Business Briefs: Pear Therapeutics, Banyan, Verinetics, Integrated Services for Behavioral Health, Mindpath Health

Pear Therapeutics announced recently that it has received Breakthrough Device Designation from the US Food and Drug Administration for reSET-A, a prescription digital therapeutic product candidate for the treatment of alcohol use disorder. It is the second such designation Pear has received from FDA, following the designation awarded for reSET-O, the first ever for a prescription digital therapeutic, which was developed for the treatment of opioid use disorder.

FDA’s Breakthrough Devices Program is intended for devices that improve treatment or diagnosis of life-threatening and irreversibly debilitating diseases and conditions. It expedites device development and prioritizes reviews of subsequent regulatory submissions.

While reSET-A has received the Breakthrough Device Designation, it has not yet received marketing authorization from FDA, and it is not available for sale in the US.

“We applaud FDA for recognizing the need to bring safe, effective, and innovative treatment options to patients and clinicians, and we look forward to working closely with FDA under the Breakthrough Devices Program to gain marketing authorization of our AUD-only PDT product candidate,” Yuri Maricich, Pear’s chief medical officer, said in a news release.

Banyan Adds Eating Disorder Program in Philadelphia

Banyan Treatment Centers, a provider of treatment for substance use and mental health disorders, announced on Monday that it is adding its first eating disorder program at its facility in Langhorne, Pennsylvania, a northeast suburb of Philadelphia.

The outpatient program is offering treatment for anorexia nervosa, bulimia nervosa, binge eating disorder, avoidant restrictive food intake disorder (ARFID), orthorexia, body dysmorphia, or other specified feeding and eating disorders. Banyan will also offer eating disorder program patients treatment for co-occurring substance use and mental health conditions.

Verinetics Awarded NIDA Grant to Develop System for Take-Home Methadone Option

Verinetics announced on Tuesday that it has been awarded a $1.5 million contract by the National Institute on Drug Abuse (NIDA) under the Small Business Innovation Research (SBIR) Phase II program to develop a system for expanding access to medications to treat opioid use disorder (MOUD).

Verinetics’ DispenSecur version I (DSv1) system is being developed as a means to increase take-home privileges for patients being treated with methadone for OUD. Current regulations require patients to receive methadone on site at an opioid treatment program, and only allow for a take-home option for some patients after they have achieved a period of stability. The DSv1 system facilitates remote supervision and autonomous dispensing deactivation, thereby reducing the need for daily office visits.

Integrated Services for Behavioral Health in Ohio Names New CEO

Integrated Services for Behavioral Health (ISBH), a multi-county not-for-profit provider of behavioral health services in southeastern Ohio, has promoted Samantha Shafer, LISW-S, to be its next CEO. Shafer succeeds retiring CEO Kevin Gillespie, effective Dec. 13. For the past 7 years, Shafer has served as the organization’s chief operating officer.

Shafer has led ISBH’s effort to expand its telehealth offerings, as well as its CARF accreditation. She is a member of the Ohio Children’s Services Transformation Advisory Council, along with the Ohio Children’s Trust Fund Board of Directors.

MindPath Health Adds Metropolitan Neuro Behavioral Institute

Outpatient behavioral health services provider Mindpath Health, the organization recently formed by the unification of MindPath Care Centers and Community Psychiatry, has expanded into Arizona with its acquisition of Metropolitan Neuro Behavioral Institute, which serves the greater Chandler, Arizona, area. The institute is led by Lauro Amezcua-Patino, MD, who will continue practicing and serving in a leadership role.

Metropolitan Neuro offers a range of psychiatric and psychological services, including medical management, psychological testing, counseling, and transcranial magnetic stimulation.