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BioLight Reports Successful Feasibility Clinical Study Results for

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midastouch017   Tuesday, 07/26/16 09:47:26 AM
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BioLight Reports Successful Feasibility Clinical Study Results for the Detection of Prostate Cancer with CellDetect® Non-Invasive Test

TEL-AVIV, Israel, July 26, 2016 /PRNewswire/ --

BioLight Life Sciences Ltd. (BOLT.TA) ("BioLight" or the "Company"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions and also in innovations in cancer diagnostics, announced promising results from a feasibility clinical study designed to detect prostate cancer cells in urine specimens using its CellDetect® technology. The study successfully demonstrated the feasibility of detecting intact cells originating in the prostate from urine samples following prostate massage.

The CellDetect® technology is being developed by Micromedic Technologies (MCTC.TA), BioLight's cancer diagnostics subsidiary, and allows an accurate diagnosis of cancerous and precancerous cells, based on a unique combination of color and morphology, by utilizing a proprietary kit containing unique extract and dyes. These study results represent a significant milestone in the commercial development of a third diagnostic product based on the CellDetect® platform technology for different cancers, and paves the way for the detection of prostate cancer through a simple urine test.

"We are very pleased with the results from this clinical study, which validates the potential we see in the CellDetect® technology to dramatically improve prostate cancer diagnostics," commented Susana Nahum Zilberberg, BioLight's Chief Executive Officer. "While prostate cancer is the second most common cancer in men worldwide, the currently available diagnostic testing is known to be unreliable or invasive and expensive. With the results that we have announced today, we are confident that CellDetect® has the potential to transform prostate cancer diagnostics, offering patients a non-invasive, accurate and reliable test, and one that could improve the healthcare system through considerable cost savings."

The feasibility clinical study was conducted in the Kaplan Medical Center in Israel. Using the CellDetect® technology, urine samples derived from prostate cancer patients and healthy subjects were examined for the existence of cancerous and precancerous cells using a unique color marker. Of the 18 samples tested, Micromedic's research team correctly diagnosed each case in the study. Assessment of the samples by an external reviewer produced encouraging results, correctly identifying most cases of prostate cancer and most of the healthy subjects as well.

"These results add momentum to what has already been a strong year for BioLight's CellDetect® platform," continued Ms. Zilberberg. "Overall, we believe this technology fills a key void in cancer diagnostics, not only for prostate cancer, but other cancer indications as well."

Last year, BioLight announced that a blinded, multi-center clinical study of CellDetect® had successfully achieved the study's primary endpoint for effectively detecting the recurrence of bladder cancer in subjects with a history of the disease. Since then, BioLight has obtained CE Marking for the use of CellDetect® testing for the detection of bladder cancer in urine, which allows the product to be marketed and sold in Europe and other territories. The Company also recently announced a partnership agreement with Axella Research LLC to advance commercialization of the bladder cancer product in the United States.

About Prostate Cancer

Prostate cancer is the second most common cancer among men worldwide. The incidence of prostate cancer in the U.S. is the highest in the world and it represents the second most common cause of cancer-related death in men. In 2014, 233,000 new cases of prostate cancer were diagnosed in the U.S., and nearly 30,000 patients died of the disease.

About CellDetect®

Micromedic's CellDetect® technology allows an accurate diagnosis of cancerous and precancerous cells, based on unique combination of color and morphology. The technology may be implemented in screening tests and monitoring tests of disease recurrence in cancer patients after being treated. Micromedic has proven the product's efficacy in diagnosing cervical cancer and bladder cancer in the framework of clinical trials, and estimates that the technology underlying the products may be implemented for use in additional cancer indications. Both the cervical cancer detection screening diagnostic test kit and detection of bladder cancer recurrence in urine are in the initial commercial stage.

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