KALLISIO INC.

Kallisio develops patient-specific solutions for precision radiation oncology. At ASTRO 2026, where the field is focused on communicating radiotherapy's value, Stentra™ offers something concrete: a published, reimbursable, FDA-cleared technology that translates organ-at-risk sparing into a scalable digital workflow available to every head and neck program today. A persistent gap exists in head and neck cancer radiotherapy. Generic intraoral devices cannot reliably displace the tongue, buccal mucosa, and soft palate out of high-dose regions, nor hold those structures reproducibly across 30 to 35 treatment fractions. The result is avoidable radiation exposure to uninvolved oral structures, contributing to mucositis, dysphagia, taste impairment, and treatment interruptions. Grade 3 to 4 oral mucositis affects 35 to 57% of patients undergoing definitive chemoradiotherapy for head and neck cancer (Trotti et al., Radiother Oncol, 2003), with incremental per-patient costs exceeding $17,000 per episode (Elting et al., Cancer, 2003). The clinical case for upstream tissue protection is established. What has been missing is a scalable, workflow-neutral solution. Stentra is a patient-specific intraoral immobilization and tissue-displacement device, designed around each patient's oral anatomy. CT or intraoral scan data is uploaded to Kallisio's HIPAA-compliant platform. Proprietary software generates a custom device geometry in minutes. The device is additively manufactured and delivered in as little as 72 hours, ready for simulation and every subsequent fraction, with no treatment planning system modifications or IT integration required. Published evidence supporting patient-specific intraoral stents: - 77.6% reduction in Grade 3 to 4 oral mucositis versus standard of care (Studer et al., Radiother Oncol, 2012) - Significant reduction in severe taste impairment (2% vs. 15%, p=0.047) and improved swallowing outcomes (21% vs. 31% moderate to severe dysphagia, p=0.013) across 462 oropharyngeal cancer survivors at MD Anderson (Stieb et al., Clin Transl Radiat Oncol, 2020) - 29.8% reduction in mean tongue radiation dose with patient-specific stents (Ramakrishnan et al., Br J Radiol, 2017) These findings align with the ASTRO 2026 Presidential Symposium focus on organ preservation as an underrecognized value of radiation therapy. Stentra makes that value visible in dose metrics, symptom outcomes, and patient-reported quality of life. Early clinical implementation experience suggests operational gains: reduced simulation re-scans, fewer unplanned interventions, and an estimated 3 to 4 hours of recovered linac capacity per treatment course. Stentra is billable under CPT 77334 (Treatment Devices, Design and Construction; Complex). Published CY2025 Medicare rate: $366.07 per patient (Hospital APC; CMS HOPPS Final Rule, effective January 1, 2025). At a 60/40 Medicare to commercial payer mix, device cost is revenue-neutral to net-positive at billing, before downstream savings from avoided hospitalizations and re-simulations. Stentra is FDA 510(k) cleared (K232293) and CE-marked. The technology is licensed from The University of Texas MD Anderson Cancer Center and is deployed at Stanford Health Care, MD Anderson, and additional cancer centers. Devices are manufactured by Ricoh USA under an ISO 13485-aligned quality system. Kallisio offers a structured proof-of-value pilot for qualified institutions, including onboarding, training, loaned equipment, and 10 to 15 devices at no cost, with CPT 77334 billing guidance provided. Beyond head and neck radiotherapy, Kallisio is extending its patient-specific platform to oral cryotherapy (Stentra CoolCare™, targeting chemotherapy-induced oral mucositis) and targeted intraoral drug delivery. Visit Kallisio at ASTRO 2026 to review outcomes data, discuss clinical partnerships, and explore how Stentra supports your program's commitment to communicating and delivering radiotherapy's full value.