News roundup: SleepioRx clears FDA 510(k), Caregility adds AI fall detection, Otsuka releases Rejoyn depression app, MD Ally’s $14M Series A, Alcove launches CallConnect247 (UK), Health Catalyst buys Lumeon for $40M

August 15, 2024 | by

Big Health’s SleepioRx digital insomnia therapeutic gains 510(k) FDA clearance. The 90-day treatment is based on a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I). The treatment adjunct is tailored to symptoms and provides daily sleep tracking, enables goal setting, and content for help falling asleep. Sleepio was originally developed in the UK (we covered in 2013!) but moved to San Francisco in 2015.  Their original Sleepio is marketed to employers and health plans to support treatment for sleep disorders and insomnia, along with other products for digital support for anxiety and depression. Their last funding was a Series C of $75 million raised in the palmy days of January 2022 and a year later acquired Limbix, provider of SparkRx, a depression management app targeted to adolescents. Release, Mobihealthnews

In my home state of NJ, Caregility announced an AI-powered fall detection upgrade to their acute care clinical observation platform. iObserver is used by hospital care teams for observation of patients at risk for falls or self-harm. Interestingly, the fall detection system is run on computer vision, which means it runs entirely on telehealth edge devices in the patient room with the AI capable of identifying and deriving information from objects and people in images and videos. Edge device use means that processing is done within the devices themselves, which eliminates bandwidth issues and upstreaming to the cloud, a failure point for privacy and as we now see, hacking risk. According to the release, the computer vision capability is available for use on every one of the more than 15,000 Caregility edge devices currently installed in hospitals around the globe. 

Otsuka Precision Health (OPH) launches Rejoyn digital therapeutic for depression.  As previewed earlier this summer [TTA 29 May], OPH launched Rejoyn, the first and sole prescription digital therapeutic cleared by the FDA for the adjunctive treatment of major depressive disorder (MDD) symptoms. Rejoyn was developed in conjunction with Click Therapeutics. It is for use by those aged 22+ on antidepressive medication. After being prescribed from the patient’s provider or Wheel Health, the Rejoyn app can be downloaded from major app stores after keying in an access code that is furnished to the provider by BlinkRx. It is currently being priced on a cash-pay basis at $50 for the six-week course, which will increase later to $200 for insurer coverage, though it is not yet covered. In a six-week trial, the use of Rejoyn reduced depression symptoms and improvement across multiple scales typically used by patients and clinicians to track depression improvement. The Otsuka release and commitment are significant as it’s also the first true involvement of a major pharmaceutical company in telemental health with a highly targeted clinical app that isn’t tied to one of their medications. It’s a long road with a lot of bumps, as Otsuka experienced with Proteus Digital Health’s smart pill tech for its Abilify MyCite, as well as failed companies like Pear and Babylon Health.  Release, Healthcare Dive

In funding news, emergency services telehealth company MD Ally now has $14 million in a Series A to add to its previous $11 million.  The raise was led by Frist Cressey Ventures, founded by Senator Bill Frist and Bryan Cressey, and anchored by General Catalyst, with participation from Techstars, Seae Ventures, Red & Blue Ventures, and Alumni Ventures. MD Ally’s value proposition centers on the non-emergency 911 call. Dispatchers and first responders, after determining the non-emergency status, can divert the call to other telehealth and community-based resources to assist the person plus a ‘care assistant’ for treatment plans and long term outcome management. MD Ally is currently in test in Phoenix and locations in Florida, Arizona, and California serving about 5 million patients. Release, Mobihealthnews

In UK related news:

Alcove expands TEC services with CallConnect247. It is a state-of-the-art 24/7 Alarm Receiving Centre (ARC) designed for communities and local authorities who are modernizing their call services for alarm management to incorporate virtual care and video welfare calls. It includes AI-powered and automated services to reduce false alarms and minimize the ‘white noise’ calls that often inundate traditional ARCs. It’s expected to grow coverage up to 8,000 users by October. Alcove release, Thiis.co.uk

Health Catalyst buys US/UK care management company Lumeon Ltd for $40 million. The $40 million purchase price was funded with a mix of $2.5 million in stock and $37.5 million in cash plus a potential recurring revenue-based earn-out of up to $25 million that, if achieved, would be paid solely in cash. (page 42 of SEC Form 10-Q). No information was provided concerning staff transitioning at Lumeon’s current HQs in Boston and London, where it adds a UK/EU footprint to Health Catalyst’s current data analytics and software businesses. Lumeon’s Care Orchestration automates care coordination processes for providers in outpatient, acute care, and post-acute settings.

Health Catalyst’s earnings were also reported in the 10-Q. Revenue for Q2 was up slightly from last year to $75.9 million, but burdened with a net loss of $13.5 million which was more than 50% reduced from Q2 2023’s $32.6 million. Q2 adjusted EBITDA improved to $7.5 million versus $3.5 million in prior year. Release, Mobihealthnews

News, acquisitions, funding roundup: Cerner CEO, CTO’s ‘stay-with-conditions’ deal, Quest buying Pack Health coaching platform, Wheel’s $150M Series C, mental health’s bubbly Lyra Health’s $235M and Big Health’s $75M

January 21, 2022 | by

Cerner CEO, CTO sticking around after Oracle acquisition, but there’s a catch. Cerner’s recently started CEO (August), Dr. David Weinberg, and their chief technology officer, Jerome Labat, both received ‘stay deals’ to remain with Oracle for 12 months from the closing date. The language in the SEC filing discloses the conditions. It’s a typical waiver of the right to leave for ‘good reason’ or ‘constructive termination’ if Oracle adversely changes their authority, duties, position, or responsibilities, which would trigger their ‘change in control’ severance. In return for the waiver, even if assigned to the data center in the Yukon, they will receive their severance benefits ($4.5 million and $2.3 million in cash respectively plus stock vesting) a year and one day later, even if they remain with Cerner. One wonders how far down the top management this goes. Becker’s Hospital Review, HISTalk

Quest Diagnostics is buying Pack Health, a chronic conditions care management, coaching, and patient engagement platform. Term details other than an all-cash equity deal were not disclosed. Pack coaches across 30 chronic conditions to address patient mental health, lifestyle behaviors, access to care, and social determinants of health (SDOH) factors. They market to payers for care management and life science companies for medication adherence. Pack will be added to Quest Extended Care, which includes Quest HealthConnect, a provider of in-person home-based risk assessment and monitoring services to supplement clinical care. The sale is expected to close in Q1. Release

Wheel, an Austin, Texas-based clinical platform that combines turnkey virtual primary care, behavioral health, urgent care, and diagnostic telehealth, announced a $150 million Series C, bringing total funding since 2018 to $215.6 million. The round was co-led by Lightspeed Venture Partners and Tiger Global. New investors Coatue and Salesforce Ventures participated in the round along with existing investors. Funds will be used to scale their platform. In 2021, they claimed 1.3 million patient visits in 2021 and is expected to triple visit volume by the end of 2022. Release

And corporate-focused mental health tech stays frothy with Lyra Health completing a $235 million Series F, bringing their funding to over $900 million with a valuation now pegged at $5.85 billion. Lyra is planning international expansion with all that loot. The round was led by Dragoneer, plus (again) Salesforce Ventures and existing investor Coatue Management. Lyra claims that it presently serves 10 million global employees. FierceHealthcare, release

Not-quite-as Big Health, which also claims millions of corporate and health system users including the NHS (offered for free in Scotland and select postal codes), raised $75 million in a Series C, led by Softbank Vision Fund 2 with ArrowMark Partners and existing investors Octopus Ventures, Gilde Healthcare, Kaiser Permanente Ventures (KPV), and Morningside Ventures. Big Health started in the UK, and our Readers there may be more familiar with their apps–Sleepio (first mentioned here in 2013! for insomnia) and Daylight (for anxiety). Big Health departed the UK for San Francisco and its greener money pastures back in 2015, noted here. Release

The NHS fail at encouraging digital health startups

August 18, 2015 | by

While Minister of Life Sciences George Freeman MP speaks very highly of the need for innovation and digital health in an NHS integrated health system, the reality is less encouraging for UK startups and their growth. The story of Big Health’s Sleepio and its move from the UK, told by Bloomberg, illustrates the difficulty that new companies and technologies have in fitting into a national framework, then selling into the 209 NHS regions plus related healthcare spenders. The long cycle and the narrowness of the frameworks are disincentives for many digital health technologies and their funders. Even if you win clients as part of being on the framework, when it expires after a few years, the business can be lost.

It’s hard to crack the code, and small companies are dependent on partners. A personal anecdote from this Editor’s time at Living Independently: the company achieved getting on a national framework with the QuietCare telecare product (2007) through partnerships with several larger telecare providers. We relied on them to offer QuietCare to the regions and councils. This had limited success and the US business far outstripped that in the UK.

Ten years ago, the situation was reversed. NHS, Government and council funding helped the earliest development and acceptance of telehealth and telecare, much as the Veterans Health Administration (VA) did with home telehealth and telemedicine in the US.  Other European markets and Canada have established private spending in this area, but these smaller markets–and funders– don’t have the potential that is possible in the US private market, even without reimbursement. The trend is reflected in investment: $4 bn in the US, less than €100 million in Europe. US developers now have a bonus in the potential of Asia, with China having the greatest interest and now funding. [TTA 23 July].  How the NHS Is Locking Out Britain’s Digital-Health Startups