Misonix, Inc., a developer of ultrasonic medical device technology for the treatment of cancer and other chronic health conditions, announced its plans to bring the Sonatherm 600, (Sonatherm) used for high intensity focused ultrasound (HIFU) treatment of soft tissue, including cancerous tissue in the kidney, into China.
The Sonatherm has been developed by Misonix in connection with the worldwide rights that Misonix acquired from Focus Surgery, Inc, a major HIFU developer. As part of the Company's strategy to enter into the world's most populous country, a distribution agreement was formed with China-based Acton Medical Device Corp. (Acton) of Guangzhou. Acton has a sales team of 156 people covering over 20 provinces.
Under the agreement, Acton will be responsible for conducting clinical procedures and acquiring all necessary government approvals for the sale of the Sonatherm in the Peoples Republic of China. Misonix will manufacture the medical device at its facilities in Farmingdale, New York, and will ship the product to Acton for use by its partners in the Chinese medical community for satisfying regulatory requirements as well as establishing regional branding. Based on successful clinical studies conducted for Misonix in other parts of the world, the Sonatherm has been demonstrated as a technologically advanced medical device for minimally invasive procedures that ablate cancerous tissue without the need to puncture the kidney organ.
Commenting on the progress made for one of the many ultrasound products in Misonix's pipeline, Michael A. McManus, Jr., President and Chief Executive Officer, said, "We are excited about this new relationship with Acton and about the introduction of our medical device as the first minimally invasive HIFU treatment of kidney cancer in China. This is an accomplishment that all of our shareholders can be proud of. Misonix is clearly strengthening its position as global leader in the development of important ultrasonic medical devices. With the Sonatherm we have now received the first clearance under 510(k) from the Food and Drug Administration in the United States, completed the very first procedures in Europe for the treatment of cancer in the human kidney, and, now, achieved a milestone as the first to enter China with such a medical device."
"We are pleased to have the opportunity to work with Misonix," said Sherry Gong of Acton Medical Device Corp. "We are excited about the use of HIFU in the kidney and perhaps later in the liver. There is a great need for these products in China and we look forward to leveraging our growth in this very large market with products that only Misonix has developed."
Acton Medical Device Corp., based in Guangzhou, China, is an importer and distributor of minimally invasive surgical equipment and devices for the Chinese market. Acton is the exclusive distributor for Ackermann, the German endoscopic product manufacturer, Arthrex, the US-based arthroscopy product manufacturer, and Disc-O-Tech, the Israel-based developer of orthopedic medical devices.
Misonix, Inc. 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.