Pear Therapeutics Announces Availability of reSET® and reSET-O® in Spanish

• reSET^® and reSET-O^® are the only FDA-authorized prescription digital therapeutics (PDTs) for the treatment of substance use disorder (SUD) and opioid use disorder (OUD), respectively, and the first PDTs available in Spanish
• Research shows nine out of 10 Hispanic Americans living with SUD are unable to receive the treatment they need at a specialty facility,¹ and those who receive treatment have poorer outcomes when compared to non-Hispanics.²
• Spanish-language availability of reSET and reSET-O addresses health equity and health care disparities and expands access to proven treatment options for those living with SUD and OUD.

Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced the launch of Spanish-language availability for reSET^® and reSET-O^®, the only FDA-authorized PDTs for the treatment of substance use disorder (SUD) and opioid use disorder (OUD), respectively. reSET and reSET-O are the first PDTs available in Spanish.

“At Pear, we are committed to addressing health disparities among underserved populations, including providing the Hispanic community with access to treatment options for substance use disorder and opioid use disorder,” said Corey McCann, M.D., Ph.D., President and Chief Executive Officer of Pear Therapeutics. "The availability of reSET and reSET-O in Spanish is an important step forward in providing all patients living with substance use disorder and opioid use disorder with access to our FDA-authorized, safe and effective prescription digital therapeutics.”

In addition to the availability of reSET and reSET-O in Spanish, a number of dedicated resources have also been developed to help Spanish-speaking patients through their recovery journey. These include dedicated Spanish-language content on www.resetforrecovery.com, reSET and reSET-O Spanish-language brochures, and dedicated bilingual patient specialists in the Pear Patient Service Center, a patient support center that delivers product education and technical support throughout the patient’s treatment journey.

The Hispanic American community faces disproportionate barriers to care.³ Research shows Hispanic Americans have less access and wait longer to receive treatment for SUD compared to non-Hispanics.^{4, 5} Nine out of 10 Hispanic Americans living with SUD are unable to receive treatment at a specialty facility¹ and those who do receive care via substance use treatment programs have poorer outcomes when compared to non-Hispanics.²

“As a clinician, I have seen firsthand how the COVID-19 pandemic has magnified the substantial disparities in access to substance use disorder and opioid use disorder treatments faced by the Hispanic community,” said Carolyn Tellez, MSN, RN, ARNP, PMHNP-BC, Psychiatric Nurse Practitioner at 2^nd Chance Treatment Center. “It is especially timely to offer Spanish-language options for reSET and reSET-O, particularly since these prescription digital therapeutics provide patients with 24/7 remote access to their treatment program, regardless of physical proximity.”

Patients across broad demographic populations, including underserved communities and minorities, have been found to use PDTs as a way to improve access and outcomes.^{6, 15- 22} Published studies and evidence have found that racial and ethnic minorities^{17, 18, 20}, broad socioeconomic^{6, 19} and educational⁶ backgrounds, and seniors^{15, 21, 22} are able to access, use, and achieve clinical benefit from software-based treatments. Given the disparate impact of many diseases, particularly mental health and addiction, on underserved and minority populations, PDTs offer a potential pathway to improve access and outcomes within these historically disadvantaged groups.

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^{6, 7}. Pear recently released publications showing the potential for improved real-world health outcomes and decreased healthcare resource utilization for patients using reSET-O^8-16. Both products, which are adjunctive to outpatient care, provide patients with cognitive behavioral therapy, fluency training, and contingency management, while clinicians receive access to clinical dashboards to inform in-office and tele 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 7^th 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 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.

Forward-Looking Statements

Certain statements and projections in this press release may be considered forward-looking statements within the meaning of the federal securities laws. Forward looking statements generally relate to future events or involving, or future performance of, Pear. For example, statements regarding anticipated access to Pear’s products are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “aim”, “estimate”, “anticipate”, “believe”, or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements.

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) delay or reluctance by patients and/or providers to adopt, request or use Pear’s products, (ii) whether Pear’s PDTs will improve healthcare access and outcomes within historically disadvantaged communities, (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 impact of the COVID-19 pandemic on Pear’s business; (vi) changes in applicable laws or regulations; and (vii) other risks and uncertainties set forth in Pear’s future filings with the SEC. 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, and Pear assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Pear gives no assurance that Pear will achieve its expectations. The inclusion of any statement in this communication does not constitute an admission by Pear or any other person that the events or circumstances described in such statement are material.

References:

1. Substance Abuse and Mental Health Services Administration. (2019). 2018 National Survey on Drug Use and Health Detailed Tables.
2. Chartier, K.G., Carmody, T., Akhtar, M., Stebbins, M.B., Walters, S.T., & Warden, D. (2016). Hispanic Subgroups, Acculturation, and Substance Abuse Treatment Outcomes. Journal of Substance Abuse Treatment, 59, 74-82.
3. https://americanaddictioncenters.org/rehab-guide/addiction-statistics/hispanic-americans
4. Wells, K., Klap, R., Koike, A., & Sherbourne, C. (2001). Ethnic disparities in unmet need for alcoholism, drug abuse, and mental health care. The American Journal of Psychiatry, 158(12), 2027-2032.
5. Substance Abuse and Mental Health Services Administration. (2012). The NSDUH Report: Need for and Receipt of Substance Use Treatment among Hispanics.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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: 1080/13696998.2020.1858581.
11. 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: 1080/03007995.2020.1846022.
12. 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: 1080/00325481.2021.1884471.
13. 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: 1080/14737167.2021.193968.
14. 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.
15. 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.
16. 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
    
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19. Chaple M, Sacks S, McKendrick K, et al. A Comparative Study of the Therapeutic Education System for Incarcerated Substance-Abusing Offenders. The Prison Journal. 2016;96(3):485-508. doi:10.1177/0032885516636858
20. Ritterband LM, Thorndike FP, Ingersoll KS, et al. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. Jama Psychiat. 2016;74(1):68. doi:10.1001/jamapsychiatry.2016.3249
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