Misonix Brings Visually Directed HIFU for Prostate Cancer Treatment to Spain.European Utilization of the Sonablate[R] 500 Continues to Increase FARMINGDALE, N.Y. -- Misonix, Inc. (Nasdaq: 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, today announced that it has expanded its European 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™. ") business with its entry into Spain. The Company's endeavors in Spain are supported by a partnership agreement formed with IMEX IMEX Industrial Materials Exchange IMEX Import and Export IMEX Worldwide Exhibition for Incentive Travel, Meetings and Events IMEX International Monetary Exchange, Inc. IMEX Imagery Exploitation (US DoD) Clinic Group. The Sonablate[R] 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 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. , Misonix has the right to utilize the same technology for treatment of tissue in the kidney, liver and breast. Misonix is an investor in Focus Surgery. According to the Comprehensive Cancer Monitoring Program in Europe, there are over 11,000 new cases of prostate cancer in Spain annually. The IMEX Clinic, a division of the IMEX Group, was founded in 1995 and had substantial medical device distribution revenues in its most recent fiscal year. The IMEX Clinic is divided into three major divisions: surgical, instrument, and capital equipment. The IMEX Group has distribution agreements with leading companies, including Carl Zeiss (Ioltech), Intralase and Allegiance (Cardinal Healthcare). IMEX has partnered with Misonix, Ltd., Misonix's wholly-owned European subsidiary, and will serve Misonix as the commercial arm within Spain offering both fee-for-use and capital sales. The partnership is intended to increase the SB500 share of an important continental European market in Spain as Misonix has done with other partners and through UKHIFU in other European countries. Integral to the success to date for Misonix and the SB500 in Europe is the results of a previously announced study on Misonix's Visually Directed HIFU. This study reported that 84% of patients were able to achieve success as measured by 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. nadir levels dropping to 0.2ng/ml or less after treatment. This measurement for success using the SB500 has not been achieved by previous published HIFU techniques; these PSA nadirs are typically associated with a surgical approach. Commenting on the HIFU entry into Spain, Michael A. McManus, Jr., President and Chief Executive Officer of Misonix, said, "We are excited about the agreement with the IMEX Group and look forward to seeing our share in Spain replicate our current and growing share across Europe. IMEX, with its extensive network of contacts in Spanish healthcare facilities, is well positioned to assist Misonix in achieving its goal of offering the market a different kind of HIFU that is visually directed. Visually Directed HIFU involves a surgeon controlled operation so that each patient is treated individually for their specific condition." "We are proud to work with Misonix in bringing Visually Directed HIFU using the Sonablate 500 to the Spanish market. We intend to aggressively present the Misonix's Visually Directed HIFU to our customer and medical community constituencies," said Jose-Maria Reiz, Managing Director of IMEX Clinic Group. About Misonix: 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 $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, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. |
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