AgNovos Healthcare Completes Enrollment for CONFIRM Clinical Study
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.
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/20211213006012/en/
Contact information
James Pilachowski
Senior Vice President, Hip Program and Marketing
+1 646 502 5868
jpilachowski@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
HORNBACH Baumarkt Selects Blue Yonder To Accelerate Its Omni-Channel, Customer-Centric Strategy19.9.2024 10:00:00 EEST | Press release
Today, retail offers a wide range of opportunities. Retailers must consistently focus on the needs of their customers if they want to be successful – even in the future. Tech innovation is accelerating. Consumers want to be free to decide whether they want to shop in the store or via smartphone or computer. Optimally, it should all be connected. Retailers are looking to innovate, add new services, and deliver experiences that consumers love, but they often face a costly and expensive fix because their tech stack was not built for modern experiences with efficiency in mind. That’s why, as a pioneer in innovation and one of the leading DIY retailers in Europe, HORNBACH Baumarkt has selected Blue YonderInventory and Commits Services, part of Blue Yonder Order Management solutions. HORNBACH Baumarkt is the largest and most important subsidiary of HORNBACH Holding. HORNBACH Baumarkt operates DIY megastores with garden centers and online stores in nine European countries. The DIY retail segm
Wolters Kluwer expert to speak at Europe's inaugural Microsoft Fabric Community Conference19.9.2024 09:00:00 EEST | Press release
Wolters Kluwer Tax & Accounting (TAA), a global leader in professional information, software solutions, and services, today announced that Simon Hjortsberg, the company's Manager of Business Intelligence, will be a keynote speaker at Europe's first-ever Microsoft Fabric Community Conference. The anticipated event will take place from September 24 to 27, 2024, at Stockholmsmässan, in Sweden. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240918799017/en/ Simon Hjortsberg, Manager, Business Intelligence, Wolters Kluwer Tax & Accounting (Photo: Business Wire) On Wednesday, September 25, Simon Hjortsberg will deliver a presentation on “Sharing Experiences with Fabric Copilot.” As an experienced Global Senior Business Intelligence Analyst, Hjortsberg will delve into the ways generative AI features are transforming data analysis, generating insights, and creating detailed visualizations and reports in Microsoft Fabric and Power BI
Murata Unveils the World’s Smallest Multilayer Ceramic Capacitor with the First 006003-inch Size (0.16mm×0.08mm) Device19.9.2024 09:00:00 EEST | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has expanded its innovative range of multilayer ceramic capacitors (MLCCs) with yet another groundbreaking addition. Exemplifying Murata’s continual commitment for minimization, it has developed the world’s first 006003-inch size (0.16 mm x 0.08 mm) MLCC. This achievement represents a volume ratio approximately 75% lower than the existing smallest product, the 008004-inch size (0.25×0.125mm). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240918232327/en/ [Murata Manufacturing Co., Ltd.] Murata’s world’s first 006003-inch size (0.16 mm x 0.08 mm) MLCC (Photo: Business Wire) In recent years, as electronic devices become more sophisticated and compact, the number of electronic components installed has increased, while simultaneously the space required for installation has been reduced. As electronic devices continue to advance in intelligence, there has been a c
Dfns Wallet Infrastructure Now Available on Temenos Exchange19.9.2024 08:37:00 EEST | Press release
Dfns, a leading provider of wallets-as-a-service (WaaS) solutions, today announced Dfns Wallet Infrastructure is available on Temenos Exchange, the partner ecosystem of integrated fintech solutions. This partnership makes Dfns the first European digital asset infrastructure provider to integrate with Temenos, joining a select group that includes Wyden, Fireblocks, and Taurus. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240918695901/en/ Dfns Wallet Infrastructure Now Available on Temenos Exchange (Graphic: Business Wire) The Dfns Wallet Infrastructure delivers critical business benefits tailored to the needs of institutional finance and banks. By integrating with Temenos, our solution offers services such as key, authentication, identity and access, blockchain, wallet and transaction management. This partnership differentiates our offering by connecting our secure and compliant wallets with the rigorous standards and busin
Aizon Launches New AI-powered eBR Light Solution to Enhance Manufacturing Productivity in Collaboration with Euroapi18.9.2024 19:00:00 EEST | Press release
Aizon, an Artificial Intelligence (AI) SaaS provider dedicated to transforming pharmaceutical manufacturing operations, is launching a new product called Aizon Execute, an innovative eBR (Electronic Batch Record) software product, developed in collaboration with Euroapi, a leading global API manufacturer. This collaboration was born out of the need to digitize operations towards more data-driven manufacturing - focusing on the essential user needs while avoiding the heavy lift currently associated with going paperless in manufacturing. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240918037613/en/ Aizon Execute is a modern, user-centric, lightweight product designed to adapt to small-scale productions and highly flexible plants like chemical API CDMOs - and has the potential to become the true backbone of digital transformation journeys. Aizon Execute light eBR is designed to facilitate the rapid transition from paper-based
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