NanoDx product to be scaled and submitted for FDA Emergency Use Authorization
BLOOMINGTON, Minn. and BOSTON, Mass. – October 6, 2021 – SkyWater Technology (NASDAQ: SKYT), the trusted technology realization partner, and NanoDx, Inc., a privately held medical device company developing breakthrough, point-of-care diagnostic solutions, today announced technology transfer for qualification and production ramp of nanoscale sensors to enhance and expand accurate, rapid testing for several indications, including COVID-19, traumatic brain injury (TBI), sepsis and stroke. NanoDx is partnering with SkyWater to scale the product and plans to pursue an Emergency Use Authorization from the U.S. FDA for rapid, two-minute, point-of-care COVID-19 testing.
Recently, NanoDx announced a licensing agreement with IBM Research for integration of its complementary metal–oxide–semiconductor (CMOS) compatible technology design with NanoDx’s highly advanced nanosensor platform to accelerate the ability to bring an extensive array of diagnostic solutions to market. NanoDx is planning to commercialize a real-time, point-of-care diagnostics platform capable of detecting and quantifying biomarkers (analytes) from a small fluid specimen. The company has built an extensive intellectual property portfolio around its nanosensor platform that encompasses the entire field of in vitro diagnostics and biosensors.
“During this global pandemic, the importance of rapid diagnostics has become ever more vital in preventing spread of the disease, enabling faster treatment of patients and shortening their recovery times,” said Sharad Joshi, president and CEO of NanoDx. “The capability to easily scale our product at SkyWater, a U.S.-owned, IP-secure facility will enable us to quickly meet the needs of diagnostic testing for COVID-19 with the potential for use with a wide variety of other clinical applications.”
The breakthrough science integrated into the NanoDx System was originally based upon the revolutionary work of Harvard University, a pioneer of nanoscale technology. The patented nanosensor design includes an array of ultrasensitive nanowires that detect and measure specific biomarkers and infections in the bloodstream or other fluid specimens. The unique size and electrical properties of the nanosensors allow detection of biomarkers and infections never before possible in a simple, portable and accurate point-of-care system.
“We are very pleased to work with NanoDx on this opportunity to potentially help early diagnosis of COVID-19 through rapid testing,” said Thomas Sonderman, SkyWater president and CEO. “Further, the company’s groundbreaking nanosensor platform can be used for other important diagnostics and SkyWater is prepared to support their efforts in these areas as well.”
SkyWater is certified to the ISO 13485 Quality Standard for Medical Devices to support the design, development and fabrication of biochip applications in a wide range of emerging biomedical market segments.
About NanoDx, Inc.
NanoDx, Inc., is a privately held medical device company developing breakthrough, point-of-care diagnostic solutions that address unmet market needs and improve patient outcomes while reducing healthcare costs. The company’s flagship product, the NanoDx™ System, is capable of detecting and quantifying biomarkers (analytes) from a small fluid specimen in less than 2 minutes. NanoDx’s platform utilizes a proprietary nanosensor technology with a broad range of potential diagnostic applications including COVID-19, Traumatic Brain Injury (TBI), Influenza, Sepsis and Stroke. www.NanoDiagnostics.com
About SkyWater Technology
SkyWater (NASDAQ: SKYT) is a U.S.-owned semiconductor manufacturer and a DOD-accredited Trusted supplier. SkyWater’s Technology as a ServiceSM model streamlines the path to production for customers with development services, volume production and advanced packaging solutions in its world-class U.S. facilities. This pioneering model enables innovators to co-create the next wave of technology with diverse categories including mixed-signal CMOS, read-out ICs, rad-hard, power discretes, MEMS, superconducting ICs, photonics, carbon nanotubes and interposers. SkyWater serves growing markets including aerospace & defense, automotive, biomedical, cloud & computing, consumer, industrial and IoT. For more information, visit: www.skywatertechnology.com.
SkyWater Technology Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements that are based on the Company’s current expectations or forecasts of future events, rather than past events and outcomes, and such statements are not guarantees of future performance. Forward-looking statements are subject to risks, uncertainties and assumptions, which may cause the Company’s actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. Key factors that could cause the Company’s actual results to be different than expected or anticipated include, but are not limited to factors discussed in the “Risk Factors” section of the prospectus the Company filed with the SEC on April 22, 2021, its quarterly report on Form 10-Q for the quarter ended July 4, 2021 and in other documents that the Company files with the SEC, which are available at http://www.sec.gov. The Company assumes no obligation to update any forward-looking statements, which speak only as of the date of this press release.
NanoDx Company Contact: Sharad Joshi | 508.599.2400 | email@example.com
SkyWater Company Contact: Tara Luther | 952.851.5023 | firstname.lastname@example.org
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