BD Accelerates Advanced Tissue Regeneration Strategy with Landmark PREVENT Trial
Rhea-AI Summary
BD (NYSE: BDX) reported completion of enrollment in the landmark PREVENT clinical trial, a large randomized study evaluating Phasix™ Mesh for prevention of incisional hernias after elective open midline abdominal surgery in high‑risk patients. The trial enrolled 477 patients across 32 sites in the United States and Europe.
According to BD, PREVENT is the first large randomized study of prophylactic reinforcement with a resorbable mesh for this complication, for which no products are currently approved. Patients will be followed to a primary endpoint at 24 months, with additional follow‑up through five years. The company expects study data to support a planned submission to the U.S. Food and Drug Administration for this indication.
Positive
- Enrollment completed in PREVENT trial with 477 patients across 32 sites
- First large randomized study of prophylactic resorbable mesh for incisional hernia prevention
- PREVENT data expected to support a planned FDA submission for Phasix™ Mesh in this indication
- Long-term follow-up to five years planned to evaluate safety and clinical outcomes
Negative
- Primary endpoint data for PREVENT not yet available; follow-up continues through 24 months and up to five years
- No products are currently approved for incisional hernia prevention after abdominal surgery, so regulatory pathway for this indication remains pending
AI-generated analysis. How Rhea-AI works. Not financial advice.
Enrollment completed in the first large-scale randomized study evaluating Phasix™ Mesh for incisional hernia prevention, a significant unmet need following abdominal surgery
The study enrolled 477 patients across 32 sites in
"PREVENT reflects our commitment to extending the impact of advanced tissue regeneration into new areas of patient care," said Rian Seger, worldwide president of Surgery at BD. "By evaluating Phasix™ Mesh in hernia prevention, we are building on decades of innovation in abdominal wall surgery and generating evidence that could help broaden the role of regenerative technologies for patients at risk of post-surgical complications. We are grateful to the investigators, clinical sites and patients whose participation made this achievement possible."
The PREVENT trial aims to generate robust clinical evidence evaluating Phasix™ Mesh for the prevention of incisional hernia following elective open midline abdominal surgery in patients at high risk of developing a hernia.
Patients will continue to be followed through the study's primary endpoint at 24 months, with longer-term follow-up planned through five years to further evaluate safety and clinical outcomes. Following completion of the primary endpoint assessments, data from the study are expected to support a planned submission to the
About BD
BD is one of the world's largest pure-play medical technology companies with a Purpose of advancing the world of health™ by driving innovation across medical essentials, connected care, biopharma systems and interventional. The company supports those on the frontlines of healthcare by developing transformative technologies, services and solutions that optimize clinical operations and improve care for patients. Operating across the globe, with more than 60,000 employees, BD delivers billions of products annually that have a positive impact on global healthcare. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase clinical efficiency, improve safety and expand access to healthcare. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X @BDandCo or Instagram @becton_dickinson.
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SOURCE BD (Becton, Dickinson and Company)