BioDirection
A Full Continuum of Care for TBI

Last night, I was watching the UEFA Champions League semi-final draw of Tottenham Hotspur versus Ajax, and an incident that occurred during the game left thinking about the prospect of traumatic brain injury detection in the field of sports. In an attempt to clear the ball, Jan Vertonghen—a Tottenham defender— collided with a fellow teammate and fell on the ground, bleeding from his nose. Seeing this, the referee stopped the game and immediately ushered in the medical staff. As the doctors patched up the wound, Vertonghen stood up and decided to continue playing. Observing his movements, the medical staff brushed away the possibility of a concussion, despite the fact that mobility of a person may not be the most viable indicator for the occurrence of the injury. Moments after the game resumed, the defender suddenly felt nauseous and called for help. If the medical staff had detected the severity of Vertonghen’s concussion when they first attended to him, they would not have allowed him to play further.

It was at this moment, where a recent conversation with Sharad Joshi struck me with a thought of how different the situation would be for the medical staff examining Vertonghen if they had access to BioDirection’s Tbit™ System. Joshi’s organization, BioDirection, has developed a technique of identifying the severity of traumatic brain injuries. In our discussion, he spoke about the applicability of the Tbit™ System in sports, which could help in the early diagnosis of concussions.

From a medical practitioner’s perspective, the adoption of technologies such as the ones developed by BioDirection in sports could potentially save lives and prevent severe brain injuries in various walks of life such as athletic events, military emergencies, and accidents, where immediate traumatic brain injury (TBI) detection and diagnosis is inaccessible.

Mobilizing TBI Detection

“The market for TBI detection, despite its unmet worth of $10 Billion, lacks the objective of point of care (POC) in terms of diagnosing the severity of concussions,” begins Joshi, President and CEO of BioDirection, while touching upon Tbit™ System’s genesis. More than 90 percent of the people with concussions never lose consciousness, which is a significant factor in determining the severity of the injury. A predicament such as this makes it all the more difficult to assess the motor functions of the injured individuals. As a result, diagnosing TBIs has become a daunting task in the medical sciences, requiring expensive CT scans that are only valid in 10 percent of the TBI cases when a brain bleed is an issue.

“There is no yardstick to measure a vast majority of TBI cases at the Point of Injury,” says Joshi. “And, every time a patient has to undertake a CT scan, they are more vulnerable to brain cancer, as the intensity of a CT scan is more than 200 times that of a simple X-ray scan.”

Addressing these challenges, BioDirection specializes in quantifying the severity of TBIs through definitive diagnosis, by utilizing biomarkers that are released following head trauma or a jolt to the human body.

We are focusing on the future of point of care and moving toward a smart and connected ecosystem from a data aggregation perspective

By studying these biomarkers, the company has laid the foundation for diagnosing TBIs in a manner that hasn’t been done before. Joshi’s team has developed the Tbit™ System, with the primary objective of developing a whole blood POC/POI test platform for TBIs. The product is built with three vital prerequisites: ease-of-use, portability, and cost-effectiveness. With just a single drop of blood, the Tbit™ System can generate diagnostics results within 2 minutes using only a tabletop or handheld analyzer and a single-use, disposable sensor cartridge. BioDirection has obtained exclusive, global rights from Harvard University for its patent portfolio of nano biosensor design and has generated significant additional intellectual property in the design and manufacturing over the past years. The sensors are based on the use of nano-wire biosensors comprising nanowires 1/10,000 the size of a human hair. The sophistication of the system enables the company to offer ultra-sensitivity and specificity in terms of the detecting TBIs.

BioDirection has chosen the GFAP and S100b as initial biomarkers of TBI, which have been clinically validated for over 50 years. That being said, Joshi points out that the versatility of Tbit™ System makes it capable of adapting to new biomarkers, offering a complete ‘multiplexing functionality’ of analyzing close to 10+ biomarkers simultaneously.

Materializing the Objective of Point of Care

“The ideology behind our solution set is to transform the TBI marketplace with a conclusive and definitive platform that is not only cost-effective but also exhaustive in terms of diagnosing the severity of an injury. We aspire to expand the utility of our Tbit™ System across diverse industry verticals not only including professional and amateur sports but also elderly falls, car accidents, and the military,” explains Joshi. “Our Chief Technology Officer and Founder, Brian McGlynn, originally developed the concept after having conversations with the military, and after a major investment by Shepard Kaplan and Krochuk, the development accelerated.”

McGlynn was brainstorming with military professionals about the occurrence of TBIs in the defense sector. In the conversations, he noted that one of the predominant challenges encountered in the defense sector is the availability and affordability tests. The armed forces required a solution that is mobile and compact enough to fit inside a Hummer or a tank while traveling to remote locations. The discussion got Brian thinking about the raw science of biomarkers and the methodology to detect them—an idea that ultimately became the cornerstone for BioDirection.

“Newer biomarkers will surely help us address more complex problems in the healthcare sector. More importantly, we are focusing on the future of point of care and moving toward a smart and connected ecosystem from a data aggregation perspective,” adds Joshi. The emphasis on the point of care is the overarching philosophy behind the conception of the Tbit™ System, which is not only battery-operated but also connected to the internet in a HIPAA compliant manner to bring in the much-needed mobility for the device and accelerate the scientific understanding of these biomarkers.

This could serve as a game changer for telemedicine where remote areas of the world in emerging markets (India & China) could gain access to a versatile TBI diagnostic tool that will connect them with a health professional. Physicians and healthcare professionals could seek expert advice remotely by video conferencing with remote patients and obtain immediate resolution.

Diversifying the Global TBI Market

Currently, BioDirection aims to cater to a broad user group, Trauma Center Emergency Departments, encompassing military training and deployment sector, hazardous work environments, senior living and nursing facilities, clinics and first responders such as ambulances, educational and recreational facilities, and disaster relief programs. Through the Tbit™ System, the company has impacted various demographics, ranging from youths to inter-scholastic, university/college graduates, and corporate professionals. Such an audience potentially represents more than 50 million people around the globe with a global market of $10 billion.

BioDirection aims to transcend the barriers of CT scans by tapping into this market potential. The pre-clinical trial results of its Tbit™ System has attained a 100 percent sensitivity specificity mark in predicting a positive CT scans for brain bleed, along with the potential ability to detect abnormal protein levels that are consistent with micro-bleed; these results cannot be obtained through a routine CT scan. The company aims to extend the value proposition of its technology by submitting for FDA approvals by the fourth quarter of 2019 while targeting the first quarter of 2020 for their first product launch.

“Our ambition is to move beyond the ‘screen to CT techniques’ of the modern day, modifying the existing TBI systems to support the development of a full continuum of care for TBI patients,” adds Joshi, while addressing the company’s technological roadmap for the calendar year. BioDirection is building upon its clinical trials utilizing the current biomarker panel to extend the applicability of its platform to injury stratification, prognosis, analyzing the motor functions of the patient, and identifying the chances of stroke or hemorrhage. Besides, advancements in newer biomarkers would surely pave the way for the diagnostics for a wide array of ailments in the medical science landscape. For example, the Tbit™ System could potentially be the answer to detecting Stroke, Alzheimer’s, or other diseases in the near future.

"Our ambition is to move beyond the ‘screen to CT techniques’ of the modern day, modifying the existing TBI systems to support the development of a full continuum of care for TBI patients"

Comprehending Joshi’s words and observing the milestones conquered by BioDirection, it is easy to visualize some of the ground-breaking advancements that could unfold in the healthcare sector. Addressing the company’s efforts as anything but remarkable would surely be an understatement in terms of the applicability of the Tbit™ System. It is safe to say that the future of TBI diagnostics is not only mobile & connected but also comprehensive with regard to understanding the severity of injuries and head traumas.