Skyline Receives Canada Approval For STREAMWAY System


Major indices were trading in the red Wednesday. The S&P 500 dipped 0.33% while the Dow 30 is showing a minor 0.03% decline. The NASDAQ was following the same trend, dropping 0.58%. Lastly, the Biotech-centric index IBB was 0.96% below its Tuesday’s close. The U.S. markets seemed to have taken their cue from global markets, which more or less remained bearish.

Eli Lilly reported negative results for its Alzheimer’s drug test, giving a jolt to the pharmaceutical industry. This failure has cast doubts about the efforts carried on by various companies to find a cure for this difficult-to-treat disease. U.S. jobless claims showed a spike last week, after touching multi-decade lows. Lastly, international markets seemed to be rattled by Lufthansa pilots’ strike, which led to the aviation company cancelling about 900 flights.

Going back to the biotech angle, Skyline Medical Inc. (NASDAQ: SKLN) announced that it received approval for its STREAMWAY System and related disposables from Canadian authorities. The company said that a number of distributors had expressed interest in selling STREAMWAY into Canada’s health-care system.

Dr. Carl Schwartz, executive chairman of Skyline Medical said, "We look forward to bringing the STREAMWAY System and its many benefits to healthcare professionals and facilities to the approximately 10,000 operating rooms across Canada."

He also added that the system had recently obtained ISO 13485:2003 certification, which was required for Canadian approval. The certification is also mandatory for CE mark and for selling goods in the European Union.

STREAMWAY system is the first true direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures. It connects directly to a facility's plumbing system to automate the collection, measurement and disposal of waste fluids.

The system has already received approval from the U.S. Food and Drug Administration (FDA). It helps in minimizing the need for human intervention.

Upon the announcement, the stock jumped 200% in Tuesday’s trading session, however gave back some of those gains in Wednesday’s session.

Skyline also recently reported its results for the third quarter. The company reported its revenues for the quarter coming in at $0.13 million while the Company posted a net loss of $1.06 million.

Skyline Medical is a medical device company. It mainly develops devices which are environmentally conscientious. Its STREAMWAY Fluid Management System is used for suctioning surgical waste fluid from the patient using standard surgical tubing. The company was earlier known as BioDrain Medical, Inc. It changed its name to Skyline Medical, Inc. in August 2013.