Misonix Announces First Global HIFU Prostate Cancer Treatment Clinical Registry.Record Number of Medical Professionals Attend Sonablate 500 Meeting and Applaud Clinical Registry as Essential for Optimizing Prostate Cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. Treatment FARMINGDALE, N.Y. -- Misonix, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :MSON MSON Multi-Service Optical Networking (SBC) MSON Medium Speed on ), a developer of ultrasonic medical device technology for the treatment of cancer and other chronic health conditions, announced the establishment of the first global 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™. ") Prostate Cancer Treatment Clinical Registry. The HIFU Clinical Registry is solely for Sonablate 500 ("SB500") users from around the world. Current and future surgeons relying on the SB500 for the most effective prostate cancer therapy will be able to access the HIFU Clinical Registry for important medical information relating to completed patient procedures. As a repository for data from all SB500 users from centers around the world, more comprehensive information will be available for research and analysis. This data will be used for the production of reports for publication in medical journals and for use in other mediums to promote the SB500 as the most efficacious and patient-friendly prostate cancer treatment. Misonix management initially announced the commencement of the HIFU Clinical Registry last week during the European Association of Urology urology Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones. Conference 2007 in Berlin, Germany, at the Annual SB500 Society Meeting for urologist Urologist A physician who deals with the study and treatment of disorders of the urinary tract in women and the urogenital system in men. Mentioned in: Congenital Bladder Anomalies, Lithotripsy, Men's Health, Overactive Bladder urologist and related medical and scientific professionals. With a record number of attendees, over 70 delegates from 17 different countries attended the Misonix event, with approximately half of the participants being prospective users of the SB500 and the balance currently trained and using the device. Leaders of the Annual SB500 Society Meeting addressed clinical results and progress reports to date, training procedures, and the latest advancements in HIFU technology, including new products and software upgrades recently introduced by Misonix. Michael A. McManus, Jr., President and Chief Executive Officer of Misonix, said, "As I noted last week during the EAU EAU European Association of Urology EAU Emiratos Árabes Unidos (Spanish: United Arab Emirates) EAU Estonian Agricultural University (Tartu, Estonia) EAU Estimated Annual Usage EAU Environmental Archaeology Unit 2007, I reiterate that the SB500 is clearly the most important trend for the treatment of prostate cancer in Europe as well as around the world. This statement is solidified by the launch and overwhelming approval from our users of the first global HIFU Prostate Cancer Treatment Clinical Registry for the SB500. Our intent is to bridge the gap between an emerging trend and mass adoption. To this end, the HIFU Clinical Registry will enable the gathering of information on a global scale through online collaboration and to leverage this resource for the placement of studies and supporting testimonials in medical journals and the publication of independent research reports to promote the efficacy and benefits of the SB500 for HIFU prostate cancer treatment." A Steering Committee is presently being established and will be comprised of executives from Misonix, respected members of the medical community that are trained users of the SB500, and select patients. With support from a universal help desk and other staff, the Committee will put in place management processes for the analysis of data in the registry and will work with surgeons in various markets where the SB500 is available to prepare and publish clinical papers on the use of the device and treatment outcomes. Analysis will include, among other measures: basic treatment evaluations collectively and within certain markets; how HIFU treatment resulted in success following failed eradication of cancer when treated by other modalities; age of patients correlated with treatment outcomes; to assess user training needs; and, other retrospective evaluations. Data entry by medical professionals will be performed via a highly secure and password protected web-based application powered by business process oriented software created specifically for this purpose. The HIFU Clinical Registry is currently in use in Germany and will be made available on a global basis in April 2007. Professors Thomas Ebert and Jan Ilg, doctors based in Furth, Germany, were involved in the initial development of the registry currently used in the German language, and will be assisting Misonix in the expansion to include multinational centers. In addition to Misonix, Takai Hospital Supply Co., Ltd. and US HIFU, Inc., both of which distribute the SB500 in certain markets around the world, will provide funding for the development and ongoing support of the HIFU Clinical Registry. The SB500 is available in over 20 countries, with more to be added, and to date over 4,000 treatments using the medical device have been completed worldwide. In a study previously announced by Misonix, prostate cancer treatment using the SB500 showed successful outcomes that far exceeded published reports for other HIFU devices and rivaled that of traditional surgical treatment. Important advantages of the SB500 over traditional surgery include that it is a non-invasive procedure that is performed on an out-patient basis. The SB500 was developed by Focus Surgery, Inc. and is manufactured by Misonix. Misonix also has the exclusive European distribution rights for the product. Misonix, Takai Hospital Supply Co., Ltd. and US HIFU, Inc. are investors and collectively hold a majority stake in privately-held Focus Surgery, one of the most prominent developers of HIFU in the world. About Misonix: Misonix, Inc. (NASDAQ:MSON) 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 $3 billion annually, Misonix's proprietary ultrasonic medical devices are used for wound debridement Debridement Definition Debridement is the process of removing nonliving tissue from pressure ulcers, burns, and other wounds. Purpose Debridement speeds the healing of pressure ulcers, burns, and other wounds. , cosmetic surgery cosmetic surgery, plastic surgery for cosmetic purposes, such as the improvement of the appearance of the face by removing wrinkles or reshaping the nose. , neurosurgery neurosurgery /neu·ro·sur·gery/ (noor´o-sur?jer-e) surgery of the nervous system. neu·ro·sur·ger·y n. Surgery on any part of the nervous system. , laparoscopic surgery laparoscopic surgery: see endoscope. , 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. 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 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, 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , subsequent Quarterly Reports on Form 10-Q Form 10-Q See 10-Q. and Current Reports on Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. . |
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