Breaking Update
Israeli Medical Device Firm Advances Prostate Treatment Toward U.S. FDA Approval
Israeli medical device firm Butterfly Medical's BPH treatment, Butterfly Prostatic Retraction Device, completed a 244-patient trial, paving the way for U.S.
Jerusalem, 11 January, 2026 (TPS-IL) — Israeli medical device company Butterfly Medical announced the successful completion of its pivotal international trial for the Butterfly Prostatic Retraction Device, a minimally invasive treatment for benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate gland.
The 244-patient study, conducted in Boston and Yokneam, Israel, confirmed the device’s safety and efficacy in restoring urinary flow without surgery. The CE Mark-approved implant is now positioned for a U.S. FDA pre-market approval application. Butterfly Medical’s device offers an alternative for men dissatisfied with medication but seeking to avoid invasive surgery, potentially reshaping global BPH care.
