New FDA-Approved Oral Stent From Kallisio Could Change the Way We Treat Cancer

Published on January 23, 2024 by Madeleine P.

Increasing research has been done in recent years on the ways that 3D printing can be used in the battle against cancer. Though much of this has understandably focused on things like bioprinting, including for the creation of prostheses and even for creating tumors to better study cancer, treatment using additive manufacturing is not just limited to that. For example, US-based Kallisio has turned to 3D printing to create an oral stent that will help in the treatment of head and neck cancers by reducing side effects from radiation therapy. Not only that, but it has officially received FDA clearance, showing it is safe and effective to use.

Radiation therapy, or radiotherapy as it is sometimes called, is a treatment in which high doses of radiation are used to kill cancer cells directly and thus shrink tumors. And though it may be less discussed than chemotherapy, it is widely used, with the WHO estimating in 2021 that more than 50% of cancer patients require radiotherapy as part of cancer care including for the most common, breast, cervical, colorectal and lung. However, that does not mean it does not come with side effects.

An image showing the impact that radiation has on organs in the mouth during treatment for head and neck cancers (image credits: Kallisio)

As anyone who has heard about Marie and Pierre Curie would know, radiation is dangerous. It is for that reason that even X-rays are closely monitored and people regularly working with the equipment needs sufficient safety gear. And as you can imagine, it does not distinguish between health and “diseased” cells like cancer, causing issues during treatment.

For example, for patients suffering from head and throat cancers (about 4% of all cancer cases in the US), radiation can cause side effects like soreness and open sores in the mouth or throat, dry mouth, trouble swallowing, nausea, earaches, tooth decay, jaw stiffness, hair loss and changes in skin texture including skin that is red, irritated, swollen or blistered. That is why Kallisio has sought a treatment that helps minimize the damage done to healthy cells. This thus improves patient outcomes and making treatment less painful.


The stent can be placed to reduce radiation on anything but the targeted area (image credits: Kallisio)

The Strentra Oral Stent from Kallisio

3D printing is the key to the Stentra™ oral stent. By combining it with digital imaging, it is possible to create a fully personalized and tailored device that is thus able to safeguard healthy tissue from radiation as it is able to match a patient’s treatment and anatomical needs. How it works, is that it is placed to immobilize the tongue, lips and other “organs at risk” (OAR). This prevents them from being exposed to the high-dose radiation target zone.

Now the stent has received 510(k) clearance, the so-called “Premarket Notification” for Stentra. This means that it has been reviewed for both safety and performance, showing that it can be safely used as well effective in its stated purpose. Next steps now involve Kallisio’s collaboration with cancer centers across the country in order to launch the product. The full solution includes as well intraoral scanning equipment and a cloud-based clinical portal ordering system with Kallisio printing the stents, though they do not mention which technology they use.


The stent is designed according to a patient’s treatment and anatomy, then 3D printed (image credits: Kallisio)

Rajan Patel, co-founder and CEO of Kallisio, concludes, “Designed to address each patient’s unique treatment and anatomical needs, Stentra delivers an unmatched level of customization and effectiveness in addressing the critical need to safeguard healthy tissue during radiation therapy. FDA clearance is an exciting milestone in our journey to improve patient experiences and quality of life.” You can learn more about the project on Kallisio’s website HERE.

What do you think of Kallisio’s patient-tailored oral stent? Let us know in a comment below or on our LinkedInFacebook, and Twitter pages! Don’t forget to sign up for our free weekly newsletter here, the latest 3D printing news straight to your inbox! You can also find all our videos on our YouTube channel.

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