Misonix receives FDA clearance for laparoscopic HIFU product

By Lisa Kerner

Erie, Pa., Jan. 30 - Misonix, Inc. said the Food and Drug Administration has granted 510(k) clearance for Misonix to market and sell the Sonatherm 600 Ultrasonic Lesion Generating System in the United States. The system is used for ablation of certain soft tissue lesions in general surgery procedures, according to a company news release.

The Sonatherm 600 Ultrasonic Lesion Generating System is based on the company's High Intensity Focused Ultrasound (HIFU) technology licensed from Focus Surgery.

The Sonatherm 600 transducer is placed on the surface of the organ to be treated and concentrated acoustic waves ablate targeted tissue without puncturing or cutting the organ. The treatment may be performed in laparoscopic or intraoperative procedures, the company said.

Misonix said it expects to launch the Sonatherm 600 in the United States in 2007 or 2008. The company expects to market the device sooner outside of the United States.

"We are proud of the progress we are making in building out our present platform in laparoscopic surgery, neurosurgery, cosmetic surgery and the development of diagnostic products," Michael A. McManus Jr., president and chief executive officer, said in the release.

"We will continue this record of growth into the development of our European market for the Sonoblate 500 for the treatment of prostate cancer and our new products in the treatment of kidney tissue, wound debridement and bone cutting."

Misonix, based in Farmingdale, N.Y., develops ultrasonic medical device technology for the treatment of cancer and other health conditions.

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