ALPHARETTA, Ga., Sept. 17, 2015 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB:SNWV), a leading shock wave technology company, today released a letter to its shareholders from company Chairman of the Board and Co-CEO Kevin A. Richardson, II.
Dear Fellow Shareholders,
I am writing today to share the exciting progress at SANUWAVE Health and detail our plans over the next few months.
As you may recall, less than three months ago, SANUWAVE was facing two primary challenges: the preliminary results for our current study involving the treatment of diabetic foot ulcers did not meet its primary 12-week endpoint and we faced a balloon payment per our debt agreement with HealthTronics. In response, our team worked diligently to take on these challenges and I am happy to say that we’ve moved the Company into a much stronger position in just a short period of time and we’ve met or exceeded all milestones we established in recent communications.
dermaPACE® PMA Submission Update: We had a great meeting with the FDA in June to determine a clear path to approval for our dermaPACE device for treatment of diabetic foot ulcers. At the meeting, the FDA agreed with our plan to analyze additional secondary endpoints in conjunction with the previously approved statistical analysis plan. FDA stated that they will look at the totality of the trial results, taking into account primary and secondary endpoints, safety, and benefit/risk assessments while reviewing a subsequent approval submission. Based on our meeting with the FDA, we are very encouraged that should the results of this trial mirror that of the previous trial, we can provide a clinically significant set of results in a PMA for the FDA’s approval consideration.
We completed our quality control reviews on the data and locked the database on schedule in late August. We are in the midst of top line data analysis and expect to have preliminary results for the public in early October. Depending on the results of the trial, we expect to complete the PMA submission process to FDA in the fourth quarter of this year or early first quarter of 2016.
Strengthened Financial Flexibility: We took two steps to improve our financial flexibility so that we can see our PMA submission through to completion. First, we successfully renegotiated our debt with HealthTronics and extended the due date from August 1, 2015 to January 31, 2017. We believe that this signals HealthTronics’ confidence in both SANUWAVE’s technology and our development process. Second, we increased the number of shares authorized for issuance from 155 to 355 million. We believe that the shares need to be available to us as we look at potential financing alternatives as we look to take our dermaPACE device to market; however, we do not intend to fully use this allocation.
Developing additional applications for our Technology: While our primary focus remains gaining approval for SANUWAVE’s dermaPACE to treat diabetic foot ulcers, we continue to pursue additional applications that also have potentially significant market opportunities. Our leading opportunities are in biofilm destruction and oil exploration and development.
In July, we presented poster data and a lab demonstration at the Center for Biofilms at Montana State University showing that our shock wave technology is highly effective in removing biofilms created by both Gram-negative and Gram-positive species (Staphylococcus aureus and Pseudomonas aeruginosa). Our work met with significant interest from medical and non-medical companies at this conference, and we have been invited to present our technology to 3M corporation’s medical and non-medical business units. In addition, we met with a number of new business contacts interested in finding solutions for their specific biofilm removal problems.
In oil exploration and development, we received a patent for use in the energy industry related to the use of shock waves, generated with laser systems, for hydraulic fracturing of rock formations, which can be employed in both secondary and tertiary oil recovery. This is SANUWAVE’s first patent for the energy industry and we believe by employing lasers for generating shock waves offers lower maintenance costs and a longer useful life than currently available technology. We look forward to meeting with potential partners to further develop this opportunity.
Next Steps for the Balance of 2015:
We have three primary goals in our sights before the end of 2015: 1) Reveal top line data from the diabetic foot ulcer study, 2) Begin submission of the PMA to the FDA, and 3) Complete a joint venture or partnership to finance the move towards commercialization of the wound care product in 2016 or complete a sale of the rights to sell the wound product. We will also continue to work on a number of other non-medical initiatives.
In conclusion, we have made significant progress to develop and monetize SANUWAVE’s patent portfolio in the past three months and we are very optimistic about our opportunities. We look forward to updating you on our progress and next steps once the top-line analysis of our latest clinical trial is available in October.
Kevin A. Richardson, II
Chairman and Co-Chief Executive Officer
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB:SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
For additional information about the Company, visit www.sanuwave.com.
CONTACT: Todd Markey IR Partners 818-280-6800 firstname.lastname@example.org Daniel Conway DC Consulting, LLC 407-792-3333 email@example.com SANUWAVE Health, Inc. Kevin Richardson II Chairman of the Board 617-778-9223 firstname.lastname@example.org