Guided Therapeutics

What Guided Therapeutics does

Guided Therapeutics, Inc. (OTCQB: GTHP) is a Peachtree Corners, Georgia-based medical technology company developing the LuViva Advanced Cervical Scan, a non-invasive cervical cancer detection device that uses patented biophotonic multimodal hyperspectral imaging combining reflectance and fluorescence spectroscopy with embedded AI to identify chemical and structural tissue changes indicative of precancerous lesions. The LuViva scan takes just over a minute at the point of care and delivers immediate results, and in a 428-woman FDA pivotal trial improved overall precancer detection from 68% to 89% by identifying 21 of 32 disease cases missed by standard colposcopy-directed biopsy, with all primary and secondary endpoints met at p < 0.0001. The platform holds 26 U.S. patents (with the CEO as named inventor), is CE marked, and is ISO 13485:2016 certified, with the company having filed a Premarket Approval application with the FDA on June 16, 2026.

The company monetizes LuViva through a hardware-plus-disposables model, selling the device and proprietary single-use disposable components to international distributors and healthcare facilities, supplemented by licensing royalties (K2 Medical for several Asian countries and Elysian Medical for worldwide breast cancer detection rights) and professional services such as training and support. Distribution is managed entirely through country-specific channel partners across more than 40 countries, with manufacturing partnerships in Hungary supporting international production, while the company itself operates with a staff of approximately three employees as of the FY2025 10-K. Recent enterprise-level channel expansion includes a $700,000 purchase order from Hangzhou Dongye Medical Technology Company Ltd and a $200,000 distribution deal with Yuanshuo Medical Instruments Corporation in China, plus active discussions with the Turkey Ministry of Health for a nationwide screening program with a potential 20 million annual test volume. The company is publicly traded on OTCQB, reported 2025 revenue of approximately $770,000, and carries an accumulated deficit of $157.1 million with substantial doubt about its ability to continue as a going concern, having funded operations through repeated small equity and warrant transactions including a $3.3 million bridge round in September 2022 and a $980,000 warrant exchange completed in March 2026.

Name

Guided Therapeutics

Legal name

Guided Therapeutics, Inc.

Website

https://guidedinc.com

Company type

Public

Founded year

2012

Operating status

Operating

Headcount range

11–50 employees

Short description

Guided Therapeutics (OTCQB: GTHP) is a Peachtree Corners, Georgia-based medical technology company that develops and distributes the LuViva Advanced Cervical Scan, a non-invasive biophotonic device using AI-analyzed hyperspectral imaging for cervical cancer detection, sold through international distributors across more than 40 countries.

Ownership category

akta.pro rank

Product category

Cancer Diagnostic Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL)

akta.pro secondary industry

Intraoperative Imaging & Guidance (C-arms, O-arm, IOUS, fluorescence) (HLAHADAH)

Keywords

• Cervical cancer detection
• Biophotonic imaging
• Non-invasive diagnostics
• Medical device manufacturing
• Cancer screening platform

Headquarters

HQ city

Norcross

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. LuViva Device Hardware Sales: Sale of LuViva Advanced Cervical Scan hardware devices to international distributors and healthcare facilities. The company has received purchase orders including a $700,000 order from Hangzhou Dongye Medical Technology and a $200,000 deal with Yuanshuo Medical Instruments.
2. Single-Use Disposables: Sale of proprietary single-use disposable components used with the LuViva device during each patient scan procedure.
3. Licensing Royalties: Licensing revenue from partners including K2 Medical LLC (Asian countries licensing rights) and Elysian Medical LLC (worldwide rights for breast cancer detection technology).
4. Professional Services: Revenue from training, technical support, and other professional services associated with LuViva deployment.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Guided Therapeutics develops, manufactures, and markets the LuViva Advanced Cervical Scan, a non-invasive biophotonic medical device that uses multimodal hyperspectral imaging (combining reflectance and fluorescence spectroscopy) with proprietary AI algorithms to detect cervical precancer and cancer at the point of care in approximately one minute. The product line consists of the LuViva scanner hardware sold alongside single-use disposable calibration/scan components to international distributors and healthcare facilities across more than 40 countries.

Product overview

Guided Therapeutics operates as a medical device company built on a proprietary biophotonic technology platform. The company's sole product is the LuViva Advanced Cervical Scan—a rapid, non-invasive cervical cancer detection device that combines hardware (spectroscopy scanner), proprietary AI software for spectral analysis, and single-use disposable components. The product line consists of hardware, proprietary software, and single-use disposables, with manufacturing partnerships in Hungary. The platform technology is designed to be applicable to other cancers including esophageal, head and neck, anal, colorectal, and skin cancer.

Differentiator

Problem solved

Functional benefit

Products and services

• LuViva Advanced Cervical Scan A rapid, non-invasive biophotonic cervical cancer detection device combining multimodal hyperspectral imaging (reflectance and fluorescence spectroscopy) with proprietary AI to detect precancerous lesions and cancer at the point of care in approximately one minute. Sold internationally alongside proprietary single-use disposable components to distributors, healthcare facilities, and government screening programs.

Quantifiable outcome

• Detection rate improved from 68% to 89% in FDA pivotal trial, with LuViva identifying 21 of 32 precancerous lesions missed by standard colposcopy-directed biopsy
• +3 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature3 records

Partnerships

Five partnerships are on record, tiered core and minor.

• Hangzhou Dongye Medical Technology Company Ltd (HDMT)coreChannel Partner/ Reseller/ Distributor · 11 December 2025Chinese distributor with $700,000 purchase order for LuViva devices and components. The partnership involves shipping multiple devices and enabling cervical cancer screening in numerous hospitals in China, ahead of anticipated NMPA regulatory approval.
• Yuanshuo Medical Instruments CorporationcoreChannel Partner/ Reseller/ Distributor · 19 November 2025Initial distribution partnership valued at $200,000 to enhance market presence in China. The partnership aims to expand Guided Therapeutics' reach in the medical instruments sector.
• K2 Medical, LLCminorOEM/ Whitelabel/ Licensing PartnerLicensing rights holder for LuViva Advanced Cervical Scan in several Asian countries. Richard P. Blumberg, a board member, is Managing Member of K2 Medical.
• Elysian Medical, LLCminorOEM/ Whitelabel/ Licensing PartnerCompany with worldwide rights for certain breast cancer detection technology developed by Guided Therapeutics. Richard P. Blumberg is Managing Member.
• Hungarian Manufacturing PartnerscoreTechnology or IntegrationManufacturing partnerships in Hungary supporting international production and distribution of LuViva devices alongside U.S.-based operations.

Scale indicators10 records

Recent moves8 records

Expansion highlights6 records

Broad incumbents

• Hologic: The dominant player in cervical cancer screening via the ThinPrep Pap Test and Aptima HPV assays. Comparable because Hologic defines the standard-of-care workflow that LuViva is positioned to complement or replace, and serves the same OB/GYN customer base.
• Roche Diagnostics: Major cervical screening franchise (cobas HPV test) and broader in-vitro diagnostics platform. Comparable as a global incumbent supplying hospitals and laboratories with cervical cancer diagnostic workflows that LuViva would compete against or integrate with.
• Becton, Dickinson and Company (BD): Provides the BD Onclarity HPV assay and broader women's health and cervical screening portfolio. Comparable as an established diagnostics competitor serving the same OB/GYN point-of-care and laboratory screening markets.
• QIAGEN: Supplies the digene HC2 HPV test and other molecular cervical screening assays widely used in labs. Comparable as a competing cervical cancer diagnostic technology (HPV molecular testing) sold to the same clinical customers globally.
• CooperSurgical: Supplier of a broad women's health portfolio including cervical screening and colposcopy instruments. Comparable as an incumbent distribution and device partner into OB/GYN clinics where LuViva is sold.

Direct peers

• TruScreen Group: Markets a real-time, non-invasive opto-electrical cervical cancer screening device used at point of care. Closely comparable to LuViva in product form factor, target users (clinicians performing cervical screening), and intended clinical workflow.
• Zilico: Developed the ZedScan, an investigational device using impedance spectroscopy for real-time cervical intraepithelial neoplasia detection. Comparable as a direct cervical-cancer point-of-care diagnostic competitor using tissue electrical/optical properties and AI-style signal interpretation.

Emerging players

• MobileODT: Provider of the EVA COLPO digital colposcope with AI-assisted cervical visualization for low-resource settings. Comparable because it targets the same OB/GYN screening use case, particularly in emerging markets, and competes for the same clinical workflow.
• DermaSensor: Develops a non-invasive, point-of-care skin cancer detection device using spectroscopic/AI technology recently cleared by FDA. Comparable as a sister application of biophotonic spectroscopy with AI, applying similar core technology to a different cancer indication.
• GeneFirst: Molecular diagnostics company focused on HPV and cervical cancer screening assays. Comparable as an emerging player applying novel diagnostic technology to the same cervical cancer screening market.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/guided-therapeutics-inc.

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds7 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Guided Therapeutics