Tag: R3 Vascular

R3 Vascular Expands Management Team with Two Senior Executives

Appointments Support Accelerated Trial Enrollment, Market Development, Scalability, and Future CommercializationMOUNTAIN VIEW, Calif., Aug. 24, 2026 (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 two senior executives as it accelerates trial enrollment, market development, scalability, and future commercialization. Robert Spanos has been appointed as Vice President, Global Market Development and Katie Segreto has been appointed as Vice President, Finance and Corporate Controller. Commenting on the appointments, Christopher M. Owens, President and CEO of R3 Vascular said, “On behalf of the R3 management team, I am very pleased to welcome Bob Spanos and Katie Segreto. Both bring exceptional expertise and proven leadership that will be instrumental as we advance the clinical development of MAGNITUDE®, accelerate our market presence, and build the infrastructure needed to support future commercialization. Bob’s deep experience in peripheral vascular markets and successful product launches will strengthen our commercial strategy and market expansion efforts, while Katie’s extensive finance leadership experience will help us scale our organization and position R3 Vascular for long-term growth. We are excited to have them join our team at this important stage for the company, including the recent rapid acceleration of our ELITE Clinical Trial enrollment, finalizing the advances in scaffold product line extensions, driving elite margin structure and setting the foundation throughout the organization to prepare for commercialization.” Robert Spanos is a seasoned cardiovascular medical device executive with more than 20 years of experience leading commercial strategy, clinical execution, and successful product launches across the endovascular and peripheral vascular markets. Throughout his career, he has built and led high-performance sales organizations while driving market adoption and revenue growth for innovative, first-to-market technologies. Prior to joining R3 Vascular, Robert held senior leadership roles including Executive Vice President of Corporate Operations for Emblok Inc., Vice President of Commercial Development at AngioDynamics, and Vice President of U.S. Sales Accounts at Eximo Medical, where he played a critical role in IDE trials, FDA 510(k) submissions, global commercial launches, and acquisition integrations. He has also served in key leadership positions at IDev Technologies, Mercator MedSystems, FoxHollow Technologies, and Guidant Endovascular Solutions, contributing to multiple successful product launches and strategic exits.   He holds a Bachelor of Business Administration in Marketing from the University of St. Thomas. Robert Spanos said, “I’m excited to join the R3 Vascular team and contribute to the advancement of MAGNITUDE, a remarkable next-generational bioresorbable platform. Its ultra-high molecular weight polymer delivers strength and flexibility needed to address the unique demands of tibial vessels in patients with critical limb ischemia (CLTI), while offering potential applications in other vascular beds, including the superficial femoral and coronary arteries.   I look forward to helping drive the successful execution of the company’s clinical, regulatory and commercial objectives.” Katie Segreto brings more than 18 years of finance leadership experience building and scaling high-performing finance organizations across the medical device, biotechnology, and technology sectors. She has guided both public and private companies through periods of substantial growth and transformation.   Prior to joining R3 Vascular, Katie served as Vice President of Finance for Kronos Bio, a publicly traded clinical-stage biotechnology company, where she led the finance organization through the company’s post-IPO expansion. Previously, Katie served as Vice President of Finance at K Health, a venture-backed health technology company, where she built the finance function from the ground up, enabling the company’s growth from $0 to $20M in sales and through its Series C and D financings. Earlier in her career, Katie held finance leadership roles at Bonobos, a high-growth ecommerce company acquired by Walmart, and spent eight years in the Life Science audit practice at PwC, advising biotech and med tech companies on audit and accounting strategy.   Katie holds a Bachelor of Arts in Business Management Economics from the University of California, Santa Cruz and is a Certified Public Accountant (inactive). Katie Segreto added, “I am thrilled to join the R3 Vascular team at such an important point in the company’s growth and to help advance this innovative bioresorbable technology. The platform’s potential to address important unmet needs and improve outcomes in vascular care is particularly compelling. I look forward to supporting the advancement of the company’s clinical and commercial objectives to ultimately bring this technology to the patients who need it most.” 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

R3 Vascular Announces First Patient Treated in ELITE-BTK Pivotal Trial for Below-the-Knee PAD Using MAGNITUDE® Drug Eluting Bioresorbable Scaffold

MOUNTAIN VIEW, Calif., April 22, 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 the first patient in its ELITE-BTK pivotal trial was treated by Dr. Brian DeRubertis, FACS, Chief of the Division of Vascular & Endovascular Surgery at New York-Presbyterian and Weill Cornell Medicine in New York City. The trial evaluates R3 Vascular’s next generation drug eluting bioresorbable scaffold, MAGNITUDE®, for below-the-knee (BTK) PAD, which according to the American Heart Association affects more than 200 million people globally, and 10 to 12 million in the U.S. older than the age of 40. The most common type of PAD affects the lower-extremity where blood flow is reduced to the legs and feet. Each year, approximately 150,000 leg amputations are performed in the U.S. alone.      

R3 Vascular Secures WCG IRB Approval and CMS Category B Medicare Coverage for the ELITE-BTK Pivotal Trial of its MAGNITUDE® Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease

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.

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