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
Elegen and Nutcracker Therapeutics to Pilot First Fully Cell-Free Manufacturing Process for RNA-based Personalized Cancer Therapeutics11.7.2025 14:00:00 CEST | Press release
Fully cell-free process aims to further democratize personalized cancer therapeutic manufacturing with shorter turnaround times and negligible bioburden and endotoxin risks. Elegen, a global leader in next-generation DNA manufacturing, and Nutcracker Therapeutics, a global leader in next-generation RNA design and manufacturing, today announced the launch of a pilot program to demonstrate the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics (PCTs). The pilot marks another step toward making PCTs more accessible, timely, and scalable. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711152688/en/ As late-stage PCT clinical trials progress and therapy developers work to create the next generation of PCTs, the speed, reliability, scaling and cost of traditional production methods pose a major challenge. Specifically, the first step of DNA template production is hi
$MBG Token Pre-Sale Set for July 15 — Only 7 Million Tokens Available at $0.3511.7.2025 10:17:00 CEST | Press release
MultiBank Group, the world’s largest financial derivatives institution headquartered in Dubai, has confirmed that its highly anticipated $MBG Token pre-sale will go live on July 15, with demand expected to be intense. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711737311/en/ With only 7 million $MBG tokens up for grabs at an exclusive entry price of $0.35, this is a rare opportunity to secure early access to what many are calling the year’s most powerful utility asset. With only 7 million tokens up for grabs at an exclusive entry price of $0.35, this is a rare opportunity to secure early access to what many are calling the year’s most powerful utility asset. Early participants can join simultaneously on MultiBank.io, the Group’s regulated crypto exchange, and Uniswap, the world’s leading decentralized platform. Supported by $29 billion in real assets and powered by over $35 billion in daily turnover, $MBG is engineered
Live Story Raises €2.7 Million to Revolutionize the Digital Experience11.7.2025 10:05:00 CEST | Press release
With a round led by Vertis, the next-generation CMS platform accelerates its focus onAI, performance, and European expansion. Target: surpass €10M in recurring revenueby 2027. Live Story, the tech company founded by Stefano Mocellini, has closed a €2.7 million seed round led by Vertis, one of Italy’s leading early-growth venture capital firms. The funding will support the company’s international expansion and technological development, with a clear goal: to exceed €10 million in annual recurringrevenue by 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711335560/en/ “We invested in Live Story because it addresses one of the major inefficiencies in digital commerce: the slow and rigid management of visual and narrative content,” says Alessandro Pontari, Partner at Vertis SGR. “The platform helps brands drastically reduce their time-to-market through a visual CMS that integrates seamlessly with any tech stack. In a wor
With a Score of 84 out of 100, Sagemcom Is Awarded the EcoVadis Platinum Medal: a Prestigious Recognition of its CSR Commitment11.7.2025 09:00:00 CEST | Press release
Sagemcom Group is proud to announce that it has been awarded, for the third time, the Platinum Medal by EcoVadis, the highest distinction granted by the leading global platform for assessing Corporate Social Responsibility (CSR) performance. This medal places Sagemcom in the top 1% of companies evaluated worldwide, across all industries. With a score of 84 out of 100, Sagemcom reaffirms its position as a committed leader in ecological transition, business ethics, sustainable supply chain management, and social responsibility. “The EcoVadis Platinum Medal is more than just an award — it is the recognition of our collective efforts to embed sustainable development principles at the heart of our corporate strategy and culture,” says Sylvaine Couleur, Executive Vice President, CSR & Communication. “Achieving this level demonstrates that our commitments are tangible, impactful, and internationally recognized. This distinction strengthens our determination to further advance and expand our C
IEEE Standards Commitment to Advancing AI Governance Includes Impactful Contributions to New International AI Standards Exchange11.7.2025 08:00:00 CEST | Press release
IEEE, the world’s largest technical professional organization dedicated to advancing technology for humanity, and its IEEE Standards Association (IEEE SA) announced today that its portfolio of over 100 global AI-related standards is included in the new International AI Standards Exchange. This Exchange is a centralized repository of international AI standards with the aim to foster collaboration and responsible AI development worldwide. IEEE and its AI global standards were recognized in the 2024 United Nations AI Advisory Body’s Report, Governing AI for Humanity, which created the impetus for the AI Standards Exchange. Due to its impactful AI standards and related work, IEEE, a major standards body, was included as a partner in the establishment of the Exchange. IEEE President and CEO Kathleen Kramer, who is speaking at the AI for Good Summit this year at the High-Level AI Standards Panel,shares, “IEEE’s mission of advancing technology for the benefit of humanity is foundational to ou
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