Teleflex begins enrollment in BIOMAG III Study for Freesolve Scaffold

• Teleflex Incorporated (NYSE:TFX) has started patient enrollment in the BIOMAG-III Study evaluating the Freesolve Resorbable Magnesium Scaffold.
• The pivotal trial will enroll 1,859 patients and compare Freesolve RMS against the Xience Drug-Eluting Stent on target lesion failure at 12 months.
• Teleflex stated the study will generate key evidence for regulatory applications and advance resorbable scaffold technology.

Teleflex Incorporated (NYSE:TFX) announced the beginning of enrollment in the BIOMAG-III Study, a global pivotal trial evaluating the Freesolve Resorbable Magnesium Scaffold (RMS).

Dr. Itsik Ben-Dor at MedStar Health in Washington, D.C. became the first implanter in the United States for this investigational device exemption trial.

“I’m proud that the very first patient in the BIOMAG-III IDE trial has been enrolled at MedStar Health,” said Dr. Ron Waksman, Chairman of the steering committee of the BIOMAG-III Study.

The randomized controlled trial will enroll 1,859 patients across up to 120 sites worldwide and compare Freesolve RMS to the Xience Drug-Eluting Stent on target lesion failure rate at 12 months, including scaffold lengths up to 40mm.

Teleflex Incorporated noted that enrollment in the related BIOMAG-II Study was recently completed ahead of schedule, with 1,861 patients.

Following the announcement, Teleflex's (NYSE:TFX) share price was unchanged.

Teleflex recently reported positive long-term data from the BIOMAG-I First-In-Human Study showing 3.5% target lesion failure at four years with no new clinical events between two and four years.

The company continues to invest in resorbable magnesium scaffold technology designed to fully resorb within 12 months, with the goal of reducing long-term complications associated with permanent metallic implants.