"The launch of RESTORE and the enrollment of its 150th patient is an important milestone for the company," said James Pilachowski, Senior Vice President of Hip Programs. “RESTORE will be one of the largest prospective orthopedic trauma studies ever conducted. The data generated will be critical in our efforts to enter new markets, including the US and Japan.”

To ensure strategic oversight and direction of the study, AgNovos Bioscience, Inc. established a global steering committee composed of experts in orthopedics, trauma, metabolic bone health, internal medicine and medical ethics. The committee is chaired by Dr. Serge Ferrari, head of the clinical service and research laboratory for bone diseases at the University Hospital of Geneva (Switzerland), and Dr. Paul Tornetta, Director of the Department of Orthopedic Trauma at Boston Medical Center (USA).

dr Tornetta explained the importance of the study from his point of view: “We all know that fragile hip fractures will be one of the biggest challenges for orthopedic surgeons in the next 10 to 20 years. Managing the contralateral risk of hip fracture will be key to overcoming this challenge. The science and research supporting this treatment is positive. I'm glad the study is being conducted because I think it could really make a difference.”

dr Ferrari noted that “pharmacological approaches to treating osteoporosis are very important, but alone are not sufficient to address the problem of secondary fracture risk, particularly in patients with recent fractures. The increased fracture risk for these patients is highest in the first year after the index fracture. If this study is successful, orthopedic surgeons will play an important new role in our efforts to reduce the risk of secondary hip fractures.”

More than two million hip fractures occur worldwide every year. Fragile hip fractures result from low-energy trauma, e.g. B. a fall from standing height or less. These fractures are associated with significant morbidity and mortality and often place a great burden on sufferers, their families and the healthcare system. Although several factors contribute to hip fracture risk, a key factor is osteoporosis and the associated bone loss and fragility.

"One of the reasons hip fractures are so devastating is that people who suffer one fracture are at increased risk of a second," explains Dr. James Howe, Co-Founder and Chief Medical Officer of AgNovos Bioscience, Inc. “The consequences of second fractures are often worse than the first. I have seen this pattern throughout my decades of clinical practice in orthopedics. I look forward to reviewing the RESTORE data with other physicians and organizations working on secondary hip fracture risk.”

About the AGN1 LOEP kit

The AGN1 LOEP Kit provides the instruments and materials to perform a minimally invasive procedure to implant AGN1, a proprietary calcium-based osteoconductive triphasic implant material. AGN1 has a unique cell-friendly surface architecture and resorption profile that allows for the rapid formation of new bone. Clinical research has shown that treatment with AGN1 LOEP rapidly, significantly and permanently increases the strength of osteoporotic femurs. The kit is available in Europe under the brand name OSSURE™ LOEP kit.

About AgNovos Bioscience, Inc.

AgNovos Bioscience, Inc. is a medical technology company developing new therapies that utilize proprietary bone-augmenting technology and regenerative medicine to address unmet needs in the treatment of bone disease. AgNovos Bioscience, Inc. is privately held and headquartered in New York City. The company's manufacturing, research and development, and support services are located in Rockville, MD. www.agnovos.com

CAUTION: The OSSURE (LOEP) kit is not approved for use in the United States.

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Contacts

Jason Foley
Associate Vice President, Spine Program und Marketing
+1 332-910-7332
jfoley@agnovos.com

Source: businesswire.com