Skyline Medical Inc.
Jun 29, 2017

Skyline Medical Issues Letter to Stockholders

MINNEAPOLIS, June 29, 2017 (GLOBE NEWSWIRE) -- Skyline Medical Inc. (NASDAQ:SKLN) ("Skyline" or "the Company"), producer of the FDA-approved STREAMWAY® System for automated, direct-to-drain medical fluid disposal, today issued the following letter to stockholders, which may be found on its website at www.skylinemedical.com.

To My Fellow Stockholders:

The past six months have been productive and busy as the staff at Skyline Medical has worked diligently to position our company for near-term growth and future success.  Looking to the second half of 2017, I'd like to take this opportunity to update our stockholders on various initiatives, some well underway and others brand new, and to discuss our business plans and milestones.

Our most recent achievement was receiving notification that we can affix the CE mark to the STREAMWAY® System, thereby allowing for us to market and sell the STREAMWAY in 32 European countries.  With this important and hard-earned milestone behind us, we are now actively engaged in the process of assembling the proper distribution network. We are specifically targeting markets we can penetrate early and more easily. We expect to launch the STREAMWAY System and record our first European sale by the end of the year. Our team anticipates a full European rollout to be complete by early 2018.

Among our areas of domestic focus are opportunities with the U.S. government.  We are speaking with several high-quality distribution partners with priority access into Veterans Affairs hospitals and other federal facilities.  Our new consultant has 60 veteran employees around the world, including 42 in the U.S. They are advocating for our product in the U.S. government market and are working with Service Disabled Veteran Owned Small Business (SDVOSB) distributors that will resell our product.

Skyline has received inquiries from many hospitals that are interested in purchasing STREAMWAY Systems for their operating and procedure rooms, and invariably the topic of installation is raised. We believe that providing a turnkey installation capability is important to support these sales. We are in discussions with installation companies for biomedical services that we plan to use for installation of our units not only in Veterans Affairs facilities, but in commercial hospitals as well.

As you know, we have been engaged in negotiations with Electronic On-Ramp (EOR) since signing a letter of intent late last year.  We have recently determined not to pursue a definitive agreement with them for a number of reasons, including the broad-based capabilities of other potential distributors as I've outlined above.  We also determined through due diligence that the pathway with EOR would not be in the best financial interest of Skyline stockholders, as the considerable funding Skyline would need to invest in the venture likely would not provide the desired return on our investment.

Regarding the opportunity we face in Canada, we are pursuing a combination of direct sales and distributor sales.  We intend to make a hire or engage a consultant in Canada to lead our sales efforts there under the direction of Peter Alex, our vice president of sales.  We are also working with the consultant who supported our CE mark application to assist us in pinpointing Canadian distributors that fit well with our product.

We continue to be focused on trade associations as a means of developing interest in STREAMWAY, including active participation with the AHRA, the Association for Medical Imaging Management.  The Association is the professional organization representing management at all levels of hospital imaging departments, freestanding imaging centers and group practices. It has 5,000 members across the country and around the world, and represents the strongest hospital call point for STREAMWAY. 

We will be exhibiting at the group's annual meeting in Anaheim, California, July 10th through 12th.  We expect our booth to provide new sales leads for STREAMWAY and to reinforce our past exhibits at AHRA meetings.  Key marketing initiatives have been incorporated into our strategy to help drive interest and booth traffic including pre-show emails, social media announcements and in-show promotions. The radiology suite is a key focus for STREAMWAY as those procedures typically result in large volumes of medical waste fluids that need to be disposed of easily and properly. 

In addition to collaborative marketing efforts with AHRA, such as advertisements and digital campaigns, we have engaged with AHRA as a proud sponsor of their Educational Foundation.  The Foundation provides resources for programs, projects, products, and services specifically designed to promote ongoing applied management education for imaging leaders. At the AHRA 2017 Annual conference we will be recognized as an Educational Foundation sponsor and have been invited to the Presidential Reception at the conference.   As a supporter of the Foundation we also benefit as a sponsor at local and regional AHRA meetings.  We look forward to building upon our growing relationship with AHRA and its members.

Skyline will be participating once again in the Vizient Clinical Connections Summit and Innovative Technology Exchange in Denver on September 14th. This event showcases the latest in health care technology designed to improve patient outcomes and advance the needs of participating healthcare enterprises in new and innovative ways. The Exchange is an opportunity to meet face-to-face with more than 2,000 hospital experts. This is a highly selective event, and we are thrilled STREAMWAY has been approved to exhibit and participate in the Innovative Technology Exchange portion of the Clinical Connections Summit.

As we announced in March, Vizient's member council agreed that STREAMWAY offers unique and incremental benefit over other products available on the market today, and recommended it for an Innovative Technology designation. We continue to work with Vizient on the marketing of STREAMWAY to their member groups, and are pleased with the progress to date.

Along with the rest of the management team, my unwavering confidence in the STREAMWAY System is grounded in its many benefits to healthcare professionals, patients and healthcare facilities.  STREAMWAY solves a significant need by replacing the laborious, dangerous manual process of collecting fluids in canisters. It also allows for continuous suction to the surgical field and within the procedure room, and provides unlimited capacity to the user so no patient procedure will ever have to be interrupted to change canisters or transport infectious fluids outside the operating or procedure room. Because STREAMWAY is wall mounted, it takes up no valuable floor space in the operating room and is the only complete in-room fluid disposal solution in the marketplace.  In addition to ease of use, STREAMWAY provides significant cost savings to hospitals.

In addition, we are actively and carefully seeking strategic acquisition opportunities that, if completed, would provide additional products for our dedicated sales representatives to market to STREAMWAY channels and/or bring to Skyline new revenue streams and market opportunities.  We believe there are attractive acquisition opportunities available. I note that this is a process that requires a great deal of care and due diligence as we seek to complete transactions that will maximize opportunity for our stockholders with a strong business and financial rationale for Skyline.

As we look to retain and add talent to our organization, I am pleased that the board of directors has agreed to award equity stock options to all Skyline employees.  We believe these grants will allow Skyline to better compete for quality employees, and by compensating employees with the opportunity to hold stock in Skyline Medical, we will more closely align the financial interest of our staff with our stockholders. Using stock options as a significant element of compensation also conserves cash for other corporate purposes.

In closing, I would like to thank our employees, customers and stockholders for their support.  We are excited to enter the second half of 2017 with growing momentum and new opportunities for growth.

Sincerely,

Dr. Carl Schwartz
Chief Executive Officer

June 30, 2017

About the STREAMWAY System

Skyline's revolutionary, FDA-cleared 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.  As of March 31, 2017, Skyline Medical customers have installed 103 STREAMWAY Systems in 52 facilities across 20 states, and in Canada.

The STREAMWAY minimizes human intervention for better safety and improves compliance with Occupational Safety and Health Administration (OSHA) and other regulatory agency safety guidelines. It also provides unlimited capacity for increased efficiency in the operating room, which leads to greater profitability. Furthermore, the STREAMWAY eliminates canisters to reduce overhead costs and provides greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the U.S.  For a demonstration please visit www.skylinemedical.com or call 855-785-8855.

About Skyline Medical

Skyline Medical produces a fully automated, patented, FDA-cleared waste fluid disposal system that virtually eliminates staff exposure to blood, irrigation fluid and other potentially infectious fluids found in the healthcare environment. Antiquated manual fluid handling methods that require hand carrying and emptying filled fluid canisters present an exposure risk and potential liability. Skyline Medical's STREAMWAY System fully automates the collection, measurement and disposal of waste fluids and is designed to: 1) reduce overhead costs to hospitals and surgical centers; 2) improve compliance with OSHA and other regulatory agency safety guidelines; 3) improve efficiency in the operating room, and radiology and endoscopy departments, thereby leading to greater profitability; and 4) provide greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills each year in the U.S.  For additional information, please visit www.skylinemedical.com.

Forward-looking Statements
Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company's business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance, if our product is not accepted by our potential customers, it is unlikely that we will ever become profitable; adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the Company's ability to implement its long range business plan for various applications of its technology; the Company's ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company's technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, which are available for review at www.sec.gov.  This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company's financial position. See the Company's most recent Annual Report on Form 10-K, and subsequent reports and other filings at www.sec.gov.

Contact:
Investors
LHA Investor Relations
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com