Teleflex targets 1,859 patients in trial comparing Freesolve with drug-eluting stent

Key Facts

Teleflex plans to enroll 1,859 patients in the BIOMAG III study to compare its Freesolve resorbable magnesium stent with the Xience drug-eluting stent, according to the company's announcement that enrollment had begun in the pivotal global trial. The study puts the device in a clinical comparison with a drug-eluting stent as part of the company's Freesolve evaluation program, which includes early trials and randomized controlled trials. Teleflex said Freesolve was designed to be absorbed within the body within 12 months of implantation, the timeframe it specified in the device's design. Discussing the stent's prospects outside the United States, Chief Executive Jason Weidman linked sales growth to clinical evidence and medical guidelines, according to an earnings call transcript published by Investing.com. Weidman said: "It's really a question of data, or a lack of data, and a question of guidelines." The enrollment target announced for the comparative trial is part of this clinical program, under which the company is also awaiting a randomized data readout from another Freesolve study.

In longer-term results announced by Teleflex, the BIOMAG I study recorded a target lesion failure rate of 3.5% at 4 years after Freesolve implantation. The company said follow-up recorded no new clinical events between years 2 and 4, specifying the subsequent period covered by this aspect of the study results. The early trial included 116 patients, according to Teleflex's announcement on the presentation of long-term follow-up results. The study was conducted exclusively at European centers, defining the geographic scope of the participants whose outcomes the company tracked over that period. The reported target lesion failure rate applies to this group of patients at the year 4 follow-up, while the announcement of no new events concerns the period from year 2 to year 4. The company's planned comparison with Xience will take place in BIOMAG III, another stage of the stent evaluation program.

On the regulatory front, Freesolve received CE marking in February 2024, according to an earlier Teleflex announcement concerning its acquisition of Biotronik's vascular intervention business. In its announcement that enrollment in the BIOMAG Long Lengths study had been completed, the company confirmed that the stent was "not approved for sale in the United States," a status separate from its receipt of the European marking. The U.S. Food and Drug Administration's Breakthrough Devices Program gives participating companies priority review of their submissions, according to the agency's explanation of the program. But designation under the program does not automatically grant a device marketing authorization, as safety and effectiveness requirements remain a condition for obtaining that authorization. The agency says devices covered by the program "must meet the FDA's rigorous standards for device safety and effectiveness in order to be authorized for marketing." Priority review of a submission thus remains a regulatory step distinct from a decision permitting the device's sale, and authorization standards must still be met.

In its evaluation of longer lengths of Freesolve, Teleflex announced that enrollment of 102 patients in the BIOMAG Long Lengths study had been completed. Enrollment took place across 14 European centers, according to the company's statement, which also specified the primary endpoint for evaluating the trial's results. That endpoint is the target lesion failure rate at 12 months after the procedure, making the specified follow-up the point at which the study's primary outcome will be measured. In its financial results update, Teleflex also said it had completed enrollment in BIOMAG II ahead of schedule. The company described the study as the first randomized controlled trial of Freesolve conducted outside the United States, part of its program to expand clinical evaluation of the device. As for the next scheduled results milestone, Teleflex expects the first randomized clinical data readout from BIOMAG II in late 2027, according to the company's earnings presentation published by the U.S. Securities and Exchange Commission.