NanoDiagnostics (BioDirection, Inc.) is a Boston-based medical device company developing point-of-care in-vitro diagnostic products using its NanoDx nanotechnology platform. NanoDx can identify and quantify blood biomarkers from a drop of blood in less than two minutes for point-of-care, point-of-injury, or remote testing. The company is targeting applications including objective detection, diagnosis and management of traumatic brain injury (TBI), virus detection, and inflammatory disease. NanoDiagnostics received FDA Breakthrough Device designation in January 2019 for its first application as a screen to CT scans for suspected mild TBI. It closed an $18M Series C on Jan. 7, 2020 led by the Alternative Investment division of Shepherd Kaplan Krochuk (SKK); proceeds will support final product validation, scale-up of NanoDx System manufacturing, and initial product introductions in the US and European markets in 2020. Subject to FDA clearance it plans a U.S. launch later in 2020, anticipates entering the European market in Summer 2020, and is also developing a rapid SARS-CoV-2 antigen test from a drop of blood or saliva on the same platform. BioDirection is a Boston, MA-based medical device company focused on rapid point-of-care products for objective management of concussion and other traumatic brain injury (TBI). Its core product is Tbit, a technology platform that uses a patented nanotechnology biosensor to rapidly detect and measure protein biomarkers released from the brain immediately following head trauma. Tbit is designed to enable testing at the earliest stages of medical diagnosis and intervention. The company expects to use recent funding to accelerate execution of the final stages of development and plans for commercialization of the Tbit system. BioDirection closed over $4M in a Series B financing and has raised approximately $10M in total funding to date. The company is led by president and CEO Eric Goorno. BioDirection develops portable, low-cost point-of-care biomarker devices for screening and monitoring brain injury built around its Tbit™ biosensor test platform. The company uses nano biosensor technology to identify biomarkers released from the brain after traumatic injury and can generate a test result in 60–90 seconds from a single drop of blood. BioDirection is privately held and completed a $3.95 million Series A financing to fund product development and miniaturization. Funds will be used to finish two Tbit operating systems: a bench-top chemical test system and a handheld unit. The company planned a bench-top launch in November of the year reported and a handheld launch in the first quarter of 2014. BioDirection emphasizes early identification and rapid testing to address gaps in symptom-based diagnosis and enable earlier medical intervention.

Total raised

$26M

Funding rounds

3

Latest round

Series C

Latest activity

Jul 2020