Kallisio

What Kallisio does

Kallisio is a Baltimore-based, privately held medical technology company founded in 2022 that develops patient-specific devices and digital workflows to support precision radiation therapy and reduce treatment-related toxicity. Its flagship product is Stentra, an FDA 510(k)-cleared (January 2024) and CE-marked (March 2026), patient-specific 3D-printed intraoral immobilization and positioning device used in head and neck cancer radiotherapy. The system combines intraoral scanning, proprietary automated design software, and additive manufacturing with biocompatible medical-grade resin to deliver sub-millimeter precision devices that displace and protect healthy tissue (notably tongue and oral mucosa) during radiation treatment. The foundational technology was developed and exclusively licensed from The University of Texas MD Anderson Cancer Center by Dr. Eugene Koay, who continues as Oncology Scientific Advisor.

Kallisio monetizes Stentra through one-time per-patient device sales, ordered via a HIPAA-compliant cloud-based clinical portal that accepts STL, DICOM, and optical scanner formats and delivers devices in as little as 72 hours without collecting, storing, or transmitting PHI. Devices are reimbursable under CPT code 77334, and the company supplies coding guidance and claim-ready documentation templates to support codability. Distribution combines direct enterprise sales to radiation oncology teams with a strategic channel partnership with RICOH 3D for Healthcare, which leverages FDA-registered 3D printing facilities and Clinical Applications Specialists for nationwide U.S. distribution from October 2024. The customer base is concentrated in top-tier U.S. academic cancer centers (MD Anderson, Stanford Health Care, Fox Chase, Penn Medicine, Texas Cancer Institute), with European expansion enabled by CE Mark and partners including sitem-insel, Decomplix, and Medical Forge Leipzig.

The company has ISO 13485 certification, a 72-hour scan-to-device workflow, and reported clinical outcomes including a 77.6% reduction in severe oral mucositis, 29.8% decrease in tongue radiation exposure, and 32.3% reduction in dysphagia. Kallisio is also extending its patient-specific platform beyond radiation oncology into localized cryotherapy and targeted drug delivery. No external funding rounds, revenue figures, or ARR have been publicly disclosed, and the company operates with 11-50 employees.

Name

Kallisio

Legal name

Kallisio, Inc.

Website

https://kallisio.com

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

1–10 employees

Short description

Kallisio is a Baltimore-based medical technology company that develops the FDA-cleared, CE-marked Stentra device — a patient-specific 3D-printed intraoral immobilization system for head and neck cancer radiation therapy — and sells it via a HIPAA-compliant digital workflow to radiation oncology teams at U.S. and European cancer centers.

Ownership category

akta.pro rank

Product category

Radiation Oncology Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Medical & Dental 3D Printing Services (patient-specific devices, dental labs) (IMAAADAG)

akta.pro secondary industry

Surgical Navigation, Tracking & Intraoperative Guidance (Ortho/Neuro/ENT) (HLAHADAG)

Keywords

• Patient-specific medical devices
• Radiation oncology solutions
• 3D-printed immobilization devices
• Head and neck cancer therapy
• Precision oncology tools

Headquarters

HQ city

Baltimore

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Technology or R&D, Operations, Personnel, Marketing or Sales

Revenue model

1. Stentra Device Sales: One-time sale of patient-specific 3D-printed intraoral immobilization devices to radiation oncology clinics and cancer centers. Devices are customized per patient, ordered through clinical portal or via RICOH distribution channel, and delivered within 72 hours for use during radiation therapy treatment course.
2. CPT 77334 Reimbursement: Stentra is eligible for reimbursement using CPT code 77334 for custom, complex radiation therapy immobilization devices. Kallisio supplies clients with coding guidance and claim-ready documentation templates to optimize codability and reimbursement.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

Kallisio develops and sells patient-specific 3D-printed intraoral immobilization devices (Stentra™) for head and neck cancer radiation therapy. Each device is custom-fabricated from a patient's intraoral scan using proprietary automated design software and additive manufacturing with biocompatible medical-grade resin. The company supports these devices with a HIPAA-compliant cloud-based clinical portal for ordering and a 72-hour scan-to-device delivery workflow.

Product overview

Kallisio offers the Stentra™ system as its primary product platform—a patient-specific precision oncology solution combining a 3D-printed intraoral immobilization device with a HIPAA-compliant digital workflow. The core Stentra™ device is a custom-fabricated oral stent for head and neck cancer radiation therapy, delivering sub-millimeter precision fit. This is supported by the Kallisio Clinical Portal for secure case management and order submission, and a 72-hour scan-to-device delivery service powered by distributed manufacturing partners (RICOH, Materialise). The company is also developing future solutions including localized cryotherapy and targeted drug-delivery applications.

Differentiator

Problem solved

Functional benefit

Brands

• Stentra™: FDA cleared and CE marked patient-specific 3D-printed intraoral immobilization and positioning device for head and neck cancer radiation therapy.

Products and services

• Stentra™ Custom 3D-Printed Intraoral Immobilization Device FDA-cleared and CE-marked patient-specific 3D-printed intraoral immobilization and positioning device for head and neck cancer radiation therapy. Custom-fabricated from intraoral scan data to achieve sub-millimeter precision fit. Immobilizes and displaces the tongue and other organs at risk to protect healthy tissue from radiation exposure while improving treatment accuracy. Reimbursable under CPT code 77334.
• Kallisio Clinical Portal Cloud-based clinical portal ordering system with real-time monitoring for placing Stentra orders. HIPAA-compliant workflow that accepts STL, DICOM, and most optical scanner formats. Uses system-generated unique device identifiers without collecting, storing, or transmitting Protected Health Information. Designed for radiation oncology clinics and cancer centers.

Quantifiable outcome

• 77.6% reduction in severe mouth sores (oral mucositis) thanks to patient-specific intraoral devices
• +4 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature4 records

Partnerships

21 partnerships are on record, tiered core, supporting and minor.

• RICOH 3D for HealthcarecoreChannel Partner/ Reseller/ Distributor · 26 September 2024Strategic manufacturing and distribution partnership. RICOH 3D for Healthcare utilizes its network of FDA-registered 3D printing facilities to produce Stentra devices and leverages Clinical Applications Specialists to distribute to radiation oncology teams nationwide. Starting October 2024, radiation oncologists order Stentra through RICOH's clinical sales team. This partnership enables scalable manufacturing and broad market reach.
• The University of Texas MD Anderson Cancer CentercoreStrategic or Co-development PartnerTechnology licensing and clinical co-development partnership. Foundational Stentra technology was developed by Dr. Eugene Koay at MD Anderson and exclusively licensed to Kallisio. Solutions are co-developed alongside MD Anderson clinical experts. Dr. Koay serves in an advisory role with Kallisio. MD Anderson has an institutional conflict of interest with Kallisio managed according to COI monitoring plan.
• Stanford Health CarecoreStrategic or Co-development PartnerClinical implementation partnership. Stanford Health Care incorporated Stentra into clinical workflow for select head and neck cancer cases. The collaboration supports clinical implementation of the FDA-cleared Stentra system, evaluating workflow integration, device reproducibility, and patient acceptance within routine radiation oncology operations.
• MaterialisesupportingTechnology or Integration3D printing services partnership. Materialise, at the forefront of 3D printing technology, enables Kallisio to revolutionize innovative personalized treatments. Partner provides additive manufacturing capabilities for producing patient-specific devices.
• iTerosupportingTechnology or IntegrationIntraoral scanner partnership. iTero provides advanced intraoral scanners and digital workflow solutions that help dental professionals visualize and execute precise orthodontic and restorative treatments. Supports the scan portion of the Stentra workflow.
• Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel)supportingStrategic or Co-development PartnerNational center of excellence in Bern, Switzerland that connects research, industry, and clinical care to accelerate the transition of medical innovations from laboratory to patient. Kallisio's clinical partner for European market development.
• CognidoxsupportingTechnology or IntegrationQuality assurance platform partnership. Cognidox provides a platform designed to help streamline medical product development and ensure regulatory compliance for medical devices.
• DecomplixsupportingImplementation/ SI/ Consulting PartnerSwiss regulatory consulting partnership. Decomplix helps navigate Swiss regulatory complexities to achieve market access for medical devices in Switzerland and potentially the EU.
• Ideas2ITsupportingTechnology or IntegrationCustom software development and product engineering partnership. Ideas2IT helps build innovative solutions using emerging technologies like AI, cloud, and data analytics for Kallisio's digital platform.
• iOLifeSciencesupportingImplementation/ SI/ Consulting PartnerVirtual MedTech incubator partnership. iOLifeScience accelerates the creation of compliant medical devices through a shared-risk model combining engineering, regulatory, and commercialization expertise.
• Medical Forge LeipzigminorImplementation/ SI/ Consulting PartnerMedTech accelerator program partnership. Medical Forge Leipzig provides startups with infrastructure, regulatory support, and clinical networks needed to successfully enter the German healthcare market.
• American Society for Radiation Oncology (ASTRO)supportingOthersProfessional radiation oncology association. ASTRO's mission is to advance radiation oncology by promoting excellence in care, supporting research, education, and professional development.
• American College of Radiation Oncology (ACRO)supportingOthersProfessional radiation oncology organization supporting radiation oncology professionals and promoting the highest quality care for radiation therapy patients through education, practice improvement, and advocacy.
• American Head and Neck Society (AHNS)supportingOthersProfessional society advancing education, research, quality of care, and equity for the head and neck oncology patient and care team.
• Association of Cancer Care Centers (ACCC)supportingOthersLeading education and advocacy organization for the cancer care community, promoting excellence in cancer care delivery and policy.
• Head and Neck Cancer AllianceminorOthersPatient advocacy organization advancing prevention, detection, treatment and rehabilitation of oral, head and neck cancer through public awareness, research, advocacy and survivorship.
• HNC Living FoundationminorOthersNonprofit providing financial aid and support to help head and neck cancer patients live life fully during and after treatment.
• HNC Support InternationalminorOthersInternational organization providing support, advocacy, and awareness for people affected by head and neck cancer through peer-to-peer encouragement, resources, and community events.
• Oral Cancer FoundationminorOthersNonprofit working to reduce the incidence and suffering of oral and oropharyngeal cancers through prevention, early detection, education, research funding, advocacy, and patient support.
• SPOHNCminorOthersSupport for People with Oral and Head and Neck Cancer nonprofit providing peer-to-peer mentorship, support groups, educational resources, and awareness programs.
• THANC FoundationminorOthersThyroid Head and Neck Cancer Foundation improving outcomes and quality of life for thyroid and head and neck cancer patients through research, education, and support.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Others

• Vision RT: Vision RT provides surface-guided radiation therapy (SGRT) and patient motion-management systems used to position patients during radiotherapy. It is an enabling/adjacent peer — complementary rather than directly competitive — since both target accurate patient positioning for radiation oncology.

Broad incumbents

• Brainlab: Brainlab is a large medical-technology platform offering software, hardware, and patient positioning/guidance solutions for radiation oncology and surgery. It is comparable as a broad incumbent addressing radiotherapy planning, positioning, and intra-procedure guidance workflows in which Kallisio's Stentra sits.
• Materialise: Materialise is a global 3D printing services and software company with an established medical division that provides patient-specific medical device printing — including a Kallisio partner for Stentra manufacturing. Comparable as the broader, incumbent medical 3D printing platform that Kallisio leverages and competes against in adjacent services.
• 3D Systems (Healthcare): 3D Systems' Healthcare Solutions business provides patient-specific 3D-printed surgical guides, anatomical models, and personalized devices, and has historically partnered with hospitals on additive manufacturing point-of-care. Comparable as a broad incumbent 3D-printing medical-device peer.
• Stratasys Direct: Stratasys Direct is the contract manufacturing arm of a leading polymer 3D printing company, offering medical-grade additive manufacturing services including custom devices. Comparable as an incumbent, scaled patient-specific 3D printing service bureau that could serve Kallisio's category.

Direct peers

• CIVCO Radiotherapy: CIVCO Radiotherapy designs and supplies patient positioning, immobilization, and motion-management accessories used during radiation therapy procedures. It targets the same radiation oncology buyer as Kallisio, including head/neck and surface-guided solutions.
• Qfix: Qfix is a long-standing manufacturer of patient positioning and immobilization devices for radiation therapy, including head, neck and SBRT systems. It competes with Kallisio in the radiotherapy positioning category, though with thermoplastic and rigid systems rather than 3D-printed patient-specific devices.
• Adaptiiv: Adaptiiv develops patient-specific 3D-printed medical devices and accessories used in radiation oncology (notably bolus and surface applicators), making it the most direct peer to Kallisio's Stentra in applying additive manufacturing to precision radiotherapy immobilization and tissue displacement.
• Klarity Medical: Klarity Medical Products manufactures radiotherapy positioning and immobilization devices (thermoplastic masks, head/neck supports, vacuum bags) used by radiation oncology departments. It is a peer to Kallisio in the radiotherapy immobilization category, focused on reusable rather than 3D-printed custom devices.

Emerging players

• Anatomics: Anatomics is an Australian-headquartered company that designs and manufactures patient-specific 3D-printed surgical implants and anatomical models, with prior FDA-cleared cranial implant products (e.g., PoreStar). It overlaps with Kallisio in patient-specific 3D-printed medical devices but addresses implants rather than radiotherapy immobilization.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/Kallisio_Inc
• LinkedInlinkedin.com/company/kallisio-inc

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Kallisio