GTHP
Industry:
Healthcare Equipment, Supplies, & Technology

DESCRIPTION

Guided Therapeutics makes a single medical device: the LuViva Advanced Cervical Scan, a non-invasive tool that detects cervical cancer and precancers by scanning the cervix with light and analyzing the reflected and fluorescent signals — no tissue samples required, with results delivered at the point of care. LuViva targets two use cases: primary screening in developing markets, where Pap test infrastructure is limited, and triage in developed markets, where it aims to reduce unnecessary colposcopies triggered by false-positive Pap or HPV tests. The company sells LuViva through a small direct sales team and regional distributors, with Turkey's Ministry of Health as a notable direct government partner. Each scan requires a single-use disposable cervical guide, creating a recurring consumables revenue stream alongside device sales. Guided Therapeutics has sold 158 devices and roughly 79,000 disposables internationally, but has not yet received FDA approval to sell in the U.S. The company remains pre-revenue at scale and has historically operated at a loss. Its manufacturing footprint is small, with final assembly outsourced to partners in Hungary and China. Near-term priorities center on filing for FDA approval following a pivotal clinical study, pursuing China NMPA approval through local partners, and securing a national screening program commitment in Turkey. Longer term, Guided Therapeutics sees its biophotonic platform as applicable to other cancers, though those programs remain early-stage.

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