Kallisio Expands Patient Access Program for Stentra in Head and Neck Cancer Radiation Therapy
Kallisio has announced an expanded patient access program designed to help people preparing for radiation therapy for head and neck cancer obtain Stentra, a custom-fit, 3D-printed intraoral device cleared by the U.S. Food and Drug Administration (FDA) under 510(k) K232293.
The initiative is intended to address a potential access barrier for patients whose treatment centers have not yet adopted Stentra. Through the expanded program, Kallisio will work directly with patients, caregivers, radiation oncology teams and dental professionals to help eligible patients obtain and use the device as part of their radiation treatment.
Head and neck cancer radiation therapy can require highly precise treatment planning because tumors may be located close to sensitive structures in the mouth and surrounding tissues. Radiation teams must deliver therapeutic doses to the intended treatment area while limiting unnecessary exposure to healthy tissue. Maintaining consistent positioning of the tongue, lips and other oral structures throughout a multi-session course of radiation can therefore be an important component of treatment planning and delivery.
Stentra is designed to support this process through a patient-specific approach. The device is manufactured using a digital dental scan of an individual patient’s mouth and is intended to be worn during radiation sessions. By helping maintain the position of oral structures from one treatment session to another, Stentra is designed to help radiation teams reproduce the planned treatment setup while keeping healthy tissue away from areas receiving higher radiation doses.
Rajan Patel, CEO of Kallisio, said patients preparing for head and neck radiation should have access to options that may help make treatment more tolerable. He added that Kallisio is working directly with patients, oncology teams and dental partners so eligible individuals can access Stentra even when their treatment facility has not yet incorporated the technology into its standard practice.
Patient-Specific Approach to Radiation Support
Stentra is based on a personalized manufacturing process rather than a one-size-fits-all device. The system begins with a digital scan of the patient’s mouth, which is used to create a custom-fit intraoral device.
This approach is intended to account for differences in individual oral anatomy. Once produced, the device is used during radiation sessions to help hold the tongue, lips and other oral structures in a consistent position.
Consistency can be particularly important during radiation therapy because patients typically undergo multiple treatment sessions over an extended period. Each session requires the patient to be positioned as accurately as possible so that radiation is delivered according to the treatment plan.
Changes in the position of oral structures can potentially affect the relationship between the treatment field and nearby healthy tissue. Stentra is designed to provide a reproducible intraoral position throughout the treatment course, supporting the radiation team’s efforts to deliver therapy as planned.
Kallisio’s patient access program is intended to make this technology available to eligible patients regardless of whether their treatment center has already established a formal Stentra program.
How Patients Can Access Stentra
Under the expanded program, patients who are scheduled to begin radiation therapy for head and neck cancer, as well as their caregivers, can contact Kallisio directly through the company’s website.
The access process begins with coordination between the patient and the treating radiation oncology team. Kallisio will work with the patient’s radiation oncologist to determine whether the patient is clinically eligible for the device.
Once eligibility is confirmed, Kallisio will arrange for the patient to receive the required intraoral digital scan through a local dental professional. The scan provides the digital information needed to produce the custom-fit Stentra device.
The company will then coordinate with the patient’s care team to facilitate the use of the device during radiation treatment.
Importantly, the program is designed to address situations in which a patient’s treatment center does not currently provide Stentra. When appropriate, Kallisio said it will sponsor the device for eligible patients at centers that have not yet become Stentra providers.
This approach is intended to reduce the possibility that patients will miss out on the technology simply because their oncology center has not yet incorporated it into its clinical workflow.
Patients, caregivers and families can obtain additional information through Kallisio’s patient resource page.
Supporting Head and Neck Radiation Treatment
Radiation therapy is an important treatment modality for many people with head and neck cancers. Depending on the type, location and stage of cancer, radiation may be used alone or alongside surgery, chemotherapy or other treatments.
Because structures in the head and neck can be located close together, treatment planning often requires careful attention to the relationship between tumors and healthy organs and tissues. The oral cavity can be particularly relevant in radiation treatment because structures such as the tongue and lips may be located close to the target area.
The ability to reproduce patient positioning during every treatment session is therefore an important consideration for radiation oncology teams.
Kallisio designed Stentra to address this positioning challenge through a patient-specific intraoral device. By helping maintain the same oral configuration during each radiation session, the system is intended to support consistency between the patient’s treatment plan and actual treatment positioning.
The company believes this approach may provide radiation teams with an additional tool for managing the treatment environment while helping patients undergo their prescribed radiation course.
Clinical Experience With Stentra
Stentra is already in clinical use at leading cancer centers in the United States, according to Kallisio. The company recently announced a collaboration involving Stanford Health Care, further expanding the clinical implementation of its patient-specific system.
Kallisio said an observational case series involving Stentra demonstrated that patients tolerated the device throughout their complete course of radiation therapy. The company also reported that positioning remained consistent from day to day during treatment.
Another reported observation from clinical experience to date is that no treatment days were missed because of the device, and there were no device-related treatment interruptions.
These observations are particularly relevant because the successful use of any patient-specific device during radiation therapy depends not only on its technical design but also on whether patients can comfortably and consistently use it throughout their treatment course.
Kallisio said more detailed clinical findings from its experience with Stentra are being prepared for peer-reviewed publication. Future published data may provide additional information regarding the device’s use, tolerability and potential role in supporting radiation therapy for patients with head and neck cancer.
Collaboration Between Oncology and Dental Professionals
The Stentra access program also highlights the role of collaboration between different healthcare professionals. Because the device is produced from a digital dental scan, dental professionals play an important role in the process.
At the same time, radiation oncologists are responsible for determining whether the device is appropriate for an individual patient’s treatment plan and coordinating its clinical use.
This multidisciplinary model allows Kallisio to connect the dental scanning and custom manufacturing process with the requirements of radiation oncology. The company’s involvement in coordinating these steps is intended to make access more straightforward for patients and caregivers.
For patients undergoing cancer treatment, navigating multiple appointments and healthcare providers can be challenging. By helping coordinate the process, Kallisio aims to reduce logistical barriers associated with obtaining a customized device before radiation treatment begins.
Expanding Access Beyond Established Provider Centers
A key feature of the expanded program is its focus on patients whose treatment centers do not yet offer Stentra.
New medical technologies often become available gradually as hospitals evaluate clinical evidence, establish workflows and train staff. During this adoption process, patients may receive care at centers where a particular technology is not yet routinely available.
Kallisio’s decision to sponsor Stentra for eligible patients in appropriate circumstances is designed to bridge this gap. Rather than limiting access to institutions that have already adopted the technology, the company is working directly with individual patients and their care teams.
This strategy could also provide Kallisio with additional real-world experience across different treatment environments and healthcare organizations.
Building on Patient-Centered Medical Device Development
The expanded Stentra access program reflects Kallisio’s broader focus on developing patient-specific medical technology for radiation therapy. The company’s approach combines digital dental scanning, customized manufacturing and clinical coordination to create an intraoral device tailored to each patient’s anatomy.
For patients with head and neck cancer, the treatment journey can involve extensive planning and multiple appointments. Technologies designed to support the consistency of radiation delivery may become an important part of efforts to optimize treatment while considering the protection of surrounding healthy tissues.
Stentra’s FDA 510(k) clearance provides a regulatory foundation for its use in the United States, while the company’s ongoing clinical experience is intended to build further evidence around its practical application.
With the expanded patient access initiative, Kallisio is now seeking to make Stentra available to a broader population of eligible patients, including those treated at centers that have not yet adopted the system.
Kallisio’s expanded access program represents an effort to bring personalized radiation-support technology closer to patients who may benefit from it. By coordinating eligibility assessment, dental scanning and communication with radiation oncology teams, the company is seeking to simplify the process of obtaining Stentra before treatment begins.
The device’s custom-fit design and intended role in maintaining consistent positioning of oral structures during radiation reflect the growing use of personalized technologies in cancer care. At the same time, the company’s reported clinical experience, including use at major U.S. cancer centers, provides an early foundation for further evaluation.
As additional clinical data are developed and prepared for peer-reviewed publication, Stentra may generate greater understanding of how patient-specific intraoral positioning can be incorporated into head and neck radiation workflows.
For now, Kallisio’s expanded program is focused on a practical objective: helping eligible patients access a custom-fit device even when their treatment center has not yet adopted it. By bringing patients, radiation oncologists and dental professionals together, the company aims to reduce access barriers and support consistent treatment positioning throughout the radiation therapy journey.
About Kallisio
Kallisio develops patient-specific devices and supportive-care technologies for cancer treatment, combining digital design and 3D printing with established clinical workflows. Stentra is FDA 510(k) cleared (K232293) using technology licensed from The University of Texas MD Anderson Cancer Center. Learn more at kallisio.com.