Pear Therapeutics Archives - Medical Design Sourcing

Pear Therapeutics stock sinks as it may look for a sale or merger

Pear Therapeutics (Nasdaq:PEAR) announced today that it engaged in a process to explore strategic alternatives to maximize shareholder value.

Shares of PEAR fell more than 30%to 41¢ apeice in midday trading on the back of the news. MassDevice‘s MedTech 100 index, which includes stocks of the world’s largest medical device companies, was up slightly.

Boston-based Pear enlisted MTS Health Partners to act as its exclusive financial advisor in evaluating potential alternatives. MTS Health Partners provides strategic and financial advice to the healthcare industry.

According to a news release, Pear’s effort could include seeking out a range of options, including an acquisition or company sale. Other options include a merger, divestiture of assets, licensing or other strategic transactions. Pear may also seek additional financing.

The company set no timetable for the process. It said in a news release that it can’t make assurance…

Layoffs in medtech: These companies recently reduced their workforce

[Image courtesy of Nastuh Abootalebi on Unsplash] The workforce reduction trend has swept the economy recently, and unfortunately, the medtech space is not immune to layoffs.

You’ve probably read about the ongoing layoffs sweeping the tech industry, media and more.

For instance, Yahoo, Disney, Zoom and more all reported workforce reductions as companies across industries grapple with economic pressures. Think inflation, supply chain challenges and more.

Medtech has shown some resilience in the present environment. Some major medical device companies released positive earnings. However, others announced headcount reductions, citing macroeconomic headwinds. Others felt the weight of regulatory issues and restructuring efforts.

Here are a few companies across medtech that enacted layoffs over the past several months.

3M

In 3M’s fourth-quarter earnings report, the company announced that it plans to reduce its global manufacturing workforc…

Pear Therapeutics posts mixed bag Q3, cuts 22% of workforce

Pear Therapeutics (Nasdaq:PEAR) shares rose after hours on mixed third-quarter results compared to the consensus forecast.

The company also announced a large set of layoffs, following a previous workforce reduction in July.

Shares of PEAR rose 7.1% at $2.70 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished today up 5.8%.

Get the full story at our sister site, Drug Delivery Business News.

Real-world data backs digital therapeutic for substance use disorder from Pear Therapeutics

Pear Therapeutics designed the reSET prescription digital therapeutic for the treatment of substance abuse disorder. [Image courtesy of Pear Therapeutics]Pear Therapeutics (Nasdaq:PEAR) announced positive data supporting its reSET prescription digital therapeutic (PDT).

Boston-based Pear designed FDA-authorized reSET for the treatment of substance use disorder (SUD). That includes alcohol, cannabis, cocaine, and stimulants like methamphetamines.

The real-world study demonstrated high rates of engagement, retention and abstinence from substances with reSET through 12 weeks. The American Journal on Addictions (AJA) published the data.

reSET provides cognitive behavioral therapy as an adjunct to a contingency management system. Its indication covers patients aged 18 years and older currently enrolled in outpatient treatment under clinician supervision. The 12-week (90-day) prescription-only treatment covers SUD patients not currently on opioid replacement ther…

What does the future hold for AI in medical devices?

(Image courtesy of the FDA)

Digital health, artificial intelligence (AI), machine learning and more — these concepts continue to generate buzz in the medtech world.

Last month, the FDA published guidance on clinical decision support (CDS) software. It helped to clear up what constitutes a medical device and what doesn’t. Early last year, the agency published a predetermined change control plan (PCCP) to help build a regulatory structure for such technology.

These topics and more spurred intriguing commentary on a panel at AdvaMed’s MedTech Conference in Boston today.

The panel featured viewpoints across all angles of the space. Dr. Yuri Maricich, CMO and head of development at Pear Therapeutics, offered thoughts from the developer of digital therapeutics. Brendan O’Leary, acting director of the Digital Health Center of Excellence at the FDA, provided the regulatory vantage point.

Cybil Roehrenbeck, a partner at Hogan Lovells, off…

What does the future hold for AI in medical devices?

(Image courtesy of the FDA)

Digital health, artificial intelligence (AI), machine learning and more — these concepts continue to generate buzz in the medtech world.

Last month, the FDA published guidance on clinical decision support (CDS) software. It helped to clear up what constitutes a medical device and what doesn’t. Early last year, the agency published a predetermined change control plan (PCCP) to help build a regulatory structure for such technology.

These topics and more spurred intriguing commentary on a panel at AdvaMed’s MedTech Conference in Boston today.

The panel featured viewpoints across all angles of the space. Dr. Yuri Maricich, CMO and head of development at Pear Therapeutics, offered thoughts from the developer of digital therapeutics. Brendan O’Leary, acting director of the Digital Health Center of Excellence at the FDA, provided the regulatory vantage po…

Pear Therapeutics announces layoffs

Prescription digital therapeutics company Pear Therapeutics (Nasdaq:PEAR) announced today that it is letting go of roughly 25 employees, representing 9% of its workforce.

The layoffs are part of an overall operations restructuring that the Boston-based company will “narrow its near-term business focus and reduce its workforce due to the macroeconomic environment,” according to an SEC filing after market close.

The Form 8-K said restructuring efforts will reduce operating expenses by roughly $28 million over the next 18 months, extending the company’s cash run.

BTIG analysts kept their Buy rating on PEAR shares after the news: “Given the challenging macroeconomic environment, we are not entirely surprised to see Pear take steps to preserve cash and extend its cash runway and believe it was prudent for management to prioritize commercial efforts,” said BTIG analysts Marie Thibault and Sam Eiber.

It’s earnings seas…

Data backs Pear Therapeutics digital therapeutic for opioid use disorder

Pear Therapeutics (Nasdaq:PEAR) today shared real-world data highlighting low costs with its reSET-O prescription digital therapeutic (PDT).

Boston-based Pear Therapeutics’ reSET-O represents the only FDA-authorized PDT for the treatment of opioid use disorder (OUD).

Get the full story at our sister site, Drug Delivery Business News.

Pear Therapeutics reports positive real-world data for chronic insomnia treatment

Pear Therapeutics (Nasdaq:PEAR) today announced real-world data from a trial of its Somryst prescription digital therapeutic (PDT).

Data showed that Somryst, the only FDA-authorized PDT for treating chronic insomnia, achieved significant reductions in symptoms of insomnia, anxiety and depression severity both immediately following treatment and at six-months follow-up.

Get the full story at our sister site, Drug Delivery Business News.

Digital therapeutics open up new opportunities in medicine

Pear Therapeutics designed the reSET prescription digital therapeutic for the treatment of substance abuse disorder. [Image courtesy of Pear Therapeutics]A wide range of companies are aiming to make waves through digital therapeutic offerings, and each is doing things differently.

“We are seeing tremendous momentum for the DTx industry, with more and more products coming to market and gaining commercial coverage and recent signals from the White House and Congress demonstrating their interest and recognition of DTx products as an important way to expand access to quality treatments for populations with public coverage, especially underserved communities,” Digital Therapeutics Alliance CEO Andy Molnar said via email. “While we are riding a massive swell, the wave hasn’t even begun to crest. The community is expanding and convening this broad coalition of stakeholders is critical to really scale the industry and drive DTx adoption and integration to truly transform healthc…

Digital therapeutics open up new opportunities in medical design

A wide range of companies are aiming to make waves through digital therapeutic offerings and each is doing things differently.

“We are seeing tremendous momentum for the DTx industry, with more and more products coming to market and gaining commercial coverage and recent signals from the White House and Congress demonstrating their interest and recognition of DTx products as an important way to expand access to quality treatments for populations with public coverage, especially underserved communities,” Digital Therapeutics Alliance CEO Andy Molnar told Medical Design & Outsourcing. “While we are riding a massive swell, the wave hasn’t even begun to crest. The community is expanding and convening this broad coalition of stakeholders is critical to really scale the industry and drive DTx adoption and integration to truly transform healthcare.”

Read: How DeepWell is developing video games as tools for treating me…

FDA grants STeP designation for Pear Therapeutics’ neurobehavioral digital therapeutic

Pear Therapeutics (Nasdaq:PEAR) announced today that it received STeP designation from the FDA for its Pear-010 product candidate.

Boston-based Pear Therapeutics designed its Pear-010 prescription digital therapeutic (PDT) candidate to provide a neurobehavioral intervention (virtual reality-delivered pain reduction) to patients 18 and older with acute postoperative and acute postprocedural pain.

The company said in a news release that it plans to utilize its PearCreate discovery and development platform to develop the Pear-010 PDT.

FDA’s Safer Technologies Program (STeP) voluntary program exists for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments and diagnostics.

The goal of STeP is to provide patients and healthcare providers with timely access to such devices by expediting their development, assessment and review while maintaining…