Economic Analysis of the Chemo Mouthpiece® Medical Device Suggests Potential Cost Savings of Over $15,000 per Patient Receiving Chemotherapy and Reduced Healthcare Resource Utilization

Peer-reviewed study highlights modeled economic and clinical impact associated with use of the Chemo Mouthpiece^® oral cooling device in adult patients receiving chemotherapy.

WILMINGTON, Del., July 22, 2026 /PRNewswire/ -- Chemomouthpiece, LLC, a privately held medical device company focused on supportive oncology care, today announced the publication of a peer-reviewed economic analysis evaluating the clinical and economic impact associated with use of the Chemo Mouthpiece^® medical device in patients receiving chemotherapy.

The analysis, published in the Journal of Comparative Effectiveness Research, suggests that use of the Chemo Mouthpiece was associated with reductions in oral mucositis (OM) and downstream healthcare resource utilization, including estimated cost savings of approximately $1,166 per patient in a single chemotherapy cycle and up to $15,395 per patient across six cycles.

The peer-reviewed study, An Economic Analysis of Chemo Mouthpiece^® Versus Supportive Care for the Reduction of Oral Mucositis Incidence in Patients Receiving Chemotherapy, utilized a predictive model to estimate outcomes in a cohort of 1,000 adult patients undergoing chemotherapy in a U.S. healthcare payer perspective. Read the full analysis here: https://becarispublishing.com/doi/full/10.57264/cer-2025-0164

Study Overview

The objective of the study was to estimate the clinical and economic impacts associated with reductions in chemotherapy induced OM with use of the Chemo Mouthpiece. The model compared two scenarios: current practice, using best supportive oral care (BSOC) alone, and optimal practice, using the Chemo Mouthpiece plus BSOC. Outcomes were assessed over both a single chemotherapy cycle and a six-cycle treatment schedule to reflect real-world oncology practice.

The economic model was informed by clinical outcomes observed in a 2025 randomized controlled trial of the Chemo Mouthpiece device, in which use of the device was associated with reductions in oral mucositis-related pain and analgesic use—clinically relevant indicators of OM burden.

Key modeled findings include:

• Approximately $1,166 in cost savings per patient during the first chemotherapy cycle
• Over $1 million in total cost savings at the cohort level (1,000 patients, single cycle)
• Estimated $15,395 in cost savings per patient over six chemotherapy cycles
• Over $15 million in total projected cost savings at the cohort level (1,000 patients, six cycles)
• Reductions in healthcare resource utilization, including hospital length of stay, emergency room visits, and medication use, consistent with modeled decreases in oral mucositis-related complications over time

Findings suggest that potential economic benefits associated with use of the Chemo Mouthpiece may increase over multiple chemotherapy cycles, reflecting the cumulative impact of oral mucositis-related complications and healthcare utilization over time.

"Oral mucositis remains one of the most clinically challenging and disruptive side effects of chemotherapy, often affecting a patient's ability to stay on treatment," said Richard Zuniga, MD, Medical Chief of Research at New York Cancer and Blood Specialists and lead author of the study. "This analysis suggests that reducing the burden of oral mucositis with the Chemo Mouthpiece may not only improve the patient experience but also help reduce the overall burden on the healthcare system. Over time, that has important implications for both clinical care and cost management."

The analysis found that the majority of projected cost savings were driven by reductions in hospitalization and related healthcare utilization associated with OM. Results also suggest that the cost of the Chemo Mouthpiece was offset by these reductions, resulting in overall net cost savings.

Addressing the Burden of Oral Mucositis in Oncology Care

OM is a common and debilitating side effect of chemotherapy, characterized by inflammation and ulceration of the oral mucosa. It is associated with severe pain that may require pain management interventions and can negatively impact a patient's ability to maintain treatment adherence.

OM is also associated with increased healthcare utilization, including hospitalizations and medication use, and may contribute to nutritional challenges during treatment.

In some patients, OM becomes a dose-limiting toxicity, slowing or preventing continuation of cancer therapies.

About the Chemo Mouthpiece

The Chemo Mouthpiece^® is a self-contained cryotherapy device designed to cool the entire oral cavity during and after chemotherapy infusion. By inducing vasoconstriction in the oral cavity, the device reduces the local presence of chemotherapy drugs, helping to mitigate mucosal injury. Available by prescription only, the device is single-patient, reusable, self-contained, and designed for use in both the clinic and at home when chemotherapy may still be circulating, supporting utility across short- and long half-life regimens. The FDA awarded the Chemo Mouthpiece Breakthrough Device Designation in December 2021 and the device was FDA 510(k) cleared in January 2024.

Chemo Mouthpiece Market Access National Account Managers (NAMs) continue to actively engage key stakeholders across the U.S. payer landscape. They are presenting the Chemo Mouthpiece's value proposition and advancing benefit coverage discussions with state, regional, and national health plans, including the three largest pharmacy benefit managers (PBMs) serving these organizations.

The Chemo Mouthpiece remains broadly accessible through prior authorization and medical exception pathways, consistent with standard new-to-market product coverage protocols. While formal med-tech committee reviews and contracting negotiations are ongoing, Chemomouthpiece, LLC continues to make progress toward expanded access and long-term reimbursement positioning, with key milestones expected later this year and into early 2027.

INDICATION FOR USE: (Rx only) The Chemo Mouthpiece^® is intended to be used to cool the oral mucosa to reduce the incidence and severity of chemotherapy induced oral mucositis in adult patients. See Important Safety Information at www.chemomouthpiece.com/resources

About Chemomouthpiece, LLC

Chemomouthpiece, LLC is a privately held medical device company headquartered in Wilmington, Delaware. Founded by a cancer survivor, the company's mission is to bring patient-driven innovation to the forefront of supportive oncology care. The Chemo Mouthpiece^® is the company's flagship product, designed to help reduce the incidence and severity of oral mucositis, one of the most common and painful side effects of chemotherapy, impacting up to 80% of patients depending on cancer type.

This release contains forward-looking statements regarding Chemomouthpiece, LLC, including potential clinical and economic outcomes associated with use of the Chemo Mouthpiece medical device. These statements are based on modeled analyses and are subject to risks and uncertainties that may cause actual results to differ. The Company undertakes no obligation to update these statements except as required by law.

For more information on Chemomouthpiece, LLC, please visit www.chemomouthpiece.com or contact; Scott Narins, Director of Investor Relations [email protected] or Bonni Tattoli, VP, Commercial Operations at [email protected]

SOURCE Chemomouthpiece, LLC