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

News roundup #2: Bright.md sells remaining customers to 98point6; Netsmart EHR up for $5B possible sale; Caregility intros two new telehealth systems

More from JP Morgan’s Healthcare Conference (JPM), CES, and after:

Bright.md’s remaining assets sold to 98point6. Now stay with your Editor as we sort through this. Bright.md was sold, we thought, to Cigna’s Evernorth MDLIVE telehealth unit last October, announcing at HLTH that MDLIVE would add Bright.md’s asynchronous telehealth technology to their platform. Evidently, Bright.md had other assets not included in that sale, namely the right to service 17 asynchronous telehealth provider customers such as Baptist Health and UAB Medicine. Those customers have been purchased by 98point6, a company that last year transitioned out of direct care into being a licensor of real-time and asynchronous telehealth, plus other software for clinical decision support and EMR integration.

98point6 pivoted last March by selling their physician group, self-insured employer business, and an irrevocable software license to Transcarent, in a deal worth potentially $100 million. What they bought from Bright.md can only be interpreted as those 17 customers were not obliged to go with MDLIVE in that earlier transaction. Those 17 customers now will license 98point6’s asynchronous telehealth. 98point6’s purchase price is 45% in cash and 55% in equity. 98point6 is also taking on six former Bright.md staff in commercial and sales. Another small puzzle is that the Bright.md website remains unchanged with last entries in July 2023 and no mention of MDLIVE. The company’s most recent LinkedIn posts also end in July 2023, yet a sample of the executive staff indicates that they remain employed at Bright.md. Axios, 98point6 release

Netsmart Technologies exploring $5 billion sale. The company is reportedly exploring a sale of its EHR and related software business via Goldman Sachs and William Blair in the coming weeks which could fetch up to $5 billion. The EHR has an estimated 754,000 users at community health centers, behavioral health centers, hospice care, and non-profits. This year’s EBITDA is estimated to be about $250 million. 

The current owners, GI Partners and TA Associates, bought it between 2016 and 2018, but its roots go back to 1992 (with an acquired company back to 1968). It went public in 1996, moved private in 2006, then went through various private equity owners including Allscripts, moving from NYC to Great River, Long Island and presently to Overland Park, Kansas. If the sale, likely to another group of PE investors, is successful, it would demonstrate signs of life in the dead healthcare M&A market.  Reuters   Axios’ sources estimate closer to a $4 billion sale

Another during CES announcement came from Caregility, which announced two new point of care telehealth edge devices. The APS200 Duo is the company’s first dual-camera, all-in-one system with onboard edge computing and a dedicated graphics engine. The new APS100 Pro is a second generation model of their all-in-one system with a wide-angle camera for remote patient observation. This can be upgraded with the APS FlexCam, an external high-definition 40x power zoom video camera for virtual nursing programs and remote patient examinations. The devices connect to the Caregility Cloud virtual care platform with multiple audio and video streams for clinical and care applications supporting workflows in acute and ambulatory settings. Release. Caregility also contributed a Perspectives on virtual nursing and telehealth in November.

Weekend recap from HIMSS23: Glen Tullman’s 5 predictions, HIStalk’s random four-day walk, Oracle Cerner integration ‘going great’, Seema Verma to Oracle, Caregility’s debuts three enhancements

From the reports on HIMSS23, it seemed almost–normal. Companies were there, attendance was back to near pre-pandemic levels, a normal exhibit hall, and while it was Chicago complete with snow flurries, and there were differences–no aisle carpet in the exhibit hall ‘for the environment’, suits were a rarity, Cerner disappeared into Oracle Health, and the industry was through a cycle of boom then bust–it was almost Old Times. 

So what’s next? Filling that hunger for a future view was Glen Tullman, late of Allscripts and Livongo, now 7wireVentures founder and CEO of Transcarent. His five predictions were:

  1. Consumers are in charge. They have an array of options unless in an emergency. The industry must build a new and different relationship with them
  2. AI will inform the experience. Eliminate paperwork, simplify documentation, analytics to optimize staffing levels, improve use of real-time data in care.
  3. Care will happen in 60 seconds. Quick and convenient response to care has to be the norm, especially for chronic conditions. Without this, three undesirables will happen: avoidance of care, wait until their condition is so serious that their healthcare costs become much higher, or wind up in the emergency department.
  4. Health systems will be the hub…maybe. They can own the consumer health experience. But health systems will need to change their payment model. 
  5. At risk is no risk. Health systems must “lead the way” to value-based care, care quality, and what appropriate care plans should look like.

Interestingly, payers aren’t mentioned in this model–and they see themselves as the hub, not health systems, through their acquisitions are providers and home health. MedCityNews

HIStalk’s random HIMSS23 walk. Perhaps the best ‘you are there’ take on HIMSS23 was published over four days by HIStalk, including Dr. Jayne’s commentary. They need no commentary from your Editor, including surviving Chicago’s weather, the distances, the no-aisle carpet exhibit hall, long lines for coffee, and local dining delights including wet beef and tavern pizza (avoid deep dish). Pro tips: if you’re an exhibitor, book meetings in advance to assure your ROI, and nothing beats F2F–true of both HIMSS and ViVE, booths were packed.  They were there so you and I didn’t have to be. Where do you think HIMSS24 will be?

Monday: Mr. HIStalk, Dr. Jayne

Tuesday: Mr. HIStalk, Dr. Jayne

Wednesday: Mr. HIStalk, Dr. Jayne

Thursday: Mr. HIStalk, Dr. Jayne  (see in Mr. H’s comments about how Microsoft has quietly taken the lead in health tech with Azure, Nuance, and now generative AI. Watch out Larry Ellison.) 

Healthcare Dive interviewed David Feinberg, now chairman of Oracle Health. According to him, everything is going great with the Cerner integration. “The integration has been pretty smooth” and they are well on their way to creating “a cloud-enabled health platform that brings all kinds of information together to make individuals and communities healthier around the world” and in building an EHR-agnostic health records database to link thousands of separate hospital databases. No mention of the troubled VA EHR implementation. (Ahem)

Announced during HIMSS as an exclusive to Healthcare Dive, Seema Verma, formerly Centers for Medicare and Medicaid Services (CMS) administrator during the Trump administration, is joining Oracle Life Sciences, the company’s clinical trials business, as senior VP and general manager. She has spent the last two years as senior adviser to private equity firms TPG and Cressey, and serving on the board of directors for health tech companies Lumeris, Monogram, Wellsky, and Lifestance.

And to this Editor, Caregility, a cloud-based virtual care and telehealth platform that connects virtual visits, clinical consultations, tele-ICU, remote patient monitoring, and point-of-care observation in hospitals, announced that they have a new portfolio of AI-enhanced hybrid care solutions built on best-in-KLAS (non-EMR) Caregility Cloud. According to the release, “A computer vision application analyzes live video streams of patients and their environment to detect movement and changes that could lead to adverse events such as falls or self-harm. A contactless monitoring system continuously captures patient vital signs, detecting variations in heart rate, breathing patterns, and movement that could be indicative of physiological events like awakening from sleep or an induced coma. An ambient clinical intelligence algorithm generates documentation from live clinician and patient conversations for the patient’s electronic health record.”

ATA conference roundup: a new board chair, a digital app review pilot, and company announcements

The American Telemedicine Association (ATA) 2022 conference and expo is a wrap, after starting on Sunday through to Tuesday. While your Editor could not attend due to other commitments that precluded a trip to Boston, one industry insider who visited the expo–his first in-person event in two years–reported that after a slow start on Sunday, the floor busied up on Monday. Business was being done, finally and not virtually. What were the busy booths and what was ‘hot’? Companies in the areas of telemental health and remote patient monitoring (RPM). (Did you attend? What was your impression? Leave comments below.)

ATA had two major announcements of its own during the conference:

  • Kristi Henderson, DNP, NP-C, FAAN, FAEN, has been named as Chair of the ATA Board for a two-year term. Henderson is the CEO of Optum Everycare, where she leads a team building digital and virtual health solutions to improve quality outcomes and experiences for patients and providers. She has served on the board since December 2020. As Chair, she is succeeding Joseph Kvedar, MD and Professor at Harvard Medical School among other positions. Dr. Kvedar will become Immediate Past Chair and Senior Advisor to the ATA. Announcement
  • ATA, the American College of Physicians (ACP), and ORCHA, the Organization for the Review of Care and Health Applications,  announced a framework for the assessment of professional and consumer digital health technologies, including mobile apps and web-based tools. ACP and ORCHA, which has experience assessing compiling libraries of apps, will be piloting a test of the framework against a database of digital health tools. The goal of the pilot is to “determine how the library can be useful to physicians in recommending high-value digital health tools to their patients, and what other barriers to wider adoption of digital health tools may exist.” Announcement

Quite a few company announcements were made during ATA–a selection:

  • Johns Hopkins Bloomberg School of Public Health highlighted the publication of a major scientific study (full text) documenting telehealth outcomes in JAMA Network Open. This Johns Hopkins-based research was partially supported by the ATA. The study followed a national cohort of 40.7 million commercially insured persons from July to December 2021 and included 21 chronic and non-chronic conditions. Fourteen-day follow-ups for persons with an initial telehealth visit were compared to persons receiving in-person care. On average, patients participating in an initial telehealth consult for a new health condition did not require more unplanned hospitalizations or follow-up ED visits within 14 days of their initial consult compared with patients making an initial in-person visit. The exception was respiratory conditions. Release
  • BioIntelliSense, which last year scored $45 million in funding for its on-body sensors, announced two major collaborations for remote patient monitoring (RPM) with UC Davis Health and Houston Methodist.
  • CDW Healthcare and Caregility announced a strategic partnership to expand their virtual care capabilities, including Caregility’s new Inpatient Virtual Engagement solution (IVE), also launched during ATA. 
  • Connect America, which snapped up Lifeline last year, launched Connect America Home, a single health and safety platform connecting (PERS) and remote patient monitoring (RPM) with supporting services, including AI-enabled virtual health assistance and Social Determinants of Health (SDoH) support, along with analytics. Release.
  • AliveCor announced the launch of KardiaComplete, a comprehensive heart health enterprise solution designed to drive improved health outcomes and reduce the cost of cardiac care. The service will be available through self-insured employers, health insurance plans, and health systems to those diagnosed with hypertension and arrhythmias, like atrial fibrillation.
  • Withings launched Withings RPM, the company’s most advanced remote patient monitoring solution designed to enhance the patient experience. It is a single platform that enables clinicians to order and send Withings RPM devices, manage data from multiple patients with automated alerts and reminders, communicate via SMS, phone, and in-app video calls, billing, sleep tracking, and more. 

TTA was a media partner of ATA 2022.