Medical Device Daily Associate
Misonix (Farmingdale, New York), a developer of ultrasonic medical device technology for the treatment of cancer and other conditions, reported that the FDA has granted it 510(k) clearance to market and sell the Sonatherm 600 Ultrasonic Lesion Generating System in the U.S. for ablation of certain soft-tissue lesions in general surgery procedures.
The Sonatherm 600 is based on the company's high intensity focused ultrasound (HIFU) technology, licensed from Focus Surgery (Indianapolis), a company in which Misonix holds a minority equity position.
The treatment entails placing the Sonatherm 600 transducer on the surface of the organ to be treated and engaging the HIFU energy. The concentrated acoustic waves quickly ablate the targeted tissue without puncturing or cutting the organ itself. The company said the treatment may be performed in either laparoscopic or intraoperative procedures.
Michael McManus Jr., president and CEO of Misonix, said, “We are excited by the news from the FDA. This result is an important milestone for our HIFU technology. We believe this technology will be used to the benefit of a large surgical marketplace and related healthcare constituents that are constantly looking for innovative therapies.“
McManus said the latest approval helps to validate the company's decision last July to spin off its Laboratory and Scientific Division in order to focus exclusively on the development of medical devices (Medical Device Daily, July 26, 2005). “This milestone provides further validation of our strategic investments in developing our platform technologies,“ he said. “We have carefully selected opportunities that have significant growth potential and can also be delivered to the market in efficient and fast development timeframes. For our shareholders, that means seeing our ultrasound therapeutic products in the market in the near term.““
McManus noted that medical devices with market potential that are similar to those in Misonix's product pipeline would typically take about “$5 million and five years each to bring to market. We are demonstrating the ability to significantly reduce the time to market for our products.“
The company said it expects the Sonatherm 600 to be launched in markets outside the U.S. sooner than in the U.S., where it will be ready for market in the 2007-2008 timeframe. “We will continue to invest in our already cleared products for wound debridement and bone cutting,“ McManus said. “These investments will enable us to bring these products to market in the short term and represent substantial benefit to our shareholders.“
He said the company is making progress in building out its present platform in laparoscopic surgery, neurosurgery, cosmetic surgery and the development of diagnostic products. “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,“ McManus said. “The true indicator of the success of our growth strategy is that each of these new products is in a market segment considerably larger than any of the present markets that we sell into.“
In an interview on the Laboratory and Scientific Division spin-off, McManus also pointed to Misonix's Hearing Innovations (Tucson, Arizona) unit as offering growth opportunities. “We continue to believe in [Hearing Innovations'] technology and are encouraged by recent studies and articles on the benefits of ultrasonic bone conduction for hearing loss. We will proceed with limited expense to conduct additional clinical work on the application for this technology.“
On news of the FDA's approval of the Sonatherm 600, shares of the company's stock surged $2.14, or roughly 47% to $6.70 at the close of Monday trading on the Nasdaq.