Misonix, Inc. (Nasdaq: MSON), a developer of minimally invasive ultrasonic medical device technology for the ablation of cancer and other chronic health conditions, today announced that it has entered into a distribution agreement with Aesculap, Inc., a subsidiary of B. Braun, for the domestic distribution of the Misonix BoneScalpel™, a new Ultrasonic Osteotome (or bone cutting device) for use in orthopedic and neurological applications related to the spine and cranium. Misonix previously received Food and Drug Administration clearance to market its Ultrasonic Osteotome medical devices. The agreement provides Aesculap with the right to sell in the United States and includes minimum purchase requirements and the payment of a royalty on sales of disposables.
“We are excited about starting to sell the Bone Scalpel in this country. We are very pleased to have our friends at Aesculap as our partner in this effort,” said Michael A. McManus, Jr., President and Chief Executive Officer of Misonix. “We have been working with Aesculap for many years in the distribution of our Sonastar™ Ultrasonic Aspirator for neurosurgery and know them to be true professionals that understand the market, particularly for technologically enhanced medical devices. The opportunity to sell the Sonastar and the BoneScalpel together will create additional leverage in the market that will be a benefit to both companies.
“The BoneScalpel is a unique ultrasonic product combining very fine, precise cutting with a soft tissue sparing capability for extra safety in complex spine procedures. The BoneScalpel has been used in well over 100 procedures by more than 7 doctors. We are very pleased with the positive responses we have received from these surgeons. We look forward to working together with Aesculap in building the market for our latest commercialized medical device.
“We will continue our progress in developing strong international distribution partners for the BoneScalpel.”
“We are excited to broaden our relationship with Misonix. The new BoneScalpel technology is a great addition to our product portfolio and we look forward to growing our business with our long term partner,” said Chuck DiNardo, President of Aesculap, Inc.
Prior to the formation of a commercial distribution agreement, the Misonix BoneScalpel had undergone testing at prestigious medical facilities with favorable results. Most recently, Misonix engaged a mix of orthopedic and neurosurgical spine surgeons in teaching and community centers with the University of Pittsburgh Medical Center (UPMC), The Pennsylvania Hospital and Huntington Hospital, NY, to evaluate the device for use in laminectomies, a surgical procedure for treating spinal conditions, such as herniated discs and spinal stenosis, by removing or reshaping of spinal matter.
The principal investigator and surgeon for the UPMC and Pennsylvania Hospital project, Dr. William Welch, is a board certified neurosurgeon who holds the title of Chief of Neurological Surgery at The Pennsylvania Hospital. Dr. Welch concluded that the device is a clinically proficient product that addresses the specialized needs of modern-day surgery:
“I have utilized the device in over 50 patients in cervical, thoracic and lumbar applications. The Misonix BoneScalpel is an extremely precise, easily controllable handheld device that provides the surgeon with increased safety and accuracy during bone cutting operations. The major advantage of the device is the ability to cut bone while preserving underlying neural and non-bony structures. This greatly reduces the risk of dural laceration.
“Aside from the increased safety, the BoneScalpel allows me to create a thinner channel in lamina than is possible using standard devices. This allows the lamina to be removed as a single unit which speeds the laminectomy process and allows re-attachment of the lamina with small bone plating systems for an osteoplastic laminectomy. Accurate reshaping of bone is simplified with the BoneScalpel, as is selective partial removal of bone. The oscillating nature of the BoneScalpel reduces bleeding from the bone edges and efficiently eliminates soft-tissue bleeding.”
The principal investigator for Huntington Hospital, NY, Dr. Arnold Schwartz, is a board certified orthopedic surgeon specializing in scoliosis and spine surgery. His experience is equally positive:
“In performing bone surgery in proximity to the spinal cord one has to be very careful, and I always feel very skeptical towards using powered instruments. This is different with the Misonix BoneScalpel, which gives me a high level of control in cutting bone structures with ease and precision while being able to stop right on the ligamentum flavum. I have performed over 70 cases for lumbar, thoracic and cervical laminectomies for single and multilevel cases and including revisions. In addition to considerably improving safety, the device allows me to reduce the amount of bone cutting work needed and saves me 30-60 minutes per case. The learning curve has been minimal and the BoneScalpel is very intuitive to use.”
The appeal of the Bone Scalpel, which cuts bone in a very precise manner, is a device that meets the growing need for specialty cutting of bone. According to the American Association of Neurological Surgeons, over 320,000 spinal procedures out of some 550,000, or 58%, required some type of bone cutting¹.
The BoneScalpel creates straight or curved cuts on any bony plane, with bone cuts as narrow as 0.5mm. There is no charring or thermal necrosis at the cutting site as the ultrasonic action with irrigation keeps the work area at a moderate temperature. The cut of the BoneScalpel is so precise that it can cut a window in an eggshell while leaving the membrane intact.
The BoneScalpel allows the surgeon to cut close to the nerve tissue, and the device is soft tissue sparing to reduce the likelihood of injury to adjacent tissue. This revolutionary device has distinct specialty applications in neurosurgery, orthopedic surgery, maxillofacial surgery, and plastic and reconstructive surgery. The device is portable, simple to operate and could be used in hospitals, clinics or physician offices.
About Aesculap:
Aesculap is the largest worldwide supplier of sterilization containers and surgical instruments. The company designs and produces surgical instrumentation and implants for neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, laparoscopic and general surgery and central processing. Aesculap is a member of the B. Braun family of healthcare companies. B. Braun is currently the fourteenth largest healthcare manufacturer in the world. For more information, please contact Customer Service at 1-800-282-9000 or visit the Aesculap website at www.aesculapusa.com.
About B. Braun:
Since 1939, B. Braun has built an unparalleled store of knowledge and expertise in delivering innovative healthcare products, medical devices and programs that enhance both patient and health-professional safety. Its 30,000 employees worldwide are proud of their commitment to translating customer needs into products with unmatched quality, superior technology, cost effectiveness and environmental responsibility.
Through its “Sharing Expertise™” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. For more information about B. Braun or its safety healthcare products, call 1-800-854-6851 or visit www.bbraunusa.com.
About Misonix:
Misonix, Inc. (NASDAQ: MSON) designs, develops, manufactures, and markets, therapeutic ultrasonic medical devices, and laboratory equipment. Misonix’s therapeutic 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 tissue without affecting surrounding healthy tissue. 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.
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 intentional tasks and currency fluctuation, 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.