Medical Device Weekly Perspective

Research evidence excerpt

Medical Device Weekly Perspective

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ABT: ALZpath Signs Global Licensing Agreement with Abbott to Advance Blood-Based

Alzheimer's Disease Testing (6/24). ALZpath, a blood test-based diagnostic solutions company

for Alzheimer's disease announced a licensing agreement with ABT to incorporate its

phosphorylated Tau 217 (pTau217) antibody into the development of an in vitro diagnostic

(IVD) test for Alzheimer's disease. The test would be designed for use on Abbott's Alinity ci-

series systems, which represents one of the largest install bases of immunoassay instruments

worldwide. ALZpath's pTau217 antibody is among the most clinically validated for detecting

Alzheimer's disease pathology, as per the company. The company also notes that backed by

more than 200 peer-reviewed publications across 18 countries, the antibody demonstrates high

accuracy and sensitivity in identifying Alzheimer's disease biology.

TFX: Teleflex Initiates Enrollment in Global BIOMAG-III Pivotal Trial of Freesolve Resorbable

Magnesium Scaffold (6/23). Teleflex announced the beginning of enrollment in the BIOMAG-III

Study, a landmark global pivotal trial evaluating the Freesolve Resorbable Magnesium Scaffold

(RMS). The first U.S. patient was implanted at MedStar Health in Washington, D.C. The study

will enroll 1,859 patients across up to 120 sites worldwide (including up to 60 in the U.S.) and

will compare Freesolve RMS to Xience Drug-Eluting Stent with respect to Target Lesion Failure

rate at 12 months. Additionally, enrollment completed ahead of schedule for BIOMAG-II (1,861

patients across 20 countries), and positive four-year BIOMAG-I data showed 3.5% TLF with no

new clinical events between two and four years. Freesolve RMS is engineered to resorb within