Better shows data on app's benefit with GLP-1s

Better Therapeutics announced top-line data suggesting that its prescription app for diabetes treatment, AspyreRx, can boost the impact of GLP-1 diabetes treatments. According to the release, a subgroup analysis of 160 participants in its pivotal trial on GLP-1 treatment found that the behavior modification app produced statistically significant reductions in A1C compared to a control group.

Better Therapeutics is racing to find a way to drum up some capital and has said it views partnerships with medical device or pharmaceutical companies as a strong option. The release about the data hints that the company could be eager to find a GLP-1 developer looking for an app to pair with its treatment.

digital therapeutics

Orexo's OUD app fails to beat standard of care

Orexo hit another snag in its quest to build a digital business. The Swedish pharmaceutical company which makes almost all of its money from a buprenorphine and naloxone drug used to treat opioid use disorder, announced that its app MODIA that's meant to support OUD treatment failed to show a statistically significant difference to standard of care for any endpoint.

According to Orexo, both treatment arms showed "unexpectedly high rates of treatment response," and though it doesn't come out and say it thinks the experiment was flawed, it stops just short, attributing the positive outcome in both arms to the weekly drug testing required by regulators and the compensation it gave to participants. The company said that it saw better results in people who completed more modules in the app, suggesting the treatment's potential benefits.

In the short term, the company will continue to offer MODIA as a "supportive resource" under FDA enforcement discretion, rather than pursuing labeling as a prescription treatment. MODIA had previously been available under regulatory rules temporarily loosened during the pandemic.

Medical Devices

Takeaways from AdvaMed

Thousands of workers in the medical device industry descended on Anaheim, California this week for the Medical Technology conference, and my colleague Lizzy Lawrence was on hand to take in all the splendor.

Device makers and analysts at the conference, hosted by device lobby AdvaMed, came together to discuss medical technology's innovation problem, the industry's deepening relationship with the Food and Drug Administration, and the growing opportunities in digital health.

Read Lizzy's takeaways here

regulation

FDA creates adcomm for digital health

For years, the health tech team has watched enviously (kidding!) as our biotech colleagues endure all-day marathon coverage of FDA advisory committee meetings about drugs. It looks like we may finally get to join the party.

The details are thin for now, but the FDA announced that it has established a committee to advise on digital health technologies, including artificial intelligence and machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. The adcomm will be operational in 2024. Who will be on it? What issues will they tackle? We have so many questions. The FDA is accepting nominations now.

digital health

Industry news

Surely you followed along with the detailed HLTH coverage in our pop up newsletters from my colleagues Mohana Ravindranath and Annalisa Merelli, but here are a couple of announcements from the week that caught my eye.

CVS Ventures made an investment of an undisclosed amount in Amalgam Rx, which helps drug companies develop mobile apps in addition to other offerings. The funding follows a $17 million investment from Novo Nordisk that was announced in January.
Cigna subsidiary Evernorth acquired Bright.md, which makes technology enabling asynchronous care, triaging, and health care navigation. It plans to add those capabilities to its MDLIVE virtual care platform.
Walmart announced it will expand virtual primary care coverage provided by Included Health to associates on its self-insured plan to 28 additional states following successful pilots in 21 states. (Only Hawaii doesn't have the benefit now.) Walmart is the largest employer in the United States, so it's very much a bellwether indicating the way benefits trends will go in coming years.
Arctop, "a software platform for brain decoding," announced $10 million in Series A funding co-led by Fifth Growth Fund and Supermoon Capital.