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NEW YORK – After finalizing its manufacturing strategy, point-of-care diagnostic firm NanoDx is working to commercialize its tramautic brain injury (TBI) and COVID-19 tests. The firm's reagent-less NanoDx System, which uses electrical currents to detect biomarkers for different diseases, uses technology developed and patented at Harvard Medical School and IBM and licensed by the Southborough, Massachusetts-based company, which was formerly known as BioDirection, Chief Commercial Officer Mike Sampson noted. The development came from the "desire... to get very simple, very fast, very accurate tests really to the point of care … so that decisions can be made right away," he said. The difference between the NanoDx System and other point-of-care devices is that the NanoDx System "doesn't rely on the reaction between the reagents and the sample," Sampson said. "Instead, it just directly measures whatever target it grabs, and so, it gets a very specific result in a very short amount of time." To use the device, a sample is applied to a single-use cartridge that is then placed in the reusable analyzer. The sample is moved over the two nanosensors within the analyzer, which run small electrical currents through the sample via nanowires coated with antibodies that bind to...

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.

*The NanoDx^™ System has not been evaluated by the FDA or other regulatory agencies. BioDirection^® DBA NanoDiagnostics^™ & NanoDx^™

Boston, MA – June 15, 2022 – NanoDx, Inc., is a privately held medical device company developing rapid, near-patient, point-of-care, in-vitro diagnostic solutions leveraging a first-of-its-kind nanowire biosensor technology to improve patient outcomes and reduce healthcare costs. The company’s flagship product, the NanoDx™ System, can detect and quantify biomarkers (analytes) from a small fluid specimen, blood or saliva, in less than four minutes. NanoDx’s platform utilizes a proprietary nanosensor technology licensed from IBM with a broad range of potential diagnostic applications, including traumatic brain injury (TBI), COVID-19, stroke, sepsis, infectious diseases, oncology, and other therapeutic areas. Mr. Serafin, a Senior Managing Director at FTI Consulting, has been acting Interim CEO for NanoDx for the last seven months. During this period, he has demonstrated the leadership ability to solve complex challenges by adopting this innovative technology in collaboration with IBM and SkyWater Technology, driving strategic objectives, and transitioning the organization from product development to preparation for commercialization. George is a 35+ year seasoned professional possessing a unique blend of industry, technology, and management consulting experience spanning R&D, engineering, supply chain, manufacturing, quality, regulatory, compliance, corporate/operations, and information technology across biotechnology, pharmaceuticals, medical device and diagnostics, and consumer healthcare. He also serves...

Boston, MA - January 10, 2022 - NanoDx, Inc., a privately held medical device company developing rapid, 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 Traumatic Brain Injury (TBI), COVID-19, Influenza, Sepsis and Stroke. Mr. Sampson joined NanoDx in November 2019 as Vice President of Sales. He is an innovative leader in the global health care industry with over 29 years of diversified experience in business development, sales, distributor management, marketing, product strategy, driving successful product launches, and creating innovative relationships with internal team members, customers, and service providers. Before joining NanoDx, Mr. Sampson spent 25 years with Siemens Healthineers holding positions of Senior Vice President and General Manager North American IVD Specialty Business; Vice President and General Manager, Global Point of Care Commercial Business; and Senior Director Global Point of Care and Business Operations, Director Program Manager. "On behalf of our Board of Directors and management team, I am thrilled...

It is immense pleasure that we announce the Dr. John E. Kelly, former Executive Vice President of IBM, will be joining NanoDx as a Technical and Strategic Advisor to the Board of Directors. Dr. Kelly will provide technical advice and assistance to the Company including strategic guidance, introduction to subject matter experts, evaluation of technical materials, and assessment of development roadmaps and progress reports. In his consulting role, Dr. Kelly will develop close working relationships with our Interim CEO, George Serafin, and our CSO, Dr. Sergey Dryga, and their supporting technical staff. In December 2020, NanoDx obtained a worldwide licensing agreement from IBM Research for use of its metal-oxide semi-conductive ("CMOS") compatible nanoscale sensors to enhance accurate, rapid testing while obtaining high throughput at significantly lower cost. The companies have been collaborating throughout 2021 on integrating the NanoDx™ System with the CMOS technology. The company anticipates the newly created strategic relationship with Dr. Kelly will help drive commercialization of this leading-edge technology in the in fields of vitro diagnostics and biosensor. Dr. Kelly has nearly four decades of experience innovating and leading in the Information Technology industry. Throughout his distinguished career, he has held significant technical and business roles driving...

BLOOMINGTON, Minn. & BOSTON--(BUSINESS WIRE)--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.

*The NanoDx^™ System has not been evaluated by the FDA or other regulatory agencies. BioDirection^® DBA NanoDiagnostics^™ & NanoDx^™

Boston, MA - NanoDx, Inc., a privately held medical device company developing breakthrough, point-of-care diagnostic solutions, today announced a licensing agreement with IBM Research for use of its metal-oxide semi-conductive ("CMOS") compatible nanoscale sensors to enhance and expand accurate, rapid testing for several indications, including COVID-19, Traumatic Brain Injury (TBI), Sepsis and Stroke. NanoDx is pursuing an Emergency Use Authorization from the U.S. FDA for rapid, two-minute, point-of-care COVID-19 testing. "The field of diagnostics has changed rapidly during the past year with the emergence of COVID-19," said Sharad Joshi, President and Chief Executive Officer of NanoDx. "This global pandemic has further highlighted the need for a convenient, fast and accurate diagnostic so proper treatments can be delivered to patients as quickly as possible with the goal of shortening recovery times. As we move forward, our access to IBM's technology in the in vitro diagnostics and biosensor fields will enable us to pursue developing a high throughput diagnostics platform at a significantly lower cost." NanoDx is commercializing a real-time, point-of-care diagnostics platform capable of detecting and quantifying biomarkers (analytes) from a small fluid specimen in less than two minutes. The company has built an extensive intellectual property portfolio around its nanosensor...

Boston, MA - June 15, 2021 – NanoDx, Inc., a privately held medical device company developing cutting-edge and rapid, point-of-care diagnostic products for the objective diagnosis and management of Traumatic Brain Injury (TBI), today announced that it has formed a partnership with the Home Base Program to increase the awareness of the long-term issues associated with TBI in both active and retired military personnel. “Early detection of TBI is critical in minimizing the long-term effects of injuries sustained in training or deployment,” stated James Wylie, Executive Chairman of NanoDx. “Our handheld NanoDx™ System was designed for rapid, point-of-injury diagnosis and is capable of delivering a direct test result in less than 2 minutes from a drop of whole blood.” Home Base, a Red Sox Foundation and Massachusetts General Hospital Program, is dedicated to healing the invisible wounds of war through world-class clinical care, wellness, education, and research.  As a National Center of Excellence, Home Base operates the first and largest private-sector clinic in the nation devoted to providing life-saving clinical care and support for the treatment of post-traumatic stress, traumatic brain injury, anxiety, depression, and other issues associated with military service. Michael Allard, Chief Operating Officer of Home Base commented, “Home...

Widespread point-of-care (POC) and at-home diagnostics have long been widely held goals. However, that hasn’t been widely translated into reality. Startup Nanodiagnostics Inc. has been working for years toward a panel of POC tests, helmed by one for traumatic brain injury (TBI) that was quick, simple and accurate enough to use at the sports stadium or on the sidelines of a soccer field.

*The NanoDx^™ System has not been evaluated by the FDA or other regulatory agencies. BioDirection^® DBA NanoDiagnostics^™ & NanoDx^™

Boston, MA – BioDirection®, Inc. d/b/a NanoDiagnosticsTM, Inc. (NanoDxTM), a privately held medical device company developing cutting-edge and rapid point-of-care in-vitro diagnostic products for the objective detection, diagnosis and management of Traumatic Brain Injury (TBI), virus detection and inflammatory disease today announced that it has closed an $18 million Series C Convertible Preferred Stock Financing. The financing was led by the Alternative Investment division of Shepherd Kaplan Krochuk, LLC (SKK), a diversified Wealth and Asset Management firm located in Boston, Massachusetts. Mr. Steve Brackett, President and Managing Member of SKK, commented "The global need for rapid, definitive and efficient diagnostic technologies has never been greater than it is currently. NanoDxTM fits SKK's investment strategy, which focuses on cutting-edge, proprietary technology platforms addressing large endemic issues and conditions in the global markets. We are impressed by the depth and breadth of NanoDx' s current products and development plans, and we are excited to be working with such an experienced and visionary team." "Based on the high level of interest and SKK's leadership in the financing, our shareholders approved an increase in the oversubscribed initial financing, originally targeted to be $15 million USD, to $18 million USD in May 2020. SKK now...