Press Release

RICOH 3D for Healthcare and Kallisio partner to enhance radiation oncology care with Stentra™

RICOH 3D for Healthcare and Kallisio partner to enhance radiation oncology care with Stentra™

Stentra & RICOH

EXTON, PA, September 26, 2024 – Ricoh USA, Inc. and Kallisio today announced a strategic partnership to manufacture and distribute Stentra™, a 510(k)-cleared, patient-specific intraoral immobilization and positioning device designed to improve radiation therapy for head and neck cancer (HNC) patients. Developed using technology exclusively licensed from MD Anderson Cancer Center, Stentra™ is engineered to protect healthy tissue by precisely displacing and immobilizing sensitive areas during treatment, allowing for more targeted and effective radiation delivery. This innovation is crucial in minimizing side effects and enhancing overall treatment outcomes.

RICOH 3D for Healthcare, a leader in the manufacturing of patient-specific medical devices, will utilize its network of FDA-registered 3D printing facilities to produce Stentra™, ensuring rapid and efficient distribution to radiation oncology teams nationwide.

 

“Our collaboration with Kallisio highlights our shared commitment to advancing cancer care by addressing critical needs in toxicity management. “Stentra™ not only protects the tongue and other healthy tissues from exposure to radiation but also enhances the precision of radiation therapy, thereby reducing side effects and improving patient quality of life.”

Gary Turner, Managing Director, RICOH 3D for Healthcare

 

Starting in October, radiation oncologists will be able to order Stentra™ through RICOH 3D for Healthcare’s Clinical Applications Specialists, marking a pivotal step in empowering medical professionals with advanced tools for personalized, patient-centered care.

 

“Partnering with RICOH 3D for Healthcare is a natural fit for our mission to transform cancer care. Ricoh’s expertise in advanced manufacturing and their robust distribution network, including point-of-care production capabilities and clinical applications team, make them an ideal partner. Together, we can ensure that Stentra™ reaches radiation oncology teams efficiently, enhancing treatment precision and patient outcomes on a broad scale.”

Rajan Patel, CEO of Kallisio

 

RICOH 3D for Healthcare and Kallisio will be showcasing Stentra™ at the ASTRO 2024 Annual Meeting, held at the Walter E. Washington Convention Center in Washington, D.C., from September 29 to October 2, 2024. Radiation oncologists and healthcare professionals are invited to visit Booth #801 to experience firsthand demonstrations of Stentra™ and learn more about its application in improving cancer care. Attendees will have the opportunity to discuss the benefits and implementation of this innovative device with Ricoh and Kallisio’s team of radiation oncology experts.

 

About Ricoh
Ricoh is a leading provider of integrated digital services and print and imaging solutions designed to support digital transformation of workplaces, workspaces and optimize business performance. Headquartered in Tokyo, Ricoh’s global operation reaches customers in approximately 200 countries and regions, supported by cultivated knowledge, technologies, and organizational capabilities nurtured over its 85-year history. In the financial year ended March 2024, Ricoh Group had worldwide sales of 2,348 billion yen (approx. 15.5 billion USD). It is Ricoh’s mission and vision to empower individuals to find Fulfillment through Work by understanding and transforming how people work so we can unleash their potential and creativity to realize a sustainable future.

For further information, please visit www.ricoh.com.
© 2024 Ricoh USA, Inc. All rights reserved. All referenced product names are the trademarks of their respective companies.

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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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