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
Venture Global Commences Commercial Operations of Phase One of Plaquemines LNG1.11.2026 16:40:00 CET | Press release
COD declared just over 53 months from FID on Phase OneFirst long-term sales and purchase agreement (SPA) cargo lifted by Shell On October 31, 2026, Venture Global (NYSE: VG) commenced commercial operations of the first phase of its second LNG export project – Plaquemines LNG – and the sale of low-cost, U.S. LNG to the first phase’s long-term customers. The commercial operations date (COD) for Phase 1 of Plaquemines LNG was reached in just over 53 months from the final investment decision on the project, making it among the fastest greenfield LNG projects ever completed. “Achieving commercial operations at the first phase of our second LNG project in 53 months is a testament to our team's relentless dedication and hard work,” said Venture Global CEO Mike Sabel. “We are thrilled to hit another major milestone that enables us to continue delivering reliable, affordable American LNG to the global market. We deeply appreciate the collaboration of our regulators and supply chain partners, wh
From the Chishui to the Han: "Moutai Night" Debuts in Seoul to Bridge Cultural Connections1.11.2026 13:44:00 CET | Press release
On October 25, the 2026 “Moutai Night” was held in Seoul, South Korea, under the theme “Born by the Chishui River, Fragrance Along the Han River.” Over a hundred guests from China and South Korea gathered around the Han River, sharing the distinctive appeal of Chinese baijiu, and fostering cultural exchange between the two countries through fine liquor and culture. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261101047521/en/ The event featured an exhibition on Moutai’s brewing techniques and brand history. Hands-on experiences with Miao batik and silverwork showcased Guizhou culture, while creative cocktails brought Chinese spirits into dialogue with Korean tastes. A city-themed video, dance performances and a violin performance rounded out the program, as guests exchanged views on liquor culture in a warm atmosphere. As a flagship cultural initiative designed for global audiences, “Moutai Night” made its Seoul debut, fol
Vedanta Aluminium’s Q2FY27: Profit doubles to INR 6,187 Cr, EBITDA rises 83% YoY31.10.2026 14:12:00 CET | Press release
Revenue at INR 22,066 crore, up 41% YoY2nd consecutive quarter with EBITDA exceeding INR 10,000 crore achievedHighest-ever quarterly aluminium production at 649 KT, up 5% YoY & 3% QoQNet debt reduced by INR 3,090 crore QoQ, with Net Debt/EBITDA improving to 0.7x Vedanta Aluminium Metal Limited (BSE: 544780 & NSE: VAML), India’s largest aluminium producer, announced its unaudited financial results for the quarter and half year ended 30 September 2026, delivering solid financial and operational performance. Revenue increased to INR 22,066 crore, up 41% YoY, supported by higher volumes and improved marketing mix. EBITDA stood at INR 10,192 crore, up 83% YoY, with an EBITDA margin of ~46%. Profit after tax stood at INR 6,187 crore, more than doubling YoY with an increase of 105%. VAML strengthened its balance sheet during the quarter, reducing net debt by INR 3,090 crore QoQ, with Net Debt/EBITDA improving to 0.7x from 0.9x in Q1FY27. The company’s credit profile was validated with India R
United States Signs Participation Contract for Expo 2030 Riyadh, Strengthening Momentum For Global Participation31.10.2026 09:38:00 CET | Press release
The United States of America has signed its Participation Contract for Expo 2030 Riyadh, marking a significant milestone in the World Expo’s preparations and further strengthening the momentum for international participation in the global event. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261031669001/en/ The Participation Contract was signed by His Highness Prince Faisal bin Farhan Al Saud, Minister of Foreign Affairs of the Kingdom of Saudi Arabia, and U.S. Secretary of State Marco Rubio, during a bilateral meeting held on the sidelines of the 2026 G20 Foreign Ministers’ Meeting in Atlanta, Georgia. The signing marks an important step in the United States’ journey towards Expo 2030 Riyadh, paving the way for the development of its pavilion, programming and visitor experience. It also reinforces the growing international commitment to Expo 2030 Riyadh, as countries move from confirming their participation to actively sha
ADNEC Group Kickstarts November with Two of the World’s Largest Events in the Energy and Tourism Sectors31.10.2026 04:53:00 CET | Press release
ADNEC Group, a Modon company, begins November by hosting two of the world’s most significant international events in the same week. ADIPEC 2026, the world’s largest energy event, takes place at ADNEC Centre Abu Dhabi from 2 to 5 November. Meanwhile, World Travel Market (WTM) London, one of the global travel industry’s leading gatherings, takes place at the Group’s Excel London venue from 3 to 5 November. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261030918463/en/ ADNEC Centre Abu Dhabi (Photo: AETOSWire) The two events, held simultaneously at the Group’s largest venues in the UAE and the UK, reflect ADNEC Group’s capability to deliver large-scale international events across multiple markets. ADIPEC has grown alongside the venue since it was first held at the ADNEC Centre Abu Dhabi in 2006. This year’s edition is set to be the largest in the event’s history, occupying the venue’s entire 153,000 square metres of exhibition
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