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
Global EV Alliance Releases EV Driver Survey Results: Myths Are Slowing EV Market17.11.2025 19:19:00 CET | Press release
In a groundbreaking survey of more than 26,000 EV drivers across 30 countries, an overwhelming 77% say persistent myths about electric cars are the single biggest obstacle to EV adoption in their nations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251118388193/en/ There are still significant differences in the EV market across countries, and not everyone has a wide range of car brands to choose from. Photo: Markus Rotevatn/Norwegian EV Association. 83% say they believe policy measures are needed to increase EV sales in their country. “Misinformation about EVs is a serious challenge. It can make policymakers less confident that electric vehicles are a viable solution to climate change and local air pollution,” says Joel Levin, chair of GEVA and Director of Plug in America. One common myth in many countries is that electric cars are a fire hazard. 88% of the EV drivers in the survey say they aren’t worried about their EV b
Dilawer Farazi Returns to Loomis Sayles as Co-Head and Portfolio Manager on the Emerging Markets Debt Team17.11.2025 16:59:00 CET | Press release
Loomis, Sayles & Company is pleased to announce that Dilawer Farazi, ACA, has rejoined the firm as Co-Head and Portfolio Manager of the Emerging Markets Debt (EMD) Team. Dilawer becomes the firm’s first London-based portfolio manager. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117681347/en/ Dilawer Farazi, ACA, has rejoined Loomis Sayles as Co-Head and Portfolio Manager of the Emerging Markets Debt Team Dilawer brings over two decades of experience in emerging markets credit, having previously served as a Senior Credit Research Analyst at Loomis Sayles from 2018 to 2020. He rejoins the firm from Royal London Asset Management (RLAM), where he led the Emerging Markets Credit team and managed approximately USD $1 billion in assets across EM credit. At RLAM, he launched the firm’s first dedicated emerging markets funds, including an emerging markets corporate bond fund and an emerging markets short duration credit fund. I
Duravant Announces Retirement of CEO Mike Kachmer, Names Jill Evanko Successor17.11.2025 16:13:00 CET | Press release
Mike Kachmer to retire following a distinguished 43-year career, including nearly 12 years as Chairman & CEO of Duravant Jill Evanko to succeed Mr. Kachmer as Duravant’s Chief Executive Officer Duravant LLC (“Duravant”), a global leader in advanced automation solutions, announced today that Mike Kachmer will retire from his role as Chief Executive Officer after a highly successful tenure with the company. Duravant’s Board of Directors has named Jill Evanko as CEO, joining the company on January 5, 2026. To ensure a seamless transition, Mr. Kachmer will continue to serve as Chairman of Duravant. Mr. Kachmer will also continue to serve on the Board of Directors for Northwestern Memorial Healthcare and The London Clinic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117036720/en/ Mike Kachmer “It has been a true honor and a humbling experience to lead this incredible company,” said Mr. Kachmer. “I am profoundly grateful to
Wolters Kluwer Enablon Control of Work Solution Now Available as Private Offer in AWS Marketplace17.11.2025 15:00:00 CET | Press release
Wolters Kluwer today announced that its Enablon Control of Work solution is now available in AWS Marketplace as a private offer. This purchasing model empowers customers to negotiate and receive tailored pricing, terms, and licensing agreements, while streamlining procurement and leveraging existing Amazon Web Services (AWS) billing workflows to accelerate deployment and optimize cloud budgets. Wolters Kluwer’s Enablon Control of Work solution consolidates permit-to-work, isolation management and risk assessments into an integrated system. Trusted by frontline workers and contractors in high-risk environments including oil & gas, pharmaceuticals, data center and manufacturing industries, the software helps streamline operations, minimize unplanned downtime and prevent serious injuries and fatalities. Richard Pulliam, SVP & General Manager of EHS & ESG for Wolters Kluwer, said: “Making Enablon's Control of Work solution available in AWS Marketplace is another step in our mission to help
Morningstar's 2026 Outlook Report Delivers Global and Regional Insights for Durable Portfolios17.11.2025 15:00:00 CET | Press release
Morningstar, Inc. (Nasdaq: MORN), a leading provider of independent investment insights, today published its 2026 Outlook, offering an overview of key challenges and opportunities for the year ahead. In a market defined by uncertainty, this year’s report emphasizes the value of preparation over prediction, equipping investors with strategies to focus on fundamentals and help build resilient portfolios that withstand both booms and busts. Drawing on insights from Equity, Manager, and Behavioral research analysts worldwide, this Outlook distills Morningstar’s thinking on how to navigate opportunity and risk across every major asset class in 2026. "Markets are unpredictable, and the geopolitical and tariff uncertainty of 2025 showed just how quickly forecasts can shift. That’s why Morningstar is redefining the Outlook, focusing on durable portfolios rather than short-term predictions,” said Dan Kemp, chief research and investment officer. “No matter what market conditions the year ahead m
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