AgNovos Bioscience Announces 150th Patient Enrolled in RESTORE Randomized, Controlled Trial
8.8.2023 16:30:00 EEST | Business Wire | Press release
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 profile that 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. www.agnovos.com
CAUTION The OSSURE (LOEP) kit is not cleared for use in the United States.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230808554123/en/
Contact information
Jason Foley
Associate Vice President, Spine Program and Marketing
+1 332-910-7332
jfoley@agnovos.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Pantheon Expands Middle East Presence With New Abu Dhabi Office and Senior Regional Appointment30.9.2026 13:56:00 EEST | Press release
Pantheon, a leading global private markets firm with approximately $84bn in assets under management, today announced the expansion of its presence in the Middle East with the opening of its first office in ADGM, the international financial center based in Abu Dhabi, alongside the appointment of Firas Mallah as Managing Director and Head of Middle East. Demand for access to private equity, infrastructure, and private credit strategies continues to build among sophisticated investors across the Middle East, who recognize Pantheon for its 40-year track record of innovation and expertise across primaries, secondaries and co-investment opportunities. Secondaries – pioneered by Pantheon in 1988 – remains a defining thread across the platform: alongside its long-established private equity secondaries business, Pantheon has among the industry's first and largest private credit and infrastructure secondaries franchises, making it a strong partner in that space across the GCC. These strategies a
34% of Global Consumers Say They Are Worse Off Financially Than a Year Ago as Households Adapt to a New Era of Permanent Uncertainty, NIQ Finds30.9.2026 13:45:00 EEST | Press release
With over a third (34%) of global consumers saying they are financially worse off than they were a year ago, and another third (30%) saying they are financially better off, consumers are no longer waiting for economic conditions to improve. Around the world, households are adapting to a future where volatility remains a persistent reality, creating increasingly different financial outcomes, spending priorities, and pathways to growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260930542911/en/ NIQ's Consumer Outlook: Guide to 2027 These findings come from NielsenIQ’s (NYSE: NIQ) latest global Consumer Outlook survey of more than 21,000 respondents across 31 countries, combined with NIQ's measurement of real-world purchasing behavior. The research reveals that economic uncertainty is no longer a temporary disruption, but a defining feature of how consumers make decisions. Findings include: 34% of global consumers globally
Neutrogena ® , Aveeno ® , and Regaine ® Present New Scientific Evidence Demonstrating How Science-Backed Ingredients Support Healthy Skin and Hair30.9.2026 13:45:00 EEST | Press release
Neutrogena®, Aveeno®, and Regaine®* will present 12 new scientific data sets at the 35th European Academy of Dermatology and Venereology (EADV) Congress taking place September 30th through October 3rd in Vienna. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260930489298/en/ New Neutrogena science showcased at EADV 2026 in Vienna, Austria Abstracts presented will share new evidence demonstrating how science-backed ingredients including niacinamide, trehalose, colloidal oat and 5% minoxidil can help address some of the most common skin and hair concerns consumers experience, including acne, oily skin, dry skin, hyperpigmentation, eczema, UV-related skin damage and androgenetic alopecia. The findings reinforce a growing body of evidence showing that innovative formulations can deliver benefits beyond traditional expectations by helping protect and strengthen the skin barrier, improve visible skin concerns, and support hair reg
Compass Pathways Appoints Kelley Boucher as Chief People Officer30.9.2026 13:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced the appointment of Kelley Boucher as Chief People Officer, effective today. This appointment strengthens the Compass executive team as the company continues to scale in support of its mission to bring the first classic psychedelic treatment to the field of psychiatry. In this role, Ms. Boucher will oversee the Company’s people strategy, with an initial focus on guiding its planned evolution towards the launch of COMP360 psilocybin, subject to FDA approval, in the first half of 2027. "We are thrilled to welcome Kelley to our executive team at this pivotal moment in Compass’ journey. As we prepare for our NDA submission in the fourth quarter of this year, we are closer than ever to achieving our goal of introducing an entirely new treatment model in mental health care with COMP360 psilocybin," said Kabir Nath, Chief Executive Officer a
NIQ Expands Google Relationship with Meridian Integration into NIQ Cadence™30.9.2026 13:30:00 EEST | Press release
NIQ (NYSE: NIQ), a leading consumer intelligence company, today announced the expansion of its relationship with Google through the integration of Meridian, Google's open-source MMM framework, into NIQ Cadence™, NIQ's AI-native marketing effectiveness operating system. The strategic partnership gives marketers a single place to measure marketing performance and act on it, shortening the distance between insights and optimization. Marketing leaders are under growing pressure to prove the return on every media dollar, and traditional measurement has struggled to keep pace. In NIQ’s latest CMO Report, 74% of CMOs said they were under more scrutiny to prove marketing ROI, while just 9% felt they had adequate access to real-time insights. NIQ Cadence™ was built to help close the 65-point actionability gap between accountability and timeliness. Rather than treating measurement as a one-time event, the integration brings Meridian into NIQ Cadence™, a unified platform which brings data, models
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom