Healthcare Industry News: Bard
News Release - July 25, 2006
Misonix Enters the French Market with Visually Directed HIFU to Treat Prostate CancerContinued Expansion of European Franchise
FARMINGDALE, N.Y.--(HSMN NewsFeed)--July 25, 2006--Misonix, Inc. (Nasdaq: MSON ), a developer of ultrasonic medical device technology for the treatment of cancer and other chronic health conditions, today announced that it has expanded its European high intensity focused ultrasound ("HIFU") business with its entry into France. Misonix began its expansion in Europe by acquiring controlling interest in its UK distributor, UK-HIFU Limited, in April 2006. In both markets Misonix is selling or making available on a fee-per-use basis the Sonablate® 500 for Visually Directed HIFU treatment of prostate cancer. The Sonablate 500 ("SB500") is a medical device developed by Focus Surgery, Inc. and manufactured and distributed in Europe by Misonix. In addition to applying HIFU to prostate cancer, Misonix has the right to utilize the same technology for treatment of tissue in the kidney, liver and breast.
France has long been underserved in effective HIFU prostate cancer treatment. According to the Comprehensive Cancer Monitoring Program in Europe, there are over 25,000 new cases of prostate cancer in France annually. With a national social security system in France that provides its citizens with access to public healthcare, prostate cancer patients will now be able to be treated by Misonix's Visually Directed HIFU, which may be considered the finest HIFU medical procedure now available in the country and a favorable alternative to other treatment modalities.
Visually Directed HIFU is a new, non-invasive high intensity focused ultrasound technique developed by Focus Surgery and Misonix and available only with the SB500. Visually Directed HIFU treatment results were first reported earlier this year 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 for prostate cancer is setting a much higher standard of care," said Dr. Illing, the lead author of the study. Visually Directed HIFU with the Sonablate 500 is now available through European distributors serving ten countries. In the UK alone, there are 33 centers that have been established as users of the Sonablate 500, all of which have been trained to perform Visually Directed HIFU.
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. Surgeons are actively involved in planning and treating each patient while performing a dynamic procedure and achieving a high rate of success for custom treatment of prostate cancer.
"Misonix continues to be a growing and focused HIFU company," said Michael A. McManus, Jr., President and Chief Executive Officer of Misonix. "With today's announcement, we have further progressed with our strategic commitment to expand our HIFU operations in Europe We are building on our significant growth in the UK and have brought this model for success to France. The SB500 Visually Directed HIFU enables patients in France the opportunity to benefit from a process that can be substantially better for all patients. The alternative HIFU treatment that has been available for some time in France is an algorithm-based procedure that in most cases requires an initial surgical procedure known as a "TURP" in advance of the HIFU treatment.
"Delivering on the promise of HIFU with Visually Directed treatments using the SB500 in France advances our strategic plan towards a pan-European approach that is driven by clinical success and strong distribution platforms. Since we brought the SB500 to Europe less than two years ago, demand for the product has increasingly grown, particularly with the introduction of Visually Directed HIFU within the past six months. We are finding that doctors and patients are interested in our technology over other HIFU and non-HIFU treatment methods. The advantage for Misonix's Visually Directed HIFU is that it achieves higher success rates with only one simple non-invasive out-patient procedure. The choice is clear and what we believe is simple and with better results."
Misonix also announced today that is has formed a strategic relationship with NewMedic France for the marketing of Visually Directed HIFU in France. Commenting on the agreement, Mr. McManus said, "We are confident that NewMedic's experienced healthcare marketing team will deliver the promise of HIFU to the French market as we have to other parts of Europe. Led by Paulo Pappalardo, they bring a background of over 20 years in prostate cancer with leading companies like CR Bard and Nucletron."
"We are fortunate to be working with Misonix in bringing Visually Directed HIFU to the French market," said Paulo Pappalardo, President, NewMedic France. "As someone who has spent a career in the prostate cancer market, I believe Misonix's Visually Directed HIFU is the definitive choice for localized prostate cancer treatment and is the most efficacious HIFU method that is now available in France."
Misonix designs, develops, manufactures, and markets medical, scientific, and industrial ultrasonic equipment, laboratory safety equipment, and air pollution control products. 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 $4 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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