TTA Snow Edition: Raises/SPACs pile up for Sharecare, Owlet, Zocdoc, Modern Health; airborne COVID detector passes test; RPM for clinical trials; Theranos and VA EHR updates

Weekly Alert

 

 

The snow won’t stop across the US, and neither do the big raises and SPACs this week. The spotlight’s on behavioral health, patient data storage–and Owlet’s baby monitoring sock. Can COVID be detected in the air?–looks like it. More ‘normal business’–a partnership for renal monitoring, care management, and Current Health’s RPM for clinical trials. Plus an update on VA’s Cerner EHR rollout and the Theranos trial.

GAO tells VA to postpone Cerner EHR implementation–but VA will be continuing (Typical government push-me-pull-you)
Deal and news roundup, 17-18 Feb: Sharecare goes SPAC for hefty $3.9 bn valuation; Humana Care Support pilots; AliveCor, AstraZeneca partner on renal, cardiac; Current Health RPM in clinical trials
The Theranos Story, ch. 70: the lab director turns Federal evidence (And nothing to do with Silicon Valley Lifestyles)
Airborne SARS-CoV-2 detection device for indoor use successfully tested (Useful for other bacteria and viruses too)
Funding roundup, 16 Feb: virtual mental health gains two (more) unicorns, Zocdoc’s fresh $150M, Owlet’s $325M SPAC (The eyeblinking raises and public offerings go on)

Only one truly dizzy deal — Signify Health — this week for a change. NHS apps try to get a handle on the pandemic and triage patients. Two US ‘neoinsurers’ raise big money, but one’s seeing the SEC and DOJ. 

News and deal roundup: Signify Health’s $564M IPO, RapidSOS’ $85M Series C, Poland’s Telemedico raise, Livongo’s Zane Burke to Bardavon
NHS touts COVID-19 Test and Trace app; Livi’s MJog notifies users of vaccine jab info (Trying to turn the corner)
Lasting effects of the pandemic lockdown on health and wealth (More Bad News)
‘Neoinsurer’ Oscar Health goes for $100 million IPO; Clover Health’s big SPAC under SEC microscope (A tale of two insurers, one a potential scandal)
NHS digital triaging app eConsult closes £7 million funding round (Deals spreading in UK)

The Dizzy Deals keep on coming with 23andMe going SPAC-y with Richard Branson for $3.5bn. HIMSS goes ‘hybrid’ for Singapore–but Las Vegas F2F is a ‘maybe’. Telehealth usage soared dizzily but unevenly during the early pandemic. Not so dizzily in the UK, B-Secur ECG algorithms get FDA clearance and Scotland’s Project Liberty advances. 

Belfast’s B-Secur obtains FDA 510(k) clearance for HeartKey ECG/EKG algorithm library (Plug and play?)
23andMe will go the SPAC route with Virgin Group in a $3.5 bn valuation (Ka-Ching!)
The shape of telemedicine during the first half-year of the pandemic: significant but wildly uneven usage (Income and speciality differences)
Short takes, 4 Feb: HIMSS 21 Global/APAC go ‘hybrid’; ATA announcements including virtual ATA2021; Hillrom acquires EarlySense monitoring tech
Communicare247 advances in Scotland’s Project Liberty social care with Stage 2 funding (Smarter homes for independent living)
Bluestream Health telehealth partners with Impresiv Health management consultants (Adding telehealth to client services)

Our third all-new Alert for 2021 has a bumper crop of 10 Dizzying Deals and equally dizzy debates about telehealth parity and coverage. And just as in the movies, Crime Does Not Pay (except in long prison sentences) for ‘telemedicine’ fraudsters being convicted as part of the $4.5 billion ‘takedown’.

Crime Does Not Pay–especially when defrauding Medicare of nearly $1 billion (Latest convictions in October’s National Health Care Fraud Takedown)
Telehealth parity, coverage, access debated in New Hampshire, South Dakota; CMS issues corrections to RPM in 2021 Medicare PFS rules (Will reimbursement advances stick?)
Funding, acquisition news roundup, round 2: Lyra Health’s $187M Series E, DarioHealth-Upright, GetWellNetwork-Docent Health, Hillrom-BardyDx (updated)
Funding news roundup: Philips buys Capsule, Hims’ SPAC + Privia partnership, Signify Health’s $100M IPO; closed funding for K Health, Aledade, Conversa Health

From Deals to COVID (only two scoops) to once again, Theranos and questions on Silicon Valley Startup Ethical Norms. The promise and peril of telehealth, especially in developing countries. Oddly, not much out of virtual editions of CES and JPM.

Comings, goings, and more: YouTube goes healthy, COVID vax distribution and EMA hack, IPO/M&A roundup, Japan’s health tech startups highlighted at CES
2021 predictions: telehealth law and if at all possible, stay away from FDA (US) (From law firm Foley; the wise advice on FDA is from Bradley Merrill Thompson)
COVID-19 and telehealth–promise or peril? And the perils of digital health in conflict countries and India. (JISfTeH’s latest edition)
The Theranos Story, ch. 69: Elizabeth Holmes ‘faked it till she made it’–like other Silicon Valley startups? (Updated) (Lifestyles of the Rich, Famous, and Busted)

Our first postings for 2021 focus on digital health’s funding Boom Town, also confirming that utilization gains made during the worst of 2020 are sticking. Haven, the three-headed hydra that was going to slay the ‘hungry tapeworm’, is closing. But never fear–CES and JPM are next week, with plenty of news to be expected.

Digital Health as Boom Town: 2020’s dizzying funding rounded up by Mercom Capital, StartUp Health (Funding fiddles merrily while COVID burns)
Telehealth claims rose 3,060 percent to October, settling in to over 5 percent of all claims–led by mental health (US) (Telehealth utilization sticks–but so is CoronaDepression)
New Year’s Deal and Event Roundup: Optum-Change Healthcare, Walgreens-Amerisource Bergen, December’s deal potpourri, CES and JPM (No sign of deal cooldown, and big events go virtual)
Haven finds no haven in healthcare, will close in February (Where lack of focus and an embarassment of egos will get you)

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Telehealth & Telecare Aware: covering the news on latest developments in telecare, telehealth, telemedicine and health tech, worldwide–thoughtfully and from the view of fellow professionals

Thanks for asking for update emails. Please tell your colleagues about this news service and, if you have relevant information to share with the rest of the world, please let me know.

Donna Cusano, Editor In Chief
donna.cusano@telecareaware.com

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Deal and news roundup, 17-18 Feb: Sharecare goes SPAC for hefty $3.9 bn valuation; Humana Care Support pilots; AliveCor, AstraZeneca partner on renal, cardiac; Current Health RPM in clinical trials

Sharecare, a free/paid app platform that enables users to consolidate all their health and wellness data in one location and use proprietary health management tools, is going the SPAC route with Falcon Capital Acquisition Corp. It will trade on NASDAQ under SHCR. Initial enterprise value is expected to be $3.9 bn with approximately $400 million in growth capital. Closing is expected to be in Q2 of this year.

Founded in 2010 by celebrity doctor Mehmet Oz, MD (now on the board and not in active management) and WebMD founder Jeff Arnold, the current CEO, Sharecare will also have an undisclosed investment by strategic partners Anthem and Digital Alpha. Anthem is looking at the AI value plus consumer engagement and personalized care. Helping to fund both the public equity and cash position is a fully committed private investment in public equity (PIPE) of $425 million at $10.00 per share which is below market value. Falcon Capital will retain about 20 percent of the company. Mr. Arnold will join the board and be retained as CEO. After the closing, Sharecare and Falcon will donate about $4 million in stock to Sharecare’s charitable foundation.

Sharecare sells the platform to enterprises such as providers, employers, health plans, government organizations, and communities, as well as individuals on their free apps. Release, FierceHealthcare, Becker’s

Rival health plan Humana is also adding to its care management tools with a pilot of the Humana Care Support program. The platform creates an integrated, personalized experience for members, including a multi-disciplinary care team and SDOH integration. The pilot targets select groups of Medicare Advantage members in Kentucky, Pennsylvania, and West Virginia with multiple chronic conditions, complex congestive heart failure, and diabetes, with multi-disciplinary care teams. Humana Care Pilot is built on Salesforce’s Health Cloud platform for viewing the patient’s medical history and integrating clinician workflows. Its analytics are powered by Microsoft’s Azure and Power BI. The goal is lowering costs and improving outcomes for this high-cost group of patients. If successful, the program will roll out to other markets this year. Humana release, FierceHealthcare

AliveCor, the developer of the KardiaMobile mobile ECG/EKG, and AstraZeneca are partnering on research for new disease management solutions in cardiovascular, renal, and metabolism (CVRM) therapeutic areas. This will use AliveCor’s monitoring system for blood potassium. The Kardia-K AI platform uses ECG/EKG neural network analysis to measure a patient’s potassium levels without a patient blood draw. Hyperkalemia (elevated blood potassium) is linked to renal issues and kidney disease as well as cardiac issues. Kardia-K received Breakthrough Device Designation status from the FDA to screen for elevated levels of blood potassium in September 2018, and was validated in a study with Mayo Clinic published in 2019. Release, Mobihealthnews

Current Health, a monitoring and care management RPM system for enterprise-level health organizations, announced its “Community” initiative to build diverse longitudinal datasets for decentralized clinical trials. Their platform is FDA-cleared and used at scale in phase III and phase IV drug trials by major pharmaceutical organizations for remote endpoint collection and for virtual trial delivery. Monitoring is performed through wearables and sent to the electronic data capture (EDC) vendor for the clinical research organization (CRO). Current Health is using Community for its own COVID-19 study to predict hospitalizations and inform clinical treatment. The study is recruiting US participants diagnosed with the virus in the last 48 hours. Current has locations in Edinburgh, London, Boston, and San Francisco according to their website. Mobihealthnews

News roundup: CVS cashing out notes, catching up with ISfTeH, India’s Stasis Labs RPM enters US, Propeller inhaler with Novartis Japan, Cerner gets going with VA

CVS Health is pricing out a tender offer for some notes. If you are holding one of a potpourri of notes with due dates of 2023 and 2025 from CVS, the company is making a cash tender offer, meaning they are cashing these notes out. This is usually done as part of rearranging financing, especially appropriate in the wake of the Aetna acquisition. The details are here in their release of 12 August. The collective value for both note years is approximately $3 bn each. An update is here on Seeking Alpha.

We have been remiss in not maintaining our following the Swiss-based International Society for Telemedicine and eHealth (ISfTeH) so we will direct your attention to their August update which features the effect of COVID on teledermatology, women’s health, teleurology, and news on members and developers. Their Journal, still edited by Professor Maurice Mars of South Africa, has published once this year in January.

India’s Stasis Labs, developer of a remote patient monitoring (RPM) platform utilizing a smartphone, vital signs devices, a bedside monitor connected into a platform, is entering the US market. It monitors six vital signs in a single monitor: heart rate, blood oxygen, electrocardiogram, respiratory rate, blood pressure, and temperature. Awarded a 510(k) clearance in April, Stasis, out of the Cedars-Sinai Accelerator program, has had a limited deployment at Texas-based emergency-care provider Hospitality Health ER and California-based Glendale Surgical Center and Orthopedic Surgery Specialists. It has also deployed to 50 cities in India. Mobihealthnews

Smartphone-connected inhaler sensor company Propeller Health has inked a deal with Novartis in Japan. Patients prescribed Novartis’ drugs for uncontrolled asthma, the Enerzair or Atectura Breezhaler, can now enroll in Propeller’s digital-management program. Data about their inhaler use will be transmitted from the sensor on the inhaler to Propeller’s smartphone app. The app also pings users with reminders and usage data. Propeller was acquired last year for a stunning $225 million by ResMed. Propeller this past May gained 510(k) FDA clearance for a sensor/app for use with AstraZeneca’s Symbicort inhaler.

Cerner’s EHR implementation with the US Department of Veterans Affairs finally took a step forward after many delays with the launch last Friday of a new scheduling system at the VA Central Ohio Healthcare System in Columbus, Ohio. Cerner migrated the information of some 60,000 veterans in preparation. The full EHR at the Mann-Grandstaff VA Medical Center in Spokane, Washington, originally scheduled for March, will go live this fall. Healthcare Dive

News roundup: LabCorp CRO boosts Medable, Propeller Health gains 510(k), EU’s 34 medtech startups, Amazon’s healthcare moves, Google’s Arizona privacy lawsuit

It does seem ages since our last one! One major winning category for digital health is clinical trials. LabCorp has one of the largest CROs (contract research organization), Covance. LabCorp has partnered with startup Medable, a Palo Alto-based company that decentralizes the gathering and analysis of clinical trial data from recruited participants through apps and telemedicine. Mobihealthnews  Confirming this trend: earlier this month, Medable cleared a $25 million venture round from GSR Ventures. Crunchbase  This does make rival CRO PRA Health Science’s pickup of Care Innovations from Intel late last year, for an undisclosed amount, look like a prescient (and likely a bargain) purchase.

Propeller Health, which specializes in digital respiratory health with sensors connected to inhalers and apps, gained 510(k) FDA clearance for a sensor/app for use with AstraZeneca’s Symbicort inhaler. This medication is used for asthma and COPD. It does not seem that long ago (2014) that the startup was at trade shows like NYeC and mHealth Summit with an exceedingly modest display of popups and brochures. Their 2019 acquisition by ResMed for the stunningly premium price of $225 million made news in late 2018. Mobihealthnews

In Europe, COVID-19 has boosted at least 34 medtech startups, including 11 in UK alone, followed by Switzerland and Sweden. This is based on a study by Oxford University data visualization spin-out Zegami. One of them happens to be Zegami on a project in using a limited dataset to distinguish between x-rays of COVID-19 infections and infections caused by viral or bacterial pneumonia, as well as images of healthy lungs. On the list are (naturally) Babylon Health and the slightly mysterious Medopad. Sweden’s Kry (LIVI in the UK) is also on the list. Kry/LIVI last made some news when Juliet Bauer of NHS Digital ankled to Kry in early 2019, Med-techInnovationNews, Mobihealthnews

Amazon’s latest stretches into healthcare are noted in a brief Becker’s Health IT article which notes AWS’ deals with Cerner and addition of healthcare-specific features with hospitals using AWS. Mayo Clinic has partnered with Alexa for voice responsive ‘Mayo Answers’. Some Amazon employees now have access to telehealth benefits (this Editor wonders why not all, beyond those Seattle warehouse workers). Industry research company CB Insights is projecting that Amazon’s next move will be a benefits marketplace for employers and payers. Meanwhile, their partnership with JP Morgan Chase and Berkshire Hathaway, Haven, has stumbled with its CEO Atul Gawande, MD, leaving the post to return to practice after less than two years. Executive turnover has been high, and the company has yet to announce a major initiative. FierceHealthcare 

Meanwhile, Arizona’s attorney general has sued Google for violating state privacy laws. Seems like Android users are trackable, even if they turn off location on their phones, through Google apps like Maps and Weather. The lawsuit also charges that Google changed its default tracking settings without informing users, using data for targeted ads. Becker’s Health IT 

Where’s the evidence? Healthcare unicorns lack the proof and credibility of peer-reviewed studies.

Another sign that too many healthcare unicorns are decoupled from the rock-solid fundamental reality–that they work. Healthcare unicorns–those startups valued over $1 bn–are unicorns because they have patents, processes, or a line of business that has immense potential to be profitable. The standard in healthcare, unlike other tech, is the peer-reviewed study. Is this process or device effective based upon the study? Does this drug looks like it will work? Is this study validating, encouraging? Peer-reviewed research takes place before a drug or device goes into clinical trials — a precursor. It ensures a certain level of disclosure, validation, and transparency at an early stage.

Instead, these unicorns largely rely on ‘stealth research’–a term coined by Dr. John P.A. Ioannidis, the co-director of the Meta-Research Innovation Center at Stanford University (METRICS). He summed it up in his latest peer-reviewed paper, “Stealth research: lack of peer-reviewed evidence from healthcare unicorns” (co-authored with Ioana A. Cristea and Eli M. Cahan), published in the European Journal of Clinical Investigation 28 Jan: 

In 2014, one of us (JPAI) wrote a viewpoint article coining the term “stealth research” for touted biomedical innovation happening outside the peer-reviewed literature in a confusing mix of “possibly brilliant ideas, aggressive corporate announcements, and mass media hype.”

The term ‘stealth research’ was prompted to the author by the practices of Theranos–ironically, a company that started and was funded in the Stanford nexus. By the time Dr. Ioannidis’ viewpoint paper was published in JAMA in Feb 2015, Theranos had ballooned to a $9 bn valuation. His paper was the first to question Theranos’ science–and Theranos aggressively pushed back against Dr. Ioannidis, including their general counsel attempting to convince the author to recant his own writing. Three years later, we know the outcome.

This latest study concludes that there is a real dearth of peer-reviewed research among healthcare unicorns–and that it’s detrimental. It measured whether these unicorns published peer-reviewed articles and whether they publish highly-cited (in other publications) articles; compared them against companies with lower valuations; and whether founders or board members themselves impacted the scientific literature through their own citations.

The meta-study looked at 18 current and 29 exited healthcare unicorns. Highlights:

  • Two companies–23andMe and Adaptive Biotechnologies published almost half of all unicorn papers–196 combined
  • Three unicorns (Outcome Health, GuaHao and Oscar Health) had no published papers, and two more (Clover Health, Zocdoc) had published just one
  • Seven of the exited unicorns had zero to one papers
  • In fact, ‘there was a negative, non-statistically significant association between company valuation and number of published or highly-cited papers’

As our Readers know, Outcome Health had a little problem around artificially inflated advertising placement wrapped in health ed and placed in doctors’ offices [TTA 29 Jan 18]. Oscar and Clover Health are insurers. Zocdoc…well, we know their business model is to get as many doctors to sign up in their scheduling app and pay as much as possible. But it’s the drug and device companies that are especially worrisome in a stealth research model. The paper points out among other examples StemCentrx, bought for $10.2 bn in 2016 by AbbVie for its Rova T targeted antibody drug for cancer treatment, was halted at Phase III because it was not effective. Acerta Pharma, also focused on cancer treatments, was bought by AstraZeneca for $7.3 bn; two years ago, AstraZeneca had to withdraw the Acerta data and admit that Acerta falsified preclinical data for its drug.

The conclusions are that healthcare unicorns contribute minimally to relevant, high-impact published research, and that greater scrutiny by the scientific community through peer-reviewed research is needed to ensure credibility for the underlying work by these startups. “There is no need for numerous papers. Discrete pivotal, high-impact articles would suffice.”

This Editor returns to #5 on Rock Health’s Bubble Meter: high valuations decoupled from fundamentals. Based on this, the lack of publishing represents risk–to investors and to patients who would benefit from better vetted treatments. To these companies, however, the risk is in having their technology or researched poached–as well as the investment in time and money research represents.

The study authors point out several ways to minimize the risk, including collaborating with academic centers in research, validation without disclosing all technical details, secure patents, and contributing their technology to other research. A higher-risk way is to “withhold significant publications until successful validation from agencies such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA)” but usually investors won’t wait that long. ‘Stealth Research’ paper, TechCrunch review Hat tip to David Albert, MD, of AliveCor via Twitter

AstraZeneca awards over $200k for heart failure telehealth

AstraZeneca Healthcare Foundation, the charitable arm of the UK based pharmaceutical company AstraZeneca, has awarded $205,564 to HSHS St. John’s Hospital in Illinois to support their Tele-Heart Pathway programme. [grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/02/HSHS.jpg” thumb_width=”150″ /]The programme provides interventions to heart failure patients in their homes to support health management. With telemedicine and telehealth technology doctors monitor symptoms and help avoid complications at home after surgery, according to the hospital.

 “We have seen a rapid evolution in the last few years of new devices and new ways of communicating with our patients,” said Mark Stampehl, MD and Medical Director of the heart failure programme at Prairie Heart Institute (PHI) at St. John’s Hospital, in an article entitled Telemedicine elevates care for heart patients published in the fall 2014 issue of the hospital’s quarterly magazine Healthy You. “Today, we are using tools to remotely monitor a patient’s condition and increase communication with other physicians to give patients access to specialty care from home.” (more…)

Medtronic, Covidien and what it might mean for digital health

“This acquisition will allow Medtronic to reach more patients, in more ways and in more places,” Medtronic Chairman and CEO Omar Ishrak

Cover the Earth? While the healthy Medtronic offer ($42.9 billion in cash and stock) for Ireland-headquartered Covidien plc is not a ‘digital health deal’, it does point to Medtronic’s strategy which includes digital health. There is of course the obvious: growth by acquisition and integration. Acquisitions require cash, and the highly controversial change of domicile to Ireland via ‘tax inversion’ will fatten the exchequer in two ways. First is through the lower overall Irish corporate tax versus the 35 percent US tax, one of the highest in the world. Second is much more flexibility in repatriating plentiful foreign earnings at lower Irish corporate rates rather than the high US rates which Medtronic has avoided. Third is increasing dividends, which can drive up stock price and investor interest. Of interest to the latter is also that Covidien adds horizontal (and global) competitive strength to Medtronic in the clinical area–surgical, vascular, respiratory and wound care.

More Ways-More Places. Not just staples and sutures, Covidien has developed its own advanced in-hospital mobile patient monitoring in Vital Sync as well as several hospital monitoring devices in their Nellcor line. In addition to technology collaboration, the next point of integration could then be with Medtronic’s post-acute telehealth devices from Cardiocom, purchased less than one year ago. We noted at the time that it gave Medtronic entreé into the “chronic condition management continuum– not only into telehealth via Cardiocom’s devices and hubs, but also their clinical and care management systems.”

Approval will take time. Both the US and UK, through various regulatory agencies, scuppered the Pfizer-AstraZeneca deal on similar tax domiciling and competitive grounds. If it does go through, there will be a lot of reorganization. But while it digests, this Editor will be watching Medtronic for its usual pattern of making smaller ‘more ways/more places’ deals in the interim with an eye to diversifying past US-taxable medical devices. One pointer is their just-announced partnering with Sanofi to develop drug delivery-medical device combinations and care management services for diabetes patients (MedCityNews).

Related reading: Medtronic hints at more acquisitions following $43 billion Covidien deal (MedCityNews); The Medtronic, Covidien Inversion Deal Is More About Dividends Than Tax (Forbes); Medtronic agrees to buy Covidien for $42.9b in cash, stock (Boston Globe); Medtronic’s $43B Covidien deal—and Irish tax move (CNBC)

 

Vodafone and AstraZeneca sign global m-health partnership

Vodafone has signed a global partnership with AstraZeneca in order to develop m-health services to improve the outcome for patients with cardiovascular conditions. The collaboration will create new mobile and internet-based services to support patients through their treatment journey, improving medication adherence and giving patients confidence to manage their condition more effectively, according to the press release.

AstraZeneca’s Intelligent Pharmaceutical Group will lead the project with Vodafone charged with providing the technology, infrastructure and expertise for the new services.

The UK-based operator said it will also look to capture data from a variety of sources to improve overall engagement between patients and healthcare professionals. All the new services will be designed to work across geographies.

“Bringing together the best in connectivity with the best in treatment and education will create powerful and compelling outcomes for patients,” according to a comment attributed to Vodafone M2M Director Erik Brennais. But there is little in the way of details of what the two companies may develop or the timescales.

So many apps, so little time

Over the past few days there seems to have been a particularly rich set of alerts related to mHealth apps (there’s even been an update to the mHealth Grand Tour website with a nice video to promote the tour that starts on 5th September). Adding to them a couple that others have kindly alerted me to, here are a few that might interest:

Let’s begin with an infographic on the rising popularity of mHealth apps that puts it all into context. However, in some countries mHealth is being held back by outdated privacy laws, and in the US lack of final FDA guidance is considered a check on progress.  If you ever wondered how much data your DNA, or your most recent scan contained, (more…)