(CVM.V) November 9, 2018 – CVR Medical Corp. has announced submission of the Carotid Stenotic Scan (CSS) to TUV Rheinland for electrical safety and EMC testing. TUV Rheinland is one of the leading providers of product safety certifications worldwide, covering an assortment of items such as medical devices, home appliances, audio/video products, medical products, textiles and telecommunication equipment.
This testing is required for the CSS’s subsequent De Novo submission to the Food and Drug Administration for U.S. market clearance, and to show the device is compliant with all IEC 60601-1 requirements. IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission. First published in 1977 and regularly updated and restructured, IEC 60601-1 is widely accepted as the benchmark for electronic medical equipment.
“It feels good to have the CSS in the hands of TUV and progressing through one of the critical final steps necessary for our FDA submission,” said CVR Medical chief operating officer Tony Robinson. “With the upcoming transition from IEC 60601-1 3rd edition to 4th edition, a change which the CSS was already designed in compliance with, the queue to get devices into TUV substantially lengthened, exceeding what we originally allocated for an intended October FDA submission. This is pushing our timeline further back, but I have complete confidence in the engineers at CVR and the quality of the product they designed.
“With their focus on developing a product that is first and foremost safe, I believe that we will progress smoothly through the TUV testing schedule without delay,” Robinson added. “With the majority of our De Novo documentation finalized and current clinical trial numbers exceeding the requirements anticipated by our industry-leading regulatory consultants, we are still targeting a submission for the end of fourth quarter. However, this is contingent on external forces and is out of CVR’s control, though all key stakeholders are working tirelessly to expedite the process.”
CVR also announces the intention to submit to Health Canada for a Canadian Medical Device Licence (MDL), which would provide approval for sales of the CSS into Canada, forthwith upon submitting to the FDA for market clearance. Obtaining the ability to distribute the CSS into Canada would open up one of the largest global economies, with diagnostic imaging representing 21 percent of its $6.7 billion medical device market.
“It only makes sense that we continue our momentum with submitting to the FDA, leveraging both relational and geographic advantages,” said CVR CEO and board chairman Peter Bakema. “With the submission requirements mirroring most of the EU technical dossier, we will be able to advance the pace of global availability.”
CVR Medical is a healthcare company that operates in the medical device industry focused on the commercialization of its disruptive, proprietary Carotid Stenotic Scan (CSS). The CSS device is a diagnostic tool that encompasses subsonic, infrasonic, and low-frequency soundwave analysis technology. The CSS is a patented device designed to detect and measure carotid arterial stenosis which significantly increases the risk of stroke. CVR is currently in pivotal clinical trials in preparation for its planned submission to the FDA. CVR is led by an experienced and proven team of professionals with extensive healthcare, medical device, international expansion, regulatory and sales experience.Disclaimer: ALWAYS DO YOUR OWN RESEARCH and consult with a licensed investment professional before making an investment. This communication should not be used as a basis for making any investment.