Q&A With Medical Technology Stock Decision Diagnostics (OTCBB: DECN)
President and CFO Discusses Lead Product Shasta Genstrip; At-Home Testing of Blood Glucose
(firmenpresse) - POINT ROBERTS, WA -- (Marketwire) -- 11/28/12 -- Investorideas.com, an investor research portal specializing in sector research for independent investors, issues an exclusive Q&A interview with Mr. Keith Berman, President and CFO of Decision Diagnostics Corp. (OTCBB: DECN). Mr. Berman discusses the market and opportunity for its lead product, GenStrip® Blood Glucose Test Strips.
Keith, for investors that aren't familiar with your company, can you give a brief outline of your lead product and what differentiates ® Blood Glucose Test Strips from its competitors?
Our Shasta Genstrip product is an at-home diagnostic product for the testing of blood glucose. Genstrip is designed specifically to run on the venerable family of Johnson+Johnson's Lifescan family of meters. This family of meters is in use by over 5 million diabetics worldwide.
At home diagnostic testing is a fast growing market, currently used to monitor blood glucose, primarily as a result of modern society lifestyle issues, and is the most important aid in the fight against spread of diabetes. Genstrip is the first product to reach the market in almost a decade as an alternative to brand name diagnostic products. Since its predecessor generic test strips were sold in the late 1990s, the market for at-home testing has grown 20-fold.
A report from MarketResearch.com recently noted -- Although the blood glucose testing segment of the in vitro diagnostics (IVD) industry is mature, certain segments of the market, such as home testing devices for diabetes management, will exhibit strong growth. Can you give investors insight as to the size of the market and opportunity?
At home glucose testing is the fastest growth segment of personal health management. The personal diabetes meter has matured to become another must-have, must-need, home appliance. While at-home testing is not a new market, my father for instance tested his glucose levels using at-home urine test strips in the 1970s, the last decade has seen explosive growth in monitoring diagnostic products The market for at-home blood glucose testing reached $1 billion per year for the first time in 2000. By 2017 the market is expected to reach $32 billion worldwide. A rule of thumb is that the U.S. and Canada account for one-half of the market, the rest of the world the other half.
According to your SEC filings the Company is underway with the FDA approval process for ®. Can you give us a brief outline of the history and the process for approval?
Shasta Genstrip, like all at-home diagnostic products, requires approval of the U.S. FDA. The process that Genstrip traveled through, called Substantial Equivalency Review ("SE"), was first put in place in the mid-1970s as a way to speed up the regulatory process. Over the last three decades this "speedy" process has morphed into something never envisioned by the U.S. Congress when these laws and regulations were first passed with near unanimous support. Approvals now take in excess of two years. The SE 510k application was filed in early December 2010.
If and when the Company does receive FDA approval what is the timeline for distribution into the sales channels? And how would this typically roll out?
We have had plenty of time to ready ourselves for the ultimate FDA approval of Genstrip. Because of its unique design all of the potential Genstrip customers already make use daily of original manufacturer's platform. Our potential customer base is well known, well studied, and by new product standards, very large.
By law the company could not take orders for Genstrip until there was/is an approval from FDA, but since February 2011 we have been allowed to do some demonstration projects to collect data etc. We used this time to familiarize the market with the upcoming product through the company's normal and historical distribution channels. We secured a supplier contract with Walmart Stores in an incredible 35 days. We have accepted, as a part of our overall responsibilities, working with the Genstrip manufacturer to make product forecasts. We readied the Genstrip Value Proposition. And, it has not hurt that all of the potential consumers of Genstrip have used the predecessor product for, in some cases, almost a decade.
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Decision Diagnostics
800-665-0411
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Datum: 28.11.2012 - 11:14 Uhr
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