Pear Therapeutics and BrightView Health Expand Pilot Program to Provide Prescription Digital Therapeutics for the Treatment of Substance Use Disorders

• BrightView expands its initiative with reSET^® and reSET-O^® to patients across Kentucky, Ohio, Delaware, Massachusetts, and Virginia

Pear Therapeutics, Inc. (NASDAQ:PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), announced today the expansion of its collaboration with BrightView Health, an addiction treatment provider that offers evidence-based, outpatient addiction treatment programs. This initiative is designed to provide eligible adults suffering from substance use disorder (SUD) and opioid use disorder (OUD) access to reSET^® and reSET-O^®. BrightView, an innovative and patient-focused leader in SUD and OUD treatment, began piloting Pear's products in its centers across six locations in Kentucky and Ohio in early 2022, and intends to expand the initiative across Kentucky, Ohio, Delaware, Massachusetts, and Virginia. BrightView currently has over 80 locations across 8 states.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230126005206/en/

"We strive to make recovery work for patients and to meet them where they are," said Shawn Ryan, MD, MBA, ABEM, ABAM, Chief Science Officer, of BrightView Health. "We believe reSET and reSET-O are beneficial to our patients, the community, and our health system. BrightView plans to continue expanding our use of Pear's PDTs to help patients achieve progress in recovery."

Substance use disorders are a major public health crisis affecting communities across the country. In 2020 alone, drug overdose deaths in Kentucky increased by nearly 50%, with a state report concluding that isolation caused by the pandemic was a major contributing factor.¹ According to RecoveryOhio's annual review from 2021, 10-15% of all Ohioans have a life history of substance use disorder.² Pear and BrightView are working together to help improve access to care for those affected by this national epidemic.

"As the severity of the addiction crisis continues to increase, Pear is proud to be working with BrightView to provide innovative treatments to Kentuckians and Ohioans," said Julia Strandberg, Chief Commercial Officer of Pear. "We look forward to expanding these efforts and engaging new patients."

The two products being piloted by BrightView -- reSET and reSET-O -- have been measured in real-world use and their therapeutic content studied in randomized controlled trials, with results published in peer-reviewed medical journals.^3,4 Additionally, Pear has released publications showing the potential for improved real-world health outcomes and decreased treatment costs for patients using reSET and reSET-O.^5-17 reSET is used as a monotherapy for patients 18 years of age or older with substance use disorder and reSET-O is used in combination with buprenorphine-based medication assisted treatment for patients 18 years of age or older with opioid use disorder. Clinicians receive access to clinical dashboards to inform visits with patients. More information may be found about the products here and here.

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:

Warnings: reSET is intended for patients whose primary language is English or Spanish 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 prescription digital therapeutic is a 12-week (84 day) software application 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 digital therapeutic.

Important Safety Information:

Warnings/precautions: reSET-O is intended for patients whose primary language is English or Spanish 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 BrightView Health

Founded in 2015, BrightView provides comprehensive, evidence-based outpatient addiction treatment to thousands of patients in recovery from substance use disorder throughout Massachusetts, Kentucky, Ohio, Virginia, Delaware, Maryland, Arizona, and North Carolina.

The organization's more than 80 centers provide a practical treatment approach that includes medication assisted treatment (MAT), individual counseling, group therapy, peer support, and wraparound social services, as well as work on co-occurring disorders. Locations are generally able to dispense medication on-site, which makes treatment comfortable and convenient for patients.

BrightView's compassionate and professional staff create an accessible and welcoming environment for physical and emotional healing. BrightView is committed to treating each patient with respect, providing positive reinforcement, and achieving long-term wellness. To learn more, please visit brightviewhealth.com.

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.

Forward Looking Disclaimer

This press release contains forward-looking statements within the meaning of the federal securities laws that are subject to risks and uncertainties and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements generally relate to future events involving, or future performance of, Pear. For example, whether Brightview expands the initiative with Pear across Kentucky, Ohio, Delaware, Massachusetts, and Virginia, whether reSET and reSET-O provide benefits to patients, the community, and the health system, whether reSET and reSET-O are beneficial for patient care and outcomes, whether Brightview plans to continue expanding its use of Pear's PDTs, and whether Pear's PDTs help patients achieve success in recovery. In some cases, you can identify forward-looking statements by terminology such as "may", "can", "should", "could", "might", "plan", "possible", "strive", "aim", "expect", "intend", "will", "estimate", "believe", "predict", "potential", or "continue", or the negatives of these terms or variations of them or similar terminology.

These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Pear and its management are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i), the rate at which customers integrate Pear's PDTs into their treatment paradigms, (ii) changes in applicable laws or regulations; (iii) the possibility that Pear may be adversely affected by other economic, business, regulatory, and/or competitive factors; (iv) the evolution of the markets in which Pear competes; (v) the ability of Pear to defend its intellectual property and satisfy regulatory requirements; (vi) the impact of the COVID-19 pandemic on Pear's business; and (vii) other risks and uncertainties set forth in Pear's filings with the SEC (including those described in the Risk Factors section). These filings will identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

Readers are cautioned not to put undue reliance on forward-looking statements, which are based only on information currently available to us and speak only as of the date of this release. Pear assumes no obligation to publicly update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. Pear gives no assurance that Pear will achieve its expectations.

References:

1. https://apnews.com/article/lifestyle-health-pandemics-coronavirus-pandemic-kentucky-9555b1ccdc9df17c9a1e206090fb14b2
2. RecoveryOhio 2021 Annual Review
3. 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.
4. 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.
5. 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.
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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: 10.1080/20016689.2021.1966187
12. 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: 10.1080/21548331.2021.1974243
13. Velez FF, Colman S, Kauffman L, Ruetsch C, Anastassopoulos K, Maricich YA. Comparison of Healthcare Resource Utilization Between Patients Who Engaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder. Clinicoecon Outcomes Res. 2021;13:909-916
    
    https://doi.org/10.2147/CEOR.S334274.
14. Velez, F.F., Anastassopoulos, K.P., Colman, S. et al. Reduced Healthcare Resource Utilization in Patients with Opioid Use Disorder in the 12 Months After Initiation of a Prescription Digital Therapeutic. Adv Ther (2022). https://doi.org/10.1007/s12325-022-02217-y
15. Shah, N., Velez, F.F., Colman, S. et al. Real-World Reductions in Healthcare Resource Utilization over 6 Months in Patients with Substance Use Disorders Treated with a Prescription Digital Therapeutic. Adv Ther (2022). https://doi.org/10.1007/s12325-022-02215-0
16. Luderer H, Campbell A, Nunes E, Enman N, Xiong X, Gerwein R, Maricich Y. Engagement patterns with a digital therapeutic for substance use disorders: Correlations with abstinence outcomes. Journal of Substance Use Disorders. 132 (2021) 108585. https://doi.org/10.1016/j.jsat.2021.108585
17. Xiong, X, Braun, S, Stitzer, M, et al. Evaluation of real-world outcomes associated with use of a prescription digital therapeutic to treat substance use disorders. Am J Addict. 2022; 1- 8. doi:10.1111/ajad.13346.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230126005206/en/