Pivotal trial of Butterfly Device for BPH reaches final completion

Butterfly Medical announced the successful completion of their pivotal randomized controlled trial (NCT05341661) of the Butterfly Prostatic Retraction Device, an investigational first-line interventional therapy (FIT) for benign prostatic hyperplasia (BPH).¹

The trial was completed with 12-month follow-up. According to the company, the results from this study are expected to support an application to the FDA for pre-market approval of the device.

"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 James C. Ulchaker, MD, Chief Medical Officer for Butterfly Medical and Emeritus Urologist at the Cleveland Clinic, in a news release from the company.¹ "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."

In total, the prospective, double-blind study enrolled 244 male patients aged 50 or older with BPH across clinical trial sites in the US.² To be eligible for enrollment, patients needed to have a prostate length of 25 mm to 45 mm, a prostate volume of 30 mL to 90 mL, and symptomatic BPH, defined as an International Prostate Symptom Score (IPSS) of 13 or higher and a score of 1 or higher on the IPSS voiding to sub-score ratio.

Patients enrolled in the study were randomly assigned 2:1 to receive the Butterfly device or undergo a sham rigid cystoscopy procedure. Cross over was permitted in the trial. The dual primary end points were change in IPSS from baseline to 3 months and baseline to 12 months.

The Butterfly device has also been evaluated in a prospective pilot study (BM-011-LT), which read out last year at the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada.³ The study included a total of 24 patients with lower urinary tract symptoms secondary to BPH.

At 5-year follow-up, the study reported a mean improvement in IPSS from baseline of 6.04 points. The overall response rate at the time of the last follow-up was approximately 61%.

"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, in the news release.¹ "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."

REFERENCES

1. Butterfly Medical Announces Completion of Pivotal Trial for Minimally Invasive Treatment of Benign Prostatic Hyperplasia. News release. Butterfly Medical. January 8, 2026. Accessed January 8, 2026. https://www.prnewswire.com/news-releases/butterfly-medical-announces-completion-of-pivotal-trial-for-minimally-invasive-treatment-of-benign-prostatic-hyperplasia-302656312.html

2. Butterfly Pivotal Study. ClinicalTrials.gov. Last updated January 15, 2025. Accessed January 8, 2026. https://clinicaltrials.gov/study/NCT05341661

3. Katz R, Sahmed M, Safadi A, et al. 5-year follow-up of a multicenter, prospective pilot study (BM-011-LT) of the butterfly prostatic retraction device in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2025;213(5S):e190. doi:10.1097/01.JU.0001109776.58983.66.11