Skyline Medical Inc. (NASDAQ: SKLN) is watching its shares more than double in Tuesday’s session after the company issued a key update for its prospective Canada sales. The company announced that it has received a Medical Device Establishment License to sell its Streamway System and related disposables in Canada.

For some quick background, the 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.

A number of distributors have expressed interest in selling Streamway into Canada’s healthcare system.  Skyline has now begun talks with several of them and expects within the next few weeks to come to terms with one or more distributors, covering approximately 1,500 hospitals in all 13 provinces of Canada.

As of September 30, 2016, Skyline Medical customers have installed 96 Streamway systems in 50 facilities across 19 states.

Dr. Carl Schwartz, Executive Chairman of Skyline Medical, commented:

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. This approval follows receipt of ISO 13485:2003 certification for the Streamway System, which not only was a requirement for Canadian approval, but is necessary for the CE Mark and subsequent sales in the European Union. We are pleased to reach this important milestone in our plans for broader distribution of the Streamway System.

Including Tuesday’s move, Skyline has outperformed the broad markets with the stock up 62% year to date.

Shares of Skyline were up nearly 130% at $4.78, with a 52-week trading range of $0.08 to $6.05.

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