BioDirection, Inc. d/b/a NanoDiagnostics, 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 represents our largest and most significant investor," said Sharad Joshi, President & CEO of NanoDxTM. "These funds will drive final product validation, scale-up of our NanoDxTM System manufacturing, and initial product introductions into the US and European markets this year."
NanoDxTM is commercializing a versatile nanotechnology platform offering the ability to identify and quantify blood biomarkers (analytes) from a drop of blood in less than two minutes at the point of care, point of injury or remote testing site. The Company received a Breakthrough Device designation from the FDA in January 2019 for its first application as a screen to a CT scan for patients suspected of having mild traumatic brain injury. The company anticipates entering the European market this Summer, 2020; and subject to FDA clearance, the company plans to launch its products in the U.S. market later this year. NanoDxTM is also developing, on the same nanotechnology platform, a rapid test to identify active SARS CoV-2 Antigen from a drop of blood or saliva.
The company's NanoDxTM System is based on proprietary nanotechnology biosensors which rapidly detect and accurately measure protein biomarkers that are released from the brain immediately following a head trauma or jolt to the body or that are present in patients with an active virus. NanoDxTM has built a powerful intellectual property position to protect its design, manufacturing process and use of biosensors which includes 14 Harvard University generated patents, 4 pending patent applications, 3 additional patent applications which will be filed shortly. The company has also developed an extensive portfolio of trade secrets related to delivering affordable, reproducible, ultra-highly sensitive and specific biosensors.
Mr. Joshi further commented, "Our biosensor technology is designed to adapt to a wide variety of health conditions. As an example, shortly after the Covid-19 pandemic began, we demonstrated the flexibility and scalability of our platform for the potential direct identification of Covid-19 with high levels of sensitivity. The modified biosensor produces a test result in about 2 minutes from a drop of blood or saliva immediately at the testing site with little preparation and no central laboratory involvement. As a result, the company is in the process of applying to the FDA for an Emergency Use Authorization for Covid-19."
About BioDirection, Inc.
BioDirection® is a privately held medical device company developing cutting-edge and rapid point-of-care products for the objective diagnosis and management of concussion and other traumatic brain injury (TBI). The company's lead product, the NanoDxTM System, delivers biologically based results shown to accurately confirm a concussion in less than 2 minutes. BioDirection's platform utilizes a patented nano biosensor technology with the potential for use in a wide range of applications in point-of-care diagnostics.
About Shepherd Kaplan Krochuk, LLC.
Shepherd Kaplan Krochuk is one of the country's largest, independently owned SEC Registered Investment Advisory firms, headquartered in Boston, MA. With more than 20 years of experience delivering fiduciary management and investing services to over $6 billion of assets. SKK provides a wide variety of services and capabilities within two divisions: Wealth Management and Asset Management, offering a targeted collection of differentiated strategies in hedge funds, direct real estate projects,venture capital, and opportunistic private equity.
