Skyline Medical Inc (NASDAQ:SKLN) Investors Hopeful for Regulatory Approval


Skyline Medical Inc (NASDAQ:SKLN) shares rose 3.31% on Wednesday as the company recently ISO 13485 Certification for its Streamline device. The company has a market cap of $9.94 million at 66.16 million shares outstanding. Share prices have been trading in a 52-week range of $0.10 to $6.76.

Skyline Medical is a medical device company that develops and manufactures The STREAMWAY System, which is a solution for the collection and disposal of infectious fluids that result from surgical procedures and post-operative care. It distributes these products to hospitals, surgical centers and other medical facilities where bodily and irrigation fluids produced during surgical procedures must be contained, measured, documented and disposed. Aside from that, Skyline Medical manufactures and sells two disposable products required for system operation: a bifurcated single procedure filter and tissue trap and a single use bottle of cleaning solution, both of which are used on a single-procedure basis.

The company has already obtained FDA approval for this device, which is already in use in over 50 facilities in the United States. Studies have shown that there are 50 million canisters of disease infected waste are dumped in to landfills in the US each year and that there are roughly 6,000 hospitals in the country that could still benefit from the STREAMWAY System.

In a recent announcement, Skyline Medical appointed Peter Alex as VP of Sales, tasked of targeting these 6,000 hospitals for sales and distribution of their STREAMWAY System in the country. To top it off, the company is seeking regulatory approval in Canada as well in order to be able to offer their products and services in the Canadian market.

There are approximately 2,000 hospitals in Canada and Skyline Medical is working on getting approval from Health Canada, which is the equivalent of the FDA there. Any positive updates on this could mean significant upside for share prices in the coming months.

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