NY-AGNOVOS-HEALTHCARE
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
Novotech Issues White Paper to Help Sponsors Strengthen Early-Phase Oncology Strategy and Execution15.12.2025 14:05:00 CET | Press release
Novotech, a leading global full-service clinical research organization (CRO) and scientific advisory company, has released a new white paper, Early-Phase Oncology – Clinical Research Landscape and CRO Enablers (2025), offering in-depth analysis of the key drivers shaping early-phase oncology development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215843975/en/ With approximately 60% of oncology agents progressing from Phase I to Phase II, but only 3–6% reaching regulatory approval, the paper outlines the factors influencing early-stage success, including trial design, patient selection, and regional development pathways. The paper highlights Australia’s continued position as a global first-in-human (FIH) and early-phase research hub. Its ethics-led review frameworks, which can support trial initiation within roughly 4–8 weeks, combined with established FIH centers, oncology networks, and cost efficiencies, position Au
Ant Group Announces Major Upgrades to Its 15-Million-MAU AI Health App AQ Amid Wider Push into Health Sector15.12.2025 14:03:00 CET | Press release
Ant Group today announced major upgrades to its AI health app AQ, with a new Chinese name “Ant A-Fu.” The character “Fu” conveys good wishes and well-being, reflecting the app’s goal to promote better health and quality of life. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215203213/en/ Ant Group’s AI health app AQ features three core capabilities: health Q&A, AI health companion, and integrated health services. The upgraded version of AQ now features three core capabilities: health Q&A, AI health companion, and integrated health services. Launched in June 2025, AQ has rapidly grown to 15 million monthly active users, making it China’s leading AI health management app. Positioned as an AI health companion service, AQ currently answers over 5 million health-related questions every day. The announcement comes amid China’s ongoing demographic shift. According to projections from the National Health Commission, by around 20
Copeland and Daikin Cooperation Brings Solutions to European Customers15.12.2025 14:00:00 CET | Press release
Strategic collaboration to bring innovative residential solutions designed to reduce emissions and enable sustainable home heating Copeland and Daikin, two global leaders in heating, ventilation and air conditioning (HVAC) solutions, today announced the expansion of their existing joint venture into Europe. Through this cooperation, the companies will introduce advanced inverter swing rotary compressors, power electronics and controls designed specifically for European residential heat pumps. This collaboration underscores both companies’ commitment to accelerate the energy transition, with heat pumps recognized by industry reports as a cornerstone technology helping to reduce global carbon dioxide emissions by an estimated 500 million tons by 2030. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215625806/en/ (Left to right) Ross B. Shuster, CEO of Copeland and Jiro Tomita, executive associate officer of Daikin As Europe
Visa Unveils New Global Stablecoins Advisory Practice15.12.2025 13:00:00 CET | Press release
Visa Consulting & Analytics combines advanced payments strategy and expert crypto knowledge to help clients innovate and grow with stablecoins technology Visa (NYSE: V), a global leader in digital payments, today announced the launch of its Stablecoins Advisory Practice. The new value-added service offering by Visa Consulting & Analytics (VCA) provides actionable insights and recommendations to guide banks, fintechs, merchants, and businesses of all sizes on market fit, strategy, and implementation. As the stablecoin market cap surpasses $250 billion, Visa’s settlement volume has accelerated, reaching a $3.5 billion annualized run rate as of November 30. Businesses are turning to Visa’s new Stablecoins Advisory Practice to unlock growth opportunities. “Putting our members first has always been our mission, and we’re committed to exploring innovations that strengthen financial health and convenience for those we serve. Stablecoins may represent an opportunity to enhance speed and lower
SK Capital Announces Definitive Agreement to Invest in Swixx BioPharma AG to Drive the Next Phase of Growth and Global Expansion15.12.2025 12:30:00 CET | Press release
SK Capital Partners, LP (“SK Capital”), a New York-based private investment firm focused on the life sciences, specialty materials, and ingredients sectors, today announced that its affiliate has reached an agreement to invest in Swixx BioPharma AG (“Swixx” or the “Company”) to accelerate the Company’s next phase of growth and global expansion. The investment values the Company in excess of EUR €1.5 billion. Swixx is the global leader in rest-of-world pharmaceutical commercialization services dedicated to delivering innovative, life-saving medications to underserved and hard-to-reach markets. Stuart Swanson and Petr Němec, Swixx’s Co-Founders, and Jean-Michel Lespinasse and Petr Pipal, Swixx’s CEO and CFO, respectively, will all retain significant ownership stakes in Swixx as part of the transaction. Existing institutional investors HBM Healthcare Investments, a Swiss-listed investment company for the global healthcare market, and Mérieux Equity Partners, a leading healthcare-specializ
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