San Diego’s prowess in computer science, medical devices, and life sciences makes it a natural hub of innovative digital health companies. The finalists in the Digital Trailblazer category of the Xconomy Awards San Diego highlight the wide variety of healthtech ideas emanating from local startups and big companies alike, ranging from virtual coaches for physical therapy patients, to experimental software designed to address Alzheimer’s symptoms.
Here are brief profiles of the finalists.
This is part of a series of articles about the finalists for the Xconomy Awards San Diego. We’ve written about the CEO, Commitment to Diversity, and Innovation at the Intersection finalists, and stay tuned for coverage of the other finalists.
Each cancer patient’s disease is different. The good news is there are now millions of potential treatment options. That can be bad news, too.
“It becomes overwhelming for even the best, most ambitious oncologist,” CureMatch CEO Bob Manning writes in an email message.
His company’s software attempts to help oncologists narrow the choices. It uses machine learning and other technologies to analyze a cancer patient’s genomic data and comb through more than 4.5 million different drug combinations to generate a scored and ranked list of what it deems the most promising treatment plans, matched to the individual patient’s disease. The software also provides evidence backing up its recommendations, Manning says.
CureMatch’s software was initially developed by Razelle Kurzrock, an oncologist and precision medicine researcher at UC San Diego’s Moores Cancer Center, and Igor Tsigelny, who has served as a research professor at Moores and the San Diego Supercomputer Center. They co-founded CureMatch along with Blaise Barrelet, who was the CEO and is now board chair. Kurzrock serves as the company’s chief medical advisor and Tsigelny as its chief science officer.
Part of CureMatch’s pitch is that its analysis is more comprehensive than tumor-profiling services from other companies because it incorporates multiple types of tumor profiling results, and it looks at all of a patient’s cancer mutations together instead of individually.
CureMatch has presented data demonstrating its software correctly predicted treatment response in almost 80 percent of the cases examined. The startup is currently running a prospective clinical trial of its technology in partnership with the MD Anderson Cancer Center, Manning says.
His company has raised about $3 million from investors, and he expects revenues to ramp up this year, thanks in part to a recent licensing deal with France-based pharmaceutical firm Servier.
Despite the many medical advances over the past 30 years, one area of healthcare that has had a frustrating lack of progress is Alzheimer’s therapies. Since a pair of old cognition-boosting drugs were approved to treat the disease in 1996 and 2003, the field has endured a series of failed experimental drugs, including ones from Roche and Biogen (NASDAQ: BIIB) this year.
Dthera Sciences CEO Edward Cox argues it’s time for a “radical rethink in the way we approach” neurodegenerative diseases such as Alzheimer’s, including adopting a multidisciplinary treatment strategy that adds digital technologies to caregivers’ arsenal, he says.
His company is developing a product that would use software and a custom tablet device to deliver reminiscence therapy to Alzheimer’s sufferers. Reminiscence therapy is a common behavioral intervention that involves presenting familiar pictures, music, and other materials to help patients remember past experiences. The problem is this intervention is labor intensive, Dthera says. The company’s pitch is that digital technologies would enable more efficient delivery of the therapy to more patients.
Dthera is positioning its system as a treatment for agitation and depression—common Alzheimer’s symptoms. Last year, the FDA gave Dthera’s experimental product “breakthrough device” status, a program meant to expedite development and review of treatments for life-threatening or irreversibly debilitating conditions.
If Dthera’s product wins FDA clearance, it would be the first non-pharmacological prescription treatment approved for Alzheimer’s symptoms, the company says. It would also be another notch in the belt for the emerging field of digital therapeutics, following FDA clearance in 2017 and 2018 for Pear Therapeutics’ mobile app-based treatments for substance use disorder and opioid use disorder, respectively.
Cox says Dthera plans to run a pivotal trial this year or next, and file for FDA approval after that, with the aim of getting the agency’s green light some time in 2020, he adds.
One of the criticisms of the digital health sector is many companies don’t undergo rigorous clinical trials to prove the effectiveness of their products. But Reflexion Health decided it didn’t have a shot at winning widespread adoption of its virtual physical therapy (PT) system without convincing clinical data.
CEO Joe Smith says his 60-person company put “a fair bit on the line” to run what it called the first “large-scale” comparison of virtual and traditional, in-person PT: a randomized, controlled trial completed by 287 patients who had undergone total knee replacement surgery. The study, run in conjunction with the Duke Clinical Research Institute (DCRI) at Duke University, tested Reflexion’s virtual system, which is intended to help patients complete their recovery at home and on their own schedule. The study showed that the system was as effective as standard therapy at improving knee function and reducing disability. It also saved an average of $2,745 per patient, due to reductions in rehospitalizations and “post-acute” care services at hospitals, clinics, and skilled nursing facilities.
Reflexion’s FDA-cleared system, VERA (“virtual exercise rehabilitation assistant”), uses Microsoft’s Kinect motion-sensing camera to monitor and analyze patient movement during at-home therapy sessions. An avatar on a touchscreen-enabled device coaches patients through exercises and models the correct movements. Video of their sessions is sent to their therapists, and the Reflexion system can also host video conferences between patients and caregivers. Clinicians are able to track patients’ progress more closely, among other benefits, Smith says.
He declined to share sales figures, but says Reflexion’s system is being used by patients in 30 states.
“We’ve proved out the cost savings and are watching the advance of bundled [insurance] payments and value-based care,” Smith says, referring to the shift away from traditional healthcare payment models that charge fees for each service rendered. “We’re kind of riding that wave, along with the data we’ve brought to bear, to drive adoption.”
Startups aren’t the only companies blazing trails in digital health. ResMed (NYSE: RMD), a 30-year-old medical device company best known for selling continuous positive airway pressure (CPAP) machines that help people manage sleep apnea, has invested heavily in digital tools in recent years.
In 2014, it connected all of its sleep apnea treatment devices to the Internet to enable remote monitoring. Today, more than 8 million ResMed devices are cloud-connected, and more than 1.5 million customers track their device usage with the company’s myAir app, a spokesperson says. The goal is to help caregivers better monitor and guide patients. The emphasis on remote self-monitoring has helped push the rate of patients adhering to their sleep apnea device usage plan to 87 percent, which is much higher than typical adherence to device and pharmaceutical treatment plans, the spokesperson says.
ResMed, which generated $2.3 billion in revenue last year and is valued at nearly $15 billion as of this writing, has also looked to outside organizations to boost its digital strategy. In 2016, it bought healthcare software developer Brightree for $800 million. And last year ResMed struck deals to buy MatrixCare, a maker of software for long-term care providers, for $750 million, and Propeller Health, a developer of connected inhalers and related software, for $225 million. ResMed also formed a joint venture last year with Verily, the life sciences subsidiary of tech giant Alphabet (NASDAQ: GOOGL), to develop software products that improve diagnosis and treatments for people with breathing-related sleep disorders.
Add it all up, and the medical device giant has become a major player in the emerging world of “connected healthcare.”
Bringing a new drug to market takes years and billions of dollars. But some of the costs and wait times are avoidable.
A 2016 Tufts University study of more than 800 clinical trial protocols—the documents that establish a study’s objectives and design—found that 57 percent of them had at least one significant amendment, and 45 percent of the amendments were deemed avoidable. Protocol amendments cause delays in drug testing and commercialization and cost the pharma industry $20 billion a year, the study estimated.
Trials.ai is using machine learning-enabled software to help drug developers more effectively design clinical trials and avoid protocol changes. It helps with decisions such as choosing criteria for patient recruitment, creating the drug dosing schedule, and picking clinical sites to run the tests, says Trials.ai co-founder and CEO Kim Walpole.
“Billions of dollars are getting squandered on preventable mistakes,” Walpole says. “This process needs to be automated and data-driven. Right now, it’s incredibly manual.”
She says she was driven to start the company after her best friend was diagnosed with pancreatic cancer and died while waiting to enroll in a clinical trial of a potential new treatment.
Trials.ai, previously known as Catalyst eClinical, initially aimed to use software to help manage clinical trials. The company later shifted its focus to earlier in the clinical development process, helping to plan trials. Much of the startup’s artificial intelligence technology was developed in-house, Walpole says. She says one of the company’s differentiators is that it has built its own ontology specific to clinical trial data, which is intended to make its natural language processing and other A.I. tools more effective.
Trials.ai has raised $1.2 million from investors to date, and it’s generating revenue from clients, including contract research organizations and pharma companies, Walpole says.