Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced it has received Safer Technologies Program (STeP) for Medical Devices designation from the U.S. Food and Drug Administration (FDA) for Pear-010, a product candidate designed for the treatment of acute and chronic pain.

Pear-010 is a PDT candidate intended to provide a neurobehavioral intervention (virtual reality delivered pain reduction) to patients 18 and older with acute postoperative and acute postprocedural pain. The product candidate is designed to reduce acute postoperative and postprocedural pain and analgesic (e.g., opioid) use related postoperative urinary retention, postoperative ileus, or postoperative unintended advancing sedation and respiratory depression.

With more than 50 million patients in the U.S. suffering from pain, it is among the most common and costly acute as well as chronic conditions, estimated to drive as much as $635 billion in annual health care expenditures, disability and loss of productivity.^1,2 The over-reliance on opioid-based therapies has led to significant adverse events and a nationwide epidemic of opioid misuse and diversion.^3-6 Effective pain management is an important factor in reducing length of hospital stay and improving outcomes for medical and surgical patients, including their risk for hospital readmission.^7-11

“We believe pain is well suited for treatment with a PDT because currently more than 50 million patients are left to choose between pain and treatment by opioids,” said Yuri Maricich, Pear’s Chief Medical Officer. “We applaud FDA for recognizing the need to help patients gain more timely access to treatments for conditions like pain.”

Pear intends to utilize its PearCreate™ platform to develop Pear-010. PearCreate is the company’s discovery and development platform.

The Safer Technologies Program (STeP) is a voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics. The goal of STeP is to provide patients and healthcare providers with timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health. STeP participation does not imply product authorization. Pear-010 has not received marketing authorization from FDA and it is not available for sale in the United States.

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 from Pear Therapeutics

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, the statement that pain is well suited for treatment with a PDT is a forward-looking statement. 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) Pear-010 may not receive authorization from FDA on a timely basis, or at all, (ii) delay or reluctance by patients and/or providers to adopt, request or use Pear’s products, (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. https://www.cdc.gov/mmwr/volumes/67/wr/mm6736a2.htm#:~:text=An%20estimated%2020.4%25%20(50.0%20million,adults%2C%20adults%20living%20in%20poverty%2C
2. Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. (2012) 13:715–24. doi: 10.1016/j.jpain.2012.03.009
3. Herzig SJ, Rothberg MB, Cheung M, Ngo LH, Marcantonio ER. Opioid utilization and opioid-related adverse events in nonsurgical patients in US hospitals. J Hosp Med. Feb 2014;9(2):73-81.
4. Bohnert AS, Valenstein M, Bair MJ, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. Apr 6 2011;305(13):1315-1321.
5. Manchikanti L, Helm S, 2nd, Fellows B, et al. Opioid epidemic in the United States. Pain Physician. Jul 2012;15(3 Suppl):ES9-38.
6. Manchikanti L, Abdi S, Atluri S, et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part I--evidence assessment. Pain Physician. Jul 2012;15(3 Suppl):S1-65.
7. Morrison RS, Magaziner J, Gilbert M, et al. Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A Biol Sci Med Sci. Jan 2003;58(1):76-81.
8. Allen Liles E, J K, M G, M A. Hospitalist management of vaso-occlusive pain crisis in patients with sickle cell disease using a pathway of care. Hosp Pract. 2014;42:70-76.
9. Epstein A, Crosbie C, Martin S, et al. 30-day-or-sooner readmissions of gastrointestinal medical oncology patients following cancer center inpatient service discharge: characteristics and preventability. Hosp Pract. 1995;42:34-44.
10. Coley KC, Williams BA, DaPos SV, Chen C, Smith RB. Retrospective evaluation of unanticipated admissions and readmissions after same day surgery and associated costs. J Clin Anesth. Aug 2002;14(5):349-353.
11. Elixhauser A, Steiner C. Readmissions to U.S. Hospitals by Diagnosis, 2010. Agency for Healthcare Research and Quality Statistical Brief. 2013;#153.

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