Pear Therapeutics launches program to offer digital therapeutics through telehealth platforms

Pear Therapeutics (Nasdaq:PEAR) announced today that it launched a program to offer digital therapeutic users access to a telehealth provider.

Boston-based Pear’s program offers patients seeking treatment for substance use disorder (SUD) or opioid use disorder (OUD) access to a telehealth provider through its “find a provider tool,” as well as in-person care options.

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Pear Therapeutics posts massive Q4 revenue uptick as product sales increase

Pear Therapeutics (Nasdaq:PEAR) missed Wall Street’s fourth-quarter revenue projections despite a major year-over-year increase in sales.

The Boston-based prescription digital therapeutic (PDT) developer posted profits of $18.8 million, or 13¢ per share, on sales of $1.2 million for the three months ended Dec. 31, 2021, for a massive bottom-line gain from losses of nearly $48 million this time last year as revenues grew from just $34,000 in that period.

Pear Therapeutics’ earnings per share of 13¢ came in 54¢ ahead of projections on Wall Street, where analysts were looking for sales of $1.5 million.

The company attributed its uptick in sales compared to the fourth quarter of 2020 primarily due to product sales of Pear’s three FDA-authorized products.

“We showed strong execution in 2021, with the company reaching its first commercial inflection point, highlighted by our rapid progress on provider adoption and payor access for our …

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Pear Therapeutics joins Epic App Orchard to enable monitoring of its digital therapeutics

Pear Therapeutics (Nasdaq:PEAR) announced today that its PearConnect platform is now available in the Epic App Orchard Gallery.

By making PearConnect available to healthcare providers through the Epic App Orchard Gallery, the providers who implement the application will be able to access PearConnect within Epic’s leading electronic health record (EHR) platform, allowing them to monitor patients who have been prescribed Pear’s prescription digital therapeutics (PDTs).

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Pear Therapeutics to develop digital therapeutic for sleep/wake disorder in Japan

Pear Therapeutics (Nasdaq:PEAR) announced today that it entered an agreement to develop a Japanese-language digital therapeutic.

Boston-based Pear struck a deal with SoftBank, a Japan-based communication and information technology service provider, to develop the digital therapeutic for the treatment of sleep/wake disorders on the Japanese market.

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Pear Therapeutics says new data backs its prescription digital therapeutic for insomnia

Pear Therapeutics (Nasdaq:PEAR) today announced data from two studies that highlight the effectiveness of its chronic insomnia treatment.

Boston-based Pear Therapeutics designed its Somryst prescription digital therapeutic (PDT) to address the underlying issues of chronic insomnia by delivering cognitive behavioral therapy for insomnia (CBTi), training the body to sleep. The nine-week PDT can be used on a mobile device, such as a smartphone or tablet as the only FDA-authorized therapeutic that delivers guideline-recommended first-line treatment for chronic insomnia.

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Pear Therapeutics advances in efforts to get CMS to cover prescription digital therapeutics

Pear Therapeutics (NSDQ:PEAR) announced that the Centers for Medicare & Medicaid Services (CMS) established new coding relevant to its prescription digital therapeutics (PDTs).

CMS established a new Level II Healthcare Common Procedure Coding System (HCPCS) code to describe prescription digital behavioral therapy — FDA-cleared — per course of treatment, which extends to PDTs including Pear’s reSET, reSET-O and Somryst.

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Pear Therapeutics closes SPAC merger, lists on Nasdaq

Pear Therapeutics today began trading on the Nasdaq market following the completion of a previously announced merger at the end of last week.

Boston-based Pear confirmed in June that it would go public by merging Thimble Point Acquisition Corp., a special purpose acquisition company (SPAC). Following approval from Thimble Point’s stockholders at the end of last month, the company announced the completion of the merger on Friday.

Today, Pear Therapeutics officially began trading on the Nasdaq market under the “PEAR” ticker. The transaction generated approximately $175 million in gross proceeds in total. Pear said it would use the funds to capitalize its position as a leader in software for treating serious disease.

Pear Therapeutics develops prescription digital therapeutics (PDTs) and currently has three authorized by the FDA for treating substance use disorder, opioid use disorder and chronic insomnia. Its alcohol use disorder treatmen…

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FDA grants breakthrough nod to Pear Therapeutics’ alcohol use disorder treatment platform

Pear Therapeutics announced today that it received FDA breakthrough device designation for its reSET-A prescription digital therapeutic.

Boston-based Pear Therapeutics designed its reSET-A PDT product candidate for treating alcohol use disorder (AUD), adding to the company’s portfolio of PDTs for treating substance use disorder (SUD) and opioid use disorder (OUD).

The breakthrough device designation granted by the FDA marks the second received by Pear after reSET-O received the first ever breakthrough nod for a PDT, with an indication for treating OUD, according to a news release. The company said there are no FDA-authorized medical devices or PDTs indicated for people suffering from AUD only at present.

“We believe that PDTs can bring effective, evidence-based treatments for alcohol use disorder to many more people and in doing so help address the public health burden of AUD,” Pear CMO Yuri Maricich said in the release. “We applaud FDA for recogni…

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Pear Therapeutics picks up another $50M ahead of going public through SPAC merger

Pear Therapeutics and Thimble Point Acquisition Corp. announced today that they received additional funding worth $50 million ahead of a merger.

Boston-based Pear Therapeutics confirmed in June that it will go public by merging Thimble Point Acquisition Corp., a special purpose acquisition company (SPAC). A special meeting will be held for Thimble Point stockholders to vote on the merger on Nov. 30, and, subject to approval, the combination is expected to close shortly thereafter.

A special meeting for Thimble Point stockholders to vote on the combination with Pear will be held virtually on November 30, 2021 at 9:00 AM, Eastern Time. Subject to stockholder approval, the business combination is expected to close shortly thereafter.

The merger with Thimble Point, whose management team is associated with the Pritzker Vlock Family Office, will result in a combined company named Pear Holdings Corp that will trade under the “PEAR” ticker on the Nas…

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Massachusetts offers Medicaid coverage for Pear Therapeutics’ digital therapeutics

Pear Therapeutics announced today that MassHealth intends to cover the company’s prescription digital therapeutics (PDTs).

MassHealth, Massachusetts’ Medicaid program, notified Pear of its plans to cover the FDA-authorized reSET and reSET-O PDTs for treating substance use disorder and opioid use disorder, respectively. The decision remains subject to certain customary conditions, including federal and state approvals as well as sufficient funding on both levels.

“We applaud MassHealth for their leadership in introducing PDTs to their Medicaid population to provide safe and effective treatment options for patients in recovery,” Pear Therapeutics president & CEO Dr. Corey McCann said in a news release. “Pear is proud to help fight addiction in Massachusetts, especially at a time when the COVID-19 pandemic is exacerbating the addiction crisis in America with national drug overdose deaths increasing by almost 30% in 2020.”

Boston-based Pear&#…

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Pear Therapeutics touts real-world data for reSET-O prescription digital therapeutic

Pear Therapeutics today announced the publication of positive results from real-world data of its reSET-O prescription digital therapeutic.

Boston-based Pear Therapeutics evaluated its FDA-authorized reSET-O PDT in the treatment of opioid use disorder (OUD) on patients treated for 24 weeks, with real-world evidence demonstrating that the treatment is associated with improved outcomes, high levels of treatment retention and fewer hospital encounters compared to 12 weeks of the treatment.

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The 18 most innovative medical devices of 2021

[Images from BD, Edwards, Alcon and CVRx]The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards.

The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition.

“The Awards Committee is excited to introduce the nominees for the 2021 Prix Galien USA Awards. These products have been created by scientists who have dedicated their lives to discovering, developing and distributing life-saving answers for patients,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Award committees and former CEO of the Bill & Melinda Gates Foundation.

“We appreciate the opportunity to honor these researchers and their tireless efforts,” Desmond-Hellmann said in a news release.

Nominees need to be FDA-approved for the market within the last five years a…

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