BOSTON & SAN FRANCISCO--(BUSINESS WIRE)--Pear Therapeutics, Inc., (“Pear” or the “Company”) today announced that it has successfully closed an $80 million Series D financing led by SoftBank Vision Fund 21 with participation from existing investors including Temasek, 5AM Ventures, Arboretum Ventures, JAZZ Venture Partners, Novartis, CrimsoNox, and EDBI, and new investors, Forth Management, Pilot House, Sarissa Capital, Shanda Group, and QUAD Investment Management.
“Pear is pleased to welcome our new investors and our new board members. SoftBank Investment Advisers represents an ideal partner to support Pear as we build the digital therapeutics industry,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “This oversubscribed round of funding will allow us to continue to invest in the launches of our three commercial products to accelerate revenue growth, which we intend to reinvest in our robust pipeline and platform.”
Prescription Digital Therapeutics (PDTs) are a new therapeutic class that uses software to directly treat serious disease, alone or in combination with drugs. Pear’s products reSET® and reSET-O® for the treatment of substance use disorder and opioid use disorder, respectively, are the first two PDTs to receive market authorization to treat disease from FDA. Pear recently launched Somryst™, for the treatment of chronic insomnia, its third FDA-authorized PDT and the third PDT to receive market authorization from FDA. Pear also recently launched its end-to-end virtual care experience combining virtual doctor visit(s) via telemedicine provider with PearConnect™, the industry’s first patient service center for PDTs. The Company’s three FDA-authorized products address large market opportunities with more than 20 million patients suffering from substance and opioid use disorders2 and more than 30 million from chronic insomnia3, in the U.S. alone. These diseases are on the rise as the pandemic has exacerbated the country’s mental health crises.4,5
Pear will use the financing to accelerate reimbursement coverage for its three commercial products, creating the first market access pathway in the PDT industry. The Company collaborates with innovators to build a broad and deep pipeline that has the potential to redefine standard of care in a range of therapeutic areas, including specialty psychiatry, specialty neurology, and a host of other non-CNS diseases. Pear has built the first scalable platform infrastructure to discover, develop, and deliver PDTs to patients.
“We believe prescription digital therapeutics are creating a new category of medicine,” said Kirthiga Reddy, Partner at SoftBank Investment Advisers. “Pear Therapeutics has combined biology and software to pioneer the first end-to-end platform for prescription digital products, with an initial focus on serious psychiatric diseases. We’re pleased to support Pear’s mission to create the next generation of therapeutics and deliver better patient outcomes.”
In conjunction with the financing, Nancy Schlichting, retired Chief Executive Officer, Henry Ford Health System, and Board Director at Walgreens Boots Alliance and Hill-Rom Holdings, Inc., and Elena Viboch, an investor at SoftBank Investment Advisers, will join Pear's Board of Directors. Ms. Reddy will contribute as a Board Observer.
“It is a privilege to join Pear at this exciting time,” said Ms. Schlichting. “Prescription Digital Therapeutics have the potential to change healthcare in many profound ways. Using technology to treat serious disease is an idea whose time has come, and I am proud to pioneer this new space with Pear and with SoftBank Investment Advisers.”
About Pear Therapeutics
Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering 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 a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from FDA. Pear’s lead product, reSET®, for the treatment of Substance Use Disorder, was the first PDT to receive marketing authorization from 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.
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 and whose reading level is at the 7th grade level 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 represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.
reSET should not be used by individuals outside active enrollment in a SUD treatment program. It should only be used as an adjunct to face-to-face counseling and contingency management. reSET is not intended to reduce the amount of face-to-face clinician time.
The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12-weeks 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 full 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 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).
reSET-O should not be used by individuals outside active OUD treatment. It is not intended to replace treatment by the patient’s medical provider. It should be used as an adjunct to clinician treatment, buprenorphine treatment and contingency management.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). 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. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.
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.
This Press Release does not include all the information needed to use reSET-O safely and effectively. Please see the full Clinician Brief Summary Instructions for reSET-O for more information.
Somryst Important Safety Information
Indications for Use
Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia – CBT-I) to patients 22 years of age and older with chronic insomnia. Somryst treats patients with chronic insomnia by improving a patient’s insomnia symptoms.
Important Safety Information:
Warnings: Somryst is not for everyone. Please use your clinical judgement to determine whether Somryst is right for your patient.
- Somryst is not for emergency use. Please instruct patients to dial 911 or to go to the nearest emergency room in the event of a medical emergency,
- Patients should be clearly instructed not to use Somryst to communicate severe, critical, or urgent information to their Health Care Provider.
- Somryst is not meant to be used as treatment without supervision of a Health Care Provider.
- Somryst is not meant to be a substitution for any treatment medication.
- Somryst contains sensitive medical information. Please instruct patients to protect their information by password-protecting their smartphone and tablet, ensuring no one else may access their device.
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Sleep Restriction (and Consolidation) within Somryst can cause sleepiness, especially in the early stages of using the PDT. Somryst should not be used if the patient needs to be alert or cautious to avoid serious accidents in their job or daily life. Examples include:
- Long-haul truck drivers
- Long-distance bus drivers
- Air traffic controllers
- Operators of heavy machinery
- Some assembly line jobs
- The usage data collected in therapy lessons by Somryst are not intended to be used as a standalone assessment of treatment progress.
This press release does not include all the information needed to use Somryst safely and effectively. Please see the full Clinician Brief Summary Instructions for Somryst for more information.
References:
1 As of the date of this press release, SoftBank Group Corp. has made capital contributions to allow investments by SoftBank Vision Fund 2 ("SVF 2") in certain portfolio companies. The information included herein is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy limited partnership interests in any fund, including SVF 2. SVF 2 has yet to have an external close, and any potential third-party investors shall receive additional information related to any SVF 2 investments prior to closing.
2 Substance Abuse and Mental Health Services Administration (2019). HHS Publication No. PEP19-5068, NSDUH Series H-54.
3 https://www.ajmc.com/view/may06-2307ps214-s220
4 https://www.psychcongress.com/article/studies-illustrate-rise-alcohol-illicit-substance-use-during-pandemic
5 https://www.washingtonpost.com/health/2020/09/03/coronavirus-sleep-insomnia/
