News and Updates about Head Genetics

A Nashville-based biotech startup promising to revolutionize concussion diagnosis is facing securities fraud allegations from investors who claim they were misled about a saliva-based testing device that has yet to receive regulatory approval or demonstrate clinical validity.

Head Genetics Inc., founded in 2022 by branding executive George Gallo and pharmaceutical veteran Fabian Maclaren, is now the subject of active litigation in both Texas and Illinois, with investors and Cirrus Investments LLC are alleging fraud in connection with what court documents describe as a "failed charitable deduction securities offering."

Head Genetics Inc. presents itself as an emerging Nashville biotech company developing a saliva-based concussion testing kit that it claims can identify traumatic brain injuries through a simple at-home sample and an AI-assisted telehealth assessment. The company markets this technology as the future of rapid concussion detection, suggesting it could transform safety protocols in youth sports, college athletics, and professional football by offering a fast, low-cost diagnostic tool. Led by founders George Gallo and Fabian Maclaren, Head Genetics promotes a storyline of innovative design, cutting-edge science, and nearly a decade of research behind its testing platform.

According to a newly filed civil lawsuit, that narrative may not be true. Investment firms Solidaris Capital LLC and Cirrus Investments LLC have sued Head Genetics, Carita Investments LLC, and individual defendant Mark Bianchi, alleging that the company fabricated key elements of its history, overstated its regulatory progress, and misrepresented the founders’ track records to raise investor funds. The plaintiffs claim they were induced to invest through what they describe as a sophisticated fraud scheme built on timeline deception, unverifiable scientific claims, and assurances about FDA status and technological development that appear to contradict public records and independent research.

Head Genetics Inc. markets a saliva-based concussion test that could change how contact sports diagnose brain injuries. The company claims its kit uses AI-assisted assessments and consumer-friendly sampling tools to identify concussions in minutes. If legitimate, the technology could transform safety standards across high school, college, and professional athletics, where concussions remain one of the most serious health risks.

The promise of a simple, accurate, non-invasive diagnostic is why investors initially viewed Head Genetics as a potential breakthrough. That optimism has collapsed into litigation. Two investment firms, Solidaris Capital and Cirrus Investments, have filed fraud complaints alleging that Head Genetics misrepresented its history, regulatory status, leadership experience, and scientific progress. The allegations describe a pattern that looks strikingly similar to the one that brought down Theranos.

A Nashville biotech startup promising to reinvent concussion diagnosis with a saliva-based test is now facing securities fraud allegations in two states. Head Genetics Inc., founded in 2022 by branding executive George Gallo and biotech entrepreneur Fabian Maclaren, marketed itself as a disruptive diagnostic innovator. But according to lawsuits filed in Dallas County, Texas, and Cook County, Illinois, 

Investors claim they were sold something closer to a mirage than a medical device.

The suits—brought by Solidaris Capital LLC and Cirrus Investments LLC—center on a “charitable deduction securities offering” tied to a program labeled Tech2head Recovery. Court filings point to broken investor relationships, missing funds, and a device that appears nowhere in FDA databases, clinical trial registries, or industry funding trackers.