Healthcare Industry News: Sonablate 500
News Release - July 16, 2008
Misonix Announces New Distribution Agreement for Sonablate(R) in the Russian FederationFARMINGDALE, N.Y.--(HSMN NewsFeed)--Misonix, Inc. (NASDAQ: MSON ), a developer of minimally invasive ultrasonic medical device technology, which in Europe is used for the ablation of cancer and worldwide for other acute health conditions, has entered into a new, three year, exclusive distribution agreement with privately-held Intermedica of Nizhny Novgorod, Russia for the distribution of the Sonablate 500 High Intensity Focused Ultrasound (“HIFU”) System. The agreement provides Intermedica with the rights to sell in Russia, Belarussia, Kazakstan and the Ukraine, and includes minimum purchase requirements.
Intermedica, headquartered in Nizhny Novgorod, also maintains facilities in Moscow. Intermedica distributes medical devices and capital equipment throughout the Russian Federation and surrounding countries, with special emphasis on neurosurgery, spine surgery, and oncologic surgery.
The Sonablate SB500, a HIFU-based, image-guided, acoustic ablation system developed by Focus Surgery, Inc., is available in over 20 countries. To date, over 6,000 prostate procedures have been completed with the SB500. In a study conducted in Europe and previously announced by Misonix, it was reported that 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 using the SB 500 has not been achieved by previous published HIFU techniques; these PSA nadirs are typically associated with a surgical approach. Important advantages of the SB500 include the fact that it is less invasive than other procedures and does not require potentially harmful radiation; treatments are patient-friendly with limited surgical side effects; it is a repeatable procedure; it typically requires a shorter procedure time; and it appeals to the medical industry's desire for innovative and advanced practices that ultimately improve healthcare and reduce costs.
“Misonix is proud to partner with Intermedica, a high-profile distributor of state-of-the-art medical equipment in the Russian Federation,” said Michael A. McManus, Jr., President and Chief Executive Officer of Misonix. “Intermedica has a quality reputation and is well known for successfully introducing high tech medical devices to their markets. By building relationships with highly regarded clinical opinion leaders, who function as reference sites, Intermedica has demonstrated their ability to effectively educate their markets to the benefits of new and exciting technologies.”
Mr. McManus continued, “The prevalence of prostate cancer has raised the need for early detection and there are now more precise methods of diagnosing early stage prostate cancer. For many men with prostate cancer, the associated risks of traditional therapies are not easily accepted. As a result, new treatments and modalities have been sought to eliminate the cancer in its earlier stage before it becomes a greater risk -- as well as when the cancer spreads and becomes a substantial life threatening risk. HIFU with the Sonablate 500, which many are considering the most important new tool for the ablation of prostate cancer in Europe as well as around the world, is proving to be the modality of choice for localized as well as broader cancer surgery in the prostate gland.”
Misonix, Inc. (NASDAQ: MSON ) designs, develops, manufactures and markets therapeutic ultrasonic medical devices and laboratory equipment. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. 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. 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, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, 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. The Company disclaims any obligation to update its forward-looking relationships.
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