Can digital health RPM achieve meaningful change with type 2 diabetics? New metastudy expresses doubt.

March 27, 2024 | by

A metastudy from the Peterson Health Technology Institute (PHTI) has reservations about the efficacy of digital diabetes management tools. Over $50 billion has been invested in the sector between development, investments, mergers, and acquisitions. Generally, the claim around digital management tools for diabetes to aid self-management and prevent poor outcomes, particularly for those at high risk, has been that they can 1) deliver meaningful and lasting clinical benefits in reduction of HbA1c (glycemic control) and 2) reduce long-term costs of poor control, benefiting patients. In the US, diabetes affects 11% of the population and is an expensive chronic condition. It also disproportionately affects people of color and those with lower income, especially as they age.

The systematic literature review of 1,100-plus studies was augmented by interviews with physicians, patients, digital health experts, along with companies. They included 120 clinical references from DarioHealth, Omada, and Virta. The PHTI grouped digital tools into three types of solutions for Type 2 diabetes in adults. All used standard glucometers, not continuous glucose monitors/CGM as well as apps to provide real time feedback to a virtual or actual coach or care team:

  1. Remote patient monitoring (glucometer plus feedback): Glooko
  2. Behavior/Lifestyle modification (glycemic feedback plus coaching features): DarioHealth, Omada Health, Perry Health, Teladoc (Livongo), Verily (Onduo), and Vida
  3. Nutritional ketosis (dietary guidance that restricts carbohydrates and monitors the patient’s glycemic and ketone levels): Virta Health

The findings did not meet their expectations in demonstrating “clear, substantial, and durable progress toward glycemic control in people with type 2 diabetes, resulting in a lower prevalence of uncontrolled type 2 diabetes across the population.”

  • They did not deliver clinically meaningful benefits compared to ‘usual care’. Only three out of 10 comparative HbA1C studies achieved a meaningful difference of 0.5 percentage points (Minimal Clinically Important Difference or MCID) in patients. Their range was 0.23 to 0.60 percentage points compared to usual care.  The nutritional ketosis program had greater benefits as long as patients maintained the rigorous requirements of the therapeutic regimen.
  • The average price impact of the solution exceeds the savings achieved from the clinical benefits. The PHTI analysis looked at commercial insurance, Medicare, and Medicaid over three years. Provider reimbursement and pricing exceed cost savings from avoided care.

So where is the worth? The PHTI study recommended that:

  • Payers use these solutions for the highest risk and diverse/underserved populations
  • Regularly analyzing outcomes and tie contracts to clinical performance
  • Focus on patients with higher starting HbA1c newly starting insulin
  • Payers could also recommend nutritional ketosis as the Virta program had greater benefits.
  • Solutions could also evolve to include GLP-1 drugs, CGMs, and nutritional ketosis.

PHTI study (free download of full report, four sections, and appendices). PHTI press release.

PHTI is also offering a free webinar on Thursday 28 March at 2pm US Eastern Time on assessing digital diabetes management tools–registration here.

Using wearables to monitor biomarkers related to neuropsychiatric symptoms post-traumatic event

January 25, 2023 | by

Tracking biomarkers related to post-traumatic outcomes via a wrist-worn wearable. A January study published in JAMA Psychiatry (full text) monitored 2,021 participants who experienced traumatic stress exposure, mainly from car accidents but also physical assault, sexual assault, serious falls, and a mass casualty incident. 

The Advancing Understanding of Recovery After Trauma (AURORA) study examined adverse posttraumatic neuropsychiatric outcomes after traumatic stress exposure, especially among socioeconomically disadvantaged patients. Qualifying patients used the (Alphabet) Verily Life Sciences’ Study Watch for a minimum of 21 hours a day over the eight-week tracking period, starting with screening and qualification in the emergency department (ED). 

  • Participants used smartphones to complete a rotating battery of questionnaires consisting of 10 common adverse post-traumatic neuropsychiatric sequelae (APNS) symptom domains: pain, depressive symptoms, sleep discontinuity, nightmares, somatic symptoms, difficulty with concentration, thinking, or fatigue, avoidance of trauma reminders, trauma reexperiencing, anxiety, and hyperarousal.
  • Using the wearable’s accelerometer feature, it monitored eight significant biomarkers for pain, sleep, and anxiety. A reduction in 24-hour activity variance was associated with greater pain severity. Six others were associated with rest-activity measures indicative of changes in pain over time and one with repeated sleep-wake disruption indicative of changes in pain, sleep, and anxiety.

Depending on the data plus self-reporting on the questionnaires, the patient could be recovering or worsening post-event. The study concluded that “wrist-wearable device biomarkers may have utility as screening tools for pain, sleep, and anxiety symptom outcomes after trauma exposure in high-risk populations.” This Editor notes that over time, wearable monitoring was coupled with plentiful subjective information.

The group was selected from an initial 19,019 patient pool drawn from 27 emergency departments. 3,040 patients met the study criteria including being within 72 hours of the trauma, aged 18 to 65 years, and were able to speak and read English. They also provided informed consent and completed baseline assessments for a final completion group of 2,021. Most of the participants were female, half of the study were African American, 34% were white and 11% were Hispanic. Nearly 80% of the study did not have a college degree, while 64% earned $35,000 per year or less. The study was headed by a team at the University of North Carolina at Chapel Hill.  Also Mobihealthnews

Mid-week roundup: Teladoc gets BetterHelp to boost Q4 ’22 revenue; fundings for Array, Paytient, Telesair, three others; layoffs hit at Alphabet’s Verily, Cue Health

January 12, 2023 | by

Teladoc may finish 2022 better than expected, at least in revenue. At the JPMorgan (JPM) annual healthcare conference, CEO Jason Gorevic shared a revised but still preliminary projection that Q4 would finish up a tick higher than expected–between $633 million and $640 million in revenue, versus their projection during Q3 that the low side would be $625 million. FY2022 revenue was updated to be the $2.403 billion to $2.41 billion range. The big contributor? Their mental health app BetterHelp. Their growth, according to Mr. Gorevic, is “staggering’. Silicon Valley Bank (SVP) analyst Stephanie Davis calculated a growth rate of 43% for the business, up from previous management targets. Teladoc’s optimism is tempered by the no/slow growth economy projected for this year, both direct to consumer and corporate. To help boost the latter, it is launching a new app for health plan members and company employees access to all of Teladoc’s clinical programs. Healthcare Dive, Becker’s

Despite the uncertain economy, funding continues in various rounds, especially in still-hot areas such as remote/virtual behavioral therapy and payments, but nowhere near the bubbly level of 2021:

CVS Health’s open piggybank helped to fund NJ-based Array Behavioral Care’s $25 million Series C. Other investors included HLM Venture Partners, OSF Healthcare System, Wells Fargo, and three others. Array will use the funds to scale its virtual behavioral therapy platform.  Mobihealthnews, Crunchbase

In that interesting area called healthcare fintech, the cleverly-named Paytient now has an additional $40.5 million in Series B funding, bringing their total to $63 million. Paytient provides corporate employees, health plan members, and health system patients with a card-based Health Payment Account (HPA) that includes a line of credit. Release, Mobihealthnews 

In hospital-to-home respiratory care, still in stealth Telesair raised $22 million in Series A funding, led by Pasaca Capital with participation from existing and new investors such as Honeywell Investors, ZhenCheng Capital, Shangbay Capital plus three others. According to the release, funding will be used for the commercialization of the Bonhawa Respiratory Humidifier for use in the ICU and the development of a second-generation, revolutionary product for hospital-to-home. Mobihealthnews   

Also highlighted in Mobihealthnews‘ article is a $10 million Series B for ModifyHealth, which delivers prepared, medically tailored meals and provides advice from dieticians. ModifyHealth provides certified low FODMAP meals for those with irritable bowel syndrome or small intestinal bacterial overgrowth (SIBO), as well as Mediterranean, low-sodium, and gluten-free (celiac disease) diet meals. Censinet, a developer of healthcare cybersecurity software, also landed $9 million in a funding round led by MemorialCare Innovation Fund, Rex Health Ventures, and Ballad Ventures plus five others for a total of over $22 million.  Release  CARI Health, a San Diego startup developing a wearable sensor for medication management, gained $2.3 million in seed funding from the San Diego Angel Conference plus four other funds. Release

The pace of layoffs may have slowed, but the numbers have not.

Alphabet’s Verily health tech development unit is discharging 15% of current staff, estimated at 240 people.  This is part of a reorganization designed to move to financial independence from Alphabet/Google. It’s categorized among Google units as ‘Other Bets’ which is appropriate given that so far, their bets haven’t hit any jackpots. An example we covered back in 2015-16 was a glucose monitoring contact lens developed with Alcon, an on-the-face of it Preposterous Idea that died about that time. Current discontinued areas include remote patient monitoring for heart failure and micro needles for drug delivery. Employees were told to leave the office for the remainder of the week; further information including separation would be sent to them via email. Since 2017, it has raised over $2 billion. You wonder where it went. CNBC

Cue Health, a home diagnostics company, is cutting 388 employees, about 26% of its workforce, effective March. This is in addition to an 170-person manufacturing worker layoff during the summer. Cue bet heavily on growth of its at-home molecular Covid testing packs sold direct on a membership plan [TTA 12 Nov 2021], plus to pharmacies and to businesses. It expanded from about 100 workers in 2020 to more than 1,500. That growth has cratered along with the entire testing market for a pandemic that is no longer there. According to Mobihealthnews, they have submitted to the FDA for new test such as an EUA for a combination flu and COVID-19 diagnostic as well as de novo clearances for its flu and COVID-19 standalone tests. 

 

News briefs: ResMed-Verily’s Primasun sleep solution; Maven Clinic’s $90M Series E; Mount Sinai genomics spinoff Sema4 lays off additional 500, exits women’s health

November 16, 2022 | by

The large conference HLTH is underway in Las Vegas and like pre-Covid, conferences are a platform for announcements. Verily, which is Alphabet’s (Google’s) life sciences and health skunk works, and ResMed, a large company in respiratory medical devices for sleep apnea and sleep disruption treatment, have formed a joint venture, Primasun. Their target market is employers and providers to identify patients at risk for sleep disorders, particularly obstructive sleep apnea. About 75% of those in the US experience some form of sleep disruption at least a few times a week, leading to behavioral and physical problems. Mobihealthnews has the basic information on the launch but also some side information on Verily. Back in September, alongside a $1 billion raise to fund precision health, controversial founding CEO Andy Conrad announced he was stepping down effective in January 2023, replaced by current president Stephen Gillett. Dr. Conrad survived a brace of bad press back in 2016 [TTA 6 Apr 2016] and multiple ups and downs in the past six years.

Maven Clinic, a virtual care company targeting women and families, bucked the trends and locked up a $90 million Series E financing. Led by General Catalyst, there are nine other investors including La Famiglia, CVS Health Ventures, and Intermountain Ventures, bringing total funding to just under $300 million (Crunchbase) and unicorn valuation last year. Maven focuses on women’s health journey from fertility through menopause. The company claims to host 15 million members through primarily companies and health plans, and has contracts with half of the Fortune 15. Recently, they launched a menopause and ongoing care program with 1.2 million lives covered across 150 employer clients.  Release, Mobihealthnews  Notably, General Catalyst has been a bullish funder of both US and UK health systems such as Banner Health, Cincinnati Children’s Hospital Medical Center, Hackensack Meridian Health, HCA, and Intermountain Health, along with Guy’s and St Thomas’ NHS Foundation Trust in the UK. Mobihealthnews

Unfortunately, Mount Sinai spinoff Sema4 continues to cut back and restructure. Their latest round of layoffs affects 500, or 32.5% of its workforce. Sema4 will be exiting its reproductive and women’s health testing business and shuttering operations located in Stamford, Connecticut by end of Q1 2023. Going forward, they will concentrate operations in Maryland. In August, they discharged 250 staff, about 13% at that time, including its founder from both the president and director slots. With this latest restructuring, their workforce has been reduced to 1,100. Their release states that they will concentrate on their high growth, high margin pediatric and rare disease business using whole exome/genome diagnostic testing, achieve annual revenue growth in excess of 20%, and reach profitability by 2025. MarketWatch, Becker’s, Mobihealthnews

News and deal roundup: Zus Health’s $34M ‘back-end in a box’, Bright Health’s IPO, Lyra Health’s $200M done, Valo Health’s $2.8B SPAC; UK’s Alcuris, Clarity Informatics, GTX test; Google’s health blues, Facebook’s smartwatch

June 18, 2021 | by

Athenahealth founder’s latest health tech venture lays track. Jonathan Bush’s new venture, Zus Health, is being pitched to tech founders as providing a ‘Lego’ like back-end for startup digital health companies. Variously compared to ‘Build-A-Bear’ or track laying, it’s an ‘in a box’ setup that provides a data record back end, a software development kit (SDK) with tools and services, and a patient interface. Presumably, this will also assist interoperability. Mr. Bush has enlisted an all-star team and is basing outside of Boston in the familiar area of Watertown, Massachusetts. Andreessen Horowitz (a16z) led the $34 million Series A, joined by F-Prime Capital, Maverick Ventures, Rock Health, Martin Ventures, and Oxeon Investments. The financing will be used for engineering the tech stack. Current clients developed in stealth include Cityblock Health, Dorsata, Firefly Health, and Oak Street Health. Not a breath about the revenue model other than ‘partnership’. Make sure you pronounce Zus as ‘Zeus’ (Athena’s father for those who aren’t up on their Greek myths). Zus release, FierceHealthcare

This week’s IPO filing by insurtech/clinic operator Bright Health with the Securities and Exchange Commission (SEC) confirmed earlier reports that the offering will crest over $1 billion [TTA 28 May]: 60 million shares with an initial valuation of $20 to $23 is at a minimum of $1.2 billion. Company valuation is estimated at $14 billion which is about midpoint of earlier estimates. It will trade on the NYSE under BHG. The cherry on the cake is a 7.2 million 30-day share purchase option to their underwriters at the initial IPO price. Timing is not addressed in the release but expect it soon. BHG release, Mobihealthnews

Lyra Health banks an additional $200 million. This week the corporate mental health therapy provider completed their Series F $200M financing backed by Coatue, new investor Sands Capital, plus existing investors, for a total of $675 million to date (Crunchbase). Valuation is now estimated at $4.6 billion. Mental and behavioral health tech remains warm, with the thundercloud on the horizon Teladoc’s myStrength app [TTA 14 May]. Lyra’s strong corporate footprint puts them, along with Ginger, in a desirable place for acquisition by a telehealth provider or payer. Lyra release, FierceHealthcare

Drug discovery and development company Valo Health is going the SPAC route with Khosla Ventures. The special purpose acquisition company (SPAC) Khosla Ventures Acquisition Co. will form with Valo Health a new company (KVAC) with a pro for­ma mar­ket val­ue of approx­i­mate­ly $2.8 bil­lion with an initial cash balance of $750 million including a $168 million PIPE led by Khosla Ventures. Valo’s flagship is the Opal Computational Platform that creates an AI-based platform for drug discovery. The current pipeline has two clin­i­cal-stage assets and 15 pri­or­i­tized pre-clin­i­cal assets across car­dio­vas­cu­lar meta­bol­ic renal, neu­rode­gen­er­a­tion, and oncol­o­gy fields. Khosla has been largely absent from digital health investments. The SPAC route to IPOs has also cooled. Valo release, Mobihealthnews  

And short takes on other news… (more…)

Can technology speed the return to office post-COVID? Is contaminated office air conditioning a COVID culprit?

July 23, 2020 | by

Most offices in the US are still not open or only ‘essential personnel’. As this Editor noted on 19 May, a number of companies, including startups, are focusing on working with employers on return-to-work strategies. There are a raft of approaches including on-site clinics, temperature screening checkpoints, and check-in/reporting apps from Verily (Alphabet) and Fitbit’s Ready to Work. These screeners generally monitor for self-reported symptoms, but some will advise and track you to testing if you demonstrate risk, such as UnitedHealth Group and Microsoft’s ‘ProtectWell’ with a closed loop of testing recommendations that are reported to the employer. Collective Go from Collective Health goes a bit further in emphasizing up-front (molecular [PCR]) testing and continuous employee monitoring into their protocols for, apparently, every worker. OneMedical, which works with 7,000 employers, adds to their on-site management and testing additional contact tracing. FierceHealthcare

Maybe it’s in the air-conditioned air you breathe? Office building air circulation may be a culprit in the spike in Florida, Arizona, and Texas cases. The uptick in cases in Southern states where the contagion rates were initially fairly light may be due to the mostly recirculated air in office air conditioning systems. Most modern buildings don’t have windows which open. Older buildings have their own problems like mold from leaky systems and ‘soot’ (from air pollution and when people used to smoke in offices, remember when?). Newer LEED buildings are so ‘tight’ and energy efficient that air tends to be stagnant. Few buildings have good ratios of air exchange with the outside plus use HEPA filtration throughout the HVAC system. The total picture is that any virus can make its way through offices–six feet of distancing, masks, sanitization, no cafeterias, and acrylic panel separators be d****d.  (Contrast your average office building with modern commercial aircraft where about 50 percent of air is recirculated at any one time, there’s a total change about every three minutes, and HEPA filters are used! AskThePilot, a great site for all things airline)

A return-to-work readiness strategy suggested here by a Harvard Medical epidemiologist whose main area is TB spread are germicidal UV lights high in the room to catch the viruses that go up, then down. UV light for sanitization and disinfection is a technology used for several years to disinfect patient care areas (PurpleSun is one). Far-UVC, versus near-UVC, and potential uses are outlined in this Nature article from February 2018.  Harvard Gazette

International news roundup: Verily ‘eyes’ India, Oxford VR trials in Hong Kong, Israel-Finland collaborate, Blue Cedar-Blackberry partner, NuvoAir inhales $3M

May 2, 2019 | by

Verily rolls along in India with eye health research. Spending its fresh $1bn in funding [TTA 17 Jan], Verily and Alphabet sibling Google are researching machine learning in screening for diabetic retinopathy and diabetic macular edema. The retinal diagnostic program is at Aravind Eye Hospital, a network of eye hospitals headquartered in Tamil Nadu. Early research at Madurai has demonstrated that the algorithm performs on par with general ophthalmologists and retinal specialists assessing the images for disease. The estimated shortage of eye doctors in India is estimated at over 100,000. The stated objective of the research is to detect retinal disease earlier and expand access to screening. Further testing is verifying safety and effectiveness. Verily has received the CE Mark for the algorithm. Verily blog

Oxford VR in pilot to manage mental health in Hong Kong. Oxford VR, AXA Hong Kong and The Chinese University of Hong Kong (CUHK) have partnered for an “immersive therapy” trial using VR. This will focus on managing common mental health issues, such as social avoidance, anxiety and depressive symptoms. The scenarios will be in both English and Cantonese. Details will be announced in June. Mobihealthnews, Oxford VR press release

Israel and Finland are launching a joint collaboration announced last December, led by the Israel Innovation Authority (IIA) and the Helsinki Business Hub. The pilot program is starting with a Call for Proposals for joint projects. The two countries will co-develop, test, improve and pilot technologies, products and services in digital health, smart mobility and information and communication technologies. According to Mobihealthnews, the countries both have strong commonalities in public health systems with coordinated data sets, digital health, genomic projects, and advanced interoperability. Also The Jewish Voice

App security innovator Blue Cedar partners with Blackberry. Blue Cedar’s securing data from the app to the provider location will work with BlackBerry Dynamics-enabled mobile apps so that development teams will not be required to manually change source code or add libraries. Both Blue Cedar and Blackberry target international high-security fields such as healthcare, government, and financial. Blue Cedar blog

Swedish respiratory device/app NuvoAir inhales $3M in new funding. NuvoAir targets those managing asthma, COPD, and cystic fibrosis who need to monitor their breathing and lung health in conjunction with their overall health. Last year, the company developed the Air Next system, a portable device that connects via Bluetooth LE to users’ smartphones or tablets. Air Next has a CE Mark. NuvoAir plans to expand into Europe, North America, and Asia. The digital respiratory therapy area is booming, with an estimated 210 million asthma and COPD patients with smartphones worldwide a strong factor. One sign: Propeller Health’s premium acquisition by ResMed.  Mobihealthnews

It’s not a bubble, really! Or developing? Analysis of Rock Health’s verdict on 2018’s digital health funding.

January 21, 2019 | by

The doors were blown off funding last quarter, so whither the year? Our first take 10 January on Rock Health’s 2018 report was that digital health was a cheery, seltzery fizzy, not bubbly as in economic bubbles.  Total funding came in at $8.1 billion–a full $2.3 bn or 42 percent–over 2017’s $5.7 bn, as projected in Q3 [TTA 11 Oct]–which indicates confidence and movement in the right direction.

What’s of concern? A continued concentration in funding–and lack of exiting.

  • From Q3, the full year total added $1.3 bn ($6.8 bn YTD Q3, full year $8.1 bn) 
  • The deals continue to be bigger and fewer–368 versus 359 for 2017, barely a rounding error
  • Seed funding declined; A, B, C rounds grew healthily–and D+ ballooned to $59M from $28M in 2017, nearly twice as much as C rounds
  • Length of time between funding rounds is declining at all levels

Exits continue to be anemic, with no IPOs (none since 2016!) and only 110 acquisitions by Rock Health’s count. (Rock only counts US only deals over $2 million, so this does not reflect a global picture.)

It’s not a bubble. Really! Or is it a developing one? Most of the article delivers on conclusions why Rock Health and its advisors do not believe there is a bubble in funding by examining six key attributes of bubbles. Yet even on their Bubble Meter, three out of the six are rated ‘Moderately Bubbly’–#2, #3, and #5–my brief comments follow. 

  1. Hype supersedes business fundamentals (well, we passed this fun cocktail party chatter point about 2013)
  2. High cash burn rates (not out of line for early stage companies)
  3. Unclear exit pathways (no IPOs since ’16 which bring market scrutiny into play. Oddly, Best Buy‘s August acquisition of GreatCall, and the latter’s earlier acquisitions of Lively and Healthsense didn’t rate a mention)
  4. Surge of cash from new investors (rising valuations per #5–and a more prosperous environment for investments of all types)
  5. High valuations decoupled from fundamentals (Rock Health didn’t consider Verily’s billion, which was after all in January)
  6. Fraud or misuse of funds (Theranos, Outcome dismissed by Rock as ‘outliers’, but no mention of Zenefits or HealthTap)

Having observed bubbles since 1980 in three industries– post-deregulation airlines in the 1980s, internet (dot.com) in the 1990s, and healthcare today (Theranos/Outcome), ‘moderately’ doesn’t diminish–it builds to a peak, then bursts. Dot.com’s bursting bubble led to a recession, hand in hand with an event called 9/11.

This Editor is most concerned with the #5 rating as it represents the largest divergence from reality and is the least fixable. While Verily has basically functioned as a ‘skunk works’ (or shell game–see here) for other areas of Google like Google Health, it hardly justifies a billion-dollar investment on that basis alone. $2 bn unicorn Zocdoc reportedly lives on boiler-room style sales to doctors with high churn, still has not fulfilled its long-promised international expansion, and has ceased its endless promises of transforming healthcare. Peleton is a health tech company that plumps out Rock Health’s expansive view of Health Tech Reality–it’s a tricked out internet connected fitness device. (One may as well include every fitness watch made.)

What is the largest divergence from reality? The longer term faltering of health tech/telecare/telehealth companies with real books of business. Two failures readily come to mind: Viterion (founded in 2003–disclosure, a former employer of this Editor) and 3rings (2015). Healthsense (2001) and Lively were bought by GreatCall for their IP, though Healthsense had a LTC business. Withings was bought back by the founder after Nokia failed to make a go of it. Canary Care was sold out of administration and reorganized. Even with larger companies, the well-publicized financial and management problems of publicly traded, highly valued, and dominant US telemed company Teladoc (since 2015 losing $239 million) and worldwide, Tunstall Healthcare’s doldrums (and lack of sale by Charterhouse) feed into this. 

All too many companies apparently cannot get funding or the fresh business guidance to develop. It is rare to see an RPM survivor of the early ’00s like GrandCare (2005). There are other long-term companies reportedly on the verge–names which this Editor cannot mention.

The reasons why are many. Some have lurched back and forth from the abyss or have made strategic errors a/k/a bad bets. Others like 3rings fall into the ‘running out of road and time’ category in a constrained NHS healthcare system. Beyond the Rock Health list and the eternal optimism of new companies, business duration correlates negatively with success. Perhaps it is that healthcare technology acceptance and profitability largely rests on stony, arid ground, no matter what side of the Atlantic. All that money moves on to the next shiny object.(Babylon Health?) There are of course some exceptions like Legrand which has bought several strong UK companies such as Tynetec (a long-time TTA supporter) and Jontek.

Debate welcomed in Comments.

Related: Becker’s Hospital Review has a list of seven highly valued early stage companies that failed in 2018–including the Theranos fraud. Bubble photo by Marc Sendra martorell on Unsplash

Verily, Google’s life sciences arm, gathers in another billion to go…where? (updated for Study Watch FDA clearance)

January 17, 2019 | by

Biotech/device company Verily added to its 2016 $800 million stake from Singapore’s Temasek a fresh $1 bn from Silver Lake Partners. with reported participation from Ontario Teacher’s Pension Plan. Verily is majority-owned by Google parent Alphabet, which has added a new member to the Verily board, CFO Ruth Porat, and Egon Durbat from Silver Lake.

CEO Andrew Conrad, who is still there despite a brace of bad press two years ago [TTA 6 Apr 16], stated that “We are taking external funding to increase flexibility and optionality as we expand on our core strategic focus areas. Adding a well-rounded group of seasoned investors, led by Silver Lake, will further prepare us to execute as healthcare continues the shift towards evidence generation and value-based reimbursement models.”

One is tempted to say, ‘whatever that means’. They have had multiple ventures from contact lenses with Novartis’ subsidiary Alcon (reportedly discontinued but dating back with Google to 2014), diabetes with Sanofi, to sleep apnea with ResMed. VentureBeat reports they are cash-profitable and even venturing into areas such as small exploding needles that can extract blood through a wearable device–not precisely for the needle-phobic. There seem to be multiple projects in multiple directions that are primarily research. Certainly their finding at $1.8 bn is an outlier even at 2018’s big scale–but with Alphabet/Google as a parent and A-list partners, the risk is minimal. Mobihealthnews, Crunchbase

FDA clearance of Verily’s Study Watch. Late last week, Verily announced that their Study Watch was given a 510(k) FDA clearance. It records, stores, transfers and displays single-channel ECG. To date, there are no plans to use it beyond a handful of research studies primarily on cardiac disease. Mobihealthnews. Meanwhile, Google, not Verily, paid Fossil $40 million for a still under development smartwatch technology to fit into Google’s Ware OS area. It’s not known whether it is health related, but their CEO admitted that it was based on tech from the Misfit acquisition–and Misfit was focused on health tech. After the sale closing, it is predicted that some Fossil R&D staff will move over to Google. Back in 2015, Fossil paid $260 million for Misfit and their fitness tech but generally has stayed in the conventional smartwatch area. The story broke in Wareable. Also Mobihealthnews.

Will there ever be a medical ‘tricorder’?

December 5, 2018 | by | 1 Comment

ZDNet teases us that ‘the race is on’, but is it? It’s a great clickbait headline, but the substance of the article illustrates the distance between today’s tech reality versus the picture of Star Trek’s Bones pointing a Tricorder at a patient and immediately pronouncing that your malady was Sakuro’s Disease or some strange Vulcan malady.

Was it that long ago that the Scanadu Scout was the odds-on bet to be the Tricorder? The hype began in 2012 [TTA 23 May 2013] with Indiegogo funding, competing for the XPRIZE, and breathless pronouncements at nearly every healthcare conference. By 2016, it missed the Qualcomm Tricorder XPRIZE finals (with Northern Ireland’s Intelesens), bricked all sold units to date to comply with FDA regulations on investigational devices, and with Chinese money in hand, moved into other testing devices. Those looking for Scanadu today will be disappointed as their website is unreachable. The DeBrowers and medical director Alan Greene, all of whom were fêted on the healthcare scene, are engaged over at Doc.ai with a new mission of decentralizing precision medicine onto the blockchain using AI, using your medical data gathered on an app (of course).

Google X was up next as Scanadu was fading. There were various devices they were hyping and testing as Google’s life sciences skunk works morphed into Verily, but to date they have all petered out, with some questions raised about people and project churn at the Alphabet unit [TTA 6 April 2016] .

Basil Leaf Technologies (as Final Frontier Medical Devices) wound up winning last year’s final Qualcomm XPRIZE with DxtER, which could diagnose and interpret a defined set of 13 health conditions to various degrees, while continuously monitoring five vital health metrics, using a mix of sensors and an AI-powered diagnostic engine. What they are planning to market first is not DxtER, but a single-disease device to monitor congestive cardiac failure (CCF) since FDA approval for DxtER “would take aeons to be approved.”

Urine tests are also a ‘wet’ way into a tricorder state, with both Basil Leaf and the University of Glasgow working on devices which could quickly scan for metabolites in urine that indicate particular diseases.

QuantuMDx’s Q-POC, from Newcastle UK, is expected to launch in 2019 with handheld diagnostics for bacterial and viral infections. In addition to quick diagnostics for outbreaks in less developed countries, they are also developing diagnostics to prescribe the right antibiotic the first time. This is critical in treatment superbugs such as MRSA and MSSA, as well as more garden variety infections which can go wrong quickly. TTA profiled their crowdfunding launch in 2014.

The ZDNet article wraps up with a bit of romance about how a tricorder is needed for Mars, but down here on Earth, the reality is that a tricorder will likely be a combination of devices and analytics, stitched together by machine learning and AI.

Rounding up the roundups in health tech and digital health for 2017; looking forward to 2018’s Nitty-Gritty

December 29, 2017 | by | 2 Comments

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/12/Lasso.jpg” thumb_width=”100″ /]Our Editors will be lassoing our thoughts for what happened in 2017 and looking forward to 2018 in several articles. So let’s get started! Happy Trails!

2017’s digital health M&A is well-covered by Jonah Comstock’s Mobihealthnews overview. In this aggregation, the M&A trends to be seen are 1) merging of services that are rather alike (e.g. two diabetes app/education or telehealth/telemedicine providers) to buy market share, 2) services that complement each other by being similar but with strengths in different markets or broaden capabilities (Teladoc and Best Doctors, GlobalMed and TreatMD), 3) fill a gap in a portfolio (Philips‘ various acquisitions), or 4) payers trying yet again to cement themselves into digital health, which has had a checkered record indeed. This consolidation is to be expected in a fluid and relatively early stage environment.

In this roundup, we miss the telecom moves of prior years, most of which have misfired. WebMD, once an acquirer, once on the ropes, is being acquired into a fully corporate info provider structure with its pending acquisition by KKR’s Internet Brands, an information SaaS/web hoster in multiple verticals. This points to the commodification of healthcare information. 

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/12/canary-in-the-coal-mine.jpgw595.jpeg” thumb_width=”150″ /]Love that canary! We have a paradigm breaker in the pending CVS-Aetna merger into the very structure of how healthcare can be made more convenient, delivered, billed, and paid for–if it is approved and not challenged, which is a very real possibility. Over the next two years, if this works, look for supermarkets to get into the healthcare business. Payers, drug stores, and retailers have few places to go. The worldwide wild card: Walgreens Boots. Start with our article here and move to our previous articles linked at the end.

US telehealth and telemedicine’s march towards reimbursement and parity payment continues. See our article on the CCHP roundup and policy paper (for the most stalwart of wonks only). Another major change in the US is payment for more services under Medicare, issued in early November by the Centers for Medicare and Medicaid Services (CMS) in its Final Rule for the 2018 Medicare Physician Fee Schedule. This also increases payment to nearly $60 per month for remote patient monitoring, which will help struggling RPM providers. Not quite a stride, but less of a stumble for the Grizzled Survivors. MedCityNews

In the UK, our friends at The King’s Fund have rounded up their most popular content of 2017 here. Newer models of telehealth and telemedicine such as Babylon Health and PushDoctor continue to struggle to find a place in the national structure. (Babylon’s challenge to the CQC was dropped before Christmas at their cost of £11,000 in High Court costs.) Judging from our Tender Alerts, compared to the US, telecare integration into housing is far ahead for those most in need especially in support at home. Yet there are glaring disparities due to funding–witness the national scandal of NHS Kernow withdrawing telehealth from local residents earlier this year [TTA coverage here]. This Editor is pleased to report that as of 5 December, NHS Kernow’s Governing Body has approved plans to retain and reconfigure Telehealth services, working in partnership with the provider Cornwall Partnership NHS Foundation Trust (CFT). Their notice is here.

More UK roundups are available on Digital Health News: 2017 review, most read stories, and cybersecurity predictions for 2018. David Doherty’s compiled a group of the major international health tech events for 2018 over at 3G Doctor. Which reminds this Editor to tell him to list #MedMo18 November 29-30 in NYC and that he might want to consider updating the name to 5G Doctor to mark the transition over to 5G wireless service advancing in 2018.

Data breaches continue to be a worry. The Protenus/DataBreaches.net roundup for November continues the breach a day trend. The largest breach they detected was of over 16,000 patient records at the Hackensack Sleep and Pulmonary Center in New Jersey. The monthly total was almost 84,000 records, a low compared to the prior few months, but there may be some reporting shifting into December. Protenus blog, MedCityNews

And perhaps there’s a future for wearables, in the watch form. The Apple Watch’s disconnecting from the phone (and the slowness of older models) has led to companies like AliveCor’s KardiaBand EKG (ECG) providing add-ons to the watch. Apple is trying to develop its own non-invasive blood glucose monitor, with Alphabet’s (Google) Verily Study Watch in test having sensors that can collect data on heart rate, gait and skin temperature. More here from CNBC on Big Tech and healthcare, Apple’s wearables.

Telehealth saves lives, as an Australian nurse at an isolated Coral Bay clinic found out. He hooked himself up to the ECG machine and dialed into the Emergency Telehealth Service (ETS). With assistance from volunteers, he was able to medicate himself with clotbusters until the Royal Flying Doctor Service transferred him to a Perth hospital. Now if he had a KardiaBand….WAToday.com.au  Hat tip to Mike Clark

This Editor’s parting words for 2017 will be right down to the Real Nitty-Gritty, so read on!: (more…)

Verily’s million points of BYO health data to take to your next doctor visit

October 11, 2017 | by

Verily‘s visit to last week’s Health 2.0 conference had an odd-but-fun tack, comparing the data received from human bodies to the billions of data points generated by an average late-model automobile in normal operations. We generate a lot less (ten orders of magnitude difference, according to Verily Chief Technology Officer Brian Otis), but Verily wants to maximize the output by wiring us to multiple sensors and to use the data in a predictive health model. Some of the Verily devices this Editor predicts will be non-starters (the sensor contact lens developed with Alcon) but others like the Dexcom partnership to develop a smaller, cheaper continuous blood glucose monitor and Liftware, the tremor-canceling silverware company Google acquired in 2014, appear promising. Key to predictive health is the Study Watch, which is a wearable that collects a lot of data but is easy to wear for a long time. Mobihealthnews

But what to do with this All That Data? Where this differs from a car is that the operational data goes into feedback loops that tune the engine’s performance, perform long-term monitoring, electrical system, braking, and more. (When the sensors go south or the battery’s low, watch out!) It’s not clear from the talk where this overwhelming amount of healthcare data generated goes to and how it becomes useful to a person or a doctor. This has its own feedback loop this Editor dubbed a few years ago as the Five Big Questions (FBQs): who pays, how much, who’s looking at the data, who’s actioning it, how data is integrated into patient records. That’s not answered, but presumably these technologies will incorporate machine learning and AI to Crunch That Data into bite-sized parts.

Which leads us back to Verily’s parent, Alphabet a/k/a Google. All that data into Verily devices could be monitored by Google and fed into other Google programs like their search engines and Adwords. Another privacy problem? 

Perhaps health systems are arriving at the realization that they have to crunch the data, not avoid it. For the first time, this Editor has observed that a CMIO of a small health system in Illinois and Sanford Health‘s executive director of analytics are actually welcoming patient data and research. Startups in this area such as PreventScripts labor on that “last mile” of clinical decision support, preventative medicine. EHRs are also into the act. Epic launched Share Everywhere, where patients can grant access to their data and clinicians can send updates into the patient portal (MyChart). What’s needed, CMIO Goel admits, is software that combines natural language processing and algorithms to track by disease and specialty–once again, machine learning. Healthcare IT News 

Diabetes management: the Next Big Health Tech Thing?

September 14, 2016 | by

Big Data? Passé. Health IT security and hacking? At a peak. So what’s the Next Big Thing? If you’re tracking where the money’s going, it’s diabetes management. This week saw the joint venture Onduo formed by the controversial [TTA 6 Apr] life sciences-focused Verily (Google Alphabet) and Big Pharma Sanofi with a nest egg of $500 million. Onduo will be combining devices with services to help Type II diabetics. Based upon CEO Joshua Riff’s statements to MedCityNews, their platforms are yet to be developed, but “will be a digital platform that will involve software, hardware, and very importantly service” to change patient behaviors. Partnerships with Sutter Health in Northern California and Allegheny Health Network of western Pennsylvania will test their approaches in a clinical setting. Xconomy, Reuters

Verily’s other diabetes project include the £540 million bioelectronics partnership announced in August with UK-based GSK in Galvani Electronics [TTA 3 Aug] with a focus on inflammatory, metabolic and endocrine disorders, including Type II diabetes. With Dexcom, Verily is also building an inexpensive, smaller next-gen continuous glucose monitoring sensor; Mr Riff was coy about whether this sensor would be used but allowed that sensors might be used in Onduo’s approaches. Verily is also developing the well-known glucose-reading contact lens with Novartis [TTA 1 Sep 15].

Also this week, Glooko and Sweden’s Diasend announced their merger (more…)

Google’s Verily joint ventures with GSK into bioelectronics (UK/US)

August 3, 2016 | by

Verily, the Alphabet (Google) life sciences research group, and GlaxoSmithKline are partnering in a joint venture that may replace drugs for disease with micro-electronic implantable devices. GSK will own 55 percent of Galvani Bioelectronics, with Verily owning 45 percent. They have pledged an investment of £540 million in the new UK-based business over 7 years, as well as contributing intellectual property rights to Galvani. Most of the staff will be at GSK in Stevenage with some at Verily’s HQ in South San Francisco, and led by Kris Famm, formerly GSK’s vice president of bioelectronics R&D. The deal is expected to close by end of year.

According to Business Insider UK, GSK has been involved with bioelectronics for four years. It’s defined as “a relatively new scientific field that aims to tackle a wide range of chronic diseases using miniaturised, implantable devices that can modify electrical signals that pass along nerves in the body, including irregular or altered impulses that occur in many illnesses.” The diseases that are being targeted are inflammatory, metabolic and endocrine disorders, including type 2 diabetes. According to the MedCityNews interview of Verily’s CTO Brian Otis, the systems will be closed loop where the devices listen to the nerve signals, do real-time signal processing and send the optimized signal back to the nerve to restore healthy function. GSK has the diagnostic and biologic expertise, Verily has the device smarts. Also Mobihealthnews, Recode

Google’s Verily rolls along. Bumpily? (updated)

April 6, 2016 | by

Several articles of late have reported on the Google Alphabet life sciences company Verily. By fall last year, they had developed partnerships with Novartis-Alcon on development of a smart contact lens (for measuring glucose), plus Dexcom, Abbvie and Biogen. STAT, a health/medicine news website owned by Boston Globe Media which is still in beta, has a well-researched article that details, seemingly with a lot of inside scoop, its current turmoil. 12 top engineering and science executives have taken a powder. Some of the execs date back to the Google X days; most have fled back to Mother Google, others to Amazon or to life sciences competitors. STAT: “No similar brain drain has occurred at Calico, another ambitious Google spinoff, which is focused on increasing the human lifespan.” The reasons are the apparently abrasive CEO Andrew Conrad, depicted as ambitious, fickle and moody–and the constant shifting of support from approved projects to short-term initiatives ‘that show little promise’. Google’s bold bid to transform medicine hits turbulence.

Update: STAT published today information on a possible conflict of interest in Verily awarding a short-term research contract to a luxury health clinic, California Health & Longevity Institute, where Dr Conrad holds a majority ownership. According to the publication, it has no documented experience with this kind of work. The clinic will gather, in a 200-person ‘feasibility study’ for the larger Baseline study, genetic, molecular, clinical, and other data. According to Dr Conrad, it was done “Because I think it’s cool. Because it’s super efficient to have everything in one spot.” What may not be cool to the participants is that Baseline is already planning to sell the data to pharmaceutical companies–with patient consent, of course, in a document not yet public. Google’s biotech venture hit by ethical concerns