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Company Background Gamma Medica, Inc., (GMI) is a revenue-stage company that develops and utilizes advanced solid-state digital detectors in health care imaging systems with leading-edge technology. CEO Bradley Patt, Ph.D., co-founded GMI in 2001. GMI acquired in 2005 IDEAS of Oslo, Norway, and in 2006 Advanced Molecular Imaging of Sherbrooke, Quebec. GMI and GE Healthcare entered a joint venture in preclinical imaging in 2008, and then Gamma Medica acquired the entire business in 2011. GMI has 60 employees and leverages contract engineers, contract manufacturers, and distributors. Projected 2012 sales will be $24.7 million, comprising 75 percent preclinical, 20 percent clinical, and 5 percent industrial electronics.  Technology Overview  GMI’s FDA-approved Molecular Breast Imaging (MBI) device is installed in 20 clinical sites and uses mild immobilization of the breast between two digital, solid-state gamma photon detectors that image cancer lesions regardless of breast density. The patient is injected intravenously with a tracer amount of Tc-99m-sestamibi, avid for tumor cells, and imaging begins within five minutes. The company has lowered radiation dose to equal screening digital mammography.  Market Potential  Clinical revenues were $1.8 million in 2010, $1.9 million in 2011, $4.9 million projected in 2012, and growing to $50 million in 2015. GMI recalibrated several market analyses using actual equipment sales and constructed Rogers/Bass diffusion models to predict market potential. The company divided the market for breast cancer imaging into three segments: general screening, high-risk screening (dense breasts, BRCA genes, family history), and secondary diagnosis. The primary application for MBI will be screening of radiographically dense breasts (40 percent of European and American population; 70 percent of Asian population). The Mayo Clinic and GMI predict that MBI utilization will grow to 10.5 million high-risk screening and 5 million secondary diagnostic procedures per year.  Competitive Advantage  Women with radiographically dense breasts carry a sixfold increased risk for breast cancer. However, mammography fails to detect most cancers in these women. In a Mayo Clinic 1,700-patient dense-breast screening trial, digital mammography detected only 2 of 20 tumors, while MBI found 18 of 20.  MBI has a clear advantage in specificity over competing technologies: a Mayo Clinic 1,000-patient study demonstrated 91 percent sensitivity and 93 percent specificity in dense-breasted women, much better than mammography and with similar sensitivity to MRI but better specificity (fewer negative biopsies). The GMI LumaGEM® system is 1.5 to 2.0 times more efficient than competing MBI systems, which results in the lowest dose. Financial Overview  Gamma Medica has been supported by $13.2 million in grants, including NCI STTR and SBIR Bridge grants, $82.4 million in product sales, $18.2 million in venture capital, and $16.3 million in debt financing. GMI is seeking $15 to $20 million to grow its Clinical Division by developing a mobile gantry, to conduct dense-breast MBI screening trials required for PMA, to develop international distribution capabilities, and to promote reimbursement, accreditation, and ACR/SBI clinical use guidelines.  Intellectual Property  The GMI technology is protected by eight patents for electronic detector readout and MBI with mild breast compression. In addition, GMI has licensed exclusively all Mayo Clinic patents and know-how related to MBI. Commercialization Strategy  GMI has developed a commercially successful (19 installations) MBI system (LumaGEM®) for breast cancer secondary diagnosis. The company is expanding usage of MBI for breast cancer screening, treatment monitoring, and guidance of biopsy and surgery.  The cost of the MBI system hardware and procedure is less than one-third that of MRI. Average reimbursement is $450 (plus professional component and radiotracer cost) and most payors have positive reimbursement policies or approve MBI with prior authorization.  Pipeline Products  GMI is developing an MBI-guided biopsy procedure (2012 commercial release). The company expects to introduce a mobile gantry in 2013, and plans to combine ultrasound with MBI in 2014-15. The same detector technology can be applied to prostate, brain, and other small organ cancer imaging. Management Team  The seasoned management team has a combined 150 years of professional experience with 110 years in management, 100 years in health care, and 60 years focused on women’s health.  Bradley Patt, Ph.D., CEO, President, Co-founder of GMI & Radiant Detectors (sold to Seiko in 2005), Director of Photon Imaging, DxRay, & TheraCell. James Hugg, Ph.D., VP R&D, CTO: GE Healthcare and Global Research, Henry Ford Health, University of Alabama - Birmingham, British Petroleum, Shell. Debbie Thomas, VP Marketing: Aurora Imaging Technology, WebMD, SAP America. Sharon Smith, VP Sales: Aurora Imaging, Naviscan, Hologic, Procter & Gamble. Deborah Matthew, VP Operations: Paragon Business Systems, Delphi Information Systems.

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.