Kallisio | Custom 3D-Printed Immobilization Device of the Year 2026

MedTech Outlook Magazine

Kallisio
A Scalable Platform for Personalized Oncology Devices

Rajan Patel, Kallisio | Medical Tech Outlook | Custom 3D-Printed Immobilization Device of the YearRajan Patel, CEO
Radiation oncology environments are often saturated with imaging and clinical software systems, making workflow integration a major barrier to the adoption of new technologies. Kallisio designed its automated scan-to-print platform to require no additional IT integration, allowing personalized treatment delivery to fit within existing clinical workflows.

Rather than centering itself around a single device, Kallisio positions Stentra, its first commercial product, as the initial application of a scan-to-print engine built for multiple patient-specific oncology applications.

Stentra is an FDA 510(k) cleared, CE marked intraoral stent that positions and immobilizes the tongue and jaw during head and neck radiation therapy, displacing healthy tissue away from the treatment field to help minimize side effects and reduce treatment interruptions. Each device is 3D printed from an intraoral scan in less than 72 hours and reimbursed in the U.S. under an established CPT code.

“We see a long-term opportunity in becoming the patient-specific device layer for precision oncology, and Stentra is the first proof point of that platform,” says Rajan Patel, CEO.
Reducing Friction in Oncology Workflows

Clinics upload intraoral scans through a HIPAA-compliant cloud portal, after which the device is manufactured and delivered. Each scan is assigned a unique device identification number, allowing hospitals to connect patient records internally without transferring protected health information externally. Clinical teams can be trained on the scanning process in minutes, reducing onboarding requirements during implementation.

Stentra also addresses limitations of traditional dental-lab fabrication, which often requires multiple patient visits, manual adjustments and turnaround times extending several weeks. Kallisio instead uses automated, software-generated geometry built around clinically validated design parameters, reducing production variability and dependence on manual technician adjustments.

  • We see a long-term opportunity in becoming the patient-specific device layer for precision oncology, and Stentra is the first proof point of that platform.


Supporting this workflow, Kallisio operates a distributed global model spanning engineering, manufacturing and clinical partnerships across the U.S. and Europe. Devices are manufactured through certified regional 3D-printing partners rather than a centralized facility, reducing shipping and customs delays while supporting faster regional fulfillment. The operating model is intentionally partner-led, allowing Kallisio to scale manufacturing, pilot programs and regional deployment without building heavily centralized infrastructure.

To maintain consistency across distributed production sites, quality assurance is built directly into the digital production chain through software-controlled validation steps, from scan validation to final production review. Validated materials, equipment and software-driven design rules help maintain reproducible device quality without depending on individual technician variability.

Expanding Beyond a Single Product

Hospitals are introduced to Stentra through proof-of-value pilot studies conducted alongside clinical partners. During these programs, hospitals evaluate workflow efficiency, treatment continuity, reimbursement feasibility and patient experience. Participating sites have reported reduced treatment interruptions, minimal device-related complications and improved operational consistency.

The technology behind Stentra originated at The University of Texas MD Anderson Cancer Center, where Kallisio licensed the foundational intellectual property before expanding clinical relationships with institutions including Stanford Health Care, UPMC Hillman Cancer Center, Penn Medicine and Fox Chase. Working with high-volume cancer centers pushed the company to design for throughput rather than isolated boutique cases, shaping how the platform handles reproducibility and scalability within larger treatment environments.

Additional cancer indications are being explored across breast, liver, pancreatic and prostate cancers, where patient-specific devices may support more individualized treatment delivery for differing anatomical and treatment requirements.

The scan-to-print engine behind Stentra is also being extended into chemotherapy supportive care, with a patient-specific intraoral cooling device for the prevention of chemotherapy-induced oral mucositis advancing toward FDA submission and clinical study preparation. Kallisio's international rollout relies on clinician champions, regional manufacturing partners and country-specific reimbursement pathways to support expansion across different healthcare systems.

As automation reduces the time and operational friction of personalized device fabrication, Kallisio is making patient-specific treatment practical for hospitals to adopt at scale. Its platform serves as a patient-specific device layer for precision oncology, supporting a shift away from standardized care models toward more individualized care delivery.

Deep Dive

Custom 3D-Printed Immobilization Devices for Precision Care

For executives evaluating patient-specific immobilization devices, the question is no longer limited to whether 3D printing can produce a better fit. The harder test is whether the device can enter a busy clinical environment without slowing treatment, adding avoidable technology burden or creating uncertainty around reimbursement. In radiation......Read more

Kallisio Viewpoints

Custom 3D-Printed Immobilization Devices Info

Q1

What Are Custom 3D-Printed Immobilization Devices?

Custom 3D-Printed Immobilization Devices are patient-specific medical devices created from digital scans to help position, stabilize or protect anatomy during treatment. In oncology, they can support more precise therapy by improving fit, reducing manual adjustment and helping clinical teams reproduce positioning across visits. Their value depends on more than printing accuracy; the surrounding workflow must also fit safely into busy care environments where time, documentation and patient comfort matter. This makes the category as much about implementation discipline as device design.

Q2

How Does Kallisio Apply Personalized Immobilization In Oncology Care?

Kallisio applies Custom 3D-Printed Immobilization Devices through Stentra, an FDA 510(k) cleared and CE marked intraoral stent for head and neck radiation therapy. The device positions and immobilizes the tongue and jaw while helping move healthy tissue away from the treatment field. It is produced from an intraoral scan in under 72 hours, giving clinicians a faster alternative to traditional manual fabrication and helping treatment teams reduce avoidable delays between planning and delivery. The product also reflects a broader patient-specific device platform for oncology.

Q3

What Problems Can Personalized Immobilization Help Solve?

Custom 3D-Printed Immobilization Devices can address problems created by inconsistent fit, lengthy fabrication cycles and treatment interruptions. In radiation oncology, even small positioning differences can affect treatment planning, patient comfort and continuity of care. A scan-based model can reduce repeat visits, standardize design parameters and make individualized devices more practical for teams that need reliable turnaround without adding avoidable complexity to already crowded clinical workflows. The goal is not personalization for its own sake, but repeatable treatment support.

Q4

What Quality Factors Matter In Custom 3D-Printed Immobilization Devices?

Quality in Custom 3D-Printed Immobilization Devices depends on validated design rules, appropriate materials, reproducible production methods and clear review steps before delivery. Digital fabrication should not remove clinical oversight; it should make quality more repeatable. Hospitals also need confidence that scanning, manufacturing, labeling and delivery can be documented consistently across each patient-specific device, especially when production is distributed across multiple approved sites. Strong quality systems help ensure customization does not become variability.

Q5

What Makes Kallisio’s Platform Scalable For Hospitals?

Kallisio supports Custom 3D-Printed Immobilization Devices with an automated scan-to-print platform that requires no additional IT integration. Clinics upload intraoral scans through a HIPAA-compliant cloud portal, and each scan receives a unique device identification number. The company also uses certified regional 3D-printing partners across the U.S. and Europe, helping reduce shipping friction while maintaining software-controlled quality checks from scan validation through final production review.

Q6

How Could These Devices Shape Precision Oncology?

Custom 3D-Printed Immobilization Devices can help precision oncology move beyond standardized accessories toward care tools shaped around each patient’s anatomy and treatment plan. As automation improves, patient-specific devices may be extended across more cancer indications and supportive-care needs, including treatment settings where fit, speed and consistency are difficult to balance. The most useful systems will combine anatomical personalization with predictable workflows, reimbursement clarity and manufacturing models that hospitals can adopt at scale.

Custom 3D-Printed Immobilization Device of the Year 2026

Company
Kallisio

Management
Rajan Patel, CEO

Description
Kallisio develops patient-specific radiation oncology devices designed to integrate within existing clinical workflows. Its automated scan-to-print platform enables rapid production of customized treatment devices, supporting precision oncology through scalable manufacturing, distributed production partnerships and operationally compatible implementation across healthcare environments.