Guided Therapeutics Inc (OTC: GTHP) is a medical device company that develops and sells non-invasive cervical cancer screening technology. Revenue comes from transactional sales of devices and disposables, primarily through international distribution partners, with product orders recorded under purchase orders and distribution agreements. The company's core product, LuViva, has received regulatory approval in Russia (August 11, 2025) and is sold in select international markets, while U.S. FDA approval remains pending as of March 25, 2026, with patient enrollment in the required clinical trial completed. GTHP operates with a stockholders' deficit as of December 31, 2025, funds operations through repeated issuances of convertible promissory notes and securities purchase agreements, and has disclosed that it will require additional fundraising with no assurance such funds can be raised on acceptable terms. Mark Faupel, Ph.D., a co-founder and inventor on 26 U.S. patents, has served as President and CEO since March 6, 2023.

Revenue model

Transactional sales of medical devices and disposables, with transaction prices fixed in purchase orders or distribution agreements. Revenue is recognized upon delivery of LuViva devices, related disposables, or accessories, with installation, training, or technical support as potential secondary performance obligations.

Products and services

LuViva, a non-invasive cervical cancer screening device sold with single-use disposables and accessories. The device is positioned as a non-invasive alternative to surgical biopsy for cervical cancer detection.

Customers and end markets

International distribution partners, hospitals, and clinics in markets including Russia, China, Turkey, and smaller Eastern European markets. In Turkey, the company is in contract discussions with the Turkish Ministry of Health, which has approved a clinical study involving approximately 800 patients across over 60 hospitals and clinics. Chinese partners HDMT and YMIC continue to place product orders as of December 31, 2025.

Value-chain role

Medical device manufacturer and IP developer. The company develops, manufactures, and sells LuViva devices and disposables, while relying on regional distribution partners for in-market sales and regulatory support. The company retains responsibility for obtaining and maintaining regulatory approvals globally.

Geographic exposure

International markets including Russia (regulatory approval received August 11, 2025), China, Turkey, and smaller Eastern European markets. The U.S. market is not yet accessible, as FDA approval had not been obtained as of March 25, 2026.

Source: SEC 10-K, filed 2026-03-31

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