Irvine’s Endocare Puts the Freeze on Prostate Cancer

In the battle against prostate cancer, medical science has tried it all--surgery to remove the diseased gland, radiation to nuke the malignant cells, even last-resort hormone treatments to make the cancer shrink.

Endocare Inc. has another way to stop the cancer cold: freeze it to death.

The Irvine company makes devices for performing prostate “cryoablation,” a fancy term for a procedure that freezes the prostate to below-arctic temperatures. As spiky ice crystals form within the cancerous tissue, tumor cells burst open to meet a chilly end.

The technique has been around since the 1960s, but only recently have scientists figured out ways to optimize cryoablation to a level that is gaining credibility within the medical community.

Just three weeks ago, results of a five-year follow-up study were released in which cryoablation was deemed as effective as radiation therapy, one of the golden standards in the treatment of prostate cancer.

Of the many prominent men diagnosed with prostate cancer, most recently New York Mayor Rudolph W. Giuliani, Nobel laureate Desmond Tutu has become an emissary of sorts for cryoablation. Since undergoing the procedure in November, the retired South African archbishop has remained cancer-free.

“The popularity is going up. We get an enormous amount of interest” for cryosurgery, said Dr. Stuart Fisher, a professor of urology at UCLA who is setting up the university’s cryocenter. The center will be one of four offering the procedure in California, Fisher said.

That’s all good news for Endocare, which according to analysts has nearly 90% of the U.S. market when it comes to prostate cryoablation technology. Smaller players include Cryomedical Sciences Inc. of Rockville, Md., and Galil Medical Ltd. in Israel.

Right now, cryoablation constitutes less than 1% of all procedures to treat prostate cancer, said Jason Wittes, a medical technology analyst with UBS Warburg in New York. But as the technique’s popularity increases, Wittes estimates, Endocare will get 10% to 15% of the prostate cancer treatment market in five years.

“And that’s a conservative estimate,” he said.

Endocare has been around since 1996, when it was spun off from Aliso Viejo medical device maker Medstone International Inc. But last year marked a pivotal turning point.

In July, Medicare coverage for prostate cryoablation was initiated--partly due to the company’s lobbying efforts in Washington--making cryosurgery available to a broader population. That allowed Endocare to commercially launch its core product--the patented cryoablation system.

Prostate cryoablation, which costs about $13,000, involves thin needle-like probes that are inserted through the skin and placed inside the prostate with the help of ultrasound guidance. Once there, the probes are cooled to subzero temperatures, forming a deadly ball of ice that spreads through the prostate.

Endocare sells the probes and generally leases the equipment that performs the treatment--and it gets a cut for each procedure.

The company’s sales surged 71% to $2.3 million last year, and the trend has continued into 2000, with reported revenue of $1.3 million for the first quarter.

That’s double that of the same period the year before.

“We’ve had quite a run so far,” said Paul Mikus, Endocare’s chief executive, an electrical engineer by training.

Endocare still isn’t profitable. Its first-quarter loss widened to $3 million, up 67% from $1.8 million a year earlier--which the company attributed to ramped-up marketing and production costs. Endocare has nearly 70 employees, including a sales force of two dozen, many of them new.

Analysts don’t see Endocare turning a profit soon. But that hasn’t discouraged investors. The company’s stock has surged in the last year, trading as high as $22.56 in the midst of the spring biotech frenzy. The stock closed at $15.88 Friday, up 38 cents in Nasdaq trading.

Endocare’s prospects may also improve as it attempts to expand cryoablation technology for the treatment of other types of cancer. Preliminary studies in which cryoablation has been used in patients with metastatic liver, kidney and breast cancer look encouraging.

For now, cyrosurgery for prostate cancer holds the most potential. Those diagnosed with the disease will number 180,400 this year, according to estimates by the American Cancer Society. Prostate cancer is the second leading cause of cancer deaths in men, although if caught early, the disease is quite treatable and survival rates are high.

Archbishop Tutu, who is nearing 70, exemplifies the kind of patient who can most benefit from the technique. His cancer had recurred after initial radiation treatment.

“Cryoablation is really the only treatment for patients who fail radiation therapy,” said Dr. Harry Clarke of Emory University Hospital, who is Tutu’s urologist.

Clark said cryosurgery is also the best option for those patients who, because of age or other health conditions, cannot undergo surgical removal of the prostate.

Cryosurgery patients can usually go home within a day. There’s generally little blood loss, and recovery time is fairly quick. But as with surgical removal of the prostate, cryoablation causes impotence in the majority of patients.

For those who can withstand it, surgical removal of the gland is still seen as the best way to make sure the tumor cells are gone. Even so, if cryoablation continues to prove itself as a reliable and safe method, there’s little doubt that more patients will seek it.

Already, the demand for the procedure has grown to thousands--a far cry from earlier years dating back to the 1960s when cryoablation was highly unpopular and discredited.

Then, patients not only lost their prostate to the procedure but often healthy surrounding tissue, because doctors had no way of telling exactly where or how far the killer ice crystals had spread.

That’s where Endocare’s technology came in. By developing a system to monitor the temperature and safeguard surrounding tissue, Endocare provided the precision that greatly advanced the field of cryosurgery. Analysts say that’s what gives the company the advantage it has today.

“There were lots of false starts,” Wittes said. “Endocare was the first to come up with a very reliable system.”

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Freezing Out Cancer

“Cryoablation” of the prostate, once viewed by most physicians as pseudo-science, experienced a comeback in the 1990s thanks to the development of better ways to monitor the procedure. An Irvine firm hopes the method can be applied to cancer treatment in other areas of the body.

* Temperature monitoring probes are inserted around the prostate to make sure the ice does not spread too far.

* A warming catheter keeps healthy surrounding tissue from freezing during the procedure

*

How Procedure Works:

1. Six to eight hollow “freezing” probes are inserted in the prostate.

2. Argon gas is circulated through the probes, cooling tips to --40 degrees Celsius.

3. A ball of ice develops on the outside tips of the probes and spreads, freezing the gland.

4. “Monitoring” probes sense the ice, which shuts system down, and prostate begins to thaw.

5. After one more round of freezing and thawing, the probes are removed and incision is closed.

The process takes about two hours. The prostate tissue killed by the ice shrinks and is eventually dissolved by body.