.(BOLT.TA)(BLGTY), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that Ronen Castro, CEO of its subsidiary IOPtima Ltd., will present at the OIS@AAO (Ophthalmology Innovation Summit @ the American Academy of Ophthalmology) on Thursday, October 16, 2014, at 10:55 a.m. at the Palmer House Hilton in Chicago, IL.
The IOPtiMate™ system uses CO2 laser technology to perform a unique filtration surgery that treats glaucoma without penetrating the inner part of the eyeball. This innovation reduces post-operative complications and the use of eye drops compared with alternatives.
Zacks Reiterates “Outperform” Rating for BIO-LIGHT ISRAELI (BLGTY)
September 30th, 2014
BIO-LIGHT ISRAELI logoZacks restated their outperform rating on shares of BIO-LIGHT ISRAELI (NASDAQ:BLGTY) in a report released on Tuesday. Zacks currently has a $14.00 price objective on the stock.
Zacks’ analyst wrote, “BioLight Israeli Life Sciences invests in, manages and commercializes biomedical innovations in the field of ophthalmology and cancer diagnostics. The company offers a rich portfolio of products, of which, IOPtiMate , laser surgical device for glaucoma and CellDetect cell staining technology for detecting and monitoring cancer cells, had a soft launch at the beginning of this year BioLight’s products address a large untapped market which provides an attractive investment opportunity. We initiate coverage on BioLight with an outperform rating.”
Merriman Capital Announces Sponsorship of BioLight Life Sciences Investments Ltd. on OTCQX
SAN FRANCISCO - September 23, 2014 - Merriman Capital, Inc., a wholly owned subsidiary of Merriman Holdings, Inc. (MERR), announced today that it will serve as the Principal American Liaison (PAL) for BioLight Life Sciences Investments Ltd. (BLGTY) ("BioLight") as it continues trading on OTCQX®.
OTCQX is the premier tier of the OTC markets. OTCQX traded companies are distinguished from more than 9,000 securities traded Over-the-Counter. These companies meet more stringent financial standards and undergo a qualitative review process. For international issuers, a PAL is selected by an OTCQX traded company to serve as a liaison between the issuer and the U.S. market. The PAL can help the issuer communicate more effectively with the U.S. investment community by leveraging the PAL`s resources and capital markets experience. PAL eligibility is limited to FINRA member investment banks or ADR banks.
"We are pleased to welcome BioLight to our universe of high-quality OTCQX sponsored companies," commented Douglas Rogers, Managing Director of Merriman`s Capital Markets Advisory Group. "The OTCQX continues to represent nearly one-half of the advisory clients that we represent and we look forward to working closely with BioLight management to advise them on what we believe are best practices regarding dissemination of material information and financial reporting requirements the markets, as well as ongoing engagement with existing and prospective investors. We look forward to supporting the BioLight management team in our capacity as their PAL to the OTCQX market."
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http://www.bio-light.co.il.
Contacts:
BioLight
Itai Bar-Natan, CFO
itai@bio-light.co.il
Tel: +972-73-2753400
At present BioLight has two clusters that focuse on Cancer Diagnostics and ophthalmic diseases. Additional clusters are in development at various planning stages.
Micromedic is a publicly traded company listed on the Tel Aviv Stock Exchange. The Company focuses, through its investee companies, on the development and commercialization of novel molecular biomarkers related to cancer, including early detection of disease, genetic risk and optimization of treatment modalities (personalized medicine).
XLVision is BioLight’s wholly owned ophthalmic cluster.
XLVision currently has three technologies: a commercial laser-based device used to reduce intraocular pressure through glaucoma surgery without penetrating the eyeball; a multi-parameter, easy-to-read test to detect, select treatment and monitor dry eye syndrome and a long-term controlled-release drug-delivery implant platform with a first indication containing latanaprost, the most prescribed glaucoma drug.
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