The Misonix BoneScalpelTM is an innovative ultrasonic cutting system with applications in orthopedic and reconstructive surgery, as well as neurosurgery. Its ultrasonic function represents a technological shift with unique advantages over traditional methods that is particularly important in spinal surgery where bone is cut in close proximity to the spinal cord and major arteries and often with significant amounts of blood loss. BoneScalpel combines key features of traditional cutting tools and adds a new dimension that only ultrasound provides: a gentle approach that reduces bleeding and spares soft tissues.
Over 1,260,000 spinal procedures are being performed annually in the U.S. based on billable procedure codes. Spine surgeries commonly consist of more than 1 procedure code. The addressable market volume for BoneScalpel in the U.S. is 750,000 surgeries per year, in which its disposables could be used. The international opportunity is similar in volume.
Spinal surgeries in general are being performed in 5,080 U.S. hospitals. The large majority of the addressable surgery volume (82%) is concentrated in 2,062 high volume institutions, characterized by bed size and status as any size teaching or large non-teaching hospitals.
Patient demographics are favorable as 47% of addressable surgeries correlate with patients age 45-64 and 31% with age 64 and above.
Spinal surgery presents a significant opportunity for the near future in the U.S. as well as overseas. Additional opportunities for future expansion exist in other orthopedic specialties.
The Misonix SonaStar® is capable of selectively fragmenting, emulsifying and aspirating unwanted soft and hard tissue i.e. bone, while leaving vital nerves and blood vessels unaffected. Growth in the number of neurosurgery procedures and other surgeries such as general (liver) is driving the ultrasonic aspirator worldwide market with considerable interest in systems such as the SonaStar®Ultrasonic Aspirator. The SonaStar® total addressable market is $120M worldwide.
In 2011, there were approximately 123,500 non-skull based craniotomies in the U.S. which represents a 20% increase in craniotomies from 2006. Also, in this same year, neuro-endoscopy (MIS) procedures including surgery for pituitary tumors represented one of the largest growth areas in neurosurgery with 25,278 procedures, a growth rate of 33%.
While the total number of surgeons specializing in MIS/pituitary tumor surgeries has decreased 10% from 2006-2012, the amount of procedures increased significantly at 49%.
The Misonix SonaStar® Ultrasonic Aspirator is an ideal choice for the surgical intervention of such neurosurgical procedures as:
- Skull/non-skull base tumor resections (SonaStar® Aspiration Tips)
- Transnasal [MIS] procedures (SonaStar® Deep Access Probes)
- Acoustic mengiomas (SonaStar® OsteoSculpt® Bone Shavers)
GENERAL (LIVER) SURGERY
Additionally, the SonaStar® Ultrasonic Aspirator is also commonly used to safely and efficiently ablate tumors of the liver. It is estimated that globally, there are over 7,000 liver tumor resection surgeries each year.
[Sources: 1) AANS National Neurosurgical Procedure Statistics: 2012 Survey and, 2) Misonix Corporate Presentation, March 2013.]
MISONIX SONICONE OR
Chronic, non-healing, wounds present a large challenge to both the individual and the health care industry. The increased prevalence of diabetes, due to the increase in the average lifespan, sedentary lifestyle and unhealthy diets are key contributing factors to the increase in chronic wounds.
In 2012, there were 26 million diabetic patients in the US and 285 million patients globally. Of these patients, approximately 15% will develop a diabetic foot ulcer and 50% of these will become infected, representing an estimated 2 million patients. The diabetic foot is the most common cause of non-traumatic lower extremity amputations in the US and Europe: there is an average of 82,000 amputations per year in the U.S., costing an estimated $1.6 billion annually. The estimated cost of foot ulcer care in the U.S. ranges from $4,595 per ulcer episode to more than $28,000 and the total annual cost of foot ulcer care in the US has been estimated to be as high as $5 billion.
Prevention is the key to reducing the occurrence of chronic wounds in diabetic patients. If a wound does occur, debridement, aimed at removing necrotic, devitalized wound bed and wound edge tissue that inhibits healing, is a longstanding standard of care for the treatment of chronic, non-healing wounds. Debridement encourages healing by converting a chronic non-healing wound environment into a more responsive acute healing environment.
The Misonix SonicOne OR is an excellent tool to perform debridement, the first step in the critical path to healing.
i MedMarket Diligence Report #S249, March 2013. “Worldwide Wound Management, Forecast to 2021:Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”
ii Gordon KA, Lebrun EA, Tomic-Canic M, Kirsner RS., 2012 Jan-Feb; “The role of surgical debridement in healing of diabetic foot ulcers.” Skinmed, 10(1):24-6.