BOSTON & SAN FRANCISCO–(BUSINESS WIRE)– Pear Therapeutics, Inc., (“Pear” or the “Firm”) right this moment introduced the second closing of its Collection D financing. The second closing included a number one nationwide Built-in Supply Community (IDN) as a brand new strategic investor. The nationwide IDN is investing $20 million, bringing the whole Collection D funding to $100 million.
“Pear is happy so as to add one among America’s main well being care suppliers and well being plans to our distinguished listing of traders as we proceed to increase affected person entry to our FDA-authorized digital therapeutics,” mentioned Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “This funding from a market main IDN within the subsequent era of medication helps our mission to be the main platform-based, product-driven PDT firm.”
Pear is utilizing its Collection D financing to speed up reimbursement protection for its three FDA-authorized merchandise, creating the primary market entry pathway within the PDT business. PDTs are a brand new therapeutic class that makes use of software program to instantly deal with illness by way of a affected person’s cell system when and the place they want it most. The Firm’s three business merchandise deal with giant market alternatives with greater than 20 million sufferers affected by substance and opioid use issues1 and greater than 30 million from continual insomnia2, within the U.S. alone. These illnesses are on the rise because the pandemic has exacerbated the nation’s psychological well being crises3,4. Pear’s purpose is to extend entry to PDTs by including them to plain formularies.
Like conventional medicines, PDTs are developed in a GMP-compliant atmosphere, examined in randomized managed trials demonstrating security and effectiveness, evaluated and licensed by regulators like FDA, and used below the supervision of a prescribing clinician5,6. Not like conventional medicines, PDTs are designed to gather actual world information to be used by prescribing clinicians and for inhabitants well being administration by payors and well being techniques. Pear not too long ago launched publications exhibiting the potential for improved well being outcomes and decreased remedy prices for sufferers utilizing its PDT reSET-O7-9.
About Pear Therapeutics
Pear Therapeutics is the chief in prescription digital therapeutics, or PDTs. Pear goals to redefine drugs by discovering, growing, and delivering clinically validated software-based therapeutics to supply higher outcomes for sufferers, smarter engagement and monitoring instruments for clinicians, and cost-effective options for payers. Pear has a pipeline of merchandise and product candidates throughout therapeutic areas, together with the primary three PDTs with illness remedy claims from FDA. Pear’s lead product, reSET®, for the remedy of Substance Use Dysfunction, was the primary PDT to obtain advertising and marketing authorization from FDA to deal with illness. Pear’s second product, reSET-O®, for the remedy of Opioid Use Dysfunction, was the primary PDT to obtain Breakthrough Designation. Pear’s third product, Somryst®, for the remedy of continual insomnia, was the primary PDT submitted by way of FDA’s conventional 510(ok) pathway whereas concurrently reviewed by way of FDA’s Software program Precertification Pilot Program. For extra info, go to Pear at www.peartherapeutics.com.
reSET Necessary Security Data
Indications for Use
reSET is meant to supply cognitive behavioral remedy, as an adjunct to a contingency administration system, for sufferers 18 years of age and older, who’re at present enrolled in outpatient remedy below the supervision of a clinician. reSET is indicated as a 12-week (90 day) prescription-only remedy for sufferers with substance use dysfunction (SUD), who will not be at present on opioid alternative remedy, who don’t abuse alcohol solely, or who don’t abuse opioids as their major substance of abuse.
It’s meant to extend abstinence from a affected person’s substances of abuse throughout remedy, and enhance retention within the outpatient remedy program.
Necessary Security Data:
Warnings: reSET is meant for sufferers whose major language is English and whose studying stage is on the 7th grade stage or above and who’ve entry to an Android/iOS pill or smartphone.
reSET is meant just for sufferers who personal a smartphone and are accustomed to use of smartphone apps (functions).
Clinicians shouldn’t use reSET to speak with their sufferers about emergency medical points. Sufferers needs to be clearly instructed to not use reSET to speak to their clinician any pressing or emergent info. In case of an emergency, sufferers ought to dial 911 or go to the closest emergency room.
reSET will not be meant for use as a stand- alone remedy for Substance Use Dysfunction (SUD). reSET doesn’t signify a substitution for a affected person’s medicine. Sufferers ought to proceed to take their medicines as directed by their healthcare supplier.
reSET shouldn’t be utilized by people exterior lively enrollment in a SUD remedy program. It ought to solely be used as an adjunct to face-to-face counseling and contingency administration. reSET will not be meant to cut back the quantity of face-to-face clinician time.
The long-term good thing about remedy with reSET on abstinence has not been evaluated in research lasting past 12-weeks within the SUD inhabitants. The power of reSET to forestall potential relapse after remedy discontinuation has not been studied.
The effectiveness of reSET has not been demonstrated in sufferers at present reporting opioids as their major substance of abuse.
This Press Launch doesn’t embrace all the knowledge wanted to make use of reSET safely and successfully. Please see the Clinician Brief Summary for reSET for extra info.
reSET-O Necessary Security Data
Indications for Use
reSET-O is meant to extend retention of sufferers with Opioid Use Dysfunction (OUD) in outpatient remedy by offering cognitive behavioral remedy, as an adjunct to outpatient remedy that features transmucosal buprenorphine and contingency administration, for sufferers 18 years or older who’re at present below the supervision of a clinician. reSET-O is indicated as a prescription-only prescription digital therapeutic.
Necessary Security Data:
Warnings: reSET-O is meant for sufferers whose major language is English and who’ve entry to an Android/iOS pill or smartphone. reSET-O is meant just for sufferers who personal a smartphone and are accustomed to use of smartphone apps (functions).
reSET-O shouldn’t be utilized by people exterior lively OUD remedy. It’s not meant to switch remedy by the affected person’s medical supplier. It needs to be used as an adjunct to clinician remedy, buprenorphine remedy and contingency administration.
reSET-O will not be meant for use as a stand-alone remedy for Opioid Use Dysfunction (OUD). reSET-O doesn’t signify a substitution for a affected person’s medicine. Sufferers ought to proceed to take their medicines as directed by their healthcare supplier. The power of reSET-O to forestall potential relapse after remedy discontinuation has not been studied.
Clinicians shouldn’t use reSET-O to speak with their sufferers about emergency medical points. Sufferers needs to be clearly instructed to not use reSET-O to speak to their clinician any pressing or emergent info. In case of an emergency, sufferers ought to dial 911 or go to the closest emergency room.
This Press Launch doesn’t embrace all the knowledge wanted to make use of reSET-O safely and successfully. Please see the Clinician Brief Summary Instructions for reSET-O for extra info.
Somryst Necessary Security Data
Indications for Use
Somryst is a prescription-only digital therapeutic meant to supply a neurobehavioral intervention (Cognitive Behavioral Remedy for Insomnia – CBT-I) to sufferers 22 years of age and older with continual insomnia. Somryst treats sufferers with continual insomnia by enhancing a affected person’s insomnia signs.
Necessary Security Data:
Warnings: Somryst will not be for everybody. Please use your medical judgement to find out whether or not Somryst is true in your affected person.
- Somryst will not be for emergency use. Please instruct sufferers to dial 911 or to go to the closest emergency room within the occasion of a medical emergency,
- Sufferers needs to be clearly instructed to not use Somryst to speak extreme, crucial, or pressing info to their Well being Care Supplier.
- Somryst will not be meant for use as remedy with out supervision of a Well being Care Supplier.
- Somryst will not be meant to be a substitution for any remedy medicine.
- Somryst comprises delicate medical info. Please instruct sufferers to guard their info by password-protecting their smartphone and pill, guaranteeing nobody else could entry their system.
- Sleep Restriction (and Consolidation) inside Somryst may cause sleepiness, particularly within the early levels of utilizing the PDT. Somryst shouldn’t be used if the affected person must be alert or cautious to keep away from severe accidents of their job or each day life. Examples embrace:
- Lengthy-haul truck drivers
- Lengthy-distance bus drivers
- Air visitors controllers
- Operators of heavy equipment
- Some meeting line jobs
- The utilization information collected in remedy classes by Somryst will not be meant for use as a standalone evaluation of remedy progress.
This press launch doesn’t embrace all the knowledge wanted to make use of Somryst safely and successfully. Please see the Clinician Brief Summary Instructions for Somryst for extra info.
1 Substance Abuse and Psychological Well being Providers Administration (2019). HHS Publication No. PEP19-5068, NSDUH Collection H-54.
5 Campbell ANC, Nunes EV, Matthews AG, et al. Web-delivered remedy for substance abuse: a multisite randomized managed trial. Am J Psychiatry. 2014;171(6):683-690.
6 Christensen DR, Landes RD, Jackson L, et al. Including an Web-delivered remedy to an efficacious remedy package deal for opioid dependence. J Seek the advice of Clin Psychol. 2014;82(6):964-972. doi:10.1037/a0037496.
7 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): Actual-World proof for a prescription digital therapeutic to deal with Opioid Use Dysfunction, Journal of Present Medical Analysis and Opinion, DOI:10.1080/03007995.2020.1846023.
8 Fulton F. Velez , Sam Colman , Laura Kauffman , Charles Ruetsch & Kathryn Anastassopoulos (2020): Actual-world discount in healthcare useful resource utilization following remedy of opioid use dysfunction with reSET-O, a novel prescription digital therapeutic, Professional Overview of Pharmacoeconomics & Outcomes Analysis, DOI: 10.1080/14737167.2021.1840357.
9 Weijia Wang, Nicole Gellings Lowe, Ali Jalali & Sean M. Murphy (2021) Financial modeling of reSET-O, a prescription digital therapeutic for sufferers with opioid use dysfunction, Journal of Medical Economics, 24:1, 61-68, DOI: 10.1080/13696998.2020.1858581