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To FDA or Not to FDA is Hot Topic at Neurogaming Conference

By Lesley McClurg

Wandering through booths at a neurogaming conference in downtown San Francisco this week was a little like finding myself in a science fiction infomercial.

This was the  the fourth annual Experiential Technology & NeuroGaming Conference and Expo, where I mingled with neuroscientists and inventors, eager to explain the technology behind their multiwired headsets or sleek brain gadgets.

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Pear Therapeutics CEO, Corey McCann, to Speak at Digital Health Summer Summit

The Fifth Annual Digital Health Summer Summit, co-located this year with BIO International Convention at the Moscone Center in San Francisco takes a deep dive into the elements of a successful digital health venture and showcases the latest digital health innovations from the industry’s most brilliant leaders and organizations who will explore the issues and opportunities facing the industry.

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Pear Therapeutics Closes $20 Million Financing

BOSTON, MA and SAN FRANCISCO, CA – Pear Therapeutics (PEAR), the creator of prescription digital therapies called eFormulationsTM, announced today that it has successfully closed on a $20M equity financing. 5AM Ventures, Arboretum Ventures, and JAZZ Venture Partners led the round, with participation from Bridge Builders Collaborative and several additional investors. The investment will allow PEAR to build and launch a portfolio of eFormulations, including reSETTM and reSET-OTM, PEAR’s digital therapies for treating Substance Use Disorder (SUD).

“PEAR is at the forefront of a new field in medicine, digital therapeutics, and we are looking forward to working with the PEAR team, along with our syndicate partners, to pave the way forward for patients globally,” said Andy Schwab, Co-Founder and Managing Partner, at 5AM Ventures.

PEAR is developing digital therapies, called eFormulations, to treat disease and enhance the efficacy of pharmaceuticals.  PEAR validates the efficacy of these digital therapies by conducting randomized clinical trials, and ultimately submitting the products for FDA approval.  “By combining novel digital interventions with drugs, PEAR has demonstrated the ability to enhance efficacy well beyond anything that is commercially available or in clinical development.  eFormulations have the ability to quickly elevate the standard of care for many of the disorders of the brain and beyond,” said Corey McCann, President and CEO of PEAR.  

“From mobile applications, to virtual reality, to predictive analytics, PEAR’s digital therapeutics platform directly boosts medication efficacy, well beyond enhanced compliance.  The proof is ultimately in the clinical data, and we are incredibly excited to back the PEAR team as they push toward FDA approval, and the delivery of these products to patients,” said Zack Lynch, General Partner at JAZZ Venture Partners.

PEAR’s first products, reSET and reSET-O, are proprietary digital therapies comprised of a patient-facing smartphone application and a clinician-facing web interface that treat SUD.  reSET and reSET-O have been tested and validated in 6 randomized clinical studies involving more than 1500 patients with SUD.  In a pivotal randomized trial, 399 patients seeking treatment for SUD related to cocaine, alcohol, cannabis, and stimulants across 10 treatment centers received either face-to-face therapy or reSET in lieu of therapist time.  Patients receiving reSET in lieu of therapist time demonstrated significantly higher rates of abstinence and higher rates of retention in treatment than patients receiving face-to-face therapy alone.  The Company plans to submit the digital therapeutic, reSET, for FDA approval in the first half of 2016.  PEAR has also developed reSET-O, an eFormulation that combines the reSET modules with pharmacotherapy for Opiate Dependence. In three separate randomized clinical trials involving over 465 patients, reSET-O has shown the ability to enhance abstinence, enhance retention in treatment, and reduce required clinician intervention time in Opiate Dependence.

“Given the dearth of treatment options for patients suffering from SUD, we are excited to launch reSET and reSET-O.  These products have demonstrated clinical data supporting enhanced abstinence, enhanced retention in treatment, enhanced quality measures like Addiction Severity Index (ASI), and significantly reduced clinician intervention time.  Enhancing efficacy while reducing costs is the holy grail for healthcare technology,” said Tim Petersen, Managing Director at Arboretum Ventures.  

In addition to PEAR’s addiction products, the Company is launching on its platform a pipeline of eFormulations for treating many of the disorders of the brain.  The Company’s product targeting schizophrenia has already demonstrated patient usability and clinical efficacy in combination with multiple medications, and is currently being examined in multiple large-scale clinical trials involving patients with schizophrenia, schizoaffective disorder, and bipolar disorder.  PEAR has also developed products enhancing medications for treating chronic pain, post-traumatic stress disorder (PTSD), general anxiety disorder (GAD), major depressive disorder (MDD), and insomnia.  These products integrate into the PEAR Platform, a modular and secure cloud-based platform for pushing patient-facing interventions and collecting and displaying data to providers and payors.

About Pear Therapeutics

Pear Therapeutics is a privately held eHealth company with offices in Boston and San Francisco.  The Company develops digital therapies to address a broad range of severe conditions including addiction, schizophrenia, pain, post-traumatic stress disorder, anxiety, depression, and sleep. PEAR’s eFormulationTM platform combines pharmaceutical preparations with user-friendly, customizable, and scientifically validated software applications.  PEAR’s patented approach provides better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payors.  For additional information please visit our website at www.peartherapeutics.com.

About Substance Use Disorder (SUD)

SUD is a chronic, relapsing disease, impacting more than 21.6 million US individuals over the age of 12. Every year, SUD results in over 200,000 deaths worldwide, and the downstream consequences of SUD are estimated to cost society more than $400 billion. Only 11% of individuals with SUD in the US receive treatment, with lack of access cited as a major barrier to receiving treatment; more than 96% of US counties lack qualified clinicians to treat SUD. For patients who do receive care, there is significant variability in quality, frequency, and utilization of evidenced-based therapies across providers as well as discrepancies between research and real-world adherence to guidelines.

About 5AM Ventures

Founded in 2002, 5AM Ventures actively invests in next-generation life science companies.  The firm is currently investing 5AM Ventures IV, L.P., a $250 million venture capital fund that closed in 2013.  With $685 million under management, 5AM has invested in over 55 early-stage companies and its successful realizations include DVS Sciences (acquired by Fluidigm), Envoy Therapeutics (acquired by Takeda), Flexion Therapeutics (FLXN), Ikaria (acquired by Mallinckrodt), Ilypsa (acquired by Amgen), Incline Therapeutics (acquired by The Medicines Company), Marcadia (acquired by Roche), Novira (acquired by J&J), Pearl Therapeutics (acquired by AstraZeneca) and Relypsa (RLYP). For more information, please visit www.5amventures.com.

About Arboretum Ventures

Arboretum Ventures is a venture capital firm specializing in the healthcare sector. Founded in 2002 and located in Ann Arbor, the firm manages $450 million in capital and has invested in more than 35 companies.  Arboretum focuses on medical device, diagnostic, healthcare IT, and healthcare service companies that can achieve significant milestones and value creation in a capital-efficient manner. More than simply a financial resource, Arboretum is a collaborative, value-added investor actively engaging our portfolio companies in strategy, operations, recruiting, fundraising, and exit planning. Arboretum’s guiding vision is to identify transformative healthcare companies that are developing improved and less costly solutions that address significant healthcare problems.  For more information, please visit www.arboretumvc.com.

About JAZZ Venture Partners

JAZZ Venture Partners invests in companies developing experiential technology that improve human performance.  At the intersection of digital consumer platforms, such as virtual and augmented reality, and neuroscience, these companies are impacting health, mind-body wellness, peak mental and physical acuity, accelerated learning and training, sports, and entertainment.  For more information, please visit www.jazzvp.com.

Video game designers tout games as prescription therapies

Inside the push for prescription video games to treat autism, anxiety, even Alzheimer’s

By: Rebecca Robbins

Hundreds of patients with mental illness are signing up to test an unusual experimental treatment: video games.

It’s part of a bold push by several companies, led by two Boston startups, to secure permission from federal regulators to market their video games as medical therapies, to be prescribed by physicians for conditions ranging from depression to autism to even, perhaps, Alzheimer’s disease…

 

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Pear Therapeutics Advisor, Patrick J. Kennedy, to speak at Cambridge Public Library on Thursday, October 22, 2015 at 7:00pm

Harvard Book Store will welcome former congressman, Patrick J. Kennedy, for a discussion of his book A Common Struggle: A Personal Journey Through the Past and Future of Mental Illness and Addiction, co-authored with Stephen Fried.

Event Details:
Cambridge Public Library
449 Broadway
Cambridge, MA 02138
7:00 pm

Event Flyer

Pear Therapeutics featured in latest issue of Neurotech Insights

Pear Therapeutics CEO, Corey McCann MD, PhD, was interviewed during the 3rd European Neurotech Investing and Partnering Summit held on September 9-10 in Geneva, Switzerland.

Read Full Article Here

Pear Therapeutics CEO, Corey McCann, to Speak at the World Medical Innovation Forum

The World Medical Innovation Forum features CEOs of industry-leading multinational medical companies, Partners HealthCare top clinicians and scientists—all Harvard Medical School faculty members—and global technology leaders. Join 1,000 international innovation decision-makers and be briefed on the state of the art in neuroscience technology, care and research directly from the CEOs bringing game-changing products to market…

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Third Annual NeuroGaming Conference & Expo Returns to San Francisco May 6-7

The Neurotechnology Industry Organization (NIO), the leading neuroscience trade association, today formally announced that its third annual NeuroGaming Conference and Expo will be held in San Francisco on May 6-7, 2015. The NeuroGaming Conference focuses on the convergence of mind and body with game play; engaging the full nervous system into the gaming experience for the purposes of entertainment, education, health and wellness…

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Pear Therapeutics Closes Financing

BOSTON, MA – Pear Therapeutics, the creator of prescription pharmaceutical-software combination products called eFormulations, announced today that it has successfully closed on additional financing. The funding round was led by 5AM Ventures, with several undisclosed additional investors contributing capital. The investment will allow Pear to build a portfolio of eFormulationsTM. Concurrently, Andrew J. Schwab, Founding Managing Partner of 5AM Ventures, has been appointed to the Pear Therapeutics Board of Directors.

Pear is developing digital health interventions to enhance the efficacy of pharmaceutical preparations. While its proprietary approach has broad clinical application, the company is initially focused on disorders of the brain, many of which impose large societal costs and yet still have limited treatment options. “From mobile applications, to virtual reality simulations, to predictive analytics, our technology directly boosts medication efficacy in incredibly significant ways, well beyond enhanced compliance. Our team has pulled together the pieces required to deliver these products to patients,” said Corey McCann, President and CEO of Pear.

“Brain-related disorders represent a significant healthcare problem that today’s pharmaceutical pipeline is ill-equipped to address. We were very impressed by early data for eFormulations in tackling mental health issues and Pear’s approach provides an opportunity to elevate the standard of care for disorders going well beyond the brain,” said Andrew J. Schwab.

About Pear Therapeutics

Pear Therapeutics is a privately held eHealth company with offices in Boston and San Francisco developing drug/software combination products to address a broad range of severe conditions. The company’s eFormulationTM platform combines pharmaceutical preparations with user-friendly, customizable, and scientifically validated software applications. Pear’s patented approach provides better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payors. For additional information please visit our website at www.peartherapeutics.com.

About 5AM Ventures

5AM Ventures actively invests in next-generation life science companies. The firm is currently investing 5AM Ventures IV, L.P., a $250 million venture capital fund that closed in 2013. With over $685 million under management, 5AM has invested in 49 early-stage companies and its successful realizations include Achaogen (Nasdaq: AKAO), Alexza Pharmaceuticals (Nasdaq: ALXA), DVS Sciences (sold to Fluidigm), Envoy Therapeutics (sold to Takeda), Flexion Therapeutics (Nasdaq: FLXN), Ikaria (sold to Madison Dearborn), Ilypsa (sold to Amgen), Incline Therapeutics (sold to The Medicines Company), Marcadia (sold to Roche), Miikana Therapeutics (sold to EntreMed), Panomics (sold to Affymetrix), Pearl Therapeutics (sold to AstraZeneca), Relypsa (Nasdaq: RLYP), Semprus (sold to Teleflex) and Synosia Therapeutics (sold to Biotie Therapies). For more information, please visit www.5amventures.com.

In Mental Health Therapy, Cautious Steps Toward the Pharmacodigital


The phrase “better living through chemistry,” derived from an old DuPont corporate slogan, has accumulated all kinds of ironic and wink-wink connotations over the decades. But there’s a fascinating revival and upgrade underway.

For people with debilitating mental health problems, many researchers, doctors, and businesspeople think the new phrase should be “better living through chemistry and digital technology.” OK, it’s clunky, but it helps describe a range of new digital therapies—delivered via mobile apps, desktop or TV-based games, and even immersive virtual reality—under development for mental health and addiction disorders that thousands of patients have already used…

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