DENVER, NC / December 13th, 2018 / CVR Medical Corp. (CVM.V) (TSXV: CVM) (OTCQB: CRRVF) (“CVR Medical”) a Canadian listed and US based healthcare company in the medical device sector announces that its patented, disruptive Carotid Stenotic Scan (CSS) has passed the IEC 60601-1-2 edition 4, General Requirements for Basic Safety and Essential Performance – Electromagnetic Disturbances conducted by TUV Rheinland of North America. TUV Rheinland of North America, 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 FDA for US market clearance and will show that the device is compliant with all IEC 60601-1-2 EMC requirements. The International Electrotechnical Commission (IEC), based in Geneva, Switzerland, publishes the 60601 series of technical standards that allow medical device developers to demonstrate the safety and essential performance of their medical equipment. Upon completion of EMC testing, TUV North America started IEC 60601-1 safety testing which includes, software and hardware validation , fire and electrical safety and mechanical failure. As announced, CVR’s previous guidance relating to FDA submission remains unchanged for Q1 2019.
In speaking to CVR’s VP of Program Management & Product Development, Lewis Crenshaw, the TUV engineer stated “CVR’s team did a tremendous job preparing documentation and hardware for IEC 60601- 1-2 EMC safety testing. This allowed the TUV team to quickly and efficiently tackle the testing, review technical documents and draft and sign the EMC test report during the busiest time of our year.”
Tony Robinson, CVR Medical’s Chief Operating Officer stated, “This represents one of the final hurdles standing between CVR and the FDA submission that we have been working so diligently towards. Many companies are significantly delayed by requirements such as EMC, but thanks to the thoroughness of the CVR engineering team and open dialogue which TUV provided, we have been able to maintain our momentum toward our objectives. Working with TUV has been the epitome of efficiency and effectiveness, even during this extraordinarily busy time. We know that when our CSS device is placed into the clinical setting we are holding ourselves to the industry’s highest standard of electrical safety.”
About CVR Medical
CVR Medical Corp. is a healthcare company that operates in the medical device industry focused on the commercialization of its disruptive, proprietary CSS Device. The CSS device is a diagnostic tool that encompasses subsonic, infrasonic, and low frequency sound wave analysis technology. The CSS Device is a patented device designed to detect and measure carotid arterial stenosis. 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. CVR Medical trades on the TSX Venture Exchange under the symbol CVM.
Additional information regarding the Company can be found in our recent filings with the SEDAR as well as the information maintained on our website at www.cvrmed.com
ON BEHALF OF THE BOARD: (signed) “Peter Bakema” CEO, President & Director