Butterfly Medical completes pivotal trial for minimally invasive BPH treatment

Butterfly Medical, developer of a proprietary non-surgical solution for benign prostatic hyperplasia (BPH), has 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, randomised 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.

Patrick MacCarthy is CEO of Butterfly Medical.

He said: “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.

“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 ageing men, affecting approximately 50 per cent of men between the ages of 51 and 60, and up to 90 per cent 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.

Dr James C. Ulchaker is chief medical officer for Butterfly Medical and emeritus urologist at the Cleveland Clinic.

He said: “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.

“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.”