Teleflex Initiates Enrollment in Global BIOMAG™‑III Pivotal Trial of Freesolve™ Resorbable Magnesium Scaffold

Key Terms

randomized controlled trial medical

A randomized controlled trial is a research method that tests the effects of a new idea or treatment by randomly dividing participants into two groups: one that receives the treatment and one that does not. This approach helps ensure that the results are fair and unbiased, providing clear evidence about whether the treatment actually works. Investors value such trials because they offer reliable information that can influence decision-making and reduce uncertainty.

target lesion failure medical

Target lesion failure is a clinical-trial outcome that measures whether a specific treated segment of a blood vessel causes serious problems after an intervention — typically defined as death related to the heart, a heart attack in the treated area, or the need for another procedure on that same spot. For investors it’s a compact gauge of a device or treatment’s effectiveness and safety, like a warranty score for a repaired pipe: fewer failures suggest better performance, faster regulatory approval, stronger sales and lower long-term costs.

drug‑eluting stent medical

A drug‑eluting stent is a tiny metal or polymer scaffold placed inside a narrowed artery that slowly releases medication to prevent the vessel from re‑clogging; imagine a small scaffold that also carries a time‑release coating to keep the passage open. Investors care because these devices combine surgical technique, drug formulation and regulatory approval, so their safety profile, patent protection, reimbursement rules and market adoption directly affect sales, liability and company valuation.

first-in-human medical

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resorbable magnesium scaffold medical

A resorbable magnesium scaffold is a temporary, tube-like medical implant made from a magnesium alloy that holds open a blocked blood vessel and then gradually dissolves and is absorbed by the body. Investors care because it promises the benefits of a traditional permanent stent while reducing long-term complications and repeat procedures, so its clinical performance, regulatory approval, and reimbursement determine market adoption and commercial value.

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Enrollment completed ahead of schedule in BIOMAG™-II

Positive four-year BIOMAG™-I results recently reported

WAYNE, Pa.--(BUSINESS WIRE)-- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the beginning of enrollment in the BIOMAG™‑III Study (NCT07258290), a landmark global study evaluating the Freesolve™ Resorbable Magnesium Scaffold (RMS).

Dr. Itsik Ben-Dor, MedStar Health in Washington, D.C., is the first implanter in the United States (U.S.) in the IDE trial of Freesolve™ RMS. Designed as a pivotal trial to support future regulatory applications, the BIOMAG™‑III Study represents the most comprehensive planned clinical evaluation of Freesolve™ RMS to date.

Chairman of the steering committee of the BIOMAG™-III Study, Dr. Ron Waksman^ǂ, Associate Director of Cardiology at MedStar Washington Hospital Center, stated: “I’m proud that the very first patient in the BIOMAG™-III IDE trial has been enrolled at MedStar Health. Contributing to this important international study is the first step towards potentially changing how we treat narrowed arteries, a very common condition we see in our clinics every day. Researching innovative therapies like Freesolve™ RMS is critical to advancing care for our patients.”

The BIOMAG™-III Study is a randomized controlled trial (RCT). The study will enroll 1,859 patients and compare Freesolve™ RMS to Xience™ Drug‑Eluting Stent (DES) with respect to Target Lesion Failure (TLF) rate^a at 12 months. The study will include scaffold lengths up to 40mm. The BIOMAG™-III Study will be conducted at up to 120 sites worldwide, including up to 60 sites in the U.S., underlining Teleflex’s strong global commitment to advancing resorbable scaffold technology.

Furthermore, enrollment recently completed ahead of schedule for the BIOMAG™-II Study (NCT05540223). This study enrolled 1,861 patients across 20 countries in Europe and Asia Pacific. The BIOMAG™-II Study is a prospective, international, multi-center, RCT comparing Freesolve™ RMS with Xience™ DES with respect to TLF rate^a at 12 months. Completion of enrollment marks a major milestone for the first large‑scale, head‑to‑head RCT evaluating Freesolve™ RMS against DES.

Additionally, Teleflex recently announced positive long-term data from the BIOMAG™-I First-In-Human (FIH) Study (NCT04157153), demonstrating 3.5% TLF^b at four years and no new clinical events between two and four years for Freesolve™ RMS¹.

“The BIOMAG™‑III Study represents an important milestone in the evolution of resorbable technologies,” said Dr. David E. Kandzari^ǂ, U.S. National Principal Investigator for the BIOMAG™-III Study, Chief, Piedmont Heart Institute, and Chief Scientific Officer, Piedmont Healthcare. “Freesolve™ RMS technology has shown positive outcomes in the BIOMAG™-I FIH trial, with a plateauing of clinical events after resorption. This has long been the vision of resorbable scaffolds.”

Freesolve™ RMS is engineered to resorb within 12 months², potentially reducing long‑term events associated with permanent metallic implants. The BIOMAG™‑III Study aims to generate pivotal evidence required to bring this technology to physicians and patients.

“The BIOMAG™‑III Study is a pivotal trial designed not only to meet rigorous regulatory standards, but also to demonstrate the long‑term safety and efficacy of a fully resorbable magnesium scaffold for patients, physicians, and healthcare systems,” says Prof. Dr. Georg Nollert, Vice President Medical Affairs at Teleflex. “We believe Freesolve™ RMS has the potential to reshape the coronary intervention landscape, and the BIOMAG™‑III Study could be the catalyst to drive that.”

About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in the world of healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

Teleflex, the Teleflex logo, Arrow, Barrigel, BIOMAG, Deknatel, Freesolve, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S. and/or other countries. All other trademarks marked with a ™ are the property of their respective owners and are solely used for identification purposes and do not imply any affiliation, endorsement, or ownership by Teleflex Incorporated or its affiliates. Information in this material is not a substitute for the product Instructions for Use. Not all products may be available in all countries.
© 2026 Teleflex Incorporated. All rights reserved. MC-012134 Rev 0.

References:

1. Torzewski, J. Lessons from the long-term DES data: how they can inform today's practice - BIOMAG-I: 4-Year Clinical Outcomes of the Resorbable Magnesium Scaffold-DREAMS 3G. pcronline.com Published May 20, 2026. Accessed June 3, 2026. https://www.pcronline.com/Cases-resources-images/Resources/Course-videos-slides/2026/EuroPCR/Lessons-from-the-long-term-DES-data-how-they-can-inform-today-s-practice?auth=true. Research sponsored by Teleflex.
2. Seguchi, M., Aytekin, A., Xheoa, E. et al. Vascular response following implantation of the third-generation drug-eluting resorbable coronary magnesium scaffold: an intravascular imaging analysis of the BIOMAG-I first-in-human study. EuroIntervention. 2024; 20(18): e1173-e1183. doi: 10.4244/EIJ-D-24-00055. Scaffold 99.0% resorbed at 12 months (markers are not resorbable). Research sponsored by Teleflex.

Disclaimers:

^a For BIOMAG™-III and BIOMAG™-II Studies, TLF is a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave Myocardial Infarction, or clinically driven Target Lesion Revascularization (TLR).
^b For BIOMAG™-I Study, TLF is a composite of Target-Vessel Myocardial Infarction (TV-MI), clinically driven Target Lesion Revascularization (CD-TLR) and Cardiac Death. BIOMAG™-I FIH Study data is based on Kaplan-Meier failure estimate analysis.

^ǂDrs. Waksman and Kandzari are paid consultants of Teleflex.

CAUTION—Investigational device. Limited by the United States law to investigational use.
Freesolve™ RMS is clinically often referred to as DREAMS 3G RMS.
Freesolve™ RMS is not approved for sale in the United States and is commercially available in CE-mark accepting countries only. Indications for Use may vary by geographic location.

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Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610-948-2836

Source: Teleflex Incorporated