Results of 244-Patient Study to Support Planned FDA Pre-Market Approval (PMA) Application
BOSTON and YOKNEAM, Israel, Jan. 8, 2026 /PRNewswire/ -- Butterfly Medical, developer of a proprietary non-surgical solution for benign prostatic hyperplasia (BPH), today announced the successful completion of the final 12-month follow-up for all patients in its international pivotal clinical study. The landmark study is designed to evaluate the safety and efficacy of the Butterfly Prostatic Retraction Device, a first-line interventional therapy (FIT) for BPH.
The prospective, double-blind, randomized controlled trial (RCT) enrolled 244 patients to evaluate the Butterfly Prostatic Retraction Device, a minimally invasive, reversible implant that mechanically retracts the lateral lobes of the prostate to restore natural urinary flow in patients suffering from the symptoms of BPH.
"This trial marks a critical step in validating the Butterfly Prostatic Retraction Device as a safe and effective solution that avoids the limitations of early-generation BPH treatments," said Patrick MacCarthy, CEO of Butterfly Medical. "Combined with our multi-year follow-up data presented last year, this study shows great promise for the Butterfly device as a durable, long-term solution for men suffering from the symptoms of BPH. Thanks to the support of our many clinical collaborators and of course all 244 patients, we are well positioned to address a significant unmet need in the global urology market."
BPH is one of the most common conditions in aging men, affecting approximately 50% of men between the ages of 51 and 60, and up to 90% of men over age 80. Despite its prevalence, many patients remain underserved. Current drug therapies often require lifelong adherence and can cause side effects like dizziness and sexual dysfunction, while traditional surgical options typically involve the invasive removal of tissue, with significant side effects and longer recovery times.
"There is a significant gap in BPH care for men who are dissatisfied with medication but want to avoid the risks of invasive surgery. The Butterfly device offers a vital middle-ground solution," said Dr. James C. Ulchaker, Chief Medical Officer for Butterfly Medical and Emeritus Urologist at the Cleveland Clinic. "Available in multiple sizes to accommodate variations in prostate size, the Butterfly device conforms to the natural anatomy, restoring urinary flow without cutting, burning or removing tissue. Completing this pivotal trial brings us one step closer to providing patients with a new safe, effective, and fully reversible FIT solution."
The Butterfly device is CE Mark approved for use in the European Union. It is an investigational device and not approved for commercial sale in the U.S.
About Butterfly Medical
Butterfly Medical is a medical device company committed to reshaping the treatment of benign prostatic hyperplasia (BPH) through its innovative, non-surgical solution. The company's flagship product works to restore natural urinary flow and provide significant, long-term relief from BPH symptoms, thereby improving patients' quality of life. The Butterfly® Medical device is CE Mark certified and an investigational device in the U.S., limited by federal law to investigational use. By offering an alternative to both medication and conventional BPH surgery, Butterfly Medical aims to improve the standard of care for millions of men worldwide.
For more information, visit: https://butterfly-medical.com. Follow Butterfly Medical on LinkedIn.
Photo: https://mma.prnewswire.com/media/2857473/Butterfly_Medical.jpg
Media Contact:
Ellie Hanson
FINN Partners for Butterfly Medical
ellie.hanson@finnpartners.com
+1-929-588-2008
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SOURCE Butterfly Medical
