Pear Therapeutics and Spero Health to Expand Access to Prescription Digital Therapeutics for People in Recovery Across Multiple Locations and States

BOSTON & BRENTWOOD, Tenn.--(BUSINESS WIRE)-- Pear Therapeutics Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced the expansion of its collaboration with Spero Health, an integrated healthcare services organization specializing in local and affordable outpatient care for individuals suffering from substance use disorders, to provide adults suffering from substance use disorder (SUD) and opioid use disorder (OUD) access to reSET^® and reSET-O^®, for each respective condition. Spero Health, which has implemented reSET and reSET-O at 14 locations in Kentucky, intends to expand access to eligible patients at its 99 locations throughout Indiana, Kentucky, Ohio, Tennessee, West Virginia, and Virginia. The expansion is part of Spero Health’s commitment to increase patient engagement and retention in recovery by offering FDA-authorized innovative treatment options.

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“Spero Health continues to find innovative ways with new technologies to bring solutions to our communities that have been devastated by drug overdose, and we are looking forward to our collaboration with Pear Therapeutics to pursue even better outcomes in treatment,” said Steve Priest, Spero Health’s CEO. “Pear’s technology equips our clinicians with vital measurements via a clinician dashboard that allows us to provide quality care to our patients who suffer from substance use disorders. We believe having access to patient reported data via Pear’s clinician dashboard gives us better insight into patient behaviors. We expect that this approach will help to increase compliance and create efficiencies in how our treatment teams deliver care.”

As one of the nation’s largest office-based outpatient opioid treatment providers, Spero Health has helped more than 35,000 patients on their journey to stable recovery. Spero Health strives to meet people where they are by offering a community-based approach to treatment utilizing an evidence-based integrated care model that combines both physical and behavioral healthcare services under one roof.

“With more than 40 million Americans living with addiction, we are proud to expand our work with Spero Health to help more patients who are seeking recovery solutions,” said Julia Strandberg, Chief Commercial Officer at Pear Therapeutics. “Through our shared commitment to break down barriers and meet patients where they are, we can deliver our innovative PDTs for the treatment of substance use disorder and opioid use disorder to help patients stay on their recovery journey.”

Prescription digital therapeutics are an innovative class of treatments that use software to treat serious disease. Like traditional medicines, these products are evaluated and authorized by regulators like the Food and Drug Administration (FDA) and used under the supervision of a prescribing clinician. Unlike traditional medicines, they are designed to collect real world data that may be used by clinicians to inform treatment and by payors and health systems for population health management.

The two products being implemented by Spero Health, reSET and reSET-O, have previously 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 Most recently, Pear 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. Find more information 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 Spero Health
Spero Health, Inc., is an integrated healthcare services organization specializing in local and affordable outpatient care for individuals suffering from substance use disorders with a mission to “Save Lives, Instill Hope, and Restore Relationships.” Spero Health utilizes an innovative evidence-based integrated care model that combines both physical and behavioral healthcare services under one roof to treat the whole patient. This integrated care model combines physician services (including medication-assisted treatment), behavioral health counseling, recovery support services, medication management and patient and family education. Its community-based approach to treatment allows patients to continue working and caring for their families as they overcome addiction. Based in Nashville, Tenn. and privately held by Heritage Group, Health Velocity Capital, South Central, Inc. and Frist Cressey Ventures, Spero Health operates 99 outpatient clinics located throughout Kentucky, Ohio, Indiana, Virginia, West Virginia and Tennessee. Spero Health is a national leader who has helped more than 35,000 patients on their journey to stable recovery from addiction and is in-network with Medicaid and most commercial insurance plans.

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
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 Pear and Aspro Health expand access to PDTs for people in recovery across multiple locations and states, whether customer access to patient reported data via the Clinician Dashboard gives them better insight into patient behaviors, whether using Pear’s PDTs increase compliance and create efficiencies in how customers deliver care, whether our products increase access, improve outcomes, and deliver value for patients, providers, and payors, and whether our products collect real world data that can be for used by prescribing clinicians to inform treatment and for population health management by payors and health systems for population health management, are forward-looking statements. 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.

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