IVDR certification enables Nanomix to market its eLab analyzer in the European Union under the newly established regulatory guidelines
EMERYVILLE, Calif., June 14, 2022 (GLOBE NEWSWIRE) — Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care diagnostics, today announced that it has received the EU Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation (IVDR) for its eLab analyzer, part of the Nanomix eLab® system.
The European Union (EU) IVDR replaces the legacy In Vitro Diagnostic Directive (IVDD) and was created to ensure a greater level of patient protection and regulation around the creation of in vitro diagnostic devices (IVDs).
The Nanomix eLab® system is a rapid, easy-to-use, quantitative detection platform that performs a range of in vitro diagnostic assays. The platform consists of a hand-held analyzer and a disposable cartridge. The eLab System utilizes a proprietary nano-biosensor with multiple detection electrodes to generate multiple electrochemical assay results from a single patient sample. The Nanomix eLab® system offers a variety of benefits, including results in minutes, lower cost, and portability, while providing accurate, quantitative results comparable in quality to those provided by central lab testing. The Nanomix eLab® system has received the CE marking in Europe.
“Achieving IVDR certification is an important milestone for our eLab system, which follows the CE mark designation in Europe for our S1 assay panel using a whole blood sample type,” stated David Ludvigson, President and Chief Executive Officer of Nanomix. “This IVDR registration of the eLab analyzer positions Nanomix and the eLab system for long-term commercial success in the EU, as it ensures market access and availability. As the EU transitions from IVDD to the new IVDR standards, our team will continue its proactive work to remain ahead of the needs of IVDR requirements and changes. We believe this certification reinforces our commitment to the highest standards of quality for healthcare professionals and their patients, which is essential in the fight against sepsis and other critical infections.”
About Nanomix Corporation
Nanomix (OTCQB: NNMX) is developing mobile point-of-care diagnostics with its Nanōmix eLab® System platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision-making and improved patient care. The company’s products are designed to broadly impact healthcare delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote or alternate-care settings, thereby enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assays address the need for faster diagnosis of critical infections as well as the rapid identification of current and prior SARS-CoV-2 infection. The company is developing a pipeline of other tests designed to improve patient outcomes by making high-quality diagnostic information available within minutes. For more information, visit www.nano.com.
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.