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
Global Millennial Capital Closes USD 100 Million IPO Opportunities Fund Focused on AI, Decentralized Financial Infrastructure, and Climate Technologies19.5.2026 17:16:00 CEST | Press release
Global Millennial Capital Ltd. (“GMCL”) today announced the final closing of its inaugural IPO Opportunities Fund at USD 100 million. Raised through a private placement with institutional and professional investors, the fund targets late-stage and special opportunities investments across mid-cap technology companies operating in high-growth sectors, including artificial intelligence, decentralized finance infrastructure, cybersecurity, digital infrastructure, enterprise software, and climate technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260519513523/en/ Global Millennial Capital announces the successful final close of its USD 100 million IPO Opportunities Fund, reinforcing its commitment to investing in high-growth technology companies across artificial intelligence, digital infrastructure, cybersecurity, and next-generation financial systems. The fund is designed to capitalize on the increasing number of tech
Miro Takes Aim at the Gap Between AI Potential and Organizational Reality19.5.2026 16:00:00 CEST | Press release
At Canvas 26, Miro establishes its AI platform as the connective layer of the modern AI ecosystem — bringing together teams, agents, and the tools they already work in to turn individual AI productivity into organization-wide transformation Miro®, the AI Innovation Workspace for teams, has announced new innovations across its AI platform, reinforcing its position as the collaboration layer where people, context, and agents from every function converge to solve hard problems, make better decisions, and build the right thing faster. Major upgrades to Miro’s agentic AI tools — including Sidekicks and Flows — alongside new Connectors, help customers close the gap between individual AI productivity and organization-wide transformation. AI is reshaping the pace of work, but often teams are not realising the benefits. In many organizations, a gap has emerged between what individuals can now do and what companies can harness. The reason? Collaboration has fractured. Teams have moved from one m
Wolters Kluwer Medi-Span Selected to Provide Personalized Medication Decision Support at The Christie NHS Foundation Trust19.5.2026 15:30:00 CEST | Press release
Roll-out at largest EU cancer center marks first Medi-Span NHS implementation Wolters Kluwer Health has implemented its industry-leading medication decision support (MDS) solution, Medi-Span®, at the world-renowned specialist oncology center, The Christie NHS Foundation Trust. “The Christie is recognized globally for its excellence and commitment to delivering exceptional patient care,” says Israel Armstrong, Vice President for Medi-Span International at Wolters Kluwer Health. “We’re proud that our first Medi-Span implementation in the NHS should be with such a prestigious institution. We look forward to more collaborations that help streamline processes further and help clinical teams make the most highly informed decisions.” The Christie is a leading expert in cancer care, research and education and is the largest single-site cancer center in Europe. The Christie treats more than 60,000 patients a year and is the first facility in the UK to be accredited as a comprehensive cancer cen
Torq Acquires Jit to Unleash the First Enterprise AI SOC Context Graph—and Rewrite the Future of SecOps19.5.2026 15:00:00 CEST | Press release
With Jit Acquisition, Torq Catapults Enterprise SOCs Into a New Realm of Detailed Contextual Investigations That Drive Precision Decision-Making Torq, the established agentic security operations leader, today announced the acquisition of Jit, the Boston-based AI Context Graph cybersecurity pioneer. This move marks a dramatic leap forward for the Torq AI SOC Platform by ensuring agentic investigations are precisely informed via organization-specific contextual data. This shift redefines agentic reasoning, moving beyond static facts such as users, devices and their relationships, to prioritize live, dynamic contextual data overlaid on top, including business drivers, and the real-time state of the enterprise. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260519044833/en/ Instead of acting on fragmented data or having investigations triggered by a single alert, Torq AI operates with a unified, continuously-updated, contextual
Nine in 10 Firms Fear In-House Systems Can’t Keep Pace with Executive Pay Demands19.5.2026 15:00:00 CEST | Press release
89% of senior HR, rewards, and compensation leaders say in-house technology cannot keep pace with executive compensation demands80% report increased participation in incentive schemes over the past three years66% identify reliance on multiple service providers as a key barrier to maintaining accurate and consistent data Managing executive compensation is a growing challenge for financial services firms, with nearly nine in 10 (89%) saying their in-house technology can’t keep pace with demand. New research by CSC, the leading provider of business administration and compliance solutions, shows that rising complexity, regulatory pressure, and expanding global participation place increasing strain on internal systems and teams.1 CSC surveyed 300 senior HR, rewards, and compensation leaders across Europe, Asia Pacific, and North America working in private markets, asset management, insurance, and investment banking. The report, The Future of Reward in Financial Services: Executive Compensat
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