China Approves Ultrasonic Osteotome System by Misonix

The State Food and Drug Administration (SFDA) of the People’s Republic of China has granted approval to Misonix Inc. to market and sell its BoneScalpel ultrasonic osteotome system in China. Misonix makes therapeutic ultrasonic products for spine surgery, skull based surgery, neurosurgery, wound debridement, cosmetic surgery, laparoscopic surgery and other surgical applications, and is based in Farmingdale, N.Y.

The BoneScalpel is an ultrasonic osteotome (bone cutting and compression device) used for safe tissue selective bone dissection designed to encourage en bloc bone removal and refined osteotomies while sparing elastic soft tissue structures. According to Misonix, most users report that the surgical field is relatively bloodless and clean, and that loss of viable bone is minimal and controllable. Company officials also reported that the BoneScalpel has been used extensively around the world for bone removal in the cervical, thoracic and lumbar spine, including for deformity cases.

“After many years of clinical and regulatory efforts, in conjunction with our distribution partner, Cicel (Beijing) Science and Technology Co. Ltd., we are extremely excited to have achieved this clearance,” said Michael A. McManus, Jr., president and CEO of Misonix. “We will now be selling the BoneScalpel in more than 48 countries outside the U.S. We believe the opportunity to sell the BoneScalpel in the People’s Republic of China and to work with prominent Chinese surgeons is an important step forward for our company. I want to thank May Lee, the president of Cicel, for all of her company’s hard work on this clearance. Cicel’s marketing group estimates that there are more than 10,000 spine surgeons in China and there are approximately 200,000 spine surgeries performed each year. Cicel, which distributes our SonaStar neuro aspirator, has been in business for more than 20 years and is a very highly regarded distributor in China. We believe there is great potential for significant sales in China in the coming years.”

“The BoneScalpel is a very advanced product and we are pleased to be able to introduce it into China,” said May Lee, president of Cicel. “This state-of-the-art device provides surgeons with a much safer and more efficient approach when compared with existing technologies. Thanks to its recent release from SFDA, we are ready to work closely with our strategic developer partner, Misonix, to further develop the market here. We are convinced that the prospects for the BoneScalpel are very favorable.”

Guihani Wang, M.D., of the neurosurgery department, Beijing, Tiantan Hospital, affiliated with Capital Medical University, said, “When applying the tip to soft tissue, there was no nerve injury observed.”

“During osteotomy, especially when very close to dura, the proper protection to dura is vitally important,” added Feng Li, M.D., of the orthopedics department at Tongji Hospital. “BoneScalpel is a great help in such cases.”

BoneScalpel is sold in more than 48 countries, including the United States.