Milestone in real-time, point-of-care diagnostics for traumatic brain injury and other disease applications

NanoDx, Inc., a developer of breakthrough point-of-care diagnostic solutions and SkyWater Technology (NASDAQ: SKYT), the trusted technology realization partner, today announced the first commercially ready nano biosensor to yield a protein response. The unique size and electrical properties of nanosensors allow detection of biomarkers and infections never before possible in a simple, portable, point-of-care system. This milestone enables NanoDx to prepare and submit the product for FDA review and eventual commercialization.

Nanosensor technology utilizes the distinctive properties of nanomaterials to detect, measure, and analyze physical quantities at the nanoscale level. Compared to traditional detection methods, nanosensors enable real-time monitoring and demonstrate significant advantages in cost. NanoDx’s system utilizes a patented nanosensor design that includes an array of highly sensitive nanowires that measure electrical resistance and are functionalized with antibodies that bind with target biomarkers.

In July 2021, NanoDx entered into a licensing agreement with IBM Research for the use of its complementary metal-oxide semiconductor (CMOS) compatible nanosensors technology, giving NanoDx the potential to provide an objective and real-time assessment of injury or infection at a greater sensitivity and specificity than traditional and other point-of-care tests. Building upon the licensed IBM Research technology, NanoDx partnered with SkyWater to co-develop and produce the nanoscale sensors. Subsequently, NanoDx engaged with FTI Consulting to further transition the organization from product development to preparation for commercialization.

NanoDx’s nanotechnology platform delivers several key advantages in patient care:

• Highly sensitive and reliable results
• Test location flexibility with simple, easy-to-use system
• Increased patient throughput: more patients treated in less time
• Streamlined workflow, which increases staff productivity, and
• Direct and indirect cost reduction.

“Leveraging the licensed IBM Research technology in collaboration with SkyWater and FTI Consulting has enabled us to achieve this milestone in record time. We can now take advantage of our FDA breakthrough designation for traumatic brain injury and prepare for pivotal trials followed by FDA submission,” said NanoDx President and CEO, George Serafin. “SkyWater’s support has been instrumental in enabling us to quickly develop our diagnostic solution and to advance its production readiness. We plan to follow this with other disease applications to address critical unmet market needs.”

“NanoDx, using IBM-licensed CMOS technology, has been co-developing this breakthrough at SkyWater by leveraging our Technology as a Service model to rapidly demonstrate concepts and optimize their architecture as they prepare to go to market and ramp to production,” said Dr. Steven Kosier, SkyWater CTO. “We are pleased with the accelerated timeline we were able to achieve and are proud to enable breakthrough advantages for diagnostic healthcare solutions.”

About NanoDx. Inc.

NanoDx is a privately-held, U.S.-based medical device company developing rapid near-patient, point-of-care testing in-vitro diagnostic products on its proprietary nanowire biosensor platform. The NanoDx™ System provides direct measurement of blood and saliva analytes normally in less than four minutes from either a drop of whole blood or a small saliva sample. The System consists of a single-use, disposable test cartridge, and an analyzer. The company is focused on two near-term indications: traumatic brain injury (TBI) and Covid-19. The NanoDx™ System offers compelling competitive advantages based on its ultra-sensitivity and accuracy, speed, value, and ease of use. Future development targets include stroke, sepsis, infectious diseases and oncology.

About SkyWater Technology

SkyWater (NASDAQ: SKYT) is a U.S. investor-owned semiconductor manufacturer and a DMEA-accredited Category 1A Trusted Foundry. SkyWater’s Technology as a Service^SM model streamlines the path to production for customers with development services, volume production and heterogeneous integration 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, ROICs, rad-hard ICs, power management, 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 its annual report on Form 10-K and quarterly reports on Form 10-Q, 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.

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