InfuSystem, Sanara MedTech Partner for Distribution Deal

InfuSystem Holdings Inc. and its joint venture partner Sanara MedTech Inc. have forged an exclusive U.S. distribution agreement with ChemoMouthpiece LLC.
 
ChemoMouthpiece owns and manufactures a U.S. Food and Drug Administration 510(k) cleared device that uses cryotherapy to reduce the incidence and severity of oral mucositis in patients undergoing stomatotoxic chemotherapy treatments. InfuSystem and Sanara MedTech have formed a joint venture called SI Healthcare Technologies LLC (formerly known as SI Wound Care LLC or “SI Technologies”) to exclusively distribute ChemoMouthpiece’s kits in the United States. SI Technologies will 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 using the product’s intellectual property.

“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,” InfuSystem CEO Richard DiIorio stated. “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.”

Sanara invested $5 million for a 6.6% ownership position in ChemoMouthpiece. SI Technologies has a purchase option that expires on Jan. 31, 2029, to purchase ChemoMouthpiece’s U.S. business, including all U.S. intellectual property related to the product.
 
“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,” Sanara MedTech CEO Ron Nixon said, “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.”

Oral mucositis causes painful mouth ulcers, which are a common complication of chemotherapy and radiation. An estimated 500,000 to 1 million U.S. patients suffer from oral mucositis annually and the estimated market size exceeds $600 million. SI Technologies is confident this product will show material cost reductions for oncology treatment centers, improve patient quality of life, and allow for continued cancer treatment for patients. ChemoMouthpiece is planning to publish studies in the future reinforcing the product’s efficacy.
 
“We are pleased to have selected SI Technologies as our exclusive distribution partner in the United States. We believe that InfuSystem’s experienced team of oncology professionals currently calling on approximately 3,000 U.S. cancer centers will accelerate the uptake of the Chemo Mouthpiece, bringing a much-needed option for patients that would otherwise suffer from the debilitating effects of oral mucositis,” ChemoMouthpiece Founder/President/CEO David Yoskowitz stated, “We understand the executive team of SI Technologies has a long history of launching products into the oncology space, and coupled with Sanara’s ownership position in ChemoMouthpiece, we are confident that they will execute the successful launch of the Chemo Mouthpiece oral cryotherapy device.”
 
Pickwick Capital Partners LLC, was the exclusive advisor to ChemoMouthpiece on this transaction.
 
ChemoMouthpiece is a privately held medical device company that develops and commercializes propriety oral cryotherapy products for cancer patients. The Chemo Mouthpiece device was developed based on Yoskowitz’s personal experience upon being diagnosed with Hodgkin’s Lymphoma and experiencing oral mucositis firsthand. His treatment options included ice chips to mitigate and minimize the pain. Yet this caused nausea, was difficult to maintain in his mouth, and did not effectively cool the entire oral cavity, which led him to search for a better option. The Chemo Mouthpiece cools down the entire oral cavity, causing vasoconstriction, which in effect slows and reduces the flow of chemotherapy in the oral cavity, thus greatly reducing the risk of developing oral mucositis. The cryotherapy approach has been positively studied for decades and the Chemo Mouthpiece has significant and improved advantages over conventional cryotherapy interventions. 
 
Sanara MedTech Inc. is a medical technology company developing and commercializing transformative technologies to improve clinical outcomes and reduce healthcare expenditures in the surgical, chronic wound, and skincare markets. The company markets, distributes, and develops surgical, wound and skincare products for use by physicians and clinicians in hospitals, clinics and all post-acute care settings and offers wound care and dermatology virtual consultation services via telemedicine. Sanara’s products are primarily sold in the North American advanced wound care and surgical tissue repair markets. Sanara markets and distributes CellerateRX Surgical Activated Collagen, FORTIFY TRG Tissue Repair Graft, and FORTIFY FLOWABLE Extracellular Matrix as well as a portfolio of advanced biologic products focusing on ACTIGENTM Verified Inductive Bone Matrix, ALLOCYTE Plus Advanced Viable Bone Matrix, BiFORM Bioactive Moldable Matrix, TEXAGEN Amniotic Membrane Allograft, and BIASURGE Advanced Surgical Solution to the surgical market. In addition, the following products are sold in the wound care market: BIAKŌS Antimicrobial Skin and Wound Cleanser, BIAKŌS Antimicrobial Wound Gel, and BIAKŌS Antimicrobial Skin and Wound Irrigation Solution. Sanara’s pipeline also contains potentially transformative product candidates for mitigation of opportunistic pathogens and biofilm, wound re-epithelialization and closure, necrotic tissue debridement and cell compatible substrates. 
 
InfuSystem Holdings Inc. is a national healthcare service provider, facilitating outpatient care for durable medical equipment manufacturers and healthcare providers. INFU services are provided under a two-platform model. The first platform is Patient Services, providing the last-mile solution for clinic-to-home healthcare where the continuing treatment involves complex durable medical equipment and services. The Patient Services segment is comprised of Oncology, Pain Management and Wound Therapy businesses. The second platform, Device Solutions, supports the Patient Services platform and leverages strong service orientation to win incremental business from its direct payer clients. The Device Solutions segment is comprised of direct payer rentals, pump and consumable sales, and biomedical services and repair. Headquartered in Rochester Hills, Mich., the company delivers local, field-based customer support and also operates Centers of Excellence in Michigan, Kansas, California, Massachusetts, Texas and Ontario, Canada.