First procedures were successfully performed under local anesthesia in an office setting by Steven Gange MD FACS, Summit Urology, Utah
Yokneam, Israel, August 3, 2022 /PRNewswire/ — Butterfly Medical, an Israeli medical device company developing a novel minimally invasive solution to treat Benign Prostatic Hyperplasia (BPH), today announced its first procedures performed in-office under local anesthesia in its clinical study in North America.
The clinical study evaluates the safety and effectiveness of Butterfly’s next generation prostatic retraction device: a proprietary nitinol implant designed to gently open and prevent the blockage from an enlarged prostate for improved urine flow and thereby alleviate the symptoms caused by BPH. It is considered a “next gen” BPH therapy as it is reversible while also not requiring heating, cooling, cutting or piercing of the prostate.
The first North American procedures were successfully performed by Dr. Steven Gange, (Salt Lake City, UT) clinical study Principal Investigator.
“Many men suffer severe urinary symptoms due to BPH, while also tolerating side effects of marginally effective medications. Today’s primary treatment is surgery, which many patients do not want,” said Dr. Steven Gange, board-certified urologist by the American Board of Urology. “This creates an excellent niche opportunity for minimally invasive BPH procedures like the Butterfly implant.”
The Butterfly procedure can be conducted under local anesthesia in an office setting usually in less than 10 minutes. It allows for faster recovery and reduced side effects such as retrograde ejaculation, pelvic pain and, removes the need for a catheter compared to previous BPH treatments.
“BPH impacts nearly 60% of men over the age of 60 and continues to progress well into the patient’s 80’s and 90’s”, said Idan Geva, Butterfly Medical CEO. “With growing clinical experience in Israel and Europe, we are excited to conduct our first clinical procedures in North America and provide opportunity for men to receive the Butterfly option. These are the first Butterfly procedures ever performed under local anesthesia and in an office setting, exemplifying the minimally invasive nature of the Butterfly platform.”
The Butterfly technology is investigational in the U.S. thus only available for appropriate patients who opt to participate in the FDA clinical trial. Dr. Steven Gange, Summit Urology, is the first physician in the Utah area and one of only a handful of sites in the U.S. to currently offer this novel urology platform to their patients.
The Butterfly Pivotal Study
The Butterfly Pivotal Study is a prospective, multi-center, blind, randomized controlled study to evaluate the safety and efficacy of the Butterfly Medical prostatic retraction device in BPH patients. Butterfly will enroll 222 participants across 15-20 investigational sites in the US. Patients will be blindly randomized to either receive the Butterfly system or undergo a sham cystoscopy procedure. After three months, patients will be unblinded and participants who underwent the sham procedure may receive treatment with the Butterfly device. Primary effectiveness will be evaluated using the International Prostate Symptom Score (IPSS) and based on the change between groups at three months and from the subject’s baseline measurement at the twelve months.
About Butterfly Medical
Butterfly Medical is a medical-device start-up, founded as part of Alon Medtech Ventures, owned by Dr Shimon Eckhouse. New Rhein Healthcare Investors and Paul Merage are also key investors in Butterfly Medical. 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 quickly, in-office, under local anesthesia if desired. Clinical trials performed in leading medical centres in Israel show a high degree of safety and effectiveness. Having already attained CE Mark, post-marketing studies are planned in leading medical centres in Europe, and a pivotal FDA study is ongoing in the U.S. For more information, see http://www.butterfly-medical.com.
