News

BRAINBox Solutions Announces Initial Series B Investments to Support U.S. Regulatory Clearance, Initial Commercialization of BRAINBox TBI Concussion Diagnostic/Prognostic Test

BRAINBox Solutions today announced initial investments into the company’s Series B financing to support U.S. regulatory clearance and initial commercialization of its BRAINBox TBI concussion diagnostic/prognostic test in adults and completion of a clinical study in pediatric patients. Genoa Ventures is leading the financing, which includes other current and new investors.

“We have made significant clinical and pre-commercial progress in developing the BRAINBox TBI test,” said Donna Edmonds, BRAINBox Solutions’ CEO. “We are working with selected platform partners as we determine the fastest path to market for use in both point-of-care and emergency department settings.” She noted that in addition to the adult population, the company is developing BRAINBox TBI tests for pediatric patients, and, through a National Institutes of Health grant, for geriatric patients.

“The BRAINBox TBI test is the first to integrate physiologic and functional testing, an approach that is designed to maximize sensitivity and specificity, and provide objective criteria for the diagnosis and prognosis of acute traumatic encephalopathy, commonly known as concussion,” said W. Frank Peacock, MD FACEP, FACC, FESC, the study’s Principal Investigator and Professor, Vice Chair for Research, Henry JN Taub Department of Emergency Medicine, Baylor College of Medicine.

The company’s key progress and achievements include:

HeadSMART II trial – The pivotal trial to support FDA clearance in adults has enrolled 2000 subjects, including subjects for the company’s Normative Data Base in support of the Neurocognitive Component of the Multi-Marker Multi-Modality Product. The company has presented its clinical data at several medical meetings over the past several months.

Pediatric Test – The company entered a funded collaboration with USA Hockey, to evaluate biomarkers in blood and saliva for concussion in elite girls and boys high school hockey players. The study aims to add to the information in the development of the company’s pediatric test by providing objective evidence of neurocognitive changes due to head impacts. The company’s pilot clinical trial in pediatric subjects is currently underway.

“In the current healthcare environment, where priorities include appropriate resource utilization, timely value-based care and patient satisfaction, both patients and clinicians strongly desire a quantitative approach that guides the next step in concussion management,” commented Chad Cannon MD, Chair & Clinical Service Chief, Professor, Department of Emergency Medicine at University of Kansas Medical Center and The University of Kansas Health System, and a Principal Investigator for the HeadSMART II trial.

 

Learn more here.

Recent News

08/26/2025

Activation Capital Names Michael Steele as President and CEO

The Virginia Biotechnology Research Partnership Authority (doing business as Activation Capital) announced today that it has appointed Michael Steele as president and chief executive officer. Steele succeeds Robert Ward, who has served as interim CEO since July 2024 during a period of rapid growth for the life sciences ecosystem development organization. Steele comes to Activation

08/25/2025

Danforth Advisors Acquires PharmaDirections

Danforth Advisors LLC, today announced the acquisition of PharmaDirections, Inc., a full-spectrum development partner to life science companies, expanding its integrated capabilities from discovery through commercialization. Founded in 2003, PharmaDirections was a pioneer of the virtual drug development model. The company brings veteran program leaders and more than 150 specialists to support strategic planning and

08/22/2025

ivWatch Technology Linked to Major Reduction in Severe IV Injuries in Newborns Over Four-Year Study

A study published this month in The BMJ (British Medical Journal) analyzed the use of optical sensor technology from ivWatch, the U.S.-based IV safety company, in the early detection of peripheral intravenous infiltration or extravasation (PIVIE) events in neonates. Presenting a comparative evaluation between conventional observational methods and continuous sensor-based monitoring, the study offers insights