frequently asked
questions

At Kallisio we aim at redefining oncology by designing patient-specific
solutions that reduce the side effects of treatment — without disrupting
clinical workflows.
Does the presence of the stent 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.

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.

What is Kallisio and what problem are you solving?

Kallisio is a medical innovation company focused on improving the quality of care in treatments through technological precision advancements. Our mission is to enhance precision, comfort, and outcomes for patients.

Is Kallisio specialized in oncology ?

Oncology is our first area of focus, starting with head and neck cancer. But our technology is designed to scale across multiple specialties where patient-specific solutions can improve treatment outcomes.

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.

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.

Who is Stentra™ designed for?

Stentra™ is designed for patients undergoing radiation therapy for head and neck cancers. It is particularly beneficial for those who need precise tongue and jaw positioning during treatment, including individuals with complex anatomies or without natural teeth (edentulous). Each device is customized to the patient’s unique anatomy to help improve the accuracy of radiation delivery and reduce exposure to healthy tissues. Ask your doctor if Stentra™ may be appropriate for your treatment plan.

What evidence supports stentra™ effectiveness?

Stentra™ is based on clinical research showing that customized oral stents can improve the precision of radiation delivery, reduce exposure to healthy tissues, and lessen treatment-related side effects. Studies also highlight improvements in patient comfort and treatment compliance, especially for those undergoing head and neck radiation therapy. Talk to your doctor about how Stentra™ may support your care.

How long does it take to receive a custom device?

After your oral scan is submitted, your custom Stentra™ stent is designed, 3D printed and delivered within 72 hours. It’s typically ready before your first radiation treatment session, ensuring there’s no delay in your care.

Do you ship internationally?

Yes. We work with international partners and can adapt shipping and support services to meet regional requirements. Please contact us to confirm availability and service options in your country.

What are the benefits of participating in the Stentra™ Proof of Value Program?

The program offers your team direct experience with Stentra™—Kallisio’s FDA-cleared, patient-specific oral stent for head and neck radiation therapy. It enables evaluation of clinical benefits such as improved patient positioning, potential reduction in oral mucositis, and enhanced treatment tolerance. Additionally, your team can assess workflow integration, billing feasibility using existing CPT codes, and potential long-term return on investment.

What’s required from my clinic to get started in the Stentra™ Proof of Value Program?

Select up to 10 head and neck cancer patients and assign a team member to upload cases via Kallisio’s secure clinical portal. An intraoral scanner is preferred—Kallisio can assist if one is not available. Device fit is verified during CT simulation. Follow-up is required to share toxicity and setup reproducibility data, which are essential to assessing clinical and operational impact.

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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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