Benign prostatic hyperplasia (BPH) is a common problem that affects one third of men over 50. Most treatments are complicated, expensive and unpleasant, and usually end up with the patent wearing a catheter for hours or days afterwards. UC-Care Medical Systems Ltd. has developed an ostensibly simple mechanical device that does not harm the urethra during prostate treatments.
UC-Care’s breakthrough involves making the urethra rigid and breaking the conceptual rigity characterizing the field. There are currently a number of treatments for BPH, all of which try to remove some prostate tissue near the urethra, which presses it and causes problems with urination, sexual performance, and quality of life. The absolute majority of current treatments operate according to the following logic: if we want to remove tissue near the urethra, the best way to do it is to insert a catheter through the urethra, and carry out the treatment through it.
One of the oldest methods is transurethral resection of the prostate (TURP), which involves inserting thin instrument called a resectoscope is passed into the urethra. One end it acts as a telescope, allowing the surgeon to view the prostate either directly or on a video monitor. A precisely controlled electric current, applied by a loop of wire at the end of the resectoscope, is used to shave off sections of the enlarged prostate. However, the procedure can damage the urethra and cause severe side effects, including an inability to urinate normally, and sexual dysfunction.
There are also other, less invasive, treatments. One of these involves inserting through the urethra a catheter that emits microwaves, which ablates prostate tissue near the urethra, but also urethra tissue. A second treatment involves inserting through the urethra an instrument with two retractable needles at the tip. These needles are extended, pass through the catheter and emit heat waves inside the prostate to ablate tissue. Although this treatment causes only minimal damage to the urethra, this is damage nonetheless.
UC-Care has cured BPH treatment fixation by realizing that it is possible to remove tissue without inserting an instrument through the urethra. The main question was how do we know that we are treating tissue adjacent to the urethra without damaging the urethra itself? The solution is one that seems simple in retrospect. UC-Care has developed a rigid catheter that resembles a miniature golf club, at the tip of which is a viewfinder. The urethra is situated precisely at the center of the viewfinder. Through tiny holes surrounding the center, it is possible to insert needles that will enter the prostate precisely parallel to the urethra, close to, but not actually touching it. These needles can emit either radio frequency (RF) or microwave energy, which ablates the tissue, or liquid nitrogen, which freezes it. UC-Care decided to use RF radiation.
The treatment is based on treatments for prostate cancer. Usually, prostate cancer requires removal of the entire organ. To ensure that surrounding organs are not injured, the usual practice is to insert through the rectum an ultrasound device that provides a three-dimensional image of the prostate. UC-Care synchronizes its viewfinder with this ultrasound image, which enables the doctor to decide where to insert devices for ablating prostate tissue.
However, this method could not solve the problem of damage to the urethra during treatment of BPH, because the doctor always inserted the needles at a 90-degree angle. The urethra is arched, and inserting needles at a 90-degree angle is liable to damage it. Straightening the urethra and making it rigid can avoid this problem.
It is possible to use ultrasound with UC-Care’s device, but it’s not necessary. Urologists are not experts with ultrasound, and many lack the instrument in their clinics. Since UC-Care’s treatment for BPH does not require ultrasound for guidance, it has a major advantage over other treatments.
2 million patients
Shaike Schatzberger developed UC-Care’s device. He was formerly an executive at Galil Medical Ltd., which has developed a treatment for prostate cancer using ultrasound and needles with liquid nitrogen. He says the development breakthrough was the realization, which came like a bolt from the blue, that guiding the system did not have to be based on ultrasound, but could carried out around the urethra itself.
“After breaking this fixation,” says Schatzberger, “it was easier to think of other things. For example, when I worked for Galil Medical, the idea of using RF was inconceivable. We used liquid nitrogen and RF was the enemy. But I gradually realized that RF was suitable for UC-Care’s first product. Why not, after all? But it was a subversive idea for me.”
Schatzberger is president and CEO of Celletra Ltd. and a member of UC-Care’s board. He co-founded UC-Care with Roni Zvuloni, who serves as CTO, and also originally came from Galil Medical. UC-Care CEO Chen Porat previously managed NanoCyte Inc. and Ultra-Spect Ltd.. Based in Meytav Technological Enterprises Innovation Center Ltd., UC-Care has raised $560,000 to date.
Porat says there are two million BPH patients in the US, of whom only 15-20% receive invasive treatment. The others either take medication to stave off the day of reckoning, although the disease worsens over time. Estrogen-based treatments are liable to cause impotence and lead to feminine features. UC-Care’s treatment is designed for patients for whom medication is insufficient, but fear invasive treatments.
“Globes”: What do you expect for your product in terms of regulations and marketing?
Porat: “We’ve begun clinical trials in Israel, and I believe that US Food and Drug Administration (FDA) regulatory procedures will be fairly straightforward, and take about 18 months. Our device is similar in its components to existing devices. We’re raising $2-3 million to finance the trials, which should be completed in a few months.”
Schatzberger: “In terms of marketing, we expect doctors to love our product. Doctors are also businesspeople, and they make more money with this treatment than from a prescription. We’ve turned a complicated procedure into a very simple one, which a doctor can carry out in his or her private clinic.”
Published by Globes [online], Israel business news - www.globes.co.il - on April 20, 2006
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