Co-founder Radvak is back as CEO. Major management changes at Response. Effort is to get things on track and renew investor confidence. Much needed change.
From the release:
"Humberto Reyes has resigned his positions as President, Chief Executive Officer, and Chairman of the Board. Bill Radvak, co-founder of Response Biomedical, has been appointed President and CEO and John Hayes has assumed the role of Chairman of the Board, on an interim basis. Further changes include the resignations of Y-c Cheng and Bruce Colwill from the Board of Directors."
From the accompanying letter to shareholders from Radvak:
"Dear Shareholder, 11 January 2001
"As co-founder of Response Biomedical, I welcome the opportunity to return as President and CEO of the Company. I understand as well as anyone, the potential of the RAMP System, and am confident in our ability to deliver a wide variety of diagnostic tests. Several years ago we set out with the high aspiration of developing the world’s best point-of-care immunoassay system. Needless to say, this may have been naïve given that perhaps fifty other companies, including some of the top diagnostic companies in the world, were out to accomplish the same thing. The bottom line is that although it has taken longer than anyone hoped, we are going to meet our goal.
"One of the single most important tasks facing me is to regain your confidence and the confidence of the investment community at large. The road to recovery begins with openness and honesty. We will show exactly where we stand, and exactly where we are going. After conducting an in-depth review of the program prior to accepting this position, I am confident that the technology now stands on its own merit and that timelines will be met.
"Here are the upcoming milestones, the achievement of which will add immense value to the Company and its shareholders, by providing independent validation of the technology:
· Myoglobin Test and RAMP Reader in Beta Testing January 2001
· Myoglobin Test and RAMP Reader in Clinical Trials March 2001
· Myoglobin Test and RAMP Reader FDA Submission June 2001
· Myoglobin Test and RAMP Reader FDA Clearance Sept. 2001 (expected)
· Troponin I and CK-MB Test FDA Submission March 2002
"I have asked our VP of R&D, Dr. Paul Harris, to tell you in his own words where we stand with the RAMP technology and how it is now performing in the real world:
“The best example of where we stand today is to examine data which we are submitting this week for peer reviewed clinical publication. These internally run clinical tests were conducted in late December 2000. Each week we obtain blood samples from a local hospital combining both normal and suspected heart attack patients. These random samples are blinded and separated into two portions. The first portion is tested at the Canadian External Quality Assessment Laboratory using a Roche COBAS Mira automated immunoassay and the second portion is tested using the RAMP system. At the completion of testing, the findings were compared. The results correlated very well between RAMP and the clinical lab analyzer. The correlation coefficient (R squared) of 0.95 is excellent when compared with other systems in the market.” We have conducted similar studies against other commercially available laboratory analyzers, including the Abbott Axsym, the Beckman Access, the Roche Elecsys 2010 and the Dade Behring Dimension RXL, with similar results. We have selected the Beckman Access as the predicate device for our clinical trials – the final phase of the product development program. Our protocols are currently in the final stages of review and with this information we are in the process of contracting clinical trial sites so that we can begin clinical testing in March. There is a lot of work to do to get ready for this but the RAMP system works well and works consistently. We are ready.”
"Thanks for taking the time to read this letter. My commitment to you is a renewed emphasis on communication. Going forward we will be forthright regarding our timelines and we are prepared to be measured against them. Please feel free to call Ryan Males, Investor Relations, or myself with any comments or questions you may have.
Sincerely,
Bill Radvak |
