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
Andersen Consulting tilføjer Multiplica3.4.2026 13:30:00 CEST | Pressemeddelelse
Andersen Consulting indgår en samarbejdsaftale med Multiplica, et digitalt konsulentfirma, der hjælper organisationer med at designe, bygge og skalere effektfulde digitale oplevelser. Multiplica, der er stiftet i Spanien og desuden har aktiviteter i Latinamerika og USA, fokuserer på brugerundersøgelser og behovsafdækning, research af kundeoplevelser, digital strategi, datamodellering og -analyse, rapportautomatisering og datavisualisering, konverteringsoptimering, produktdesign og design af brugeroplevelser. Virksomheden hjælper organisationer med at fremskynde den digitale transformation ved at opbygge digitale kompetencer, teams og aktiver, der fremmer ekspertise på tværs af digitale produkter, rådgivning og talentudvikling. Multiplica gør det muligt for kunder at prognosticere nye tendenser inden for digitale oplevelser og transformere deres forretninger gennem styrkede digitale kanaler og kundeengagement. "Samarbejdet med Andersen Consulting udgør en spændende mulighed for at udvid
Enry’s Island Unveils “Enry’s Island Adventures”: Venture Capital Becomes a Videogame and Launches the “Strap” Movement on Kickstarter3.4.2026 09:47:00 CEST | Press release
Gaming, finance, and lifestyle merge to democratize the startup ecosystem: Enry’s Island opens 2026 applications for game development studios seeking more than just capital. Enry’s Island SpA (WBAG: EIOS), the world’s first publicly traded Venture Builder, today announced the upcoming Kickstarter launch of Enry’s Island Adventures (EIA), developed by its New York-based portfolio company, Enry’s Island Adventures LLC. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260402548535/en/ The game is designed to make venture capital accessible to new generations, transforming startup creation into an engaging and social gaming experience. After three years of R&D, EIA introduces a "bleisure" model (business + leisure): players learn to launch and manage startups through gameplay that includes real business KPIs, a customizable and evolving personal island, synchronous and asynchronous multiplayer modes, social events, and community-d
SES Announces Results of the Annual General Meeting2.4.2026 16:49:00 CEST | Press release
SES (the “Company”) held the Annual General Meeting (“AGM”) of Shareholders today in Betzdorf, Luxembourg. Following the recommendations made by the Board of Directors of SES, the shareholders have voted in favor of all resolutions, including the Company’s 2025 annual accounts and the proposed annual dividend of EUR 0.50 per A-share (EUR 0.20 per B-share). The total dividend amount comprises the interim dividend of EUR 0.25 per A-share (EUR 0.10 per B-share), which has already been paid to shareholders on October 16, 2025. The final dividend of EUR 0.25 per A-share (EUR 0.10 per B-share) will be paid to shareholders on April 16, 2026. “I would like to sincerely thank our shareholders for their active engagement, visionary support and continued confidence in SES’ strategy,” said Adel Al-Saleh, CEO of SES. “The outcomes of today’s AGM underscore our shared commitment to a bold multi-orbit approach, with Medium Earth Orbit as the strategic backbone of a dynamically evolving global interco
Andersen Consulting styrker sine kompetencer med tilføjelsen af Lukkap2.4.2026 16:31:00 CEST | Pressemeddelelse
Andersen Consulting tilføjer samarbejdspartneren Lukkap, et konsulenthus med fokus på oplevelsesdrevne kompetencer, der er tilpasset kundernes skiftende behov inden for transformation af medarbejdere, kunder og det digitale område. Lukkap, der blev stiftet i 2009 og har hovedsæde i Spanien, leverer integrerede løsninger, der hjælper organisationer med at transformere, hvordan de betjener kunder, engagerer medarbejdere og frigør værdi gennem adfærdsindsigt og dataanalyse. Virksomhedens tværfaglige tilgang spænder over nytænkning af kunderejsen, effektive programmer for medarbejderoplevelser, talent- og ledelsesudvikling, prædiktiv analyse samt omfattende outplacement- og transitionsydelser. Lukkap arbejder på tværs af sektorer — herunder sundhedsvæsen, medicinalindustri, forbrugsgoder, detailhandel, finans og bankvæsen — for at opbygge menneskecentrerede strategier, der skaber målbare forretningsresultater. "Ved at kombinere vores erfaringsdrevne metode med Andersen Consultings globale
Forrester: Three Years Into GenAI, Enterprises Are Still Chasing Its True Transformative Value2.4.2026 16:00:00 CEST | Press release
Low AI fluency, uneven adoption, and marginal productivity gains are limiting enterprise-scale impact According to Forrester’s (Nasdaq: FORR) latest report, Accelerate Your AI Voyage, most enterprises are struggling to turn growing AI adoption and investment into measurable business impact. One of the key factors holding businesses back is low artificial intelligence quotient (AIQ) — Forrester’s measure of AI aptitude — with many employees lacking a clear understanding of how to use AI. Other barriers include an overemphasis on productivity-focused use cases, difficulty measuring impact, and siloed adoption within individual functions. While these challenges can leave firms frozen in doubt or indecision, the wait-and-see approach to AI adoption is no longer viable. To unlock AI’s full potential, organizations need to focus on four key areas: Define the business outcomes and success metrics for what they want AI to achieve; identify specific use cases for AI deployment aligned to those
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