SUWANEE, Ga., Aug. 30, 2016 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCQB:SNWV), today reported a record order book for the 2016 year with 45 firm orders for the Company’s orthoPACE ® and dermaPACE ® Systems. This is up 280% from the 16 total orders for the same systems in all of 2015 primarily due to strong interest in international markets, notably South Korea and Italy. The Company is continuing to work with our various distributors to further improve this record pace for 2016. The outlook for 2017 is expected to be even stronger than 2016, with the company anticipating FDA approval in the first quarter of 2017 of the de novo petition filed for dermaPACE for the treatment of diabetic foot ulcers.
This growth in the order book can be attributed to multiple factors. In South Korea, the increase in orders is directly attributable to SANUWAVE receiving approval for wound indications in March 2016. Additionally, in May 2016, SANUWAVE executives visited much of our distributor base in Asia and Europe to discuss the various markets and to better understand similarities and differences in the diversified markets represented. As a result of these productive, and sometimes frank discussions, the Company has been reworking individual distributor agreements that will help them to gain traction in their respective markets.
In addition to visiting some of our existing distributor base, the SANUWAVE management team visited potential distributors in markets not currently served. By the end of 2016, we anticipate having a presence in 10 countries, up from 7 in 2015.
“We are extremely excited with our record order book this year. These results are the culmination of our efforts to add new indications to existing markets, and more importantly, our desire to listen to our customers and respond positively to their needs,” stated Kevin A. Richardson, II, Chairman of the board of SANUWAVE. “We feel this is just the beginning of anticipated growth in international markets currently served, in new markets, and most importantly, in the United States. Having achieved our critical goal of submitting our de novo petition to the FDA for review and classification of the dermaPACE to treat diabetic foot ulcers, the anticipated approval in Q1 2017 will only fuel this growth,” concluded Mr. Richardson.
SANUWAVE will continue to issue periodic updates of the progress of the Company’s order book to help the community gauge the Company’s progress. The next update is expected to occur in October 2016. We will continue to issue updates to the order book through the remainder of 2016 and throughout 2017. We do not anticipate to continue these updates in 2018.
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. 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 .
Contact: Millennium Park Capital LLC Christopher Wynne 312-724-7845 cwynne@mparkcm.com SANUWAVE Health, Inc. Kevin Richardson II Chairman of the Board 978-922-2447 investorrelations@sanuwave.com
