Optical Biopsy System Improves Cancer Diagnosis While Lowering Costs
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SpectraScience's WavSTAT® Optical Biopsy System uses light-based fluorescence spectroscopy to diagnose cancer in the colon during colonoscopy procedures. It is currently in late-stage European clinical trials and poised to commence sales in Europe initially targeting colorectal cancer screening. Studies have found the technology could increase colonoscopy's ability to correctly identify non-cancerous tissue to around 96%. Crystal Research Associates published a 48-page report analyzing SpectraScience and its WavSTAT technology, market opportunities in colorectal cancer screening, competitive advantages, growth strategies and leadership team.
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Optical Biopsy System Improves Cancer Diagnosis While Lowering Costs
- 1. . o Advanced, minimally invasive diagnostic products using light- based technologies that seek to improve a physician’s ability to diagnose cancer while lowering the cost of diagnosis o SpectraScience’s WavSTAT® Optical Biopsy System is in the final stages of a 1,200-patient European study and is poised to commence sales - initially targeted to the colorectal cancer screening - meets needs of new colonoscopy guidelines o Studies have found that adding SpectraScience’s technology to the colonoscopy could increase the procedure’s negative predictive value to ~96% Crystal Research Associates Presents: New Independent Equity Research A 48-page Executive Informational Overview® (EIO) by Crystal Research Associates is available on SpectraScience, Inc. (SCIE-OTC) at www.crystalra.com.
- 2. . • Crystal clear, comprehensive report on a company in a manner that is easily understood by the Wall Street financial community • Product/technology/service offerings, market size(s), key intellectual property, leadership, growth strategy, competition, risks, financial statements, key events, and other fundamental information are detailed • Free of investment ratings, target prices, and forward-looking financial models • Complete risks and disclosures • Written exclusively by experienced, award-winning analysts What is an EIO?
- 3. . Overview of SpectraScience, Inc. (SCIE-OTC) • Up to 80% of colorectal biopsies performed are estimated to be identified as normal, non-cancerous tissue. Replacing these invasive physical biopsies with an optical biopsy, as WavSTAT4 does, reduces risks to patients and may lead to a healthcare cost savings of over $1 billion in the U.S. alone. • WavSTAT4 is designed for ease of integration into the current standard of care. It entails essentially the same process as how physicians screen for cancer today, and is compatible with existing endoscopes. SpectraScience adds a layer of diagnostic interpretation by notifying physicians that, at a particular tissue location, they do not need to take a physical biopsy that they otherwise might have performed. • Tissue that WavSTAT4 finds to be precancerous or cancerous returns a red “suspect” icon. Unlike the traditional method of visual inspection, there is no ambiguity to the result and no need for physician interpretation. • SpectraScience’s patent portfolio in the field of optical methods to detect cancer, cancer precursors, and tissue abnormalities includes 34 U.S. utility patents, seven U.S. design patents, 25 foreign counterpart patents, and an exclusive license to the Massachusetts General Hospital’s optical forceps patent. • Clinical results suggest potential for WavSTAT in bladder cancer and other oncology indications, such as esophageal screening where endoscopes are also a typical diagnostic tool of choice. • The Company’s leadership has extensive experience in the medical device industry, specifically in the areas of strategic management, engineering, manufacturing, global sales, and marketing.
- 4. . Experienced Leadership Team Background Michael Oliver President & CEO ♦ 25 years of experience in the medical device field spanning management, sales and marketing ♦ Particular expertise in commercial operations and product management ♦ Four previous successful turnaround / restarts at Prescription Health Services, Diatek, Inc., New Image Industries, and “A” Company Orthodontics ♦ MBA, George Washington University; BS, United States Naval Academy Lowell Giffhorn Chief Financial Officer ♦ More than 20 years of senior management experience spanning finance, operations, strategic planning and turnaround situations ♦ Former CFO of Patriot Scientific & Sym-Tek Systems, Inc. ♦ Raised more than $20MM in public equity ♦ MBA, National University; BS in Accounting, University of Illinois Hughes Wielemans Director, European Sales ♦ More than 20 years experience in medical device sales and marketing ♦ Experience with direct sales and distributor models ♦ Previous companies: US Surgical, Tyco Healthcare, Covidien ♦ Fluent in English, French, Dutch and German ♦ Economic Sciences degree from ICHEC, Brussels, and Vierick-Leuven Ghent Business School • Board with more than 150 years of medical device experience • Internationally renowned Medical Advisors
- 6. . The WavSTAT® Optical Biopsy System in Colorectal Cancer Screening • Applies laser-induced fluorescence spectroscopy for the differentiation of normal, precancerous, or cancerous tissues in the lower GI tract • Enables the real-time diagnosis of precancerous colon polyps (≤5 mm) during colonoscopy, without requiring that the physician physically biopsy the abnormal tissue and send it to a pathology laboratory for analysis • Capable of performing pathologic analysis onboard the system and displaying immediate results for physicians on screen as they move the endoscope over the suspect colorectal tissue • Holds a CE Mark in the European Union for use in detection of all cancer types and has received regulatory approval in Saudi Arabia • Clinical validation study of WavSTAT4 is ongoing at sites in the UK, Italy, Germany, France, Sweden, Denmark, the Czech Republic, Poland, and Belgium
- 7. . Diagnostic Output: “Not Suspect” or “Suspect”
- 8. . Potential Competitive Advantages ▪ Minimally invasive versus a physical biopsy where tissue is cut out of a patient and sent to a pathologist for examination ▪ Improves the physician’s diagnostic accuracy in determining whether small colon polyps are pre‐cancerous or cancerous ▪ Improves patient survival rates by earlier detection and treatment of cancers, and more importantly pre‐cancers, by more accurately identifying cancers or pre‐cancers the physician may misdiagnose ▪ Improves the patient’s quality of life by providing an immediate analysis of the tissue, thereby eliminating the anxiety of waiting several days to hear the pathology results ▪ Diagnostic results with WavSTAT4 are available to the physician within one second versus prolonged laboratory analysis, thereby enabling the physician to diagnose and treat the patient during the same endoscopy procedure with the same biopsy instrument—potentially reducing the need for scheduling a second expensive endoscopy for treatment purposes ▪ Reduces the number of physical biopsies performed and reduces the number of unnecessary follow‐on endoscopies performed ▪ Reduces the number of misdiagnosed patients, eliminating costly follow‐up procedures ▪ Essentially the same process as how physicians screen for cancer today, and is compatible with existing endoscopes; SpectraScience is not asking doctors to do anything different, other than notifying them that, at a particular tissue location, they do not need to take a physical biopsy that they otherwise might have performed ▪ Less expensive for healthcare payors ▪ Device can also be used by nurse endoscopists, providing them with the same diagnostic capability as expert physicians. This is a critical benefit in countries where screening colonoscopies are often performed by nurse endoscopists.
- 9. . Market Opportunities • Diminutive (very small) polyps under 5 mm in size are found in approximately half of adults undergoing colorectal screening but are rarely malignant. The standard of care has been to resect and submit to a pathologist every polyp or suspect dysplasia seen in a colonoscopy, due largely to the inability of the physician to adequately identify which of these small polyps are precancerous. • SpectraScience’s technology has shown to be capable of distinguishing between “suspect” (potential to become cancerous) and “not suspect” colon polyps under 5 mm in size. Larger polyps are removed as a matter of standard practice, but these smaller polyps found in roughly 50% of colonoscopy patients do not need to be removed if there is a reliable method of confirming they are not cancerous. • A study published in Endoscopy in 2011 found that not performing pathologic assessment for diminutive polyps would lead to a savings in healthcare costs of over $1 billion in the U.S. alone. • WavSTAT4 is designed to enable healthcare payors to realize the savings of forgoing unnecessary biopsies and laboratory tests and to save patients from the risks of numerous invasive biopsies that ultimately remove normal, healthy tissue.
- 11. . Crystal Research Associates, LLC (www.crystalra.com) is an independent research firm that has provided institutional-quality research on small- and mid-cap companies for the past decade. We are led by veteran Wall Street sell-side analyst Jeffrey Kraws, who is well known by the international financial media for his years of work on Wall Street and for providing consistent award-winning analyses and developing long-term relationships on both the buy- side and sell-side. He has been consistently ranked among the Top Ten Analysts for pharmaceutical stock performance in the world for almost two decades as well as ranked as the Number One Stock Picker in the world for pharmaceuticals by Starmine and for estimates from Zacks. Additionally, Mr. Kraws has been 5-Star ranked for top biotechnology stock performance by Starmine. About Us Corporate Headquarters: 880 Third Avenue, 6th Floor New York, NY 10022 Office: (212) 851-6685 Fax: (609) 395-9339Jeffrey J. Kraws, Chief Executive Officer Karen B. Goldfarb President & COO
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