Healthcare Industry News: focused ultrasound
News Release - July 17, 2008
Misonix Receives FDA Approval of Second Sonatherm(R) Soft Tissue Ablation System
FARMINGDALE, 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 received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market its Sonatherm 600i High Intensity focused ultrasound (“HIFU”) Soft Tissue Ablation System in the United States, which will be used to ablate certain soft tissue lesions, excluding the prostate gland, in general surgery.The Sonatherm 600i System is an evolution of the Company’s Sonatherm 600 System that received FDA clearance in January, 2006. The Sonatherm 600i System adds imagery and motion capability. To date, the two Sonatherm Systems are the only HIFU-based soft tissue ablation systems that have received FDA clearance for general surgery.
The Sonatherm 600i utilizes HIFU to ablate tissue intra-operatively or laparoscopically from a focal point back to the surface of the tissue of the lesion, eliminating the need to puncture or otherwise invade the tissue mass. This capability differentiates the Sonatherm from other conventional surgical devices; i.e. cryo or radio frequency, which generally requires the tissue mass, or organ, to be punctured with multiple needles or probes.
A series of clinical cases are being conducted under the guidance of noted HIFU expert, Dr. Michael A. Marberger, Chairman and Professor of the Department of Urology, Vienna, Austria. Dr. Marberger has published numerous clinical papers in support of this modality. According to Dr. Marberger, procedures to date were successfully competed with positive ablation effect noted in tumors within human kidneys. The Company expects to arrange for a number of leading physicians from the U.S. to observe the Sonatherm 600i in clinical practice at the University of Vienna hospital prior to performing surgical procedures in the U.S. Clinical data collection will take place at several sites in the U.S. prior to commercial sale of the product.
“The FDA approval represents another important milestone for our HIFU program in which we are working on treatment in several organs. We believe this technology addresses a large surgical marketplace and provides healthcare professionals, who are constantly looking for innovative therapies, important surgical and therapeutic benefits,” said Michael A. McManus, Jr., President and Chief Executive Officer of Misonix.
About Misonix:
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.
Source: Misonix
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