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One Less Thing for Patients to Worry About

FDA 510(k) Cleared

The Chemo Mouthpiece® is an oral cryotherapy device intended to be used to cool the oral mucosa to reduce the incidence and severity of chemotherapy-induced oral mucositis in adult patients.

FDA 510(k) Cleared
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Oral Mucositis From Cancer Treatment

Oral mucositis is a common side effect of cancer treatment that can result in redness, swelling and painful mouth sores. It is a significant health issue for cancer patients going through treatment and is cited as the most troubling side effect by more than 40% of patients. It can lead to further health complications that can have a negative effect on their treatment plan.

Symptoms from OM can make it extremely difficult for patients to eat, drink, swallow, speak or even sleep normally. It can cause breaks in treatment, infections, significant weight loss and can be a large financial burden as well.

Cryotherapy Simplified

(Data on file) Thermal imaging shows how the Chemo Mouthpiece cools the entire oral cavity evenly. Darker areas represent colder temperatures.

When placed in a freezer, the specially designed Chemo Mouthpiece devices have an inner core frozen solid and an outer chamber of cold liquid. When used in the mouth, the system delivers cryotherapy (cold temperature) throughout the oral cavity. When chemotherapy drugs are circulating in the body during and after infusion, the cold temperature reduces blood flow in the mouth and the chemo drugs are physically limited from contacting and damaging sensitive tissue in the mouth.

Comprehensive Cooling
Hassle-Free Use
Clinically Backed Results

Redefining Protection for Patients

  • Clinical studies show that the Chemo Mouthpiece® significantly reduces the incidence and severity of oral mucositis, offering a scientifically proven method of protection during chemotherapy. A clinical study also demonstrated significant reductions in patient oral pain and in opioid/analgesic use.

  • This innovative Oral Cryotherapy Device cools the entire oral cavity evenly, achieving better results than traditional methods like ice chips or rinses by effectively limiting chemotherapy drug exposure to healthy tissues.

Confidence in Every Step.

Testimonials

"... I didn’t even get one mouth sore."

“When I tried [the Chemo Mouthpiece®] the first time, I didn’t even get one mouth sore. For anyone going through chemo I would definitely recommend Chemo Mouthpiece®. It helped me so much, it changed my life, it changed my perspective on chemo.”

- Briele S.
(Patient and RN)
"I have been using the Chemo Mouthpiece® for over 3 months... and have had ZERO instances of mouth sores"

“I have been using the Chemo Mouthpiece® for over 3 months (3 more months to go) and have had ZERO instances of mouth sores. I am taking 5FU and get infusions every two weeks.”

- Peter J.
(Patient)
“CMP was a game changer on my last round of chemo."

“CMP was a game changer on my last round of chemo. My mouth isn’t numb, my tastebuds are intact and my throat doesn’t feel like razor blades. I’ve recommended you guys already in multiple cancer groups.”

- Michal M.
(Patient)
"The results following the use of the mouthpiece in round two of treatments were overwhelmingly positive."

“We followed all medical advice and used all mouthwashes as prescribed for round one. It did not work. The results were devastating and ended up with hospitalization. After some research, we stumbled upon the Chemo Mouthpiece®. The results following the use of the mouthpiece in round two of treatments were overwhelmingly positive. No mouth sores. Full appetite. Able to drink. Very happy with our results and so is our doctor.”

- Joel D.
(Patient)
"The results have been nothing short of miraculous!"

“I was diagnosed with Stage 4 Metastatic Breast Cancer in June 2024. I started weekly chemo infusions in July 2024. I was told that two of my chemo medicines would cause mouth sores (doxorubicin and temsirolinus). I was advised to "chew on ice cubes" to avoid mouth sores from developing. After the second week, I started developing mouth sores and by week five, I had sores all over my mouth, my lips and my tongue. They were so bad that I could only eat through a straw, and I found it very hard to speak. The pain was excruciating. I researched chemo mouth sores on the internet and found ChemoMouthpiece.com. I used the Chemo Mouthpiece® the following chemo session, as instructed, 15 minutes before and 30 minutes after each infusion. The results have been nothing short of miraculous! Since using the chemo mouthpiece on a weekly basis, I have had ZERO mouth sores! The scars from all the past sores have disappeared and I have not had to use any of the many prescriptions given to me for mouth pain. I am extremely grateful to all the staff at Chemo Mouthpiece. I have told many others in my same situation about this product and how well it has worked for me and will continue to be an advocate as I believe this is the only solution on the market for chemo induced mouth sores.” (NOTE: this is edited from a longer response from this patient).

- Deborah G.
(Patient)

Designed For Ease

Revolutionary Protection
Reduces chemotherapy drug exposure to the oral cavity with full-mouth cooling technology.
Designed For Ease
Simple, reusable, and travel-ready to support you throughout treatment.
Clinically Trusted
Proven in studies to minimize the severity and incidence of oral mucositis.

Take Control of Your Treatment

Chemo Mouthpiece® puts the power of comfort in your hands. Engineered for simplicity and effectiveness, it’s a trusted solution for reducing the frequency and severity of the pain and complications of oral mucositis.
Comfort Where It Matters
Built for Convenience

Your Comfort,
Our Priority

The Chemo Mouthpiece® is redefining comfort during chemotherapy. Designed to reduce the severity and incidence of oral mucositis.

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All-in-One Relief

Uniformly cools the entire oral cavity, providing unmatched reduction in incidents and severity of oral mucositis.

Clinically Proven

The Chemo Mouthpiece® was studied in a multi-institutional, randomized, controlled trial.

Patient-Friendly

Single-patient, multi-use, safe, and simple to use throughout your treatment journey.

Frequently Asked Questions

What is the Chemo Mouthpiece®?

The Chemo Mouthpiece® (“CMP”) is an oral cryotherapy device, intended to be used to cool the oral mucosa (the inside surfaces of the mouth) to reduce the occurrence and severity of chemotherapy-induced oral mucositis in adult patients. When placed in a standard freezer for at least six hours, the specially designed devices will have a frozen inner core and an outer chamber which will be a cold liquid. When placed in the mouth, the system works to deliver cryotherapy (cold temperature) throughout the oral cavity. The devices are for single-patient use and are reusable throughout your course of treatment.

How Do I Get a Chemo Mouthpiece®?

The Chemo Mouthpiece® is available by prescription (Rx) only through your healthcare provider and is distributed in the USA by specialty healthcare service provider InfuSystem. The devices are supplied as a Patient Kit including six (6) pre-filled and reusable CMP devices, cooling packs, cleaning brushes, insulated sleeves, a carrying cooler and instructions for use.

What is Oral Mucositis?

Oral mucositis (OM) is a painful and debilitating side effect of many chemotherapy drugs. OM is characterized by inflammation and ulceration of mucous membranes in the mouth, which occurs when chemotherapy drugs attack and cause damage to those cells. These painful sores and ulcers can occur throughout the mouth including the hard and soft palate, tongue, gums, cheeks and lips.

How Does the Chemo Mouthpiece® Work?

Oral cryotherapy (temporarily cooling the inside of the mouth) restricts the flow of blood in that area. When chemotherapy drugs are circulating in the body, the restricted blood flow in the oral cavity means the chemotherapy drugs are physically limited from contact in that area. The reduced presence of chemotherapy drugs means a reduction in the damage they can cause to the sensitive lining of the mouth (the oral mucosal layer).

Why Does Chemotherapy Cause Mouth Sores?

According to the Mayo Clinic Staff, “Chemotherapy and radiation — alone or combined — can cause mouth sores. That’s because these cancer treatments are intended to kill rapidly growing cells, such as cancer cells. Some healthy cells in your body also divide and grow rapidly, including the cells that line the inside of your mouth. Unfortunately, these healthy cells are also damaged by chemotherapy and radiation. Damage to the cells in your mouth makes it difficult for your mouth to heal itself and to fend off germs, leading to sores and infections. Both chemotherapy and radiation can impair your body’s germ-fighting system (immune system). With an impaired immune system, viruses, bacteria and fungi can more easily infect your mouth, causing mouth sores or making mouth sores worse.”

Who is at Risk of Developing Oral Mucositis?

Oral mucositis is a common side effect of many different chemotherapy treatments, and a significant proportion of chemotherapy patients will experience some grade of OM. Many factors may affect the development and severity of oral mucositis, including but not limited to the specific chemotherapy regimen (type, dosages, frequency, cycle), patient age, oral health, and lifestyle factors.

When Do I Use the Mouthpiece?

The best way to protect yourself from the occurrence and severity of chemotherapy-induced oral mucositis is to be proactive in your approach and use the Chemo Mouthpiece from the very first chemotherapy infusion. The best efficacy has been shown when patients begin to use the Chemo Mouthpiece to cool the oral cavity starting 10 minutes prior to every chemotherapy infusion, use it throughout every infusion, and continue with additional oral cryotherapy sessions at home. See the full Instructions For Use for additional information, and be sure to discuss your specific therapy with your doctor.

Is the Chemo Mouthpiece® Safe and Easy to Use?

Yes! Chemo Mouthpiece® was engineered by a cancer patient with the fellow patients in mind. It’s simple makeup of FDA medical grade silicone/plastic, water and salt assures patients it’s a safe and effective non-toxic device. Remember to follow proper care instructions to keep the device clean!