Butterfly Medical Ltd. could be on the verge of metamorphosis into a major player in the benign prostatic hyperplasia treatment field. The Yokneam, Israel-based company just raised $7 million in a series B financing led by New Rhein Healthcare Investors LLC, of Philadelphia. In addition, positive early results from a clinical trial of its novel implantable device appear to support initiating a pivotal registration study.
The series B funds included $5 million from New Rhein and $2 million from existing stockholders. As part of the deal, New Rhein Managing Partners Greg Parekh and Ivan Gergel will join Butterfly’s board of directors. Initial funding for the company came from Alon Medtech Ventures, an Israeli medical device venture capital firm.
The new funds will primarily be used to open a U.S. headquarters in Philadelphia and fund a pivotal American clinical trial. The company plans to enroll 200 patients in a trial that will compare implantation to a sham procedure, cystoscopy, pending U.S. FDA approval, Butterfly CEO Idan Geva told BioWorld. The device is approved for use in Israel and Geva expects it to receive a CE mark in 2021.
The Butterfly Prostatic Retraction Device offers non-surgical treatment of issues associated with an enlarged prostate, a problem that affects 50% of men between the ages of 51 and 60 and up to 90% of men over age 80.
The prostate doubles in size during puberty and then grows slowly throughout a man’s life. Over time, the enlarging prostate often starts to impinge on the urethra, forcing the bladder to work harder. In many cases, the bladder muscles weaken, resulting in retention of urine, which can cause a range of problems and may lead to bladder or kidney damage in severe cases.
While benign prostatic hyperplasia (BPH) does not increase the risk of cancer, its symptoms can significantly reduce quality of life and limit activities. Common symptoms of BPH include a sense of never truly voiding, urgency, weak or “start-stop” urine flow, straining to urinate, and frequent waking in the night to urinate.
Current treatments of BPH include medications that improve urine flow such as alpha blockers, a class that includes alfuzosin, doxazosin, silodosin, tamsulosin, and terazosin. Alpha blockers may cause dizziness, fatigue, and difficulty ejaculating. DHT-blocking drugs, 5-alpha reductase inhibitors, can be used to shrink the prostate. Finesteride and dutasteride are in this class. Both may cause erectile dysfunction and reduced sex drive and may take months to provide relief.
A variety of surgical procedures use lasers, electricity, or high-pressure water jets to kill prostate tissue that is blocking the urethra. The less invasive transurethral incision of the prostate (TUIP) uses a laser beam or electricity to widen the urethra at the opening to the bladder instead of reducing the prostate. Many of the surgical options affect sexual function and may lose their impact over time. Some are associated with incontinence and erectile dysfunction.
It’s in the wings
“We don’t believe in a one-size fits all approach to BPH treatment. We believe we’ve developed a simpler, safer device to complement existing therapies and offer a less invasive alternative to patients,” Geva said.
The Butterfly Prostatic Retraction Device is an anatomically shaped nitinol implant that is positioned in the urethra using an ordinary cystoscope in about six minutes in the urologist’s office. The procedure does not involve removal of any prostatic tissue. Instead, it “mechanically retracts the lobes of the prostate, thus restoring urine flow and alleviating symptoms,” according to Geva. The device comes in a range of sizes to permit matching to individual need.
Unlike drugs, “Butterfly improves symptoms without affecting the sexual quality of life,” Geva noted. “The surgery improves urine flow quite dramatically but causes retrograde ejaculation in most patients and other more severe side effects in smaller numbers. It takes 1+ hours and requires hospitalization and long recovery. The Butterfly procedure takes minutes to complete, recovery is much faster and no need for hospitalization. There is no retrograde ejaculation, and other side effects are in much smaller numbers.”
Patients return to work and daily life within a few days of the Butterfly implantation and recover fully in two to four weeks.
In clinical trials performed to date, researchers demonstrated improvement on the International Prostate Symptoms Score-symptoms severity questionnaire (IPSS) within two weeks of the procedure. Patients continued to improve over time, with a 35% reduction in symptoms seen one month post-procedure and a 42% improvement noted in patients who had the device for 12 months.
Implanting the Butterfly Prostatic Retraction Device provides a permanent solution for some patients. Others may be able to delay surgery and its adverse effects. Some patients have asked to have the device removed. “The easy removal is one of the main advantages of the Butterfly: A surgery can’t be reversed,” Geva noted.