Healthcare Industry News: Sonablate 500
News Release - April 6, 2006
Misonix Announces Results for 'Visually Directed HIFU' Treatment of Prostate Cancer at European Association of Urology Conference 2006Visually Directed HIFU Setting New Standards for Success in Prostate Cancer Treatments
FARMINGDALE, N.Y., April 6 (HSMN NewsFeed) -- Misonix, Inc. (Nasdaq: MSON ), a developer of ultrasonic medical device technology for the treatment of cancer and other health conditions, today announced results of a study on "Visually Directed HIFU" treatment of prostate cancer at the European Association of Urology (EAU) Conference 2006 being held April 5-8 in Paris, France.
Visually Directed HIFU treatment results were reported by researchers from the Clinical Effectiveness Unit, the Royal College of Surgeons of England, London, UK, including Dr. Rowland Illing, Dr. Sam Dawkins, Dr. Chris Ogden and Dr. Mark Emberton. The results show that with the new HIFU technique, 84% of patients were able to achieve success as measured by PSA nadir levels dropping to 0.2ng/ml or less after treatment. This measurement for success has not been achieved by previous published HIFU techniques; these PSA nadirs are typically associated with a surgical approach.
Visually Directed HIFU is a new, non-invasive high intensity focused ultrasound technique available only with the Sonablate® 500, the therapeutic prostate cancer medical device developed by Focus Surgery and manufactured and distributed in Europe by Misonix.
"Visually Directed HIFU for prostate cancer is setting a much higher standard of care," said Dr. Illing, the lead author of the study. "Misonix has set a high standard for success in treating prostate cancer and the Sonablate® 500 product is surpassing that standard."
"We have received an overwhelming reaction at the EAU conference in response to the clinical results announced," said Michael A. McManus, Jr., President and Chief Executive Officer of Misonix. "The enhanced technology and impressive clinical results provide us with distinct and compelling advantages to other HIFU products in the market as well other prostate cancer treatment modalities."
In Visually Directed HIFU treatment of prostate cancer, the surgeon uses real-time feedback provided by the device during the procedure to adjust the amount of energy needed to precisely treat the diseased tissue. With the Sonablate 500's Visually Directed HIFU, physicians are, for the first time, capable of performing a dynamic procedure and achieving a very high rate of success for custom treatment of each patient suffering from prostate cancer.
European Association of Urology (EAU) Conference 2006
Misonix is presenting the results of the clinical study on Visually Directed HIFU for prostate cancer and participating with a large exposition booth (#M07) at the European Association of Urology Conference 2006 in Paris. The European Association of Urology is the largest scientific urological organization in Europe. The EAU connects 16,000 urologists, urologists-in- training and urological scientists in Europe and worldwide.
As the most influential European medical society with direct relevance to healthcare practitioners that are constantly seeking the latest technology for treating prostate conditions, Misonix is using the 2006 event as a springboard for showcasing the progress it has achieved and to commence an aggressive marketing campaign.
Misonix has scheduled a European Sonablate 500 User Group meeting for April 6, 2006. Researchers will address clinical results and progress reports to date, training procedures, and the latest advancements in HIFU technology.
Also on April 6, Misonix is hosting a dinner cruise to celebrate its HIFU success. Leading urologists from throughout Europe will join Misonix on the dinner cruise on board the "Le Bretagne" at the Port de la Bourdonnais in front of the Eiffel Tower.
Milestones Achieved in Marketing of Sonablate 500 in Europe
Based on the promise of the Sonablate 500 and its unique Visually Directed HIFU, Misonix has made considerable progress in marketing the product in Europe. The Sonablate 500 is now available through European distributors serving nine countries. These countries are Austria, Belgium, Germany, Hungary, Ireland, Italy, The Netherlands, Switzerland and the United Kingdom. Setting an extraordinary rate of growth, in the past 18 months, 33 centers have been established as users of the Sonablate 500. To date, the Sonablate 500 has been used in over 2,200 procedures in over 64 centers around the world.
"While enjoying success in the urological field, we are leveraging our strengths as a different kind of HIFU company," continued Mr. McManus. "Our HIFU strategy is focused on developing both products and markets. We intend to build strong distribution channels so that we can be more responsive to address the needs of surgeon and patients as we develop new HIFU medical devices. Therefore, we will continue to fund our marketing initiatives in Europe for the Sonablate 500 as well as invest in research and development and clinical studies on the other HIFU technologies within our portfolio of ultrasonic medical devices."
Misonix develops, manufactures, and markets medical, scientific, and industrial ultrasonic and air pollution systems. Misonix's ultrasonic platform is the basis for several innovative medical technologies. Misonix has a minority equity position in Focus Surgery, Inc. which uses high intensity focused ultrasound technology to destroy deep-seated cancerous tissues without affecting surrounding healthy tissue. Addressing a combined market estimated to be in excess of $3 billion annually, Misonix's proprietary ultrasonic medical devices are used for wound debridement, cosmetic surgery, neurosurgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company's Web site at www.misonix.com.
With the exception of historical information contained in this press release, content herein may contain "forward looking statements" that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. In particular, the Company may not be successful in its efforts with respect to strategic opportunities for its Laboratory and Scientific Division and the affect this activity may have on the other businesses within the Company. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include 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, including the timing and monetary requirements of such activities, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company's business lines, and other factors discussed in the Company's Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
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