Response Biomedical Corporation (Response), a Canada based medical devices company, has reported total revenues of CAD5.8 million for the full year of 2008. It has reported a net loss of CAD13.6 million, or CAD0.10 loss per share, for the full year of 2008. As of December 31, 2008, the company had about $2.9 million in working capital.
“We accomplished many significant Company goals during 2008 and especially in the fourth quarter, despite the current market conditions which have negatively impacted our share price,” said S. Wayne Kay, chief executive officer. “We added another blue chip strategic partner when we signed Roche Diagnostics as our partner for our cardiovascular product line. Coupled with our partnerships with 3M HealthCare and Shionogi of Japan, we believe we have set a strong framework to ensure our products are well introduced in the global market in 2009 and beyond. We also received regulatory clearance for the Flu A+B product that 3M launched in the fourth quarter, as well as the new RAMP(R: 26.93, 0, 0%) 200 Reader. We achieved a key U.S. Food and Drug Administration (FDA: undefined, undefined, undefined%) clearance to market our NT-proBNP diagnostic test, which will permit Roche to begin marketing the product to U.S. customers. We successfully moved into a state-of-the-art manufacturing facility on March 31, 2008. The facility is essential for supplying the expected volume of quality products to our partners and for reducing our manufacturing costs. The facility successfully completed a FDA Quality System Inspection Technique (QSIT: undefined, undefined, undefined%) Audit in the third quarter of 2008. We believe it is imperative that we continue to focus on building the business that will sustain the Company moving forward and the market will ultimately recognize and reward these efforts.”
“In 2009, we are focused on execution; especially in meeting the requirements for the Roche launch of our cardiovascular product line,” continued Mr Kay. “While the state of the capital markets creates significant uncertainty, we are actively pursuing financing alternatives to fund our working capital and other business needs. We have completed the clinical trials for our RSV Test for 3M, and we are preparing the data to submit for regulatory clearance to the FDA. We are hopeful that we will have that clearance and launch the RSV Test toward the end of 2009, during the next RSV/Flu season. Additionally, Roche is funding work for a next generation Troponin-I assay and a CLIA-waiver trial for NT-proBNP. This work is a key focus for the Company in 2009. We are also continuing discussions with other potential partners for additional applications of the RAMP(R: 26.93, 0, 0%) technology, which we hope to garner during the year. It is definitely an exciting time for our Company and our stakeholders.”