Tuesday June 5, 4:02 am Eastern Time
Press Release
Misonix Announces Interim Results for Prostate Cancer Treatments Using Focus Surgery's High Intensity Focused Ultrasound Sonablate
ANAHEIM, Calif.--(BW HealthWire)--June 5, 2001--Misonix Inc. (Nasdaq:MSON - news) today announced that Dr. Toyoaki Uchida, M.D., professor of the Department of Urology at Kitasato University, Tokyo, presented clinical results of an on-going clinical trial for the treatment of prostate cancer (T1, T2) using Focus Surgery's Sonablate(TM) high intensity focused ultrasound (HIFU) device.
The Sonablate(TM) system, developed by Focus Surgery Inc. of Indianapolis is capable of killing deep-seated cancer tissue by rapidly elevating the temperature in a precise focal zone, without affecting the intervening tissue, and without side effects such as ionization or radiation.
The treatment is precise, bloodless and has minimal complications. The treatment is guided by ultrasound imaging that also combines HIFU technology. Misonix currently owns approximately 20 percent of Focus and has the rights to produce its products.
Uchida presented the results of his study on 30 patients with prostate cancer at the 2nd annual meeting of HIFU users organized by Focus Surgery during the American Urology Association Annual Meeting yesterday in Anaheim, Calif.
All patients showed complete response to the HIFU treatment with a Prostate Specific Antigen (PSA) level of less than 0.75 and a negative biopsy as a measure of complete response. Twenty patients have been followed for over 12 months without any complications.
Uchida said: ``The patients treated with the Sonablate(TM) show significant improvement in their PSA scores within a month of treatment and have fewer complications as compared to other prostate cancer treatment procedures. This treatment is found safe and has improved the quality of life for these patients.''
The treatment protocol being used at Kitasato University is similar to the protocols approved by the Food and Drug Administration (FDA) for Phase I clinical studies in the USA. Focus Surgery has selected Indiana University School of Medicine, Indianapolis, and Case Western Reserve University, Cleveland, for these studies.
Under the FDA approved studies, a total of forty patients will be treated using the Sonablate device. In one study, primary capsule confined prostate cancer patients will be treated and in the second study recurrent prostate cancer patients will be treated.
These patients typically do not have a treatment option available to them. Dr. T. A. Gardner and Dr. M. O. Koch from Indiana University School of Medicine visited Kitasato University, and observed two patient treatments by the Sonablate(TM) so that they can offer the same treatment in Indianapolis to their patients.
Narendra T. Sanghvi, president and chief executive officer of Focus Surgery said: ``Our long term research and development of High Intensity Focused Ultrasound has shown very promising results for the treatment of cancer in the laboratory environment and is now becoming a reality for clinical use. HIFU is a promising science that will help improve treatment for many other cancer diseases as we learn more from these studies.''
Michael M. McManus, president and chief executive officer of Misonix said: ``We are very pleased with the progress of Focus Surgery. Misonix has completed technology transfer of the new Sonablate(TM) from Focus Surgery and is now manufacturing the new Sonablate(TM) devices that are going to be shipped to Japan. We are continuing to explore other HIFU applications with our partner Focus Surgery.''
Focus Surgery is the leader in the development and commercialization of minimally invasive surgical devices using HIFU for the treatment of various diseases including Benign Prostate Hyperplasia (BPH) and prostate cancer.
Misonix Inc. develops, manufactures, and/or markets medical, scientific, and industrial ultrasonic and air pollution systems, and maintains a minority equity position in Focus Surgery as its exclusive manufacturer of the Sonablate(TM) system.
Forward-Looking Statements: Statements in this news release looking forward in time are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties, including general economic conditions, delays and risks associated with the performance of contracts, uncertainties as a result of research and development, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, and regulatory risks including approval of pending and/or contemplated 510K filings.
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Contact:
Misonix Inc.
Michael McManus, Jr., 631/694-9555
www.misonix.com
or
Focus Surgery Inc., Indianapolis
David P. Quigley, 317/541-1580
www.focus-surgery.com
or
Lippert/Heilshorn & Associates Inc.
Kim Sutton Golodetz, 212/838-3777 (Investor Relations)
www.lhai.com
kim@lhai.com |
