ALPHARETTA, Ga., Dec. 15, 2015 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCQB:SNWV) today reported positive business developments leading to a strong outlook for its fourth quarter ending December 31, 2015.
“The positive actions taken during 2015 have positioned SANUWAVE for a strong fourth quarter and, more importantly, a breakthrough 2016,” noted Kevin A. Richardson, II, Chairman of the Board of SANUWAVE Health. “We continue to work towards our near-term goals of PMA submission to the FDA for dermaPACE® and closing funding for the Company to move forward.”
- Accelerating Sales and Record Order Backlog: The Company expects to post revenues of $300,000 to $400,000 in the fourth quarter of 2015, up strongly from $236,662 from the prior year period and $143,605 in the quarter ended September 30, 2015. Order backlog is expected to exceed $100,000 at the end of the quarter. The full year revenue results are expected to be $894,000 to $994,000, up 6% to 17% from the 2014 total revenue of $847,367.
- FDA Submission Update: SANUWAVE is working on a Pre-Submission package to be presented to FDA in January, 2016. In this Pre-Submission package, the Company will discuss the positive results of the combined studies and will present SANUWAVE’s submission strategy. A meeting with FDA is expected in Q1 2016 to finalize the submission strategy, with full submission for FDA approval to follow shortly thereafter.
- Patent Portfolio Continues To Grow: In 2015, SANUWAVE has been awarded 5 patents, bringing the portfolio of issued patents and applications up to 52. The patents issued in 2015 provide protection on new device design elements to improve functionality and efficiency and on new applications of shock wave technology in cleaning and tenderizing meat, cleaning and sterilization of implant tissue and for energy production.
- Financing Update: During the fourth quarter of 2015, we made an offer to our Series A Warrant holders to exchange those warrants for shares of the Company’s common stock, and to certain holders, shares of the Company’s newly created Series B Convertible Preferred Stock. Each warrant holder will be issued shares of stock based on a pre-determined exchange ratio. We are in the process of closing this offer and currently have 89 percent of the outstanding Series A Warrants accepting the offer. The conversion of these outstanding warrants will be an asset to the Company as we prepare to raise capital with an investment banker.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (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. Diabetic Foot Ulcer treatment is also approved in South Korea. 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.
Forward-Looking Statements
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.