BD announced that it performed its first Phasix™ Mesh laparotomy reinforcement case in Greece, placing the fully resorbable mesh prophylactically at the incision of a 63‑year‑old male undergoing a sigmoidectomy at George Papanikolaou General Hospital in Thessaloniki. The case demonstrates the product’s newly approved prophylactic indication for high‑risk abdominal surgery in Europe and provides the first real‑world safety data for the expanded use.
The company also updated on its PREVENT multicenter randomized controlled trial, which is enrolling patients in both Europe and the United States. The trial has reached more than 85 % of its target enrollment and is expected to complete enrollment in 2026. The study is designed to generate the clinical evidence needed for a U.S. Premarket Approval submission, a critical regulatory milestone that would open a high‑margin, high‑volume market for BD in the United States.
Phasix™ Mesh, a fully resorbable monofilament scaffold made of poly‑4‑hydroxybutyrate, is already CE‑marked for prophylactic use in Europe and has been available in three new sizes since 2025. While the product is not yet indicated for incisional hernia prevention in the United States, the Greek case and the PREVENT trial progress signal BD’s intent to pursue FDA approval and expand its surgical portfolio beyond repair into prevention.
Incisional hernias affect up to 30 % of patients after abdominal surgery and cost the UK health system an average of £23,148 per repair. By preventing hernias, Phasix™ Mesh could reduce these costs and improve patient outcomes, creating a compelling value proposition for surgeons and payers. The trial’s enrollment momentum and the first Greek case provide early evidence that the product performs safely and effectively in a real‑world setting, strengthening BD’s case to regulators and clinicians.
Rian Seger, worldwide president of BD Surgery, said, “With Phasix™ Mesh, we’re not just repairing hernias—we’re preventing them. This milestone reflects our commitment to improving long‑term patient outcomes.” The statement underscores BD’s strategic shift toward preventive solutions and highlights the potential for significant revenue growth once U.S. approval is obtained.
The Greek case and trial progress are expected to accelerate regulatory review and market adoption. If the U.S. PMA is approved, BD could capture a share of the U.S. incisional hernia prevention market, which is estimated to be worth billions of dollars annually. The company’s focus on a fully resorbable mesh also positions it favorably against competitors that rely on permanent synthetic materials, potentially giving BD a competitive edge in a market that increasingly values biocompatibility and long‑term safety.
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