Pear Therapeutics and Crossroads Treatment Centers to Provide More Patients Access to Prescription Digital Therapeutics as Standard of Care for the Treatment of Substance Use Disorders

• Expansion of Crossroads’s existing initiative with Pear’s prescription digital therapeutics (PDTs), reSET^® and reSET-O^®, has the potential to reach thousands of additional patients per month on their recovery journey across Kentucky, New Jersey, Pennsylvania, and Virginia

• This expansion underscores shared commitment by Crossroads and Pear to expand access to innovative treatment options to fight against the addiction crisis

More adults struggling with substance use disorder (SUD) and opioid use disorder (OUD) will gain access to innovative treatments as Pear Therapeutics, Inc. (Nasdaq: PEAR) and Crossroads implement a prescription digital therapeutic (PDT) initiative across three new states. Crossroads, a national leader in the treatment of OUD, began implementing Pear’s reSET-O^® PDT technology in its centers across western Pennsylvania in January 2020. Now, Pear’s reSET^® and reSET-O^® PDTs have the potential to reach thousands of additional patients per month as a standard of care for eligible patients in Crossroads locations across the rest of Pennsylvania and into Kentucky, New Jersey and Virginia.

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According to a new report from the U.S. Centers for Disease Control and Prevention, America's addiction crisis is the deadliest it has ever been¹. More than 100,000 people died of drug overdoses in the United States during the 12-month period ending in April 2021, up 28.5% from the same period a year earlier - nearly doubling over the past five years¹.

“Crossroads is extremely excited to continue our cooperation with Pear Therapeutics, says Tripp Wylie, Director of Transformation for Crossroads. “Innovative technologies like reSET and reSET-O, allow us to pursue our mission of helping those struggling with SUD and mental health illnesses get their lives back.”

“Having 24/7 access to cognitive behavioral therapy is a game changer for patients in recovery,” adds Wylie. “With access to patient-reported data, our clinicians can provide measurement-based care throughout a patient’s treatment journey to help improve outcomes. We feel that Pear is aligned with our vision to provide the most convenient, comprehensive, high-quality care, and we couldn’t be happier to extend our collaboration.”

Crossroads has been providing outpatient medication-assisted treatment (MAT) for more than 16 years to people suffering from OUD. At the forefront of treating patients with OUD, Crossroads is committed to bringing critical services to communities across the U.S. to improve access to treatment for those who need it most. This expansion underscores the shared commitment by both Crossroads and Pear to provide access to innovative treatment options in our fight against the growing addiction crisis.

“As the severity of the addiction crisis continues to increase, Pear’s expansion with Crossroads comes at a time when it’s more important than ever to provide people with SUD access to evidence-based treatments,” said Julia Strandberg, Chief Commercial Officer of Pear. “Our PDTs are innovative, FDA-authorized therapeutics designed to be delivered remotely to help patients 24/7.

PDTs are a new therapeutic class that use software to treat serious disease. Like traditional medicines, PDTs are developed in a Good Manufacturing Practice-compliant environment; tested in randomized controlled trials to demonstrate safety and effectiveness; authorized by the FDA; and used under the supervision of a prescribing clinician^1,2. Unlike traditional medicines, PDTs are designed to collect real-world data for use by prescribing clinicians and for population health management by payors and health systems.

reSET and reSET-O have been measured in real-world use and their therapeutic content has been studied in randomized controlled trials, with results published in peer-reviewed medical journals^2,3 Pear recently released publications showing the potential for improved, real-world health outcomes and decreased treatment costs for patients using reSET-O^4-11. Both products, which are adjunctive to outpatient counselling, provide patients with cognitive behavioral therapy, fluency training, and contingency management. Clinicians receive access to clinical dashboards to inform in-office and virtual visits.

reSET Important Safety Information

Indications for Use:

reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older, who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90 day) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse.

It is intended to:

• increase abstinence from a patient’s substances of abuse during treatment, and
• increase retention in the outpatient treatment program.

Important Safety Information for Clinicians:

Warnings: reSET is intended for patients whose primary language is English with a reading level of 7th grade or above, and who have access to an Android/iOS tablet or smartphone. reSET is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).

Clinicians should not use reSET to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.

reSET is not intended to be used as a stand-alone therapy for substance use disorder (SUD). reSET does not replace care by a licensed medical practitioner and is not intended to reduce the amount of face-to-face clinician time. reSET does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.

Patients with substance use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with substance use disorder also have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should engage in their normal care practices to monitor patients for medical problems and mental health disorders, including risk for harming others and/or themselves.

The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12 weeks (90 days) in the SUD population. The ability of reSET to prevent potential relapse after treatment discontinuation has not been studied.

The effectiveness of reSET has not been demonstrated in patients currently reporting opioids as their primary substance of abuse.

This Press Release does not include all the information needed to use reSET safely and effectively. Please see the Clinician Brief Summary for reSET for more information.

reSET-O Important Safety Information

Indications for Use

reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only prescription digital therapeutic.

Important Safety Information:

Warnings: reSET-O is intended for patients whose primary language is English with a reading level of 7th grade or above, and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications). Clinicians should not use reSET-O to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET-O to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.

reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). reSET-O does not replace care by a licensed medical practitioner and is not intended to reduce the frequency or duration of in-person therapy. reSET-O does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.

Patients with opioid use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with opioid use disorder have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should undertake standard of care to monitor patients for medical problems and mental health disease, including risk for harming others and/or themselves.

The long-term benefit of reSET-O has not been evaluated in studies lasting beyond 12 weeks (84 days) in the OUD population. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.

This Press Release does not include all the information needed to use reSET-O safely and effectively. Please see the Clinician Brief Summary Instructions for reSET-O for more information.

About Pear Therapeutics

Pear Therapeutics, Inc., which is traded on Nasdaq as PEAR, is the parent company of Pear Therapeutics (US), Inc. Pear is the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs). Pear aims to redefine care through the widespread use of clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has the first end-to-end platform to discover, develop, and deliver PDTs to patients and a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA. Pear’s product, reSET^®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O^®, for the treatment of opioid use disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst^® for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.

About Crossroads

Crossroads is a behavioral healthcare company that has combined outpatient MAT, and measurement-based care for over 16 years. With more than 110 centers across 10 states, Crossroads exists to help people with SUDs and mental health illnesses get their lives back and strives to be the most convenient, comprehensive, high-quality behavioral health solution in the country. For more information about Crossroads, or to find a location near you, please visit our website at crossroadstreatmentcenters.com or call 800-805-6989.

References:

1. https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2021/20211117.htm
2. Campbell ANC, Nunes EV, Matthews AG, et al. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014;171(6):683-690.
3. Christensen DR, Landes RD, Jackson L, et al. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972. doi:10.1037/a0037496.
4. Yuri A. Maricich, MD, Xiaorui Xiong, PhD, Robert Gerwien, PhD, Alice Kuo, BA Fulton Velez, MD MBA, Bruce Imbert, MD PhD, Keely Boyer, MBA, Hilary F. Luderer, PhD, Stephen Braun, BA, Karren Williams, PhD (2020): Real-World evidence for a prescription digital therapeutic to treat Opioid Use Disorder, Journal of Current Medical Research and Opinion, DOI:10.1080/03007995.2020.1846023.
5. Fulton F. Velez , Sam Colman , Laura Kauffman , Charles Ruetsch & Kathryn Anastassopoulos (2020): Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic, Expert Review of Pharmacoeconomics & Outcomes Research, DOI: 10.1080/14737167.2021.1840357
6. Weijia Wang, Nicole Gellings Lowe, Ali Jalali & Sean M. Murphy (2021) Economic modeling of reSET-O, a prescription digital therapeutic for patients with opioid use disorder, Journal of Medical Economics, 24:1, 61-68, DOI: 10.1080/13696998.2020.1858581
7. Yuri A. Maricich, Warren K. Bickel, Lisa A. Marsch, Kirstin Gatchalian, Jeffrey Botbyl & Hilary F. Luderer (2020) Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder, Current Medical Research and Opinion, DOI: 10.1080/03007995.2020.1846022
8. Fulton F. Velez, Hilary F. Luderer, Robert Gerwien, Benjamin Parcher, Dylan Mezzio & Daniel C. Malone (2021) Evaluation of the cost-utility of a prescription digital therapeutic for the treatment of opioid use disorder, Postgraduate Medicine, DOI: 10.1080/00325481.2021.1884471
9. Fulton F. Velez, Charles Ruetsch & Yuri Maricich (2021) Evidence of long-term real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic, Expert Review of Pharmacoeconomics & Outcomes Research, DOI: 10.1080/14737167.2021.193968
10. Fulton F. Velez & Daniel C. Malone (2021) Cost-Effectiveness Analysis of a Prescription Digital Therapeutic for the Treatment of Opioid Use Disorder, Journal of Market Access & Health Policy, 9:1, DOI: 1080/20016689.2021.1966187
11. Yuri A. Maricich, Robert Gerwien, Alice Kuo, Daniel C. Malone & Fulton F. Velez (2021) Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder, Hospital Practice, DOI: 1080/21548331.2021.1974243

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