ALPHARETTA, Ga., May 1, 2013 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCBB:SNWV) today announced the Company has appointed Daniel M. Jorgensen, MD, MPH, MBA as its Chief Medical Officer. Dr. Jorgensen is an accomplished physician executive with more than 15 years of experience in both earlier stage biotech companies and large pharmaceutical companies, including Pfizer. As Chief Medical Officer, Dr. Jorgensen will oversee the Company’s clinical programs, including the upcoming supplemental clinical trial utilizing dermaPACE® for the treatment of diabetic foot ulcers.
Dr. Jorgensen’s experience spans across research, development, clinical, regulatory and commercialization activities for all product types and devices, and across multiple therapeutic areas. Throughout his career, Dr. Jorgensen has played a key role in multiple FDA submissions and approvals, and in FDA Advisory Committee Meetings. He is board-certified in three medical areas: pediatrics, infectious diseases, and preventive medicine.
“Dr. Jorgensen brings a wealth of experience overseeing the design, conduct, and management of late-stage clinical trials, and an impressive track record of FDA approvals,” commented Joseph Chiarelli, Chief Executive Officer of SANUWAVE. “In addition, he has a thorough understanding of clinical-regulatory pathways for small molecules, biologics, and devices. Dan has forged close relationships with investigators and contract research organizations (CROs), which has led to timely completion of clinical trials and high quality data. Dan will be an integral part of our team as we advance the clinical development of dermaPACE in the U.S. and seek to expand orthoPACE® into other indications.”
“I am excited to be joining SANUWAVE at such an important time in the Company’s history,” commented Dr. Jorgensen. “I look forward to managing the execution of the dermaPACE supplemental clinical trial and potentially receiving FDA approval, so dermaPACE may be available to the millions of U.S. patients who suffer from debilitating diabetic foot ulcers. Overall, I believe there is great potential in the medical community for the dermaPACE and orthoPACE devices, and I look forward to advancing their development into other clinical areas.”
Mr. Chiarelli continued, “I’d also like to thank our Vice President of Clinical Affairs, Joel Batts for playing an integral part in designing the supplemental pivotal trial and wish him the best of luck as he moves on to pursue other endeavors. Joel’s responsibilities will be assumed by our contract research organization, our Vice President of Operations, and Dan.”
About Dr. Jorgensen
Dr. Jorgensen most recently served as Senior Vice President, Clinical Development and Chief Medical Officer of PolyMedix, Inc. where he successfully conducted an international, multi-site clinical trial of a novel compound used to treat serious skin infections, and gained regulatory support for future development, including the prevention and treatment of ulcers on mucous membranes. Previously he served as Vice President, Clinical Research at AMAG Pharmaceuticals, where he oversaw ten global clinical trials across multiple medical areas. At Pfizer, Dr. Jorgensen held senior leadership positions in the Global Research and Development Division, and most notably, was the global clinical leader for Zmax (single-dose azithromycin) and Pfizer’s first vaccine development group leader. During his 27 year career in health care, Dr. Jorgensen has also worked at Aventis Pasteur, at the Centers for Disease Control and Prevention (CDC) as an Epidemic Intelligence Service Officer, and as Montana’s State Medical Officer. Dr. Jorgensen received his undergraduate degree from Yale, his MD from the University of Wisconsin, his MPH from the University of Washington, and his MBA from Yale.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of noninvasive, biological response activating devices for the repair and regeneration of tissue, musculoskeletal and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the body’s normal healing processes and regeneration. SANUWAVE intends to apply its 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 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 and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology in 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.
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SANUWAVE Health, Inc.
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Chief Financial Officer and COO
