BioDirection Inc.

vs.

Drug Free Therapeutix (DFTx)

Describe your device and how it will benefit healthcare.

The Tbit system is the first point-of-care platform for diagnosing concussions. This system uses a drop of blood to rapidly detect and measure abnormal quantitative levels of brain protein biomarkers released minutes after a concussion, or traumatic brain injury (TBI). Similar to a glucose meter, the low-cost Tbit system uses a drop of blood placed onto a disposable cartridge, which is then inserted into a portable analyzer. The device provides objective results in less than 90 seconds. BioDirection holds exclusive worldwide rights to over 14 issued patents, both domestic and international.

The Exact device maximizes the quality and safety of therapy from existing FDA-approved neurostimulators for chronic pain by linking changes in patient-reported pain symptoms to the measured neural responses to electrical stimulation delivered by an implanted or external (e.g., TENS unit) stimulator. It then transforms the device programming interface from a complicated set of adjustable electrical stimulus characteristics to a set of dials that directly control the quality of pain relief, letting patients convey their experience to the stimulator and teaching it to meet their therapeutic needs. Most neurostimulators can be enhanced with Exact through a firmware or software upgrade.

How does your product differ from the competition?

Today’s standard methods for concussion diagnosis rely on subjective, symptom-based tests some 30+ years old, the majority of which are paper-based questionnaires that have major confounding issues. Misdiagnosis, under-diagnosis, and even over-diagnosis of concussions is prevalent. In fact, even in the emergency room, 56% of patients who enter with a concussion are not diagnosed correctly or at all. The Tbit system is the world’s first simple point-of-care objective blood test for concussions.

Exact “learns” how to efficiently and effectively provide therapy based on signals measured from the patient's body and user-entered pain descriptors. An algorithm stores and analyzes the device settings, measured efficacy, and patient-reported efficacy to adapt to each user’s pain-relief needs. This simplifies programming, replacing a complicated stimulus parameter tuning system with a simple set of dials that control individual patient pain. Selling points include elimination of crossinterference, improvement in accuracy, improvement in signal-to-noise ratio, improvement in device robustness, reduction in sample requirements (enabling therapy to be initiated in minutes rather than months), and increase in market acceptance.

Do you have customers yet?

The Tbit system is currently entering clinical testing in the United States.

We do not have customers yet, but are actively negotiating partnerships and licensing deals with 3 different companies.
 

How much money have you raised?

Approximately $6 million

$100,000

Who are your investors?

Primarily high net-worth individuals and one investment fund

Friends and family

What is the next milestone for your device?

Clinical trials

Demonstrate the interoperability of our medical device software platform with third-party neurostimulators and fulfill regulatory requirements for our line of intelligent TENS units (Exact Persona)