SUWANEE, GA--(Marketwired - Jun 14, 2017) - SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company has appointed BIOACCESS™ to act as Territory Sales Manager for sourcing and screening of potential distributors and access to clinical trials participation for SANUWAVE's products in Colombia.
André Mouton, V.P. International Sales and Relations of SANUWAVE, stated, "This decision to engage [LATAM Market Access] was made to increase our focus and visibility within South America. It is of the utmost importance that we partner with distributors that have influence and a good track record within the Colombian market. We also need speedy access to potential clinical trials to ensure we add value to our product offering as well as clinically-proven outcomes. These factors will lead to faster market entry and closer ties with identified Key Opinion Leaders (KOL's)," concluded André Mouton.
Julio G. Martinez-Clark, BIOACCESS™' CEO, stated, "LATAM Market Access is an ideal partner for SANUWAVE by providing regulatory and commercial support when introducing and expanding the company's medical device portfolio in Colombia."
"By partnering with BIOACCESS™, SANUWAVE will have access to a multidisciplinary team of life science professionals in Colombia that will facilitate SANUWAVE's local market access efforts," continued Mr. Martinez-Clark. "Our expertise in medical device clinical trials and commercialization, knowledge of the local market, and our wide network of local contacts enable us to offer a wide range of services to forward-thinking companies like SANUWAVE. This partnership will allow SANUWAVE to successfully enter the market and achieve long-term growth and success in Colombia."
SANUWAVE is using this occasion to further educate on our lead wound care product dermaPACE®. This Extracorporeal Shockwave Technology (ESWT) device, based upon electrohydraulic principles, is CE Marked and has enjoyed success in certain markets within the European Union treating a wide variety of skin conditions such as pressure ulcers, burns, post-operative wounds, and scar reduction. dermaPACE has been proven, in two US-based clinical trials enrolling 336 subjects, to be safe and effective in the treatment of Diabetic Foot Ulcers.
Within a few weeks of initial treatment, wounds treated with dermaPACE reduced the wound area at superior rates compared to control subjects. dermaPACE exhibits superiority in wound area reduction within 12 weeks of initial treatment and exhibits superiority in wound closure within 20 weeks of initial treatment. The use of dermaPACE allows the clinician to more easily, and more cost-effectively, manage wounds. More importantly, the patient's quality of life improves significantly.
For more information on SANUWAVE's technology, please read our blog, "Shock This", on our website at www.sanuwave.com.
BIOACCESS™ is based in Orlando, FL and helps medical device companies conduct early-stage clinical trials and have access to the Colombian market. The company offers a wide range of market access services including market research and testing, product and trademark registration, regulatory legal representation, distributor search and selection, new entity set-up, and operations services for life science companies looking to enter and achieve long-term growth in Latin America -- with a special focus on Colombia. The company has helped medical device manufacturers like Avinger, Mitralign, MitraSpan conduct clinical trials in Colombia; and companies like ClarVista Medical, CeloNova BioSciences, Abiomed, Volcano, and Mount Sinai's Center For Personalized Cancer Therapeutics register their products and formulate a market access strategy in Colombia.
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 de novo petition 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.
Julio G. Martinez-Clark, CEO
Millennium Park Capital LLC
SANUWAVE Health, Inc.
Vice President International Sales and Relations