What Chemo Mouthpiece does

ChemoMouthpiece, LLC (d/b/a Chemo Mouthpiece®) is a privately held Delaware-incorporated medical device company that develops and commercializes oral cryotherapy products for adult cancer patients undergoing chemotherapy. Its commercial focus is reducing the incidence and severity of chemotherapy-induced oral mucositis (CIOOM), a side effect that affects up to 40% of standard-dose and up to 80% of high-dose chemotherapy patients and is associated with mouth sores, opioid use, treatment delays, and per-patient costs of up to $25,000 in severe cases. The company serves two primary segments: adult oncology patients at risk of CIOOM, and the oncologists, nurse practitioners, and oncology practices who prescribe the device.

The company's core product is the Chemo Mouthpiece®, an FDA 510(k)-cleared, single-patient multi-use oral cryotherapy device. The proprietary dual-chamber architecture freezes filtered water in an inner core while keeping a proprietary saline solution liquid in an outer chamber, producing uniform cooling of the entire oral cavity rather than the localized cooling of ice chips. Integrated breathing tubes allow patients to breathe normally during infusion. The Patient Kit bundles six pre-filled reusable devices with insulated sleeves, gel ice packs, a cleaning brush, a carrying cooler, and instructions for use. All wetted components are medical-grade silicone, HDPE plastic, and GRAS-classified materials. Clinical validation rests on a 164-patient multi-institutional randomized controlled trial across 16 U.S. sites, published in peer-reviewed journals including Supportive Care in Cancer, demonstrating a 46% reduction in oral pain episodes, a 68% reduction in opioid/analgesic use, and 80% pain-free time during peak symptom days.

The device is sold by prescription only. In the United States, fulfillment is handled through an exclusive partnership with Zeal Specialty Pharmacy, which manages prescribing coordination, benefits investigation, prior authorization, patient onboarding, and a Patient Assistance Program that provides the Patient Kit at no cost to income-eligible patients. Internationally, the company operates a distributor inquiry program for non-US markets. Through 2024, ChemoMouthpiece completed three SEC-registered exempt offerings totaling approximately $15.9 million, coinciding with FDA 510(k) clearance in January 2024. The company is led by founder David Yoskowitz, a cancer survivor who developed the device after experiencing oral mucositis during treatment for Hodgkin's lymphoma.

Name

Chemo Mouthpiece

Legal name

ChemoMouthpiece, LLC

Website

https://chemomouthpiece.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

ChemoMouthpiece, LLC develops and commercializes an FDA 510(k)-cleared oral cryotherapy device that reduces chemotherapy-induced oral mucositis in adult cancer patients. It is distributed via Zeal Specialty Pharmacy in the US and through global distributors internationally.

Ownership category

akta.pro rank

Headquarters

HQ city

Closter

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Marketing or Sales, Technology or R&D, Personnel

Revenue model

1. Medical Device Sales: The Chemo Mouthpiece is sold as a Patient Kit containing six pre-filled, reusable oral cryotherapy devices along with cooling packs, cleaning brushes, insulated sleeves, carrying cooler, and instructions for use. Available by prescription only, fulfilled by Zeal Specialty Pharmacy in the US.
2. Private Placement Funding: The company has raised capital through private placement offerings. SEC filings indicate offerings of $900,000, $5 million, and the company completed a $10 million private funding round in early 2024.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Chemo Mouthpiece develops and commercializes the FDA 510(k)-cleared Chemo Mouthpiece®, a single-patient, multi-use oral cryotherapy medical device intended to cool the oral mucosa and reduce the incidence and severity of chemotherapy-induced oral mucositis in adult cancer patients. The device is sold as a Patient Kit containing six pre-filled reusable devices plus insulated sleeves, gel ice packs, cleaning brush, and carrying cooler, and is available by prescription only, fulfilled through Zeal Specialty Pharmacy in the U.S.

Product overview

Chemo Mouthpiece offers a single FDA-cleared medical device—the Chemo Mouthpiece®—as its core product, an oral cryotherapy device designed to reduce chemotherapy-induced oral mucositis. The device is sold as a Patient Kit containing six reusable units along with accessories (insulated sleeves, cleaning brush, gel ice packs, and carrying cooler). The product works by cooling the entire oral cavity uniformly during and after chemotherapy infusion to restrict blood flow and limit drug exposure to sensitive oral tissues. The company also provides a Patient Assistance Program offering the device at no cost to eligible patients.

Differentiator

Problem solved

Functional benefit

Products and services

• Chemo Mouthpiece® Oral Cryotherapy Device FDA 510(k)-cleared, single-patient multi-use oral cryotherapy medical device with a dual-chamber design (inner frozen filtered-water core and outer liquid saline chamber) and integrated breathing tubes. Intended to cool the oral mucosa to reduce the incidence and severity of chemotherapy-induced oral mucositis in adult cancer patients. Made from medical-grade silicone, filtered water, HDPE plastic, and proprietary saline solution. Available by prescription only and fulfilled through Zeal Specialty Pharmacy in the U.S.
• Chemo Mouthpiece Patient Kit Bundled package containing six pre-filled and reusable Chemo Mouthpiece devices, two insulated sleeves, one cleaning brush, six reusable gel ice packs, one insulated cooler with carrying strap, and instructions for use. Available by prescription only and fulfilled through Zeal Specialty Pharmacy in the U.S.; eligible patients may receive the kit at no cost through the Patient Assistance Program.

Quantifiable outcome

• 46% reduction in oral pain episodes vs. control group
• +8 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• Zeal Specialty PharmacycoreChannel Partner/ Reseller/ Distributor · 18 June 2026Partnership to expand US access to the Chemo Mouthpiece oral cooling device. Zeal Specialty Pharmacy provides prescribing coordination, benefits investigation, prior authorization support, patient onboarding, and Patient Assistance Program services for oncology practices and patients across the United States. The partnership supports the company's prescription-only distribution model.

Scale indicators10 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Soligenix: Develops SGX942 (dusquetide) for oral mucositis in head and neck cancer patients, representing a direct therapeutic competitor in the same patient population that Chemo Mouthpiece targets.
• Galera Therapeutics: Clinical-stage biotechnology company developing therapeutics specifically for radiotherapy- and chemotherapy-induced oral mucositis, making it a direct peer addressing the same indication with a complementary mechanism of action.
• Camurus (Episil): Commercializes Episil oral liquid for the management of oral mucositis pain, directly competing in the same symptomatic treatment space as the Chemo Mouthpiece.
• EUSA Pharma (Caphosol): Markets Caphosol, a supersaturated calcium phosphate rinse indicated for oral mucositis, directly competing with Chemo Mouthpiece as an established supportive-care product for the same indication.
• MuGard (AMAG Pharmaceuticals legacy): MuGard is an FDA-cleared oral mucositis rinse — a directly comparable prescription product for managing oral mucositis, offering an alternative formulation-based intervention to Chemo Mouthpiece's cryotherapy approach.

Emerging players

• Monopar Therapeutics: Clinical-stage company developing therapeutics for cancer supportive care, including oral mucositis prevention, representing an emerging competitor in the same indication with a drug-based rather than device-based approach.
• Nuvora (NeutraSal): Markets NeutraSal for oral mucositis and dry mouth, an OTC product addressing overlapping symptoms. While not a direct device competitor, it competes for the same patient-driven demand for oral care during cancer treatment.

Broad incumbents

• Baxter International: Large medical device and specialty therapeutics company with established oncology supportive-care products and a global hospital distribution network — representing the type of strategic acquirer that could commercialize Chemo Mouthpiece at scale.
• Helsinn Group: Established Swiss specialty pharma company focused on cancer supportive care, including products for chemotherapy side effects. As a larger, multi-product incumbent in the same therapeutic area, it represents a potential acquirer or competitor for Chemo Mouthpiece.

Regional players

• Access Biologicals: Develops and distributes specialty supportive-care products including options for oral mucositis, with established distribution relationships in US oncology channels that overlap with Chemo Mouthpiece's go-to-market approach.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/CMPdevice
• Facebookfacebook.com/people/ChemoMouthpiece-LLC/61574151322905
• LinkedInlinkedin.com/company/chemomouthpiece-llc
• Instagraminstagram.com/chemomouthpiece

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds3 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Chemo Mouthpiece