Each year over 234,000 new cases of prostate cancer are diagnosed in the U.S. Treatment options include surgery, radiation therapy, hormone therapy, “watchful waiting” and cryotherapy. Treatment depends on factors including the patient’s age, the stage of the cancer and the presence of other pre-existing medical conditions.
To date, radical prostatectomy has been the preferred treatment – surgically removing the cancerous tissue carries a high success rate, but is often associated with unwanted side effects such as impotence and incontinence. Radiation therapy, which includes traditional external radiation and interstitial radioactive seed therapies (brachytherapy), is used to treat the early-stage disease. Hormone therapy and chemotherapy are used to slow the growth of cancer and reduce tumor size, but are generally not intended to be curative.
Cryotherapy, a relatively new treatment option, involves controlled freezing of tissue to destroy cancerous cells. Outcomes are comparable to surgery and radiation therapy in low risk cases and comparable or superior in medium to high risk cases. The procedure is minimally invasive and typically results in a shorter recovery period. It may also result in a lower incidence of incontinence. Finally, unlike radiation therapy or surgery, cryotherapy can be repeated if the cancer recurs; it can also be used on patients who have been previously treated with surgery or radiation therapy.
Endocare’s Cryocare TCAP (Targeted CryoAblation of the Prostate) procedure uses the Cryocare CS system. It includes the AutoFreeze, a computer controlled automated freezing mechanism. This integrated Ultrasound technology provides a way to visualize the prostate gland using CryoGuide planning and mapping software. The argon gas-based system delivers lethal ice in a controllable and repeatable fashion and the FastTrac, a percutaneous access device, offers a simplified one-step insertion process to significantly reduce procedure time.
To date, the majority of Endocare’s cryotherapy procedures have been performed in medium to high risk patients. The company has developed a nerve-sparing procedure for lower risk patients that may reduce the incidences of impotence. Several clinical studies are underway to determine the success rates attainable with this procedure. The company is also expanding its focus to include the ablation of tumors in the lung and liver, as well as management of pain resulting from bone metastases.
The number of domestic cryoablation procedures grew by more than 20% in 2007. The company’s revenues grew by 6% and gross margin (gross profit as a percent of total revenues) improved by 11 percentage points in the year ended December 31, 2007 compared to the 2006 totals. Total revenues from continuing operations for the 2007 year were $29.7 million, compared to $28.0 million for 2006.