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Will CTIX be Presenting next week?
Wells Fargo Securities Research, Economics & Strategy
2016 Wells Fargo Healthcare Conference
September 7-8 | The Westin Boston Waterfront | Boston
Forbes article will not open, however
Copied and pasted an excerpt as posted on another message board...
SHOW TIME AT OPKO FORBES
New products and FDA approvals. These are two key factors investors should focus on before putting their trust and money in a biopharma or biotech company, particularly the young ones. And some savvy investors may have spotted such an opportunity with OPKO Health, Inc. (OPK). a diversified drug and medical diagnostics company, with its own significant proprietary drug portfolio.
The reason: One of OPKO’s major drugs, Rayaldee, an oral vitamin D treatment aimed at people suffering from chronic kidney disease, is expected to be approved by the Food and Drug Administration by the end of March.
The expectation for the approval is based on OPKO’s obtaining recently a PDUFA (Prescription Drug User Fee Act) dated March 29, 2016. The PDUFA date represents the deadline for the FDA to approve a new drug. As a result, Wall Street analysts have been effusive in their positive comments about OPKO and its stock. Chronic kidney disease afflicts more than 26 million people in the U.S. alone, according to the National Kidney foundation. Driving the worldwide spread of chronic kidney disease in developed countries are an aging population and the growing problem of obesity.
“The upcoming Rayaldee PDUFA represents the new major catalyst for OPKO,” says Dana Flanders, equity analyst at J.P. Morgan Securities, who rates the stock, currently trading a $11.59 a share, as “overweight.” The analyst notes that OPKO has held labeling discussions with the FDA, and that the company is now researching product pricing, manufacturing preparations and inventory, as well as key hiring of sales representatives for Rayaldee’s launch.
Flanders sees Rayaldee as a “meaningful growth driver” for OPKO and forecasts sales reaching about $500 million by 2025. To demonstrate how big a product Rayaldee could be, that $500 million figure is more than OPKO’s consolidated revenues for all of 2015.
Favorable article in Forbes at 3:33 this afternoon.
I can't get the link to open for me. Someone on another board posted excerpts which looked very positive..
Maybe someone can open link and copy/paste here.
TIA
IsoRay's Proprietary Cesium-131 Product Line Will Be on Display at the American Society for Radiation Oncology (ASTRO) Convention
Three Private Dinners Will Provide a Forum to Discuss Recently Published Cesium-131 Study Results Involving Brain, Lung, Prostate and Gynecologic Cancers
Marketwired IsoRay, Inc.
October 14, 2015 8:15 AM
RICHLAND, WA--(Marketwired - October 14, 2015) - IsoRay, Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced it will host a booth (505) at the 57thAnnual Meeting of the American Society for Radiation Oncology (ASTRO). The annual meeting will take place October 18-21, 2015 in San Antonio, Texas at the Henry B. Gonzalez Convention Center. According to IsoRay CEO Dwight Babcock, "The medical community is becoming increasingly aware of the innovative alternatives that our products offer as an important advance over previous brain, lung, prostate and gynecologic cancer treatments."
IsoRay's Cesium-131 seeds, sutured seeds, stranded mesh and the GliaSite® radiation therapy system give physicians the ability to directly place a specified dosage of radiation in areas where cancer is most likely to remain after tumor removal or when placed directly within the organ. The ability to precisely place a specified dose of radiation means there is less likelihood for damage to occur to healthy tissue compared to other alternative treatments. IsoRay's cancer fighting products diminish the ability of the tumor to recur, providing important benefits for patients in longevity as well as quality of life.
Babcock says "These private dinners provide a forum for peer to peer discussions with other leaders who share their successes in the use of Cesium-131 for some of their most challenging cases. Medical thought leaders recognize the important need for this new powerful weapon in the battle against cancer and Cesium-131 is that solution. A number of new institutions are in the process of licensing Cesium-131 for use within their facility."
IsoRay is the exclusive manufacturer of Cesium-131. The pioneering brachytherapy therapy is one of the most significant advances in internal radiation therapy in 20 years. Cesium-131 allows for the precise treatment of many different cancers because of its unrivaled blend of high energy and its 9.7 day half-life (its unequaled speed in giving off therapeutic radiation).
In addition to its CMS codes, Cesium-131 is FDA-cleared and holds a CE mark for international sales in seed form for the treatment of brain cancer, prostate cancer, lung cancer, ocular melanoma cancer, colorectal cancer, gynecologic cancer, head and neck cancer and other cancers throughout the body. The treatment can be deployed using several delivery methods including single seed applicators, implantable strands and seed sutured mesh, and several new implantable devices including the GliaSite® radiation therapy system.
About IsoRay
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of GliaSite® and Cesium-131 by visiting www.isoray.com. Join us on Facebook/Isoray. Follow us on Twitter @Isoray.
Safe Harbor Statement
Statements in this news release about IsoRay's future expectations, including: the advantages of our products and their delivery systems; future demand for IsoRay's existing and planned products; whether revenue and other financial metrics will improve in future periods, whether IsoRay will be able to continue to expand its base beyond prostate cancer; whether sales and use of our products will continue at historic levels or increase; whether additional medical centers will begin using our products; whether awareness of our products in the medical community will continue or increase; whether our sales and marketing efforts will be successful; whether additional studies will be published or presented with favorable outcomes from treatment with our products; whether we will invest in research and development in the future; and all other statements in this release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of IsoRay's products, changing levels of demand for IsoRay's current and proposed future products, IsoRay's ability to reduce or maintain expenses while increasing sales, patient results achieved using our products in both the short and long term, success of future research and development activities, patient results achieved when our products are used for the treatment of cancers and malignant diseases beyond prostate cancer, IsoRay's ability to successfully manufacture, market and sell its products, IsoRay's ability to manufacture its products in sufficient quantities to meet demand within required delivery time periods while meeting its quality control standards, the success of our sales and marketing efforts, IsoRay's ability to enforce its intellectual property rights, changes in reimbursement rates, changes in laws and regulations applicable to our products, whether additional studies and protocols are released and support the conclusions of past studies and protocols, whether ongoing patient results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in their various forms, continued compliance with ISO standards as audited by BSI, and other risks detailed from time to time in IsoRay's reports filed with the SEC. Unless required to do so by law, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
PCG Advisory Group
535 Fifth Avenue
24th Floor
New York, NY 10017
info@pcgadvisory.com
(646)-863-6341
Drone Aviation Holding Corp. Publishes Chairman Letter
October 07, 2015
JACKSONVILLE, Fla., Oct. 7, 2015 (GLOBE NEWSWIRE) -- Drone Aviation Holding Corp. (OTCQB:DRNE) ("DAC" or "Drone Aviation"), manufacturer of tethered drones and lighter-than-air aerostats, today published a letter from the Company's Chairman below.
To All of Drone Aviation Holding Corp.'s Stakeholders:
I am writing to you today to highlight some of the critical actions that we believe must be taken to position Drone Aviation Holding Corp. (DAC) to benefit from the growth just now beginning to emerge in the commercial drone market.
In the four months since I was recruited by Dr. Phil Frost to serve as Chairman, I have spent my time, together with the Board and management team, evaluating our business from its leadership to its technology and its sales operations, in an effort to build our company into a leading global manufacturer of commercial tethered drones.
To that end, in coordination with the Board and management team, I wanted to inform all of our stakeholders – our shareholders, employees, partners and customers – that we are beginning the process of taking those actions necessary to seek listing on a national stock exchange such as NASDAQ. Listing the stock on a national exchange requires that the company meet a number of critical requirements, foremost among them being balance sheet capitalization thresholds, corporate governance and best practice standards for operating the business, as well as the maintenance of a minimum share bid price. To achieve this minimum bid requirement, the Board has asked for, and received, majority shareholder consent for a reverse stock split to be executed no later than September 13, 2016. Once the reverse split has been completed, we intend to pursue listing on a national exchange, assuming the other requirements can be met at that time.
Operationally, we plan to continue pursuing the following initiatives:
Manufacturing: With final product research and developments nearly completed on our initial WATT tethered drone, we intend to commence preliminary product production including the creation of a WATT demonstration fleet that will be utilized to support both our Government and commercial sales efforts.
Sales and Support Staffing: To support both domestic and international sales efforts, we plan to hire and train new staff as "flight crews" supporting our WATT demonstration fleet as well as additional sales and customer service and support personnel.
Technology and Engineering: We intend to continue to invest in advanced vision-based navigation and guidance technology applicable to both drones and future autonomous robotic systems built around the exclusive technology rights we secured from Georgia Tech Research Corporation.
We look forward to providing all of our stakeholders with updates on our progress and we encourage you to contact us with any questions you may have.
Jay H. Nussbaum
Chairman of the Board
Forward-Looking Statements
This letter contains projections of future results, business initiatives, listing of our stock and other forward-looking statements that involve a number of risks and uncertainties and are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Important factors that may cause actual results and outcomes to differ materially from those contained in the projections and forward-looking statements included in this letter are described in our publicly filed reports with the SEC. Factors that could cause these differences include, but are not limited to, the acceptance of our products, lack of revenue growth, failure to realize profitability, inability to raise capital, market conditions that negatively affect the market price of our common stock, failure to meet stock exchange listing requirements and those other factors identified under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the SEC. The Company disclaims any responsibility to update any forward-looking statements.
CONTACT: Michael Glickman
MWGCO, Inc.
(917) 397-2272
mike@mwgco.net
Drone Aviation Corp.
Great News....But!
Does anyone know the approval process down there? Do they have to file in individual countries or is there one governing body for the whole area? What time frame are we looking at, 6 months,a year?
Any ideas?
Sprout’s Female Libido Drug Brings Up More FDA Dissent and Men-Oriented Testing
inShare
9/17/2015 9:25:51 AM
Sprout’s Female Libido Drug Brings Up More FDA Dissent and Men-Oriented Testing
September 17, 2015
By Mark Terry, BioSpace.com Breaking News Staff
A memo published by the U.S. Food and Drug Administration (FDA) regarding Sprout Pharmaceuticals’ female libido drug, Addyi (flibanserin), shows details about regulators’ concerns over the drug.
On Aug. 18, 2015, Raleigh, N.C.-based Sprout Pharmaceuticals announced that Addyi had been approved for the treatment of low sex drive in women, or what is technically called generalized hypoactive sexual desire disorder (HSDD). The drug comes with controversy, not just because it addresses a sometimes taboo subject in American culture, women’s libido, but because it has been repeatedly turned down by the FDA.
Addyi was originally developed by Boehringer Ingelheim and acquired in 2011 by Sprout. In 2010, while Boehringer was trying to develop it, the drug received a Complete Response Letter from the FDA, which basically states that “a new or generic drug will not be approved in its present form.”
Sprout resubmitted the New Drug Application (NDA) in February 2013 with additional trial data. Again, it was rejected by the FDA. The company then included data from a Phase I pharmacokinetic study and a Phase I driving study in February 2014. On June 4, 2015, an FDA panel voted 18 to 6 to recommend approval, which the FDA did on Aug. 18.
The drug will come with a Boxed Warning because of serious side effects and the need for a strict monitoring program. Addyi can cause severe low blood pressure, which can lead to fainting. This side effect is exacerbated when taken with alcohol and other drugs. It will only be prescribed by pharmacies that are certified by Sprout and will require training on counseling patients on the risks and side effects. The alcohol side effect is particularly alarming in that the drug is taken once a day, every day, and about 50 percent of people in the U.S. drink alcohol.
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The memo indicates that at least three of the reviewers with the FDA recommended rejecting the drug. The memo states that those concerned suggested that “the marginal clinical benefits do not outweigh the serious risks.” Another point brought up is that one reviewer wanted more study on the Addyi-alcohol interaction in women, because most of the clinical trials focused on the alcohl interaction were conducted on men. The memo also indicates that the drug only helped about 10 percent more patients than a placebo.
The primary arguments for approval of the drug, as summarized by Hylton Joffe, director of the FDA’s Division of Bone, Reproductive and Urologic Products, was that there were no other similar drugs for women, and that physicians and pharmacists prescribing the drug are required to take an online training course. Patients are also required to sign a form citing that they are aware of the risks.
The concern about the study’s coverage of the alcohol interaction and gender appears legitimate. Apparently Sprout examined the interaction between the drug and alcohol in 23 men and two women. Given that the drug is to be prescribed solely to women, this would seem to be a legitimate concern and worrying oversight. The drug was, overall, studied in about 3,000 generally healthy premenopausal women.
“This approach is not unreasonable but, in my view,” Joffe wrote in the memo, “is not required because flibanserin is being approved, assuming that the alcohol interaction in women is at least as severe as the alcohol interaction in men. We will continue to assess the risk-mitigation approaches as more data become available.”
The FDA approved the drug with the idea that there will be three additional post-market studies with women.
On Aug. 20, 2015, Canadian-based Valeant Pharma (VRX) announced it had acquired Sprout for $1 billion in cash and a share of future milestone payments. Sprout will stay in Raleigh and Cindy Whitehead, chief executive officer and co-founder of Sprout, will continue to run the company, but as a division of Valeant.
PR reflecting Dr. Frost's investment in DRNE
Several days ago someone questioned Dr. Frost's ownership in any shares of DRNR. I think the following article from Aug 2014 will tell the truth.
Dr. Phillip Frost Leads Investment in Drone Aviation Holding and Is Appointed Chairman of Its Strategic Advisory Board
August 8, 2014 8:55 AM
JACKSONVILLE, FL--(Marketwired - Aug 28, 2014) - Drone Aviation Holding Corp. (OTCQB: DRNE), a developer of specialized tethered drones and lighter-than-air aerostats, today announced that it formed a Strategic Advisory Board that will be headed by Dr. Phillip Frost and that it has accepted subscriptions in a private placement of securities of the Company. Joining Dr. Frost on the newly formed Board is Mr. Steve Rubin.
The Company accepted subscriptions for an aggregate of 1,100,333 shares (the "Shares") of the Company's Series F Convertible Preferred Stock, each of which is convertible into one (1) share of Common Stock of the Company, in a private placement of up to $1,500,000 of its securities to certain accredited investors at a purchase price of $0.75 per Share for an aggregate purchase price of $825,250. Dr. Frost led the investment in the private placement.
"Dr. Frost has a distinguished entrepreneurial track record of success throughout the business community as well as the public marketplace and we are honored to have him Chair our Strategic Advisory Board and as an investor in our Company," stated Felicia Hess, CEO of Drone Aviation Holding Corp. "His extensive government and military relationships during his 13 year tenure as a Director of Northrop Grumman, combined with his capital market expertise, make him an ideal Chairman to lead our newly formed Strategic Advisory Board."
Phillip Frost, M.D. currently serves as the Chairman of the Board and Chief Executive Officer of OPKO Health, Inc., a specialty pharmaceutical company. Additionally, Dr. Frost serves as Chairman of the Board of Directors of TEVA Pharmaceuticals, Ltd., Ladenburg Thalmann Financial Services, Inc. and Prolor Biotech, Inc. and also serves as a Director of Castle Brands, Inc.
Previously, Dr. Frost served as a Director for Northrop Grumman Corp., a global defense company that generates approximately $25 billion in annual revenue and provides technologically advanced, innovative products, services and solutions in systems integration, defense electronics, information technology, advanced aircraft, shipbuilding and space technology. With more than 120,000 employees and operations in all 50 states and 25 countries, Northrop Grumman supplies products and services to the U.S. and international military, government and commercial sectors.
He also previously served as the Chairman of the Board of Directors and Chief Executive Officer of IVAX Corporation until its sale to TEVA and Director of Continucare Corp. prior to its sale to Metropolitan Health Networks Inc. Dr. Frost also served on the Board of Directors of IVAX Diagnostic (Chairman) and the American Stock Exchange (Co-Vice Chairman).
Mr. Rubin has served as Executive Vice President and as a director of OPKO Health, Inc. since February 2007. He has extensive experience as a practicing lawyer, general counsel, and board member to multiple public companies.
About Drone Aviation Holding Corp.
Drone Aviation Holding Corp. (OTCQB: DRNE) provides critical aerial and land based surveillance and communications solutions to government and commercial customers. Utilizing a unique tethering capability, Drone systems operate in the National Airspace within FAA guidelines for safe operations. Drone systems are designed and developed in-house utilizing proprietary technologies and processes that result in compact, rapidly deployable aerostat solutions and mast based systems that have been proven to fulfill critical requirements by the military and law enforcement in the U.S. and to our allies around the world. For more information about Drone Aviation Holding Corp., please visit www.DroneAviationCorp.com, or view our reports and filings with the Securities and Exchange Commission on http://www.sec.gov.
Forward-Looking Statements
This press release contains certain forward-looking statements that involve a number of risks and uncertainties and are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements include those regarding Drone's ability to leverage any of Dr. Frost's or Mr. Rubin's connections or relationships, Drone's strategic relationships and our ability to continue and/or expand such relationships, the suitability of the Drone products for any particular application, the ability of the Drone products to satisfy customer demands or requirements or meet any specific challenges, the ability of the Drone products to function in accordance with their design expectations, the ability of Drone to secure further business with new customers or grow revenues, and the ability of Drone to execute on its strategies or to accomplish any of its goals or objectives. The words "forecast," "project," "intend," "expect," "plan," "should," "would," and similar expressions and all statements, which are not historical facts, are intended to identify forward-looking statements. These forward-looking statements involve and are subject to known and unknown risks, uncertainties and other factors, any of which could cause the Company to not achieve some or all of its goals or the Company's previously reported actual results, performance (finance or operating) to change or differ from future results, performance (financing and operating) or achievements, including those expressed or implied by such forward-looking statements. Important factors that may cause results and outcomes to differ materially from those contained in these forward-looking statements included in this press release are described in our publicly filed reports. The Company assumes no, and hereby disclaims any, obligation to update the forward-looking statements contained in this press release.
Contact:
Drone Aviation Holding Corp.
Chris Camarra
ccamarra@droneaviationcorp.com
Rob and SB
Thanks for a great dialogue. Much appreciate all points of view and the civility of the exchange. Thanks
By the way, I have lost track of when the room temp is supposed to be ready. Any answers on that?
Thanks again.
Alliqua BioMedical, Inc. Reports Second Quarter Financial Results
Revenue Growth of 202% Year-Over-Year in Q2; Gross Margin Increases to 56%
LANGHORNE, Pa., Aug. 6, 2015 (GLOBE NEWSWIRE) -- Alliqua BioMedical, Inc. (Nasdaq:ALQA) ("Alliqua" or "the Company"), a provider of advanced wound care products, today announced financial results for the second quarter ended June 30, 2015.
Q2 Highlights:
Total revenue increased 202% year-over-year to $3.1 million. Organic revenue growth was approximately 99% year-over-year.
Products revenue increased 383% year-over-year to $2.7 million, of which organic product revenue growth was 188% year-over-year.
Gross margin was 56.2% compared to 19.3% last year and 42.9% in the first quarter of 2015.
On April 16th, Alliqua announced that the Company's Biovance® Human Amniotic Membrane Allograft received coverage from Novitas Solutions, Inc. ("Novitas"), a Medicare Administrative Contractor, or "MAC".
On May 4th, the Company raised gross proceeds of $34.5 million through a follow-on offering of 7,582,418 shares of its common stock at a price to the public of $4.55 per share.
On May 29th, the Company completed its acquisition of Celleration, Inc. ("Celleration"), a privately held medical device company, for initial cash and stock consideration of approximately $30.7 million.
On June 3rd, the Company announced the appointment of Nino Pionati to the position of Chief Strategy and Marketing Officer.
Highlights Subsequent to Quarter-End:
On July 23rd, the Centers for Medicare and Medicaid Services ("CMS") released a local coverage determination that will allow Biovance to receive coverage for venous leg ulcers and diabetic foot ulcers, beginning on September 6th, from First Coast Service Options, Inc. ("First Coast"). First Coast is a MAC whose jurisdiction includes Florida.
"Our second quarter performance reflects another quarter of strong organic growth driven by balanced contributions from sales of our Biovance, Therabond and Sorbion products, as well as the contributions from our recently acquired MIST Therapy portfolio," said David Johnson, Chief Executive Officer of Alliqua. "In addition to our strong sales this quarter, we successfully completed our acquisition of Celleration ahead of our original stated timeline and we raised important growth capital in a follow-on offering. Lastly, in accordance with our goal of obtaining MAC coverage for our Biovance Human Amniotic Membrane Allograft, we added our first MAC, Novitas, during the quarter, and I am pleased to announce that our second MAC, First Coast, will begin covering Biovance in early September."
"We look forward to continuing our current pace of progress through the second half of the year and beyond, and remain focused on increasing our salesforce productivity as we expand and penetrate the addressable market for our advanced wound care products."
Second Quarter 2015 Results:
Revenue Summary
($, Thousands) Three Months Ended June 30, Increase / Decrease
2015 2014 $ Change % Change
Products $2,653.7 $549.0 $2,104.7 383.4%
Contract Manufacturing 482.7 488.4 -5.7 -1.2%
Revenue, net $3,136.4 $1,037.4 $2,099.0 202.3%
Total revenue for the second quarter of 2015 increased $2.1 million, or 202% year-over-year, to $3.1 million. Organic revenue growth was approximately 99% year over year Sales of the Company's products – including hydrogels, sorbion, Biovance, TheraBond and MIST Therapy® increased $2.1 million, or 383%, year-over-year, of which organic product growth revenue was 188% year-over-year. Revenue from MIST Therapy, acquired from Celleration on May 29th 2015, was approximately $850 thousand.
Gross profit for the second quarter of 2015 was $1.8 million, or 56.2% of sales, compared to a gross profit of $201 thousand during the same period last year. The increase in gross margin was driven by the increase in sales of our wound care products, which typically command higher gross profit margins. Gross margin on our product sales was approximately 76% in the second quarter of fiscal year 2015. We expect our future gross margin to continue to increase as a result of our products' sales becoming a higher proportion of our total sales.
Total operating expenses for the second quarter of 2015 increased $3.5 million, or 55% year-over-year, to $9.9 million. Excluding the acquisition-related expenses and change in fair value of contingent consideration, adjusted operating expenses increased $2.7 million, or 46%, year-over-year. The increase in adjusted operating expenses in the second quarter of 2015 was driven primarily by higher compensation and benefits expenses, due to increased headcount. Compensation and benefits was $2.8 million and $1.6 million for the three months ended June 30, 2015 and 2014, respectively.
Loss from operations for the second quarter of 2015 was $8.1 million, compared to a loss of $6.2 million for the same period last year. Net loss for the second quarter of 2015 was $7.0 million, or ($0.32) per diluted share, compared to a net loss of $6.0 million, or ($0.39) per diluted share, last year. In the second quarter of 2015, the Company recorded an income tax benefit of approximately $1.4 million. The income tax benefit is related to the release of valuation allowances resulting from the acquisition of Celleration in May 2015.
Non-GAAP net loss for the second quarter of 2015 was $4.4 million, or ($0.20) per diluted share, compared to a non-GAAP net loss of $3.5 million, or ($0.23) per diluted share, last year. The Company defines non-GAAP net income as its reported net income (GAAP) excluding income tax (benefit) expense, stock-compensation expense, one-time charges and other non-recurring operating costs and expenses, intangible asset amortization, change in fair value of contingent consideration and change in value of warrant liability.
For the six months ended June 30, 2015 revenues increased by $3.6 million, or 223%, to $5.2 million from $1.6 million for the six months ended June 30, 2014. For the six months ended June 30, 2015 and 2014, we had a net loss of $14.7 million, or ($0.66) per diluted share, and $15.0 million, or ($1.08) per diluted share, respectively. Non-GAAP net loss for the six months of 2015 was $7.8 million, or ($0.35) per diluted share, compared to a non-GAAP loss of $7.0 million, or ($0.50) per diluted share last year.
As of June 30, 2015, the Company had $35.8 million in cash and cash equivalents, compared to $16.8 million at December 31, 2014. The increase was largely attributable to net proceeds from the issuance of common stock of $32.2 million and net proceeds from long term debt of $14.2 million, offset by cash used in operating activities of $12.4 million and $14.9 million used to fund the acquisition of Celleration during the six months ended June 30, 2015.
Net cash flow used in operating activities included approximately $2.8 million of transaction costs related to the Company's acquisition of Celleration during the six months ended June 30, 2015. Changes in working capital increased cash flows used in operating activities by approximately $3.0 million in the six months ended June 30, 2015, compared to the six months ended June 30, 2014.
Fiscal Year 2015 Revenue Outlook:
The Company is maintaining its revenue guidance for the fiscal year 2015 period, which was last updated on April 23rd, 2015.
For the fiscal year ending December 31, 2015, the Company expects total revenue of $16.3 million to $18.8 million, representing growth at the mid-point of the range of approximately 267% year-over-year. The Company's revenue guidance includes the incremental contributions from the acquisition of Celleration, based on the closing date of May 29th, in the range of approximately $5.3 million to $5.8 million.
Conference Call
The Company will host a teleconference at 8:00 a.m. Eastern Time on August 6th to discuss the results of the quarter, and to host a question and answer session. Those interested in participating on the call may dial 888-378-0320 (719-325-2491 for international callers) and provide access code 7036127 approximately 10 minutes prior to the start time. A live webcast of the call will be made available on the investor relations section of the Company's website at http://ir.alliqua.com.
For those unable to participate, a replay of the call will be available for two weeks at 888-203-1112 (719-457-0820 for international callers); access code 7036127. The webcast will be archived on the investor relations section of Alliqua's website.
About Alliqua BioMedical, Inc.
Alliqua is a provider of advanced wound care solutions, committed to restoring tissue and rebuilding lives. Through its sales and distribution network, together with its proprietary products, Alliqua provides a suite of technological solutions to enhance the wound care practitioner's ability to deal with the challenges of healing both chronic and acute wounds.
Alliqua currently markets its line of dressings for wound care under the SilverSeal® and Hydress® brands, as well as the sorbion sachet S® and sorbion sana® wound care products, and its TheraBond 3D® advanced dressing which incorporates the TheraBond 3D® Antimicrobial Barrier Systems technology. The Company's Mist Therapy System® uses painless, noncontact low-frequency ultrasound to stimulate cells below the wound bed to promote the healing process. Alliqua also markets the human biologic wound care product Biovance®, as part of its licensing agreement with Celgene Cellular Therapeutics.
In addition, Alliqua can provide a custom manufacturing solution to partners in the medical device and cosmetics industry, utilizing its hydrogel technology. Alliqua's electron beam production process, located at its 16,500 square foot Good Manufacturing Practice (GMP) manufacturing facility, allows Alliqua to custom manufacture a wide variety of hydrogels. Alliqua's hydrogels can be customized for various transdermal applications to address market opportunities in the treatment of wounds as well as the delivery of numerous drugs or other agents for pharmaceutical and cosmetic industries. The Company has locations in Langhorne, PA and Eden Prairie, MN.
For additional information, please visit http://www.alliqua.com. To receive future press releases via email, please visit http://ir.stockpr.com/alliqua/email-alerts.
Legal Notice Regarding Forward-Looking Statements:
This release contains forward-looking statements. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of our control that can make such statements untrue, including, but not limited to, the adequacy of the Company's liquidity to pursue its complete business objectives; inadequate capital; the Company's ability to obtain reimbursement from third party payers for its products; loss or retirement of key executives; adverse economic conditions or intense competition; loss of a key customer or supplier; entry of new competitors and products; adverse federal, state and local government regulation; technological obsolescence of the Company's products; technical problems with the Company's research and products; the Company's ability to expand its business through strategic acquisitions; the Company's ability to integrate acquisitions and related businesses; price increases for supplies and components; and the inability to carry out research, development and commercialization plans. In addition, other factors that could cause actual results to differ materially are discussed in our filings with the SEC, including our most recent Annual Report on Form 10-K filed with the SEC, and our most recent Form 10-Q filings with the SEC. Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise.
ALLIQUA BIOMEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, December 31,
2015 2014
(Unaudited)
ASSETS:
Current Assets:
Cash and cash equivalents $ 35,759,632 $ 16,770,879
Accounts receivable, net 2,332,202 968,616
Inventory, net 2,862,063 1,411,748
Prepaid expenses and other current assets 699,471 477,824
Total current assets 41,653,368 19,629,067
Improvements and equipment, net 1,757,317 1,434,027
Intangible assets, net 35,672,418 4,387,293
Goodwill 20,924,893 4,100,295
Other assets 173,042 173,042
Total assets $ 100,181,038 $ 29,723,724
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable $ 2,411,561 $ 1,757,742
Accrued expenses and other current liabilities 3,074,781 2,067,859
Contingent consideration, current 5,584,794 --
Warrant liability 3,033,572 304,223
Total current liabilities 14,104,708 4,129,824
Long-term debt, net 11,646,093 --
Contingent consideration, long-term 13,289,395 2,931,598
Deferred tax liability 1,510,830 67,000
Other long-term liabilities 79,902 84,071
Total liabilities 40,630,928 7,212,493
Commitments and Contingencies
Stockholders' Equity
Preferred Stock, par value $0.001 per share, 1,000,000 shares authorized, no shares issued and outstanding -- --
Common Stock, par value $0.001 per share, 45,714,286 shares authorized; 27,680,771 and 16,202,689 shares issued and outstanding as of June 30, 2015 and December 31, 2014, respectively 27,681 16,203
Additional paid-in capital 144,216,471 92,537,742
Accumulated deficit (84,694,042) (70,042,714)
Total stockholders' equity 59,550,110 22,511,231
Total liabilities and stockholders' equity $ 100,181,038 $ 29,723,724
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Three Months Ended June 30, Six Months Ended June 30,
2015 2014 2015 2014
Revenue, net of returns, allowances and discounts $3,136,390 $1,037,448 $5,249,954 $1,628,023
Cost of revenues 1,373,602 836,715 2,580,666 1,468,414
Gross profit 1,762,788 200,733 2,669,288 159,609
Operating expenses
Selling, general and administrative* 8,422,748 5,956,091 14,931,919 14,602,635
Research and product development 279,664 -- 300,434 --
Acquisition-related 914,797 419,658 2,860,586 485,640
Change in fair value of contingent consideration liability 265,055 -- 372,591 --
Total operating expenses 9,882,264 6,375,749 18,465,530 15,088,275
Loss from operations (8,119,476) (6,175,016) (15,796,242) (14,928,666)
Other (expense) income
Interest expense (233,039) (92) (233,039) (384)
Interest income 13,223 9,429 19,190 13,976
Change in value of warrant liability (90,179) 214,950 (78,137) (68,317)
Total other (expense) income (309,995) 224,287 (291,986) (54,725)
Net loss before income tax (8,429,471) (5,950,729) (16,088,228) (14,983,391)
Income tax benefit (expense) 1,439,735 (3,500) 1,436,900 (7,000)
Net loss $(6,989,736) $(5,954,229) $(14,651,328) $(14,990,391)
Basic and diluted net loss per common share $(0.32) $(0.39) $(0.66) $(1.08)
Weighted average shares used in computing basic and diluted net loss per common share 22,108,703 15,243,718 22,103,377 13,822,858
*Inclusive of stock-based compensation of $2,200,232 and $4,141,144 for the three and six month periods ended June 30, 2015 and $1,951,631 and $7,095,946 for the three and six month periods ended June 30, 2014
ALLIQUA BIOMEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
Six Months Ended June 30,
2015 2014
Operating Activities
Net loss $(14,651,328) $(14,990,391)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 831,815 457,832
Amortization of deferred lease incentive (4,169) (4,169)
Deferred income tax (benefit) expense (1,436,900) 7,000
Provision for doubtful accounts 46,304 --
Provision for inventory obsolescence 13,247 (36,588)
Stock-based compensation expense 4,323,012 6,990,465
Amortization of debt issuance and discount costs 84,928 --
Stock issued for services rendered -- 185,334
Change in value of warrant liability 78,137 68,317
Fair value adjustment of contingent consideration liability 372,591 --
Changes in operating assets and liabilities:
Accounts receivable (533,300) (305,969)
Inventory (1,122,419) (5,697)
Prepaid expenses and other current assets (14,902) (254)
Accounts payable 345,204 755,975
Accrued expenses and other current liabilities (690,988) 503,919
Net Cash Used in Operating Activities (12,358,768) (6,374,226)
Investing Activities
Payment for distribution rights -- (200,000)
Purchase of improvements and equipment (76,738) (6,596)
Acquisition of business, net of cash acquired (14,947,813) (1,999,526)
Net Cash Used in Investing Activities (15,024,551) (2,206,122)
Financing Activities
Net proceeds from issuance of common stock 32,196,540 14,372,503
Net proceeds from long-term debt 14,243,875 --
Proceeds from the exercise of stock options 300,153 1,219,161
Proceeds from the exercise of warrants -- 5,125,947
Payment of withholding taxes related to stock-based employee compensation (368,496) (452,377)
Net Cash Provided by Financing Activities 46,372,072 20,265,234
Net Increase in Cash and Cash Equivalents 18,988,753 11,684,886
Cash and Cash Equivalents -- Beginning of period 16,770,879 12,100,544
Cash and Cash Equivalents - End of period $35,759,632 $23,785,430
Use of Non-GAAP Financial Measures
We present these non-GAAP measures because we believe these measures are useful indicators of our operating performance. Our management uses these non-GAAP measures principally as a measure of our operating performance and believes that these measures are useful to investors because they are frequently used by analysts, investors and other interested parties to evaluate companies in our industry. We also believe that these measures are useful to our management and investors as a measure of comparative operating performance from period to period.
The Company has presented the following non-GAAP financial measures in this press release: non-GAAP net income, and non-GAAP net income per share. The Company defines non-GAAP net income as its reported net income (GAAP) excluding income tax (benefit) expense, stock-compensation expense, one-time charges and other non-recurring operating costs and expenses, intangible asset amortization, change in fair value of contingent consideration and change in value of warrant liability.
ALLIQUA BIOMEDICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP to Non-GAAP results
(Unaudited)
Three Months Ended June 30, Six Months Ended June 30,
(U.S. dollars in thousands) 2015 2014 2015 2014
Table of Reconciliation from GAAP Net Loss to Non-GAAP Net Loss
GAAP Net Loss $(6,990) $(5,954) $(14,651) $(14,990)
Stock-based compensation 2,291 2,014 4,323 7,176
Acquisition related expenses 915 420 2,861 486
Intangible asset amortization 434 191 667 297
Change in fair value of contingent consideration 265 -- 373 --
Change in value of warrant liability 90 (215) 78 69
Income tax (benefit) expense (1,440) 4 (1,437) 7
Non-GAAP Net Loss $(4,435) $(3,540) $(7,786) $(6,955)
Table Comparing GAAP Diluted Net Loss Per Common Share to Non-GAAP Diluted Net Loss Per Common Share
GAAP diluted net loss per common share $(0.32) $(0.39) $(0.66) $(1.08)
Non-GAAP diluted net loss per common share $(0.20) $(0.23) $(0.35) $(0.50)
Shares used in computing GAAP & Non-GAAP diluted net loss per common share 22,108,703 15,243,718 22,103,377 13,822,858
CONTACT: Investor Relations:
Westwicke Partners on behalf of Alliqua BioMedical, Inc.
Mike Piccinino, CFA +1-443-213-0500
AlliquaBiomedical@westwicke.com
Alliqua, Inc. logo
Source: Alliqua BioMedical, Inc.
Released August 6, 2015
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Blogger Todd Cox from SA article on ISR
Copied from another board...Very interesting article...
IsoRay: A Little Biomedical Company With Big Potential
Three months ago I informed readers of the upcoming release of a long term lung study results using IsoRay's(NYSEMKT:ISR) Cesium-131. I reported the results were coming within weeks, the results would be positive and would be the catalyst that sent IsoRay share price back above $2 and possibly much higher in the coming weeks. Exactly three weeks to the day of the articles release, the results of Cesium-131 lung study result were published and propelled IsoRay's share price from $1.48 to $4.00 in a 24 hour span. The day after the results were published an article came out accusing IsoRay of "taking liberties with lung cancer study results to prop up stock price." An immediate, and in my opinion, over exaggerated panic set in as numerous law firms began advertising they were seeking lead plaintiffs for a class action law suit against IsoRay. IsoRay's share price quickly dropped to $2.01 the following day and continue dropping for the next two and a half months to where it closed at $1.38 yesterday.
The class action suits have been filed and combined into one class action lawsuit that is set to go before the United States District Court, Eastern District of Washington. The docket number is 15-cv-05046. It appears there is a total class action investor loses of only around $200,000. So even if the lawsuit is not dismissed for lack of merit when it goes before a judge, which I believe it will be, the small amount of the lawsuit and IsoRay's insurance should cause this to be a non-issue as pertaining to share price anyway.
Some retail investors may still be nervous about the lawsuit and the possibility that IsoRay exaggerated the lung results, which they did not. The results were actually much better than expected. Cesium-131 was used on high risk patients while the other treatments were used on low risk and Cesium-131 still had better results than the other treatments.
There appears to be another study about to be released, by Dr. Parashar and WCMC, it is "Cesium-131 Seed Brachytherapy Plus Subtotal Resection for Lung Cancer Patients Who Are Not Candidates for Lobectomy or Patients With High Risk of Local Recurrence." The main objective of the study was to, "assess local control of localized lung cancers after limited resection (wedge resection or segmentectomy) and Cesium-131 seed placement in comparison to previously assessed local control of localized lung cancers after limited resection and Iodine-125 seed placement." The study also assessed "quality of life (as related to side effects) of Cs-131 seed placement after limited surgical resection in lung cancers and compare it to already existing data on Iodine-125."
I spoke with CEO Dwight Babcock yesterday, he said publications had contacted IsoRay about various pending studies to mainly ask one of the most important question, how much did IsoRay pay for the studies? He said nothing was paid for the studies, they are independent clinical studies.
Verifying whether IsoRay is paying for a study obviously helps publications verify that the trial is independent and unbiased. This generally happens towards the end of the process before sending an article to be published. It appears some study results should be coming soon.
What will probably be the most important study for Isoray is the one that was done by Dr. Steven Franks of The University of Texas MD Anderson Cancer Center in Houston Texas. MD Anderson is the number one hospital in the United States for cancer care. MD Anderson has been named one of the top two cancer hospitals in the United States every year since 1990 when they began the survey. It has been ranked number one for 11 of the last 14 years, including 2015-2016. Having the number one cancer hospital in the United States doing a clinical study of Cesium-131 is a big deal for IsoRay and Cesium-131. You can bet Big Pharma will be looking at these results. These results could be the make or break for IsoRay.
MD Anderson began ordering Cesium-131 for a prostate cancer study back in October 2011 to continue its research into brachytherapy treatment to control intermediate risk prostate cancer. Intermediate risk is a classification of early stage prostate cancer that has a high recurrency rate even after surgery and radiation therapy. The MD Anderson study compared Cesium-131 to other forms of brachytherapy for treating prostate cancer. This stage of the study is completed and pending the published report.
Dr. Frank has accrued all the patient data and already discussed the prostate cancer trial results at the "Advances in Brachytherapy Symposium" in New York on May 8th-9th. This is the same symposium that Dr. Parashar discussed his Cesium-131 lung trial results at shortly before they were published. It looks like the published results should be coming any time now.
The results of Cesium-131 in the MD Anderson Cancer Center prostate cancer trial is evidently extremely positive as compared to other forms of brachytherapy treatment, since Dr. Frank and MD Anderson have continued to order and use Cesium-131 on their patients even though the study is completed.
An update on the little seven year old Peruvian girl, who back in March of 2014 was diagnosed with inoperable and life threatening brain cancer. The pressure of the tumor on her brain had caused the girl significant weakness, trouble walking and maintaining alertness. She had a drain placed in her brain in an attempt to help ease the increasingly worsening problems. She was also given chemotherapy and whole brain radiation which did nothing to improve the increasingly deteriorating problem. Her doctor, Dr. Carlos Alvarez Pena knew about IsoRay's Cesium-131 and its use in treatment of high risk cancers. He worked with IsoRay and they designed and manufactured a custom implant for her. In July 2014, Dr. Alvarez implanted the Cesium-131 implant directly into the tumor.
According to doctors, her recovery was incredible. She was alert and eating the next day. Within a couple weeks, she was walking again without assistance. Ten weeks after the Cesium-131 treatment, an MRI scan showed a 70% reduction of the tumor. She also returned to her normal activities and was back in school again without assistance or special accommodations.
Dr. Alvarez, had stated "We knew she faced a very short life expectancy. The remarkable 70% reduction in the tumor and the other early results are far better than expected. We are working on a scientific paper in order to share with the scientific community this exciting new way of dealing with these life-threatening cancers."
She is reportedly doing well and Dr. Alvarez has completed the scientific paper on the procedure. The paper is pending publication. This will be another huge catalyst when it is published and more importantly, another life saved.
All the previous independent study have been remarkable as well as the experimental surgery on the Peruvian girl. They all appear to show Cesium-131 to be a superior cancer treatment for high risk cancers. I expect the upcoming clinical trials to continue with the same positive results. The incredible results alone will cause Cesium-131 to become the standard care in certain cancer treatments. But lets also not forget that Cesium-131, with its low initial dose rate and shorter half-life compared to other permanent isotopes, significantly reduce patient side effects as well as reduces radiation exposure to the doctors and other medical staff providing the treatment. This makes IsoRay's Cesium-131 much safer and more beneficial to the patient and the doctors as well.
Isoray also had a large increase in Cesium-131 interest by doctors and medical centers as a result of all the positive clinical trials. This past April, IsoRay had more doctors and medical centers inquire about Cesium-131 than they have in the past two years combined. And it appears that the interest is going to continue increasing with the coming clinical studies and medical papers being written about Cesium-131's incredible results.
This increased interest in Cesium-131 appears to be increasing IsoRay's revenue. Revenue estimates for the quarter ending June 15, 2015 are expected to grow by 36% to $1.3 million. The following quarter, September 2015, when most of the new sales will begin to be realized, the revenue estimates jump almost 189% to $3.01 million. This is expected to continue year over year with revenue expected to increase a whopping 203% to $13.86 million in 2016.
Conclusion
Isoray is a complicated company for investors. It is a small biomedical company that is financially healthy, with over $20 million cash on hand, low cash burn, no debt and a line of patented products, including Cesium-131, a multi cancer treatment that is currently FDA approved for treating brain cancer, prostate cancer, lung cancer, ocular cancer, head and neck cancer, and other cancers throughout the body. Cesium-131, has an unbelievably high success rate and minimal side effects compared to other cancer treatments. While it consistently shows to be far superior to other cancer treatments, it seems every time good news has come out there is something negative that brings the share price back down. It then takes months before more positive news comes out to give retail investors their confidence back. However, institutional ownership seems to be growing, it is up 17.5% quarter to quarter, revenue is expected to finally start increasing steadily, IsoRay knows what the lawsuit value is in a worst case scenario, it looks like news and study results are about to start coming out consistently for the next several months and physicians and major medical centers are finally accepting Cesium-131 as a better cancer treatment. I believe IsoRay is a great company with an incredible lifesaving product and an extremely undervalued share price of around $1.38. I am looking for IsoRay share price to begin moving up and surpass the analysts $5 price target within the year due to increased revenues and interest. Also look for interest from Johnson & Johnson(NYSE:JNJ) Pfizer(NYSE:PFE) Merck(NYSE:MRK) Bristol-Myers Squibb(NYSE:BMY) and Bard(NYSE:BCR). They will not be able to ignore the MD Anderson Cancer Center prostate cancer study results and the fact that the number one cancer hospital in the nation is using IsoRay's Cesium-131.
Why is this company's product available in 50 states?
and ours can't be sold?
Can't copy and past link.. the ad was sent to me in the newsletter, Marijuana Business Daily...
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Diabetes Newsletter Interview with ALQA part 2
Dr. Janice Smiell: Biovance and the Future of Chronic Wound Care, Part 2
Dr. Janice Smiell: Biovance and the Future of Chronic Wound Care, Part 2
Dr_Janice_Smiell
This week we have the second part of our two-art interview with Dr. Janice Smiell, CMO at Alliqua BioMedical, Inc. Dr. Smiell, and we delve a little deeper into the specifics of this new technology to heal chronic wounds using placental biomaterials.
Steve Freed: With all the testing that is done and the work involved in obtaining the placentas, is sounds like this could be a very expensive product.
Dr. Janice Smiell: This is why Medicare/Medicaid is very careful in determining and covering reimbursement. They want to see that there are some clinical data and some sort of comparative effectiveness before they will provide coverage. There is a lot of work that is going on, not only with our product, but other products like it. It is confusing because for the most part, if human tissue is processed properly, and nothing is introduced that would create an issue with it, then for the most part they all work toward supporting wound healing. The key has been looking at the ease of using them. Some of them come freeze-dried. Some of them, like ours, are dehydrated and have a longer shelf-life. Some of them keep the dead cells there. Ours happens to be decellularized completely. Some of them have living cells and are frozen, cryopreserved, so you have to thaw them in a special way before you can use them. It is a very confusing world. Our recommendation is simply look at price, look at ease-of-use, and look at the benefit from data that have been collected, and then it still may mean that you have to come down to trying it on a patient. That is the best you can do....
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SF: Is using your product more cost-effective than other top-of-the-line wound products?
Dr. S: Many dressing-type products are less expensive, and those are the ones that should be tried first. No one will support going immediately to an expensive, more advanced therapy like Biovance. If you feel that you’re getting progress with more standard types of treatment, good. No matter what, you have to start by getting a good debridement; then get down to good, clean tissue; get rid of the infection; do the offloading of pressure, in the case of diabetic foot; or if it’s a venous ulcer, you are going to apply compression to combat the venous disease. You have to perform that good, standard care no matter what. A percentage of people will respond to that good, standard care. If, however, you provide the standard care and it is still not going anywhere, then you know you have an issue. You’ve already controlled their glucose, you’ve offloaded them, you’ve cleaned up the wound, you provided the moist environment, and it is not going anywhere— then you need to move to something more advanced. Which advanced therapy do you go to? If you are savvy, you are going to look at the evidence and still probably be confused, because there are a lot of products out there that have clinical studies backing them. Some clinical studies are better than others; you will have to make a decision. If you are working in a hospital, some of the decision is driven by what your hospital has on formulary, and what is reimbursed if you are in the outpatient office. What is reimbursed has to be part of your decision-making. You are going to decide based on a number of factors, not just the individual patient. I can tell you that with Biovance, we took it out there in a broad, registry-type study. We handed it off to 19 different sites and said, “Put this on wounds that you think need it, together with your good wound care, and tell us what you observe.” The only exclusion was you could not put it on an infected wound. In the all-comers scenario, we saw that 50 percent of the wounds closed in about a week. What does that mean? We’ve heard other products get 80 percent closed in a similar timeframe. Those were in clinical studies where they’ve controlled who can enter the study. You had to have certain hemoglobin A1c. You had to have no renal insufficiency. You couldn’t have this; you couldn’t have that. It was very controlled. Ours was with all controls off. In fact, when we looked at our population of 230 patients, we found that more than half of them would have been excluded from a prospective study. It was truly an all-comers scenario. We are now doing a prospective study in which we control who enters it. We will be able to show what the effect is in that situation as well, so there can be a direct comparison with other products. I feel comfortable predicting that in any scenario, our product will show benefit. Anecdotally, as it is out there now, we hear marvelous things about people who have had a non-healing wound for two years, four years, and are amazed how this product puts them back into healing mode and closes the wound. I put it on myself about 10 years ago and I, too, was amazed by how well it did. I can’t even find the site of my wound today. Cosmetically, I was quite pleased. If you have diabetes, your number one thought every day is, if I have a wound, am I going to lose this extremity? When you talk about cost, I know the average patient in my study used two pieces of Biovance over that eight-and-a-half-week period. The cost of two pieces was a very small price to pay to save a limb, or even to provide the peace of mind that comes when you see that your wound is healing. I got into this business because I had non-healing wounds. I had vasculitis. I knew what it felt like, the change of dressing every day, and hear people say, “Oh big deal! It’s a Band-Aid you are changing every day.” Well, it wears on you. When you can start to see that things are going in the right direction that is a huge relief. Wound closure means a lot. Everything is done nowadays by the vascular surgeon, the podiatrist, the physiatrist—everyone has come such a long way in providing the support and the elements that are needed for wound healing. It is rare to go to amputations so quickly. The shorter the time you have an open wound, the less you are at risk for infection, for further breakdown, for infection of the bone that can lead you toward that amputation. You know that in a diabetes patient, once you get to a certain level of amputation, you then have to be concerned about the extra work that puts on the heart—which has the same vascular disease that the leg did. Then you talk about losing a life not long after losing a limb. It’s a snowball effect that you want to avoid.
SF: So you have to be specially trained to use this product. Can you share with us the potential treatment cost for a standard chronic wound? What could the cost be if you don’t have medical insurance that covers it?
Dr. S: The special training for Biovance is considered a surgical application. A podiatrist or surgical healthcare provider will learn how to place and anchor it, and it can be anchored with tape or sutures or whatever the doctor feels is necessary. It requires a person who is trained and certified in wound care. As for the cost, the smallest pieces are available for around $300. The average expenditure is probably around $1,000 to $2,000. As far as payment goes, if Biovance is placed in the OR at the time of debridement, then that is not an out-of-pocket cost to the patient. If it is an outpatient scenario where there is no insurance coverage, there could be that cost. There is a patient assistance network (PAN) that a patient can go to if they can’t afford this or any treatment. If they qualify, the patient can ask for assistance to cover co-pays or their entire care.
SF: If a person comes into the office and they have a tiny little wound that some Bactine and a Band-Aid would take care of, you are not going to recommend this product, obviously.
Dr. S: Correct. You are going to see if it gets taken care of using traditional methods of treatment. If in four weeks it goes nowhere, and you’ve done everything you could with what you have on hand, then you might want to consider Biovance.
SF: So what you’re saying is that after four weeks of no improvement, it’s time to consider other alternatives.
Dr. S: Yes. There are very good data out there, in both diabetic and venous ulcers, that say that if you do not have 40 to 50 percent closure of the area of your wound in that four-week timeframe, that you need to do something with a big gun.
SF: Can you provide us your website name?
Dr. S: It’s Alliqua.com.
SF: Can medical professionals and patients both find relevant information about Biovance there?
Dr. S: Yes.
SF: Thank you for your time—this was very informative and interesting. Clearly we’ve learned more in the last five years than we have in the last 50. I would like to be around for the next hundred, just out of curiosity!
Dr. S: I think everything is moving toward customized care. These fields are not any different than cancer, endocrinology and everything else.
SF: It’s fascinating what we are producing out there. It’s just exciting to be part of it, and to learn about it and to report on it. For me, it is truly exciting.
Dr. S: There's work being done with the stem cells that come from a placental source so that they can decrease the kind of reactions you have for rejection of the tissue in pancreatic transplants and others.
SF: That’s very interesting. I guess one day we will live forever, but it won't be today.
Dr. S: It's not going to be us!
SF: Right. It’s going to be the next generation. Good for them. Thank you again for your time. I appreciate it. I learned a lot.
Dr. S: Thank you.
Dr. Janice M. Smiell, M.D., Chief Medical Officer, brings more than 20 years of wound care, regenerative medicine, and clinical development experience to Alliqua BioMedical. She is the former VP of Medical Affairs at LifeCell Corporation, where she oversaw clinical development and product safety programs from 2007 to 2011. LifeCell develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures. Prior to joining LifeCell, Dr. Smiell was the Executive Director of Global Clinical R&D at Celgene, where she led the clinical development of biomaterials and stem cells at the Company’s Cellular Therapeutics Division. From 1994 to 2003, Dr. Smiell was the Senior Director of Global Clinical R&D at Johnson and Johnson where she was awarded the prestigious Johnson Medal in recognition of her development work on Regranex, a growth factor for wound healing. Before joining Johnson and Johnson, Dr. Smiell served as the Medical Director of the Wound Care Center at Morristown Memorial Hospital. Dr. Smiell received her M.D. from the Medical College of Pennsylvania in Philadelphia (now Drexel University School of Medicine).
Dr. Janice Smiell: Biovance and the Future of Chronic Wound Care, Part 2
IsoRay's Cesium-131 Cancer Fighting Portfolio was on Display at the American Association of Physicists in Medicine (AAPM) Convention
8:30 am ET July 16, 2015 (Market Wire) Print
IsoRay Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced it participated at the American Association of Physicists in Medicine by hosting a private dinner and booth display. The annual AAPM meeting took place July 12-16, 2015 at the Anaheim Convention Center in Anaheim, California.
IsoRay CEO Dwight Babcock commented, "IsoRay is pleased to once again participate at the AAPM annual meeting. At this venue, we have a great opportunity to meet physicists from major institutions who are instrumental in the dosimetry planning for the use of Cesium-131 for a specific patient's treatment. With peer reviewed publications continuing to show the positive results patients are achieving with the use of Cesium-131, physicists are increasingly becoming interested in the innovative alternative our Cesium-131 products offer the patient."
IsoRay's various products, including Cesium-131 seeds, sutured seeds, stranded mesh and the GliaSite(R) radiation therapy system, give physicians the ability to directly place a specified dosage of radiation in areas where cancer is most likely to remain after completion of a tumor removal or by placing seeds within the prostate. The ability to precisely place a specified dose of radiation means there is less likelihood for damage to occur to healthy surrounding tissue compared to other alternative treatments. IsoRay's cancer fighting products diminish the ability of the tumor to recur, resulting in important benefits for patients in longevity as well as quality of life. Cesium-131 is now being used for the treatment of a wide array of cancers throughout the body including brain, lung, head and neck, chest wall, prostate and gynecologic cancers.
About IsoRay IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of GliaSite(R) and Cesium-131 by visiting www.isoray.com. Join us on Facebook/Isoray. Follow us on Twitter @Isoray.
Safe Harbor Statement Statements in this news release about IsoRay's future expectations, including: the advantages of our products and their delivery systems, whether interest in and use of our products will increase or continue, whether awareness and adoption of our products in the medical community will continue or increase, whether peer-reviewed publications of treatment results using our products will report favorable results, and all other statements in this release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released and support the conclusions of past studies, whether ongoing patient results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers and malignant diseases beyond prostate, successful completion of future research and development activities, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in its various forms, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing efforts, changes in reimbursement rates, changes in laws and regulations applicable to our products, and other risks detailed from time to time in IsoRay's reports filed with the SEC. Unless required to do so by law, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
IsoRay Medical
Info@Isoray.com
(509) 375-1202
SOURCE: IsoRay, Inc.
Alliqua featured in Diabetes Newsletter
Alliqua is featured in the July 14th newsletter "Diabetes in Control". This is directly emailed to Medical Professionals through out the US (and hopefully other countries).
Dr. Janice Smiell: Biovance and the Future of Chronic Wound Care, Part 1
This week we are excited about our exclusive interview with Dr. Janice Smiell, CMO at Alliqua BioMedical, Inc. Dr. Smiell and her team have been doing some groundbreaking work on battling chronic wounds using placental biomaterials.
Dr_Janice_SmiellSteve Freed: Welcome, Dr. Janice Smiell. Let's begin by having you tell us a little bit about yourself. What do you do and how did you get involved?
Dr. Janice Smiell: Presently, I’m chief medical officer at Alliqua BioMedical, Inc. Alliqua is a relatively new company aimed at helping healthcare professionals take care of their patients’ chronic wounds, such as diabetic foot ulcers. As for myself, I started off as a general surgeon and had a general surgery practice. I became interested in wound healing and ended up running the wound care center for my hospital. Once my family came along, I decided I needed to make a change in my career so I could help raise my children. I looked toward industry to see what was going on with wound healing products. I saw that Johnson & Johnson was working hard to come up with advanced therapy that would be beneficial for diabetes patients with ulcers, and I became involved with that. From there, I went to other companies that were working on chronic wound management and healing. Eventually, I came to Alliqua. One of those other companies was Celgene Cellular Therapeutics, which had a division that was working with placentas. During my tenure there, I started developing products from placental biomaterials. The company was also working on stem cells from cord blood and placental origins that they are putting into ischemic diabetic foot ulcers, to see if they can simulate healing there....
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During my time there, we took the amnion, and did minimal processing to come up with a membrane product that could be used on wounds. We tested in a number of wounds—all different types of chronic wounds and some acute wounds—and found that it could be beneficial as long as it was used along with good wound care for the patient. That product is Biovance. Because Celgene was focused on its stem cell initiatives, progress on bringing Biovance to the market was shelved until Alliqua came along. Alliqua licensed Biovance from Celgene so that we could distribute it to sectors of the wound care community where it is needed.
SF: I see. Can you tell us in more detail what Biovance is?
Dr. S: Biovance is a very simple, pure, amniotic membrane that has had the cells removed from it. Amnion is, typically, avascular, and the non-cellular layer of placental membrane. It does have a layer of epithelium that sits on top of it. The amniotic membranes are created from the same layer of the developing fetus, so it is an extension of fetal skin. It covers the entire interior of the uterus, and around the umbilical cord, and then extends as the fetal skin. The amniotic layer is the one closest internally to the baby. It keeps the baby from sticking inside the womb. Then, beneath that top layer is the chorion, which is more collagen-laden, but not as strong—this tissue that has more cells within it. Beneath that is the layer that is right up against the uterine wall that is from maternal origin—it is called the decidua. That maternal layer and the chorion layer, in effect, have fingers projecting into one another, and that’s where exchange of nutrients can happen between mother and fetal membranes. After birth of the baby, the placenta is delivered. It is typically a waste product, but these are now being harvested from healthy, normal-term deliveries. The amnion is very easy to strip apart from the chorion and the other parts of the membrane. Then, very gently, amnion is processed by scraping off the epithelium and rinsing it, which removes the cells from it. Then it is slowly dried to a dehydrated state and cut into a variety of sizes of sheets, so that doctors have a choice of which to use depending on the wound size. So it is simply providing a very thin, very pure amnion. It’s almost like plastic wrap, or tissue-paper thin—but inside, it’s a powerhouse. This is because it gives you a basement membrane, which is important since cells will attach to that membrane and create the epithelium you need for the outer of layer skin and it has an extracellular matrix that is mainly collagen. (Most of our body’s structural parts include collagen.) It involves different types of collagen that have with them other proteins, and glycogen-type molecules. There are also proteoglycans, your glycosaminoglycans, as well as other proteins that cells get attracted to. While it comes with no cells, it does allow for cells to infiltrate it. Once they sit there in the extracellular matrix, they will release whatever cytokines and growth factors are needed to keep the process going toward wound healing. There are structural collagen proteins to use, and it attracts the cells that are needed. We’ve actually done some recent benchtop research to show that it can wake up the cells that are senescent, which is a problem specifically with diabetes patients. They tend to have senescent cells, and therefore healing stalls. You need to do something to wake those cells up. This is something that benchtop research with models seems to show is happening.
SF: What type of wounds can be treated with Biovance?
Dr. S: We’ve done a study where we’ve treated all types. We’ve treated acute wounds and burns, we’ve treated diabetic pressure ulcers, venous stasis ulcers, those with collagen vascular disease, and those with ischemia. We found that there is some benefit across the board. Every wound needs to have new tissue built into it, and then the epithelium covers over it in order for the wound to be healed. If you allow the wound to do it on its own, and have the cells do all the building work, you end up with a scar. The scar tends to be a different color and a different texture than the skin around it. It continues to change in color and vascularity as it remodels over six months to a year’s time. It’s never quite as strong as normal skin. However, if you can provide some building blocks for that healing wound that look very much like native tissue should, then these will be welcomed and used by the wound, and cut short the process of cells having to rebuild everything from scratch. That is called regenerative healing. Regenerative healing actually cuts down on inflammation, which prolongs the vicious cycle of stalled wounds. It keeps it moving along. When you cut down on inflammation and provide the native-looking structural proteins that are needed, you end up with a wound that has minimal scarring, much softer and more functional tissue. I don’t have the data, if you will, to say that the strength returns to normal, but for all purposes it appears to be like normal tissue should be in the area. You can minimize scarring, and minimize the negative effect of having fibrosis by delayed healing.
SF: What about rejections? If you take a placenta from one individual and use it in an individual from a different racial background, what does that do?
Dr. S: Those two are not the same things. Under the skin, color is not there, so there’s no concern about any of that. The interesting thing about amnion is that it is immunologically inert. It has to be, or mothers would be rejecting their fetuses. It has this HLA class that is unique and that doesn’t allow for that specific kind of rejection. There are no foreign markers so that it is not seen as foreign. As long as you do nothing to rearrange its structure, like cross-link it or damage it in some way, then the body sees it as itself, and it doesn’t matter who you are. Now, if you have a product that will introduce maternal cells, which is possible if you include the chorion, then you may also include maternal cells if you don’t decellularize it; you may see some mild kind of reaction that happened. It is typically self-limited. It is inflammation. That was one of the reasons why, when Biovance was produced about 15 years ago, it was decided to only go with the amnion and not to use the chorion, and to remove all cells so that you wouldn’t have a cell marker issue. You just have the purest, most beneficial, and least risky layer of tissue.
SF: How long has it been in research and development? I assume it is FDA-approved—how long has that been the case?
Dr. S: The FDA does not require that human tissue allografts be approved. What they do is regulate how they are processed and advertised. It is treated just as a unit of blood would be: you don’t have to get it approved to use it for someone who needs the unit of blood. This is true as long as you’re using human tissue in a homologous way, meaning that where you are going to use it requires knowing its function in the donor. Because this is an extension of fetal skin, the FDA states that you can use it on a wound as a homologous function to provide a barrier from the outside world. It keeps moisture in, provides a structural component like it did in utero for the fetus, and offers protection. The other beautiful thing is that in utero, this was a tissue used to a highly hostile environment, because it didn’t have its own vascular supply—so it tends to tolerate some ischemia well whenever it is placed in wounds. It also has a native ability to protect from infection. We see that these chronic wounds are clean. There’s always a concern when you have any bio-burden that you are going to have proteases that will simply chew up whatever tissue product you put on them; but it’s able to withstand a pretty good amount, certainly not something you want to put into an infected situation. That’s true of any product. You want to take care of infection before you try to actively treat anyone.
SF: Is this covered by insurance/Medicare?
Dr. S: Presently, Biovance has Medicare coverage in one U.S. region. We’re going to the Medicare providers in the rest of the country and attempting to get on their approval lists. Commercial insurances have not denied its coverage. Those with diabetes who get ulcers typically tend to be older, and so Medicare coverage is very important. That is what we’re working toward at this point.
SF: Is limited availability an issue?
Dr. S: It hasn’t been so far. It’s interesting, isn’t it? There is certainly a lot of placental product out there now, but it doesn’t seem to be an issue. We have a five-year shelf life. There are babies born every day, so harvesting it hasn’t been a problem. We hope we won’t ever run into that shortage situation. There is no issue from an ethical standpoint.
SF: How do you get your placenta product? A woman goes into hospital, gives birth. There is a placenta…
Dr. S: The company that produces this product for us is one of the divisions of Celgene. You may know Celgene from its work in cancer drugs. They have a cord blood bank. They are in hospitals for people who want to store their cord blood. They also accept donations for the research, as well as develop some of their stem cell products. These placentas come from voluntary donors who were willing to undergo the testing that is necessary, just like when you donate blood. You have certain tests that are run on your blood. These folks have blood tests done to look for viruses that are of concern. The product itself is tested for bacteria and fungi, and just like all other human tissue product, goes through a very rigorous schedule test that it has to pass. The donors also go through social screening. They are asked a lot of questions, just like you do when you give a unit of blood. You have to pass the social history and medical history to be a donor. It is a very hands-on kind of processing, so you have all this testing that has to occur. In the meantime, you’ve got the processing going on—because it takes a while to get all that medical and social history, the history of the birth, and all the blood testing that takes place at the same time that the product is being physically processed. The FDA mandates that with human tissues, each donor is one lot. The one placenta makes up only one lot. You can only process one lot at a time. It is all hand-processed, and tracked very carefully from the manufacturer all the way through to the patient, so that if any issue comes up, even after it’s been cleared for use, you know exactly who used what placenta where.
Next week, Part 2 of our Exclusive Interview with Dr. Janice Smiell.
Dr. Janice M. Smiell, M.D., Chief Medical Officer, brings more than 20 years of wound care, regenerative medicine, and clinical development experience to Alliqua BioMedical. She is the former VP of Medical Affairs at LifeCell Corporation, where she oversaw clinical development and product safety programs from 2007 to 2011. LifeCell develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures. Prior to joining LifeCell, Dr. Smiell was the Executive Director of Global Clinical R&D at Celgene, where she led the clinical development of biomaterials and stem cells at the Company’s Cellular Therapeutics Division. From 1994 to 2003, Dr. Smiell was the Senior Director of Global Clinical R&D at Johnson and Johnson where she was awarded the prestigious Johnson Medal in recognition of her development work on Regranex, a growth factor for wound healing. Before joining Johnson and Johnson, Dr. Smiell served as the Medical Director of the Wound Care Center at Morristown Memorial Hospital. Dr. Smiell received her M.D. from the Medical College of Pennsylvania in Philadelphia (now Drexel University School of Medicine).
Discussion of Practical Implementation of SGLT-2's with a Patient
Editor's Note, GLP-1 Analog Special Edition, July 2015
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This article originally posted 12 July, 2015 and appeared in Diabetes Clinical Mastery Series Issue #249
Past five issues: Diabetes Clinical Mastery Series Issue #249 | Issue 789 | Diabetes Clinical Mastery Series Issue #248 | Issue 788 | Diabetes Clinical Mastery Series Issue 247 |
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Alliqua BioMedical, Inc. to Announce Second Quarter of Fiscal Year 2015 Results on August 6th
LANGHORNE, Pa., July 14, 2015 (GLOBE NEWSWIRE) -- Alliqua BioMedical, Inc. (Nasdaq:ALQA) ("Alliqua" or "the Company"), a provider of advanced wound care products, today announced plans to release second quarter of fiscal year 2015 financial results before the market opens on August 6th.
Chief Executive Officer, David Johnson, and Chief Financial Officer, Brian Posner, will host a teleconference at 8:00 a.m. Eastern Time on August 6th to discuss the results of the quarter and to host a question and answer session. Those interested in participating on the call may dial 888-378-0320 (719-325-2491 for international callers) and provide access code 7036127 approximately 10 minutes prior to the start time. A live webcast of the call will be made available on the investor relations section of the Company's website at http://ir.alliqua.com.
For those unable to participate, a replay of the call will be available for two weeks at 888-203-1112 (719-457-0820 for international callers); access code 7036127. The webcast will be archived on the investor relations section of Alliqua's website.
About Alliqua BioMedical, Inc.
Alliqua is a provider of advanced wound care solutions, committed to restoring tissue and rebuilding lives. Through its sales and distribution network, together with its proprietary products, Alliqua provides a suite of technological solutions to enhance the wound care practitioner's ability to deal with the challenges of healing both chronic and acute wounds.
Alliqua currently markets its line of dressings for wound care under the SilverSeal® and Hydress® brands, as well as the sorbion sachet S® and sorbion sana® wound care products, and its TheraBond 3D® advanced dressing which incorporates the TheraBond 3D® Antimicrobial Barrier Systems technology. The Company's Mist Therapy System® uses painless, noncontact low-frequency ultrasound to stimulate cells below the wound bed to promote the healing process. Alliqua also markets the human biologic wound care product Biovance®, as part of its licensing agreement with Celgene Cellular Therapeutics.
In addition, Alliqua can provide a custom manufacturing solution to partners in the medical device and cosmetics industry, utilizing its hydrogel technology. Alliqua's electron beam production process, located at its 16,500 square foot Good Manufacturing Practice (GMP) manufacturing facility, allows Alliqua to custom manufacture a wide variety of hydrogels. Alliqua's hydrogels can be customized for various transdermal applications to address market opportunities in the treatment of wounds as well as the delivery of numerous drugs or other agents for pharmaceutical and cosmetic industries. The Company has locations in Langhorne, PA and Eden Prairie, MN.
For additional information, please visit http://www.alliqua.com. To receive future press releases via email, please visit http://ir.stockpr.com/alliqua/email-alerts.
CONTACT: Investor Relations:
Westwicke Partners on behalf of Alliqua Biomedical, Inc.
Mike Piccinino, CFA +1-443-213-0500
AlliquaBiomedical@westwicke.com
10 AM and NO volume!
Are we halted for partnership news????
Alliqua BioMedical, Inc. to Ring the Nasdaq Stock Market Opening Bell on July 6th
LANGHORNE, Pa., June 29, 2015 (GLOBE NEWSWIRE) -- Alliqua BioMedical, Inc. (NASDAQ:ALQA) ("Alliqua" or "the Company"), a provider of advanced wound care products, will ring the opening bell at the Nasdaq Stock Market in Times Square to celebrate the Company's acquisition of Celleration, which closed on May 29, 2015.
When:
Monday, July 6, 2015 - 9:15 a.m. to 9:30 a.m. ET
Where:
Nasdaq MarketSite - 4 Times Square - 43rd & Broadway - Broadcast Studio
About Alliqua BioMedical, Inc.
Alliqua is a provider of advanced wound care solutions, committed to restoring tissue and rebuilding lives. Through its sales and distribution network, together with its proprietary products, Alliqua provides a suite of technological solutions to enhance the wound care practitioner's ability to deal with the challenges of healing both chronic and acute wounds.
Alliqua currently markets its line of dressings for wound care under the SilverSeal® and Hydress® brands, as well as the sorbion sachet S® and sorbion sana® wound care products, and its TheraBond 3D® advanced dressing which incorporates the TheraBond 3D® Antimicrobial Barrier Systems technology. The Company's Mist Therapy System® uses painless, noncontact low-frequency ultrasound to stimulate cells below the wound bed to promote the healing process. Alliqua also markets the human biologic wound care product Biovance®, as part of its licensing agreement with Celgene Cellular Therapeutics.
In addition, Alliqua can provide a custom manufacturing solution to partners in the medical device and cosmetics industry, utilizing its hydrogel technology. Alliqua's electron beam production process, located at its 16,500 square foot Good Manufacturing Practice (GMP) manufacturing facility, allows Alliqua to custom manufacture a wide variety of hydrogels. Alliqua's hydrogels can be customized for various transdermal applications to address market opportunities in the treatment of wounds as well as the delivery of numerous drugs or other agents for pharmaceutical and cosmetic industries. The Company has locations in Langhorne, PA and Eden Prairie, MN.
For additional information, please visit http://www.alliqua.com. To receive future press releases via email, please visit http://ir.stockpr.com/alliqua/email-alerts.
Legal Notice Regarding Forward-Looking Statements
This release contains forward-looking statements. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of our control that can make such statements untrue, including, but not limited to, the adequacy of the Company's liquidity to pursue its complete business objectives; inadequate capital; the Company's ability to obtain reimbursement from third party payers for its products; loss or retirement of key executives; adverse economic conditions or intense competition; loss of a key customer or supplier; entry of new competitors and products; adverse federal, state and local government regulation; technological obsolescence of the Company's products; technical problems with the Company's research and products; the Company's ability to expand its business through strategic acquisitions; the Company's ability to integrate acquisitions and related businesses; price increases for supplies and components; and the inability to carry out research, development and commercialization plans. In addition, other factors that could cause actual results to differ materially are discussed in our Annual Report on Form 10-K filed with the SEC on February 24, 2015, and our most recent Form 10-Q filings with the SEC. Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise.
CONTACT: Investor Relations:
Westwicke Partners on behalf of Alliqua Biomedical, Inc.
Mike Piccinino, CFA +1-443-213-0500
AlliquaBiomedical@westwicke.com
IsoRay's Cesium-131 Selected by Chicago Prostate Cancer Center for Use in the Launch of a Study of the Focal Treatment of Prostate Cancer
Cesium-131 Use in Prostate Focal Cancer Treatment Hopes to Minimize Side Effects and Improve Patient Quality of Life
Marketwired IsoRay, Inc.
2 hours ago
RICHLAND, WA--(Marketwired - Jun 29, 2015) - IsoRay, Inc. (NYSE MKT: ISR), a medical technology company and innovator in brachytherapy and medical isotope applications, today announced that Dr. Brian J. Moran, Director of Chicago Prostate Cancer Center in Westmont, Illinois, has initiated a study of focal prostate cancer treatment using Cesium-131 brachytherapy.
Focal therapy is treatment directed solely at the malignancy and its immediate surrounding tissue, rather than the entire gland or organ that is involved. The goal of focal therapy for prostate cancer is to eliminate the targeted cancer while sparing men the side effects that often come with whole gland treatment.
Dr. Moran stated, "I think the mindset of prostate cancer treatment until today has been all or none. In other words, one size fits all and you do either whole gland radiation or surgical removal. The medical community has been very slow to evaluate the concept of focal therapy for the treatment of prostate cancer."
Dr. Moran plans to build on observations derived from his previous focal cases and further noted, "Our initial experience with focal therapy was patient-driven by individuals who were deciding between active surveillance and full gland treatment. We initially embarked on this approach approximately 10 years ago. Over time, it became very apparent that the results were encouraging. Cancer control rates were excellent and toxicity was negligible. This should be the goal of any cancer therapy: to eradicate the malignancy while not impairing quality of life. Naturally, patient selection is of paramount importance when choosing focal therapy to treat prostate cancer. For the past 10 years, we have been offering a transperineal mapping biopsy that is very comprehensive. The information using this technique allows us to identify the exact location of the cancer within the prostate."
Dr. Moran's focal study will employ Cesium-131 radioactive seed implantation to the affected area of the prostate. Dr. Moran further noted, "We chose Cesium-131 due to its generous energy and homogeneous dose. This minimizes potential cold spots and offers adequate margin to the area being treated."
The study is currently open for enrollment, and will analyze patterns of response in a structured fashion.
IsoRay Chairman and CEO Dwight Babcock commented, "We are pleased that a growing number of leading physicians and medical institutions are embracing the use of Cesium-131 in fighting cancers throughout the body. We continue to receive inquiries from new physicians and institutions based on recently released peer reviewed publications reporting on the successes of using Cesium-131. Medical professionals rely on these publications to further their practice and learn about new leading edge products."
IsoRay's various products, including Cesium-131 seeds, sutured seeds, stranded mesh and the GliaSite® radiation therapy system, give physicians the ability to directly place a specified dosage of radiation in areas where cancer is most likely to remain after completion of a tumor removal or by placing seeds within the prostate. The ability to precisely place a specified dose of radiation means there is less likelihood for damage to occur to healthy surrounding tissue compared to other alternative treatments. IsoRay's cancer fighting products diminish the ability of the tumor to recur, resulting in important benefits for patients in longevity as well as quality of life.
About IsoRay
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of GliaSite® and Cesium-131 by visiting www.isoray.com. Join us on Facebook/Isoray. Follow us on Twitter @Isoray.
Safe Harbor Statement
Statements in this news release about IsoRay's future expectations, including: the advantages of our products and their delivery systems, whether IsoRay will be able to continue to expand its base beyond prostate cancer, whether the use of our products will increase or continue, whether awareness and adoption of our products in the medical community will continue or increase, whether ultimate study results will be favorable, whether current and future studies of treatment of various cancers using our products will have favorable results, and all other statements in this release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released and support the conclusions of past studies, whether ongoing patient results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers and malignant diseases beyond prostate, successful completion of future research and development activities, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in its various forms, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing efforts, changes in reimbursement rates, changes in laws and regulations applicable to our products, and other risks detailed from time to time in IsoRay's reports filed with the SEC. Unless required to do so by law, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
IsoRay Medical
Info@Isoray.com
(509) 375-1202
Or
Worldwide Financial
Info@wwfinancial.com
(954) 360-9998
FUNMAN... Very familiar with BAE
from a few years ago when MRAPs were the chosen vehicle of the Army and Marines. BAE, FRPT and GD were the main providers. I know that BAE has a great relationship with the armed services. And now with Nussbaum and Wise, it has to be better for a working partnership with DRNE..
Thanks for all your help..
$H...Thanks for the welcome.
Cowen & Co Initiates coverage with $9 PT 6/26/15
According to Benzinger, Cowen & Co Initiated coverage of Alliqua today with a $9. PT.
Read the headline on TD Amer, but unable to copy and paste.
Yup.. Just answered my own question.
Went back and read some PRs and posts here.
FUNMAN...
Followed you over.
Am I to understand that ROX is going into one or more of the Russel Index Funds?
Thanks for your input..
FUNMAN
Thanks...Great info.
I'm familiar with several other Frost companies including ROX, COCP,CDXC, and VGR..Not in those but keep watching!
Started following back in the days of Key Pharmaceuticals and then into IVAX..
He is a very astute business man.
Wish I had his patience.... (and money)
FUNMAN.. thanks for the article.
And thank you for all the information you provide. I have been a fan of Dr. Frost for a long time and currently have a few of his companies in my portfolio.(LTS, ALQA, OPK)
Looking to get in to DRNE also.
Perhaps you could help me with a question. I have gone to the web site, checked Yahoo, IHUB, TD and can not find out who the competition is, if any.
Are you aware of any companies presently manufacturing these type drones and do any of them have relationships with the US govt as does DRNE who is also working together with Troll and BAE on separate but similar projects?
TIA
Alliqua BioMedical, Inc. Announces the Publication of Results From a Biovance(R) Use Registry Study in WOUNDS
LANGHORNE, Pa., June 25, 2015 (GLOBE NEWSWIRE) -- Alliqua BioMedical, Inc. (Nasdaq:ALQA) ("Alliqua" or "the Company"), a provider of advanced wound care products today announced that a review of an observational study, focusing on the use of the Company's Biovance Amniotic Tissue Allograft to treat chronic wounds was published in WOUNDS, the most widely-read, peer-reviewed journal focusing on wound care and wound research.
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Release PDF
The review, authored by Janice Smiell, Terry Treadwell, Helen Hahn and Michel Hermans, is titled, Real-world Experience with a Decellularized, Dehydrated Human Amniotic Membrane Allograft1. It is focused on the chronic wound data subset from a larger observational study with 230 subjects/244 chronic and acute wounds at 19 centers across the US. This review includes 165 subjects with 179 chronic wounds across the 15 wound care centers that treated chronic wounds.
"This review demonstrates what can be expected when treating chronic wounds in patients with multiple comorbidities in the real-world-setting, without the restrictions of inclusion and exclusion criteria found in prospective randomized controlled trials," said Dr. Janice Smiell, Alliqua's Chief Medical Officer. "It was an 'all comers' study; only patients with actively infected wounds or known hypersensitivity to decellularized, dehydrated human amniotic membrane allografts were excluded. More than half of the 165 subjects included in our sample would have been excluded from a randomized, controlled trial because of comorbid conditions."
"Despite the presence of factors and comorbidities, which may have a negative impact on healing, 49.6% of compliant patients with chronic wounds achieved complete wound closure at a mean-time-to closure of 7.4 weeks (median 6.3 weeks), including many cases where prior treatment with advanced biological therapies had failed. This is an improvement over the wound closure outcomes in the standard care control arms of prospective randomized studies with venous or diabetic ulcers are reported to be between 24 and 34%. As my co-authors and I concluded, these findings demonstrate the effectiveness of human amniotic membrane allografts like Biovance in a broad, real-world population of all types of chronic wounds. In the health care environment of 2015, where health care providers are increasingly reliant on quality metrics and real-world data, we believe that this study will help practitioners to more effectively navigate the challenges brought by the complexities of chronic wounds."
About Alliqua BioMedical, Inc.
Alliqua is a provider of advanced wound care solutions. Through its sales and distribution network, together with its proprietary products, Alliqua provides a suite of technological solutions to enhance the wound care practitioner's ability to deal with the challenges of healing both chronic and acute wounds.
Alliqua currently markets its line of dressings for wound care under the SilverSeal® and Hydress® brands, as well as the sorbion sachet S® and sorbion sana® wound care products, and its TheraBond 3D® advanced dressing which incorporates the TheraBond 3D® Antimicrobial Barrier Systems technology. The Company's Mist Therapy System® uses painless, noncontact low-frequency ultrasound to stimulate cells below the wound bed to promote the healing process. Alliqua also markets the human biologic wound care product Biovance®, as part of its licensing agreement with Celgene Cellular Therapeutics.
In addition, Alliqua can provide a custom manufacturing solution to partners in the medical device and cosmetics industry, utilizing its hydrogel technology. Alliqua's electron beam production process, located at its 16,500 square foot Good Manufacturing Practice (GMP) manufacturing facility, allows Alliqua to custom manufacture a wide variety of hydrogels. Alliqua's hydrogels can be customized for various transdermal applications to address market opportunities in the treatment of wounds as well as the delivery of numerous drugs or other agents for pharmaceutical and cosmetic industries. The Company has locations in Langhorne, PA and Eden Prairie, MN.
For additional information, please visit http://www.alliqua.com. To receive future press releases via email, please visit http://ir.stockpr.com/alliqua/email-alerts.
Legal Notice Regarding Forward-Looking Statements
This release contains forward-looking statements. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of our control that can make such statements untrue, including, but not limited to, the adequacy of the Company's liquidity to pursue its complete business objectives; inadequate capital; the Company's ability to obtain reimbursement from third party payers for its products; loss or retirement of key executives; adverse economic conditions or intense competition; loss of a key customer or supplier; entry of new competitors and products; adverse federal, state and local government regulation; technological obsolescence of the Company's products; technical problems with the Company's research and products; the Company's ability to expand its business through strategic acquisitions; the Company's ability to integrate acquisitions and related businesses; price increases for supplies and components; and the inability to carry out research, development and commercialization plans. In addition, other factors that could cause actual results to differ materially are discussed in our Annual Report on Form 10-K filed with the SEC on February 24, 2015, and our most recent Form 10-Q filings with the SEC. Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise.
1 http://www.woundsresearch.com/article/real-world-experience-decellularized-dehydrated-human-amniotic-membrane-allograft
CONTACT: Investor Relations:
Westwicke Partners on behalf of Alliqua Biomedical, Inc.
Mike Piccinino, CFA +1-443-213-0500
AlliquaBiomedical@westwicke.com
Alliqua, Inc. logo
Source: Alliqua BioMedical, Inc.
Released June 25, 2015
CN... in your opinion
If you are correct in your assumption there is a possible buyout of Nulief, what value would be left to NRTI? Or are you saying buyout of the whole company?
IMO, The share price would plummet (if Nulief is sold) lower than it is now.
Either way, it will be a longgggg road back to the share price we saw last year, if ever.
IsoRay Intends to Vigorously Defend Litigation
Retains Wilson Sonsini as Counsel
RICHLAND, WA--(Marketwired - Jun 23, 2015) - IsoRay, Inc. (NYSE MKT: ISR) has retained Wilson Sonsini Goodrich & Rosati to defend the Company and certain officers named in several lawsuits filed against it related to a press release on May 20, 2015.
The lawsuits relate to a May 20 Company press release, regarding a May 19 online publication of the peer-reviewed article in the journal Brachytherapy titled "Analysis of Stereotactic Radiation vs. Wedge Resection vs. Wedge Resection Plus Cesium-131 Brachytherapy in Early-Stage Lung Cancer" by Dr. Bhupesh Parashar, et al.
We believe the lawsuits are without merit and we intend to contest them vigorously.
About IsoRay
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of GliaSite® and Cesium-131 by visiting www.isoray.com . Join us on Facebook/Isoray. Follow us on Twitter @Isoray.
Safe Harbor Statement
Statements in this news release about IsoRay's future expectations, including: whether the pending litigation has merit, IsoRay's intention to contest the pending litigation vigorously, and all other statements in this release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as the actual claims made in the litigation, the complexities and expense of litigation, the uncertain nature of litigation and judicial processes, future developments with respect to the filed claims, the potential perceptions of the Company's current and future customers regarding the litigation, and other risks detailed from time to time in IsoRay's reports filed with the SEC. Unless required to do so by law, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
IsoRay Medical
Info@Isoray.com
(509) 298-3360
Or
Worldwide Financial
Info@wwfinancial.com
(954) 360-9998
Must be some news. AH trade
At 4:08 293,600 shares at 1.60 HOD
stargazer...thanks
for that great review.
Tomorrow, you should post it on the "Frost Plays" board so more people can view it. message board http://investorshub.advfn.com/Phillip-Frost-Plays-27154/
Great info.. thanks
OPK can be another Key pharmaceuticals and IVAX. Dr. Frost has been tremendous at building companies by acquiring others with stock.
CN... Great post....
Did you also email it to him or do you believe he monitors this board?
What do you think if we all copy & paste and email it to him? Maybe send it to Kras also!!
RBC Capital issues $8 price target
Can't paste the link in.
Saw it on Ameritrade
While management is twiddling their thumbs.....
others are making progress and could soon pass us.
Interesting last paragraph....
June 2, 2015
The Emergence of High-CBD Edibles: Q&A With Sweet Seed Farms’ Gideon Murray
By John Schroyer
Gideon Murray spent time as an investment banker, a business development executive, a real estate investor and an English teacher before becoming the chief executive officer of a medical marijuana dispensary in Colorado.
Now, he’s getting into the edibles business.
Murray is seeking investment capital for his latest company, Sweet Seed Farms, which plans to begin selling high-CBD, low-THC products soon.
He certainly seems to be on the right track. Murray participated in a mock investment pitch contest at the Spring Marijuana Business Conference and Expo in Chicago last month and wound up taking home the trophy.
Murray wants to focus much more on the medicinal side of cannabis than the recreational. He has good reason to do so: Based on his experience in Aspen, Colorado, there’s a huge and untapped market for quality CBD products.
Murray spoke with Marijuana Business Daily after winning the pitch contest about his vision of the future of CBD products, how he plans to make his business work, and what he’s found has appealed to potential investors.
What makes you think the market for CBD products can eventually rival the market for high-THC infused products?
There’s more and more demand from patients asking about CBD. And THC has been bred so high into the plant, that nobody really has a firm understanding of CBD and the potential benefit there.
You also see all these states passing laws to allow Charlotte’s Web, which is obviously a high-CBD, low-THC strain. I think that there may be a lot of states that are going to allow for CBD products well before they allow for high-THC products.
How did you come up with this business idea? Was it just from working at the Aspen dispensary and realizing the current industry couldn’t meet the demand for CBD products?
Being involved with the dispensary, I saw that the competition was severe, and the real way to have great longevity and profitability is to differentiate yourself.
To do that, you have to have some science and unique products behind you. When I met my partners, who were working on high-CBD strains, I realized that this was incredibly powerful from a breeding perspective, because they had not only high-CBD, low-THC, but also high-yielding plants.
And from a medicinal standpoint, I think there’s a real opportunity. Being someone who speaks to investors quite frequently, the big money really wants to get into the medicinal side of cannabis. They’re not really interested in doing dispensaries, grows, and edible products with high THC.
How long do you think it will be before CBD products catch up to THC?
I think it’s going to be sort of state-specific. In Colorado, it could happen fairly quickly, maybe in the next couple of years. I think once that happens in Colorado…the ability could be there for companies like ours to expand into other states.
What are some of the obstacles you’ve encountered as a new infused product manufacturer in a state like Colorado, which is a fairly established market with a good number of competitors?
I don’t see anybody competing on a high-CBD level. I see a lot of THC. And quite honestly, I’m not impressed with the products that are out there, because they’re all high-fructose corn syrup-type sugary products, and very few of the offerings out there are healthy.
The obstacles, honestly, are getting investors. I’ve been through the ringer getting licensing with the state and local authorities. If we can find an investor who’s willing to take the sort of operating capital/equity piece, that’s the tough one. There are very few people who are willing to take the risk.
But I think that risk is fairly nominal compared to the potential upside.
What kind of advice can you offer to companies pitching investors, based on your success at the Pitch Slam in Chicago?
From what I saw from our competitors, I think one of them didn’t fully understand the cannabis market. So obviously understand your market.
Also, a lot of it went down to nerves. Some people went too fast and left people in the dust, and others didn’t practice enough. I spoke to GreenBroz who won in November, and they just said, practice, practice, practice. So I did that for months.
What’s your sense of the overall climate for investing in cannabis companies? Have you found any particular approaches that work or don’t work?
I think investors are eager for cannabis companies that have a real level of professionalism, and our team is very dynamic. We have a master herbologist, we have a doctor, we have people who have been breeding for half a dozen years, and my background in business and banking.
There’s more and more professionals coming into the industry. So investors are looking for that business sense.
I keep hearing over and over again that investors would rather have a good team with an average idea than a poor team with a great idea. So if you have a great idea and a great team, that helps a lot.
John Schroyer can be reached at johns@mjbizmedia.com
WOW!
I hope the court sticks it to them...
CN... Are you
the new marketing partner? You certainly should be paid like one. Good thing you are providing them guidance!
Thanks
IsoRay (ISR) Results 'Exceptional', Maxim Group Says; Reiterates Buy Rating, $5 PT
1:58 PM ET, 05/20/2015 - StreetInsider
Maxim Group analyst Jason Kolbert reiterated a Buy rating and $5 price target on IsoRay, Inc. (NYSE: ISR) announced the on-line publication of the first major peer reviewed study showing improved results using IsoRay's Cesium-131 seeds in the treatment of lung cancer. Cesium-131 showed 96% success in local control and 100% survival at 5 years in high risk patients.
Kolbert commented, "We believe Cs-131 is a more efficacious, safer alternative to the SOC isotopes Iodine-125 or Palladium-103. Cs-131 hits the tumor faster and harder (shorter half life) which should convince physicians to adopt. As Cs-131 is now in centers in the east, west and central parts of the US, we believe adoption will continue. More data and more publications are coming to help the push."
IsoRay's Cesium-131 Lung Cancer Treatment Reports 96% Success in Local Control and 100% Survival at 5 Years in High Risk Patients in Newly Published Report
8:15 am ET May 20, 2015 (Market Wire)
IsoRay, Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced the on-line publication of the first major peer reviewed study showing improved results using IsoRay's Cesium-131 seeds in the treatment of lung cancer.
IsoRay CEO Dwight Babcock commented, "We are extremely excited to have our Cesium-131 isotope seeds and mesh used in the treatment of non-small cell lung cancers with such outstanding patient outcomes. Notable physicians, including the authors of this study, are seeking better solutions and outcomes for their patients. We are continuing to develop our product offerings internally with support from these industry leaders. With every success that has been reported, the medical community is rapidly becoming aware of the innovative alternative our Cesium-131 products offer to cancer patients."
Dr. Bhupesh Parashar MD, of Weill Cornel Medical College, is lead author of the publication titled: 'Analysis of Stereotactic Radiation vs. Wedge Resection vs Wedge Resection Plus Cesium-131 Brachytherapy in Early-stage Lung Cancer'. The study noted that the survival rate at 5 years was exceptional for the Cesium-131 group, which included many high risk patients, and Cesium-131 added no noticeable side effects. Treatment with Cesium-131 was performed at the time of the surgery as a single treatment, in contrast to another treatment option, external radiation, which requires numerous hospital visits. To review the report as published online as of May 19, 2015, please follow the link provided here: http://www.sciencedirect.com/science/article/pii/S1538472115004559
Babcock said, "Published studies are the final step to commercialization as leaders in the medical arena recognize the important need for a new powerful weapon in the battle against cancer. This latest publication, in conjunction with other recent published reports on metastatic brain cancer and gynecological cancers, are proving Cesium-131's time is now. Not only does Cesium-131 work but it is a single application providing improved quality of life for the patient."
IsoRay's various products, including Cesium-131 seeds, sutured seeds, stranded mesh and the GliaSite(R) radiation therapy system, give physicians the ability to directly place a specified dosage of radiation in areas where cancer is most likely to remain after completion of a tumor removal or by placing seeds within the prostate. The ability to precisely place a specified dose of radiation means there is less likelihood for damage to occur to healthy surrounding tissue compared to other alternative treatments. IsoRay's cancer fighting products diminish the ability of the tumor to recur, resulting in important benefits for patients in longevity as well as quality of life.
IsoRay is the exclusive manufacturer of Cesium-131. The pioneering brachytherapy therapy is one of the most significant advances in internal radiation therapy in 20 years. Cesium-131 allows for the precise treatment of many different cancers because of its unrivaled blend of high energy and its 9.7 day half-life (its unequaled speed in giving off therapeutic radiation).
In addition to its CMS codes, Cesium-131 is FDA-cleared and holds a CE mark for international sales in seed form for the treatment of brain cancer, prostate cancer, lung cancer, ocular melanoma cancer, colorectal cancer, gynecologic cancer, head and neck cancer and other cancers throughout the body. The treatment can be deployed using several delivery methods including single seed applicators, implantable strands and seed sutured mesh. IsoRay also sells several new implantable devices, including the GliaSite(R) radiation therapy system.
About IsoRay IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of GliaSite(R) and Cesium-131 by visiting www.isoray.com. Join us on Facebook/Isoray. Follow us on Twitter @Isoray.
Safe Harbor Statement Statements in this news release about IsoRay's future expectations, including: the advantages of our products and their delivery systems, whether IsoRay will be able to continue to expand its base beyond prostate cancer, whether sales of our products will continue at historic levels or increase, whether the use of our products will increase or continue, whether we will continue to receive support from industry leaders, whether awareness of our products in the medical community will continue or increase, timing of commercialization of our products, and all other statements in this release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released and support the conclusions of past studies, patient results achieved with our products, successful completion of future research and development activities, our ability and the ability of our distributors and customers to receive and maintain all required regulatory approvals in the U.S. and internationally, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing efforts, changes in reimbursement rates, changes in laws and regulations applicable to our products, and other risks detailed from time to time in IsoRay's reports filed with the SEC. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
IsoRay Medical
Info@Isoray.com
(509) 375-1202
Or
Worldwide Financial
Info@wwfinancial.com
(954) 360-9998
SOURCE: IsoRay, Inc.
H.C. Wainwright Assigned a Buy Rating to Alliqua
By George Macdonald
In a report published on May 15, Swayampakula Ramakanth from H.C. Wainwright Assigned a Buy rating to Alliqua (NASDAQ: ALQA), with a price target of $11. The company’s shares closed last Friday at $4.48.
Alliqua has an analyst consensus of Strong Buy, with a price target consensus of $8.
The company has a one year high of $7.20 and a one year low of $3.70. Currently, Alliqua has an average volume of 90.85k.
According to TipRanks, Ramakanth is a 3-star analyst with an average return of 4.6% and a 28.1% success rate. Ramakanth covers the Healthcare sector, focusing on stocks such as IntelGenx Technologies, Sorrento Therapeutics, and Aldeyra Therapeutics.
Alliqua BioMedical Inc is a biomedical company providing wound care solutions. It is also engaged in contract manufacturing.
FDA Says CBD Products.....
http://mjbizdaily.com/fda-says-cbd-products-dont-qualify-as-dietary-supplements/
May 15, 2015
FDA Says CBD Products Don’t Qualify as Dietary Supplements
FDA
The U.S. Food and Drug Administration has ruled that cannabidiol products don’t fit under the legal definition of dietary supplements and therefore can’t be marketed as such under the federal Food, Drug and Cosmetic Act.
The news could force many companies already producing CBD products across the country to either revise their marketing strategies or possibly even alter their product labels.
“Products containing (CBD) are outside the definition of a dietary supplement,” the FDA’s site now reads. “There is an exception if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol.”
Factbook300x150 FDA Says CBD Products Dont Qualify as Dietary SupplementsThe agency didn’t specify what types of enforcement actions it may take against companies that continue to market CBD as a dietary supplement. The site does say that the FDA “considers many factors” in such decisions, including input from other federal agencies and state officials, and whether such products constitute a threat to public health.
The lack of scientific research and evidence into the medicinal and dietary benefits of marijuana-based products has long been a stumbling block for cannabis companies, including those that specialize in hemp-based CBD products.
The FDA acknowledged this point, and wrote that it will continue to work with companies that are “interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of marijuana.”