Misonix, Inc. designs, manufactures, markets, sells and distributes minimally invasive surgical ultrasonic medical devices. These products are used for precise bone sculpting, removal of soft and hard tumors, and tissue debridement, primarily in the areas of neurosurgery, orthopaedic surgery, plastic surgery, wound care and maxillo-facial surgery.
The company also exclusively markets, sells and distributes skin allografts and wound care products used to support healing of wounds, and which comp...
Misonix, Inc. designs, manufactures, markets, sells and distributes minimally invasive surgical ultrasonic medical devices. These products are used for precise bone sculpting, removal of soft and hard tumors, and tissue debridement, primarily in the areas of neurosurgery, orthopaedic surgery, plastic surgery, wound care and maxillo-facial surgery.
The company also exclusively markets, sells and distributes skin allografts and wound care products used to support healing of wounds, and which complement its ultrasonic medical devices.
The company receives revenues from various regions worldwide, including the United States, the United Kingdom, the European Economic Area, Asia and the Asia Pacific, and South America. Its sales made in the United States are made primarily through its direct sales force and various distributors. The company’s sales outside the United States are made through distributors.
Segments
The company operates through two segments, Surgical and Wound.
The Surgical segment consists of the company’s neXus, BoneScalpel, and SonaStar products.
The Wound segment consists of the company’s SonicOne, TheraSkin, Therion and TheraGenesis products.
Products
Each of the company’s medical device systems consist of a proprietary console and handpiece that function to convert electrical current into ultrasonic energy, ultimately delivered via a disposable titanium tip, to produce a therapeutic effect.
neXus
neXus is an integrated ultrasonic surgical platform that combines various features of the company’s existing solutions, including BoneScalpel, SonicOne and SonaStar, into an integrated platform that would also serve to enable future solutions. The device incorporates Smart Technology that allows for setup and use.
neXus’ power improves tissue resection rates for both soft and hard tissue removal making it a surgical platform for various surgical specialties. In addition, neXus’ enables physicians to leverage neXus’ set of capabilities via its digital touchscreen display and smart system setup. The company’s ultrasonic applications, which are BoneScalpel, SonaStar and SonicOne, all work on the neXus generator. This allows a hospital to access the company’s product offerings on this console. It principally sells neXus in the United States.
BoneScalpel
The BoneScalpel is an ultrasonic bone cutting and sculpting system capable of enabling precise cuts with minimal necrosis, minimal burn artifact, minimal inflammation and minimal bone loss. The device is also capable of preserving surrounding soft tissue structures because of its ability to differentiate soft tissue from rigid bone. This device could make precise linear or curved cuts, on any plane, with precision not normally associated with powered instrumentation. The effect on surrounding soft tissue is minimal due to the elastic and flexible structure of healthy tissue. In addition, the linear motion of the blunt, tissue-impacting tips avoids accidental ‘trapping’ of soft tissue, while eliminating the high-speed spinning and tearing associated with rotary power instruments. The BoneScalpel allows surgeons to improve on existing surgical techniques by creating new approaches to bone cutting, sculpting, and removal.
SonaStar
The SonaStar System provides precise aspiration following the ultrasonic ablation of soft tissue. The SonaStar is used for various surgical procedures applying both open and minimally invasive approaches, including neurosurgery and general surgery. The SonaStar might also be used with OsteoSculpt probe tips, which enable the precise shaping or shaving of bony structures that prevent open access to partially or completely hidden soft tissue masses.
SonicOne
The SonicOne Ultrasonic Cleansing and Debridement System is a tissue specific approach for the removal of devitalized or necrotic tissue and fibrin deposits, while sparing viable, surrounding cellular structures. The ultrasonic debridement process separates devitalized tissue from viable tissue layers, allowing for a defined treatment and, usually, a reduced pain sensation.
TheraSkin
TheraSkin is a biologically active human skin allograft that has the relevant characteristics of human skin needed to heal wounds, including living cells, growth factors, and a collagen matrix. TheraSkin is derived from human skin tissue from consenting and screened donors and is regulated by the FDA as a Human Cells, Tissues, and Cellular and Tissue-Based Product. LifeNet Health processes and supplies TheraSkin to the company under a supply and distribution agreement that gives it exclusive rights to sell TheraSkin in the United States. TheraSkin is indicated for use on all external skin tissue wounds, including but not limited to difficult to heal diabetic foot ulcers, venous leg ulcers, dehisced surgical wounds, necrotizing fasciitis, burns, Mohs and wounds with exposed structures.
Therion
Therion is indicated for use as a cover and barrier for homologous use for wound care and surgical procedures. Therion is a dehydrated and terminally sterilized chorioamniotic allograft derived from human placental membrane and is regulated by the FDA as a Human Cells, Tissues, and Cellular and Tissue-Based Product. CryoLife processes and supplies Therion to the company under a supply and distribution agreement that gives it exclusive rights to distribute the product in the United States. CryoLife processes Therion using a proprietary process that removes the maternal-derived decidua cells from the placental membrane, leaving the amnion and chorion layers in their native configuration.
TheraGenesis
TheraGenesis is a Bilayer Wound Matrix and Meshed Bilayer Wound Matrix consisting of a porcine collagen sponge layer and a silicone film layer that provides a scaffold for cellular invasion and capillary growth for management of wounds, including partial and full-thickness wounds, chronic wounds, surgical wounds, trauma wounds and draining wounds. The company obtains TheraGenesis under an exclusive supply and distribution agreement with Gunze Limited that gives it exclusive rights to distribute the product in the United States.
Sales and Distribution
In the United States, the company sells its products through its direct sales force, in addition to a network of commissioned agents assisted by company personnel. Outside of the United States, it sells BoneScalpel and SonaStar through distributors who then resell the products to hospitals. The company sells to various major markets in the Americas, Europe, the Middle East, the Asia Pacific, and Africa.
Research and Development
During the year ended June 30, 2021, the company incurred research and development expenses of $5.0 million.
Trademarks, Patents, and Copyrights
The company owns 69 U.S. patents and 57 foreign patents. In addition, it has 17 pending U.S. patent applications and 53 pending foreign patent applications. Patents relating to the company’s Nexus product are scheduled to expire in 2028 and 2040. Other patents that it considers major to its business would expire from 2025 to 2037.
The company also holds 19 U.S. and 7 foreign registered trademarks protecting the Misonix name and its product names.
Regulation
The company’s products are subject to regulation particularly as to safety, efficacy, and adherence to FDA Quality System Regulations (QSR) and related manufacturing standards. Its products marketed in the United States are marketed pursuant to 510(k) pre-marketing clearances and are either Class I or Class II devices.
As a medical device manufacturer, the company’s manufacturing facilities are subject to inspection on a routine basis by the FDA. It is required to adhere to applicable regulations setting forth Good Manufacturing Practice requirements, as set forth in the QSR, which require manufacturers, including its third-party manufacturers, to follow design, testing, control, documentation, and other quality assurance procedures during various phases of the design and manufacturing process.
The company must also comply with post-market surveillance regulations, including medical device reporting requirements, which require that it reviews and reports to the FDA any incident in which its products might have caused or contributed to a death or serious injury.
The company’s labeling and promotional activities in the U.S. are also subject to scrutiny by the FDA and, in certain circumstances, by the Federal Trade Commission. Its devices are sold in multiple other countries and often need to be registered with local regulatory bodies, such as the National Medical Products Administration in China, Health Canada, the Therapeutic Goods Administration in Australia, and the Agência Nacional de Vigilância Sanitária in Brazil. The company is subject to the Foreign Corrupt Practices Act of 1977, as amended.
The company also operates and maintains a Quality Management System that complies with the requirements of International Standards ISO 13485: 2016 Medical Devices – Quality Management Systems, including the U.S. FDA Title 21 CFR Part 820 Quality System Regulation.
Competition
The company’s various major competitors are Johnson & Johnson, Söering, Stryker Corporation, Smith & Nephew, and Integra Life Sciences, Inc. for its Surgical segment; and MiMedx, Smith & Nephew, Integra Life Sciences and Organogenesis for its Wound segment.
History
Misonix, Inc. was founded in 1959.
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