MOUNTAIN VIEW, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce that it received WCG Institutional Review Board (IRB) approval for the ELITE-BTK Pivotal Trial of its MAGNITUDE Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease (PAD). This approval allows the trial to take place at institutions that utilize WCG IRB as their central IRB in the United States. Additionally, the company announced that the Centers for Medicare & Medicaid Services (CMS) has granted Category B approval for the investigational device exemption (IDE) study, ensuring Medicare coverage for the device, related and routine items, and services for the ELITE-BTK trial.
Tag: R3 Vascular
FDA Grants R3 Vascular IDE Approval for ELITE-BTK Pivotal Trial of its MAGNITUDE® Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease
MOUNTAIN VIEW, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce that the U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval to initiate its ELITE-BTK pivotal trial of its next generation drug eluting bioresorbable scaffold, MAGNITUDE®, for below-the-knee (BTK) PAD.
R3 Vascular Appoints Josh Smale as its Vice President of Global Clinical and Scientific Affairs
MOUNTAIN VIEW, Calif., July 09, 2024 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce the appointment of Josh Smale as its Vice President of Global Clinical and Scientific Affairs. Prior to joining R3 Vascular, Mr. Smale served as Vice President of Clinical Affairs for the Peripheral Intervention business unit of Becton Dickinson (BD) where he was responsible for all aspects of clinical evidence generation and dissemination for the company’s complex and diverse device portfolio. Prior to his tenure at BD, Mr. Smale served in roles of increasing responsibility for Bard Peripheral Vascular, Inc. (BPV) which was acquired by BD, and as Regulatory Affairs Manager for SenoRX, Inc. which was acquired by BPV. He also served as Regulatory Affairs Manager for Endologix, Inc. and in various roles at BPV. Mr. Smale holds a Bachelor of Science in Engineering with an emphasis on Molecular and Cellular Engineering, and Biochemical Engineering from Arizona State University. He also served on the board of the Peripheral Intervention business unit of BD, has received numerous awards, is the co-author of several publications, and holds five Vena Cava Filter patents. Commenting on the appointment of Mr. Smale, Christopher M. Ownes, President and CEO of R3 Vascular, said, “On behalf of the R3 management team, I am very pleased to welcome Josh Smale as Vice President of Global Clinical and Scientific Affairs. Josh has a proven track record and more than 20 years of relevant medical device experience specializing in clinical and regulatory affairs strategy, clinical evidence generation and dissemination, and physician education. Among other key clinical and scientific affairs programs, Josh will lead our clinical trial efforts, including our pivotal ELITE trial for our next generation Magnitude drug eluting bioresorbable scaffold. We look forward to his contributions as we work towards establishing R3 Vascular as the leader in the development and manufacturing of fully bioresorbable vascular scaffolds.” Mr. Smale said, “I am very excited to join R3 Vascular and work closely with Chris Owens, Kamal Ramzipoor, and the rest of the R3 Vascular team to build upon the success of the company and support the adoption of its breakthrough technology for treating below-the-knee peripheral arterial disease (BTK PAD). R3 Vascular’s novel next generation bioresorbable scaffolds will transform the field of peripheral interventions by providing a new standard of care and improving the health of patients around the world.” Mr. Smale joins R3 Vascular’s leadership team which, among others, includes Christopher M. Owens, President and Chief Executive Officer and Kamal Ramzipoor, R3 Vascular’s Founder and Chief Technology Officer (CTO). In May of 2024, R3 Vascular announced the closing of its $87 million Series B financing round. About R3 Vascular Inc.R3 Vascular is a privately-held medical device company that develops a novel technology platform for the next generation of fully bioresorbable drug eluting sirolimus coated vascular scaffolds. These are designed to deliver the ‘stent-like’ support of a scaffold along with the anti-inflammatory and anti-proliferative result of sirolimus, but ‘disappearing’ over time as the vessel heals. R3 Vascular is headquartered in Mountain View, California. More information can be found at www.r3vascular.com. Media Contact:David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c861cb09-8ed9-4401-8f89-6e69934fd0d3
R3 Vascular Announces $87 Million in Series B Financing and Appoints Christopher M. Owens as new President and CEO
R3 Vascular, Inc. announced the closing of its $87 million Series B financing round and the appointment of a new President and Chief Executive Officer
R3 Vascular Inc. Completes Series A Financing
$17.8 million in proceeds will fund clinical development of innovative devices to treat peripheral artery diseases (PAD) such as CLI MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–R3 Vascular Inc. today announced closing of its Series A financing round, including new equity investments of $15 million and the conversion of $2.8 million of convertible notes. […]