SAN FRANCISCO--(BUSINESS WIRE)--Ivivi Health Sciences, LLC, a leading innovator in the development and commercialization of portable electrotherapy devices for post-operative indications, has secured $9.5 million in the initial close of its Series A Preferred financing. The initial closing of the financing provides Ivivi with $4.0 million of new investment and converts a $5.5 million bridge loan to equity. A second tranche of $4.0 million is expected within the next 90 days. Proceeds from the Series A financing will be used by Ivivi Health Sciences and its newly formed subsidiary Ivivi Orthopedic Health, Inc. to accelerate commercialization of Ivivi’s non-invasive and proprietary FDA-cleared electrotherapy devices for reduction of post-surgical pain and edema in orthopedic specialties. Proceeds will also be used to expand clinical development in additional musculoskeletal diseases, including osteoarthritis of the knee.
The Ivivi Torino II is a portable, simple-to-use, battery-operated, non-invasive device that generates a targeted low-intensity, time-variant electromagnetic field (tPEMF). In multiple peer-reviewed publications, Ivivi has presented data from preclinical and well-controlled clinical trials demonstrating that its electromagnetic field accelerates the local endogenous calcium/calmodulin (Ca+/CaM) dependent nitric oxide (NO) cascade that is central to the anti-inflammatory and tissue repair processes in humans. tPEMF accelerates the body’s natural anti-inflammatory activity and reduces production of a key pro-inflammatory cytokine, IL-1β. Use of the Ivivi Torino II results in significant, rapid and durable reductions in pain and edema. These reductions have been shown to be similar and, in some cases, superior to those of approved pain medications, such as narcotics and non-steroidal anti-inflammatory drugs (NSAIDs). Most importantly, the Ivivi Torino II has been demonstrated to be safe and well-tolerated, with no evidence of the common narcotic and gastrointestinal side effects or potential for addiction that are risks associated with currently used post-surgical, opiate-based pain medications.
“Ivivi deeply appreciates the support of our Series A investors who share our goal of improving quality of care, enhancing health outcomes and reducing healthcare costs, especially those associated with prolonged post-surgical hospitalization due to ineffective control of pain,” said Steven Gluckstern, Founder, Chairman and Chief Executive Officer of Ivivi Health Sciences, LLC. “The Ivivi Torino II is simple in design but profound in its therapeutic utility and benefits for patients and surgeons, as we continue to demonstrate in clinical studies. We are especially excited about tPEMF’s regenerative potential relative to tissue repair and treating inflammatory diseases, such as osteoarthritis.”
In addition to completing the first phase of its $13.5 million Series A financing, Ivivi Health Sciences has appointed Eric V. Dremel as Chief Executive Officer of the company’s Ivivi Orthopedic Health, Inc. subsidiary. Headquartered in Seattle, Washington, the company will focus on commercialization, business development and continued clinical development of Ivivi’s Torino II device as well as expansion of the company’s orthopedic product line. Mr. Dremel is an experienced and successful sales, marketing and corporate development executive who has held senior commercial, operating and strategic positions with some of the largest US and global orthopedic manufacturers, including Zimmer Holdings, DePuy Orthopaedics (a Johnson & Johnson Company) and Stryker, as well as with several mid-size and start-up device companies. In a career spanning more than two decades, Mr. Dremel has been responsible for ensuring the market success of a broad range of medical and orthopedic devices.
“I believe that the Ivivi Torino II has the potential to enhance orthopedic practice and establish a new standard of care in post-operative control of pain and swelling. I am eager to work with Ivivi’s distinguished scientific advisors and clinical experts to ensure a successful commercial introduction for this important product,” said Mr. Dremel. “Advances in surgical technique achieved by today’s highly skilled orthopedic surgeons are now matched by Ivivi’s remarkable innovation in treating post-operative pain and swelling. This will significantly speed the recovery and rehabilitation process for patients. The Ivivi Torino II is a major technological advance with immense therapeutic and commercial potential. I am committed to ensuring that it achieves rapid and broad uptake in the global orthopedic market.”
About Ivivi Health Sciences
Ivivi Health Sciences is an emerging leader in the field of inductive electrotherapy. Its lead product, the Ivivi Torino II, has a demonstrated mechanism of action and proven clinical outcomes, and has been granted FDA clearance for the reduction of post-surgical pain and edema. The company is currently focused on the post-operative orthopedic market through its subsidiary, Ivivi Orthopedic Health, Inc., with plans underway to expand the therapeutic indications for the Torino II to treat osteoarthritis and other degenerative inflammatory conditions. Among Ivivi’s advisors are some of the most accomplished and respected scientists, researchers and clinicians in the country, including: Arthur Pilla, PhD, of Columbia University, who is a co-inventor of the Bone Growth Stimulator as well as Ivivi’s tPEMF technology; Nancy Lane, MD, Endowed Professor and Director of the UC Davis Center for Healthy Aging; David Lawrence, MD, former Chairman & CEO of Kaiser Foundation Health Plan, Inc. and Kaiser Foundation Hospitals; and Roy K. Aaron, MD, Professor of Medicine at the Brown Medical School, Director of both its Center for Restorative and Regenerative Medicine and its Orthopaedic Cell Biology Laboratory. Ivivi was founded in 2010 by Chairman & CEO Steven M. Gluckstern and President and COO Kathryn Clubb. The company is headquartered in San Francisco, CA. For more information, please visit the Ivivi website at http://www.ivivihealthsciences.com.