Misonix Announces Focus Surgery's Positive Prostate Cancer Results Using High Intensity Focused Ultrasound - HIFU.Business Editors & Health/Medical Writers FARMINGDALE, N.Y.--(BUSINESS WIRE)--Oct. 25, 2002 Misonix, Inc. (Nasdaq:MSON) today announced that Focus Surgery has released outstanding interim results for the treatment of prostate cancer using the Sonablate(R) High Intensity Focused Ultrasound HIFU (high intensity focused ultrasound) (sometimes FUS or HIFUS) is a highly precise medical procedure using high-intensity focused ultrasound to heat and destroy pathogenic tissue rapidly. (HIFU HIFU High-intensity focused ultrasound Surgery A method that focuses ultrasound to heat/ablate target tissue without injuring surrounding structures. See Sonablate 200™. ) device. Results have been obtained in both Japanese clinical trials of approximately 100 patients at 10 locations, and 15 patients in the U.S. clinical trials at Indiana University School of Medicine The Indiana University School of Medicine is the medical school of Indiana University, part of the Indiana University Purdue University at Indianapolis (IUPUI) campus located in Indianapolis, Indiana. Established in 1903, the school had an initial class of 25 students. in Indianapolis, Indiana. Misonix currently owns approximately 20% of Focus and has the right to produce its products. The Sonablate(R) system, developed by Focus Surgery, Inc. of Indianapolis, IN, 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. Dr. Toyoaki Uchida, MD in Tokyo, Japan released results at the September Societe Internationale d'Urologie (SIU) Meeting in Stockholm, Sweden indicating that patients in a 50 patient study with pre-treatment prostate specific antigen PSA (Prostate specific antigen) A tumor marker associated with prostate cancer. Mentioned in: Tumor Markers (PSA (Professional Services Automation) An information system designed to organize, track and manage all opportunities, work, resources, costs, revenues and invoices to improve the productivity and efficiency of the workforce. ) scores of less than 20ng/ml have a 95% success rate and a 100% negative biopsy. Narendra Sanghvi, President of Focus Surgery, said, "Patients in the 10 to 20ng/ml PSA range represent much higher risk patients and we were still able to get good results. Even more encouraging is the low rate of complications for the patients after the treatments. Adverse effects of most prostate cancer treatments include significant blood loss, incontinence and total impotency. With HIFU, we have a bloodless, outpatient procedure." Mike McManus, President of Misonix, said, "It is encouraging to know that our results in the United States are similar to Dr. Uchida's in Japan. Currently, the 15 patients treated in the U.S. are experiencing a quick PSA drop and a mean PSA level of 0.44ng/ml at 180 days for an outpatient treatment with no blood loss or incontinence." 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 Benign prostate hyperplasia (BPH) Enlargement of the prostate gland. Mentioned in: Paruresis (BPH BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. ) 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 and manufactures the SB-500 devices for Focus Surgery. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. and/or court proceedings, and regulatory risks including approval of pending and/or contemplated 510K filings. |
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