AgNovos Bioscience Announces 150th Patient Enrolled in RESTORE Randomized, Controlled Trial

2023-08-08

临床研究

NEW YORK--(BUSINESS WIRE)-- AgNovos Bioscience, a medical technology company working to transform the treatment of bone disease by addressing persistent unmet needs in the care of patients, announced today that it has enrolled the 150th patient in the clinical study titled “Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures” (RESTORE). RESTORE is a randomized, controlled, prospective, single-blinded, global study designed to evaluate whether women undergoing surgical repair of a fragility hip fracture, and treated contralaterally with the AGN1 LOEP kit, are at reduced risk of a second hip fracture. The Company has activated more than 30 study sites across Japan, Germany, Spain, France, Italy, the UK, the Netherlands and Austria. RESTORE is expected to include more than 50 study sites and enroll at least 650 patients. “The initiation of RESTORE and the enrollment of the 150th patient is a major milestone for the Company,” explained James Pilachowski, Senior Vice President of Hip Program. “RESTORE will be one of the largest prospective orthopaedic trauma studies ever conducted. The data generated will be critical to our efforts to gain access to new markets, including the U.S. and Japan.” To ensure strategic study oversight and guidance, AgNovos Bioscience, Inc. has chartered a global steering committee comprised of experts in orthopaedics, trauma, metabolic bone health, internal medicine and medical ethics. The committee is co-chaired by Dr. Serge Ferrari, head of the Clinical Service and Research Laboratory of Bone Diseases at the Geneva University Hospital (Switzerland) and Dr. Paul Tornetta, director of the Orthopaedic Trauma department at Boston Medical Center (USA). Dr. Tornetta shared his perspective on the importance of the study: “We all know that fragility hip fractures will be one of the biggest challenges facing orthopaedic surgeons over the next 10-20 years. Addressing contralateral hip fracture risk will be key to meeting that challenge. The science and research supporting this treatment is positive. I am glad the study is underway; I think that it could make a real difference.” Dr. Ferrari noted that “pharmacological approaches to treatment of osteoporosis are very important but are not sufficient by themselves to solve the challenge of secondary fracture risk, especially in patients with recent fractures. The incremental risk of fracture for these patients is highest during the first year following the index fracture. If this study is successful, orthopaedic surgeons will have an important new role to play in our efforts to reduce secondary hip fracture risk.” More than two million hip fragility fractures occur globally every year. Hip fragility fractures result from low-energy trauma such as a fall from standing height or less. These fractures are associated with significant morbidity and mortality, and often create significant burden for affected individuals, families and healthcare systems. Although multiple factors contribute to hip fracture risk, a key factor is osteoporosis and related bone loss and fragility. “One of the reasons hip fragility fractures are so devastating is that individuals suffering one fracture are at increased risk for a second,” explained Dr. James Howe, the Co-Founder and Chief Medical Officer of AgNovos Bioscience, Inc. “The outcomes of second fractures are often even worse than those of the first. I saw this pattern during my decades of clinical practice in orthopaedics. I look forward to reviewing the data generated by RESTORE with other clinicians and organizations committed to addressing secondary hip fracture risk.” About the AGN1 LOEP Kit The AGN1 LOEP Kit contains the instruments and materials to perform a minimally invasive procedure to implant AGN1, a proprietary, calcium-based, osteoconductive, and tri-phasic implant material. AGN1 is uniquely formulated with a cell-friendly surface architecture and a resorption pro enables the rapid formation of new bone. Clinical research has shown that AGN1 LOEP treatment delivers rapid, substantial and durable increase in 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 leverage proprietary, bone-building technology and regenerative medicine to address unmet needs in the treatment of bone disease. AgNovos Bioscience, Inc. is privately held and has its corporate headquarters in New York City with manufacturing, research & development, and corporate support services located in Rockville, MD. CAUTION The OSSURE (LOEP) kit is not cleared for use in the United States.