Misonix, Inc. Receives Clearance for the Sale of the BoneScalpel™ in the
People's Republic of China
FARMINGDALE, N.Y., July 16, 2013
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.
Misonix Contact: Investor Relations Contact:
Richard Zaremba Joe Diaz, Lytham Partners
SOURCE Misonix, Inc.
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