CHARLOTTE, N.C., April 30 /PRNewswire/ -- As Phase I U.S. trials of the Sonablate(R) 500 come to a close at Indiana University School of Medicine in Indianapolis, U.S. HIFU prepares to educate physicians and patients on the features of high intensity focused ultrasound (HIFU) as used in approved countries and on the progress of the U.S. clinical trials of HIFU for the treatment of localized prostate cancer, locally recurrent prostate cancer and benign prostatic hyperplasia (prostate enlargement). Highlights from Phase I U.S. clinical trials will be presented in a private presentation to physicians during the American Urological Association’s annual meeting on May 11, 2004 in San Francisco. The presentation will also offer insight from European and Japanese physicians using the device, as well as plans for potential future application and thoughts on the economic impact of prostate cancer.
The Sonablate(R) 500, which is approved for use in Europe, parts of Asia, and the Dominican Republic, uses intersecting, precision-focused ultrasound waves to raise the temperature of the target tissue to more than 80 to 90 degrees Celsius in two to three seconds, a technique known as “acoustic ablation.” The result is “coagulative necrosis” and the destruction of the cancer cells leaving the healthy cells and surrounding organs untouched. HIFU treatment in approved countries can be given in one to three hours on an outpatient basis with epidural anesthesia. Patients typically walk out of the recovery room on their own within hours after their treatment.
In addition to being noninvasive, HIFU energy is non-ionizing “clean energy” that can be applied repeatedly without damaging other tissue, unlike radiation-based therapies. In approved countries, it has also been used as a salvage therapy when other treatments have failed. As many as one-third of patients who receive either external radiation therapy or brachytherapy (radioactive seed implants) have a recurrence of cancer.
Dr. George Suarez, a Miami-based, board-certified urologist and medical director of U.S. HIFU, said, “I have been performing HIFU in the Dominican Republic for the past year and have had an opportunity to treat a number of patients with localized prostate cancer. Although early, the results to date have been amazingly impressive in that there has been no evidence of recurrence as determined by PSA of less than one. Equally important is that there has been no incidence of incontinence or erectile dysfunction. More so, there has been no other morbidity or associated complications. Similar results have been reported in European and Asian medical journals where HIFU has been available since 1992.” Elevated PSA (prostate-specific antigen) levels in the blood in patients with prostate cancer are an indication of residual or recurrence of the cancer.
“With the exception of a temporary foley catheter attached to a leg bag that is placed under the pants and worn for approximately a week, most men return to a normal life and daily activities almost immediately,” stated Suarez. “This is truly an amazing application of the most advanced technology, science and medicine coming together. In countries where it is approved, HIFU has revolutionized the treatment of localized prostate cancer by its efficacy, prognosis and the impact it has had on the quality of life of men and their families.”
“It’s tragic enough to be diagnosed with prostate cancer, but it’s equally tragic if the treatment puts the patient at risk of impotence and urinary incontinence. Unfortunately with cancer, sometimes the treatment can be as devastating as the cancer itself,” said Suarez.
A recent report presented at the annual meeting of the European Association of Urology by Dr. Joachim Deuster, a practicing urologist in Heidelberg, Germany, and a prominent figure in the field of prostate cancer treatment, showed that in 88 percent of the patients studied, HIFU technology produced PSA measurements below 1.0 within one year following treatment with a lower incidence of erectile dysfunction and urinary incontinence than reported in studies of other therapies. In another paper released at the same conference, John Rewcastle, Ph.D., of Calgary, Canada, presented similar data in a review of HIFU and the various competitive technologies. In Rewcastle’s data, the Sonablate(R) 500 appears to have a distinct advantage over similar technology in its ability to image and treat simultaneously.
The American Cancer Society estimates that approximately 230,110 men will be diagnosed with prostate cancer in the U.S. in 2004. It is the second leading cause of cancer death in men, exceeded only by lung cancer, and is most common among men between the ages of 60 and 80. The known risk factors for prostate cancer include age, race and family history.
About U.S. HIFU
U.S. HIFU, a development company located in Charlotte, N.C., is the exclusive distributor of the Sonablate(R) 500 in North, Central and South America and the funding source for Phase II-III U.S. clinical trials of the device. The device was created by Focus Surgery Inc. of Indianapolis and is manufactured by Misonix Inc. of Farmingdale, N.Y. Misonix holds a minority equity position in Focus Surgery and exclusive distribution rights in Europe. Takai Hospital Supply Ltd. (THS) of Tokyo also holds a minority equity position in Focus Surgery and is the exclusive distributor in Asia. U.S. HIFU is now enrolling various hospitals for Phase II-III trials. For more information on U.S. HIFU or future clinical trials, visit U.S. HIFU online at http://www.ushifu.com/ .
About George M. Suarez, M.D., F.A.C.S., F.A.A.P
Dr. Suarez is a board-certified urologist who completed his residency at Tulane University. He is currently in private practice in Miami and is the only urologist from the United States, outside of Indiana University where Phase I clinical trial were done, who is actively performing HIFU. He travels to the Dominican Republic bimonthly, where the technology is approved and a HIFU center exists under the direction of Dr. Rafael Estrella, chairman of the department of urology at the Universidad Madre Y Maestra in Santiago, Dominican Republic. As medical director of U.S. HIFU, he will oversee future U.S. clinical trials of the Sonablate(R) 500 and will serve as a consultant to Focus Surgery.
U.S. HIFU
CONTACT: Melisa LaVergne, +1-704-442-9100, for U.S. HIFU
Web site: http://www.ushifu.com/
