A geneally positive report, other than a three month slip in their product time schedule. No surprise in the share dilution story.
ST. PAUL, Minn., Nov. 26 /PRNewswire/ -- Quantech Ltd , announced today that its shareholders elected Robert Case to the Board of Directors and approved an increase in the company's authorized shares of stock to 120 million shares.
R.H. Joseph Shaw, president and chief executive officer of Quantech, said, "The election of Robert Case, a leading medical design consultant, exemplifies the success we are having in building a team
of highly skilled individuals who have extensive experience in the medical diagnostic industry. In the last year, we have hired a chief financial officer and the heads of marketing and sales, manufacturing and engineering, in addition to various support individuals.
"We also have engaged consultants in the areas of regulatory affairs, project management, mathematics, software design, market research, industrial design and product engineering. This group adds to the critical mass required to complete the final commercialization of our diagnostic product.
"Over the past year, substantial progress has been made. We have operating prototype systems, the FDA has received and accepted our protocols for the preparation of our 510(k) submission, our basic disposable and instrument configurations have been finalized, our marketing plan is in progress and market research continues to confirm the potential for our product. We are also in the process of evaluating clinical sites.
"Our development and manufacturing teams have identified a number of opportunities to improve the performance and cost of the instrument and the disposable, to improve the reproducibility of the tests to be performed, and to identify multiple suppliers for many of our key components.
"Everyone is working very hard to complete the product and no one sees any major problems in doing so. The expectation is that we will make our 510(k) submission to the FDA in early 1997 and launch the product in the summer of 1997. We believe that our current funds are sufficient to allow us to make the FDA submission," Shaw said.
Based in St. Paul, Minn., Quantech is a development stage company working to commercialize its surface plasmon resonance (SPR) technology for the critical care medical diagnostic market. The
company's diagnostic system is being designed for hospital critical care units, initially the emergency department, to provide rapid, quantitative results using whole blood. The first test planned for
introduction will detect and quantify cardiac markers that aid physicians in the diagnosis of a heart attack. Plans call for the development of additional tests that will allow the system to provide a full range of testing capabilities. SOURCE Quantech Ltd. |
