Theranica received FDA 510(k) clearance for its Nerivio device for migraine prevention in patients 12 and older. Theranica’s devices are based on a pain inhibition mechanism known as Conditioned Pain Modulation (CPM) where someone who suffers pain has a dysfunctional response to harmless stimuli. According to their product information, Nerivio wraps around the upper arm and uses non-painful remote electrical modulation (REN) to activate peripheral nerves to modulate pain. In addition to the device, the app allows users to customize their migraine treatments, receive reminders for preventive treatments, track patterns, and share migraine data with their doctor, as well as a guided relaxation routine. Theranica is based in Israel and New Jersey. Release, Mobihealthnews
Google’s Pixel Watch added fall detection to capabilities. It uses the motion sensors already in the watch and machine learning to detect a hard fall. If the wearer hasn’t moved within 30 seconds, it will vibrate, sound an alarm and display an on-screen notification that can be called off by pressing ‘I’m OK’ (left) or ‘I need help’. If the former, the alarms escalate until an automated call to 911 is made. The user has to activate the feature and Google claimes that the ML will help it avoid false positives. A very useful feature for older people, lone workers, and runners/walkers, but at the price point of $350 at Best Buy or $11/month via AT&T or Verizon, perhaps not all that attractive to cost-conscious users. Engadget, Google blog post, Mobihealthnews
And in the Delays Must Be Catching Department, Veradigm, the former Allscripts, is delaying its Q4 and FY 2022 reporting due to a software flaw that affected its revenue reporting. Originally 1 March, the new date is yet to be determined, but they anticipate a reduction of $20 million dollars against what was previously reported from Q3 2021 into estimates for Q4 2022. Not exactly confidence-making for a company in the data management/software business. Coincidentally, the company which bought then-Allscripts’ large hospital/practice EHRs, now called Altera, Canadian giant Constellation Software, is also delaying its Q4/FY 2022 reporting, in this instance due to the Altera acquisition [TTA 15 Feb]. Veradigm’s release gives you the more complicated explanation.
Walmart Health’s Big Announcement is that it will be doubling the number of its Health Centers from the current 32 to over 75. By Q1 2024, Walmart’s plan is to open 28 new locations in the following metros: Dallas (10), Houston (8), Phoenix (6) and Kansas City MO (4). Missouri and Arizona are new states. All these will include the Epic EHR and the infrastructure improvements previewed earlier this week [TTA 1 Mar]. Release
Insurtech Bright Health may have a dim future. 18 months ago, Bright Health seemed to be the most promising insurtech out there, with a healthy Medicare Advantage plan base, family and individual plans, substantial growth, acquisitions of Zipnosis (‘white label’ telehealth triage for health systems) and development of the NeueHealth value-based care provider management network. Bright Health had a buttoned-up management team from UnitedHealth Group, investment groups, Target, CVS, and the Advisory Board. They raised $2.4 billion from prestige investors, including Cigna Ventures and Bessemer, went public on the NYSE in June 2021, and added $925 million in two post-IPO raises in December 2021 and October 2022 (Crunchbase). Fellow insurtechs Oscar and Clover struggled through their own financial and management challenges after an IPO and SPAC respectively. Oscar was sued last year by shareholders for misleading information; Clover lost $558 million in 2021, but reduced to $338.8 million in 2022 and promising a path to profitability. Healthcare Finance.
Bright Health now appears to be a broken-bulb-filament away from default and bankruptcy. They ended 2021 with a $1.2 billion loss which is not unusual with companies of this type (see above). Bright exited individual and family plans in six states plus cut back MA expansion plans, also not atypical. Healthcare Finance This didn’t appear to help. By last December, their stock declined to below $1 triggering a notice of delisting from the NYSE if it’s not above $1 by May. The stock continues to trade below $0.50. They reported a 2022 loss of $1.4 billion, $0.2 billion up from 2021, on increased revenue. This week, it’s been reported they have told investors that they are facing credit insolvency, having run through $350 million in revolving credit, violated a liquidity covenant, and need $300 million to cover it by end of April. Further analysis in FierceHealthcare and on an interesting LinkedIn post by Ari Gottlieb, ‘Pay for Failure’.
And if there weren’t enough proof that the High Wide and Handsome Days Are Over, the Department of Justice (DOJ) indicted CEO Terren Peizer of Ontrak, a telemental health provider, with insider trading using Rule 10b5-1 trading plans. This rule was actually set up by the SEC to allow insiders to safely trade their shares by setting up a predetermined plan that specifies in advance the share price, amount, and transaction date, plus certifying that they are not aware of non-public information that can influence the price. The last is the rub. DOJ alleges that during mid-year 2021, Peizer was aware that the largest Ontrak customer, Cigna, was at high risk of departing on the heels of Aetna, and sold his stock. If convicted, Peizer may be facing up to 45 years in Club Fed plus disgorgement of funds. Ontrak trades on Nasdaq, today at about $0.60. FierceHealthcare