In the mid 1990’s, a second-generation cryosurgery systems emerged, based on an advanced gas expansion method (Joule-Thomson principle). Although these systems demonstrated significant improvement in controlling the freezing process, they employ relatively thick 3.2 mm diameter probes that are inserted in a cumbersome fashion requiring the use of a special insertion kit. Due to their wide diameter, a maximum of 8 probes can be used simultaneously, resulting in low accuracy, poor controllability and non-uniform lethal temperature distribution.

In April 2000, Galil introduced SeedNet™ cryotherapy system for the treatment of prostate cancer and other urological diseases. This introduction coincided with a number of events that have built considerable momentum for cryotherapy usage as a mainstream procedure.

July 1999, the Health Care Financing Administration (“HCFA”) provided for national Medicare coverage of cryosurgery as a "primary" treatment for localized cancer of the prostate.

January 2001, AMA approved and published a CPT code for prostate cryosurgery; CMA (formerly HCFA) activated the CPT code and assigned payment to the procedure. The results of recent studies have enabled cryotherapy to continue to gain momentum as a therapy of choice for prostate cancer among urologists and patients.

In March 2001, The Journal of Urology published the results of a five-center, 975 patient study involving five-year patient progress data that concluded that cryoablation outcomes and morbidities are comparable to radiotherapy.

"FIVE-YEAR RETROSPECTIVE, MULTI-INSTITUTIONAL POOLED ANALYSIS OF CANCER-RELATED OUTCOMES AFTER CRYOSURGICAL ABLATION OF THE PROSTATE"

By JOHN P. LONG, DUKE BAHN, FRED LEE, KATSUTO SHINOHARA, DOUGLAS O. CHINN, AND JOSEPH N. MACALUSO, JR

Conclusions. For each risk group, the 5-year BFS and positive biopsy rate after CSAP was comparable to matching outcomes reported after radiotherapy. Morbidities also seemed comparable, with impotence rates higher and rectal injury rates lower after CSAP than after radiotherapy. These data indicate that CSAP can be performed with low morbidity and can produce cancer-related results comparable to those reported for patients undergoing radiotherapy. UROLOGY 57: 518–523, 2001. © 2001, Elsevier Science Inc.

In June 2001, The Journal of Urology also recently reported that in a clinical study 87% of patients who were unsuccessfully treated with radiation therapy remained disease-free nearly two years following cryosurgery for such "radiation failure."

"'RESULTS OF SALVAGE CRYOABLATION OF THE PROSTATE AFTER RADIATION: IDENTIFYING PREDICTORS OF TREATMENT FAILURE AND COMPLICATIONS"

BY JOSEPH L. CHIN, STEPHEN E. PAUTLER, VLADAMIR MOURAVIEV, NAJU TOUMA, KIMBERLY MOORE AND DONAL B. DOWNEY

Conclusions: Salvage cryoablation after radiation can achieve reasonable biochemical and histological results with acceptable morbidity. Cryoablation appears to be a reasonable treatment option for this patient population with few viable therapeutic options, provided vigorous patient selection criteria are adhered to.

July 2001, HCFA revised the policy it was now permissible to perform cryotherapy as a salvage procedure

In January 2002, Galil Medical received FDA clearance for kidney cryoablation

In May 2002, during the Annual AUA meeting in Orlando, FL a series of abstracts were presented which included a 7-Year Outcomes in the Primary Treatment of Prostate Cancer which provided compelling validation of Cryosurgical Ablation of the Prostate as an efficacious treatment modality for the treatment of prostate cancer

"TARGETED CRYOABLATION OF THE PROSTATE: 7-YEAR OUTCOMES IN THE PRIMARY TREATMENT OF PROSTATE CANCER"

By DUKE K. BAHN, FRED LEE, ROBERT BADALAMENT, ANIL KUMAR, JEFFREY GRESKI, AND MICHAEL CHERNICK

Conclusion: TCAP was shown to equal or surpass the outcome data of external-beam radiation, 3- dimensional conformal radiation, and brachytherapy. These 7-year outcome data provide compelling validation of TCAP as an efficacious treatment modality for locally confined and locally advanced prostatic carcinoma. UROLOGY 60 (Suppl 2A): 3–11, 2002. © 2002, Elsevier Science Inc.

In October 2002, The Journal of Urology published prospective results of 5-year study of prostate cancer patients. The results were that cancer-specific survival rate was 98.6%.

"PROSPECTIVE TRIAL OF CRYOSURGICAL ABLATION OF THE PROSTATE: FIVE-YEAR RESULTS"

By B. J. DONNELLY, J. C. SALIKEN, D. S. ERNST, N. ALI-RIDHA, P. M. A. BRASHER, J. W. ROBINSON, AND J. C. REWCASTLE

Results. Follow-up biopsies were performed in 73 patients, and 72 were negative for malignancy after one or more treatments. Ten patients required two treatments and 1 patient required three treatments. The 5-year overall and cancer-specific survival rate was 89% (95% confidence interval, 83% to 97%) and 98.6% (95% confidence interval, 96% to 100%), respectively.

Conclusions. The results of this prospective evaluation show cryosurgery to be both a safe and an effective option in the treatment of localized prostate cancer. UROLOGY 60: 645–649, 2002. © 2002, Elsevier Science Inc.

On February 2003, presented at the 8th Annual Prostate Cancer Symposium in Scottsdale, Arizona was the summary of an ongoing multi-center study, which summarizes the Galil Medical 17-Gauge Third Generation Cryosurgery. Results indicate that these and other studies that are currently being performed now enable cryotherapy to compete favorably with the brachytherapy and radical prostatectomy (%RP%), which are associated with significant morbidity and side effects. An extract of the results are listed below.

"TREATMENT OF ORGAN-CONFINED PROSTATE CANCER WITH THIRD GENERATION CRYOSURGERY-PRELIMINARY MULTICENTER EXPERIENCE"

By Ken-ryu Han, Los Angeles, CA, James Lugg, Cheyenne, WY, Danielo G Freitas, Los Angeles, CA, Stacy J Childs, Cheyenne, WY, Jeff K Cohen, Ralph J Miller, Pittsburgh, PA, Barry Shuman, Albany, NY, Maury A Jayson, Bayshore, NY, Neal D Shore, Myrtle Beach, SC, Yan Moore, Uniondale, NY, Amnon Zisman, Los Angeles, CA, Horst Zincke, Rochester, MN, Allan J Pantuck, Arie S Belldegrun, Los Angeles, CA

Preliminary Results: This study started in August 2000 and to date one hundred sixty one patients (161) with a mean age of 69 year old have been followed. Results of the primary/salvage cryoablation patients are summarized. The complications included tissue sloughing (2.6%/11.1%), stress/total incontinence (1.9%/7.1%), scrotal swelling (3%/11.1%), urinary tract infections (0%/3.8%) and pelvic pain (4%/6%). There were no reported cases of fistulas. Post-operative impotence was 70% in patients who were potent prior to cryoablation. All patients except 2 were discharged the next day.

In October 2003, following the AUA Annual Meeting in Chicago, IL where an abstract of the Multicenter Study results were presented, the information was selected for publication by The Journal of Urology. Results indicate that 3rd generation cryosurgery offers more precise prostatic ice ball formation and offers the flexibility to place an increased number of probes where necessary. With the evolution of TRUS guidance, urethral warmers and smaller needles, the morbidities associated with this treatment alternative have become comparable to other available treatment options and are within an acceptable range. An extract of the results are listed below.

"TREATMENT OF ORGAN CONFINED PROSTATE CANCER WITH CRYOSURGERY: PRELIMINARY MULTICENTER EXPERIENCE THIRD GENERATION"

By Ken-ryu Han, Los Angeles, CA, James Lugg, Cheyenne, WY, Danielo G Freitas, Los Angeles, CA, Stacy J Childs, Cheyenne, WY, Jeff K Cohen, Ralph J Miller, Pittsburgh, PA, Barry Shuman, Albany, NY, Maury A Jayson, Bayshore, NY, Neal D Shore, Myrtle Beach, SC, Yan Moore, Uniondale, NY, Amnon Zisman, Los Angeles, CA, Horst Zincke, Rochester, MN, Allan J Pantuck, Arie S Belldegrun, Los Angeles, CA

Preliminary Results: Complications in patients undergoing primary cryosurgery included tissue sloughing (5%), incontinence (pads, 3%), urge incontinence/no pads (5%), transient urinary retention (3.3%) and rectal discomfort (2.6%). There were no cases of fistulas or infections. Postoperative impotence was 87% in previously potent patients. For patients who underwent salvage cryosurgery there were no fistulas reported and 2 (11%)patients required pads after salvage cryosurgery. A total of 96 (81%) patients achieved a PSA nadir of 0.4 ng/ml or less at 3 months of followup, while 79 of 106 (75%) remained free from biochemical recurrence at 12 months. A total of 42 (78%)low risk patients (Gleason score 7 or less and PSA 10 or less) remained with a PSA of 0.4 ng/ml or less at 12 months of followup, compared to 37 (71%) high risk patients. All patients were discharged within 24 hours.