Participated · Equity · Nov 2023

RefleXion Medical develops and commercializes SCINTIX biology-guided radiotherapy, a therapy that uses a single radiotracer injection to generate real-time signals to guide autonomous radiotherapy. SCINTIX is delivered via the RefleXion X1, a dual-treatment modality platform that also provides image-guided radiotherapy. The company positions SCINTIX to treat all stages of indicated solid tumor cancers, including metastatic disease, by addressing targeting and motion-management barriers. SCINTIX has received FDA De Novo marketing authorization and a Breakthrough Device designation for lung tumors, and is indicated for FDG-guided treatment of lung and bone tumors. The X1 platform is also cleared for image-guided external-beam radiotherapy for solid tumors located anywhere in the body. RefleXion plans to use proceeds from its recent equity raise to extend commercialization of SCINTIX therapy. RefleXion Medical is a privately held therapeutic oncology company developing biology-guided radiotherapy (BgRT) and commercializing the RefleXion X1 radiotherapy platform. The X1 is cleared for delivery of stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT). The company is developing BgRT, which uses PET imaging to enable tumors to continuously signal their location and synchronize that data with a linear accelerator. RefleXion is pursuing commercialization of X1 while preparing BgRT for regulatory review and future clinical use. The company is building a radiopharmaceutical program and has a co-development agreement with Telix Pharmaceuticals to explore a PSMA-targeted PET tracer for use with BgRT. RefleXion recently hosted a cancer symposium with clinicians from 30 top U.S. cancer programs to support clinical engagement and adoption. RefleXion Medical is a privately-held therapeutic oncology company developing biology-guided radiotherapy (BgRT) and the RefleXion X1 system to enable treatment of multiple tumors, including metastatic disease. The X1 is currently cleared for stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT), while BgRT is pending regulatory review and not commercially available. BgRT incorporates PET radiotracer imaging to continuously signal tumor location and synchronizes those data with a linear accelerator to direct radiotherapy with subsecond latency. The company has positioned BgRT to expand radiotherapy to late-stage cancers and the technology recently received FDA Breakthrough Device designation for use in lung tumors. RefleXion reports delivering nearly 2,000 patient treatments, completing a feasibility study, securing an additional radiopharmaceutical agreement, and expanding its commercial footprint. The $80 million financing will fund further development and commercialization of the BgRT platform. RefleXion develops the RefleXion X1 system and is pioneering biology-guided radiotherapy (BgRT), which uses PET imaging data to enable tumors to continuously signal their location and allow radiotherapy with sub-second latency. The X1 is currently cleared for delivery of stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT); the BgRT capability requires additional 510(k) clearance and is not yet available for sale. The company says BgRT is designed to scale radiotherapy from one or two tumors to all visible tumors, including those that move rapidly due to breathing or digestion, in the same treatment session. Commercialization efforts began in mid-2020 and the company reports a promising market ramp since then. Financially, RefleXion completed a Series D financing that now totals $150 million, reflecting continued investor support as it approaches broader commercialization. The company is based in Hayward, Calif., and emphasizes partnering with pharmaceutical agents and international investors to establish a global footprint. RefleXion develops the RefleXion X1, a biology-guided radiotherapy (BgRT) system designed to treat multiple visible tumors, including those that move due to breathing or digestion, within the same session. The BgRT approach incorporates PET imaging data so tumors continuously signal their location and the system synchronizes those data with a linear accelerator to deliver radiotherapy with subsecond latency. The company recently received FDA clearance for stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT). RefleXion notes that the BgRT capability requires a separate 510(k) clearance and is not yet available for sale. The company has secured its first system order at a leading cancer center and is focused on scaling market and clinical adoption of the X1 platform. To support commercialization and validation of BgRT in practice, RefleXion closed a $100 million equity financing led by PSP Investments.