The Chemo Mouthpiece® Medical Device Significantly Reduces Oral Pain and Opioid/Analgesic Use During Chemotherapy in Multi-Center Pivotal Clinical Trial
WILMINGTON, Del., Aug. 20, 2025 /PRNewswire/ -- Chemomouthpiece, LLC, a privately held medical device company that develops and commercializes supportive cancer care products, today announced the peer-reviewed results from its pivotal, multi-center, randomized, controlled trial were published in Supportive Care in Cancer, the official journal of the Multinational Association of Supportive Care In Cancer (MASCC).
The study, "Multi-institutional, randomized, controlled trial to assess the efficacy and tolerability of a reusable, self-contained cryotherapy delivery device", evaluated the Chemo Mouthpiece®, an FDA 510(k) cleared intraoral cryotherapy device, and demonstrated statistically significant reductions in patient-reported oral pain and opioid or analgesic use during chemotherapy treatment.
Use of the Chemo Mouthpiece resulted in a 46% reduction in patient-reported oral pain symptoms compared to the control group. Additionally, there was a 68% reduction in opioid or analgesic use compared to the control group. The device showed efficacy across more than 30 chemotherapy regimens and 17 cancer types. The Chemo Mouthpiece was well-tolerated by patients, with no reported safety issues. Notably, 83% of patients indicated they would recommend the device for patients undergoing chemotherapy.
A Practical Advancement in Oral Mucositis Management"Cryotherapy is a well-established strategy for mitigating oral mucositis, but its traditional delivery using ice chips presents practical challenges for patients and care teams," said Stephen Sonis, DMD, DMSc, Senior Lecturer in Oral Medicine at the Harvard School of Dental Medicine and a member of the senior faculty at the Dana-Farber Cancer Institute and Brigham and Women's Hospital. "The data from this trial indicate that cryotherapy delivered by the Chemo Mouthpiece provided patients with an effective and well-tolerated alternative to ice that could be used throughout their treatment period, both in the clinic and at home. Chemo Mouthpiece-delivered cryotherapy reduced patients' symptoms and need to rely on analgesics for pain management."
Richard Zuniga, MD, Medical Chief of Research at New York Cancer and Blood Specialists and lead study investigator, said, "The data from this rigorous, multi-center trial clearly validate the Chemo Mouthpiece as a safe and effective tool for addressing oral mucositis-related pain and related opioid use. The scope of chemotherapy regimens and cancer types included in the study underscores the potential to benefit the diverse patient population impacted by oral mucositis. These findings represent a meaningful step forward in supportive oncology care."
Innovation Driven by Personal Experience The Chemo Mouthpiece device was developed by company founder and CEO David Yoskowitz, a cancer survivor who experienced firsthand the debilitating effects of oral mucositis from chemotherapy and the lack of effective, tolerable options. At the time, his treatment options included ice chips to mitigate and minimize oral pain; however, they often caused nausea, were difficult to maintain in his mouth, and failed to effectively cool the entire oral cavity. These challenges led him to engineer a better solution.
"This study is not just a scientific milestone, it's deeply personal," said Yoskowitz. "It's incredibly rewarding to see the clinical data confirm the device's impact on pain reduction and patient quality of life. Not only for me, but for our original goal, to help reduce the suffering associated with oral mucositis for every at-risk patient."
About the TrialThe randomized trial enrolled 164 patients undergoing chemotherapy and assigned them in a 2:1 ratio to receive either the Chemo Mouthpiece plus best supportive care (arm A) or best supportive care alone (arm B) across 16 U.S. study sites. Inclusion criteria allowed broad tumor diagnoses and chemotherapy regimens. Patients used the device during infusion and for five days post-infusion across two treatment cycles. They completed daily questionnaires to assess oral pain and analgesic use. Device tolerability was also assessed via patient surveys.
Unlike traditional oral cryotherapy approaches, which are generally recommended only for chemotherapy drugs with a short half-life during infusion, the trial included regimens with both short and long half-life agents. The portability, tolerability, and user-friendly design of the Chemo Mouthpiece made it practical for patients to continue use at home, when chemotherapy agents may still be circulating in the body. This extended use was associated with improved efficacy across a variety of chemotherapy regimens.
The study was published in Supportive Care in Cancer, the official journal of MASCC: Zuniga, R., Dembla, V., Alam, N. et al. Multi-institutional, randomized, controlled trial to assess the efficacy and tolerability of a reusable, self-contained cryotherapy delivery device. Support Care Cancer 33, 732 (2025). https://doi.org/10.1007/s00520-025-09795-x
About Oral MucositisOral mucositis is a painful and often debilitating side effect of chemotherapy, characterized by inflammation and ulceration of the mucous membranes in the mouth. It can interfere with a patient's ability to eat, drink, speak, and sleep and ultimately can reduce quality of life and delay treatment. Clinical impacts may include:
Delays or dose reductions in cancer therapy
Increased risk of infection due to open oral wounds
Significant weight loss and nutritional challenges
Greater dependence on opioids and analgesics
Higher rates of ER visits and hospitalizations
Increased financial and emotional burden for patients
About the Chemo MouthpieceThe 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 reusable, pre-filled, 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.
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, LLCChemomouthpiece, 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 its potential benefits and future development plans, which 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 our website at www.chemomouthpiece.com or contact; Scott Narins, Director of Investor Relations snarins@chemomouthpiece.com or Bonni Tattoli, VP, Commercial Operations at btattoli@chemomouthpiece.com
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SOURCE Chemomouthpiece, LLC
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