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

Femtech’s huge potential global healthcare market–but needs to connect with payers and employers

‘Femtech’ is one of those newish umbrella terms that corrals health tech that enables women to manage their health better. Most of women’s health products cluster in birth control, fertility, pregnancy, and early maternity, with little outside this area or for older women. A number have gotten substantial funding rounds–in Q3, Nurx (birth control, $52M), The Pill Club ($51M, ditto), and Cleo (pregnancy and post-partum coaching, $27.5M). Rock Health

Research2Guidance has dug a little deeper in its new study,
The Global Market Of Digital Women’s Health Solutions 2017-2024
  and discovered 3,000 app-based solutions, 151M annual downloads and millions of active users globally. 20 percent of US women in the femtech core demographic use a health app, and R2G projects global market revenue will reach $297 million. Global market expansion is likely to be greatest in countries like India and China

What femtech lacks, according to R2G’s Ralf Jahns, is validation. Those 3,000 companies haven’t quite concentrated on their user case and benefits which could lead to validation and payer/employer reimbursement. And strategies haven’t quite jelled yet.