InfuSystem and Sanara MedTech Inc. Announce Exclusive United States Distribution Agreement with ChemoMouthpiece, LLC

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ROCHESTER HILLS, Mich., September 11, 2024--(BUSINESS WIRE)--InfuSystem Holdings, Inc. (NYSE American: INFU) ("InfuSystem" or the "Company"), a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers, and its joint venture partner Sanara MedTech Inc. ("Sanara"), announced today the execution of an exclusive United States distribution agreement with ChemoMouthpiece, LLC ("ChemoMouthpiece").

Richard DiIorio, InfuSystem’s CEO, stated, "Sanara and InfuSystem entered into our partnership in order to bring together our combined technical, operational and commercial strengths to deliver proprietary efficacious products to patients. We believe this exclusive agreement, which builds on our partnership, will allow us to do that by offering the Chemo Mouthpiece®, an oral cryotherapy device, bringing potential relief to thousands of cancer patients suffering from oral mucositis."

Ron Nixon, Sanara’s CEO, stated, "Oral mucositis is a debilitating condition impacting hundreds of thousands of oncology patients annually. ChemoMouthpiece has developed a clinically validated product with FDA 510(k) clearance that can bring relief to affected patients. The American Medical Association has recently issued the CPT code (effective July 2024) to be applied for potential reimbursement by physicians and payers for the use of an oral cavity device for cryotherapy procedure in conjunction with chemotherapy. The product aligns well with Sanara’s skincare strategy, which includes the licensed collagen peptides from Tufts University that focus on radiation dermatitis. We look forward to providing the Chemo Mouthpiece®, an oral cryotherapy device, to oncology patients undergoing chemotherapy."

Transaction Overview

  • ChemoMouthpiece owns and manufactures a 510(k) cleared device that uses cryotherapy to reduce the incidence and severity of oral mucositis in patients undergoing stomatotoxic chemotherapy treatments.

  • SI Healthcare Technologies, LLC (f/k/a SI Wound Care, LLC) ("SI Technologies"), a 50/50 joint venture between Sanara and InfuSystem, will be the exclusive distributor of ChemoMouthpiece’s kits in the United States.

  • SI Technologies plans to market and distribute the product through InfuSystem to approximately 3,000 cancer centers through InfuSystem’s existing Oncology sales team.

  • SI Technologies will purchase the product kits from ChemoMouthpiece at a fixed price and pay a royalty on net revenues for the use of the product intellectual property.

  • Sanara invested $5 million for a 6.6% ownership position in ChemoMouthpiece.

  • SI Technologies will have a purchase option that expires on January 31, 2029 to purchase the U.S. business of ChemoMouthpiece, including all U.S. intellectual property related to the product.