Mid-week roundup: Promising Langone AI/LLM predicts hospital readmits; Huma gains FDA 510(k) Class II clearance; telepsychiatry’s challenges; layoffs/asset buys/losses from 23andMe, Cityblock, Thirty Madison, Butterfly

New York University’s Langone Health’s large language model (LLM) accurately predicting hospital readmissions, more. NYU’s academic medical center NYU Langone Health has developed an LLM using medical language, NYUTron, from unstructured clinical notes in patient records, then fine-tuned it across a wide range of clinical and operational predictive tasks. The dataset was immense:  ‘NYU Notes’ covers 7.25 million clinical notes (for example, radiographic reads, history, and physicals) from 387,144 patients across four hospitals, and more. According to their study published in Nature on 7 June, it was tested for predictive ability in five areas: 30-day all-cause readmissions, in-hospital mortality, comorbidity index, length of stay, and insurance denial. The NYUTron system in testing has achieved results improved over conventional structured models’ baselines. From the Nature study:

  • For 30-day readmission prediction, it had a median area under the curve (AUC) of 79.9% ± 0.168% with a 5.36% improvement
  • On in-hospital mortality prediction, NYUTron had a median AUC of 94.9% ± 0.168% with a 7.43% improvement.
  • On comorbidity index imputation, NYUTron had an OVR median AUC of 89.4% ± 0.275%
  • On binned LOS prediction, NYUTron had a median AUC of 78.7% ± 0.179% with a 12.3% improvement 
  • On insurance denial prediction, NYUTron had a median AUC of 87.2% ± 0.246% with a 14.7% improvement.

In a test of the system during January-April 2022, the system analyzed 29,286 discharged encounters, with 3,271 patients (11.17%) returning within 30 days. NYUTron predicted 2,692 of the 3,271 readmissions (82.30% recall) with 20.58% precision. Also HealthcareITNews

London-based Huma (the former Medopad) gained US FDA 510(k) Class II clearance for their Software as a Medical Device (SaMD) platform. This is defined as disease and age-agnostic digital health pathways through which data are collected from patients for self-management or to be assessed remotely by healthcare professionals. Huma also recently obtained EU MDR Class IIb approval and with Health Canada through the FDA’s joint eStar program. Huma’s tech also includes remote patient monitoring (RPM) systems and companion apps to enable disease management, with third-party device integration. For providers, the platform hosts AI algorithms that use automated data analytics to support screening, diagnosis, dosing recommendations, clinical decision making, and prognostication for identification of at-risk patients and early intervention. In 2020, Huma acquired BioBeats and TLT; more recently, last year iPLATO patient engagement and in January clinical trials data specialist Alcedis.   Huma release, Mobihealthnews

The growth of behavioral health has come to a screeching halt with the demonstrated abuse of online prescribing, then the US Drug Enforcement Administration (DEA)’s uncertainty around controlled substance prescribing. This interview with the CEO of Array Behavioral Care, one of the Ur-companies in telepsychiatry (1999, originally InSight Telepsychiatry and Regroup Telehealth), points out how the DEA’s post-Public Health Emergency (PHE) policies around Schedule II and higher teleprescribing disrupted their operations. The flexibilities established during the PHE have been waivered to 11 November, though a final rule must replace the temporary extension rule and comply with the Federal Ryan-Haight Act [TTA 11 May]. Other issues addressed are dealing with medical affairs (clinical licensure, primary source credentialing, facility privileging, and payer enrollment), and the potential for AI to create new tools to aid clinicians in evaluating mental health, such as natural language processing (NLP) in transcribing video sessions and suggesting clinical notes, as well as scanning patient intake stories and analyzing that information for the likelihood of certain diagnoses. HealthcareITNews

The slow drip-drip-drip of layoffs, folded companies’ asset sales, and company losses that started in 2022 continue, though at a diminished pace compared to consumer companies:

  • Genomics and DNA testing company 23andMe announced layoffs of 9% of staff or 75 people. This will take place by the end of their FY 2024, which ends next 31 March. In a 9 June filing, the company claimed that it would reduce annualized payroll and benefit expenses by $12.8 million, which leads one to wonder about the compensation level of those 75 and from what area they are in. South San Francisco-based 23andMe continues to be money-losing, increasing annual net losses from $217 million to $317 million in the 12 months ending in March, according to its May earnings report despite a 10% revenue gain. 23andMe is yet another ‘cracked SPAC’, having gone that route in 2021 with a Virgin-backed SPAC. Once trading at highs of $12-13 on the NYSE, it closed today at $1.96. However, they don’t have debt, are hanging on to a valuation of $924 million, and their cash position is apparently strong enough to hold it for two years.  Becker’s, SF Chronicle, Yahoo Finance, SimplyWallStreet
  • Another well-financed company, Cityblock Health, is laying off 12%, or 155 staff. Spun off from Sidewalk Labs (Alphabet Health-Google) at the end of 2017, their CEO announced the layoffs in a blog post late last week and effective immediately for those affected. Cityblock serves Medicaid and low-income ‘duals’ with both Medicare and Medicare in value-based care models with a heavy reliance on technology. Their CEO who joined the company in March phrased it as a restructuring, using technology to automate processes, and reducing staff layer. In contrast to others, Cityblock has had no trouble raising funding in the past; in December 2020 they raised $160 million in a December 2020 Series C, plus another $192 million in a Series C extension in March 2021, then a reported $400 million Series D in September 2021 with total raises over $890 million. But their cash burn with high-cost operations in six states (HQ New York, Massachusetts, Indiana, North Carolina, Ohio, and Washington DC) is also likely high. FierceHealthcare
  • Thirty Madison buys assets from bankrupt The Pill Club. The assets? Over 100,000 patient files for $32.3 million. The Pill Club entered Chapter 11 in April after being charged by California authorities of defrauding the state Medicaid program. It paid $18.3 million to settle the charges. But that wasn’t all. According to Mobihealthnews, “the settlement came just days after a state court unsealed a whistleblower complaint against the company in which former nurse practitioners alleged it had defrauded private insurers in at least 38 states. According to a statement from their attorneys regarding the settlement, the whistleblowers would receive approximately $5 million.” The patients covered by The Pill Club’s prescriptions will be converted over to another Thirty Madison brand, Nurx, and offered other services such as behavioral health and dermatology services. The Pill Club raised a lot of money from 2016–$51 million in Series B funding in 2019 and another $41.9 million in 2021. Thirty Madison is a private multi-line of consumer-marketed brands such as Keeps (hair), Picnic (allergies), Cove (migraine), and Facet (psoriasis, eczema) and is at a Series C with a total raise of $209 million. Axios, 
  • Butterfly Network, which some years back developed a hand-held ultrasound device (Butterfly iQ) and entered a crowded field with GE HealthCare’s VScan, Mobisante (apparently defunct), and Philips Lumify, reported Q1 revenue of $15.5 million, flat year-over-year compared to Q1 2022 and which missed analyst estimates (again). Somewhat better news was narrowing last year’s loss to a Q1 loss of $33.5 million which was less than Q1 2022’s loss of $44.5 million. It’s another early SPAC that hasn’t had a great time of it. Since its debut on the NYSE in December 2021, the stock has had the typical drop in altitude from $19.79 to $2.42. It has since expanded to enterprise imaging with Blueprint. Mobihealthnews, Yahoo Finance, Zachs

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

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.