Wire #32

  • J&J Decentralized Study: Johnson & Johnson’s SGLT2 inhibitor Invokana has been shown to have a significant effect on heart failure symptoms in a clinical trial that relied exclusively on patient-reported symptom monitoring using a smartphone app, the first study of its kind. The completely ‘virtual’ randomized controlled trial opens the door for applying the approach to the testing of other cardiovascular therapies focusing on health status.
  • Keeps Hair Restoration Clinic: Early next year, direct-to-consumer telehealth company Thirty Madison will be opening its first brick-and-mortar hair transplant clinic in NYC, taking the brand equity built from its popular Keeps products and applying it to in-person treatment. The Keeps Hair Restoration Clinic will offer hybrid treatment options after hair restoration procedures, which the company says is part of a wider initiative to begin providing end-to-end treatments.
  • Telemedicine Leads to Fewer Treatments: When patients meet with their primary care providers via video, they receive far fewer prescriptions and diagnostic tests. That’s from a pre-pandemic Kaiser Permanente study (n = 1.1m patients, 2.2 appointments) that found video visits were far less likely than clinic visits to result in prescriptions (38.6% vs. 51.9% of visits) or lab tests and imaging orders (29.2% vs. 59.3%). Although telemedicine visits were slightly more likely to require in-office follow-ups within 7 days (25.4% vs. 24.5%), they did not lead to more ED visits or hospitalizations.
  • Notable Labs Pipeline: Predictive medicine pioneer Notable Labs announced that it is acquiring the rights to volasertib (PLK-1 inhibitor with demonstrated activity in acute myeloid leukemia) from Oncoheroes Biosciences as it begins to develop its therapeutic pipeline. Notable Labs will leverage its Predictive Precision Medicines Platform to identify volasertib-responsive patients prior to treatment in order to fast-track volasertib’s phase 2/3 clinical trials. Both Notable Labs and cancer patients stand to benefit greatly if the combination of expedited development and therapy ownership is successful.
  • AppliedVR Approval: A lot can change in a week, and in the time between now and when we covered AppliedVR’s Series B round on Monday, the company’s flagship EaseVRx digital therapeutic has been granted de novo approval by the FDA for treating chronic lower back pain. EaseVRx is now the first VR prescription to receive approval for back pain management, and AppliedVR has a freshly raised $36m to help bring the solution to market.
  • In-Home Health Evaluations: Signify Health CMO Marc Rothman, MD, recently wrote about the value of in-home health evaluations (IHEs) to supplement annual wellness visits, making the case that IHEs can provide clinicians with a better view into patients’ social determinants of health. Dr. Rothman points out that many health inequities (lack of food, transportation issues, etc.) are hiding in plain sight, but unobservable in an office setting, a gap that can be filled with an IHE.
  • Employer Benefits Survey: KFF released its 2021 Employer Health Benefits Survey, which indicated that premiums for employer-sponsored plans rose 4% over the past year to an average $22k. One of the standout metrics from the report was that 39% of employers with over 50 employees made changes to mental health and substance abuse benefits since the beginning of the pandemic, highlighting why so many investors have been directing funds to those spaces.
  • Concussion App: A new NIH study suggests that pupillary light reflex measurements performed with smartphone apps might be able to identify concussed patients, improving both diagnosis and treatment. The researchers analyzed data from patients who used the BrightLamp Reflex iPhone app, finding that patients with and without concussions had significantly different pupillary light reflex metrics (e.g. max & min pupil diameter, recovery time).
  • Information Blocking: Deputy National Coordinator Steve Posnack has a new blog post that provides a clear overview of the Cures Act’s information blocking provision and its intersection with other laws. If you’re interested in exploring some nuances of the regulation, or want some concrete examples of information blocking exceptions (e.g. denying a patient’s access to their own data in order to reduce risk of physical harm), then the blog is worth a read.
  • Nursing Home Telehealth: A new study out of the University of Missouri found that the rapid adoption of telehealth at US nursing homes during the onset of the pandemic had several benefits (reduced stress, improved access), but was not without its drawbacks. Nursing home administrators reported difficulty for residents with cognitive impairment, worsening social isolation, and a preference for in-person encounters, issues that the authors suggest addressing with mitigation strategies for affected patients.
  • PillCam FDA: Medtronic’s unique PillCam gained FDA 510(k) approval for at-home endoscopy procedures. The PillCam SB3 @HOME kits are delivered directly to patients, allowing gastroenterologists to remotely examine patients’ small bowels. The FDA clearance adds endoscopy to the growing list of historically in-person procedures that are migrating to the home setting, improving convenience and access to care for a wide range of patients.

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-- The Digital Health Wire team