SAN LEANDRO, Calif. (August 18, 2022) – Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in mobile, affordable, point-of-care diagnostics, today announced that it has received ISO 13485:2016 certification for its new facility in San Leandro, California.
Nanōmix began the transition to its new manufacturing facility in April 2022. The new facility is 9327ft2 and accommodates the Company’s increasing headcount. Investment in the facility includes additional automation that expands immediate capacity and allows significant flexibility for demand-driven scaling of the Nanōmix proprietary, multiplex cartridge technology and tests.
Vidur Sahney, Chief Operating Officer of Nanōmix, stated, “The receipt of the ISO certification validates and affirms the strong quality system Nanōmix has in place. Additionally, this is a major milestone and the result of a successful transfer of our manufacturing technology to our new facility. Notably, this ISO certification marks the continuation and acceleration of our manufacturing scaling to meet customer demand for the eLab S1 critical infection panel and other future products.”
ISO 13485:2016 an internationally recognized quality standard that is intended to ensure that medical devices and related services have consistent design, development, production, and sale of products that are fit for purpose as per intended use. To be certified, organizations must demonstrate that their Quality Management Systems are able to provide products and related services that consistently meet customer and applicable regulatory requirements.
Nanōmix (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 including sepsis. 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.nanomixdx.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.
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