After own struggle during cancer therapy, engineer develops device to treat oral mucositis
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Key takeaways:
- Chemo Mouthpiece is designed to cool the oral cavity for the entire duration of chemotherapy treatment.
- The manufacturer of the device is seeking FDA clearance on the strength of a randomized clinical trial.
A cancer survivor who experienced oral mucositis during chemotherapy treatment has designed a device to improve quality of life for patients dealing with this painful side effect.
Chemo Mouthpiece is a cryotherapy device that provides uniform cooling of the oral cavity to relieve symptoms of treatment-induced oral mucositis. The device, which is being launched in partnership with EVERSANA, has delivered promising results in an interim analysis of a randomized clinical trial and is advancing toward FDA clearance.
“While I was going through treatment, I almost immediately began to develop mouth sores, and it was brutal,” ChemoMouthpiece LLC founder and CEO David Yoskowitz told Healio. “It hurt to eat; it hurt to talk. I looked for anything I could find to help me.”
In the end, Yoskowitz invented his own solution.
Yoskowitz and ChemoMouthpiece LLC chief commercial officer Frank Jacobucci spoke with Healio about the origins of this device and its potential to improve quality of life in patients undergoing cancer treatment.
Healio: How did this device come to be?
Yoskowitz: I was diagnosed with Hodgkin lymphoma in January 2014. It was stage II bulky disease. During treatment, I was in really good shape — I was 35 years old and had just run a marathon 1 month before. It didn’t matter — I still got a lot of mouth sores. I couldn’t find anything that really helped. They give you a mouthwash that numbs you, and that helps, but it only covers up the pain temporarily. Luckily, I didn’t have any oral infections from the open sores in my mouth, but some patients do, and that is a debilitating side effect.
About a year and a half after my treatment, I woke up in the middle of the night and had this idea for Chemo Mouthpiece.
Healio: How did you design this device?
Yoskowitz: I am an engineer — I started out as a physics major at Columbia University and switched to operations research and economics, but my background is in engineering. So, when the idea came to me, I was able to connect the dots into something that could actually work. Chemo Mouthpiece has two chambers — an inner chamber with pure water that freezes solid and an outer chamber with a proprietary saline solution that does not freeze. The saline solution circulates around the inner core and mouthpiece to keep the entire oral cavity cool. The uniqueness of the design allows Chemo Mouthpiece to fit 95% of patients.
I used to own a commercial heating and air conditioning manufacturing company, and through that company I had seven other patents. I had gone through this process with those types of products — I did the prototyping and worked with 3D printing companies. I went through these steps to get to a device that works.
Healio: What is it made of and how does it work?
Yoskowitz: It’s made of medical-grade silicone, highly purified water and table salt — everything is generally regarded as safe. You take it out of the freezer, open the plastic bag, and place it in your mouth. It’s very simple and, depending on the size of the patient, it stays cold anywhere from 30 to 45 minutes. It has thicker silicone around where it comes in contact with your teeth to avoid significant tooth sensitivity issues. It uses cryotherapy to cool the oral cavity, causing the blood vessels to constrict, therefore, minimizing or eliminating the flow of chemotherapy in the oral cavity. This reduction in chemotherapy in the oral cavity reduces the rate and pain associated with oral mucositis. Chemotherapy drugs attack rapidly dividing cells, such as your hair and your oral mucosa, and this reduces the circulation of these drugs.
Healio: How has it been tested so far, and what are the findings?
Jacobucci: We have embarked on a large clinical trial looking at the device in several hundred patients. We’re getting ready to close out that portion of the trial. We’re looking at about 11 tumor types and about 30 different chemotherapy regimens. Some of these tumor types and chemotherapy regimens have utilized cryotherapy and some haven’t, because of the limitations of the delivery of ice to the oral mucosa for extended periods of time. This device is so friendly that patients can use it for 3 to 4 hours at a time, whereas it’s unlikely that patients would be able to tolerate ice in their mouths for that long. Because this device is like a sports mouthpiece and is made of soft silicone, it enables patients to tolerate it longer.
We can’t report the data because it isn’t available yet, but in the previous interim analysis we saw a large improvement over the current standard of care, meaning many more patients are spared the pain of mucositis. This device may reduce the need for opioids and analgesics to control pain, which potentially is huge.
Healio: There has been an increased focus in cancer treatment on not just prolonging life, but also maintaining quality of life. How does this device help with that?
Yoskowitz: My quality of life was significantly diminished due to the mouth sores that I had while going through treatment. This significantly reduces that for patients. We expect it to help hundreds of thousands of patients with cancer every year in the United States once we get to market. It’s going to improve their quality of life as they go through treatment and help them persist with their treatment so they can live longer.
Healio: What is next in the regulatory process?
Yoskowitz: We’re finishing the trial and collecting all the data, which we will submit to the FDA. We’re looking for FDA clearance to market the product with the claim that it prevents or manages/reduces the overall rate and pain associated with severity of oral mucositis in patients undergoing chemotherapy.
Healio: Is there anything else you’d like to mention?
Jacobucci: We have had quite a few patients who were ready to throw in the towel and give up on chemotherapy because of the severity of their oral mucositis. They had lost so much weight and were in so much pain that they were willing to stop chemotherapy. This is a well-documented phenomenon about cancer treatment — sometimes, these debilitating side effects are such that they’d rather stop than continue their fight. This device has enabled a lot of patients to continue because it improves their quality of life while they are going through treatment.
For more information:
Frank Jacobucci can be reached at ChemoMouthpiece, 10 Railroad Ave., Closter, NJ 07624; email: fjacobucci@chemomouthpiece.com.
David Yoskowitz can be reached at ChemoMouthpiece, 10 Railroad Ave., Closter, NJ 07624; email: dyoskowitz@chemomouthpiece.com.
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