Ultrasonic BoneScalpel? Making Spine Surgery Safe and Efficient - Applied Clinical Trials

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Ultrasonic BoneScalpel? Making Spine Surgery Safe and Efficient


Ultrasonic BoneScalpel™ Making Spine Surgery Safe and Efficient

PR Newswire

FARMINGDALE, N.Y. , June 4, 2014 /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 that Dr. Ajay Krishnan of the prestigious Stavya Spine Hospital and Research Center in India concluded after a comparative study in 100 consecutive patients that the BoneScalpel is better than conventional methods in terms of safety and efficacy as it reduces the number of dural tears and neurological deficit, reduces blood loss and shortens operating time. The results, first presented at the 27th Annual Conference of the Association of Spine Surgeons of India (ASSICON), which was held in conjunction with the World Conference of the Scoliosis Research Society from January 23-26, 2014 in Kolkata, India, were just recently released and have been submitted for publication in a scientific journal.

Dr. Ajay Krishnan is a well-recognized orthopedic spine surgeon who has gained extensive surgical experience as part of his training at multiple renowned spine centers in India and in Phoenix, AZ. In addition, he has worked as assistant professor at the Medical College in Bhavnagar and Surat. He is one of the leading surgeons at Stavya Spine Hospital & Research Institute, which is a dedicated hospital for comprehensive neck & back care with four locations in Mithakhali, Ellisbridge, Ahmedabad, and Gujarat, India, and where 700-800 major surgeries relating to spinal column and spinal cord are performed annually.

The retrospective study was conducted between 2013-2014 to assess whether the use of the ultrasonic BoneScalpel has the potential to improve peri-operative outcomes in decompression of thoracic spinal stenosis, which is frequently associated with postoperative worsening in 15-20% of cases. A total of 100 consecutive cases were examined, 55 using BoneScalpel and 45 using conventional manual bone punches. Following a short learning curve with comparable results between both methods, use of the BoneScalpel led to a reduction in the occurrence of dural tears and an absence of neurological worsening post surgery. Blood loss was reduced by 27.5%. Total operative time was reduced by 22%, operative time per spinal segment by 28.5%. The increase in efficiency can be attributed to the surgeon's ability to resect bone in large segments (en-bloc) rather than being limited to the smaller bite sizes of 2-3 mm bone punches as performed in conventional microscopic surgery.

Better outcomes with reduced risk of complications and improvements in operative efficiency are major challenges for hospitals and surgeons throughout the world. Incidental dural tears add to the length of hospital stay and represent additional expense for these procedures. Increased blood loss leads to higher anesthesia risks, increase use of blood transfusions and, with that, higher risk of disease transmission or adverse reactions. Increase in blood loss, blood transfusion and operative time are further associated with an increased risk for surgical site infections. Therefore, studies concluding that the BoneScalpel can improve peri-operative outcomes and operating room efficiency indicate significant economic benefit to healthcare systems around the globe.

Summarizing his study findings, Dr. Krishan explained, "All orthopedic surgeons are well familiar with the difference between a traditional plaster cutter and an oscillating cast saw. Likewise, the ultrasonic BoneScalpel is a precise, tissue-specific bone cutting tool, and in fact, a quite magical tool in my armamentarium. It has empowered me as a surgeon, making potentially dangerous thoracic spine procedures into more predictable, safer procedures with better patient outcomes. In addition the BoneScalpel reduces overall blood loss and surgical time, thus reducing patient morbidity and hospital stay."

Michael A. McManus, Jr., President and Chief Executive Officer of Misonix, commented, "We are extremely excited about Dr. Krishnan's findings which support findings in previous reports that use of the BoneScalpel improves spine surgery as measured in standard metrics such as blood loss, breach of the outer layer of the spinal cord and operative time. These findings are statistically significant in a large series of consecutive patients and demonstrate a significant gain in economic value for the hospital. The results support why more and more leading spine surgeons around the world regard BoneScalpel's ultrasonic technology as a game changer.  We are pleased that our Misonix BoneScalpel is setting new surgical standards for bone removal in orthopedic and neurological procedures in some of the most prestigious institutions throughout the world."

About Misonix

Misonix, Inc. designs, develops, 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 .

Safe Harbor Statement

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 Contact:

Richard Zaremba

Joe Diaz

631-694-9555

Lytham Partners

invest@misonix.com  

602-889-9700


info@misonix.com  

SOURCE Misonix, Inc.

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