Fortrea Holdings Inc. ((FTRE)) announced an update on their ongoing clinical study.
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Fortrea Holdings Inc. (FTRE) is collaborating with Stryker Craniomaxillofacial on a pivotal clinical trial titled ‘A Pivotal Clinical Trial Evaluating the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant When Used as a Dural Sealant in Spinal Procedures.’ The study aims to assess the safety and effectiveness of the Adherus™ Dural Sealant in spinal surgeries, comparing it to the FDA-approved DuraSeal Exact Spinal Sealant. This trial is significant as it could offer a new alternative in spinal duraplasty procedures, potentially improving patient outcomes.
The intervention being tested is the Adherus™ Dural Sealant System, an in situ polymerizing sealant designed to be used during spinal surgeries. It is compared against the DuraSeal Exact Dural Sealant System, which serves as the active comparator in this study.
The study follows an interventional design with randomized allocation and a parallel intervention model. It employs single masking, where the participant is unaware of the treatment group assignment. The primary purpose of the study is treatment-focused, aiming to evaluate the new device’s effectiveness and safety.
The study began on July 30, 2020, and is currently enrolling by invitation. The last update was submitted on February 20, 2025, indicating ongoing progress. These dates are crucial as they provide a timeline for investors to gauge the study’s development and potential market entry.
This clinical update could influence Fortrea’s stock performance positively if the results demonstrate superior safety and effectiveness compared to the existing product. The successful introduction of a new spinal sealant could enhance Fortrea’s competitive position in the medical device industry, potentially impacting investor sentiment favorably.
The study is ongoing, with further details available on the ClinicalTrials portal.