If you are a manufacturer dealing with the high cost and complexity of surgical BPH tools — this project developed a Nitinol implant that can be deployed in under 4 minutes. This shifts the procedure from the operating room to a simple clinic setting.
Office-Based Minimally Invasive Implant for Benign Prostatic Hyperplasia Treatment
Imagine a tiny, flexible spring made of a special metal that acts like a gentle brace for the prostate. Instead of invasive surgery or lifelong pills, a doctor can slide this implant in during a quick office visit to open up the urine path. It works like a small support beam that keeps the channel open without any cutting or burning.
What needed solving
BPH treatments currently force a choice between ineffective drugs with side effects or invasive surgeries that require expensive hospital stays and long recovery times.
What was built
A Nitinol prostate implant and a 22French disposable delivery system that allows for a 4-8 minute office-based procedure.
Who needs this
Who can put this to work
If you are a clinic owner dealing with limited operating room access and high patient turnover — this project developed a device that allows BPH treatment under local anesthesia in the office. This reduces the need for hospitalization and expensive OR time.
If you are a payer dealing with the indefinite costs of BPH medication and expensive hospitalizations — this project developed a fully reversible implant. This reduces long-term drug costs and eliminates the high overhead of traditional surgery.
Quick answers
What is the cost or pricing model for this device?
Based on available project data, specific pricing is not mentioned, but the device is designed as a fully disposable delivery system to reduce capital equipment investment.
How is the technology scaled for industrial production?
The project focuses on a low profile (22French) fully disposable delivery system, indicating a shift toward high-volume, single-use manufacturing.
What is the IP and licensing status?
The technology is protected by 3 granted patents and has already achieved a CE mark.
What regulatory hurdles remain?
The project aims to gain FDA and MDR approvals through pivotal trials involving 222 patients across 20 EU and US hospitals.
What is the timeline for market entry?
The project period runs from 2023-09-01 to 2025-08-31, with the current focus on completing pivotal trials.
Who built it
The project is led by a single Israeli SME, Butterfly Medical Ltd. This 100% industry-led consortium indicates a high drive for commercialization and a streamlined decision-making process, avoiding the typical delays of academic-industrial partnerships.
Contact Butterfly Medical Ltd in Israel for licensing or partnership inquiries.
Talk to the team behind this work.
Contact us to explore partnership opportunities with Butterfly Medical for US/EU market entry.