Butterfly Medical Receives CE Approval

Its Next Generation Medical Device to Noninvasively Treat BPH

The new device changes the treatment paradigm for enlarged prostate patients, with a non-surgical procedure completed under local anaesthesia in less than ten minutes in the urologist’s office

Butterfly Medical, today announced that its next generation device to reduce or eliminate benign prostatic hyperplasia (BPH) symptoms has obtained European CE Mark approval.

BPH is a condition where the prostate enlarges and is highly prevalent in men, 50+ years old. Its symptoms often include problems urinating, urgency to urinate, getting-up during the night, as well as sexual dysfunction all having a significant negative impact on quality of life. Medication is often the first line of therapy, but relief can be inadequate and temporary, with patients needing invasive surgical procedures.

Butterfly’s next generational device provides a much-needed simple, fast and minimally invasive treatment option, by focusing on the truly obstructive aspects of BPH. Its unique anatomically shaped proprietary nitinol implant is positioned in the prostatic urethra in order to open the urine path in the prostate for improved urine flow thereby relieving BPH symptoms. The device comes in multiple sizes, and, unlike more invasive approaches, does not require any resection, cutting, or ablation of prostatic tissue.

The procedure can be completed with local anaesthesia in under ten minutes in the urologist’s office, with patients being able to get back to normal activities immediately. It is also completely reversible, with the device easily removed, ensuring patients can benefit from any future therapy, if necessary.

Results from clinical trials are very promising with blocked urethras successfully opened having an immediate and long term effect on patients’ quality of life.

“We are proud to bring a simple, non-surgical treatment option to the millions of men worldwide afflicted by BPH. Using the Butterfly Medical device, urologists can now provide treatment quickly and easily in their office,” said Idan Geva, CEO Butterfly Medical. Dr Shimon Eckhouse, Chairman of Butterfly added: “The minimally invasive, non-surgical device market for BPH treatment is a very active market with significant M&A deals in the range of a few hundred million to one billion dollars. Butterfly’s innovative solution has great potential to become a leading solution for this market.”

About Butterfly Medical

Butterfly Medical is a medical-device start-up, founded as part of Alon Medtech Ventures, owned by Dr Shimon Eckhouse. The company is developing a fast, simple, and minimally invasive alternative treatment to medication and surgery used for Benign Prostate Hyperplasia (BPH) treatment. Its innovative device transfers the procedure from the operating room to the clinic, with the device being placed in under 10 minutes, in-office, under local anaesthesia. Clinical trials performed in leading medical centres in Israel show a high degree of safety and effectiveness. Further, post-marketing studies are planned in leading medical centres in Europe, and a pivotal FDA study is planned in the US. For more information