Misonix, Inc. Receives Clearance for the Sale of the BoneScalpel™ in the People's Republic of China
FARMINGDALE, N.Y., July 16, 2013 /PRNewswire/ -- Misonix, Inc. (NASDAQ: MSON), an international surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic products for spine surgery, skull based surgery, neurosurgery, wound debridement, cosmetic surgery, laparoscopic surgery and other surgical applications, announced today that Misonix has received the necessary Registration Certificate from the State Food and Drug Administration (SFDA) of the People's Republic of China (PRC) to market and sell its BoneScalpel (Ultrasonic Osteotome System) product in China.
The BoneScalpel is a novel ultrasonic osteotome (bone cutting and compression device) used for safe tissue selective bone dissection that encourages en bloc bone removal and refined osteotomies while sparing elastic soft tissue structures. Most users report that the surgical field is relatively bloodless and clean. Loss of viable bone is minimal and controllable. 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 chief executive officer 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."
Dr. Guihani Wang, 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."
Dr. Feng, LI, Orthopedics Department, Tongji Hospital added, "During osteotomy, especially when very close to dura, the proper protection to dura is vitally important. BoneScalpel is a great help in such cases."
In addition to being sold in more than 48 countries, the BoneScalpel is now being used in the United States at prestigious institutions such as Johns Hopkins, Texas Back Institute, New England Baptist Hospital and Children's Hospital of Los Angeles, among others.
Misonix, Inc. designs, manufactures and markets therapeutic ultrasonic medical devices. 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.
Private Securities Litigation Reform Act of 1995
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, Inc.