Silvia Garcia Codony, CEO, Mira Therapeutics.

Silvia Garcia Codony, CEO, Mira Therapeutics. – AARON HOUSTON

Every day, when individuals across New Jersey walk, run or engage in other forms of exercise, they’re doing something else besides getting healthier. Their Apple Watch, Fitbit or other wearable digital device is sending valuable information to their health care team at RWJBarnabas Health and other institutions. It’s all part of the broad concept commonly known as digital therapeutics.

“In 2018, we began evaluating and developing the concept of linking our EMR [electronic medical records] with wearable technology,” said Jordan Ruch, vice president and chief innovation officer at RWJBH. “In 2019 we completed it, deciding to go with the Apple Health system, instead of creating our own one-off system.”

The Apple Health app consolidates data from a user’s iPhone, Apple Watch and third-party apps and devices. The ability to then aggregate data that originates among multiple sources — from a patient’s jump-rope session to RWJB lab results — “helps their care team to get a holistic view,” Ruch added. The data can then be synced with RWJB health records so they can be analyzed by the institution’s medical professionals.

Other kinds of digital therapeutic devices are also having an impact. In October, MedRhythms Inc., a Portland, Maine-based digital therapeutics company, announced that five rehabilitation hospitals and research centers — including the East Hanover-based Kessler Foundation — would conduct randomized controlled trials of the company’s new product MedRhythms Stride. The digital therapeutic tool uses sensors attached to a patient’s feet to record information about their gait, which is then analyzed by a smartphone app that pairs the patient’s walking movements with music.

The trial marks an important phase in a new approach, according to Karen Nolan, a senior research scientist in the Kessler Foundation’s Center for Mobility and Rehabilitation Engineering Research.

“Previously, most stroke rehabilitation devices simply compensated for deficits,” she said. “But a few years ago, we began to use robotics — like Ekso, a wearable, battery-powered exoskeleton that allows wheelchair users with lower-extremity weakness to stand and walk — in an attempt to help people recover long-term movement instead of just to compensate.”

The MedRhythms device is the first one the foundation used “that combines auditory stimulation in a digital package for stroke rehabilitation” she said. “We look forward to evaluating it among the 20 or so volunteers at this site.” Nolan anticipates that the data-collection phase will take up to nine months, followed by up to another six months to evaluate the short-term outcomes.

The FDA already has approved some new digital therapies, “such as Boston-based Pear Therapeutics’ Reset mobile application for the treatment of substance abuse, and Stockholm, Sweden-based Natural Cycles’ birth control app,” according to a report issued by the global audit and assurance, tax and consulting firm PwC. “Results from clinical studies of Pear Therapeutics Reset substance abuse app, for example, show increased abstinence from alcohol, cocaine, marijuana and stimulant substance use compared with patients who didn’t use the app.”

No threat to pharmas

The emerging digital therapeutics market represents an opportunity, not a threat, for drugmakers, said Karen Young, U.S. Pharmaceutical and Life Sciences leader at PwC. “Digital therapeutics can represent a new revenue stream for pharmaceutical companies, especially at a time where there’s an expectation of connecting more directly with patients,” she said. “They can collaborate with technology companies for direct engagement.”

PwC noted that GlaxoSmithKline, for example, is partnering with Propeller Health, a Madison, Wis.-based digital therapeutics company that uses digital sensor technology to track and optimize patient inhaler usage.

Young said these kinds of partnerships make good business sense. “Each one brings different skill sets and capabilities to the table,” she noted. “The tech firms have sensor, data collection and other capabilities, while the drug companies — in addition to their medications — also have experience in regulatory filings, which can be challenging.”

Still, businesses will need to develop new skills for these kinds of collaborations, according to a report by Deloitte, an international audit, consulting, advisory, and tax services firm. “Companies will need to develop cross-industry connections and robust alliance management competencies,” it noted. “In turn, technology acquisitions will need to find and negotiate deals based on criteria, diligence focus, valuation approach, and terms that fall outside the usual life sciences acquisition playbook.”

Brett Davis, general manager, ConvergeHEALTH by Deloitte, part of Deloitte Consulting LLP’s Innovation group.

Davis

The investment of time and resources is worth it, said Brett Davis, the general manager at ConvergeHEALTH by Deloitte, part of Deloitte Consulting LLP’s Innovation group. “An emerging body of literature shows that digital intervention combined with traditional therapeutics may lead to better outcomes, and possible lower costs,” he said. “Biopharmas in particular may wish to review their portfolios and consider where digital intervention — alone or in concert with traditional therapies — makes sense.”

In October, ConvergeHEALTH launched MyPATH, a platform designed to help health systems, biopharmaceutical, medical device and health plan innovators deliver digital patient-support services and therapy management “across the patient journey, improving their overall experience while cultivating a rich, real-world data set.”

Other organizations are jumping on board. Jefferson Health, which operates care centers across Pennsylvania and New Jersey, uses “many app-based technologies for our patients,” said Christina Micoli, project manager at Jefferson Strategic Ventures. “One of our more recent partnerships has been with a local behavioral health startup company, NeuroFlow,” which developed IntegrateHealth, a HIPAA-compliant “provider-facing dashboard and a patient app that has the ability to integrate with wearable technology like Apple Watch and Fitbit.”

Christina Micoli, project manager, Jefferson Strategic Ventures.

Micoli

IntegrateHealth supports general behavioral health conditions like anxiety and depression, while the NeuroFlow product “gives patients access to a library of content and activities that allow them to take their care into their own hands,” added Micoli. “The NeuroFlow platform also sends information to the provider, allowing the provider to have insights to the patient’s behavioral health outside of the office visit. We’ve seen that 79 percent of patients using NeuroFlow have seen an improvement in depression scores.”

Digital health approaches provide the ability to leverage technology to expand the reach of interventions at lower cost than more personnel-intensive approaches, said Dr. Mitesh Patel, director of the Penn Medicine Nudge Unit, which bills itself as the world’s first behavioral design team embedded within a health system.

“There are a growing number of digital health applications but few that leverage behavioral insights in their design,” he said. “Our work has found that incorporating behavioral economic principles to address predictable barriers to behavior change can make these interventions more impactful.

A digital solution playbook

Mira Therapeutics, a Hoboken-based startup, is one of the companies developing digital therapeutic applications. “Digital health is a great opportunity,” said Chief Executive Officer Silvia Garcia Codony, who’s also the Entrepreneur-In-Residence at Stevens Institute of Technology. “Technology has been used for so many other things, now we’re using it for health — in our case, focusing on changing the way people recover and grow from trauma, including PTSD [post-traumatic stress disorder], and other kinds of physical and mental assault.”

The Mira App from Mira Therapeutics. - AARON HOUSTON

The Mira App from Mira Therapeutics. – AARON HOUSTON

Initially developed by Stevens students CJ Internicola and Seth Kirschner, Internicola is still involved, in business development, Mira is a two-stage system. When patients feel a flashback or other symptom approaching, they can use the Mira App to access a crisis assistant tool that provides a variety of “interactive grounding exercises, based on proven techniques,” Codony said, noting it also gives them the option of logging in their symptoms.

As the patient uses the tools, the app builds a roster of symptom reports that can be shared with a therapist, who can evaluate treatment options based on the robust, patient-generated set of data. There’s a big market for the app, since about 3.5 percent of U.S. adults — and an estimated one in 11 people overall — will be diagnosed with PTSD in their lifetime, according to the American Psychiatric Association.

“People suffering from trauma may experience an attack at any time, not just when they’re near a support source,” Codony added. “So, tools like Mira can help them to self-manage. Then, the information collected will assist in data-based therapy, helping to provide valuable insights to the therapists and other providers.” Without that kind of assistance, she added, “some people resort to undesirable coping mechanisms such as self-harm and substance abuse in order to numb or escape those feelings.”

Right now, the mobile phone app is being Beta tested by more than 30 active users, “with encouraging results,” she said. “People like it so they use it. We’re continuing to develop add-ons for the app, and we expect to launch in the general market sometime in 2020.”

In its current format, MiraView doesn’t require FDA approval, which removes a lot of cost and time obstacles, according to Codony. “So far we’ve been able to bootstrap our funding ourselves,” she said.

“Later Mira apps may require FDA approval, and of course we also want to beef up our marketing budget once it gets into the marketplace. Once we get on the general market, we’ll probably look for VC or other funding.”





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