News roundup: Apple Watch flagships cease sale due to Masimo ITC ruling (updated); Noom, WW enter GLP-1 telehealth business; Oracle sees health side up despite Cerner drag; Cigna has multiple bidders for MA business

Apple Watch Series 9 and Ultra 2 going off sale in the US this week, upholding the ITC patent ruling favoring medical device developer Masimo. On 26 October, the International Trade Commission (ITC) ruled that Apple in the Series 6 and later violated Masimo’s patents on pulse oximetry (SpO2) sensors and software. [TTA 27 Oct] While this is awaiting presidential approval in the 60-day review period which ends on Christmas Day, Apple proactively restricted US sales of its flagship Series 9 and Ultra 2 watches which contain the blood oxygen sensors. (The SE model does not and continues to be available for direct sale.) According to 9to5Mac, online sales end on 3 pm Eastern Time on Thursday 21 December, while in-Apple Store sales stop after Christmas Eve. Of course, this won’t stop resales of existing stock through outlets like Amazon, Best Buy, and eBay. Under the ITC order, Apple cannot import either model after 25 December as the ITC issued a Limited Exclusion Order (LEO) plus a Cease and Desist Order (CDO). 

The ITC is rarely vetoed by the White House in patent actions. After that point, Apple is free to appeal in Federal District Court, which is highly likely and where the deepest pockets usually win. Also HIStalk 20 Dec and Strata-gee 21 Dec

There are other wrinkles with Masimo, though. Strata-gee.com earlier this month (13 Dec) timelines Masimo’s patent difficulties with the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruling against the very same patents, decisions upheld by the Federal Circuit Court. The PTAB also ruled against Masimo in the requested review of two Apple patents. Apple’s retaliation is to threaten lawsuits on Masimo’s new smartwatches. The icing on this messy cake is the November Delaware Chancery Court decision against Masimo, awarding $17.8 million in legal fees to activist investors/shareholders Politan Capital Management and Politan Capital NY LLC in a board fight that culminated in two seats to Politan directors.  One can sense that Apple is biding its time, though they could end all of this by negotiating a royalty to Masimo. Updated: see report on the stay effective 27 December here.

Noom and WW enter the weight loss drug-by-telehealth race. Ozempic and Wegovy, GLP-1 agonists, are increasingly popular in off-label use for obesity to produce weight loss, prescribed and managed by telehealth teams.

  • Noom, previously stressing behavioral change via app coaching direct-to-consumer, in October announced at HLTH Noom Med, a drug-focused program prescribing medications such as Saxenda (liraglutide), Wegovy (semaglutide), and the new Zepbound (tirzepatide), a dual GLP-1/G1P, all of which are injectable medications along with other GLP-1 medications such as Ozempic.
  • WW or WeightWatchers last week announced the WeightWatchers Clinic program. Via their recently acquired telehealth weight loss platform Sequence, it will offer weight loss meds and team management.  

They join Teladoc in developing weight loss programs, though Teladoc supports a physician-based care product for employers [TTA 21 April]. Both Noom and WW emphasize that member patients must qualify for the programs based on weight, BMI, and medical condition. Participants are educated through materials, coaching on behavioral management, managing appetite, and nutrition, especially in maintaining adequate protein as these medications not only induce weight loss, but also muscle loss (sarcopenia). One hopes that their teams are also knowledgeable on how these medications that slow down digestion to induce a feeling of fullness don’t mix well with surgical sedation, and that they issue cautions to patients before elective surgery. MedCityNews, FierceHealthcare, Forbes   

Noom has also replaced most of its top management since its new CEO joined in July. There’s a new CFO, chief technology officer (CTO), general counsel, two senior VPs (corporate development and partnerships, healthcare sales and services) a senior director of brand and communications, chief growth officer, chief product officer, and head of people. FierceHealthcare

Oracle Q2 results miss forecasts in rebuilding Cerner. Oracle Health, including the former Cerner, and slowing cloud growth were the culprits in their fiscal Q2 2024. Total revenue was $12.9 billion, up 5% in US dollars (4% in constant currency). Analysts expected $13.05 billion. Excluding Cerner, growth would have been 6% though Oracle did not separately break out revenue for the Cerner EHR business. Investors have noted two consecutive quarters of off-track growth and a weaker forecast for the remainder of the year. According to CEO Safra Catz and chairman Larry Ellison on the earning call, many upgrades and “modernizations” are being made to Cerner Millenium that will wrap up this FY. Half of Millenium customers will be moving over to Oracle Cloud Infrastructure (OCI) by February. They are also “rewriting” Cerner’s health and data intelligence platform, Cerner HealtheIntent, to get into population-scaled health management. ‘Transforming healthcare’ is an expensive proposition indeed. No word on the VA.  FierceHealthcare, Oracle release

And a quick follow up on Cigna’s sale of their Medicare Advantage business. Two payers so far–Health Care Service Corp. (HCSC) and Elevance–are reported to be bidding for Cigna’s MA business. The value of the business is estimated to be about $3 billion and with just under 600,000 members as of September. Both HCSC and Elevance are much larger players in MA. HCSC has over 1 million MA members in Blue Cross Blue Shield affiliates in Illinois, Texas, New Mexico, Oklahoma, and Montana. Elevance, the former Anthem, has over 2 million MA members. Bidding is expected to close this week. While MA is losing money for Cigna, they could refuse to sell if bids are unsatisfactory. FierceHealthcare, Becker’s

News roundup: Cano Health board fight, board shakeup; Memora Health’s $30M raise; Teladoc enters weight management race

The continuing drama at Florida-based primary care provider Cano Health focuses on the board and CEO. The three board members who resigned in late March [TTA 7 April]–Barry Sternlicht, Elliot Cooperstone, and Lewis Gold (who we’ll dub the Cano 3)–are now demanding that the company board reopen the window for director nominations at the 2023 Annual Meeting of Stockholders. In a letter/press release targeted to fellow shareholders released on Monday, the group cited “drastically changed circumstances”, exclusion of the three from decision-making prior to their resignation, and “the emergence and disclosure of additional self-dealing and concerning related-party transactions that were not previously disclosed – have cast serious doubt on the credibility and fitness of the current Board and CEO Marlow Hernandez.” The letter/release also focuses on the company’s negative (-83%!) performance over the past year. The three own 36% of the common stock of Cano Health, which means they have a very loud voice.

Cano management responded on Monday with a very long letter/press release of its own rebutting the “destructive actions” of the Cano 3  with a lengthy but somewhat anodyne six-point action plan to move the company toward profitability, improve performance, and increase liquidity. Point 6 was quite the kicker: appointing a non-executive chairman of the board, Solomon (Sol) Trujillo. This separated the chairman and CEO roles, with the highly controversial founder Dr. Marlow Hernandez remaining as CEO. Not addressed were the issues around Dr. Hernandez. He has been accused of self-dealing in two instances: $23 million to the CEO’s father for general contracting work, and $8.5 million to a dental care company owned by Mrs. Hernandez. Earlier coverage included dubious transactions with Miami medical claims recovery company MSP Recovery (also known as LifeWallet).

What’s interesting about this is that it may turn into a battle royal between two major figures: chairman Sol Trujillo against Barry Sternlicht. Mr. Trujillo is highly experienced in board/CEO roles in high-stress turnaround situations, such as at Orange SA and most recently Australia’s Telstra Communications. Mr. Sternlicht is well known as the CEO of Starwood Hotels and is a major real estate and private investor.

Cano Health was founded in 2009 and went public via a SPAC in 2021. It lost $426 million in 2022. The shareholder meeting date hasn’t been released yet, but in 2022 it was in May. Stay tuned. Healthcare Dive, MarketWatch

Memora Health raises $30 million. This venture round was led by General Catalyst and joined by several health systems including Northwell plus existing investors Andreessen Horowitz, Transformation Capital, and Frist Cressey Ventures. Memora has AI-based technology for complex care management and digitizes clinical and administrative workflows. FierceHealthcare, Crunchbase

Teladoc to premier weight management program using GLP-1 agonist drugs. This will be part of their physician-based care product for employers, and will target patients needing additional assistance in weight loss and diabetes prevention. The program provides access to a Teladoc-employed doctor for a personalized care plan, along with daily coaching with digital tools. Debut is projected during Q3. GLP-1 drugs such as the widely advertised (in US) Ozempic injectable were originally designed for diabetes management but have found a different market in weight loss. Companies such as Calibrate, Ro, and Sequence (acquired recently by Weight Watchers) are competitors. Healthcare Dive

Wearables ‘shocker’: Website beats fitness tracker in weight loss program

The shock waves are reverberating through the wearables industry, but it is likely less than it seems. The JAMA study being cited was testing the hypothesis that technology could assist a weight loss program, and also what type of technology did best. The subject group of 471 at the University of Pittsburgh was young–18-35, prime for a wearable–overweight to moderately obese, and tracked for 24 months between 2010 and 2012 (!) The participants were started on a group weight loss program supported with calls and texts for the first six months, then randomized into two groups that monitored their diet and fitness either through a fitness tracker plus website (enhanced intervention group), or those using a website only (standard intervention). Both groups lost weight but the enhanced/fitness tracker group lost 5.29 pounds less than the website-only group.

The caveats: According to Mobihealthnews, the fitness band used was BodyMedia SenseWear, which was acquired by Jawbone and as they noted, put out of business. Fitness bands now also look and feel different than this early generation. Mobile tracking apps are now the standard versus going online which was necessary four years ago–a huge jump in convenience. But tracking itself may change behavior. The authors speculate that tracking data might actually demotivate people, or that activity ‘congratulations’ may lead to a bit of cheating. But they should try it with up to date trackers. Also Healthcare Dive and Reuters

Swiss capsule monitors blood fat

Without the hype of Airo, a Swiss research team at ETH-Zurich has designed and is testing on mice a blood fat-detecting capsule that releases a satiation hormone when excessively high fat levels are detected, suppressing appetite. The circuit in the capsule can measure several types of fat, including several saturated and unsaturated animal and vegetable fats. If further developed, this could have impact on weight loss for humans.  Gizmag, Daily Mail