True Bearing Diagnostics

True Bearing Diagnostics, Inc.

Scientifically validated Infection Diagnostics 

achieved through research

resulting in data-backed, peer reviewed results

Summary

Competitive Landscape

Currently available tools to diagnose infection include –

• white blood cell count (+/- 60% accurate)
• CT scan (expensive),
• exploratory surgery (expensive and invasive).

At +/- 90% accuracy with our TruNAV blood based diagnostic approach –

We are offering a better initial test within an already existing market. We are looking at and detecting the human response to infection.

TruNAV is able to see

• bacterial,
• viral, and
• biofilm infections
• in addition to measuring the magnitude of the infection which allows us the potential to track the therapy that is undertaken (example – antibiotics).

No other test offers this comprehensive initial diagnostic tool enabling doctors to make informed decisions about patients who may have an infection and allowing the efficient and accurate ability to make more informed decisions about patient care.

Market size

True Bearing has developed an RNA-based blood test to assist with diagnosing internal infections that will address a $50+ billion-dollar market. Initially focused on abdominal infections, our TruNAV test fills a large diagnostic void in medicine.

In 2020, there were 11 million emergency department (ED) visits for the narrow diagnosis of “Stomach and abdominal pain” (Table 1) (1).  On average from 2007-2013 there were 20.3 million emergency department visits for the larger class of abdominal and digestive diseases (1, 2).  However, of people experiencing acute abdominal pain, only about half go to an ED, with the other half going to a primary care physician (2).  Furthermore, of people that experience abdominal pain, only about half seek medical care of any type (2).  Thus, the abdominal pain market is certainly several times larger than the 11 million patients that present to the ED.  From very large survey analysis of 10,000 patients with abdominal pain (2) and other analyses, we reconstructed roughly the distribution of abdominal pain cases according to how they are likely to seek medical care (Table 1).

We estimate that there are at least 28.5 million visits to the emergency room, urgent care, and doctor offices each year for abdominal pain

What experts are saying about True Bearing Diagnostics and

TruNAV – Infection Diagnostic Test:

“Thank you for … detailing the FDA Clearance study: The Neutrophil Activation Test Using RNA Levels (The NATURAL Study).  After discussing it, we have a good understanding of the goals and methods of the study, and we’d be very interested in participating in this important research protocol at The Mayo Clinic ED.” PatrickRonna L. Campbell, M.D., Ph.D. (Associate Research Chair, Professor of Emergency Medicine, Mayo Clinic)

“Life Technologies Corporation (LTC) looks forward and is pleased to continue supporting the successful market deployment of TBD’s TruNAV … technology.” Patrick Policelli (Business Development Manager, Thermo Fisher Scientific, Commercial Supply & OEM – Life Sciences Solutions Group)

“JLABS invites emerging companies to join JLABS based on the following criteria: compelling and credible science and/or technology; potential to meet an area of significant medical or market need; and the quality of the team. Using these criteria, True Bearing Diagnostics was selected to join and has the full support of JLABS for accomplishing their goals. Sally Allain, MSc, MBA (Head, JLABS Washington, DC, Johnson & Johnson Innovation)

“The Emergency Department at the University of Virginia Health Sciences Center is eager to engage in the forthcoming multi-center FDA clearance NATURAL Trial to further assess the efficacy and accuracy of the TruNAV diagnostic tool.” Dr. Chad A Hoyt, MD, FACC, FRCPE (Executive Director of Clinical Growth & Outreach, UVA Health System, Associate Professor of Medicine, Division of Cardiovascular Medicine)

“It was a privilege to examine the foundational scientific data and the three pivotal clinical studies utilizing the TruNAV RNA Biomarkers for detecting intra-abdominal infections (IAIs). In our discussions, we noted that our Emergency Department physicians frequently encounter these conditions, underscoring our need for innovative diagnostics to accurately deterimine the causes of abdominal pain. Consequently, the Emergency Department at the University of Virginia Health Sciences Center is eager to engage in the forthcoming multi-center FDA clearance NATURAL Trial…” Thomas Hartka, MD, MS, MDMS (Interim Vice-Chair for Research Department of Emergency Medicine, University of. Virginia)

“Poorly differentiated abdominal pain is a major problem in young adults and a common cause of presentation to our Emergency Department at Children’s National Medical Center. The NATURAL Study is very much aligned with our clinical and research priorities and we are excited to be a part of it…We can certainly foresee how the TruNAV test could be used in children and young adults where there is an ongoing confusion in determining the underlying etiology for their symptoms. In patients that are likely to be discharged with an inconclusive diagnosis, we would be very interested in ordering a TruNAV test to help direct their post-ED care, to help determine whether an infection is involved or not.” Dr. Elaise Hill, M.D. (Children’s National Hospital, Washington DC)