A behavioral health diagnostics firm that developed the first attention-deficit/hyperactivity disorder test approved by the U.S. Food and Drug Administration has raised more than $6 million since May as it continues to expand its device into new markets in the U.S and Europe.
BioBehavioral Diagnostics Quotient testing device measures motion and attention state to report objective data on hyperactivity, impulsivity and inattention — the three core ADHD symptom areas. Above all, the test measures a person’s ability to think before responding.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Much has changed since Byron Hewett joined as CEO. The company’s head office has moved from Massachusetts to Pennsylvania as Hewett is based in the suburban Philadelphia town of Bryn Mawr. The supersized diagnostics device has been reduced to a portable size that’s more cost effective to produce.
The market opportunity for ADHD alone is estimated at $800 million. But the company is researching other applications as well. Dr. Calvin Sumner is the chief medical officer and senior vice president for clinical development. He has overseen the company’s research on applications beyond ADHD, such as for Parkinson’s disease and evaluating people before and after brain surgery. He said the Quotient testing system should be thought of as a platform technology that can be broadly applied.
One area it is looking at is when people undergo brain surgery for a neurological problem. When people undergo this kind of surgery, it can create other problems. The assessment platform could be used before and after surgery to help determine what the consequences are of the surgery and how long it could take to recover. Still, in terms of clinical development for applications beyond ADHD, Sumner said it has a long way to go. It expects to prioritize three to five additional applications for the device within a year.
But its main priority is expanding the use of the diagnostics device in the U.S. among physicians as well as neurologists and psychiatrists. It is also pursuing CE Mark clearance in Europe. One thing that frustrates Hewett, as with a lot of other young companies in the medical device sector, is the medical device tax that began in January, particularly since it hits revenue and they have not even begun to make a profit yet. And that has led to the company raising additional revenue. It is seeking to raise an additional $3 million this year, Hewett said.
