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Misonix Enters Into Exclusive Supply and Distribution Agreement With Gunze Limited for TheraGenesis® Bilayer Wound Matrix

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Misonix, Inc. (MSON) announced an exclusive agreement with Gunze Limited for the supply and distribution of its TheraGenesis® Bilayer Wound Matrix in the U.S. TheraGenesis, an FDA-cleared collagen wound matrix, is designed for treating trauma, burn, and reconstructive wounds. This partnership aims to enhance Misonix's position in the over $1 billion U.S. skin substitute market, complementing its existing product offerings. Misonix’s CEO highlighted the potential for market share growth, leveraging Gunze’s success in international markets.

Positive
  • Exclusive supply and distribution agreement with Gunze Limited to market TheraGenesis in the U.S.
  • TheraGenesis enhances Misonix's wound care portfolio, positioning the company to capture market share in the $1 billion U.S. skin substitute market.
  • CEO forecasts the partnership will leverage Gunze's established success with the product internationally.
Negative
  • None.

FARMINGDALE, N.Y., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Misonix, Inc. (Nasdaq: MSON) (“Misonix”) a provider of minimally invasive therapeutic ultrasonic medical devices and regenerative tissue products that enhance clinical outcomes, announced today that it has entered into an exclusive supply and distribution agreement with Gunze Limited for TheraGenesis® Bilayer Wound Matrix. TheraGenesis is a proprietary, FDA cleared, porcine tendon derived collagen wound matrix with a silicone film layer used to treat trauma, burn and reconstructive wounds.

Stavros Vizirgianakis, Chief Executive Officer of Misonix, commented, “We are honored to have entered into a partnership with Gunze Limited and very much look forward to working together with their world-class team. The addition of TheraGenesis to our wound product portfolio, allows us to effectively compete in the U.S. xenograft skin substitute market. We have witnessed the success that Gunze Limited has achieved in marketing TheraGenesis outside the US under the brand name Pelnac®, and we are confident that we will substantially build upon that success in the domestic market. The addition of TheraGenesis positions Misonix to compete effectively and gain market share in the traumatic, burn and reconstructive wound market, whereas TheraSkin®, is our leading skin substitute to treat chronic wounds, and the recently added Therion® allows us to compete in the amniotic tissue market for both wound and surgical applications. We are the only company to offer the competitive advantage of state-of-the-art ultrasonic debridement with SonicOne® together with best-in-class skin substitutes to ensure optimal wound bed preparation resulting in better outcomes.”

TheraGenesis is complimentary and expansive to Misonix’s current tissue regeneration wound portfolio of TheraSkin and SonicOne, offering a strong competitive entry into the xenograft skin substitute segment of the over $1 billion U.S. skin substitute market and enables Misonix to leverage the growth opportunities in healing chronic wounds as well as in treating trauma and burn wounds.

Shinichiro Morita, Corporate Officer and General Manager of the Medical Division of Gunze Limited added, "Partnering with Misonix to bring TheraGenesis to the U.S. market is an exciting and positive development for Gunze. This alliance allows Gunze to expand its global footprint with a clinically proven skin substitute, Pelnac, while providing Misonix with an opportunity to synergistically expand their advanced wound care product portfolio. For the past 20 years, we have been providing innovative solutions for tissue engineering and regenerative medicine to medical professionals across over 35 countries, helping patients and health care providers achieve better clinical outcomes.”

About Misonix, Inc.
Misonix, Inc. (Nasdaq: MSON) is a provider of minimally invasive therapeutic ultrasonic medical devices and regenerative tissue products. Its surgical team markets and sells BoneScalpel and SonaStar, which facilitate precise bone sculpting and removal of soft and hard tumors and tissue, primarily in the areas of neurosurgery, orthopedic, plastic and maxillo-facial surgery. The Company's wound team markets and sells TheraSkin, Therion, TheraGenesis and SonicOne to debride, treat and heal chronic and traumatic wounds in inpatient, outpatient and physician office sites of service. At Misonix, Better Matters! That is why throughout the Company’s history, Misonix has maintained its commitment to medical technology innovation and the development of products that radically improve outcomes for patients. Additional information is available on the Company's web site at www.misonix.com.

About Gunze Limited
Gunze was founded in Kyoto, Japan in 1896, and today operates a diverse business as a leading developer and manufacturer of Medical Devices, Apparel, Plastic Films, Plastics and Electronic Components. Gunze has more than 6,100 employees worldwide across 10 countries. The Medical Device business, established in 1985, has a substantial footprint over 35 countries. Its’ head office and manufacturing facility is located in Kyoto, Japan, and has subsidiaries in the U.S., EU, and China. By applying innovative fiber and polymer processing technologies, Gunze manufactures a comprehensive range of medical products focused on bioabsorbable and biocompatible materials such as skin substitutes, tissue reinforcement felt, bone fixation devices, dural substitutes and suture thread. Our mission will continue to be centered on advancing the quality of life of patients by providing innovative solutions to improve clinical outcomes.

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, the impact of COVID-19, or other pandemics, and the impact of related governmental, individual and business responses. This includes our ability to obtain or forecast accurate surgical procedure volume in the midst of the COVID-19 pandemic; the risk that the COVID-19 pandemic could lead to further material delays and cancellations of, or reduced demand for, surgical procedures; curtailed or delayed capital spending by hospitals and surgical centers; potential closures of our facilities; delays in gathering clinical evidence; diversion of management and other resources to respond to the COVID-19 outbreak; the impact of global and regional economic and credit market conditions on healthcare spending; the risk that the COVID-19 virus disrupts local economies and causes economies in our key markets to enter prolonged recessions; the ability of our staff to travel to work; our ability to maintain adequate inventories and delivery capabilities; the impact on our customers and supply chain, and the impact on demand in general. These forward-looking statements are also subject to uncertainties and change resulting from 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 clearance of pending and/or contemplated 510(k) filings; our ability to achieve and maintain profitability in our business lines; access to capital; and other factors described from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the fiscal year ended June 30, 2020, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking statements.

Contact:      
Joe Dwyer                                                                                 Norberto Aja, Jennifer Neuman
Chief Financial Officer                                                              JCIR
Misonix, Inc.                                                                             212-835-8500 or mson@jcir.com
631-694-9555  


FAQ

What is the significance of Misonix's partnership with Gunze Limited?

The partnership allows Misonix to distribute TheraGenesis, enhancing its product portfolio and competitive position in the U.S. skin substitute market.

What is TheraGenesis and its intended use?

TheraGenesis is a proprietary collagen wound matrix used for treating trauma, burn, and reconstructive wounds.

How does TheraGenesis fit within Misonix's product offerings?

TheraGenesis complements Misonix's existing wound care products like TheraSkin and SonicOne, aimed at chronic and traumatic wound treatment.

What market opportunity does Misonix see with TheraGenesis?

Misonix aims to capture market share in the $1 billion U.S. xenograft skin substitute market through the TheraGenesis product.

When was the agreement with Gunze Limited announced?

The agreement was announced on September 21, 2020.

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