After clearing a major regulatory hurdle to use its virtual reality treatment for chronic pain, AppliedVR is now planning to run multiple VR therapy clinical trials from patients' homes.
Curebase, a company that provides decentralized clinical trials software, signed a one-year partnership with AppliedVR to test its VR-based digital therapeutics across five studies.
AppliedVR's platform has been used by more than 30,000 patients in more than 240 of the top health systems globally.
The clinical trials with Curebase will focus on studying a self-administered, at-home VR therapy program, with Curebase software managing online patient recruitment, consent and participant engagement as well as collecting patient-reported outcomes. Curebase's software also will support clinical workflows and coordination of VR headset and trial kit distribution, the companies said.
AppliedVR's VR platform—which uses goggles and headsets to create an immersive, 3D virtual world—has been aimed at alleviating everything from labor pains during childbirth to the pain from burns to discomfort experienced undergoing infusions for cancer treatment.
The company is working to build a VR pharmacy that personalizes therapies, content and media based on patient needs. The company has developed more than 40 different VR modules to provide relaxation, engagement and mindfulness.
AppliedVR recently collected $29 million in series A funding backed by F-Prime Capital, JAZZ Venture Partners, Sway Ventures, GSR Ventures, Magnetic Ventures and Cedars-Sinai.
The startup received FDA breakthrough designation for its platform's use in chronic lower back pain and treatment-resistant fibromyalgia last October.
In February, AppliedVR announced results from a trial, which were published in the Journal of Medical Internet Research, finding VR can be a holistic treatment for chronic pain.
The Los Angeles-based medical technology company is aiming for FDA de novo clearance for its digital therapeutic.
The Curebase platform will help AppliedVR study participants each day comply with research protocols and report basic data about outcomes.
"We needed to secure a partner that would allow us the flexibility and dynamic ability to cater different studies to different endpoints and enable us to hone in on the clinical value proposition for different types of patients and study sizes," Josh Sackman, president and co-founder of AppliedVR, told Fierce Healthcare.
VR holds the potential to both improve and lower the cost of how physicians treat chronic pain while also reducing America’s dependence on pharmacological interventions, he said.
"Demonstrating that requires effective clinical trials, and Curebase’s technology gives us a user-friendly, end-to-end solution that is highly workflow-oriented and specialized for digital therapeutic study designs,” Sackman said.
He added, "Curebase offered the flexibility to be able to run multiple studies, leverage their infrastructure and combination of professional services support to set up the studies but still allow autonomy for AppliedVR to manage the platform."
The Curebase approach delivers a high-end patient experience for participants anywhere in the country, said Tom Lemberg, CEO and founder of Curebase, in a statement.
“Applied VR will be empowered to recruit more quickly, experience improved trial compliance rates and a more rapid research timeline," he said.
Speeding up the research timeline is important for early-stage companies that are developing products they plan to take through the regulatory pathway, Sackman said.
"Delays in research costs a lot in terms of lost time and money," he said.
Digital therapeutics are gaining ground in healthcare, but there continues to be skepticism about the impact on health outcomes, cost, effectiveness and return on investment, according to Sackman.
"There are also questions around, how do you price this and how do you access the real value when launching digital therapeutics to the market? To get buy-in and alignment among patients, providers and payers, it gets down to the quality, diversity and robustness of the evidence we have available," he said.
To date, the digital therapeutics industry has lacked high-quality evidence to gain that alignment in the industry, he said.
"We have invested in the types of research activities to address cost-effectiveness and health outcomes and to evaluate how this is administered in a real-world setting," he said. "We need to look at the impact on healthcare utilization and cost, including medical cost and pharmacy cost, and, more broadly, how does this get operationalized and where does virtual reality-based therapy fit into the paradigm of care?"
Healthcare VR is a growing sector, and other digital health companies are using the technology to address different conditions and medical issues, including mental health.
U.K.-based Oxford VR, which is backed by Optum Ventures, offers a clinically validated VR platform to treat mental health patients. MindMaze raised $100 million in funding for its VR technology that has primarily been used for stroke victim therapy in European hospitals.
Kaia Health also developed software using machine learning that enables patients to self-manage conditions such as back pain, chronic obstructive pulmonary disease and osteoarthritis using an app.