Traumatic Brain Injuries (TBI) and sports related concussions have become very common and are increasing at an alarming rate. There is an enormous unmet global market need to take care of up to $10 Billion Traumatic Brain Injuries (TBI). CDC estimates the direct or indirect cost spent on treatment of these concussions to be greater than $76 Billion in the US alone. Over 75 percent of TBI are classified as mild traumatic brain injuries while 90 percent of the people with concussions never lose consciousness. There is a lack of an objective point-of-injury (POI) or point-of-care (POC) test. TBI testing today is symptomatic diagnosis, which has a high error rate and is not at all definitive. This is where BioDirection, Inc. steps in and has the potential to manage the diagnosis in a specific and timely fashion.
BioDirection is a privately held medical device company developing cutting-edge and rapid point-of-care or point-of-injury products for the objective diagnosis and management of concussion and other traumatic brain injury (TBI). It is leveraging the power of nanotechnology to address the rapid and definitive diagnosis of TBI
BioDirection Tbit™ System
The company’s first product Tbit™ System is a whole blood POC or POI test platform for traumatic brain injury. It is rapid and affordable test that generates a result in less than two minutes from a single drop of blood. The system measures targeted brain biomarkers released from the brain following a head trauma or jolt to the body.
The platform is easy-to-use, portable and low-cost system (affordable), it consists of two components: tabletop or handheld analyzer and a single-use, disposable sensor cartridge. The disposable sensor drives significant revenue – razor blade annuity. Tbit™ System has the potential to generate a high margin business with strong cash flow.
BioDirection has exclusive, global rights to a Harvard generated patent portfolio for acquired brain injury and Sepsis plus extensive nano-wire based biosensor design or manufacturing know-how. The system is based on design of nanowire biosensor produced from nanowires. A single nanowire is 1/10,000 of a human hair. Tbit™ System offers ultra-sensitivity and specificity.
It uses the selected GFAP and S100b as initial targeted biomarkers; these are clinically validated over 50-60 years as acute biomarkers for TBI. S100b is approved as a screen to CT in over 20 countries world-wide outside of USA. Tbit™ System is a flexible and versatile platform and is not biomarker dependent and readily adaptable to new biomarkers. It has full multiplexing functionality, capable of measuring 2, 3, 5, 10 or more biomarkers simultaneously. It is a game changing technology and the company is targeting market entry late Q1 2020.
The Outstanding Leadership
Sharad Joshi, the President and CEO at BioDirection is a dynamic leader who fosters a mission-centric, fun, and collaborative environment. He holds B.Sc (Mechanical Engineering) degree with a Pre-Med minor from Northeastern University and graduated cum laude with an MBA from Babson College in Wellesley, MA.
He has over three decades of experience in the medical device field including management positions as CEO, President, & COO, Marketing, International Sales, Engineering, among other executive positions. He has also been the inventor and author of numerous patents and publications. Sharad has also served as a business advisor or technical consultant at various companies including pre-revenue start-ups, mid-market companies to large scale companies, such as Proctor & Gamble. He also has the expertise in creative product development, marketing, and technical sales instrumentation and capital equipment.
Serving Global & Diverse Market
BioDirection estimates up to a 5-Billion-dollar market in USA alone for its products with potential to treat greater 50 Million people around the globe. TBI injury impacts all walks of life and age groups with high potential targets extending well beyond sports (all levels – youth, interscholastic, university/college, and professional). Additional targeted markets include military training and deployment, hazardous work environments, senior living or nursing facilities, medical clinics and physician offices, first responders and ambulances, rural medicine, educational facilities, recreation and disaster relief.
BioDirection’s first targeted market is a screen to a CT scan, which it estimates is up to 5 million CT scans for head injury per year in the USA. The company is awaiting its final trial results, which the company believes will approach 100 percent sensitivity to positive CT scans (100% NPV) and ability to detect abnormal protein levels consistent with micro-bleeding not found in negative CT scans.
It has already received FDA Breakthrough Device Designation in January 2019. Subject to FDA review and clearance, BioDirection’s first target is to launch Q1 in 2020; this is subject to FDA review and clearance process.
Future Road Map & Development Strategies
Moving beyond the screen to CT, BioDirection plans to modify the existing TBI™ System providing the full continuum of care for TBI patients including stratification of injury, prognosis, and post-operative return to activity or play. Additionally, the company is also seeking a partner to develop rapid testing products for sepsis, which also require rapid diagnosis in critical conditions.