Press Release

FDA clears Kallisio’s patient-tailored intraoral immobilization and positioning device for head and neck cancer (HNC) treatment

FDA clears Kallisio’s patient-tailored intraoral immobilization and positioning device for head and neck cancer (HNC) treatment

Kallisio CEO Rajan Patel presenting Stentra

Highly customized 3D printed Stentra™️ enables targeted and precise HNC radiation therapy while safeguarding healthy tissue

 

Press Release

BALTIMORE, MD (January 18, 2024)—Kallisio, focused on developing solutions to manage toxicity in cancer care, announces FDA 510(k) clearance for Stentra, an individually tailored 3D printed intraoral immobilization and positioning devicet solution designed to protect healthy tissue in Head and Neck Cancer (HNC) patients. Customized for each patient, the Stentra oral immobilization device effectively directs radiation to the target tumor area while reducing harmful impact to surrounding tissue.

By integrating patient oral data with advanced 3D printing, Stentra is meticulously tailored to mitigate target positioning discrepancies associated with radiotherapy methods like IMRT (intensity-modulated radiation therapy). A Stentra device immobilizes tongue, lips, and other OARs (organs at risk), keeping them clear of the high-dose radiation target zone.

Key Stentra™️ Benefits

  • High Treatment Accuracy: Patient-customized solution for precise and targeted radiation therapy

  • Effective Toxicity Management: Protects surrounding healthy tissue from high doses of radiation

  • Rapid Scan-to-custom-device Delivery: Patient tailored oral solutions are fabricated in less than 5 days

 

“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.”

Rajan Patel, Kallisio Co-founder and CEO

 

The foundational technology behind Stentra was licensed by Kallisio from The University of Texas MD Anderson Cancer Center, where it was developed by Eugene Koay, M.D., Ph.D., Associate Professor of Gastrointestinal Radiation Oncology at MD Anderson.

Kallisio is collaborating with cancer centers across the U.S. to launch Stentra. The solution includes top-tier intraoral scanning equipment and a cloud-based clinical portal ordering system with real-time monitoring, best-in-class compliance, and seamless integration into the radiation oncology workflow.

Disclosure
Dr. Koay serves in an advisory role with Kallisio. MD Anderson has an institutional conflict of interest with Kallisio, and this relationship will be managed according to an MD Anderson Conflict of Interest Management and Monitoring Plan.

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A profile view of a person using the Kallisio Stentra intraoral positioning system. The image features a semi-transparent anatomical overlay showing the device positioning the tongue and soft tissues within the mouth and jaw. A heatmap overlay indicates the targeted radiation treatment area for head and neck cancer.
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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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