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

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

UK news roundup: West Wales’ CONNECT project, WelcoMe app for disabled access, X-on Surgery Connect expands, Arc Health in 46 care homes, Alcove’s £75M contract with Suffolk County Council

The CONNECT project, which launched in West Wales at the very beginning of the pandemic last March, is a community support project using both technology enabled care (TEC) and human support. Covering individuals who are older, need home care support, and live at home, it is run by Carmarthenshire County Council’s (CCC) Delta Wellbeing team and covers Carmarthenshire, Ceredigion and Pembrokeshire. To date, they have assessed 1,800 people, supported 8,500 individuals isolated during lockdown with necessities like food, made 18,500 proactive wellbeing calls in the first three months, responded to 1,646 call outs with fewer than 100 requiring emergency services, and responded to over 500 falls with 97 percent within 60 minutes. The CCC is using Tunstall kit for alarms, fall detection, GPS tracking, and 24/7 community response service. Delta Wellbeing is a Local Authority Trading Company, completely owned by CCC, and is the largest digital monitoring platform in Wales. Wales Herald

WelcoMe is an free app that enables businesses to better support the needs of their disabled customers or patients. It’s designed for use on mobile or desktop so that a person can create a simple profile that outlines personal key requirements and information about what support they need during their visit. Those requirements are communicated to the business or practice staff so that they can be ready on arrival. It makes for an easier visit all around and eliminates surprises. This Editor discovered WelcoMe through an announcement by the The London Centre for Cosmetic Dentistry, the first UK dental practice to adopt the app for their practice. There is a small fee for businesses–£30/mo plus a £49 onboarding fee. The app was developed by Neatebox Limited. Release (PDF). Hat tip to Suzy Ellis of Ellis & Boyd PR

X-on Surgery Connect, a provider of cloud telephony for primary care surgeries, has added another 116 practices in Greater Manchester (Stockport’s 36 practices) and London (80 practices within North Central London Clinical Commissioning Group). The Surgery Connect system provides telephone triaging, call center support, remote working support, telehealth remote consultation and video support. The deployment covers approximately one million patients, out of a total of 8.5 million patients in 835 practices in England and Wales. Unfortunately the release was supplied only via email and not online/PDF.  

Arc Health remote diagnostic platform has been installed  in 46 care homes in South East London. Arc’s video clinical exam and diagnostic technology connects the care homes to primary care surgeries via guided or patient self-use of Arc’s exam tools. The Arc kit used in the care home includes a stethoscope, blood pressure, pulse, and a camera wand to perform ear and throat exams and connects to a video platform that captures the information. Arc Health is part of the National Innovation Collaborative funded by NHSX. The care homes are part of South East London CCG, and the Lambeth Together and One Bromley borough health and care partnerships. Release on HealthTechDigital.

Alcove has inked a contract with Suffolk County Council (SCC) valued at £75 million over three years. Renewal is possible for another four years on an annual basis. According to UK Authority, Alcove will be developing a “new operating model for leveraging care technologies and data in the adult social care sector, with the potential to take this into wider health and care.” The procurement contract will be available for other authorities, fire and rescue, ambulance, probation, and community services in the east of England. SCC has been using Alcove technologies, including their Carephone service, to keep isolated older people connected with services during the pandemic. 

News roundup: Cera hits £89.5M revenues, Alcove Carephone in new elder housing, Everlywell home test kits raise $179M; FDA clears Lucira’s all-in-one COVID test kit, Apple Watch new ECG feature

Farringdon, London-based Cera announced a high point in its revenues of £89.5 million ($120 million) since their 2016 launch. While it is primarily a home care company d/b/a-ing under Cera Care (and seeks to hire an additional 5,000 staff, mostly professional carers), we noted back in March their £52 million ($70 million) raise and the launch of SmartCare, a sensor-based analytics platform that uses machine learning and data analytics in real-time on behaviors to personalize care and detect health risks with a reported 93 percent accuracy. Cera also has a proprietary app to connect families with Cera on visits and progress. Unfortunately the Cera website is singularly uninformative on company news and SmartCare. Mobihealthnews

Alcove is partnering with Cornell Court in Saffron Waldon, Essex, an extra-care community developed and run by L&Q Living, to fit out apartments with their in-residence Carephone tablet. Having the access to the tablet, residents can easily initiate a group video call with family members, as well as attend virtual care and therapy sessions and activities including bingo and exercise classes. There is also access to a ‘virtual concierge’. The combination of onsite services and the Carephone access helps with resident independence. All helpful as the UK remains on a non-virtual lockdown in most places and Christmas looks distinctly un-festive this year, especially for older adults. Local Authority Building & Maintenance (LABM) Online.

COVID-19 has certainly been a boom of a boon for at-home testing companies.

  • Everlywell just raised a hefty Series D of $179 million. They market and process over 30 FDA-cleared kits, including (of course) symptomatic COVID-19 (SARS-CoV-2, lower nasal swab) with a follow up from the lab in 24-48 hours via their app coupled with a telehealth consult. Other kits include thyroid, indoor/outdoor and food allergies, and hepatitis C, at prices ranging from $49 to a comprehensive food sensitivity test at $259. Prediction: Everlywell and similar companies will be 2021’s 23andMe/Ancestry.com.  Fierce Biotech
  • An equally intriguing ‘home run’? FDA cleared the first ‘all-in-one’ home test for COVID-19 under an EUA (Emergency Use Authorization). The Lucira Health molecular test from a nasal swab sample is completed by a battery-powered handheld unit that includes all the reagents needed to process the test. The unit then shows the result with a green light for positive or negative. Average time: 2 minutes. Molecular tests are more sensitive and accurate than the current quick tests of antigens. Go-to-market of the single-use test kit is expected early spring 2021, at a cost of $50. The by-prescription test can also be performed in point of care settings. The company will be filing early next year to have as an option prescription via telehealth. Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Ft. Lauderdale participated in the trials and will be first on distribution. Fierce Biotech, Lucira press release, FDA release

Remember when any burp from Apple was Major News, breathlessly awaited? Now ho-hum. FDA cleared the latest update of the Apple Watch’s ECG monitoring. Now the feature enables heart rate detection up to 150 beats per minute and adds a classification category called A-Fib with high heart rate. The Apple Watch has been used in some studies to monitor for atrial fibrillation. No release date is set for the watch. However, AliveCor is suing Apple on patent infringement of three patents, from the Apple Watch Series 4 and later devices, so stand by. Mobilhealthnews

Bexley, Wandsworth Councils onboarding remote monitoring, video calls with COVID-19 the spur (UK)

With Round 2 of the pandemic hitting the UK (and rising rates in EU and also parts of the US), it’s timely that borough councils have already stepped up their efforts to extend home monitoring and connectivity to the most vulnerable older adults and disabled. Here’s a short roundup:

  1. The London Borough of Bexley has been working with Docobo to install their DOC@HOME technology to connect residents with their GP to manage their health and well being at home. DOC@HOME connects with the patient via tablet (Android) tablet, computer, Docobo TV, or smartphone to their clinical teams to enroll, set up, and manage their patients using Docobo’s reporting platform. This version of DOC@HOME used two types of question sets: to set up a doctor consult requested by the resident or staff member and to conduct monthly wellness checks. The pilot was completed with one care home with these results (2019 vs 2018 same period): 71 percent fewer visits by GPs to the care home, and 36 percent fewer visits by residents to A&E. Bexley is now rolling out to 20 care homes using an NHS Digital pathfinder grant. Later plans will be rollout to individual homes.
  2. The Bexley Council is also piloting another Docobo product, ARTEMUS, a risk stratification platform, with the Bexley Clinical Commissioning Group (CCG) to create an analytics and decision support platform to support a more holistic approach to health and wellbeing at the individual level. Risk stratification at its most essential level uses data to classify residents or patients at their level of health risk (multiple chronic conditions) with the objective of mitigating long-term escalations in care needs and emergencies and integrate support, particularly to integrate support for those with dementia. 1 and 2 from NHS AI Lab Hat tip to Adrian Flowerday of Docobo for his LinkedIn post.
  3. Wandsworth Council is working with Alcove to provide the Carephone tablet to their residents who receive a care or support package. The Carephone enables them to make video calls with family, friends, care workers, and other approved service providers. Wandsworth Council article.

Kent County Council announces videophones for vulnerable residents in £1.5 million COVID response initiative (UK)

Kent County Council has launched an initiative to connect 2,000 of its most vulnerable residents to KCC support staff. Alcove, an assisted care technology provider, and care transformation consultancy Rethink Partners will set up the videophone tablet-type units. The £1.5 million Video Carephone program will support “vulnerable and digitally disadvantaged elderly residents and those with a learning disability (who) will be able to receive virtual video care and health consultations, as well as video contact with friends and family while minimising the infection risk to other residents and care staff.” The unit is delivered to the person’s home, ready to go; presumably there is already in place an internet connection with a router as the KCC website release is not specific on the technical side.

This was rolled out in response to the COVID pandemic, but this program is also aligned with the national digital switchover program starting in 2023. The release also includes a testimonial from Robert Greenfield of Gravesend (above left). Diagnosed with multiple sclerosis 20 years ago, he set it up himself, using it not only to communicate with his home care provider but also friends and family. An interesting sidelight is that Mr. Greenfield edits a magazine (MS) for others with the MS diagnosis and will be writing about it.