Sanuwave Appoints New CMO

Daniel M. Jorgensen, M.D., MPH, MBA (pictured left), has been named new chief medical officer (CMO) of Sanuwave Health Inc. The Alpharetta, Ga.-based company makes non-invasive, biological response activating devices for the repair and regeneration of tissue, musculoskeletal and vascular structures.

Jorgensen is a physician executive with more than 15 years of experience in both earlier stage biotech companies and large pharmaceutical companies, including Pfizer. As CMO, Jorgensen will oversee the company’s clinical programs, including the upcoming supplemental clinical trial using Dermapace for the treatment of diabetic foot ulcers.

Jorgensen has experience in research, development, clinical, regulatory and commercialization activities for all product types and devices, and across multiple therapeutic areas. Throughout his career, Jorgensen has participated in U.S. Food and Drug Administration (FDA) submissions and approvals, as well as FDA advisory committee meetings. He is board-certified for 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,” said Joseph Chiarelli, CEO 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, 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 United States and seek to expand Orthopace into other indications.”

Dermapace is a wound healing device built on Sanuwave’s PACE (pulsed acoustic cellular expression) platform. The technology uses high-energy acoustic pressure waves in the shock wave spectrum to produce compressive and tensile stresses on cells and tissue structures to elicit a series of biological responses. In March, Dermapace was approved for commercialization in Australia and New Zealand, and already holds a CE mark approval for sale in the European Union. The device recently completed a pivotal Phase III, investigational device exemption (IDE) study for the treatment of diabetic foot ulcers, but is not yet regulated by the FDA.

Jorgensen most recently served as senior vice president of clinical development and CMO 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. He received his undergraduate degree from Yale University in New Haven, Conn., his M.D. from the University of Wisconsin, his MPH from the University of Washington, and his MBA from Yale.