NY-AGNOVOS-HEALTHCARE
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
Ahead of Holiday Season, Visa Identifies Five Transformative Forces Reshaping Global Payment Security20.11.2025 19:50:00 CET | Press release
New Biannual Threats Report Reveals Fundamental Shift in Fraud Operations as Criminals Adopt Industrial-Scale Tactics To celebrate International Fraud Awareness Week, Visa (NYSE: V) today released its Fall 2025 Biannual Threats Report, revealing five forces that are transforming the global payments security landscape. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251120412198/en/ The report, produced by Visa's Payment Ecosystem Risk and Control (PERC) team, draws on intelligence from Visa's global network to identify how criminal operations are evolving with unprecedented speed, scale, and sophistication. "The payments ecosystem is experiencing a paradigm shift in how fraud operates," said Paul Fabara, Chief Risk and Client Services Officer at Visa. "Criminals are no longer working as opportunistic individuals-- they're operating like tech startups, building reusable infrastructure and deploying systematic, industrial-scale
Suzano Forms Partnership with Tencent and Ecofuturo Institute at COP30 for AI-Powered Conservation and Nature Education20.11.2025 18:25:00 CET | Press release
New agreement signed at COP30 will see organisations collaborating to use artificial intelligence tools for biodiversity monitoring and digital platforms to boost public engagement in conservation efforts. The world’s largest pulp supplier, Suzano, today announces the signing of a Memorandum of Understanding (MoU) with the multinational technology business Tencent and the Brazilian non-profit Ecofuturo Institute, to pioneer new digital approaches to drive public engagement in conservation. The collaboration will leverage Suzano’s expertise in sustainable forestry, Tencent’s cutting-edge digital technology, and Ecofuturo’s expertise in environmental education, to pilot joint initiatives in both Brazil and China. These include enhancing ecological awareness, accelerating biodiversity solutions, and leveraging digital platforms to foster public engagement in conservation. The partnership will result in a pilot project where advanced AI tools for species recognition developed by Tencent’s
EMVCo Working on How Global Specifications Can Support Agentic Payments20.11.2025 17:38:00 CET | Press release
EMVCo – the technical body that creates and manages EMV® Specifications and programmes that enable seamless and secure card-based payments worldwide – has announced that it is working on how global specifications can support innovation in agentic payment solutions by increasing trust and interoperability across the ecosystem. Agentic commerce is rapidly reshaping the shopping experience by enabling AI agents to act on the consumer’s behalf. This is driving significant momentum for agentic payments, which introduce AI agents as new actors that can initiate transactions with merchants – without requiring direct involvement from the consumer. While agentic payments have the potential to increase convenience and personalisation, they present unique considerations for how transactions are initiated, authenticated and secured. As industry adoption and innovation accelerate, a globally interoperable and scalable approach may be beneficial in realising trusted agentic payments for consumers, m
Université Paris-Saclay and Owkin: A Unique Alliance to Propel University Medical Research to the Top of the European Rankings Through AI20.11.2025 15:17:00 CET | Press release
Université Paris-Saclay and Owkin announce the signing of a memorandum of understanding to explore the potential of K Pro Free - Owkin’s AI co-pilot for biology - for use by Paris-Saclay. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251120130113/en/ K Pro Free will now be available to the entire Université Paris-Saclay community, and in particular teachers, researchers and doctoral students working in the biomedical sciences. The partnership includes workshops, training sessions and events designed to promote the discovery and adoption of K Pro Free, as well as the co-organization of communication and dissemination initiatives around the use of AI in health. In this way, the partnership will promote user training, but also enrich and continuously improve the co-pilot's models through feedback and use cases from the l’Université Paris-Saclay community. This partnership is part of Université Paris-Saclay’s strategy to integr
Frasca Advances Flight Training Technology with New Visual System Powered by Unreal Engine20.11.2025 15:05:00 CET | Press release
Frasca International, Inc., a FlightSafety International company and leader in flight simulation, today announced the launch of VITAL FVS 100, the next evolution of its visual system technology. Building on the proven TruVision Global platform, VITAL FVS 100 was developed using Epic Games’ Unreal Engine and delivers unprecedented realism, scalability, and innovation in pilot training. The Unreal-powered VITAL FVS 100 system introduces major advancements in visual fidelity and training realism, further enhancing the capabilities of Frasca, a leading developer of flight simulators and training devices. The new system includes physically based renderings, advanced lighting effects, and a new volumetric cloud model that creates dynamic, weather-rich environments. Terrain imagery now includes one-meter resolution coverage for the contiguous United States and Hawaii, with expanded global datasets covering European buildings and tree covered regions. Additionally, enhanced particle effects re
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