News roundup 16 Oct: Walgreens shuts 1,200 stores–500 in ’25, CVS exiting core infusion biz, Masimo v. Apple update, DEA recommends 3rd telehealth extension, Change hack costing UHG $705M, Owlet back in NYSE compliance

October 16, 2024 | by

A roundup of chickens coming home to roost? But some chickens are just happy to come home.

Walgreens’ Mound of Misery just grew a little higher. The headlines today were all about Walgreens’ closing 1,200 stores over the next three years. Their current store location roster is about 9,000, according to their website. 500 of these will be closed during their upcoming FY2025.  Their release stated this would be “immediately accretive to adjusted EPS and free cash flow”. (Were they making any money at all?) This helped to give their share price a nice bump from $9 to above $10 at market close today. Last year, Walgreens’ shares were priced above $22.

Q4 (closing 31 August) closed with a 6% boost in retail sales. However, losses were $3.0 billion versus a net loss of $180 million in the prior year’s Q4. The reasons cited in their release were a higher operating loss, a $2.3 billion non-cash charge for valuation allowance on deferred tax assets primarily related to opioid liabilities recognized in prior periods, and a non-cash impairment charge related to equity investment in China. The operating loss related to a non-cash goodwill impairment charge for CareCentrix. 

The full year was not cheery. Sales were $147.7 billion, an increase of 6.2% from a year ago (in constant currency, 5.7%). But losses in their FY2024 were $14.1 billion, a stunning increase of 104.5% compared to prior year.

VillageMD is being monetized along with other assets. “CEO Tim Wentworth said in the earnings call that the company is focused on “monetizing non-core assets to generate cash,” naming VillageMD as an example, to focus on its core retail pharmacy business.” HIStalk 16 Oct Can Walgreens shrink itself to profitability? Fierce Healthcare

Over at CVS, they’re doing their own shrinking. CVS is closing its core infusion services business, with plans to either close or sell 29 related regional pharmacies. Infusion services were bought from Coram LLC in 2013 for $2.1 billion. This Reuters exclusive was based on an 8 October memo and confirmed by a CVS press representative. Patients relying on antibiotics, drugs supporting muscular health, and intravenous nutrition services will be transferred to other providers. CVS will continue to provide certain services: specialty medications and enteral nutrition, or tube feeding, at pharmacies in Minnesota, Pennsylvania and San Diego, with nationwide nursing services. Hat tip to HIStalk 16 Oct.

Masimo wins one big patent challenge, loses one (or four), to Apple. 

The Win: Apple had sued Masimo in the US District Court of Delaware for patent infringement of Apple’s utility patent 10,942,491 B2 (“the ‘491 patent”). Masimo was charged as violating Apple’s patent on 19 features. Masimo appealed to the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office (USPTO) for an inter partes review (IPR) of the patent on the grounds of ‘unpatentability’, a very high proof. Masimo succeeded in this, rendering Apple’s ‘491 patent useless. Apple can appeal but the likelihood of success against the PTAB ruling that required three administrative patent judges to review, at this level of proof, is low. In this Editor’s view, this may spur other developers to come up with innovations now that these 19 features have been deemed unpatentable.

The Loss (I think): In review in the Delaware District Court are four complicated lawsuits between the two combatants, with Apple’s premise that Masimo has infringed upon other patents. Masimo alleged “inequitable conduct” by Apple in their patent filings with the PTO, essentially alleging fraudulent filings on multiple patents. Apple has been granted a summary judgment on Masimo’s claims, throwing them out.

Interestingly, Masimo–never shy to announce wins versus their foe Apple under the prior leadership of Joe Kiani–has remained strangely mum. (Perhaps everyone is waiting for the takeover dust to settle?) Will the ‘new’ Masimo be so combative against Apple? A far more detailed analysis for the patent mavens is in Strata-gee. A very large hat tip and bow to their editor, Ted Green, who writes about marketing primarily in the audio/visual business but has been 100% on top of The Masimo Saga–thank you!

To no one’s surprise, DEA kicks the telehealth waiver can down the road–for the third time. The Drug Enforcement Administration (DEA) sent to the White House’s Office of Management and Budget (OMB) a proposed rule to extend telehealth prescribing of Schedule II and higher controlled substances without changes. These waivers which removed the in-person examination requirement under the Ryan-Haight Act were instituted during the Covid pandemic and extended twice [TTA 11 Oct 23, 11 May 23] with a final expiration of 31 December 2024. In September, reports indicated that DEA not only wanted to restore prior restrictions but also wished to introduce additional ones. However, their timing (September!) given Federal standards of publishing draft rules and lengthy comment periods before a final rule was impossible to be achieved by year’s end. [TTA 13 Sept]

Whether OMB will approve the extension (to a date that cannot be confirmed since the text is unavailable, but reportedly one year) is not certain, as it may be disputed by the Department of Health and Human Services (HHS). Since the waiver is due to expire at the end of the year, this may help to assure the multitude of mental health and other telehealth companies dependent on legal remote diagnosis and prescribing controlled substances that their businesses can continue. FierceHealthcare

UHG didn’t have a happy quarter either due to Change. The total hit to UnitedHealth Group of the Change Healthcare hack is now estimated at $705 million, or 75 cents a share. Their 2025 guidance on profit is a lackluster $30 per share–below Wall Street estimates of $31.18. Government plans’ cuts in payments for Medicare Advantage plus and low state payment rates for Medicaid are affecting UHG as well as nearly every other payer. UHG’s share price on the news reacted negatively, falling 9% and dragging down other payers as well. UHG must rue the day they bought Change Healthcare, as it has been largely bad news ever since. CNBC

And winding up on a happy note–Owlet is back in good graces with the NYSE. Last year, they faced a NYSE notification that they were out of compliance with the $50 million minimum valuation of the company over a consecutive 30-day trading day period. They are now in compliance and their Class A shares can trade without the ‘BC’ black mark and no longer be listed as such on the NYSE website. The NYSE will be following its standard procedure of a 12-month follow-up on compliance. Release, Mobihealthnews

The baby sock and baby monitoring company has had a rough couple of years between a cracked SPAC (2021), FDA notifying them at the end of 2021 that they considered the Smart Sock a medical device, forcing the company to pull it from distribution [TTA 4 Dec 21], mounting losses, layoffs, and rebuilding with an FDA-cleared BabySat and enhanced Dream Sock [TTA 21 June 23]. Usually, this concatenation of events means the company either shuts or sells, but Owlet has done neither and bootstrapped itself. Revenue in their Q2 ending 30 June was up 58% year over year with a narrower operating loss of $2.2 million, compared with $6.7 million in prior year. It recently expanded their European distribution of the Dream Sock after CE Mark certification in May to a total of 11 countries [TTA 18 Sep]. 

News roundup: Owlet expands to EU, mPulse buys Zipari, New Mountain PE merges 3 payment integrity firms in $3B smush, Candid Health’s $29M raise, Oura buys Veri, Bloomer Tech’s cardio bra

September 18, 2024 | by

It’s a dogpile of catchup news.

Owlet announced that it’s expanding its European distribution of the Dream Sock. The new countries are Greece, Poland, the Czech Republic, Romania, Slovakia, Hungary and Bulgaria. It is currently, according to its website, available in France, Belgium, the Netherlands, and Luxembourg. It received its CE Mark certification in May. The Dream Sock is a non-prescription device that reports, for babies 1-13 months and 6 to 30 pounds, pulse rate, oxygen, wakings, and sleep trends in real-time via the Owlet Dream App. The app also allows alerts outside of range to be set. Owlet’s financials have improved substantially, though still in the loss column, as detailed in the Mobihealthnews article.

mPulse acquired Zipari for an undisclosed price. Both companies are in the healthcare ‘consumer experience (CX)’ segment which broadly includes using consumer information to ‘personalize health journeys’ that enhance the consumer experience for its health plans. Zipari is apparently more the back end of CX software solutions for insurers, third party administrators, and healthcare payers. There was no disclosure of sale price nor of transition of Zipari staff or the brand name. mPulse now covers 400+ leading healthcare organizations, including 29 of the 30 largest health plans in the country. mPulse is private and controlled by PSG. Release

Private equity company New Mountain Capital, in a $3 billion move, merges three payment integrity companies. New Mountain merged The Rawlings Group, Apixio’s Payment Integrity business, and Varis into a single $3 billion, 2,000 employee company around payment accuracy using various technologies. Rawlings is the largest with over 1,400 employees. It identifies third parties responsible for paying medical claims and is over 40 years old. Apixio provides administration, clinical, and financial program services for payers, previously part of Centene. The remainder of the company–its connected care platform and value-based care services–will be acquired by Datavant. Varis provides overpayment identification solutions including diagnosis-related groups (DRG) and ambulatory payment classification (APC) prospective payments. ‘Smushing’ makes sense if there is one controlling investor and the services dovetail with each other; from the description, the main company will be Rawlings. One hopes that they work out the ‘big bang’ details. FierceHealthcare

In a rare fairly large Series B funding, Candid Health scored $29 million. Candid is a revenue cycle automation and integration platform that simplifies billing for providers through API integrations with current system. The raise was led by 8VC with participation from existing investors First Round Capital, BoxGroup, and Y Combinator. Their total funding since 2019 is $47 million. Release

The Oura ring from Finland is not only still around, but is acquiring a metabolic health company, Veri. One of those ‘neat ideas’ which this Editor thought was gone is still around, having sold 2.5 million rings both direct and through Best Buy currently for $69.99 annually plus local tax, and now tracks over 20 biometrics around sleep, activity, heart health, and stress. Oura has had $148 million of funding since 2013, with its last big $100 million Series C back in the Palmy Days of 2021, with a small venture round in 2022. Veri is also Finnish, already partners with Oura, and has an app that via CGM (Abbott FreeStyle Libre) guides users to the right foods and habits for their bodies. Oura will be launching in conjunction with Veri a new feature, Meals, to help members to see how meal timing affects health metrics like sleep, stress, and recovery. Many of Veri’s team will be joining Oura, including their three founders. Release, Mobihealthnews 

An ECG that looks and wears like a bra. That is the device designed by Bloomer Tech, a MIT spinout. This wearable violates the “smaller and less obtrusive is better” dictum to collect more and more accurate data. The bra design places sensors all around a woman’s torso, the best position for heart data, in an accustomed way to collect data on heart function, lungs, hormones, and metabolism. It connects to an app that collects information and sends it to the wearer’s health provider. Bloomer Tech’s market will be women at risk or with heart disease, with the bra as a prescription item. Its first clinical trial was launched in March, funded by a $1.9 million grant from the National Institutes of Health. It comes in 12 sizes from 32B to 44C, Axios Boston

The two women founders, Chong Rodriguez and Aceil Halaby met in the MIT’s masters degree program, founding it in 2018. They named it after Amelia Bloomer, a 19th Century American suffragette, social reformer, publisher/writer, and advocate for less restrictive forms of dress than the whalebone corsets and tight dresses customary of the period. MedCityNews

Short takes 2: Humana’s CEO changeover; Owlet Dream Sock CE Mark, UK approval; TytoCare goes to school; LG enters home health with Primefocus; Samsung $92M buys Sonio (FR); raises by Blackwell in health cybersec, Watershed Health

May 16, 2024 | by

Keeping it short and sweet for the end of the week.

Payer Humana changing out CEOs. The wrap for current CEO Bruce Broussard is coming a little earlier than anticipated, with the planned changeover to Jim Rechtin on 1 July. Mr. Broussard will depart the board of directors but stay on as a ‘strategic advisor’ until 2026, which is a typical arrangement for CEOs usually tied to compensation. Mr. Rechtin’s experience prior to joining Humana as president/COO in January was as Envision Healthcare’s CEO and with OptumCare and DaVita. Last year, Humana and Cigna failed to merge after shareholders disapproved and the evident conflict in PBMs [TTA 13 Dec 23]. 2024 earnings were revised downwards in April due to ongoing losses in Medicare Advantage plans. Release, FierceHealthcare

Owlet’s Dream Sock now has EU CE Mark, UK medical device approvals. The European medical device clearance by the EU notified body was announced on 2 May, with the UK certification following on 14 May. As certified for the EU and UK, the Dream Sock is intended for use with healthy infants between 0-18 months and 2.5-13.6 kg. The Dream Sock measures oxygen saturation and pulse rate which are reported on a smartphone app and on a base station to provide baby sleep insights. In the US, it was FDA cleared under de novo last November. It is sold without prescription through retailers and directly through Owlet. Owlet plans to debut it in Germany, France, and the UK later this year. CE Mark, UK releases. Mobihealthnews

TytoCare expands a logical market–school RPM. Their school health initiative that started before the pandemic has added or expanded in five healthcare systems. This brings primary and urgent care services to over 2,500 schools in 31 states. Three of the five systems are Cone Health (North Carolina), Sentara Health (Virginia), and A Plus Family HealthCare (Kentucky). TytoCare works with school nurses and adminstrators for remote diagnostics, not only for children presenting with illness but also for monitoring children with chronic conditions. Blog, Mobihealthnews

LG NOVA launches Primefocus Health in North America. LG, well known for monitors and TVs in healthcare settings, is introducing a “provider-focused, patient-centric healthcare platform” to connect patients in home care with their providers. It will use “innovative non-invasive technology for tracking patient progress for multiple medical conditions, which can be integrated with the provider’s electronic health record system, artificial intelligence and machine learning capabilities for ease of use.” No demos or further specifics are provided.  LG NOVA is LG Electronics North America Innovation Center and demonstrates an interest in additional healthcare expansion. Release, Mobihealthnews

LG’s rival Samsung buying France’s Sonio for $92 million. The fetal AI ultrasound company originally partnered with Samsung Healthcare France in 2021 in order to confirm the efficacy of its AI for pregnancy/prenatal monitoring. It raised a $14 million Series A last year for a US commercial launch of their AI FDA 510(k) cleared Sonio Detect, a machine-agnostic AI assistant software for reporting and imaging. Samsung Medison, the ultrasound division of Samsung, must await French regulatory approvals, including the French Ministry of the Economy and Finance. Release, MedTech Dive

And in latest fundings:

Healthcare focused Blackwell Security now has a $13 million Series A, led by co-creators General Catalyst and Rally Ventures. The funding will expand their Managed Healthcare Extended Detection and Response (MHXDR) offering. They are also acquiring their first CEO, Geyer Jones, from cybersecurity/IoT companies Cylera and RSA.  Release, Mobihealthnews

New Orleans-headquartered Watershed Health completed a $13.6 million venture round funding. This was led by First Trust Capital Partners with participation from FCA Venture Partners, Create Health Ventures, Impact Engine, 450 Ventures, LDH Ventures II/Launchpad Digital Health, and others that adds to a 2022 $9.8 million venture round. The new funding will be to expand their SaaS platform plus grow the engineering, development, customer success and sales teams. Watershed is a care coordination platform with a community focus that connects clinical and non-clinical providers such as SDOH resources. Release

News roundup: UHG CEO’s Bad Day at Capitol Hill; Kaiser’s 13.4M data breach; Walgreens’ stock beatup; Cigna writes off VillageMD; Oracle Cerner shrinks 50%; Owlet BabySat gets Wheel; fundings for Midi, Trovo, Alaffia, Klineo

May 2, 2024 | by

It was a Bad Day at Boot (Capitol) Hill for UnitedHealth Group’s CEO Andrew Witty. On May Day, he was the Man In The Arena facing two Congressional grillings–the first from the Senate Finance Committee in the morning, and the second in the afternoon from the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations. The precipitating event was the Optum/Change Healthcare data breach and system hacking by ALPHV/BlackCat, a disruption which is as of today not fully resolved.  Millions of patients may have had data stolen and exposed–a number that has yet to be determined, but an outcome for which UHG, while paying the ransomwaristes, has prepared. Already, the VA has notified 15 million veterans and families of that possibility.

This Editor will be linking below to multiple articles and Mr. Witty’s prepared testimony. Interested Readers can also refer to YouTube for extensive links to video testimony. Highlights:

  • Both houses criticized the slow response and amount of financial assistance given to providers after the shutdown of Change’s systems prevented (and still is preventing) timely claims processing and payment. While ‘near normal’ volumes of medical claims and 86% restoration of payment processing sounds good, that leaves a lot of wiggle room on over two months of totally disrupted processing and payment. The billion or so cited sounds impressive but much of this is in loans. Most practices and groups simply do not have the financial cushion or billing skillset to bridge this disruption, to pay back loans, or to bookkeep this.
  • Also criticized at this late date was UHG being unable to determine how many individuals had PHI exposed in the breach.
  • As to cause, the description of UHG finding that surprise, surprise, Change’s systems were way out of date, stored on physical servers versus the cloud, and used Citrix remote access without multi-factor authentication (MFA) was utterly savaged. According to Mr. Witty, ALPHV after days of knocking around got in on the one server that did not have MFA authentication.

The blunt fact is that UHG had close to two years (January 2021-Oct 2022) before the buy closed. Due diligence consisting of a full audit had to have been done on Change’s IT systems. They processed what UHG wanted to buy. In this Editor’s estimation, Job #1! for UHG should have been ensuring that Change’s systems were hardened, then upgrading to what Mr. Witty called UnitedHealth’s standards. This Editor will go further. A minimum requirement for the sale should have been security hardening. There was time before the closing.

Senator Thom Tillis, R-North Carolina, had the best riposte. He brought a copy of “Hacking for Dummies” to the hearing, highlighting MFA. I doubt he was much moved by UHG now bringing in cybersecurity company Mandiant to both investigate and harden their systems, nor by UHG having to pay ransom, without knowing whose data was compromised.

  • Beyond the breach, UHG was called ‘monopolistic’ by both Republican and Democrat Members. There were calls to break up UHG as not ‘too big to fail’. UHG has grown by acquisition and consolidation of services. As this Editor has speculated, this is likely coming to an end with the new, much more stringent Merger Guidelines. This sentiment paints a large, unmissable target on UHG’s back for aiming FTC’s and DOJ’s missiles. (DOJ also has a huge score to settle with UHG dating back to the failure to block the Change sale.)

By the end of the day, Mr. Witty looked quite the worse for wear–tie and collar askew, slightly sweaty, versus the perfect poses of the various Members. Becker’s, FierceHealthcare, Axios, HealthcareDive    Mr. Witty’s Senate testimony statement, House testimony statement

Speaking of data breaches, Kaiser Permanente reported a big one to Health and Human Services (HHS). This relates to ad tracker information shared with third-party advertisers such as Google, Microsoft, and X. Kaiser used it in secured areas of their website and mobile apps. Information disclosed could be name and IP. Kaiser reported it on 12 April but only disclosed on 25 April that 13.4 million records may have been affected. The ad trackers have since been removed. TechCrunch, FierceHealthcare 

Walgreens stock not recovering. April was WBA’s worst month in five years and May is no better, with the stock muddling around $17.50. The month slid around 18%. Their 52-week high was $33. As of now, CEO Tim Wentworth’s actions such as closing locations and writing down VillageMD haven’t convinced Mr. Market of WBA’s worth, but in fairness it’s early in his tenure. In the Insult to Injury Department, it was revealed that the IRS is seeking to claw back $2.7 billion in unpaid 2014-2017 taxes. Crain’s Chicago Business

Cigna is also writing down its interest in VillageMD. Almost forgotten is that in late 2022, Cigna invested $2.5 billion into VillageMD. They have now written down $1.8 billion of that ‘low teens’ ownership. The planned tie was connecting Village Medical into Evernorth, Cigna’s medical services area. It was also supposed to provide Cigna with an annual return on investment, but one assumes it did not. The writeoff threw Cigna’s Q1 into the red with a net loss of almost $300 million versus a prior year profit of $1.3 billion, despite a strong quarter that grew revenue 23% versus prior year to $57.3 billion. Healthcare Dive

Oracle Health has been successful–in shrinking Cerner by close to half. Records of employment at Cerner’s Kansas City-based operation have declined from 11,900 people in 2022 (Kansas City Area Development Council) to a current 6,400 (internal documents). Cerner itself reported 12,778 local full-time-equivalent employees in 2022. Oracle had multiple layoffs of Cerner affecting Kansas City workers and has consolidated multiple office buildings and campuses. Becker’s

In more cheerful news:

Baby monitor Owlet announced a strategic partnership with Wheel for Owlet’s BabySat. BabySat is Owlet’s FDA-cleared prescription vital signs monitor for infants 1-18 months. Wheel clinicians can now prescribe BabySat which enables parents to order BabySat from Owlet and other suppliers. With Wheel, BabySat also integrates with durable medical equipment (DME) suppliers who accept and can bill for the product through many insurance providers for partial or full reimbursement. Wheel is a virtual care platform and physician/nurse-practitioner online network available direct to consumer and to enterprises. Owlet release

And rounding up funding:

MidiHealth closed a $60M Series B funding. This was led by Emerson Collective with participation from Memorial Hermann, SemperVirens, Felicis, Icon Ventures, Black Angel Group, Gingerbread Capital, Able Partners, G9, and Operator Collective for a total of $99 million in funding. Midi provides virtual support for women going through peri- and full menopause. The fresh funding will help them expand national insurance coverage, hire and upskill an additional 150 clinicians by end of year, diversify service lines, and scale to care for 1 million+ women per year by 2029. Release

Trovo Health launched with $15 million in seed funding, led by Oak HC/FT. The NYC-based AI-powered provider task assistance platform will use the funding to build its technology platform, clinical operations, and leadership team. Mobihealthnews 

In the same roundup, NYC-based Alaffia Health scored a $10 million Series A round. This was led by FirstMark Capital with participation from Aperture Venture Capital. Alaffia creates generative AI solutions for payment integrity in health insurance claims operations, with the aim of eliminating insurance fraud, waste, and abuse for health plans, third-party administrators, self-insured employers, stop-loss carriers, and government agencies. Their total raise to date is $17.6 million. Paris-based Klineo also raised €2 million for its oncology clinical trials search platforms, assisted by AI, for the use of doctors and patients. BPIFrance and business angels participated in the round.

Davids (AliveCor, Masimo) v. Goliath (Apple): the patent infringement game *not* over; Masimo’s messy proxy fight with Politan (updated)

April 4, 2024 | by

Apple’s legal department certainly hasn’t been maxing their relaxing this year, what with DOJ and pesky upstarts taking them to court. The big one keeping them busy is the US Department of Justice (DOJ) giving Apple a dose of its own medicine in filing an antitrust lawsuit against Apple for monopolizing smartphone markets [TTA 22 Mar]. Apple also continues to fight antitrust and intellectual property (patent) infringement in Federal district courts, the US Patent and Trademark Office (USPTO)’s Patent Trial and Appeal Board (PTAB), and the International Trade Commission (ITC), brought by ECG reader AliveCor and Masimo‘s pulse oximetry reader and software. Masimo succeeded in disrupting Apple’s sales of the Watch Series 9 and Ultra 2 right at the Christmas holiday sales season [TTA 28 Dec 23], forcing Apple to disable the pulse ox feature [TTA 18 Jan] in future imports in one of Apple’s few losses.

The DOJ lawsuit does not address Apple’s copycat activities against either AliveCor or Masimo. Both companies worked with Apple.  AliveCor integrated its early KardiaBand (2016) with early Apple Watches, only to have cardiac readings integrated into the Apple Watch two years later (2018). Masimo and Apple were in mid-stages of a 2021 partnership that Apple broke off, but Masimo then accused Apple of hiring its employees working on the project [TTA 27 Oct 23].

AliveCor hasn’t been quite so successful as Masimo in challenging Apple, but it has been fighting Apple as a David v Goliath on multiple fronts for years. In February, AliveCor lost a round in the US District Court for the Northern District of California on the heart rate algorithm changes Apple made in 2018 that made their SmartRhythm app provided to Apple non-functional. That decision reportedly is still under seal. However, AliveCor has multiple Federal patent infringement lawsuits going against Apple. The differing rulings of the PTAB against and an ITC ruling finding for AliveCor went to the Federal circuit court level. According to CEO Priya Abani in an excellent MedCityNews article, AliveCor expects to see action on this by summer. Abani also scored Apple’s annoying (understatement) habit of IP infringement and broken partnerships. “Apple’s vast resources allow them to squash small innovators,” she said. “They have more lobbyists and lawyers on their payroll than we have employees.”

AliveCor and Masimo aren’t the only ones battling Apple. In the MedCityNews article, NYU Langone cardiologist Joseph Wiesel has sued Apple on patent infringement on his atrial fibrillation app (2021), also involving the USPTO, an action that is wending its way through courts now. While this Editor has long been mystified by Apple’s continued combativeness against small innovative companies when certainly it would be cheaper (and more respectful) to pay a license or settlement, FTA in MedCityNews citing Dr. Wiesel’s attorney Andrew Bochner, “Apple is known among the legal community to have a certain modus operandi: they do “not entertain any sort of real settlement discussions” and instead battle “tooth and nail” in order to wear out their rivals with fewer resources.” The shocker here is that Apple, in this case, stated to Bochner that it filed “roughly 10%” of the USPTO’s total post-grant proceedings, which take place after a patent has been granted and generally challenge a patent’s validity. One wonders whether DOJ will even take note of this anticompetitive activity involving Apple Watches in its blunderbuss action on iPhones and the US smartphone market.

Masimo itself is being roiled by a shareholder proxy fight over who controls the company. Masimo is a publicly-traded (Nasdaq) electronics company that is primarily focused on health devices, including smartwatches, and data software monitoring for the clinical and consumer markets, notably pulse oximetry.

  • Last week, activist investor group Politan Capital Management accused CEO Joe Kiani and others of mismanagement, announcing the nomination of two more independent candidates from Politan for the board of directors. Politan already has two seats on the BOD and a win here would give Politan majority control.
  • The bone being picked is Masimo’s February 2022 $1 billion acquisition of consumer audio brand Sound United (Polk, Marantz, Denon, and others) which didn’t mesh well with their health tech business. This drove down the share price from that time, with Politan subsequently swooping in and picking up shares, successfully winning two BOD seats in 2023.
  • Masimo announced on 22 March that their consumer ‘hearables’ division would be spun off.
  • Politan’s response on 26 March was to object to the spinoff on governance grounds, nominate the additional directors, and heavily criticize CEO Kiani’s ‘control and influence’. Strata-gee 26 March

Yesterday’s follow-up is that Kiani and Masimo are rebutting all of Politan’s claims and more. Strata-gee 2 April, Masimo release 1 April, MedTechDive

This Editor notes that products in their personal monitoring line combine both audio and vital signs monitoring–the (out of stock) Stork, that appears with its baby sock to be directly competitive with Owlet’s Dream Sock.

This will all play out at the yet-to-be-announced 2024 Shareholders Meeting. This Editor notes that Politan picks its battles and is rarely defeated. Our Readers may recall that Politan swooped in on Centene Corporation in late 2021, and in short order ousted long-time directors, added new friendly ones, shook up management and forcibly retired 25+ year CEO Michael Neidorff (since deceased). Masimo’s victory over Apple may go down as either not mattering much–or that Apple will be fighting a much deeper-pocketed backer that knows how to win.

Update: It gets stranger. Masimo’s Consumer (audio) division’s brand president and general manager Joel Sietsema announced on Tuesday that he is no longer with the company. He came to Masimo through the Sound United acquisition being with them for a decade. He announced his departure on LinkedIn. It was apparently a mutual decision that preceded the current turmoil. Strata-gee 4 April

News roundup: Owlet’s Dream Sock, BabySat go to market; General Catalyst’s HATco agrees to buy Summa; Cigna’s contrasting provider strategy; new ElliQ robot assistant debuts at CES

January 18, 2024 | by

JP Morgan’s Healthcare Conference (JPM) and CES are as expected big generators of news around digital health–here’s a selection from then and more:

Owlet launches Dream Sock and BabySat at CES. Both were FDA-cleared in November and June 2023 respectively. The Dream Sock baby monitor received first-of-kind de novo clearance for pulse oximetry and sends real-time Health Notifications for low pulse rate, high pulse rate, and low oxygen to parents’ smartphones. Target market is infants 1-18 months and 6 to 30 pounds with direct sale on the Owlet website at $299.

The BabySat is the prescription-only version (left) targeted to infants 1-18 months and 6-30 pounds, but with acute or chronic medical conditions. It also has the unique capability not only to track vital signs but also for the provider to customize alarms for oxygen saturation and pulse rate. Owlet’s BabySat information page explains in plain English the type of medical conditions where the BabySat would be of assistance and the steps to obtain a prescription that is fulfilled through their partner AdaptHealth. A virtual Rx and insurance reimbursement are in the works. A small drawback is that it is only usable with an iPhone. Happily, their stock is also on the rebound at the highest point in six months. Having followed them since the ‘telehealth for the bassinet set’ days of 2012-2013, their continued independence, their rebound from some dark days, as well as their focus on baby health, this Editor continues to wish them bonne chance. Owlet release (via Yahoo Finance).

Big Investor General Catalyst announced their first acquisition move for the Health Assurance Transformation Corporation (HATCo) not at JPM but today (17 Jan). Summa Health is a $1.8 billion (in revenue) non-profit integrated healthcare system headquartered in Akron, Ohio that encompasses hospitals, community medical centers, a health plan, an accountable care organization, a multi-specialty physician organization, medical education, research and the Summa Health Foundation. HATCo’s objective is to transform healthcare towards a goal of “health assurance”, defined as “a more affordable, accessible and proactive system of care” where presumably their extensive experience in investing in healthcare gives them expertise. [TTA 10 Oct 2023] The letter of intent initially sets up a partnership with immediate investment in Summa while due diligence takes place, then when completed moves to a definitive agreement with details of the acquisition and a transaction price in the next few months. Summa would move from a non-profit to a for-profit in becoming a subsidiary of HATCo. According to their information, current management will remain in place.

Summa’s incentive is to stem losses, reportedly at $37 million through Q3 2023, more than double the prior year. HATCo in November stated its desire to buy a health system in Summa’s $1 to $3 billion range. As usual, the buy is subject to regulatory approvals and a final closing date.  HATCo release, Summa Health statement on “our future”, FierceHealthcare

To the contrary, Cigna prefers to partner, not own, healthcare providers. As a payer closer by many degrees to hospitals and practices than General Catalyst, structured much like UnitedHealth Group with Evernorth its counterpart to Optum, they have avoided the aggressive ownership of physician practices. UHG employs about 10%–90,000–physicians through ownership of practices as of December 2023. MedPageToday  At JPM, Cigna CEO Eric Palmer emphasized ‘strategic relationships’ like a minority share of VillageMD (majority owned by Walgreens) in their acquisition of Summit Health, and creating an ‘ecosystem’ that connects to the best partners. Their investments will be wrap-around services in home health, behavioral and virtual care now that a merger with Humana is once again off the table. Becker’s Payer They’ll have some cash to do so; Cigna’s sale of their Medicare Advantage business will likely be to Health Care Service Corporation (HCSC) and fetch $3 to $4 billion. Becker’s Payer

Intuition Robotics debuts ElliQ 3 at CES. An interactive desktop companion robot designed to improve social connection and alleviate loneliness of older adults and those with assistive needs, the new version updates the robot hardware and software capabilities including generative AI capabilities powered by Large Language Model (LLM). The new design from Yves Behar’s design studio, Fuseproject, is also 1.3 pounds lighter and has a 36% smaller footprint which makes it easier to both place and handle, along with a fully integrated screen. Technical improvements include an octa-core SoC and a built-in AI processing unit (APU); 33% more RAM, twice the amount of computing power and memory, and an inclusion of a dual-core AI processing unit (APU), all of which are needed to power generative AI for greater ‘conversant’ capabilities. The LLM technology integrated into the Relationship Orchestration Engine makes real-time decisions regarding actions, scripted conversation, and generative AI conversations. For instance, the person speaking with ElliQ may talk about activities and beliefs, which are stored and classified. In another conversation, ElliQ may use that information to suggest participation in activities and social interactions, while ensuring that the context and flow of conversation is ‘guardrailed’ and appropriate. The AI can also assist the person in activities such as painting or writing poems together.

Current partners include the New York State Office for the Aging, Inclusa (a Humana company), and the Area Agency on Aging of Broward County, as well as newer partners like The Olympic Area Agency on Aging, Ypsilanti Meals on Wheels, and others. Release

Israel-based Intuition Robotics most recently raised $25 million in August 2023 in an unlettered round with $20 million in venture capital plus $5 million in venture debt. TTA 19 Sept 2023

Short takes: Owlet Dream Sock FDA clearance; Best Buy-Mass General partner for at-home care; Amazon offers Prime members deeper One Medical discount

November 10, 2023 | by

Some really good news for Owlet. The Dream Sock finally got to the mountain top and received de novo FDA clearance for pulse oximetry. To date, it is the only over-the-counter medical pulse oximetry device for the baby market. This adds to the device’s Baby’s Live Health Readings, including pulse rate and oxygen saturation level. The platform also provides Health Notifications, which send alerts to a smartphone with lights and alarm sounds if baby’s readings fall outside of preset ranges. Existing and new Dream Sock buyers will be upgraded to the new features by end of 2023. The Dream Sock is for use with infants 1-18 months and 6 to 30 pounds. Pricing observed for the current Dream Sock is in the $300 range. Owlet release

This follows FDA clearance for the prescription BabySat in June [TTA 21 June]. That is scheduled to be introduced later this year in the US only. The non-prescription Dream Duo, which combines the Dream Sock with a baby cam, will continue to be sold. 

Financially, things have improved a lot since last year. The stock as of 11 July was restored to NYSE listing, but it required a reverse split and an 18 month compliance plan, Currently, it’s trading at about $4.80 which is NYSE compliant, up from well below $1 in June. Also in July, they hired a new president and chief revenue officer, Jonathan Harris, from recently acquired air purification system Molekule. In August, they reported a Q2 adjusted EBITDA loss of $4.3 million, narrowed substantially from prior year Q2’s $16.7 million. This was achieved on lower revenue of $13.1 million versus last year’s $18.3 million. Q1 revenue was $10.7 million. Q3 will be reported on 13 November. Release  Having followed them since the ‘telehealth for the bassinet set’ days of 2012-2013, their continued independence, and their focus on baby health, this Editor continues to wish them bonne chance.

Mass General Brigham’s hospital-to-home and home care programs get a Best Buy boost. Mass General plans to integrate Best Buy’s delivery capabilities for their Healthcare at Home program in several areas. For Home Hospital acute care, Best Buy will supply the Current Health remote patient monitoring program to build out a technology-enabled clinical delivery model that connects patients to nurses, paramedics, advanced practitioners, and physicians. For Home Care, Best Buy will supply Lively Mobile Plus personal emergency response system (PERS) and leverage out capabilities such as Geek Squad to supply Mass General Brigham (MGB) patients with delivery of home-based care and logistics management for the care team. MGB plans to introduce Best Buy as part of Home Hospital in five Boston-area acute care hospitals. The program is for patients with heart disease, chronic obstructive pulmonary disease (COPD) and infections. While their Home Care operation is stated by MGB to be the largest certified provider in New England, the Home Hospital program can presently cover only 33 patients at a time. MGB’s goal is to shift 10% of inpatient care to patients’ homes over the next five years, so expanding capacity and capabilities are critical. FierceHealthcare, Mobihealthnews, MGB release

Get your One Medical now, just $99 per year or $9 a month! It’s an offer hard to refuse for Amazon Prime members. It’s half off the annual membership of $199, with additional members up to five for only $6 a month or $66 annually. What Prime members get is 24/7 virtual care access without further charge through their app that includes video chats with licensed providers plus their “Treat Me Now” service, fast care for common issues like cold and flu, skin issues, allergies, and urinary tract infections. It does not include any One Medical in-office services, if available in the member’s area. The 200 million+ Prime members were briefly offered in February a $144 membership but apparently this new incentive is not only at a deeper discount, but also longer term or permanent.

Time to make that $3.9 billion acquisition pay off. This push is clearly to build up One Medical membership, which stood at only 836,000 members at end of 2022, and build up cash flow. Amazon is not reporting on the success of the earlier discount offer. A question this Editor has–if 1 million Prime members signed up–that’s only a 0.5% rate–does One Medical have the telehealth capacity to serve these patients, especially at peak usage such as cold and flu season?

Prime members are also able to access Amazon Care, which is virtual only, cash-only by medical event asynchronous telehealth services. If a Prime member goes in person to a One Medical practice, they do take insurance. FierceHealthcare, Healthcare Dive, Amazon Prime offer page

Wednesday roundup: Owlet BabySat monitor clears FDA; Rosarium Health seed $1.7M led by Rock Health; Optum Startup Studio shuts; CareRev lays off 100, changes CEOs; pet telehealth Fuzzy shuts, leaves workers and vendors in lurch

June 21, 2023 | by

Owlet’s BabySat medical pulse-oximetry device receives FDA clearance. The wire-free sock design connects to a mobile app and tracks pulse rate and oxygen saturation level. The app alerts parents and caregivers when those readings fall outside ranges set by a physician. Launch is projected for later in 2023. Unlike other Owlet socks and systems, it will be by physician prescription only for babies that the doctor determines should have additional monitoring at home. There is a button for interested consumers (and presumably clinicians) to be notified of release information. Owlet release, Owlet product page, Mobihealthnews.  The original Smart Sock continues to be offered as a consumer product outside of the US and Canada. Owlet’s Dream Sock tracks non-clinical quality sleep quality indicators, including heart rate, average oxygen, wakings, and baby movements. In December 2022, FDA accepted Owlet’s de novo application for an enhancement to Dream Sock that provides heart rate and oxygen notifications in addition to sleep monitoring tools [TTA 18 Mar]. Perhaps these mean a turnaround is in the offing in this now much smaller company. They received a $30 million private placement lifeline in February, but the stock on the NYSE, while rising, is still well below $1. [TTA 16 May].

Rosarium Health receives a pre-seed round of $1.7 million from Rock Health and two other investors. It’s surprising because Rosarium is in the business of medically necessary home modifications to enable safe aging at home. Not your typical digital healthy, sexy, techy, buzzy Rock Health investment. But one that bears a few important checkmarks: since 2019, the Centers for Medicare & Medicaid Services (CMS) has covered home modifications in two different programs: Medicare Advantage (MA) through supplemental benefits, and Medicaid, through Medicaid Waivers (Section 1115 Waivers) or Medicaid Managed Care programs. In the current environment, that assurance of payment makes it most attractive indeed. Rock Health was joined by Primetime Partners with participation from Flare Capital. Rock Health release

Just when you think it’s getting better….

  • Optum Startup Studio fades to black–report. Startup Studio was Optum’s startup incubator and graduated over 100 early-stage companies that received mentorship and a chance to pilot their offerings through Optum’s companies and systems plus receive $25,000 to $50,000 in non-dilutive grant funding. The report in Axios attributed the program’s end to a reorganization within Optum that left mentors like Liz Selvig, who joined it in 2022, out in the cold. The timing could not have been worse for just-shuttered fertility planning startup Bunnii. Optum’s abandonment quickly killed interest from a potential lead investor who looked at Optum’s program and piloting as a vote of confidence. This Editor notes that the website and application pages are still live.  If this report is incorrect, we invite Optum to contact us.
  • CareRev, a short-term nursing/CNA staffing app platform, reportedly is laying off 100 employees or one-third of its staff. The same reports claim $100 million raised to date, but Crunchbase lists ~$50 million through a Series A in April 2021. Earlier this month, CareRev’s co-founder and CEO, Will Patterson, BSN, RN, resigned after The Information inquired on allegations that he used drugs and encouraged employees to try LSD and cannabis. CareRev subsequently named Brandon Atkinson, formerly COO of cardiac digital health Cleerly Health. Release. Becker’s
  • Fuzzy, a veterinary care digital health/e-commerce startup based in San Francisco, folded last week without paying employees or vendors. It raised about $80 million through a Series C from 2016. Backers included Icon Ventures, Greycroft, Crosscut, and Matrix Partners, private vet practices in the US, UK and Germany plus individual investors. Its $15/month subscription-based model included 24/7 live chat and telehealth, ship-to-home prescriptions, educational content, vet-curated pet items, and programs for nutrition, training, and obedience. The bad part: reports from employees on Twitter and Glassdoor indicated that the company stopped paying health insurance and salaries two weeks ago but were not formally notified of the company shutting until Saturday 16 June, and that vendors as well as contractors were misled on payment for weeks. The website is dark and CEO Zubin Bhettay’s LinkedIn profile plus Twitter handle are gone. Coverager

Monday roundup: Envision files Ch. 11, who’s to blame for Meta Pixel abuse?, CVS Health to shut clinical trials unit, Amino Health scoops $80M, DocGo flat but optimistic, Owlet way down in revenue

May 16, 2023 | by

What was envisioned last week came to pass for Envision Healthcare on Sunday. The hospital and physician staffing company filed for Chapter 11 reorganization five years after it was taken private by investment company KKR. At the time of that massive buyout, the value of the company was pegged at $10 billion. Things started to go south for Envision after 2020 with the pandemic drying up patient volumes for two years, with the added factors of regulations kicking in on ‘no surprise’ billing, inflation, staffing shortages, and major fights with health plans around out-of-network inflated charges plus a huge claims dispute with UnitedHealthcare [TTA 12 May]. Ironically, Envision won the main dispute with UHG; that $91 million won in arbitration in an insider’s view would have staved off the bankruptcy this year.

KKR will apparently lose its $3.5 billion equity in the company as $8 billion in debt restructuring takes place. What’s before the court is that the Envision staffing operation will be separated from the AmSurg surgical clinics. Senior lenders will have their debt rearranged into equity into one or the other company. Junior lenders, bondholders, and KKR will receive zero, or as we say locally, bupkis. It’s envisioned (sic) that the restructuring will take about three to four months.  Financial Times, Envision release

The hospitals, that’s who! If you believe Meta, it’s the hospitals that abused those poor Pixels, making them do things against their wishes to tattle all sorts of PHI and PII to Big Bad Meta which sends patients all those Nasty Intrusive Ads. Meta is being sued by parties from the ACLU to patients in class action lawsuits on how the Pixel was used on hospital patient portals and scheduling websites. Meta’s argument is that the health systems’ developers could but did not control how the ad trackers were used and that “Meta did not implement or configure” the Pixels used on the health systems’ websites. In fact, Meta claims that they have filtering tools that screen out sensitive data and that would alert the developer. “It’s ultimately the developer, not Meta, that controls the code on its own website and chooses what information to send,” according to the May 5 filing in that busy US District Court of Northern California.

This could influence outcomes in the multitude of lawsuits being filed against health systems like Kaiser Permanente, UCSF Health, and LCMC Health in New Orleans plus Willis-Knighton Health in northwest Louisiana (Healthcare Dive). If the District Court finds that Meta, and possibly other ad trackers such as those from Google, Twitter, or Bing were not inherently liable for personal health data violations that monetized PHI, then the health systems are 100% on the hook for the data breaches (or ‘wiretapping’ in a creative use of terminology). It also makes the potential paydays possibly less lucrative–in the eyes of this Editor, as Meta and Google have far deeper pockets than any ol’ health system. SC Media, Paubox   The Meta Pixel backstory here

CVS Health to shut its clinical trials unit by December 2024. CVS, like Walgreens and Walmart, jumped into the clinical trials business during the Covid-19 pandemic, seeing a need in the market with pharmaceutical companies and a ready-made, 100 million deep diverse base of patients among their pharmacy users. CVS cited to Healthcare Dive that the shutdown was to better concentrate on core business. Current active trials on the website include narcolepsy, rheumatoid arthritis, and kidney health. No disclosure as to profitability but CVS has a lot to digest with new buys Signify Health and Oak Street Health.

Amino Health’s $80 million funding is a bright spot in this sideways spring. With a digital guidance model that works with employers and health plans to help 1.6 million members navigate their care, their new funding will be used for technology scaling. Equity and debt financing were led by Transformation Capital, which will be joining the Amino board, and Oxford Finance LLC. Amino is being boosted by the Federal Transparency in Coverage (TIC) Rule which makes pricing disclosure a key part of plan navigation. Amino originally started with a direct-to-consumer model but shifted to enterprise, including brokers and third-party administrators. Amino’s total raise is now $125 million (Crunchbase). Mobihealthnews, Amino release

DocGo’s two services, mobile health and medical transport, essentially swapped revenue this quarter in a better-than-average picture. Their mobile health services area in Q1 fell 19% to $72.9 million from $90.1 million in Q1 2022, while transportation services grew 44% to $40.1 million from $27.8 million in Q1 2022. This added to total revenue of $113 million with a net loss of $3.9 million. Their 2023 revenue guidance remains at $500-$510 million with adjusted EBITDA guidance of $45-$50 million. 

What’s promising here is that it’s a SPAC that didn’t crack like practically every other. DocGo pointed out in their release that they have a backlog of $205 million in total contract value over approximately three years and they have doubled their RFPs. Their patient target for 2023 is 50,000. Share price today on Nasdaq ticked up to $8.77. Considering their high last year of $11.08, they are not doing badly in this time at all. Mobihealthnews .We last saw DocGo providing mobile clinics in a Tennessee pilot with Dollar General [TTA 24 Jan] which now is tied in with the state of Tennessee, plus a pilot in NY and NJ with Redirect Health. They provide services in 26 states and the UK.  

This Editor is trying to be as cheerful as the baby at left about baby sock/monitor Owlet, which has had a rough ride in the past two years. Their revenue dropped to $10.7 million in Q1 2023 versus $12 million in Q4 2022 and $21.5 million in Q1 2022. Owlet ended 2021 with a nastygram from the FDA that pulled their original Smart Sock off the market [TTA 4 Dec 2021] but rebounded early in 2022 with the Dream Sock and Dream Duo [TTA 16 Feb 2022] that avoided the claims that sent them into 510(k) Marketing Neverland.  Still, they were delisted by the NYSE in December 2022. On the positive side, Owlet wound up 2022 with $69.2 million in revenue and a good-sized private placement of $30 million in February [TTA 18 Mar]. It has submitted to FDA for two products, including the steep de novo climb on an enhancement to the Dream Sock. Now a much smaller company than it was last year, they have reduced operational expenses to $15.1 million from $24.1 million in Q4 2022 to get to breakeven by end of this year and to be relisted on the NYSE in the future. Having followed them since the early ‘telehealth for the bassinet set’ days of 2012-2013, this Editor wishes them bonne chance. Owlet release, Mobihealthnews

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

August 11, 2022 | by

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 here.  Cynerio 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.]

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

July 15, 2022 | by

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.

Weekend short takes, UK edition: Tunstall acquires Germany’s BeWo, AWS UK healthtech accelerator launches, Fidgetbum bed sleep aid gains US patent

March 11, 2022 | by

Tunstall Healthcare has acquired BeWo Unternehmensgruppe (BeWo), a German call center services, social alarm, and device technology and management company, effective 1 March. Terms and management transitions were not disclosed. The BeWo operation, which had previously worked with Tunstall in Germany, will initially be using its call center operations combined with Tunstall Cognitive Care, which uses advanced artificial intelligence (AI) in combination with technology in the home to monitor changes in condition that could be predictive of changes in health. Their information also indicates expansion into social care applications in hospitals and care homes. InsiderMedia, IoTNow, Yorkshire Post

Amazon Web Services (AWS) has named its 12 finalists in its first-ever UK healthtech accelerator. 

  • Dr Julian, a telemental health platform
  • C the Signs, AI for early identification of cancer
  • Infinity Health, a software-as-a-service (SaaS) task management tool for planning and coordinating care
  • Dignio, which connects patients and professionals through a digital platform
  • Sapien Health, a digital clinic to help patients prepare for surgery through sustainable lifestyle changes
  • WYSA for stress management through AI
  • DDM Health using digital therapeutics to improve patient health outcomes
  • PEP Health, which uses AI to help patients share their thoughts in real time
  • Remedy Rx, capturing around 95% of the data that sits outside the healthcare system to link doctors and patients
  • Birdie, a tech platform for home care providers
  • Abtrace, which uses data to detect, monitor, and treat long-term disease
  • Thymia, which analyses speech, video, and behavioral data gathered via video games to assess patients’ mental health conditions

The four-week accelerator programs will help the startups in business models, regulatory pathways, clinical validation, electronic health record integration, specialized AWS training and promotional credits, mentoring from healthcare domain and technical subject matter experts, business development, go-to-market guidance, and investment guidance. The group was selected in partnership with govtech accelerator Public, from a pool of over 100 applicants. ComputerWeekly

The interestingly named Fidgetbum is on the face of it, off our normal healthtech beat. It’s meant to help transition young children from crib to bed and sleep through most of the night through a stretchy wrap-around device that snugly holds the covers in place without restricting the child. The sensory effect is being hugged, without the heaviness and heat generation of a weighted blanket, and has been used successfully with children who have sensory needs, such as autism and epilepsy, or simply feel insecure. Founder Melanie Wood was recently granted a US design patent, which will open up the US market for the company. It’s perhaps this Editor’s recent sleeplessness, but this sounds like a natural cross-promotion with Owlet’s new Dream Sock Plus that fits up to 5 years [TTA 16 Feb]. THIIS

Owlet gets back into the baby zzzzz’s market with Dream Sock and Dream Duo–but now not medical devices!

February 16, 2022 | by

Without a splash or fuss, Owlet reintroduced its baby monitoring sock as the Dream Sock last month. Formerly known as the Smart Sock, Owlet got into FDA Hot Water in October [TTA 4 Dec 21] with their marketing the Smart Sock, which monitored sleep patterns, blood oxygen saturation, and pulse rate, as a medical device that would fall under 510(k) marketing clearance requirements, including premarket approval (PMA). The Smart Sock and Smart Duo were pulled from market on 22 November.

The Dream Sock, according to Owlet’s product page, is all about baby sleep, measuring sleep quality indicators, including wakings, heart rate, and movement. It provides a sleep quality score via a sleep coaching app. The difference between the old sock and app is that the blood oxygen saturation (SpO2) measuring capability is deleted. The SpO2 monitoring and the claims they were making were likely causes of the FDA’s warning.

The web store listing is for $299 for a Dream Sock fitting up to 18 months, with the Dream Sock Plus, which fits 0-5 years, at $359. The Dream Duo adds the Cam video baby monitor to the system for babies up to 18 months for $399. Sales are restricted to the US at this time. The products can also be found on the usual web stores.

On both the home page and on the product pages, the disclaimer statement is loud and clear:

WARNING: Owlet products are not medical devices. They are not intended for use as medical devices or to replace medical devices. They do not and are not intended to diagnose, cure, treat, mitigate, alleviate or prevent any disease or health condition, or investigate, replace or modify anatomy or any physiological process. [snip]

Digging into the website, Owlet states that they are “actively pursuing submitting a medical device application to the FDA to bring the Smart Sock technology to medical and consumer markets in the future.”

Owlet shares (OWLT:NYSE) have taken a massive value drop since it completed its SPAC with Sandbridge Acquisition Corporation and parked in the Unicorn Lot last July. It opened at $8, crested to over $10 in mid-August, then started to drop precipitously before Labor Day. It closed on Tuesday at $1.83. If only for the Cute Factor, one wishes them luck.

Owlet sock pulled from US distribution after FDA warning letter

December 4, 2021 | by

Awwww turning to Owwwww! High-flying Owlet has lost some altitude due to the consequences of a 5 October FDA warning letter. The outcome, at least for now, is that Owlet cannot sell its Smart Sock in the US. The Smart Sock measures sleep patterns, blood oxygen saturation, and pulse rate through pulse oximetry. FDA is now considering it a medical device that falls under 510(k) marketing clearance requirements, including premarket approval (PMA). Effective 22 November, the Owlet app will no longer be downloadable, although current owners who have downloaded the app for the Smart Sock and the Cam will not be affected. There are Owlets in the reseller pipeline, such as Amazon, which have now been rendered non-working. The Owlet Smart Sock can be sold outside the US, but not from the website.

What is surprising from the FDA letter is that they have had this issue with Owlet for five years. From the letter: “Since 2016, the FDA has corresponded with Owlet that the Owlet Smart Sock meets the definition of a device under the FD&C Act and does not fall under the compliance policy for low-risk products that promote a healthy lifestyle (General Wellness guidance).” The latter is a catch-all that has enabled various tech products to go to market with statements such as “not intended to diagnose, cure, treat, alleviate or prevent any disease or health condition”. It may have been either an escalation of monitoring capabilities, of marketing, or of the FDA deciding after the SPAC that Owlet needed to be treated differently. Owlet came to market in 2013.

Owlet’s letter to customers alludes to the FDA warning letter and that no safety issues were raised. They promise here and on the website that they will “transition to a new app and consumer wellness product that addresses FDA’s concerns”. The website continues to sell the Owlet Cam and Dream Lab, with ‘Coming Soon’ in January for the new Dream Sock and Dream Duo, but with no details. What’s not known are any details on their capabilities, whether they will fall under ‘general wellness’, and whether Owlet has begun the laborious and long process of filing as (likely) a Class II device.

Owlet enjoyed a SPAC during the summer [TTA 23 July] that nabbed it $135 million and a valuation of over $1 billion. It traded then at $8. Today’s close was $3.95. Its market cap is now less than half. It’s disappointing to this Editor that Owlet didn’t file with FDA well before the SPAC. They now have the opportunity to get FDA clearance, but the more likely outcome is that, at least for now, they will market a less capable device that falls under ‘general wellness’. Deseret News, FierceBiotech, CNET, The Verge

News and deals roundup: Owlet’s $1B SPAC, Carbon Health’s $350M Series D, Series Bs by Woebot Health and b.Well, digital health rakes in $15bn

July 23, 2021 | by

Baby monitoring system Owlet closed its SPAC late last week with Sandbridge Acquisition Corporation. It is now trading on the NYSE (OWLT) for around $8 per share. With Sandbridge’s investment and the concurrent private placement (PIPE), Owlet now has $135 million and a valuation of over $1 billion, far exceeding the $325 million estimated [TTA 17 Feb]. Owlet started in 2013 with a ‘Smart Sock’ (right) at $299 using pulse oximetry to monitor baby heart rate, oxygen levels, and sleep patterns with readouts via their app, but has expanded to include an Owlet Cam and a Dream Lab to encourage good baby sleep, which parents will be the first to appreciate. Mobihealthnews

Carbon Health, which is certainly an odd name for a primary care provider plus virtual health with a streamlined patient record/EMR system and makes insurers happy because they charge only Medicare rates, received a hefty $350 million Series D raise. Led by Blackstone Horizon Partners with Atreides, Homebrew, Hudson Bay Capital, Fifth Wall, Lux Capital, Silver Lake Waterman, and BlackRock participating, along with returning investors Dragoneer Investment Group and Brookfield Technology Partners along with a slew of private investors, it follows on last November’s Series C of $100 million for a total raise since 2016 of $522 million. Valuation is what used to be an eye-blinking $3.3 billion. Carbon’s locations are a bit strange–concentrated in California and SF area with outposts, many of which are limited service or ‘pop-ups’, in Florida, Arizona, Kansas, and NYC. Unlike the recently covered One Medical, it does not require any kind of annual concierge fee. The model is an interesting one in positing high service and low cost. The founders are also staking out becoming the largest US primary care provider, which Village Medical or UnitedHealth Group would not be delighted about. One wonders if all this staking out will work, or is to attract payer investment when the VCs decide to exit. FierceHealthcare, Mobihealthnews (referring to them as multimodal, which sounds like ocean/rail transport or articulated lorries), Forbes

Also in the Mobihealthnews article: a Series B $90 million raise by Woebot Health, developer of a mental health chatbot (ok, relational agent), and the $32 million Series B raise of b.well Connected Health, a patient-facing health management platform that will get a big boost from interoperability around patient records required under the Cures Act. Woebot’s twee infographic about their therapeutic bond study in the JMIR is woeful, though, as large parts are unreadable.

No surprise that digital health funding hit a $15 billion high in the first half of 2021, up 138%, driven in large part by telehealth investment. This is based on a report from Mercom Capital Group. FierceHealthcare

Deals and news roundup, April Fool’s Edition: SOC Telemed’s $196M acute care telehealth buy, HIMSS takes over SCAN Health, Livongo’s Burke joins Owlet board, CirrusMD text app raises $20M

April 2, 2021 | by

(We’ve gone bug-eyed for 1 April!)

SOC Telemed ponies up a Spritely $196 million for competitor Access Physicians. The completed combination forms, according to SOC, the largest acute care telemedicine provider in the US serving 1,000 facilities, including over 700 hospitals, across 47 states. The deal is cash and stock. No transitional information other than the CEO of Access Physicians joins the SOC Telemed board. Both companies are in the enterprise acute care telemedicine area, facilitating virtual consults between specialists and to patient bedsides. In its SEC 10-K filing released earlier this week, SOC Telemed reported $59 million in 2020 revenue, up from $66.2 million in 2019. Q4 was a mixed bag: a 95 percent increase in Q4 bookings but a 13 percent revenue decline due to reduced hospital visits. Losses are limited–a net loss per share of $3.55 which is light for like telehealth companies (more in SOC release). For 2021, the projection is $107 to $113 million in pro forma annual revenue. SOC Telemed was one of the first digital health companies to use a SPAC to go public (amazingly) less than one year ago and with substantial assets at formation [TTA 4 Aug 20]. The combined company connects specialists in neurology, psychiatry, critical care, infectious disease, cardiology, maternal-fetal medicine, and nephrology. SOC Telemed release, Mobihealthnews, Becker’s Hospital Review 

HIMSS assumes the operations of SCAN Health, a networking and events company concentrating on best practices in the healthcare supply chain. SCAN was founded by the Canadian government out of the University of Windsor’s Odette School of Business. Their events are held with over 100 partners in North America and Europe, and will transfer to HIMSS effective immediately. SCAN’s founder, Dr. Anne Snowdon, launched the Clinically Integrated Supply Outcomes Model, a supply chain infrastructure strategic roadmap, with HIMSS Analytics in 2019. HIMSS release, Healthcare IT News.

Zane Burke, former CEO of Livongo, has joined another board–this time, with ‘sock’. Mr. Burke joins the board of Owlet, the baby monitoring sock company. In February [TTA 17 Feb], Owlet announced their SPAC estimated at $325 million. The transaction is expected to complete in Q2. Becker’s Health IT

CirrusMD, an on-demand text-first telehealth app, raised $20 million for its Series C led by The Blue Venture Fund and 7wire Ventures. Total funding to date is $47 million. Visits cover primary or urgent care, chronic condition management, women’s health, pediatrics, and behavioral health with text first then connection to a board-certified physician within one minute. Release, Mobihealthnews