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Kallisio

HardwareBaltimore, MD, USAFounded 2022· One of 1817 Hardware companies tracked by AMPulse

Kallisio develops patient-specific 3D-printed oral immobilization devices for head and neck cancer radiation therapy, anchored by its FDA-cleared and CE-marked Stentra™ system.

CEO / Founder
Rajan Patel
Team Size
1-10
Stage
Growth Stage
Key Investors
iO Life Ventures

Technology & Products

Key Products

Stentra™ — FDA 510(k)-cleared and CE-marked patient-specific 3D-printed intraoral immobilization and positioning device for head and neck cancer radiation therapy; cloud-based clinical portal ordering system; intraoral scanning workflow integration

Technological Advantage

Digital workflow from intraoral scan to automated design to 3D printing to delivery in 72 hours; biocompatible medical-grade resin; cloud-based clinical portal; CPT-reimbursable code (77334); scaling via RICOH's network of FDA-registered 3D printing facilities

Differentiation

Value Proposition

Sub-millimeter precision 3D-printed custom oral immobilization devices delivered in 72 hours that reduce radiation side effects in head and neck cancer patients, are CPT-reimbursable, and integrate into existing clinical workflows.

How They Differentiate

Fully patient-customized (not pre-formed or semi-custom); sub-millimeter precision fit via 3D printing from intraoral scan; 72-hour turnaround from scan to delivery; CPT-reimbursable (CPT 77334); technology exclusively licensed from MD Anderson Cancer Center; clinical studies showing reduction in severe oral mucositis

Market & Competition

Target Customers

Radiation oncology departments at cancer centers and hospitals; head and neck cancer patients undergoing radiotherapy

Industry Verticals

Medical devices; Radiation oncology; Head and neck cancer treatment; Precision medicine

Competitors

3D Systems (Healthcare); IZI Medical Products; Qfix/Civco Radiotherapy

Growth & Milestones

Major Milestones

Founded 2022; FDA 510(k) clearance for Stentra (January 2024); Exclusive technology license from MD Anderson Cancer Center; Strategic partnership with RICOH 3D for Healthcare (September 2024); Clinical implementation at leading cancer centers (December 2025); CE Mark certification under EU MDR (March 2026); Named Best New Radiology Technology Solution in MedTech Breakthrough Awards (May 2026); Texas Cancer Institute adopts Stentra as standard of care (May 2026)

Notable Customers

MD Anderson Cancer Center; Stanford Health Care; Penn Medicine; Fox Chase Cancer Center; Texas Cancer Institute

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