News & Media
IVIVI HEALTH SCIENCES SECURES SERIES A FINANCING TO ACCELERATE COMMERCIALIZATION OF FDA-CLEARED ELECTROTHERAPEUTIC DEVICE, THE IVIVI TORINO II
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.
SAN FRANCISCO | February 15, 2011 | 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?fs 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.
ERIC DREMEL JOINS IVIVI ORTHOPEDIC HEALTH AS CEO
Ivivi Health Sciences, LLC, a leading innovator in the development and commercialization of portable electrotherapy devices for post-operative indications, has appointed Eric V. Dremel as Chief Executive Officer of the company's Ivivi Orthopedic Health, Inc. subsidiary.
SAN FRANCISCO | February 15, 2011 | Ivivi Health Sciences, LLC, a leading innovator in the development and commercialization of portable electrotherapy devices for post-operative indications, 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.
Electromagnetic Pulses Provide Pain Relief for Osteoarthritis
Electromagnetic pulses significantly decrease pain and inflammation associated with osteoarthritis of the knee, according to Henry Ford Hospital researchers.
In the double-blind, randomized placebo-controlled study, 34 patients used a portable battery-operated device that emits a low-intensity pulsating electromagnetic frequency and experienced more than 40 percent pain relief on their first day.
"Our results show pulsed electromagnetic fields caused a significant decrease in pain" says Fred Nelson, M.D., associate program director for research and director of the Osteoarthritis Center, Department of Orthopaedics, Henry Ford Hospital.
Dr. Nelson will present the results this week at the Orthopaedic Research Society's annual meeting in New Orleans.
Dr. Nelson explains that in the laboratory, electromagnetic signals have been shown to decrease calcium in cartilage cells. This sets off a series of chemical events that can lead to reduced inflammation. Previously, the electromagnetic fields have been used to control pain related to cosmetic surgery.
"We are really fine-tuning what we are doing to the cell environment with a very specific pulse sequence and frequency," says Dr. Nelson.
Patients strapped the small, ring-shaped plastic device around their knees for 15 minutes, twice daily for six weeks. The device was lightweight and patients could position the device directly over clothing. All participants were given a device with a coil that appeared to work but some were assigned active coils and others were given non-active coils. The electromagnetic device was developed by Ivivi Health Sciences of Montvale, New Jersey.
Osteoarthritis of the knee is a leading cause of disability and loss of independence. It is a slow, progressively degenerative disease in which the joint cartilage gradually wears away due to trauma, aging or infection. As the cartilage thins, the surrounding bone thickens and often bones rub against one another, causing additional wear. Normal activity becomes painful and difficult.
Current treatments include drug therapies like anti-inflammatory medication or pain relievers; physical therapy; support devices; health and behavioral modifications such as weight loss; surgery and joint replacement.
Dr. Nelson explains that medications often have variable success and can produce considerable side effects such as changes in kidney and liver function, a reduction in the ability of blood to clot as well as abdominal pain, nausea and indigestion.
"The exciting thing about this new approach is that it has been found to have no side effects, it is relatively low-cost in the long-run and the onset of pain relief is immediate," says Dr. Nelson. "We look at electromagnetic pulses as a potential way to improve quality of life and independence for those who suffer from osteoarthritis of the knee."
Dr. Nelson says researchers will continue to look at the consistency of the relief, how long the pain relief lasts and if electromagnetic pulses might affect other joints.
Funding for the study: Ivivi Health Sciences.
Source: Henry Ford Health System
Ivivi Health Sciences Announced Completion of Asset Purchase
Natural, non-invasive FDA-cleared anti-inflammatory poised for growth as the industry looks for technology that lessens use of pharmaceuticals
San Francisco, CA, February 18, 2010 | Ivivi Health Sciences, a newly formed privately held company and the leading innovator in the non-invasive treatment of post-operative pain and swelling, today announced it has purchased the key assets from its public predecessor, Ivivi Technologies Inc.
As a private company Ivivi Health Sciences has positioned itself to secure the financial, clinical and human resources necessary to continue growth within its current markets, including: post-operative, plastic and reconstructive surgery, orthopedic surgery, wound treatment, and veterinary care. The company plans to offer a variety of newly designed electrotherapeutic products that make treatment easier for the patient and applicable to a wider range of symptoms, diseases and healing needs.
?gThe mission of Ivivi Health Sciences is to exploit the electrochemical pathways which are the foundation of all biological activity, bringing together biological sciences and principles of physics to promote and accelerate the body?fs inherent healing processes,?h explains Steven Gluckstern, CEO of Ivivi Health Sciences. ?gIvivi?fs technologies are designed to work with the body?fs natural systems rather than disrupt them, the trademark of most drug regimens. The use of non-invasive, non-pharmacological therapies will be the next therapeutic paradigm in health care and we expect to be one of the companies driving that change.?h
Ivivi?fs treatment products employ inductive pulsed electromagnetic fields, which can neither be felt nor seen, to stimulate cell activity that reduces tissue inflammation, relieving pain and accelerating the body?fs natural healing process. Ivivi?fs products effectively treat a variety of health concerns. The technology has been FDA approved for the treatment of post-operative pain, and Medicare and Medicaid reimburse the use of these therapies for the treatment of wounds. Ivivi products have no harmful side affects, do not introduce foreign or potentially dangerous chemical compounds into the body, and have no risk of addiction development or overdose.
Steven Gluckstern former CEO of Ivivi Technologies will serve as Chairman and CEO of Ivivi Health Sciences with company President and COO Kathryn Clubb. Sean Hagberg, PhD, has been appointed as Vice President of Science and Ed Hammel has been appointed as Vice President of Finance and Administration. David Saloff will serve as Vice President of Sales and Marketing, and Andre DiMino has been named as Vice President of Engineering, Manufacturing and Regulatory. Arthur Pilla Ph.D., inventor of the technology, has been appointed Chair of the Company?fs Scientific Advisory Board and Dr. Berish Strauch will serve as Chair of the Company?fs Medical Advisory Board.
About Ivivi Health Sciences:
Ivivi Health Sciences, established in 2010, is the leading innovator in the non-invasive, electrotherapeutic treatment of post-operative pain and swelling. Ivivi?fs technology has been FDA approved for the treatment of post-operative pain, and Medicare and Medicaid reimburse the use of these therapies for the treatment of wounds. For more information visit www.ivivihealthsciences.com.
