An enlarged prostate is a big problem for men, no pun intended.
According to Yale Medicine, about 50% of men between the ages of 51 and 60 have benign prostatic hyperplasia (BPH) or an enlarged prostate. The problem among older men is worse, with 70% among those aged 60 to 69 and around 80% of men over 70 reporting the condition. For some, it’s mainly an annoyance, but many experience a whole host of symptoms, including increased urinary frequency, urgency, and an inability to fully empty the bladder.
The most common treatment is drugs like Flomax, though others progress to surgery, be it a surgical resection of the prostate, laser vaporization, or other invasive measures. One Israeli company, Butterfly Medical, is hoping to provide options to men who would rather not take drugs — drugs like Flomax have an impact on sexual performance among several other side effects — or wish to avoid surgery. The company is developing the Butterfly Prostatic Retraction device, which allows urologists to deliver an implant endoscopically inside the prostate to relieve pressure on the urethra. In early January, Butterfly Medical announced that it had completed the final 12-month follow-up for all patients in its international pivotal clinical study of the device, a first-line interventional therapy (FIT) for BPH.
“The safety data has been very, very positive. The outcomes data we’re still blinded to because the study just ended, data’s being extracted and with the statisticians right now,” said CEO Patrick MacCarthy in a recent interview.
Just under 245 patients were enrolled for the trial across 26 sites, most of them in the U.S, MacCarthy noted. The device is already approved in Europe and MacCarthy expects to submit the study data to the FDA in the next couple of months to win premarket approval.
“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 Dr. James C. Ulchaker, chief medical officer for Butterfly Medical, in a statement announcing the study completion. “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.”
Ulchaker was formerly the vice-chairman and co-director of the prostate center at the Cleveland Clinic’s Glickman Urological & Kidney Institute.
Depending on the size of the prostate, urologists doing the procedure can choose among four differently-sized nitinol (nickel-titanium) implants. The implant is delivered endoscopically through the penis and is deployed inside the bladder, where it is pulled back and expanded to retract the lateral lobes of the prostate obstructing the urethra. The implant opens up like a butterfly, retracting the obstructing prostate tissue, allowing urine to flow.
The procedure can be completed in the urologist’s clinic or in an ambulatory surgical center, which is less expensive than a surgical setting in a hospital.
The Nitinol Implant (zoomed in)
Other less invasive devices are currently available in the market — the UroLift, which MacCarthy explained established the efficacy of pushing apart the lateral lobes of the prostate to deliver relief for BPH symptoms. But he said that Butterfly’s product is inherently different.
“The UroLift had a way to retract the lateral lobes of the prostate using some sutures and tags … but nothing that could provide any kind of what we would consider truly minimally invasive,” he explaned.
The videos of the companies’ approaches — Butterfly’s and that of UroLift, which Teleflex acquired — indeed highlight the contrast.
However, there is a second device that appears to be similar to that of Butterfly Medical in the way it opens up and pushes the prostate tissue on two sides — the iTind system from Olympus, where MacCarthy previously worked. But that is a temporary implant, which is removed after 4-5 days and provides symptom relief for four years and beyond, per the Olympus website. In other words, this may be an interim treatment until the patient progresses toward surgery.
Contrast the Butterfly Medical device, which is intended to be permanent, although it can be removed if the patient desires, MacCarthy said.
But all three devices promote similar benefits — no cutting, no burning, no removing issue and preservation of sexual function, something that drugs adversely affect.
MacCarthy noted that through the pivotal trial, safety of implant removal has also been established, even though it is designed to stay inside the body.
“So we have had some patients that typically, for irritation reasons, but sometimes for lack of symptom relief, if the underlying root cause was not obstruction that they were taken out, they were able to be removed very easily, very safely,” he said.
After submitting to the FDA in the early part of the second quarter, the goal is to commercialize in 2027.
