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
Volue Welcomes TA Associates as New Strategic Investor13.2.2026 11:15:00 CET | Press release
Partnership Strengthens Volue’s Position as a European Leader in Electrification Technology Volue, a global leader in electrification and energy technology, today announced that TA Associates (“TA”), a leading global private equity firm, has joined as a new strategic investor alongside Advent International (“Advent”), Generation Investment Management (“Generation”) and Arendals Fossekompani. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213436945/en/ Over the past 18 months, Volue has undergone a strategic transformation to sharpen its focus on the energy sector. During this period, Volue divested non-core activities and invested in targeted R&D innovation and strategic acquisitions to further position Volue as a leading provider of integrated technology solutions for power trading and generation, grid optimization, and energy market intelligence. Operating at the center of one of the most mission-critical markets of our
ABB strengthens electrical engineering advisory capabilities in Europe with Premium Power acquisition13.2.2026 10:30:00 CET | Press release
Acquisition strengthens ABB’s ability to deliver system-level advisory support at scale to help critical industries manage increasingly complex electrical infrastructures and safeguard energy resilience Enhances ABB’s Electrification Service division offering in power system studies, grid modelling and electrical risk management for data centers, pharmaceuticals and other critical industries Solidifies ABB at the electrical system level, embedding trusted advisory expertise at the point where operational risks, resilience and performance are defined ABB today announced it has entered into an agreement to acquire Premium Power, a leading electrical engineering consultancy headquartered near Dublin, Ireland. For more than two decades, Premium Power has established its reputation as a trusted advisor to large customers, particularly in data centers, pharmaceutical manufacturing and other mission-critical sectors where electrical resilience, uptime and regulatory compliance are essential.
EnergyAustralia, Enerven and NHOA Energy Mark Financial Close and Project Launch of the 245 MWh Hallett Battery in South Australia13.2.2026 08:00:00 CET | Press release
The project will support grid stability in the National Electricity Market, strengthening NHOA Energy’s long-term commitment to the Australian market NHOA Energy, global provider of utility-scale energy storage systems, today marked together with EnergyAustralia and Enerven the official project launch of a 245 MWh Battery Energy Storage System (BESS) in Hallett, near the town of Canowie, in South Australia, following the achievement of financial close and the project’s transition into the delivery phase. The milestone was announced today during a project launch ceremony held at the Hallett Power Station, attended by representatives of EnergyAustralia, Enerven, NHOA Energy, government, Traditional Owners and local community stakeholders. Owned and developed by EnergyAustralia, the Hallett BESS is being built alongside the existing Hallett gas-fired power station and represents the first stage of a broader site development. As delivery partner for Stage 1 of the project, NHOA Energy will
Echoworx Encryption Arrives on AWS Marketplace: Frictionless Security for a Global World13.2.2026 07:00:00 CET | Press release
Echoworx, the trusted name in email encryption, is now live on AWS Marketplace—fully deployed on AWS infrastructure. For global businesses, this means securing sensitive communications just got a whole lot easier, starting from purchase. Why AWS Marketplace? Why Now? Echoworx’s mission has always been to make secure communications as easy and accessible as possible. By joining the AWS Marketplace, Echoworx is taking this mission a step further, ensuring that customers can procure its encryption solution with the same ease and efficiency they experience when using it. Cross-border compliance, taxes, and billing headaches slow teams down. With AWS Marketplace, Echoworx customers bypass the usual red tape: automated tax and regulatory handling, simple multi-currency billing, and support for Private Offers. That translates to custom pricing and contracts in local currencies, less foreign exchange guesswork, and a procurement process built for modern enterprise. "Our partnership with AWS Ma
Align Partners Issues Formal Shareholder Proposals to Gabia13.2.2026 01:37:00 CET | Press release
Align Partners Capital Management Inc. (“Align Partners”), a shareholder of Gabia, Inc. (“Gabia” or the “Company”), has submitted formal shareholder proposals for inclusion in the agenda of Gabia’s upcoming 27th Annual General Meeting (“AGM”) and issued a call for strengthened governance practices to address the Company’s persistent undervaluation. Align Partners noted that, as shareholder proposals will be presented at this year’s AGM, Gabia should follow the Korea Exchange (KRX) Corporate Governance Key Indicators by publishing the AGM convocation notice at least four weeks prior to the meeting date. Align Partners emphasized that last year’s AGM notice was issued only 16 days before the meeting, limiting shareholders’ ability to adequately review the agenda and exercise informed voting rights. Gabia is widely recognized as a leading Korean IT services and cloud infrastructure company with solid operating performance. Despite these strengths, Align Partners believes the Company conti
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