News and funding roundup: BioIntelliSense ‘stickers’ $45M, Exo ultrasound scans $220M, Enovation gets Scotland OK, WellSky snaps up Healthify, Cerner’s good quarter despite VA

Sticker shock? BioIntelliSense, which has been flying under the radar for over a year [TTA 17 July 2020] since inking a deal with Philips to integrate their BioSticker sensors into their post-acute remote patient monitoring (RPM) systems, scored a $45 million Series B funding for a total of $82 million since 2018. Lead investor is Chimera (UAE) with participation from 7wire Technology Partners, Mary Tolan of Chicago Pacific Founders, James Murren, formerly of MGM Resorts International, as well as Pendrell Corporation, Royal Philips, and Fresenius Medical Care North America.

BioIntelliSense has two wearables: the BioSense on-body sensor for 30 days of continuous vital sign monitoring, and the new BioButton for up to 60 days of RPM. The BioButton is touted for Covid-19 monitoring. “Temperature checks have proven to be unreliable and even amplified testing (PCR) has proven to be ineffective in identifying the virus in the early days of infection.” The button will be connected to the BioMobile screening survey app which will feed the user the latest CDC health screener and then scan for ‘subtle physiological changes’ in temperature, respiratory rate and heart rate at rest. The app generates a non-PHI report indicating ‘cleared’ or ‘not-cleared’. The BioSticker is 510(k) FDA-cleared; the BioButton is not, but is being marketed as an enterprise solution for employee health clearance. Mobihealthnews

Hand-held ultrasound gets ultra-funding. The Exo hand-held ultrasound snagged a hefty $220 million in Series C funding for a total of over $320 million since last year. Their point-of-care tool includes nano-materials, sensor technology, and advanced signal processing and computation in a platform called Exo Works. Exo is in a crowded field pioneered by GE Healthcare’s Vscan [TTA 27 March] back in 2010, but including Butterfly IQ, Mobisante, and Philips LumifyMobihealthnews

Enovation also approved by Scotland. With our news from Alcuris last week that they were selected by Scottish Digital Telecare as a security-assessed supplier, Enovation (formerly Verklizan), notified your Editors that they also were selected. Our quote from their management is from Andy Grayland, Chief Information Security Officer, Digital Office for Scottish Local Authorities. “The Scottish digital telecare security-assessed suppliers scheme reviewed a submission from Enovation for an Alarm Receiving Centre application. The assessment panel was very impressed with pre-existing security security culture and standards within Enovation. Both this assessment scheme, and Enovation’s positive response to it, will help ensure that vulnerable telecare users across Scotland are protected against the threat posed by cyber criminals when using these services.” 

WellSky to acquire SDOH provider Healthify. WellSky is a provider of software, analytics, and services for community care. Healthify builds and manages accountable networks for SDOH services, working with health plans, providers, and community partners in all fifty states. Previously, Healthify had raised $25.5 million in five rounds from 2013 (Crunchbase). Healthify is the fifth company WellSky has acquired since 2018, the last CarePort Health for $1.4 billion in 2020 (Crunchbase). Terms were not disclosed. Closing anticipated in Q3. The release does not indicate management transitions or HQ location.  

Despite their VA troubles and layoffs, Cerner had a very good quarter indeed: revenue up 10%, adjusted EPS $0.80 versus $0.63, exceeding analyst expectations for both. They laid off 500 employees in the quarter and eliminated 300 open positions, which will deliver $70 million in annualized savings. plus half their owned space is now unneeded so up for sale. Their Department of Defense EHR rollout is going well with 42 commands and 663 locations with 41,000 activated users. The Coast Guard’s deployment will be completed this year. As to VA, “results of the VA’s strategic review focused on governance, training, and readiness rather than Cerner-caused problems.” More in the lead article in HISTalk 8/2/21. Cerner’s announcement, transcript of earnings call on Seeking Alpha

Nanowear’s ‘smart clothing’ in NY/NJ hospital trials to monitor patients for early-stage COVID. Is it the Year of the Sensor?

Nanowear, a NYC-based developer of cloth-based nanosensors and monitoring systems, has entered a clinical trial collaboration with two major NY/NJ-area hospital systems to test for vital signs which may be predictive of an advancing case of COVID-19. 

The goal of the investigative teams at Hackensack Meridian Health, the largest health system in north and central New Jersey with 17 hospitals plus 500 patient care sites, and Maimonides Medical Center of Brooklyn, affiliated with Northwell Health, is to determine and assess patients for early signs of the ‘cytokine storm’ in the heart and lungs which indicates inflammation within the circulatory system, often leading to severe complications and death in COVID patients. The clinical trial will monitor patients with confirmed or suspected COVID-19. The release is not specific as to whether the garment will be issued to patients monitored solely in the hospital or inclusive of patients still at home.

Nanowear’s SimpleSENSE adjustable undergarment continuously captures key physiological signs related to the onset of COVID–real-time ECG, systolic and diastolic blood pressure, blood flow hemodynamics, respiration, lung volume and fluid, and temperature. The vital signs are then transmitted via a mobile app to a physician portal for monitoring and interpretation.  

The garment test is also significant as it is a contactless monitoring system–highly applicable to contagious diseases.

Last July, SimpleSENSE launched in a heart failure management clinical trial with Penn State Hershey Medical Center in Pennsylvania and Hackensack Meridian. The patented cloth-based nanotechnology sensors can capture up to 120 million data points per patient per day. The HF management trial was designed to validate and provide a pathway to clear its own diagnostic algorithm generated from the garment. The SimpleSENSE device and mobile platform have been submitted to FDA for Class II 510(k) clearance.  Also mHealth Intelligence.

This may be the Year of the Sensor. Human contact is out, remote monitoring is in. Earlier this week, we covered Philips integrating BioIntelliSense‘s BioSticker into its RPM systems. During 2018-2019, we profiled Doncaster UK-based MediBioSense, which uses the VitalPatch from VitalConnect. They recently announced that an enhanced VitalPatch suitable for seven-day use and body temperature sensing received CE Class IIa medical certification as well as FDA clearance. We last covered them when MBS adopted the Blue Cedar app security system in 2018, but based on their website press section, much has happened since in extending their sensor-based technologies. This Editor will try to catch up with Simon Beniston of MBS.