AgNovos Healthcare Receives Investigational Device Exemption (IDE) for Breakthrough Spine Device
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.
Senior Vice President, Hip Program and Marketing
+1 646 502 5868
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
METRO-HAUL demo uses ADVA’s FSP 3000 OLS in public safety showcase6.5.2021 09:00:00 CEST | Press release
ADVA (FSE: ADV) today announced that its FSP 3000 open line system (OLS) played a key role in a demo showcasing a real-time public safety application. In the METRO-HAUL field trial, AI-based thermal-imaging and pan-tilt-zoom video cameras were used to secure a surveillance area. Advanced video analytics and active camera control require the transport of high-bandwidth video and latency-critical control traffic to a remote control center. Using the ADVA FSP 3000 OLS with flexible micro-ROADMs as well as QuadFlex™ transponders, the demo featured a programmable metro network with edge nodes for time-critical computing. Conducted at Fraunhofer HHI’s test beds in Berlin as part of the 5G Infrastructure Public Private Partnership (5G PPP) initiative’s METRO-HAUL project, the trial involved ADVA and several research center and university partners. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210506005044/en/ ADVA‘s FSP 3000 OLS p
Greece’s Eurobank Selects Temenos to Reimagine Wealth Management for the Digital Age6.5.2021 08:30:00 CEST | Press release
Temenos (SIX: TEMN), the banking software company, today announces that Eurobank in Greece has selected Temenos Wealth to strengthen its position in wealth management and affluent segment services. Eurobank, the third largest bank in Greece, will use Temenos Wealth to create a fully-digital investment portfolio management service offering Robo-Advisor and Goal-Based Investing apps to target the mass affluent and affluent market. These growing market segments want personalized offerings and are used to convenience through digital channels. With the Temenos solution, Eurobank combines an efficient back-office and product-building engine with modern omnichannel customer experiences powered by AI to meet the segments’ high expectations. The new Robo-Advisor app will allow Eurobank’s customers to create or adjust a desired portfolio, based on personalized criteria such as risk tolerance, target dates and asset size, by themselves or with an advisor. The solution manages the investments auto
Olympus Targets Carbon Neutrality by 20306.5.2021 08:00:00 CEST | Press release
Olympus Corporation (”Olympus” – Director, Representative Executive Officer, President and CEO: Yasuo Takeuchi) announced today it is targeting carbon neutrality by 2030, while also agreeing with recommendations by the Task Force on Climate-Related Financial Disclosures (TCFD), and adding carbon neutrality and enabling a circular economy to its environmental, societal and governance (ESG) enhancement measures. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210505006248/en/ Olympus has in place a variety of environmental initiatives across its global operations. However, the company is acutely aware of the damaging effects of climate change on natural ecosystems. For this reason, it has added carbon neutrality and enabling a circular economy as an additional ESG materiality criterion. In its corporate strategy announced in November 2019, Olympus listed four distinct ESG criteria as material ESG enhancement measures: (1) healt
Chestertons Global Expands Footprint Including New Offices Across the Caribbean, Europe and North Africa6.5.2021 08:00:00 CEST | Press release
Global estate agency, Chestertons Global Franchise Holdings Limited, today announced that Chestertons Cyprus has joined its expanding network, which has seen rapid growth over the past year. Since Chestertons Ionian, headquartered in Corfu, was welcomed on board as the first Global Franchise Partner in early March 2020, the business has gone from strength to strength, with new teams joining the Chestertons network in the following locations: Barbados, Antigua & Barbuda, Portugal, Morocco, the Costa del Sol, Gibraltar and now Cyprus. Chestertons Cyprus, headed up by Principal Andrew Constantinou, has launched its first office in Paphos, with plans for additional offices in the works. With the Portugal and Costa del Sol openings bringing five offices apiece to the network, the new franchise offering has secured 16 offices in total to date, increasing the number of property listings on the global business’ books by 300%. The expansion of the franchise business means Chestertons’ geographi
SES Announces EUR 100 million Share Buyback Programme6.5.2021 07:30:00 CEST | Press release
SES S.A. today announces a share buyback programme of up to EUR 100 million to be executed by 31 December 2021 under the authorisation given by the Annual General Meeting of shareholders held on 1 April 2021. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210505006251/en/ SES announces EUR 100 million share buyback programme (Photo: Business Wire) The company will purchase up to 12 million A-shares and up to 6 million B-shares in equal proportion to maintain the ratio of two A-shares to one B-share, as required by the Articles of Association. The aggregate value of the programme shall not exceed EUR 100 million and the shares acquired under the programme are intended to be cancelled to reduce the total number of voting and economic shares. SES affirms its commitment to maintain balance sheet metrics consistent with investment grade ratios. “The share buyback programme that we are announcing today reflects our confidence in t
SES: Q1 2021 Results6.5.2021 07:30:00 CEST | Press release
SES S.A. announces financial results for the three months ended 31 March 2021. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210505006250/en/ SES Q1 2021 Results (Photo: Business Wire) Strong execution delivering revenue of €436 million and Adjusted EBITDA(1) of €268 million Improving trajectory in Video from -8.0% YOY(2,3) in FY 2020 to -4.6% YOY(2,3) in Q1 2021 Solid Networks performance (flat YOY(2,3)) in the COVID environment with strong prospects for future growth 7% YOY(3) reduction in recurring Operating Expenses, reflecting S&A(4) gains, supporting higher YOY Adjusted EBITDA margin (61%) Solid cash flow generation and financial discipline supporting lower YOY leverage ratio(5) of 3.1 times at 31 March 2021 Adjusted Net Profit up 42% YOY to €75 million On track to deliver 2021 outlook. Growth investments and C-band proceeds supporting future growth and value creation Over 85% of 2021 revenue outlook (€1,760-1,820 mil
AMD President & CEO Dr. Lisa Su to Keynote at COMPUTEX 2021 on High-Performance Computing Ecosystem6.5.2021 07:08:00 CEST | Press release
TAITRA (Taiwan External Trade and Development Council) announced today that Dr. Lisa Su, President and CEO of AMD, is invited back to deliver a keynote address at COMPUTEX 2021. This digital keynote will be on Tuesday, June 1, at 10:00 AM Taipei time, with the keynote theme “AMD Accelerating – The High-Performance Computing Ecosystem”. COMPUTEX displays will be digital this year, with keynotes and forums running on hybrid. “It has been a year unlike others. Technology has gotten us through some of the most challenging times,” said James Huang, TAITRA Chairman. “We will continue to transform our exhibition models and practices to meet the evolving needs of our exhibitors, visitors, and media, without losing the most essential element of a trade show – connection.” Dr. Lisa Su is proud to join COMPUTEX once again in 2021. “The past year has shown us the important role high-performance computing plays in our daily lives – from the way we work to the way we learn and play. At this year’s C