BOSTON, and SAN FRANCISCO, September 14, 2017– Pear Therapeutics, the leader in a new era of prescription digital therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Pear’s De Novo request, allowing the company to market reSET® for the treatment of patients with substance use disorder (SUD) under a new class of treatment. This is the first time that the FDA has cleared a Prescription Digital Therapeutic with claims to improve clinical outcomes in a disease.
“This is a defining moment for digital therapeutics and for patients with substance use disorder,” said Corey McCann, President and Chief Executive Officer of Pear Therapeutics. “As the first FDA-cleared Prescription Digital Therapeutic for disease treatment, reSET® has demonstrated improved abstinence and treatment retention in a randomized controlled clinical study. We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas. Pear was impressed by the collaborative approach the FDA took in reviewing this innovative technology.”
The New England Venture Capital Association on Tuesday announced nominees in more than a dozen categories of its 5th annual NEVY Awards.
The awards are sponsored this year by General Electric (NYSE: GE) and winners will be announce May 17 at an event at the House of Blues.
“New England is home to some of the world’s brightest innovators and our new headquarters,” Sue Siegel, CEO of GE Ventures, said in a statement. “From the area companies solving complex challenges, to the venture capitalists funding the ideas, it’s important to recognize all the great work happening across the ecosystem and we’re happy to support the NEVYs to do just that.”
Utilizing Software Modules as an Enhancement to Pharmaceuticals for Chronic Conditions Is Poised to Be Critical Component of Digital Healthcare
NEW YORK, NY–(Marketwired – Oct 6, 2016) – Psilos Group, in its seventh annual Outlook outlining major emerging healthcare trends, says digital therapeutics is a $6 billion market opportunity by 2021. Digital therapeutics — “software as a drug” — deploys software modules as an enhancement, or even a substitute, to a drug. It is poised to become a critical component of digital health and to substantially improve the efficiency of American healthcare.
Health, technology, research, human behavior and public policy intersect at Connected Health Symposium 2016. Over 1,000 visionaries, leaders, practitioners and thinkers will gather for the 13th year at this premier destination event hosted by Partners HealthCare Connected Health.
The 13th Annual Connected Health Symposium: Digital Technology that Cares: Bringing the Human Element to Life
October 20-21, 2016, at Boston’s Seaport Hotel and World Trade Center
The Largest and Longest Study of Patients with Schizophrenia Interacting with Digital Therapeutics Results Released
Pear Therapeutics to Bring to Market Digital Therapeutics Based on Clinical Research from Dr. Dror Ben-Zeev et al for Patients with Severe Mental Illness
BOSTON, MA and SAN FRANCISCO, CA – Pear Therapeutics (PEAR), the creator of prescription digital therapies called eFormulationsTM, announced today results from a real-world implementation study examining a research version of THRIVETM, PEAR’s digital therapy for treating patients with Serious Mental Illness including schizophrenia, schizoaffective disorder, and bipolar disorder.
Pear Therapeutics Advances the First Regulated Digital Therapies for Addiction
Pear Therapeutics has grown significantly over the past year and now boasts forty employees split between the Boston, MA office and the San Francisco, CA location. NeuroInsights caught up with Dr. Corey McCann, founder and CEO, to learn about Pear’s progress developing digital therapeutics.
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.
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.
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.
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…