the only patient-specific intraoral device for head and neck radiation therapy

Stentra™ is the only FDA cleared and CE marked, fully patient-specific intraoral device for head and neck radiation therapy. Custom-designed from a 15-minute scan. Delivered in 72 hours.

  • CPT-reimbursable
  • sub-millimeter precision

protecting healthy tissue while radiation does its job

Generic immobilization devices can’t account for each patient’s oral anatomy — leading to imprecise targeting, avoidable side effects, and treatment interruptions. Stentra™ is custom-built to fit each patient precisely, positioning the tongue and protecting healthy tissue with sub-millimeter accuracy.

precision-built for your patient, streamlined for your workflow

  • Custom-fit for sub-millimeter immobilization Crafted from each patient's unique intraoral scan
  • Ready in 72 hours Delivered before your patient’s first radiation session
  • CPT-reimbursable under code 77334
  • Reusable across all sessions Includes validated reprocessing instructions and a dedicated storage container
  • End-to-end HIPAA compliant No PHI transfer. No additional software required.

our community

ACCC
Astro
Materialise
Ricoh

Research

tongue displacement device in decreasing the radiation dose to tongue…

New E-BOOK

Advancing Precision Medicine in Head & Neck Cancer…

In the News

…Clinical Implementation… Patient-Specific Stentra™ System 

the numbers speak for themselves

Stentra™ efficacy is supported by multiple peer-reviewed clinical studies. The results below reflect documented outcomes across real patient populations showing fewer side effects and better outcomes.

77.6%

reduce mucositis
severity1

29.8%

decrease radiation to
tongue area2

32.3%

diminish difficulty
swallowing3

1 Are intraoral stents effective for reducing the severity of oral mucositis during radiotherapy for maxillary and nasal cavity cancer? (2020), Journal of Oral and Maxillofacial Surgery
2 Tongue displacement device in decreasing the radiation dose to tongue and preventing proton beam overshoot (2021), Frontiers in Physics
3 The impact of tongue-deviating and tongue-depressing oral stents on long-term radiation-associated symptoms (2020), Clinical and Translational Radiation Oncology

from scan to treatment-ready in 72 hours

Stentra™ fits into your existing clinical workflow without disruption — no additional hardware or software required, and end-to-end HIPAA compliant. Accepts STL, DICOM, and most optical scanner formats.

Stentra scan
Scan your patient

15min

Capture a precise 3D model of your patient's oral anatomy using a standard intraoral scanner. Scans are uploaded securely to the Kallisio portal, enabling same-day design initiation

1
Stentra scan
Stentra in container
Receive their custom device
in 72 hours

Each device is digitally modelled to the patient's anatomy and 3D-printed in medical-grade, biocompatible resin by ISO-certified manufacturing partners. Delivered before your patient’s first radiotherapy session

2
Stentra in container
Nurse setting up Stentra in a patient's mouth before radiation treatment
Treat with confidence
every session

Confirm fit and begin therapy. Stentra™ ensures consistent, repeatable positioning with minimal prep. Reusable across all sessions with validated reprocessing instructions. CPT-reimbursable under code 77334

3
Nurse setting up Stentra in a patient's mouth before radiation treatment

leading centers using stentra

We collaborate with top-tier medical centers across the U.S. and Europe to bring personalized oral protection into real-world oncology workflows. Together, we turn innovation into standard care — one patient at a time.

real stories,
real relief

Dr. Paiman Ghafoori, Radiation Oncologist, Texas Cancer Institute
“We are committed to providing the most advanced patient-centered care to our community. Implementing stentra™ allows us to enhance treatment precision while proactively protecting healthy tissue, an important step forward in improving both clinical outcomes and the patient experience.”

Dr. Paiman Ghafoori

Radiation Oncologist, Texas Cancer Institute

“We are committed to providing the most advanced patient-centered care to our community. Implementing stentra™ allows us to enhance treatment precision while proactively protecting healthy tissue, an important step forward in improving both clinical outcomes and the patient experience.”

no more one-size-fits-all
no more avoidable suffering

Everything your team
needs to know

Is Stentra™ reimbursable under existing CPT codes?

Yes. Stentra™ is eligible for reimbursement using current CPT codes for radiation therapy immobilization devices—typically CPT 77334 for custom, complex devices. Reimbursement amounts will vary based on payer policies, correct code selection, and supporting documentation. We supply clients with onboarding tools including coding guidance and claim-ready documentation templates to optimize codability and reimbursement.

What 3D printing process and materials are used to manufacture Stentra™?

Stentra™ devices are manufactured using a high-resolution additive manufacturing process (3D printing) with a biocompatible, medical-grade resin. This approach ensures clinical precision, consistent reproducibility, and a smooth surface finish—critical for intraoral comfort, safety, and anatomical conformity.

Does the presence of the immobilization & positioning device impact the radiation beam or planning accuracy?

No. Stentra™ is fabricated from low-density, non-metallic materials that are radiographically visible on CT but do not attenuate or scatter the therapeutic radiation beam. It integrates seamlessly into standard treatment planning workflows and does not require dose modification or beam compensation, preserving planning accuracy and clinical efficiency.

How should the Stentra™ device be reprocessed between treatment sessions?

Stentra™ is designed for repeated use throughout the patient’s treatment course. Each device is provided with a validated Instructions for Use for reprocessing and a dedicated reusable storage container. Radiation therapists can safely clean, disinfect, and store the device between sessions by following the recommended procedures—maintaining device integrity, safety, and patient comfort.

Will radiation affect more than just the cancer?

Yes. Although radiation therapy is designed to target cancerous tissue, it can also impact nearby healthy structures — particularly in the head and neck region. Common side effects include oral pain, mouth sores, difficulty swallowing, dry mouth, and changes in speech. These effects can interfere with daily life, make it harder to complete treatment, and may persist even after therapy ends.

How does Kallisio’s mission to deliver precision therapeutic devices translate into better patient care today?

Kallisio’s mission to deliver precision therapeutic devices directly translates into better patient care by enabling clinicians to provide highly targeted, anatomically accurate, and patient-specific support during treatment. Our digital platform combines clinical insight, design automation, and rapid 3D manufacturing to produce personalized devices—like Stentra™—that improve treatment precision, and enhance patient comfort and adherence. This integration of technology and care helps minimize delays, optimize clinical outcomes, and support a more compassionate, effective treatment experience from day one.

What makes Kallisio’s intraoral platform different from other immobilization or tissue-protection tools on the market?

Kallisio’s Stentra™ platform stands apart by offering true personalization through millimeter-accurate, 3D-printed devices designed from each patient’s unique anatomy and treatment plan. Unlike prefabricated or semi-custom tools, Stentra™ not only immobilizes but also displaces critical structures such as the tongue, optimizes oral aperture, and enhances radiation delivery precision. Our simulation-ready devices are delivered within 72 hours, require no additional software, integrate seamlessly into existing workflows, and are CPT-reimbursable—enabling scalable, high-precision care without disrupting clinical operations.

What clinical expertise informs the development of Kallisio’s technology?

Kallisio’s platform was co-developed with clinical experts at leading institutions, including MD Anderson Cancer Center, and is informed by deep expertise in radiation oncology, maxillofacial prosthodontics, and medical physics. The technology behind our flagship product, Stentra™, is FDA-cleared and built on rigorously validated clinical protocols. Our multidisciplinary team brings decades of experience in oncology, digital health, and advanced manufacturing to ensure each solution meets the highest standards of patient care and regulatory compliance.

Is the Kallisio Clinical Portal HIPAA-compliant?

Yes. The Kallisio Clinical Portal is fully HIPAA-compliant. It is designed to neither collect, store, nor transmit Protected Health Information. Each case is managed using a system-generated unique device identifier, ensuring patient confidentiality while maintaining institutional control and traceability.

Why choose Stentra™

Stentra™ is the only FDA-cleared, fully patient-specific intraoral immobilization solution designed for head and neck radiotherapy. Engineered for precision, it offers rapid production and delivery within 72 hours and customizable configurations to accommodate individual tumor anatomy and treatment plans. Clinically validated and available for immediate use.

Why choose Stentra™
Stentra™ is the only FDA-cleared, fully patient-specific intraoral immobilization solution designed for head and neck radiotherapy. Engineered for precision, it offers rapid production and delivery within 72 hours and customizable configurations to accommodate individual tumor anatomy and treatment plans. Clinically validated and available for immediate use.
Yes. Stentra™ is eligible for reimbursement using current CPT codes for radiation therapy immobilization devices—typically CPT 77334 for custom, complex devices. Reimbursement amounts will vary based on payer policies, correct code selection, and supporting documentation. We supply clients with onboarding tools including coding guidance and claim-ready documentation templates to optimize codability and reimbursement.
Kallisio’s mission to deliver precision therapeutic devices directly translates into better patient care by enabling clinicians to provide highly targeted, anatomically accurate, and patient-specific support during treatment. Our digital platform combines clinical insight, design automation, and rapid 3D manufacturing to produce personalized devices—like Stentra™—that improve treatment precision, and enhance patient comfort and adherence. This integration of technology and care helps minimize delays, optimize clinical outcomes, and support a more compassionate, effective treatment experience from day one.
Kallisio’s Stentra™ platform stands apart by offering true personalization through millimeter-accurate, 3D-printed devices designed from each patient’s unique anatomy and treatment plan. Unlike prefabricated or semi-custom tools, Stentra™ not only immobilizes but also displaces critical structures such as the tongue, optimizes oral aperture, and enhances radiation delivery precision. Our simulation-ready devices are delivered within 72 hours, require no additional software, integrate seamlessly into existing workflows, and are CPT-reimbursable—enabling scalable, high-precision care without disrupting clinical operations.
Kallisio’s platform was co-developed with clinical experts at leading institutions, including MD Anderson Cancer Center, and is informed by deep expertise in radiation oncology, maxillofacial prosthodontics, and medical physics. The technology behind our flagship product, Stentra™, is FDA-cleared and built on rigorously validated clinical protocols. Our multidisciplinary team brings decades of experience in oncology, digital health, and advanced manufacturing to ensure each solution meets the highest standards of patient care and regulatory compliance.
Stentra™ devices are manufactured using a high-resolution additive manufacturing process (3D printing) with a biocompatible, medical-grade resin. This approach ensures clinical precision, consistent reproducibility, and a smooth surface finish—critical for intraoral comfort, safety, and anatomical conformity.
Yes. The Kallisio Clinical Portal is fully HIPAA-compliant. It is designed to neither collect, store, nor transmit Protected Health Information. Each case is managed using a system-generated unique device identifier, ensuring patient confidentiality while maintaining institutional control and traceability.
No. Stentra™ is fabricated from low-density, non-metallic materials that are radiographically visible on CT but do not attenuate or scatter the therapeutic radiation beam. It integrates seamlessly into standard treatment planning workflows and does not require dose modification or beam compensation, preserving planning accuracy and clinical efficiency.
Stentra™ is designed for repeated use throughout the patient’s treatment course. Each device is provided with a validated Instructions for Use for reprocessing and a dedicated reusable storage container. Radiation therapists can safely clean, disinfect, and store the device between sessions by following the recommended procedures—maintaining device integrity, safety, and patient comfort.
Yes. Although radiation therapy is designed to target cancerous tissue, it can also impact nearby healthy structures — particularly in the head and neck region. Common side effects include oral pain, mouth sores, difficulty swallowing, dry mouth, and changes in speech. These effects can interfere with daily life, make it harder to complete treatment, and may persist even after therapy ends.

ready to bring stentra™ to your patients?

Whether you’re a clinician or healthcare partner, we’re here to deliver smarter, safer, and more personalized cancer support solutions. Connect with our team to explore how our technology-enabled services can integrate into your care journey. We’ll respond within 24 hours.

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Radiation Oncologist Details

Stentra™ is FDA cleared and prescribed (Rx) by the Radiation Oncologist. To build a Stentra device, we need to know how the Radiation Oncologist wants to position the patient's tongue. We also need the patient's target simulation date to ship Stentra™ in time for planning. Once we have the information outlined in this form and the required oral optical scans, the Stentra™ device can be delivered in as little as 72 hours. Please review the Stentra™ types below and fill out the following information:

Stentra™ types

If you are not the patient's Radiation Oncologist but are placing this order on their behalf, we need your information as well.

Radiation Oncologist Details

Stentra™ is FDA cleared and prescribed (Rx) by the Radiation Oncologist. To build a Stentra device, we need to get the order and prescription from the patient's radiation oncology team. We also need the patient's target simulation date to ship Stentra™ in time for planning. Once we have the required oral optical scans, the Stentra™ device can be delivered in as little as 72 hours. Please provide the following information:

Case approval

Providing Additional Information

If you would like, you can download and print out our brochure found on our patient page under « talk to your doctor ». Please bring this brochure to your Radiation Oncologist and ask them to look into whether this is a good option for your case.

Your dental practice

Your Radiation Oncologist

Your dental practice or provider equipped with an intraoral optical scanner

What happens next

Thank you for submitting the order request. When this form is submitted, if you provided an email to us, we will dispatch an onboarding invite to the radiation oncology clinic via email requesting that they register their practice and authorize the order for your patient. If no email was provided, please call the patient's radiation clinic to get them onboard and fill out an order form through our website.

What happens next:

  1. Review instructions. Detailed scan protocols and submission instructions will be emailed to the addresses associated with your dental clinic listed in your request.
  2. Continue with the scan. If all dental work has been done and the patient is cleared to start radiation therapy, continue with the scan following the instructions sent to you.
  3. Oncology setup. Once the radiation oncology team completes their setup, authorizes and confirms the order, we can start fabricating the device.

Thank you for your partnership in getting this patient ready for treatment.

Billing Information

Reimbursement information — for reference only. This is not billing advice and does not guarantee coverage or payment. Providers are responsible for code selection, documentation, and claim accuracy.

CPT® 77334 (Treatment devices, design and construction; complex) covers complex radiation therapy devices designed and fabricated for an individual patient. Physician involvement in device selection, design, and placement should be documented.

Stentra™ is an FDA 510(k) cleared (K232293), patient-specific intraoral positioning device. Providers may consider CPT 77334 for its design and construction, subject to their own coding review.

Delivery method: the code is not limited to one technique and may apply across IMRT, 3D-CRT, and other external beam approaches.

Multiple devices: when a thermoplastic mask and Stentra™ each serve a distinct, documented purpose, each may be separately reportable, subject to NCCI edits, MUE limits, and payer policy.

Questions: contact Kallisio at care@kallisio.com. For coding decisions, consult your coding and compliance team.

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