NY-AGNOVOS-HEALTHCARE
19.4.2021 14:02:12 CEST | Business Wire | Press release
AgNovos Healthcare, a developer of medical technology products leveraging regenerative medicine to treat the local effects of bone disease, announced today that its newest investigational product, AGN1 Local Osteo-enhancement Procedure (LOEP) Small Volume (SV) kit has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration. The IDE for the AGN1 LOEP SV kit will enable the study of the device’s ability to reduce pain and support mobility in patients with vertebral compression fractures.
"We are pleased that FDA has approved the IDE for the STAND study,” said Tanner Howe, President and CEO of AgNovos Healthcare. “We believe that the AGN1 LOEP SV kit has the potential to transform the treatment landscape for vertebral compression fractures. It is designed to work differently than traditional vertebral augmentation because the AGN1 implant material is intended to be resorbed and replaced by new bone. This treatment is in line with the Company’s mission of improving the quality of life of millions of women and men impacted every day by bone disease, including osteoporosis.”
“This approval allows us to advance our clinical research program and continue to evaluate the treatment’s safety and efficacy in the STAND study,” added Stephanie Kladakis PhD, Senior Vice President of Research & Development and Global Regulatory Affairs at AgNovos. “Our team has spoken with numerous clinicians in the U.S. and Europe who are looking for alternative approaches to traditional vertebral augmentation to treat patients with certain vertebral compression fractures. I am pleased that we are one step closer on our pathway to making a new approach available to this patient population.”
Almost 1.5 million vertebral compression fractures are diagnosed every year. These fractures are often caused by bone loss associated with osteoporosis. They can lead to debilitating pain and a downward spiral of reduced mobility, independence, and increased risk of additional fractures. Given aging populations in the U.S. and globally, the burden to healthcare systems is expected to increase over time. Other surgical approaches to address painful fractures in the spine exist but can have downsides, including the potential to increase fracture risk in adjacent vertebral bodies due to changes in the stiffness of the treated vertebral bodies.
About AGN1 LOEP SV Kit
The AGN1 LOEP SV kit is an investigational device intended to treat stable but painful vertebral compression fractures in a minimally-invasive procedure. The device was previously granted Breakthrough Device designation by FDA. The Breakthrough Devices program is intended to expedite the development and review of devices that are either novel or have the potential to benefit patients with life-threatening or debilitating conditions.
The AGN1 LOEP SV kit contains all instruments and components necessary to prepare the fractured vertebral body for injection with AGN1, a resorbable, osteoconductive, tri-phasic implant material. While this kit is investigational in all jurisdictions, the AGN1 implant material is available in a CE-marked kit to form new bone in the pelvis and other extremities. Preclinical and clinical research has shown that treatment with the device leads to the formation of new bone and an immediate, substantial and durable increase in the strength of osteoporotic femurs.
About AgNovos Healthcare
AgNovos is a developer of new medical technology products leveraging regenerative medicine to address the local effects of bone disease. The Company’s first product, the OSSURE® Local Osteo-enhancement Procedure kit is CE-marked to form new bone in the pelvis and extremities. AgNovos 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 an investigational device that is not cleared or approved in any jurisdiction, including the U.S.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210419005156/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
ProAmpac Pushes the Limits of Fiber Packaging with New High Barrier Packaging Innovation Platform17.2.2026 18:08:00 CET | Press release
ProAmpac, a global leader in flexible packaging and material science, announces the expansion of its ProActive Recyclable® RP-2000 High Barrier Series. This curbside recyclable, fiber-based packaging platform is designed to help brands transition away from traditional non-recyclable high-barrier multilayer structures, such as paper/foil, paper/metalized polyethylene terephthalate (METPET), and certain film laminations. The RP-2000 platform provides strong barriers to oxygen and moisture, making it well-suited for sensitive dry food products such as oatmeal, granola, cereal, spices, snacks, dried fruits, and nuts. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260217779741/en/ ProAmpac's RP-2000MHB Series “Supporting the growing Fiberization of Packaging® movement, and as adoption of fiber-based structures accelerates, it is critical that ProAmpac continues to expand the functional performance envelope of paper-based material
ChipAgents Raises $74M to Scale an Agentic AI Platform to Accelerate Chip Design17.2.2026 16:00:00 CET | Press release
Company opens 20,000 sq ft HQ in Silicon Valley to deploy AI Agents to accelerate chip design workflows. Sandeep Bharathi joins Advisory Board. ChipAgents, the category leader for Agentic AI platforms in the semiconductor design industry, announced it has closed an oversubscribed $50 million Series A1 funding round, bringing total capital raised to $74 million. The round was led by Matter Venture Partners, a TSMC-backed HardTech VC firm, with participation from existing investors Bessemer Venture Partners, Micron, MediaTek, and Ericsson. As part of the investment, Wen Hsieh, Founding Managing Partner of Matter VP, will join ChipAgents' Board of Directors, bringing over two decades of expertise and relationships in semiconductor design and manufacturing. Building the AI Workforce for Chip Design Companies This new capital will enable ChipAgents to aggressively scale its Agentic AI platform, expand its engineering and research organization, and accelerate global deployment of multi-agent
Toshiba Showcases End-to-End Innovations Shaping What’s Next in Retail at EuroShop 202617.2.2026 15:45:00 CET | Press release
At EuroShop, Toshiba showcases intelligent, scalable solutions that combine AI, computer vision, and energy-efficient design to transform the future of retail. At EuroShop 2026, Toshiba Global Commerce Solutions will showcase how retailers across Europe are using scalable, sustainable innovation to address today’s challenges and build what’s next. Exhibiting in Hall 6, Booth C41 from the 22nd to 26th February, Toshiba will demonstrate technologies designed to evolve with retailers, empowering flexibility, resilience, and long-term growth, and prepare them for what’s next. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260216755053/en/ At EuroShop, we’re showing how Toshiba empowers retailers across all segments to transform with confidence by scaling intelligent solutions to deliver lasting impact. “Retailers are under pressure to move faster, operate more efficiently, and deliver better experiences than ever before. At Euro
Andersen Consulting Expands Executive Talent Capabilities With Lansdowne Executive Search17.2.2026 15:30:00 CET | Press release
Andersen Consulting strengthens its human capital practice through a Collaboration Agreement with Lansdowne Executive Search, a Dublin-based firm specializing in executive search, interim management and board level appointments. Founded in 2015, Lansdowne Executive Search is an Irish-owned firm, delivering C-level executive search, fractional executives, and board placement services. As a partner-led, boutique practice, Lansdowne is known for the deep involvement of senior leadership in all client engagements. Lansdowne helps clients navigate complex leadership transitions and growth strategies across a wide range of sectors including financial services, construction, nonprofit, agriculture, higher education, public sector, and TMT. “Great leadership is contextual and getting it right means understanding far more than just a resume,” said Tom Keane, partner at Lansdowne Executive Search. “Collaborating with Andersen Consulting gives us the scale and access to expertise we need to conti
Caidya Names Michael Clay COO to Drive Operational Excellence and Advance Multi-Regional Clinical Development17.2.2026 15:10:00 CET | Press release
Caidya, a leading global, mid-sized CRO focused on accelerating clinical development for innovative biopharmaceutical companies, today announced the appointment of Michael Clay as chief operating officer (COO). Clay will lead Caidya’s global operational delivery, client engagement model, and execution strategy, further strengthening the company’s ability to serve innovative biopharma sponsors across the U.S., Europe, and Asia-Pacific. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260217431202/en/ Michael Clay, Caidya's Chief Operating Officer Clay brings a distinguished track record in global project delivery and site relationship strategy. He has led large-scale global programs across 60+ countries and built high-performing delivery organizations known for operational rigor and sponsor trust. Notably, Clay has extensive leadership experience across Asia-Pacific, where speed, regulatory nuance, and close site collaboration
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