Weekend short takes: May telehealth claims up to 5.4%; three health plan breaches, one at its law firm–affecting over 400,000 patients; layoffs hit Calm, Truepill (updated)

FAIR Health’s telehealth claims took two bumps up in both April and May. In April, telehealth medical claims moved slightly upward to 4.9% from March’s 4.6%, but May increased 10% to 5.4%, a percentage not seen since May 2021. Mental health conditions still make up the vast bulk of claims at 62.8%, but 3.6% of telehealth claims involve COVID-19 diagnoses, with 3.2% of claims for respiratory diseases and infections. This is attributed to a regional increase in the Southern and Western states of the latest variants of COVID-19. FAIR Health monthly tracker main page

Priority Health, a Michigan-based nonprofit health plan company, was breached through its law firm Warner Norcross & Judd (WNJ). The October 2021 breach at WNJ wasn’t reported to Priority Health until 6 June. The unauthorized party potentially accessed first and last names, pharmacy and claim information, drug names, and prescription dates from certain prescriptions filled in 2012. 120,000 members were affected. What the information was doing at the plan’s law firm was not disclosed. Priority Health is Michigan’s second-largest plan with over one million members.

In other breaches, Texas-based Behavioral Health Group (BHG), had a data incident that affected 197,507 individuals. The unauthorized party had potentially removed certain files and folders from portions of its network on 5 December 2021.  The files include names, Social Security numbers, driver’s license numbers, financial account information, biometrics, medication information, medical record numbers, dates of service, passports, payment card information, and health insurance information. However, the information accessed doesn’t appear to have been misused.

First Choice Community Healthcare in Albuquerque, New Mexico, also had a data security incident that involved 101,541 patients. The PHI in the 27 March breach included names, Social Security numbers, patient ID numbers, medications, dates of service, diagnosis and treatment information, birth dates, health insurance information, medical record numbers, patient account numbers, and provider information. Again, there appears to be no misuse to date. HealthITSecurity

More health tech companies lay off staff.

  • Calm, one of those incessantly advertised (in US) meditation apps, is discharging 20% (90) staffers, at least 12 in marketing, according to a report in the Wall Street Journal (may be paywalled). From this Editor’s LinkedIn post in response to early reports:
    • Calm was strategically ‘off’ in spending. They overspent on direct to consumer–expensive TV spots on major networks and sponsorships, paid social and search. If you wanted Calm’s full features, you paid for them. Expensive meditation apps are merely a “nice to have” and there are a bunch of free ones available. 
    • There’s also too much app overlap and mistargeting out there. Calm was trying to sell the app to businesses as a benefit (ROTFL) but was hedging its bets with buying Ripple, which designs apps for care coordination and condition management (another crowded area).
    • Another sign–new sole CEO named this summer. Now sole CEO David Ko came from Ripple and the two Calm founders moved over to co-chair roles.
    • This is a company that raised well north of $200 million to become a $2 billion unicorn as early as 2019, another sign of too much cash, too soon, and VCs/equity investors following the fad. ‘Mindfulness’ became a fad as early as 2018.
  • Truepill is up to its third layoff–33% or 175 staff, including all UK staff plus much of the product and data teams.  Their cutbacks relate to multiple failures, the first in betting on ADHD controlled substances, the second in blowing through vast amounts of funding but unable to obtain more (a Series D of $142 million but unable to float a Series E). Truepill’s ADHD med bet fell apart with its relationship with Cerebral, now under Federal investigation [TTA 16 June]. As early as May, Truepill, Cerebral’s primary mail order provider, had stopped filling their prescriptions for Schedule 2 medications [TTA 1 June]. This follows on a June layoff of 15% or 150 people. Truepill had also expanded into telehealth and diagnostics, two areas which will only be lightly supported going forward. TechCrunch

Week-end news roundup: Allscripts on the acquisition hunt, Amwell’s CVS telehealth deal, Cerner’s $1.8M racial discrimination settlement, predicting Parkinson’s progression via smartwatch data

Another company on the hunt for strategic buys. Health IT and EHR company Allscripts is seeking to add to its Veradigm analytics, research, and provider/payer platforms with some strategic acquisitions. Announced on its Q2 earnings call by new CEO Rick Poulton is the intent to expand the company from its current provider base into a more diverse one serving payers and life sciences. Allscripts does have some free cash–about $700 million–having recently sold its hospital and large physician practice EHRs to Constellation Software/N. Harris Group, though there were some settlements around their Practice Fusion EHR now incorporated into Veradigm [TTA 2 Apr]. With a free cash flow from continuing operations around $120 million and about 7% growth, they feel the time is here for some accretive, strategic, and proven acquisitions–at the right price. FierceHealthcare

Amwell’s Q2 earnings call also had good news for shareholders, who of late haven’t had much to cheer. CEO Ido Schoenberg, MD announced that Amwell will provide CVS Health’s Virtual Primary Care, formally launched in late May  Amwell will be providing primary, behavioral health, and chronic care management through the platform. CVS will be providing these services to Aetna fully-insured, self-insured plan sponsors, and CVS Caremark clients effective first half 2023. As this Editor wrote earlier this week, CVS Health is making no secret of its intent to expand into delivering primary care and home health. One way Virtual Primary Care will be leveraged is converting in-store health services to virtual, such as non-emergency treatment and nutrition/wellness programs. CVS is even dabbling into blockchain with downloadable non-fungible tokens (NFTs) for virtual services. HealthcareFinance 

Cerner, on the other hand, is paying out $1.8 million to settle a racial discrimination lawsuit brought by the US Department of Labor. As a Federal contractor, Cerner went under review by the Office of Federal Contract Compliance Programs. That office alleged that Cerner systematically discriminated against qualified Black and Asian applicants who applied for positions at five facilities in Missouri and Kansas between 2015 and 2019. Cerner agreed to pay $1,860,000 in back pay and interest to 1,870 applicants in areas such as medical billing, system engineers and technical solution analysts. Certainly Oracle wanted to get this off the plate before the cutover on 1 October. HealthcareFinance, Department of Labor release

Can enough data collected build a predictive model for the progression of  Parkinson’s? Koneksa, a digital biomarker builder, is working with the Michael J. Fox Foundation for Parkinson’s Research to build a predictive model on how Parkinson’s will progress over time in an individual. The Fox Foundation already has a database to analyze — the Parkinson’s Progression Markers Initiative, launched in 2010, with health information and biosamples from Parkinson’s patients. Added to this will be data from Verily’s smartwatch:  activity tracking, gait analysis, and sleep cycles, which will be analyzed using Koneksa’s algorithms and additional machine learning. The award by the Fox Foundation was not disclosed, but it is the second for Koneksa after another grant awarded in mid-June to analyze vocal abnormalities relating to early progression of the disease, in conjunction with Northwestern University. FierceHealthcare

Mid-week news roundup (updated 18 Aug): CVS eyeing Signify Health for in-home/VBC; Babylon Health mixed pic of revenue and losses up; Geisinger doubles telemed specialties; connected IoT devices expand cyber-insecurity (more); Owlet layoffs

CVS has dropped another sandal as to their quest to add primary care and home health to their portfolio [TTA 5 Aug]. Reports indicates that CVS Health is bidding to acquire Signify Health, which is up for sale. Signify is best known as a major provider of in-home health care in both evaluations and community-based services, with users such as health plans, health systems, community groups, non-profits, and government. In March, they added provider value-based care with Caravan Health, a mid-sized Accountable Care Organization (ACO) management service organization (MSO), for $250 million.  This would give CVS both leverage in in-home care and access to value-based care models in health systems and practices, adding a network of jumbo (100,000 lives+) ACOs to Aetna’s 500 ACOs.

Signify did take a bit of a bath with its acquisition/merger of Remedy Partners in 2019 which marked their entry into the Federal shared savings programs around Episodes of Care. While it created a $600 million company. Remedy’s Episodes of Care in the CMS Bundled Payments for Care Improvement (BPCI) program was always problematic for Signify on multiple levels (Editor’s experience). Signify announced its exit from the successor BPCI-A (Advanced) model last month to concentrate on home care and the Caravan business. The wind-down, which will take some time as these are Federal programs through CMS, will save Signify about $115-120 million in costs, compared to their annual direct and shared costs of $145 million. Restructuring costs such as severance may be only $35 million. After IPO-ing in February 2021 at $24 per share, it has only recently climbed to $23, having recently hit a 52-week low of $10.70. FierceHealthcare, HealthcareFinanceNews

Updated Perhaps in preparation for acquisition, Signify Health is shedding 489 people starting 1 October, including 45 in Connecticut, with the remainder in Texas, South Dakota, and New York. The information comes from required notices to the Connecticut Department of Labor. The majority of employees affected are remote workers. It appears to be related to Signify’s winding up of BPCI and Episodes of Care activity which are likely on calendar year contracts. The legacy company, Remedy Partners, had been headquartered in Connecticut with staff in New York. Moving forward with layoffs now makes the company more attractive for sale, as the separation expenses will not be an acquiring company liability. The 1 October start date is also a tell.  CT Insider, Becker’s

A mixed picture for Babylon Health. Its Q2 results were up substantially in revenue–4.6x year-over-year from $57.5 million to $265.4 million–along with key indicators such as US members up 220% and a 7.5% improvement in medical margins over three quarters. The US has been very very good to Babylon with value-based care membership growing 3.2x year-on-year to a total of approximately 269,000 US VBC members with 40% of its VBC revenue from Medicare contracts. However, losses are up along with growth–$157.1 million compared to $64.9 million loss PY. Babylon at end of July announced worldwide layoffs of at least 100 people of its current 2,500 in their bid to save $100 million in Q3. Babylon release, Mobihealthnews

Geisinger Health was one of the pioneers in telehealth and remote patient monitoring, from ur-days in the early 2010s to today. Much of its patient base in Pennsylvania is rural or semi-rural, living well away from care centers, with a clinician base equally scattered. They went with a single system–Teladoc–integrated into Epic. By the early days of the pandemic, Geisinger was able to expand their telehealth coverage from 20 to more than 70 specialties, 200 providers to more than 2,000 providers, and over two years (2020-2022) completing over 784,000 telehealth visits to homes, local clinics, or local hospitals. Case study in HealthcareITNews

If you’re a health system CIO managing lots of connected devices, you may need to go to a psychiatrist with your feelings of insecurity. That’s the gist of a new report, the Insecurity of Connected Devices in Healthcare 2022. A new-to-this-Editor cybersecurity firm, Cynerio, partnered with researchers at the Ponemon Institute to survey 517 executives at US health systems to find that their Internet of Medical Things (IoMT)/Internet of Things (IoT) vulnerabilities haven’t changed much since this Editor banged the gong about them well before the pandemic:

  • Cyberattacks–frequent: 56% of respondents experienced 1+ cyberattacks in the past 24 months involving IoMT/IoT devices; 58% averaged 9+ cyberattacks. Adverse impacts on patient care were reported by 45% and 53% of those resulted in increased mortality rates. 24% of hospitals noted an impact on their mortality rates.
  • Data breaches are routine: 43% of hospitals had one in the past two years
  • Risks may be high, but the reaction is sluggish: 71% rated security risks as high or very high, but only 21% report a mature stage of proactive security actions. 46% performed accepted procedures such as scanning for devices, but only 33% keep inventory.
  • Ka-ching! Goes the ransomware! When attacked, 47% paid the ransom, and 32% were in the $250-500,000 range.

The full report is available for download here. Those who prefer a webinar must wait till 17 August at 2pm (EDT)–registration hereCynerio release, HealthcareITNews

Updated. Having sat in on the webinar, some further information points from the Ponemon survey deepen the ‘gravity of the risk’:

  • IoT is different because a hack or cyberransoming prevents the device from working. It isn’t fixed by backup as data can be.
  • Health systems are still using IoT computer systems running Windows XT/95–and earlier (!)
  • The average total cost of the largest data breaches is $13 million–the most common cost is in the $1-5 million range. 
  • 88% of these data breaches involved at least one IoT/MT device
  • Risks are known, but action is lagging. 72% of health organizations report a high level of urgency in securing devices–yet 67% of organizations do not keep an inventory of IoT/IoMT devices that they scan
  • 79% don’t consider their activities to be ‘mature’
  • Security investment doesn’t reflect the gravity of the risk–only 3.4% of IT budgets focus on IoT/MT device security.

And in sad layoff news, Owlet Baby Care is shedding an unknown number of employees. Here is the notice on LinkedIn. We noted their FDA problems and a fast pivot last in February, but their going public via a SPAC has been rocky at best with shares lingering at $2 from the IPO at $8. Marketing a pricey baby monitor direct to consumer is expensive, even if it meets a need, and this is likely a cash crunch. At least the ‘leader of people & culture’ is giving them a proper sendoff of thanks–and more usefully, providing their contact information for potential job openings with other companies.

[This is in contrast to the gone-viral spectacle of the CEO of something called HyperSocial posting on LinkedIn his angst about laying off staff–along with a selfie of him weeping. Not exactly confidence-making and All About Him. This Editor’s comment is one of 6,000-odd posts which are largely doubtful to negative.]

Oracle’s Big Vision will be missing a lot of people; layoffs hit Cerner, customer experience, marketing staff

‘Healthcare Transformation’ will ring hollow for the many employees at Oracle and Cerner who will be getting 60-day notices — or less — to depart.

One group is within Oracle in the US customer experience division and marketing, and apparently more. According to Bloomberg, the customer experience area that provides analytics and advertising services had been lagging for some time and has been reorganized, losing in the process junior sales employees, a division sales director, and marketing positions. Numbers are not provided, nor information on severance. Also Becker’s.

On the Oracle thread on TheLayoff.com, Oracle Cloud Infrastructure (OCI) North America has been substantially downsized effective 15 August, especially those supporting a Startups product. 

More extensive are the Cerner cuts. This Editor has been following postings as they happen on both the Reddit r/cernercorporation and TheLayoff threads (Oracle thread here). Areas mentioned appear to be primarily internal/non-customer facing: technical project management in population health, enterprise change management, enterprise process improvement, multiple VPs, sales engineers, application services/support, marketing (of course), talent acquisition, and other areas. People ranged from new hires who had offers pulled, to those under one year, to highly experienced employees with a decade or two in the company. UK tech site The Register has an estimate from one posting of 10,000 layoffs. Given that Cerner has about 20,000 employees, that is close to 50%.

As is typical of mass layoffs, those at Cerner reported that they were notified en masse by managers on Monday through snap meetings. Their packages were cleverly designed to skate through the 60-day WARN notice to the state in the US, providing for an end date in 60 days, just before the official cutover to Oracle on 1 October. Severance packages without insurance or benefits after the 60 days were two weeks for every year at Cerner, not particularly generous given the uncertain economy and freezes all over tech. If the individual sought and was offered a position at Oracle, the severance package would be pulled, which is the usual maneuver to discourage any internal job-seeking from this group.

There is no indication of any cuts to Cerner outside the US, yet. The Independent, citing The Information, indicated that further Oracle cuts may come from Canada, India, and Europe. Oracle has a goal of saving $1 billion.

In this Editor’s view, Oracle is erasing Cerner as fast as it can [TTA 19 July] and doing internal housecleaning (bloodletting) at the same time. As to the former, Mike Sicilia’s testimony to the Senate committee about Cerner at the VA [TTA 28 July] had a distinct tone of cleaning up the previous regime’s mess–this should be no surprise. Yet Cerner’s tippy-top management remains in place, with generous compensation and separation arrangements in place [TTA 19 July with links to prior articles]. Cerner’s healthcare customers should take note, either way.

Having been there and done that more than once, our best wishes to everyone affected. Remember that you are not your job, pack up your learnings in your kit bag for a new journey, and you will land a good job soon.

Hat tip to HISTalk as well for covering this story and reaching many on the provider and partner side in the industry that we do not.

Week-end roundup of not-good news: Teladoc’s Q2 $3B net loss, shares down 24%; Humana, Centene, Molina reorg and downscale; layoffs at Included Health, Capsule, Noom, Kry/Livi, Babylon Health, more (updated)

Teladoc continues to be buffeted by wake turbulence from the Livongo acquisition. The company took a $3 billion goodwill impairment charge in Q2, adding to the $6.3 billion impairment charge in Q1. The total impairment of $9.3 billion was the bulk of the first half loss of nearly $10 billion. While their revenue of $592.4 million exceeded analyst projections of $588 million, adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of $46.7 million were barely up from projections and were down from $66.8 million year prior. Losses per share mounted to $19.22, versus $0.86 in Q2 2021.

Another weak spot is their online therapy service, BetterHelp, which in the US is pursuing a substantial TV campaign. CEO Jason Gorevic in the earnings release pointed out competitors buying the business at low margins and consumer spending pullbacks. Teladoc’s forward projections are bolstered by Primary360 and Chronic Care Complete. Projected revenue for Q3 is $600 million to $620 million. Shares on Thursday took a 24% hit, adding to the over 50% YTD drop misery. At best, Teladoc will muddle through the remainder of the year, if they are lucky. MarketWatch, Mobihealthnews, FierceHealthcare

Health plans are also presenting a mixed picture. 

  • Humana announced a healthy earnings picture for the quarter and YTD. It earned $696 million in profit for Q2, up nearly 20% year over year. For first half, Humana earned $1.6 billion, an increase of 14.8% from 2021’s $1.4 billion. Cited were growth in their primary care clinics, Medicaid membership, and investment in Medicare Advantage. Earnings surpassed Wall Street projections and Humana increased its guidance to $24.75 in earnings per share. At the same time, they announced a reorganization of its operating units that separates their insurance services (retail health plans and related) and CenterWell for healthcare services including home health. Some key executives will be departing, including the current head of retail health plans who will stay until early 2023, ending a 30 year Humana career. FierceHealthcare, Healthcare Dive
  • Under new leadership, Centene posted a Q2 loss of $172 million which in reality was a significant improvement over Q2 2021’s $535 million and looked on favorably by analysts.
    • Their ‘value creation plan’ has sold off its two specialty pharmacy operations to multiple investors, using third-party vendors in future, and agreed this week to sell its international holdings in Spain and Central Europe — Ribera Salud, Torrejón Salud, and Pro Diagnostics Group — to Vivalto Santé, France’s third-largest private hospital company.
    • Medicaid, their largest business line, has been growing by 7%.
    • Centene is continuing to divest much of its considerable owned and leased real estate holdings, which marks a radical change from the former and now late CEO’s* ‘edifice complex’ to house his ‘cubie culture’. As a result, it is taking a $1.45 billion impairment charge.  Healthcare Dive. [* Michael Neidorff passed away on 7 April, after 25 years as CEO, a record which undoubtedly will never be matched at a health plan.)
    • A cloud in this picture: Centene’s important Medicare Advantage CMS Star quality ratings for 2023 will be “disappointing” which was attributed to the WellCare acquisition (accounting for most of the MA plans), two different operating models between the companies, and the sudden transition to a remote workforce. For plans, WellCare operated on a centralized model, Centene on a decentralized one, and the new management now seems to prefer the former. (Disclosure: your Editor worked over two years for WellCare in marketing, but not in MA.) Healthcare Dive
  • One of the few ‘pure’ health plans without a services division, Molina Healthcare, is also going the real estate divestment route and going full virtual for its workforce. Their real estate holdings will be scaled down by about two-thirds for both owned and leased buildings. Molina does business in 19 states and owns or leases space across the US. Net income for the second quarter increased 34% to $248 million on higher revenue of $8 billion. Healthcare Dive

Many of last year’s fast-growing health tech companies are scaling back in the past two months as fast as they grew in last year’s hothouse–and sharing the trajectory of other tech companies as well as telehealth as VCs, PEs, and shareholders are saying ‘where’s the money?’. 

  • Included Health, the virtual health company created from the merger of Grand Rounds and Doctor on Demand plus the later acquisition of care concierge Included Health, rebranding under that name, has cut staff by 6%. The two main companies continued to operate separately as their markets and accounts were very different: Grand Rounds for second opinion services for employees, and Doctor on Demand for about 3 million telehealth consults in first half 2020. As Readers know, the entire telehealth area is now settling down to a steady but not inflated level–and competition is incredibly fierce. FierceHealthcare
  • Unicorns backed by big sports figures aren’t immune either. Whoop, a Boston-based wearable fitness tech startup with a valuation of $3.6 billion, is laying off 15% of its staff. (Link above)
  • Digital pharmacy/telemedicine Capsule is releasing 13% of its over 900 member staff, putting a distinct damper on the already depressed NYC Silicon Alley.  FierceHealthcare also notes layoffs at weight loss program Calibrate (24%), the $7 billion valued Ro for telehealth for everything from hair loss to fertility (18%), Cedar in healthcare payments (24%), and constantly advertising Noom weight loss (495 people). Updated: Calibrate’s 150-person layoff was reported as particularly brutally handled with employees. Many were newly hired the previous week, given 30 minutes notice of a two-minute webinar notice, then their laptops were wiped. Given that the company makes much of its empathy in weight loss, facilitating prescription of GLP-1 along with virtual coaching, for a hefty price of course. HISTalk 8/3/22
  • Buried in their list are layoffs at Stockholm-based Kry, better known as Livi in the UK, US, and France, with 100 employees (10%).
  • Layoffs.fyi, a tracker, also lists Babylon Health as this month planning redundancies of 100 people of its current 2,500 in their bid to save $100 million in Q3. Bloomberg

Oracle’s ‘new sheriff’ moving to fix Cerner EHR implementation in the VA: the Senate hearing

Last week’s (20 July) hearing on the VA’s increasingly wobbly EHR transition from VistA to Cerner showcased Oracle’s executive vice president for industries Mike Sicilia. His testimony to the Senate Committee on Veterans’ Affairs had a heaping helping of ‘the new sheriff has arrived in Dodge City’.  As of six weeks ago, after the Transformational Big Vision kvelling faded, Cerner’s painful stumbles became Oracle’s VA Migraine [TTA 21 July, 21 June]. Cerner is now part of the Oracle Global Health business unit that falls under him.

First, the pledge made in his statement: “Unlike Cerner alone, Oracle brings an order of magnitude more engineering resources and scale to this formidable challenge.” After outlining the work that Oracle has done for CDC and NIH on Covid-19, he testified:

You should consider that in effect the VA, the Department of Defense (DoD) and the Coast Guard obtained a new, vastly more resourced technology partner overnight to augment Cerner. We also strongly believe in this mission and consider it not only a contractual obligation but a moral one to improve healthcare for our nation’s veterans and their caregivers. We intend to exceed expectations. 

Of the list of 36 issues detailed by the committee to VA Deputy Secretary Remy, Sicilia condensed them into three main areas: performance, design, and functionality. The concrete moves are:

  • Oracle will move the implementation to the cloud and rewrite Cerner’s pharmacy module, completing both tasks within 6-9 months
  • They have set up a ‘war room’ consisting of Oracle’s top talent of senior engineers and developers, working on the entire DoD/VA EHR systems as priority #1, with the first order of work a top-to-bottom analysis. While integrating with the Cerner team, the statement makes it clear that Oracle “brings an order of magnitude larger engineering team than Cerner”.
  • The Cerner EHR system is currently running on a dated architecture with technology that is in some cases two decades old and thus will be moved within 6-9 months to Oracle’s Generation 2 cloud. (That must be reassuring to thousands of hospitals and practices!)
  • Shortly after the closing, Oracle fixed a database bug that caused 13 of the last 15 outages, and as of last week there were no further outages. 
  • Testifying on the status of the “unknown queue”,  he stated it was designed to account for human error rather than to mitigate it, so it will be redesigned–it will be automated more on the front end and on the back end will have a better process.
  • Oracle will “start over” with the Cerner pharmacy module, rebuilding it as a showcase of a cloud-optimized web application.

VA’s EHR leaders also testified at the Senate hearing. Terry Adirim, Executive Director of the Electronic Health Record Modernization Integration Office at the VA, confirmed that unsurprisingly, Cerner’s next rollouts scheduled for the Boise VA Medical Center and other centers have been postponed indefinitely due to multiple ongoing system stability issues: change control and testing; challenges with increased capacity; basic functionality; its resilience design, and its response in last resort disaster situations. These specific issues overlapped but were more specific than those covered in Sicilia’s statement, which focused on the actions that Oracle would take.

Adirim and Kurt DelBene, the VA’s CIO, were roasted by the senators as painting a “very rosy picture”. The OIG report itemized at least 60 recommendations before going further. Adirim, to his credit, noted that DoD had similar stability issues in its system which was a warning, but the VA’s system is far more complex and care oriented than DoD which presumably exacerbated those issues. FedScoop and especially HISTalk’s Monday Morning Update 7/25/22

Amazon moves to acquire One Medical provider network for $3.9B (updated)

Amazon joining the in-person provider network space for real. Amazon Health Services last week moved beyond experimenting with in-person care via provider agreements (Crossover Health, TTA 17 May) to being in the provider business with an agreement to acquire One Medical. Earlier this month, news leaked that One Medical as 1Life Healthcare was up for sale to the right buyer, having spurned CVS, and after watching their stock on Nasdaq plummet 75%.

  • The cash deal for $3.9 billion including assumption of debt is certainly a good one, representing $18 per share, a premium to their $14 share IPO in January 2020. (The stock closed last Wednesday before the announcement at just above $10 per share then plumped to ~$17 where it remains.)
  • The announcement is oddly not on One Medical’s website but is on Amazon’s here.
  • The buy is subject to shareholder and the usual regulatory approvals. The IPO was managed by JP Morgan Securities and Morgan Stanley. It is primarily backed by Alphabet (Google).
  • One Medical’s CEO Amir Dan Rubin will stay on, but there is no other executive transition mention.
  • Also not mentioned: the Iora Health operation that serves primarily Medicare patients in full-risk value-based care models such as Medicare Advantage (MA) and Medicare shared savings, quite opposite to One Medical’s membership-based concierge model. However, Iora’s website is largely cut over to One Medical’s identity and their coverage is limited to seven states.

There is a huge amount of opinion on the buy, but for this Editor it is clear that Amazon with One Medical is buying itself into in-person and virtual primary care for the employer market, where it had limited success with its present largely virtual offering, and entree with commercial plans and MA. One Medical has over 700,000 patients, 8,000 company clients and has 125 physical offices in 12 major US markets including NYC, Los Angeles, Boston, and Atlanta. It has never turned a profit. Looking at their website, they welcome primarily commercial plans and MA (but not Medicare supplement plans).

Amazon, with both a virtual plus provider network, now has a huge advantage over Teladoc and Amwell, both of which have previously brushed off Amazon as a threat to their business. There is the potential to run two models: the current Amazon Care pay-as-you-go model and the One Medical corporate/concierge model. This puts Amazon squarely in UHC’s Optum Health territory, which owns or has agreements with over 5% of US primary care practices, is fully in value-based care models such as Medicare shared savings through its ACOs, and is aggressively virtual plus integrating services such as data analytics, pharmacy, and financial. Becker’s

What doesn’t quite fit is Iora Health and the higher cost/higher care needs Medicare market that is less profitable and requires advanced risk management, a skill set that Amazon doesn’t have. This Editor will make a small prediction that Iora will be sold or spun off after the sale.

This Editor continues to believe that the real game for Amazon is monetizing patient data. That has gained traction since we opined that was the real Amazon Game in June and October last year, To restate it: Amazon Care’s structure, offerings, cheap pricing, feeds our opinion that Amazon’s real aim is to accumulate and own national healthcare data on the service’s users. Then they will monetize it by selling it to pharmaceutical companies, payers, developers, and other commercial third parties in and ex-US. Patients may want to think twice. This opinion is now shared by those with bigger voices, such as the American Economic Liberties Project. In their statement, they urged that the government block the buy due to Amazon’s cavalier attitudes towards customer data and far too much internal access, unsecured, to customer information (Revealnews.org from Wired). Adding PHI to this is like putting gasoline on a raging fire, and One Medical customers are apparently concerned. For what it’s worth, Senator Bernie Sanders has already tweeted against it.   MarketWatch

Whether this current administration and the DOJ will actually care about PHI and patient privacy is anyone’s guess, but TTA has noted that Amazon months ago beefed up its DC lobbying presence last year. According to Opensecrets.org, they spent $19.3 million last year. In fairness, Amazon is a leading Federal service provider, via Amazon Web Services. (Did you know that AWS stores the CIA’s information?)  One Medical is also relatively small–not a Village MD/Village Medical, now majority owned by Walgreens Boots. This is why this Editor believes that HHS, DOJ, and FTC will give it a pass, unlike UHG’s acquisition of Change Healthcare, especially if Amazon agrees to divest itself of the Iora Health business.

Treat yourself to the speculation, including that it will be added as an Amazon Prime benefit to the 44% of Americans who actually spend for an Amazon Prime membership. It may very well change part of the delivery model for primary care, and force other traditional providers to provide more integrated care, which is as old as Kaiser and Geisinger. It may demolish telehealth providers like Teladoc and Amwell. But as we’ve also noted, Amazon, like founder Jeff Bezos, deflects and veils its intents very well. FierceHealthcare 7/25, FierceHealthcare 7/21, Motley Fool, Healthcare Dive

Midweek heat wave roundup: GE Healthcare’s new name, hospital-to-home health trending big, over 2 million patient records hacked

GE’s breakup into three public companies, announced last November [TTA 12 Nov 21], has been formalized with brand names. No surprise, the healthcare business has but a teeny tiny change to GE HealthCare (logo left) and after the spinoff will be trading sometime in early 2023 under GEHC on Nasdaq because “GE HealthCare will benefit from the exchange’s profile and track record as a market for innovative, technology-led public companies, particularly in the healthcare sector. The heritage ‘meatball’ (as we called it in marketing internally, but formally the Monogram) will be retained but the color will change from poison green to “compassion purple” to reflect more humanity and warmth and achieve greater distinction”. The hardest hit part of GE, the energy businesses, will be spun off as GE Vernova and key color an ‘evergreen’. What is left will be GE Aerospace, retaining its name and change its color to an ‘upper atmosphere’ blue that is almost black. Outer space, anyone? GE release, interview on YouTube

Au courant is hospital-to-home (H2H) and home health, digitally enabled mais bien sûr.

  • Mass General Brigham (MGB) is reportedly expanding its current 25-bed program to 200 in the next 2.5 years. Since 2016, MGB has treated nearly 1,800 H2H patients. By end of 2023, they plan 90 hospital-at-home beds managed across Massachusetts General Hospital, Brigham and Women’s Hospital, Newton-Wellesley Hospital, and Salem Hospital. Their new head for home-based care will be Heather O’Sullivan, who comes from EVP and chief clinical innovation officer spots at Kindred at Home, acquired by Humana in 2021. FierceHealthcare
  • Out in rural Wisconsin, Marshfield Clinic is rolling out a H2H program with DispatchHealth, to coordinate medical care for injuries and illnesses including viral infections, COPD exacerbations, congestive heart failure, and more. The goal is to reduce non-emergency ED visits. DispatchHealth can also perform services such as onsite diagnostics, mobile imaging, and CLIA-certified labs for kidney function, electrolytes, and urinalysis. In March 2021, they closed a $200 million Series D bringing their funding to unicorn level. HealthcareITNews
  • UHG’s Optum has moved closer on its $5.5 billion acquisition of LHC Group home health and hospice [TTA 31 Mar] with shareholder approval on 21 June. Once closed later this year, LHC will be integrated into Optum Health. LHC operates in 37 states and the District of Columbia, employing about 30,000 individuals. Home Health Care News, Becker’s

And what would a week with a heat wave that melts runways at RAF Brize Norton and Luton be without a couple of big data breaches to heat up things? Stolen: an iPad chock full of 75,000 Kaiser Permanente patients’ PHI from Kaiser’s Los Angeles Medical Center’s COVID-19 testing center. While the information on the iPad included first and last names, dates of birth, medical record numbers, and dates and location of service (but not SSN or financial information), Kaiser was able to remotely erase the data. At this point, there is no evidence of theft or misuse. NBC Los Angeles, Becker’s   An even larger breach of 2 million records came via a February hack attack on health provider debt collector Professional Finance Company (PFC). Hackers got into PFC’s computers and accessed patient names, addresses, SSN, health insurance, and medical treatment data. Among the 650 client companies affected were Banner Health and Nevada physician network Renown Health. Healthcare Dive

Cerner’s business now consolidated under Oracle Health

The internal memo doesn’t say so but doesn’t really have to. The sunsetting of the Cerner brand (logo left) has begun. HISTalk this evening reported on Friday 15 July’s Cerner internal announcement posted on Reddit, vetted by the Kansas City Business Journal (paywalled), and it’s not all that surprising:

  • The business unit is now called Oracle Health Global Industry Unit (GIU) or Oracle Health
  • The chairman of Oracle Health will be David Feinberg, MD, late CEO of Cerner and previously of UCLA Health, Geisinger Health, and Google’s last effort at Health. 
  • Travis Dalton is being promoted to run the Oracle Health GIU as General Manager from running Cerner Government Services as Client Services Officer
  • Cerner’s engineering and product executives will be reporting to Oracle’s Don Johnson who runs all Oracle engineering for all applications and platform services. This includes former CTO Jerome Labat who received a stay deal along with Dr. Feinberg [TTA 21 Jan, 26 Jan]. Mr. Labat has at least 11 million good reasons (and Dr. Feinberg 22 million) to stay for the next year and a day from the closing on 8 June.
  • Cerner’s corporate functions, such as IT, finance, legal, and HR, will move into Oracle’s centralized, global teams, which typically means that pink slips will be the order of the day if they haven’t already been received
  • More disclosed to employees at a town hall on that Friday 
  • No external announcement has been made as of 1845 19 July (Eastern Time)

Our Readers who have been following the acquisition and personally been through acquisitions know the stage was set by Larry Ellison’s Big Pronouncements on Healthcare Transformation at the closing [TTA 14 June]. It was all about what Oracle would be doing in building a national health record database and more, with nary a mention of Cerner. The eventual elimination of the Cerner name should thus be no surprise to industry observers. Cerner was a pearl bought at a great price ($28 billion) to make Oracle the Visionary Leader In Healthcare and provide Mr. Ellison with a Grand Finale.

How this will be received by health system and provider customers–including DOD and the ever-troublesome VA–is anyone’s guess. This Editor has previously speculated that health systems with Cerner EHRs were not going to be enthusiastic about replacing Cerner’s current third-party vendors with Oracle services and technology, especially if they worked well or if Oracle costs more. If the move to OCI–Oracle Cloud Infrastructure–doesn’t go as smooth as brand new glass, another black mark in the copybook. The other would be resentment of Oracle’s announced and completely expected hard sell on other services to make up the cost of the pearl. [TTA 15 June]

Almost an ideal scenario for Epic to sell against, one would think. As for the VA, Oracle needs to fix the Cerner Millenium rollout now under heavy scrutiny–fast and right.  

Weekend reading roundup: Amwell’s Schoenberg opines to Politico; Teladoc’s new CMO also opines, SPACs are done, done, done

If Teladoc’s Jason Gorevic [TTA 1 July] and new CMO Vidya Raman-Tangella (below) are suddenly available to the health press, can a Schoenberg brother be far behind? This brief Q&A with Politico is with Roy Schoenberg of Amwell and covers the state of telehealth, obstacles, abortion, consolidation, and automation. He stays pretty much on message with no surprises as the questions are short and, as is the practice, pre-submitted:

  • Telehealth is a distribution arm of healthcare, not just videoconferencing
  • The biggest war in telehealth remains state licensure–as it was pre-pandemic, past the ‘jumping in’ stage
  • Telehealth will not be a ‘pill mill’ for abortion pills (abortifacients) or controlled substances–it will be based on clinician professional judgment. (In the Editor’s opinion, this ‘hot potato’ was pre-written by the legal department.)
  • Consolidation as a question is not answered. We will see telehealth delivered by large healthcare organizations and telehealth that works with multiple brands. (What is not addressed is what telehealth services large healthcare organizations will go forward in using–the ‘high-priced spread’ of all-inclusives or the white-labels)
  • His opinion around automation is that it will be split between the camps of replacing clinicians, or augmenting them plus giving patients the opportunity to manage their health reality. (One wonders for what reality Amwell is preparing)

Teladoc’s new chief medical officer Raman-Tangella is also on the healthcare charm offensive with a Healthcare Dive interview on strategy and new products. She discusses enterprise clinical strategy and whole-person care, which echoes the Gorevic interview. There’s a diversion to ‘health equity’ which is first defined as a continuum [Editor’s term] of gathering data, taking solutions to customers, and seeking outcomes that validate the first two. She then moves on to closing care gaps through this information, especially in musculoskeletal and physical therapy, and returning to health equity, disparities and then (what we used to define as) proactive care based on all this patient information.

Forget the fork. SPACs as an IPO method are burnt and heading to the trash bin. Again [TTA 9 June] we have PrivCo’s Daily Stack addressing their demise, this time quantifying the crack of the full SPAC market (in and outside healthcare):

  • From one in 2009 to 248 in 2020
  • 2021: an estimated 50% of the total US IPO market in Q1 with 299 listings valued at $98.3 billion
  • 2022: 18 registrations this entire 2022 year and still in the process of raising $2 billion. (This Editor noted that the only healthcare SPAC apparently in progress is VSee and iDoc Telehealth with Digital Health Acquisition Corporation to close in Q3.)

As we’ve previously noted, SPACs are under attack by the SEC and by perpetual hair-on-fire for the press Senators such as  Elizabeth Warren. According to Bloomberg (sign-in needed), 30 SPACs have been called off this year. And as we’ve noted, there are healthcare SPACs like SOC Telemed which went private at a fire sale discount. Others like Owlet, Headspace, and Talkspace are struggling. Watchful eyes are on late SPACs such as Pear Therapeutics and Babylon Health. It’s a less-than-grand finale to what was touted as a low-muss way to IPO.

Thursday news roundup: RVO Health JV combines Optum-RV Health consumer health assets; Holmes sentencing for Theranos fraud delayed

Red Ventures, Optum combine consumer savings, digital health coaching, education assets into RVO Health. Quietly announced via Moody’s Investor Services (PDF) and appearing on LinkedIn, this offloads media holding company Red Ventures’ RV Health, consisting of Healthline health news/education media (Healthline, Medical News Today, Psych Central, Greatist, and Bezzy), plus the Healthgrades doctor rating, FindCare doctor locator and PlateJoy meal planner services. Optum contributes their Perks prescription savings card, Store shopping service, and coaching platforms Real Appeal, Wellness Coaching, and QuitForLife. For Red Ventures, this moves 20% of their company earnings into the JV, leaving media such as Bankrate.com and CNET. For Optum, this expands their coaching and consumer savings capabilities into an established digital audience–Red Ventures claims 100 million monthly users of its health media and other services. For Red Ventures, it opens up new solutions available through Optum’s parent, UnitedHealth Group.

According to Moody’s analysts, this is part of Red Ventures’ de-leveraging: “Under the terms of the JV arrangement, in exchange for the contributed assets, RV received cash proceeds, which were used to pay down the term loan. UHG will consolidate the financials of RVO Health in its future financial statements.” Based on LinkedIn, it will be located in Charlotte, North Carolina. Unannounced is who will be managing RVO Health.  FierceHealthcare, Becker’s 

Ironically, Healthline Media’ main competitor, WebMD, bought the former data analytics part of Healthgrades, Mercury Healthcare, on 29 June (release).

Elizabeth Holmes gets a three-week extension on her freedom. Her sentencing, originally scheduled for 26 September at the US District Court, Northern District of California, in San Jose has been moved to 17 October. No reason was given by the court for the extension. Judge Edward Davila will be presiding over the sentencing on four of the original 11 Theranos wire fraud charges [TTA 4 Jan]. Each one of these charges carries a penalty of up to 20 years, but generally in financial fraud, sentences are carried out concurrently. Judge Davila, known as a tough sentencer according to the Mercury News (mercifully not paywalled) may be considering factors such as that Holmes was, after all the founder and CEO but that Theranos did not start as a scam, proceeding to fraud when the technology was oversold and financially started to go under; and that she is a mother of a child not yet out of diapers. (This Editor will add the smoke around Sunny Balwani’s emotional abuse.) She will also be in a Federal facility for women likely located not far from San Jose. It is expected that she will appeal the verdicts and the sentences.

There is also the Balwani Factor. Sunny Balwani was convicted on 12 wire fraud charges and as Theranos’ president, was depicted as the ‘enforcer’. That book, when thrown after Holmes’ sentencing, will not be a paperback. Although he will want to stock up on reading for his expected long stay in Club Fed. Also CBS News.

The clunk continues: Q2 2022 digital health funding fades to $4.1B in Q2, down 50% from 2021

Digital health funding continues to take a plunge. Knocked about by the hangover from the pandemic, a grinding war between Russia and Ukraine, gasoline prices jacked up worldwide, and knock-on inflation and looming stagflation, funding continues to slide. The decline in Q2 digital health deals and funding to $4.1 billion more truly reflects the downturn than Q1’s relatively buoyant $6.1 billion, which benefited from the carryover of deals negotiated during 2021’s boom and closing then [TTA 6 April]. Year over year, it was half of 2021’s high of $8.3 billion.

  • 2022’s first half (H1) total of $10.3 billion was down 31% from 2021’s $15 billion. Despite this, it is 63% above the pandemic-stricken 2020’s H1 $6.3 billion. 
  • Average deal size has dropped to $31.2 million from 2021’s full-year $39.5 million and even 2020’s $30.6 million, accounting for inflation in the past two years. Looking at funding size by series year over year, Series A funding is flat but funding for Series B, C, and D+ have dropped substantially.
  • No startups went public but four digital health companies announced plans to go public or were reported to be planning public exits. One SPAC was announced in June to close in Q3, that of VSee and iDoc Telehealth with Digital Health Acquisition Corporation. SPACs, as this Editor has noted, have gone from Funding Hero to Zero under 2022’s economics, causing many SPACs to crack (Owlet, Talkspace) and increased scrutiny by the Feds [TTA 9 June]. SOC Telehealth, an early SPAC, went private after a 90% share price drop [TTA 8 Feb].
  • Average monthly M&A has dropped substantially. 2021’s monthly average of 23 has dropped to 20 in Q1 and 13 in Q2, for a H1 average of 16.
  • Most popular funding areas are mental health (a far ahead #1 at $1.3 billion), oncology, and cardiovascular. Diabetes dropped from #2 to #4, skewed last year by Teladoc’s acquisition of Livongo. Oncology rose to #2 from #6 in 2021. For mental health, given increased Federal scrutiny and legal problems of companies like Cerebral plus the expansion of Teladoc and Amwell into the area, this Editor does not expect telemental health companies to continue to attract this level of funding but may be attractive for M&A.
  • Disease monitoring (a/k/a RPM) as a value proposition moved from #8 to #3 in investment at $1.4 billion. R&D and on-demand healthcare remained in their #1 and #2 positions.

As TTA has noted previously, this was all to be expected. Will 2022 funding perk up like 2020’s did through Q3 and Q4, or fall off like in 2019 as money sits on the sidelines? Rock Health does try to put a rosier shine on the retrenchment in its roundup, as has venture capital–reality can be good for you. Another depressive factor is regulatory uncertainty in multiple areas and Federal involvement, which some companies can work to their advantage. The Rock Health summary discusses this at length. Also Mobihealthnews

Verdict Balwani: guilty on all 12 Theranos fraud charges

Breaking. A not-so-bright day for Sunny Balwani in the US District Court, Northern District of California, in San Jose. Today, after five days of deliberations, the jury returned verdicts on the ‘summer rerun’ of the two Theranos trials, that of former president Ramesh ‘Sunny’ Balwani. Unlike CEO Elizabeth Holmes, Balwani was found guilty of all 12 criminal fraud charges.

Each of the 10 wire fraud counts carries a maximum of 20 years imprisonment in Federal prison, plus a $250,000 fine and restitution on each count. The two additional conspiracy to commit wire fraud charges carry five years each. No date has been set yet for sentencing by Judge Edward Davila, who will be sentencing Holmes in September on her conviction on four of 11 counts and a possible 20 years as a member of Club Fed.

The trial called 24 witnesses, most of whom testified in the Holmes trial. The prosecution’s case centered on Balwani’s responsibilities in defrauding investors on the Theranos technology in order to get funding and placement in Safeway and Walgreens, as well as his knowledge that the labs didn’t work. The defense, calling only two witnesses, maintained that Balwani was a true believer in the technology, that the prosecution’s case was incomplete, he had no intent to defraud, and lost millions in direct investment and in shares. 

It is expected that Balwani will appeal the verdict. Undoubtedly, more details to come. Mercury News (mercifully, not paywalled), CNBC, KTVU2

Thursday news roundup: IBM Watson Health sale closed, now Merative; OneMedical inviting buyers–maybe; worst healthcare data breaches rounded up

It’s a post-Independence Day and early summer holiday relatively quiet week….

It’s Merative, not IBM Watson Health anymore. Francisco Partners‘ buy from IBM of Watson Health closed last Thursday (30 June) but didn’t make the news until after the holiday. The announcement of the new brand, Merative, was splashed on HLTH’s website today (not HIMSS) with the usual language about how their data connects and transforms health through pioneering “cloud, real-world data and industry-leading AI” through health systems, hospitals, health plans, life sciences, and government. Speaking of data points:

  • HQ now in Ann Arbor, MI
  • New CEO Gerry McCarthy from CEO of eSolutions, a former Francisco Partners portfolio company that exited to Waystar in October 2020
  • The former general manager, Paul Roma, will be a Senior Advisor to Francisco Partners
  • Merative will have six product families: Health Insights; MarketScan; Clinical Development; Social Program Management and Phytel; Micromedex, and Merge Imaging 
  • Other investors include True Wind Capital and Sixth Street

Since 2015, IBM had built up Watson Health through four acquisitions and over $4 billion in investment. They sold it for perhaps $1 billion to get it off their books. Once upon a time they were the leader, now they’re up against Oracle and a dozen other competitors like IQVIA that sell connectedness and ‘actionable insights’ across and in chunks of their business (example, life sciences). Given the track record of the controlling private equity partner, Merative needs to become profitable quickly. Merative will not be a long term investment for them. FierceHealthcare. Our prior coverage: 7 Jan, 22 Jan, 25 Feb (Who needs Watson Health?)

Also apparently up for sale to the right buyer is One Medical. The clinic group flirted with but ultimately sent packing CVS Health. One Medical offers concierge in-person and telehealth primary care in seven metros and has over 700,000 members. They bought Medicare value-based primary care provider group Iora Health a year ago [TTA 11 June] but since then their stock (trading under 1Life Healthcare) and valuation has cracked by 75%. Not mentioned in the Bloomberg article is whether Iora is included in the possible deal.

And for those who like their Hackermania on the Wild Side, there’s a massive list over at Wired that racks up the Greatest Hits. It’s only halfway through 2022, but the data breaching and ransomware perps have multiplied. From Russia/Ukraine to extortion gangs like Conti and Lapsus$ to cryptocurrency theft and China, the Old Reliable Healthcare continues to star. Our recent list is here but topping out the Wired list are Shields Health Care Group, Baptist Health System, Resolute Health Hospital, Kaiser Permanente, and Yuma Regional Medical Center. Also Becker’s.

Weekend news, deal roundup: Teladoc CEO’s tapdance interview, VA EHR cost reporting now law, Tunstall-Doncaster Deaf Alliance partner, Cleveland Clinic’s $33M medtech spinoff

Teladoc CEO Jason Gorevic’s curious tapdance of an interview. Teladoc has had a rough 2022 to date. Their 2022 Q1 financials [TTA 4 May] were disastrous, their share price has not recovered since it cracked in late April with a 62% year-to-date plunge, the Livongo acquisition is shaping up to be the healthcare equivalent of Eastern Airlines’ takeover by Texas Air Corporation circa 1986, and shareholders are filing class action lawsuits. Now this Editor doesn’t mean to pile on. As a professional in two fields, she does understand the value of the press and leadership being available. But FierceHealthcare’s Heather Landi cleverly got Mr. Gorevic to stake his ground for growth yet again on “holistic, integrated solutions” that combine multiple care services from primary to complex care as the ‘longitudinal’ way to go. Yet Ms. Landi does have the nerve to bring up recent history and their long-time competitors like Amwell and Doctor on Demand (now Included Health) in the same space. Then there are the slices taken by players in the direct-to-consumer and niche target players (she cites troubled Cerebral and Talkspace–I’d offer DTCs like Babylon Health and the ‘white-labels’ like Bluestream Health and Zipnosis, now owned by BrightHealth, which are directly and cost-effectively working with providers). Think of this: in an economic downturn, will providers buy the ‘premium spread’ that requires a big implementation lift, or get by a less comprehensive solution that’s easier to implement and costs less?  Surprisingly, given the ‘everyone wants everything’ strategy, he again blames the cost of paid search advertising and brushes off Microsoft and Amazon. I’m not so sure that so soon after their Q1 bad news in May, with lawsuits centering on statements to investors, and nothing new in good news, this interview was particularly good timing.

VA corralled by Congress on Cerner EHR. The Department of Veterans Affairs now, by Federal law enacted late last week, has to prepare quarterly reports on its transition to the Cerner Millenium EHR to both House and Senate Veterans committees on performance and cost, including a breakdown of program funding sources. The new bipartisan law’s title is the VA Electronic Health Record Transparency Act.  Healthcare Dive

Tunstall Healthcare is now working with a local trust, the Doncaster (UK) Deaf Trust, to provide support for deaf and hearing-impaired children and adults. With Whitley Parish Council, Tunstall is working with the specialist gardening team at Communication Specialist College, part of Doncaster Deaf Trust, to secure over 100 plants for the planters which have been grown at the Trust’s gardens. Tunstall volunteers planted them in the planters across the village. Doncaster Free Press

Cleveland Clinic’s successful spinoff, Centerline Biomedical, closed a $33 million Series B equity financing. Leading it was Cleveland Clinic with participation by GE Healthcare, RIK Enterprises, JobsOhio, Jumpstart Ventures, and G2 Group Ventures. Centerline’s technologies improve visualization and guidance of stents, catheters, and guidewires in endovascular procedures, reducing dependence on radiation and contrast agents with the goal of improving patient outcomes. These include sensors and electromagnetic tracking that create 3-D color visualization and navigation of the human vascular system. Release, Becker’s

‘Bionic clothing’ to aid mobility tested for foot drop in MS patients

A combination of smart clothing and an exoskeleton to aid those with mobility issues. The Neural Sleeve uses functional electronic stimulation (FES) to aid walking in those with multiple sclerosis (MS) and similar conditions. In a small clinical trial, it reduced foot drop, which is the inability to dorsiflex, or raise the front part of the foot, due to weakness or paralysis of the muscles in the front of one’s lower leg. This is seen in the gait of those with MS, traumatic brain injury, stroke, spinal cord injury, and cerebral palsy. (This Editor also knew someone for whom leg drop was an initial sign of a brain aneurism.) This disturbed gate dramatically increases fall risk.

The Neural Sleeve works through sensors in the sleeve that monitor movement for muscle firing and limb position, while the analysis, connected to the device through an app, determines the FES to activate the necessary muscles precisely coordinated to the gait cycle. The developer is Cionic, located in the Bay Area of California, still in seed rounds, but marketing to both physicians and direct to consumer. 

Of 34 final participants with a mixture of causes in a small clinical trial:

  • It improved foot angle in 96% of participants, a 3.4% increase in heel-toe time, and a 5.2% increase in dorsiflexion at heel strike
  • Inversion (turning in) of the foot also was reduced by 3.6 degrees on average.
  • After eight weeks of use, mobility improved 30% on average.
  • In addition, the number of patients reporting moderate to severe pain reduced by 60%, and the number reporting moderate to severe anxiety or depression dropped by 75%.

The clinical trial is in preprint 6 June in Medrxiv as Augmenting gait in a population exhibiting foot drop with adaptive functional electrical stimulation.

The Neural Sleeve received FDA Class II medical device clearance in March. However, it is still in pre-orders, selling out 2022, with 2023 to open later this summer. Multiple Sclerosis News Today, Medium post on foot drop in the Cionic blog, other Medium posts  Hat tip to TTA founder Steve Hards