Article

Making Sparing Organs-at-risk Actionable: The Next Step in Precision Head & Neck Radiotherapy

Making Sparing Organs-at-risk Actionable: The Next Step in Precision Head & Neck Radiotherapy

Communicating Radiotherapy’s Value to Advance Care | Visit Kallisio at ASTRO 2026 Booth #2624

Kallisio develops patient-specific solutions for precision radiation oncology. At ASTRO 2026, where the field is focused on communicating radiotherapy’s value, Stentra™ offers something concrete: a published, reimbursable, FDA-cleared technology that translates organ-at-risk sparing into a scalable digital workflow available to every head and neck program today.

A persistent gap exists in head and neck cancer radiotherapy. Generic intraoral devices cannot reliably displace the tongue, buccal mucosa, and soft palate out of high-dose regions, nor hold those structures reproducibly across 30 to 35 treatment fractions. The result is avoidable radiation exposure to uninvolved oral structures, contributing to mucositis, dysphagia, taste impairment, and treatment interruptions. Grade 3 to 4 oral mucositis affects 35 to 57% of patients undergoing definitive chemoradiotherapy for head and neck cancer (Trotti et al., Radiother Oncol, 2003), with incremental per-patient costs exceeding $17,000 per episode (Elting et al., Cancer, 2003). The clinical case for upstream tissue protection is established. What has been missing is a scalable, workflow-neutral solution.

Stentra is a patient-specific intraoral immobilization and tissue-displacement device, designed around each patient’s oral anatomy. CT or intraoral scan data is uploaded to Kallisio’s HIPAA-compliant platform. Proprietary software generates a custom device geometry in minutes. The device is additively manufactured and delivered in as little as 72 hours, ready for simulation and every subsequent fraction, with no treatment planning system modifications or IT integration required.

Published evidence supporting patient-specific intraoral stents:

  • 77.6% reduction in Grade 3 to 4 oral mucositis versus standard of care (Studer et al., Radiother Oncol, 2012)
  • Significant reduction in severe taste impairment (2% vs. 15%, p=0.047) and improved swallowing outcomes (21% vs. 31% moderate to severe dysphagia, p=0.013) across 462 oropharyngeal cancer survivors at MD Anderson (Stieb et al., Clin Transl Radiat Oncol, 2020)
  • 29.8% reduction in mean tongue radiation dose with patient-specific stents (Ramakrishnan et al., Br J Radiol, 2017)

These findings align with the ASTRO 2026 Presidential Symposium focus on organ preservation as an under-recognized value of radiation therapy. Stentra makes that value visible in dose metrics, symptom outcomes, and patient-reported quality of life. Additionally, early clinical implementation experience suggests operational gains: reduced simulation re-scans, fewer unplanned interventions, and an estimated 3 to 4 hours of recovered linac capacity per treatment course.

  • Stentra is billable under CPT 77334 (Treatment Devices, Design and Construction; Complex). Published CY2025 Medicare rate: $366.07 per patient (Hospital APC; CMS HOPPS Final Rule, effective January 1, 2025). At a 60/40 Medicare to commercial payer mix, device cost is revenue-neutral to net-positive at billing, before downstream savings from avoided hospitalizations and re-simulations.
  • Stentra is FDA 510(k) cleared (K232293) and CE-marked. The technology is licensed from The University of Texas MD Anderson Cancer Center and is deployed at Stanford Health Care, MD Anderson, and additional cancer centers. Devices are manufactured by Ricoh USA under an ISO 13485-aligned quality system.

Kallisio offers a structured proof-of-value pilot for qualified institutions, including onboarding, training, loaned equipment, and 10 to 15 devices at no cost, with CPT 77334 billing guidance provided. Beyond head and neck radiotherapy, Kallisio is extending its patient-specific platform to oral cryotherapy (Stentra CoolCare™, targeting chemotherapy-induced oral mucositis) and targeted intraoral drug delivery.

Visit Kallisio at ASTRO 2026 (booth #2624) to review outcomes data, discuss clinical partnerships, and explore how Stentra supports your program’s commitment to communicating and delivering radiotherapy’s full value.

— Rajan Patel
Founder and CEO, Kallisio

Share :

Similar articles

Radiation Kallisio
3D printing Kallisio
Hospital US

let’s make treatments

safer, together

Whether you’re a clinician, patient, or partner, we’re here to answer your questions and help you take the next step with patient-specific protection. Reach out — we’ll respond within 24 hours.
Kallisio — Advanced Contact Form V2.1.1 (multi-step)

Contact Us

Great — you can pick a slot directly in our scheduler.

Book a demo →

I am a…

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.

Financial Responsibility, Prescription & Accuracy Attestation

Attesting Information

Attestation to Truthful Information

Tell us more

We'll route your message to the right team.

Book a demo

Pick a slot that works for you:

Open the scheduler →

Stay informed

Newsletter

Don’t miss any updates, resources or opportunities! Subscribe to our newsletter and join our community.

Newsletter: Newsletter form

By submitting this form, you consent to receive marketing emails from Kallisio. You can unsubscribe at any time via the link in any email. See our Privacy Policy.

Stay informed

Newsletter

Don’t miss any updates, resources or opportunities! Subscribe to our newsletter and join our community.

Newsletter: Newsletter form

By submitting this form, you consent to receive marketing emails from Kallisio. You can unsubscribe at any time via the link in any email. See our Privacy Policy.