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Company Background

Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) is developing a rapid and painless testing platform for the early detection of cancer based on its patented biophotonic technology. Guided was founded in 1994 and went public via an IPO in 1997 as SpectRx, Inc. The company is the developer of the BiliChek® Non-invasive Bilirubin Analyzer, which uses spectroscopy to measure bilirubin in infants. That product is now sold by Philips Medical. The company changed its name to Guided Therapeutics in 2007 to focus on developing its cancer detection platform. Guided Therapeutics has 38 employees. 

Technology Overview

LuViva is a diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. Unlike Pap, HPV tests, or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which eliminates costly, painful, and unnecessary testing. LuViva is currently approved for use in Canada and is under PMA review in the U.S. and CE mark review in the European Union.

Market Potential

LuViva is designed for use in women who have undergone initial Pap test screening and are called back for follow up with a colposcopy examination, which in many cases, involves taking a biopsy of the cervix followed by histopathological examination of the biopsy specimen. LuViva is designed to triage patients to help physicians determine if a woman should undergo a colposcopy exam. About 55 million American women undergo Pap tests with 5 percent to 10 percent requiring follow up. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.

Competitive Advantage

LuViva’s advantages over existing methods include immediate results, no painful tissue samples and no lab-based infrastructure required. In addition to detecting precancer up to two years earlier than the current standard of care, LuViva has been shown to reduce the number of unnecessary procedures.

Financial Overview

In addition to grants from NCI, the company raises additional funding through partnering, contract work and the sale of equity. In 2011, the company raised $6.2 million through these methods. Since its inception in 1993, the company has raised approximately $78 million. The company anticipates requiring approximately $3 to $5 million for an initial product launch.

Intellectual Property

Guided Therapeutics has 16 issued patents pertaining to the technology platform.

Commercialization Strategy

In the U.S., Guided Therapeutics plans a mix of dedicated sales force and selected regional distributors. Internationally, the company is employing country-specific or regional distributors with an established presence in the gynecological market.

Pipeline Products

Guided Therapeutics has entered into a partnership with Konica Minolta Opto to develop a non-invasive test for early esophageal cancer in patients with Barrett’s Esophagus using the biophotonic technology platform.

Management Team

Mark L. Faupel, Ph.D., President, Chief Executive Officer and Director has more than 25 years of experience as a senior executive developing non-invasive alternatives to surgical biopsies and blood tests, especially in the area of cancer screening and diagnostics. Prior to coming to SpectRx in 1998 as Vice President of Business Development and then co-founding Guided Therapeutics, Dr. Faupel was a senior executive and co-founder of Biofield Corp. In 2007, he became President and CEO of Guided Therapeutics.

Richard L. Fowler, Sr. Vice President, Engineering is responsible for identifying new technical and business opportunities for Guided Therapeutics. These opportunities include new technologies, product lines, or business acquisitions that are strategic to the company's business. Mr. Fowler was formerly VP of Engineering at Guided Therapeutics where he oversaw the successful development of the BiliChek® Non-invasive Bilirubin Analyzer.

Shabbir Bambot, Ph.D. Vice President, Research and Development, is a co-founder of Guided Therapeutics. He has 20 years of experience in developing medical diagnostic products and is co-inventor of the technology behind the company’s cancer diagnostic products. He currently manages the development of the company’s esophageal cancer surveillance product in partnership with Konica Minolta Opto, Japan.

Company Background

Metabolomx is commercializing a non-invasive, rapid, and inexpensive breath test for cancer with the potential to revolutionize cancer diagnosis. 

Technology Overview

Metabolomx has developed technology enabling the identification of lung cancer from its metabolomic fingerprint in exhaled breath, currently in a second round of efficacy trials at Cleveland Clinic and other distinguished clinical centers. At the heart of the system is a high dimensional array of diversely reactive chemical indicators that change color upon interaction with volatile species or mixtures.

Using the first generation of the Metabolomx sensor a recent Cleveland Clinic study (Mazzone et al., 2012, Journal of Thoracic Oncology) reported 85 percent specificity and sensitivity for lung cancer detection, comparable to a CT scan, the present gold standard. In the first quarter of 2012, the Cleveland Clinic and National Jewish Health Center in Denver (led by Dr. Jim Jett, Editor-in-Chief of JTO) began testing a Metabolomx sensor over 100 times more sensitive than the version used in the Journal study. The Mayo Clinic, led by Dr. David Midthun, is scheduled to begin testing in the second quarter of this year. Metabolomx’s technology will be in the clinic at the country’s three top-ranked lung care centers (U.S. News and World Report), reflecting the promise of this new paradigm for lung cancer assessment.

Market Potential 

First indication: A companion diagnostic to CT scan 

Metabolomx’s first FDA indication will be as a diagnostic adjunct to an inconclusive CT scan. Results from the 53,000 patient National Lung Screening Trial (NSLT) indicate that a CT scan screening of high-risk patients extends life expectancy over 20 percent (NEJM, June 2011). The study has already prompted a powerful shift toward widespread use of CT, with Wellpoint recently announcing it will cover CT screening of the enormous at-risk population (more than 55 years of age, more than 30 pack years) identified in the study. However, CT generates a large number of false positives (the NLST found 27% of the high-risk group had a positive CT). Millions of people who have a positive CT are faced with the difficult decision of whether to monitor with follow-up CT or submit to an invasive and expensive biopsy, magnifying the need for a diagnostic adjunct to inconclusive CT. The estimated market size of this first indication is 10 million units per year in the U.S., with revenue of $1 billion.

Pre-screen of high-risk population to triage who should receive CT 

The financial costs of CT, risks involved with radiation exposure, and the enormous size of the at-risk population defined in the NLST calls for a non-invasive, inexpensive initial test to better triage who should be screened by CT. Metabolomx expects to gather data on more than 1,000 patients to confirm that the breath test is a candidate pre-CT screen of the high-risk population. The estimated market size to pre-screen the high-risk population is 25 million units per year in U.S., with revenue of $2 billion.

Monitor efficacy of chemotherapy

Metabolomx is gathering data to confirm that the breath signature declines when chemotherapy is effective in curtailing tumor growth. The estimated potential market to monitor treatment is 15 million units per year in the U.S., with revenue of $1.5 billion.

Correlation between metabolomic breath fingerprint and effective treatment

Metabolomx is compiling an unmatched database allowing the post-hoc assessment of whether there is a predictive correlation between the metabolomic breath fingerprint and the efficacy of a particular treatment. With each treatment often tailored to intervene in a particular metabolic pathway, Metabolomx predicts that the metabolomic fingerprint in exhaled breath will allow individualized selection of treatment.

Competitive Advantage 

The technology is a five minute, inexpensive (less than $100), non-invasive test for lung cancer and other cancers, based on the VOC profile present in the bloodstream and picked up in exhaled breath. Each cancer has its own “smell,” and canines have been documented more than a 95 percent accurate in detection across stages, signaling the extraordinary promise of this new paradigm. 

Financial Overview 

Metabolomx has received several government development contracts, including a NCI Phase I/Phase II Fastrack award of $1.135 million. The company seeks a $5 million Series A round to reach clinical quantification of the level of accuracy of the second generation lung cancer detection system (building on the 85 percent accuracy of the first generation system) and submission to the FDA. Financial information on Metabolomx is available to interested parties under NDA.

Intellectual Property 

The company holds exclusive, worldwide rights to an estate of fundamental enabling technology, including both the sensor itself and application IP. Additional private information is available to interested parties under NDA.

Commercialization Strategy 

The Metabolomx breath analysis instrument will be sold or leased to the same hospitals and testing centers that use CT. The bulk of the company revenue is from the disposable sensor arrays and the balance from equipment and support. The company’s first FDA indication will be as a diagnostic adjunct to indeterminate CT scan. 

Pipeline Products 

The first product is a breath test for lung cancer, but tests for other cancers will follow.

Management Team 

Paul Rhodes, Ph.D., CEO leads a diverse group of technology companies, which have received $13 million in DARPA contracts to develop next-generation sensory systems. 

Ray Martino, COO, who, during a 20-year career at Symbol Technologies was General Manager of its mobile business ($500 million in division sales) and then CTO of Symbol prior to its acquisition by Motorola for $3.9 billion in 2007. 

Sung Lim, Ph.D., Chief Scientist, is a co-inventor of the company’s proprietary nanoporous pigment array optical sensing technology, along with Metabolomx’ co-founder, University of Illinois Professor Ken Suslick.

A Clinical Advisory Board has been formed, and includes deep practical expertise in FDA approval processes.