COMPANY

RefleXion Medical

HQ: Hayward, CA source · reflexion.com ↗ · West Coast

Keywords: oncology tumors metastatic cancer Cancer Central Nervous System Cancer Thoracic Gastrointestinal Cancer Cancer Gynecologic Genito-Urinary Cancer Cancers Lymphatic Cancer Head and Neck Thoracic Cancer Head and Neck Cancer Pelvic Cancer Hepatobiliary Carcinoma in Situ Retroperitoneal Cancer Distributed and Orphan Tumors Lung Cancer Bone Cancer Metastasis to Lung Metastasis to Bone Registry - Observational

Location: Hayward, CA · source · Oct 14, 2026

Profile checked Oct 10, 2026

3Trials (company is sponsor)1FDA records (2 yrs)7NIH grants

Timeline

Dec 18, 2025 FDA FDA 510(k) clearance: RefleXion Medical Radiotherapy System, Reflexion X2 — K252071, Dec 18, 2025. Applicant at approval: Reflexion Medical, Inc. source ↗
Dec 1, 2025 Trial start Not phased (device or behavioral study): SCINTIX [BgRT} Using RMRS in Solid and Soft Tissue Tumors source ↗
Apr 12, 2022 Trial start —: Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System source ↗
Mar 26, 2021 Trial start Not phased (device or behavioral study): Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System (BIOGUIDE-X) source ↗

Upcoming milestones

Jan 1, 2027 (ESTIMATED) · Not phased · SCINTIX [BgRT} Using RMRS in Solid and Soft Tissue Tumors · NCT06634706

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 3

Record	Title	Phase	Status	Start	Primary completion
NCT05406167	Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System	Not listed	Recruiting	Apr 12, 2022	Apr 25, 2026 (estimated)
NCT06634706	SCINTIX [BgRT} Using RMRS in Solid and Soft Tissue Tumors	Not phased (device or behavioral study)	Not yet recruiting	Dec 1, 2025	Jan 1, 2027 (estimated)
NCT04788147	Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System (BIOGUIDE-X)	Not phased (device or behavioral study)	Completed	Mar 26, 2021	Dec 20, 2021 (actual)

FDA records (last 2 years)

Dec 18, 2025 FDA 510(k) clearance: RefleXion Medical Radiotherapy System, Reflexion X2 — K252071, Dec 18, 2025. Applicant at approval: Reflexion Medical, Inc. source ↗

NIH awards 7

Annual award amounts. Total $4.1M.

Mar 18, 2020 NIH award 5R44CA228753-03 FY2020: $950,000 awarded for that fiscal year; activity R44 (SBIR); PI MAZIN, SAMUEL; recipient as written: REFLEXION MEDICAL, INC., HAYWARD, CA. Pre-clinical validation and verification of source ↗
Mar 27, 2019 NIH award 4R44CA228753-02 FY2019: $1,050,000 awarded for that fiscal year; activity R44 (SBIR); PI MAZIN, SAMUEL; recipient as written: REFLEXION MEDICAL, INC., HAYWARD, CA. Pre-clinical validation and verification o source ↗
Apr 6, 2018 NIH award 1R44CA228753-01 FY2018: $300,000 awarded for that fiscal year; activity R44 (SBIR); PI MAZIN, SAMUEL; recipient as written: REFLEXION MEDICAL, INC., HAYWARD, CA. Pre-clinical validation and verification of source ↗
Jul 28, 2016 NIH award 5R44CA153466-04 FY2016: $66,210 awarded for that fiscal year; activity R44 (SBIR); PI MAZIN, SAMUEL; recipient as written: REFLEXION MEDICAL, INC., HAYWARD, CA. Rotating PET and linear accelerator system fo source ↗
Jul 28, 2015 NIH award 5R44CA153466-03 FY2015: $264,232 awarded for that fiscal year; activity R44 (SBIR); PI MAZIN, SAMUEL; recipient as written: REFLEXION MEDICAL, INC., HAYWARD, CA. Rotating PET and linear accelerator system f source ↗
Sep 3, 2014 NIH award 2R44CA153466-02A1 FY2014: $1,169,548 awarded for that fiscal year; activity R44 (SBIR); PI MAZIN, SAMUEL; recipient as written: REFLEXION MEDICAL, INC., HAYWARD, CA. Rotating PET and linear accelerator syst source ↗
Sep 26, 2011 NIH award 1R43CA153466-01A1 FY2011: $260,006 awarded for that fiscal year; activity R43 (SBIR); PI MAZIN, SAMUEL; recipient as written: REFLEXION MEDICAL, INC., HAYWARD, CA. Real-time PET guided radiation therapy for source ↗

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