NY-AGNOVOS-HEALTHCARE
11.1.2022 14:02:11 CET | Business Wire | Press release
AgNovos Healthcare, a developer of new therapies that leverage proprietary, bone-building technology and regenerative medicine to address unmet needs in the treatment of bone disease, announced today the completion of enrollment for its CONFIRM study. CONFIRM is designed to generate additional data supporting the safety and efficacy of the Company’s AGN1 Local Osteo-Enhancement Procedure (LOEP) product when used in post-menopausal women with osteoporosis. With 60 subjects, CONFIRM is the fourth and largest study of LOEP to complete enrollment. This study includes women receiving unilateral or bilateral treatment with the CE-marked AGN1 LOEP kit.
“The completion of patient enrollment in CONFIRM is an important development for the Company.” said Adam Lowe, Senior Vice President of Clinical Research and Quality at AgNovos Healthcare. He continued, “we look forward to completing the collection, analysis and publication of this data.”
Dr. Jo De Schepper is an orthopedic surgeon and principal investigator at the highest enrolling site, AZ Nikolaas in Sint Niklaas, Belgium. He commented, “the response to the study and technology has been very positive. I know my colleagues in orthopedics and metabolic bone health are interested to see this data. We know the impact that fragility fractures associated with osteoporotic bone loss have on our local communities and are encouraged by the promise of this therapeutic approach.”
CONFIRM patients are being enrolled in an extension study to evaluate LOEP’s impact during the five years following treatment.
About AGN1 LOEP Hip Kit
The AGN1 LOEP Hip 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. Preclinical and clinical research has shown that AGN1 LOEP treatment delivers immediate, substantial and durable increase in the strength of osteoporotic femurs. The kit is available in select markets under the brand name OSSURE® LOEP kit.
About AgNovos Healthcare
AgNovos Healthcare is a developer of new therapies that leverage proprietary, bone-building technology and regenerative medicine to address unmet needs in the treatment of bone disease. AgNovos Healthcare 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 this press release refers to a CE-marked device. The OSSURE Local Osteo-enhancement (LOEP) Kit is not cleared in the United States.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211213006012/en/
Link:
About Business Wire
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
Only 7% of Companies Achieve Full Compliance as Global Expansion Increases Legal Complexity11.5.2026 15:00:00 CEST | Press release
47% of general counsels say beneficial ownership rules pose the biggest risks to legal operations44% lack confidence in meeting cross-border data security requirements As businesses accelerate their global expansion in 2026, compliance fails to keep pace. In fact, only 7% of organizations report full compliance across their global entities, according to a new study by CSC, the leading provider of global business administration and compliance solutions. CSC surveyed 350 general counsel (GCs) and senior legal professionals across Europe, North America, and Asia Pacific to examine how their teams navigate international expansion, regulatory pressure, and the increasing adoption of artificial intelligence (AI).¹ The findings appear in CSC’s latest report, General Counsel Barometer 2026: From Complexity to Control. Most organizations report partial compliance, with over half (53%) estimating they are 50–75% compliant, and a further 35% placing themselves between 76%–99%. This leaves just 7%
IFF Opens Vanilla Innovation Center in Madagascar11.5.2026 14:15:00 CEST | Press release
Advancing science‑led flavor innovation where vanilla is grown IFF (NYSE: IFF)—a global leader in flavors, fragrances, food ingredients, health & bioscience—today announced the opening of its Vanilla Innovation Center in Madagascar, reinforcing vanilla as a strategic and priority tonality for IFF and strengthening its ability to innovate at origin. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508110162/en/ IFF's Vanilla Innovation Center in Madagascar “The opening of the center marks an important step in how we approach vanilla innovation,” said Adam Jańczuk, Ph.D., senior vice president, research, creation and design, Taste, IFF. “By strengthening our presence at origin, we connect science, creativity and sustainability more closely, responding to climate changes, safeguarding quality and creating value across the supply chain.” Located in Toamasina, Madagascar’s principal seaport, near vanilla growing areas and post‑h
ARIS Recognised as a Leader in Gartner® Magic Quadrant™ for Process Intelligence Platforms, Believes This Reinforces Its Role in Enabling Enterprise AI at Scale11.5.2026 14:00:00 CEST | Press release
ARIS, the process context foundation platform for enterprise AI deployment, today announced its recognition as a Leader in the Gartner® Magic Quadrant™ for Process Intelligence Platforms. This is the fourth consecutive year that ARIS has been recognized as a Leader in the report and the company believes it underscores a continued commitment to innovation and growth as enterprises focus on turning AI ambition into measurable business outcomes. While technology has advanced rapidly, companies are struggling to operationalise AI across complex operating models. ARIS sees this recognition by Gartner as a reflection of its strength in delivering a single unified platform for process intelligence, providing the context layer on which G2000 organisations can successfully deploy and scale agentic AI. “AI is moving from experimentation to execution – but many enterprises are finding it difficult to scale,” said Guillaume Bacuvier, CEO of ARIS. “The reason is simple: AI lacks the context it need
HistoSonics Moves to Advance Additional Histotripsy Applications Announcing FDA Submission for Kidney Tumors11.5.2026 14:00:00 CEST | Press release
HistoSonics, the developer of the Edison® Histotripsy System and novel histotripsy therapy platform, today announced it has submitted a De Novo request to the U.S. Food and Drug Administration seeking authorization to expand the use of its Edison® Histotripsy System to include the destruction of kidney (renal) tumors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511268688/en/ HistoSonics Edison® Histotripsy System This milestone marks a significant step forward in the company’s mission to transform the treatment of solid tumors with a completely non-invasive technology that harnesses focused ultrasound to mechanically liquefy and destroy targeted tissue, reducing the risk of many complications and side effects associated with surgery, radiation, and other common therapies. “This submission is an important milestone in expanding histotripsy beyond the liver and into the kidney, an area where patients and physicians are s
Logistics Reply Named a Visionary in 2026 Gartner® Magic Quadrant™ for Warehouse Management Systems and Ranks #2 for Level 2 and #3 for Level 3 Operations Use Cases in Gartner® Critical Capabilities Report11.5.2026 14:00:00 CEST | Press release
Logistics Reply, the Reply Group company specializing in innovative solutions for supply chain execution, is proud to announce its recognition as a Visionary in the Gartner® Magic Quadrant™ for Warehouse Management Systems for the seventh consecutive year, as its global team of warehouse technology professionals continues to drive innovation that puts customers first. Additionally, Logistics Reply for its LEA Reply™ WMS is recognized in the 2026 Gartner® Critical Capabilities for Warehouse Management Systems report where it ranked #2 for Level 2 Warehouse Operations and #3 for Level 3 Warehouse Operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511344452/en/ We believe these important recognitions underscore Logistics Reply's commitment to delivering intelligent, flexible and scalable warehouse execution solutions for enterprise customers around the world. For us, our placement in the Visionaries Quadrant reflects
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