NEWS - How many years have we been waiting for this? Hopefully the FDA will not stall on getting this approved. Most of us were expecting this release so only a moderate market action on the news. Did get filled at .43 for 4000 first thing this morning, The company has come a long way in the last couple of years so at today's price there is great value here.
Dick
Response Biomedical Files For US FDA Market Clearance of
> Additional RAMP® Cardiac Tests
>
> The Company Submits Clinical Trial Results of RAMP Tests For Troponin I
> and CK-MB
>
> Vancouver, British Columbia, December 8, 2003 - Response Biomedical Corp.
> (RBM: TSX Venture Exchange; RBQ: Frankfurt), today announces it has filed
> a regulatory submission with the US Food and Drug Administration (FDA)
> seeking market clearance to commercially introduce its lead medical
> application in the United States. The regulatory submission follows
> positive results from the recently completed multi-center clinical trial
> of RAMP* tests for troponin I and CK-MB, two cardiac marker tests used
> with the RAMP Reader in the early diagnosis of heart attacks. Last year,
> the Company announced receipt of FDA 510(k) market clearance of the RAMP
> Reader for general clinical use, as well as its cardiac test for
> myoglobin. Subsequently, the Company also received CE Mark for the RAMP
> Reader and all three cardiac tests.
"Given the exceptional performance of the troponin I assay, the promising
> clinical data has added significant impetus to the Company's formative
> negotiations with several potential marketing partners for the RAMP
> cardiac tests," states Bill Radvak, President and CEO. "As we continue to
> evaluate opportunities and enter into agreements with international
> marketing partners over the coming weeks and months, we anticipate a
> timely review by the US FDA in preparation for entering the US market
> expected early next year," adds Radvak.
>
> The RAMP System provides a quantitative result in less than 20 minutes,
> considerably faster than traditional laboratory testing often limited by
> turnaround times of up to 24 hours. In clinical applications, RAMP is
> designed to be used by healthcare professionals at the point-of-care
> (POC), including physicians' offices, medical clinics, hospital emergency
> departments and laboratories worldwide.
To demonstrate substantially equivalent performance of the RAMP System,
> the Company sponsored a dual-predicate clinical trial using an FDA-cleared
> POC device and a leading lab-analyzer. RAMP and the POC device tested
> whole blood samples from both normal subjects and patients with symptoms
> of suspected acute myocardial infarction. Both RAMP tests showed strong
> correlation with the lab-analyzer and the high sensitivity RAMP Troponin I
> Test showed significant performance improvement versus the market-leading
> POC device at low troponin I concentrations. The clinical results will be
> submitted for peer-review and publication in an industry journal over the
> coming weeks.
>
> Myoglobin, troponin I and CK-MB are the three commonly utilized cardiac
> markers measured to assist in the diagnosis of acute myocardial infarction
> (heart attack). Studies have determined that these cardiac markers are
> essential for diagnosis of heart attack, for assessing risk of adverse
> outcomes, and for guidance of therapy and intervention in suspected heart
> attack patients.
The global POC market generated revenues worth $3.3 billion in 2002 and is
> expected to reach $5.5 billion in 2009. This market is growing faster than
> the total in vitro diagnostics market. The world cardiac rapid assay
> market is expected to achieve an average annual growth rate of 20% - 25%
> for the near future.
>
> Each year in the United States, more than six million Americans are
> admitted to emergency rooms for severe chest pain, according to the
> American College of Cardiology. Only approximately 10% of those
> hospitalized suffer a heart attack. The majority is eventually diagnosed
> with strained muscles, bruises or heartburn. The total cost of
> unnecessary admissions and misdiagnosis is over US$4 billion.
> Misdiagnosed heart attack cases also account for nearly 25% of malpractice
> claims against emergency room physicians.
>
> Response Biomedical develops, manufactures and markets rapid on-site RAMP
> tests for medical and environmental applications providing reliable
> information in minutes, anywhere, every time. RAMP represents an entirely
> new class of diagnostic, with the potential to be adapted to more than 250
> medical and non-medical tests currently performed in laboratories The RAMP
> System consists of a portable fluorescent Reader and single-use,
> disposable Test Cartridges. RAMP tests are commercially available for the
> early detection of heart attack, environmental detection of West Nile
> virus, and biodefense applications including the rapid on-site detection
> of anthrax, smallpox, ricin and botulinum toxin.
Response Biomedical is a publicly traded company, listed on the TSX
> Venture Exchange under the trading symbol "RBM". The Company is also
> listed on Frankfurt Stock Exchange under the trading symbol "RBQ". For
> further information, please visit the Company's website at
> www.responsebio.com.
>
> Although the Company has filed a regulatory submission with the US FDA
> seeking 510(k) market clearance, RAMP tests for detecting troponin I and
> CK-MB are not currently available in the United States.
> The TSX Venture Exchange has not reviewed and does not accept
> responsibility for the adequacy of the content of the information
> contained herein. The statements made in this press release may contain
> certain forward-looking statements that involve a number of risks and
> uncertainties. Actual events or results may differ from the Company's
> expectations.
>
> - 30 -
>
> Media Contact:
> Don Bradley
> Director, Corporate Communications,
> Response Biomedical Corp.
> Tel (604) 681- 4101 ext 202
>
> Email: dbradley@responsebio.com
>
> |
