Forgot your password?

Forgot your username?

database > company
Oncoscope, Inc.
Medical Devices & Tech
324 Blackwell St
Durham, NC 27701 USA
phone:919-251-8030
fax:919-251-8044
Symbol Private
Founded 2006
Employees
www.oncoscope.com
Research Sector Medical Devices & Tech
Summary Description
Optical biopsy devices to detect esophageal cancer.
Management
Perry A. Genova, PhD, President & CEO; John Autrey, MBA, CFO; Gary Pace, Chief Counsel; Micki Lew, Dir. Regulatory Affairs
Keywords
Gastroenterology, diagnostic, oncology, medical device

Comment | Printable Version | Modify profile |
Updated: Apr. 12, 2012

Description
Oncoscope, Inc. is a medical device company that develops proprietary optical imaging systems for epithelial tissues in the oral cavity, esophagus, stomach, colon, lung, cervix and bladder. These systems provide measurements of the diameter and density of cell nuclei in vivo and up to tissue depths of 500 microns. Oncoscope recently completed its commercial a/LCI system prototype and has commenced clinical testing under a multi-center study sponsored by an SBIR grant from the National Institutes of Health. The first two clinical sites in this trial are The Center for Esophageal Diseases & Swallowing at the University of North Carolina, Chapel Hill under the direction of Dr. Nicholas J. Shaheen and the Thompson Cancer Survival Center in Knoxville, TN under the direction of Dr. Bergein F. Overholt. Since it was formed, Oncsocope has diligently pursued new and expanding patent rights across the field of optical biopsy. Broad U.S. patent claims were received in 2009 and several other key patent filings are pending in the U.S. and abroad.
Products / Services
Oncoscope's Panocyte device addresses a significant unmet need in screening for pre-cancerous tissue in the esophagus. The current esophageal tissue monitoring method is expensive, invasive, imprecise, and consists of removing 30 or more biopsies from the esophagus every three months to two years. Approximately 1.6M cancer screening esophageal endoscopies are performed annually in the U.S. costing in excess of $4.0B. Histopathology examination of these invasive biopsies dominates the procedure time and cost. Physicians have little confidence in the ability of conventional biopsy to detect cancer. Poor detection and monitoring leads to very high mortality rates; Barrett's Esophagus (BE) patients have a 30-150 times increased risk of developing esophageal cancer with a five year survival rate of only 16%. The strength of Oncoscope's optical system is its focus on the primary early marker of cancer examined by pathologists: enlarged cell nuclei. The system examines scattered light to determine average cell nuclei size using a proprietary technology called angle-resolved Low Coherence Interferometry, or a/LCI. Oncoscope's system is fast (< 1sec/mm2 spot), accurate (90% sensitivity, ~80% specificity), and non-invasive. Oncoscope's first product, Panocyte, targets the rapid in vivo identification of pre-cancerous tissue in the esophagus during standard esophageal endoscopy addressing a large unmet need. Panocyte consists of a base unit, a probe compatible with current esophageal endoscopes, and a disposable single-use probe cover.
Technology / Differentiation
Oncoscope's Panocyte device addresses a significant unmet need in screening for pre-cancerous tissue in the esophagus. The current esophageal tissue monitoring method is expensive, invasive, imprecise, and consists of removing 30 or more biopsies from the esophagus every three months to two years. Approximately 1.6M cancer screening esophageal endoscopies are performed annually in the U.S. costing in excess of $4.0B. Histopathology examination of these invasive biopsies dominates the procedure time and cost. Physicians have little confidence in the ability of conventional biopsy to detect cancer. Poor detection and monitoring leads to very high mortality rates; Barrett's Esophagus (BE) patients have a 30-150 times increased risk of developing esophageal cancer with a five year survival rate of only 16%. Oncoscope's core technology is applicable to the more than 12 million invasive biopsy procedures performed annually ($25B, U.S.) to detect cancerous epithelial tissue. Many cancers, esophageal cancer in particular, cannot be reliably detected at early stages with conventional biopsy methods that randomly sample a limited tissue area, often missing pre-cancerous cells despite numerous invasive biopsy bites. Early detection in cancer could significantly improve 5-year survival rates.
Market / Customers
Detecting cancer is a key clinical priority with over 12 million procedures performed in the U.S. annually in the gastrointestinal tract for the epithelial tissues targeted by Oncoscope's products. The total cost of these procedures, inclusive of physician, facility, equipment and disposable charges, exceeded $25B in the U.S. in 2006. Oncoscope's first product, Panocyte Guided Biopsy, for esophageal endoscopy enables monitoring of esophageal tissue. Presently, 1.6 million endoscopy procedures costing $4B are performed each year to detect esophageal cancer through tissue biopsy. Market trends support increased demand for this product since the incidence of esophageal cancer is increasing, demanding more surveillance of at-risk patients including those with Barrett's Esophagus.
Competitors / Substitutes / Alternatives
The current standard of care guidance suggests 4-quadrant random biopsies every 1 to 2 cm of Barrett's Esophagus. It is widely held that this screening methodology is wholly inadequate at finding pre-cancerous lesions and therefore often misdiagnoses result producing a large unmet medical need. Only two of the many devices attempting to detect epithelial cancer can see early stage growth. Of these, only the Oncoscope system examines large areas of tissue and deep tissue layers where cancer begins. Furthermore, Panocyte is real time, non-invasive, does not require patient pre-treatment with a contrast agent, and does not require a pathologist to interpret the data.
Strategy
Oncoscope is focusing its efforts initially on its Panocyte device for esophageal screening. By the end of 2012 Oncoscope will have completing product development, received a CE mark, launched in Europe, completed a pivotal clinical trial, filed for U.S. regulatory approval, and identified the next tissue target for product development. Furthermore, product line extensions and the next generation optical biopsy technology will be developed. Through the next 2 years, several significant value inflection points will be achieved providing several exit events.
Funding
Early funding came from SBIR and NIH grants ($2.0M) and a series A equity financing of $3.1M. An $8.0M equity offering is planned for 2010 to achieve key objectives including U.S. and EU regulatory approval, new product validation, manufacturing capacity development, ongoing clinical trial support for regulatory, reimbursement and adoption purposes, and commercial product launch and support.
Status
To date, Oncoscope has generated data from over 140 patients from 2 clinical sites. These excellent results (90% sensitivity, ~80% specificity) exceed commercialization thresholds for optical biopsy products. Additionally, Oncoscope has two issued patents with a total of 6 patent families presently being prosecuted. Oncoscope recently received regulatory clarity from the FDA on its clinical plan as well as Non-Significant Risk status. Further, the Company has commissioned several reimbursement analyses which demonstrate an attractive, definitive short-term reimbursement scenario as well as a high probability of long-term reimbursement at a commercially appropriate level. Finally, Oncoscope's excellent management team, complimented by world renowned medical advisors, has proven itself capable of efficiently allocating capital while executing value-centric strategic plans. Oncoscope is well positioned for a venture-backed series B investment to deliver significant enterprise value.