Skyline Medical Inc (NASDAQ:SKLN) producer of the FDA-sanctioned STREAMWAY® System posted that it has obtained a Medical Device Establishment License to offer the STREAMWAY System and associated disposables in Canada.
Many distributors have shown interest in offering STREAMWAY into Canada’s healthcare arrangement. Skyline has now commenced discussions with many of them and anticipates within the upcoming few weeks to finalize terms with one or more suppliers, covering about 1,500 hospitals in 13 provinces of Canada.
The management speaks
Dr. Carl Schwartz, the executive Chairman of Skyline, said that they look forward to getting the STREAMWAY System to healthcare facilities and professionals to the nearly 10,000 operating rooms in Canada. This nod follows acceptance of ISO 13485:2003 authorization for the STREAMWAY plan, which not only was a prerequisite for Canadian nod, but is required for the CE Mark and following sales in the European Union. The management is delighted to achieve this vital milestone in their plans for broader delivery of the STREAMWAY System.
Earlier in the month, the company updated on the highlights of 3Q2016. Skyline finalized a deal with GLG Pharma, Inc. to be the sole distributor of the STREAMWAY in the U.K., Poland and some of the Central European nations. In association with GLG, it will also advance diagnostic kits to be utilized with the STREAMWAY System. The company finalized a LOI to establish a JV with EOR.
The CEO of Skyline said that the third quarter have been very active as they took many decisive measures to support company’s growth in the approaching months, and to fix a foundation for highly considerable longer-term opportunities. They are grateful to their investors for their support and their collective optimism for firm’s future.
The company broadened its management team with the recruitment of Peter Alex as VP of Sales, and engaged world-class, renowned advisors and board members. Collectively these additions are enhancing pipeline of potential products and sales channels, and open new prospects for Skyline Medical.