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
Meiji Seika Pharma: Positive Results from the Phase III Integral-1 Trial of Nacubactam, a Novel β-Lactamase Inhibitor, in Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis ― Published in The Lancet15.5.2026 03:00:00 CEST | Press release
Meiji Seika Pharma Co., Ltd. (headquartered in Tokyo; President and Representative Director: Toshiaki Nagasato) today announced that the results of the Integral-1 study, one of two global Phase III clinical trials evaluating the efficacy and safety of its novel β-lactamase inhibitor nacubactam (development code: OP0595), have been published in The Lancet. The article is entitled “---Efficacy and safety of cefepime–nacubactam and aztreonam–nacubactam compared with imipenem–cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis (Integral-1): a double-blind, randomised phase 3 trial” (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00596-9/fulltext) Integral-1 is a global, double-blind, randomized Phase III trial (jRCT2031230075) in patients with complicated urinary tract infection or acute uncomplicated pyelonephritis that compared the efficacy and safety of nacubactam co-administered with either cefepime or aztreonam versus imipenem-c
Boomi Teams up With Gong to Bring Revenue AI to Boomi Agentstudio14.5.2026 18:00:00 CEST | Press release
Gong's revenue AI is now natively available in the Boomi Enterprise Platform Boomi, the data activation company for AI, today announced a collaboration withGong, the leader in Revenue AI, to bring revenue signals captured in Gong natively into the Boomi Enterprise Platform. This collaboration enables enterprises to establish an active data foundation designed to transform customer conversations into coordinated, automated actions across systems and functions enterprise-wide with Boomi Agentstudio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514443012/en/ Boomi Teams Up with Gong to Bring Revenue AI to Boomi Agentstudio Gong goes beyond capturing deal activity to surface real-time insights into risk, buyer intent, competitive dynamics, and key engagement signals. That intelligence moves from conversation to coordinated action, flowing across CRM, ERP, product, and operational systems with the governance and security tha
Xsolla and Skich Announce Strategic Partnership to Bring Merchant of Record Payments to an Alternative Mobile Game Marketplace14.5.2026 18:00:00 CEST | Press release
Partnership Enables Developers To Monetize Games On The Skich Store With Xsolla Handling Payments, Tax Compliance, And Commerce Infrastructure Xsolla, a leading global video game commerce company, today announced a strategic partnership with Skich, an alternative mobile game marketplace operating on iOS in the EU under Apple's Digital Markets Act provisions and on Android globally. Under the agreement, Xsolla will serve as Merchant of Record for in-app purchases and paid game sales distributed through the Skich Store. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514867730/en/ Graphic: Xsolla Skich serves as an alternative to traditional mobile storefronts, offering developers a way to reach players outside platform-controlled distribution channels. The partnership with Xsolla enables Skich to offer a fully compliant payment and commerce layer, with Xsolla managing payment processing, tax collection, refunds, and regulat
Boomi and Guru Partner to Deliver AI-Powered Enterprise Knowledge Enriched by Real-Time Data Activation14.5.2026 16:30:00 CEST | Press release
Guru becomes a launch partner for Boomi Connect, integrating with Boomi’s managed connector service and MCP Registry to transform fragmented enterprise data into governed, actionable intelligence for AI agents Boomi, the data activation company for AI, and Guru, the AI-powered enterprise knowledge platform, today announced a technology partnership to help organizations unlock the full value of their enterprise data for AI-driven decision-making. Unveiled at Boomi World 2026, the partnership makes Guru a launch partner for Boomi Connect, Boomi’s new managed connector service, and integrates Guru’s knowledge agents with Agentstudio and the Boomi MCP Registry to deliver richer, more accurate, and more actionable insights to knowledge workers and AI agents alike. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514440755/en/ Guru was selected as a Boomi Connect launch partner because its AI-powered knowledge platform represents
IQM and Real Asset Acquisition Corp. Announce Public Filing of Form F-4 Registration Statement with the SEC14.5.2026 15:55:00 CEST | Press release
This filing marks an important milestone in the transaction, moving IQM closer to becoming the first European quantum computing company to go public. Global commercial leader with 23 systems sold to customers to date – including 4 out of the top 10 supercomputing centres and increasing adoption by enterprise customers. Industrial leader with 15 systems delivered (largest number publicly disclosed by selected quantum companies1), 30+ computers built, own chip factory, assembly line and quantum data centre. The transaction values IQM at a pre-money equity valuation of approximately USD 1.8 billion. With the close of this transaction, IQM’s cash position is expected to be up to EUR 397 million (USD 465 million).2 Significant business momentum, with 2025 revenue of USD 36 million3 or over EUR 31 million. IQM intends to apply for its shares to be admitted to trading on Nasdaq Helsinki following the Business Combination. IQM Finland Oy, a global leader in full-stack superconducting quantum c
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