News roundup: Proteus dissolves with Otsuka, EHRs add 16 min. per patient, DrChrono mobile EHR raises $20M, CareBridge LTSS launches, ‘flyover healthtech’ soars

January 17, 2020 | by

The much-touted partnership of Proteus Digital Health with Otsuka Pharmaceutical of Japan for a digital version of Abilify has ended prematurely. Abilify MyCite was the first drug cleared by FDA with a digital tracking system in November 2017 [TTA 14 Nov 17]. Otsuka was also going to fund Proteus for further development of drug tracking.

In the payout for the Proteus license, Otsuka has the right to use Proteus’ technology for its own mental illness drug research. Proteus will abandon its research in mental illness and cardiovascular conditions and concentrate on digital meds in cancer and infectious disease. Before the holidays, we saw reports that ‘Proteus may be no-teous‘ and that layoffs and office closures were in the works. STAT reports that the Proteus-Otsuka breakup is one of several recently: Sandoz and Pear Therapeutics, Sanofi and Alphabet’s Onduo.

Where does a doctor’s time go? EHR use, for one. A study of 155,000 ambulatory medical subspecialists and primary care physicians in 2018 clocked EHR use per encounter at over 16 minutes on average, with chart review, documentation, and ordering functions accounting for most of the time (33, 24, and 17 percent, respectively). Percentages changed by subspecialty. PhysiciansWeekly,  ACP Annals of Internal Medicine (abstract only) 

Speaking of EHRs, DrChrono, one of the first mobile-friendly EHRs/practice management/revenue cycle platforms, raised $20 million in a Series B led by ORIX Growth Capital. Its total funding in nine years tops $48 million. Crunchbase, Mobihealthnews

Long term care (LTC) has been ‘about to be hot’ for at least 10 years. Where the real money may be made is in the ‘back end’. This week, a new long-term support services (LTSS) firm, CareBridge launched out of Nashville, backed with $40 million in fresh funding with a BOD helmed by a former US senator and physician, Bill Frist. Created in part through the acquisition of two other companies, HealthStar and Sinq Technologies, it will concentrate on electronic visit verification by caregivers for in-home service delivery, provide real-time sharing of clinical information, support members with enhanced tablet-based telehealth services, and is building a predictive model for service support. BusinessWire

Flyover tech soars, indeed. We note that CareBridge is in Nashville, which snobs on both coasts demeaningly call ‘flyover country’. Well, there’s gold in Middle America’s hills when it comes to health tech, with some of the choicest high flyers at this week’s JP Morgan Healthcare Conference from places like Nashville, Minneapolis, Ann Arbor, Denver, and Iowa. Utah alone has enough tech to earn it the nickname ‘Silicon Slopes’. Utah’s highlighted company is one this Editor found back in 2013—Owlet–still (baby) socking it to them, cutely. Others, unfortunately, are wince-worthy–the prize goes to the Ōmcare med dispenser, which makes darn sure via two Wi-Fi-enabled interactive cameras that those pills are not only being taken, but also being swallowed. Really. Observer

Breaking: FDA approves the first drug with a digital ingestion tracking system

November 14, 2017 | by | 1 Comment

Not many drug approvals warrant an FDA press release, but this one did and deservedly so. The US Food and Drug Administration (FDA) approved a version of the psychiatric drug Abilify (aripiprazole) equipped with the Proteus Digital Health ingestible tracking system. Abilify MyCite has been approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. It is the first approved commercial version of a drug equipped with the Proteus Discover system, which tracks the ingestion of the pill from a sensor in the tablet activated by gastric juices to a patch worn by the patient and then to a smartphone app. The patient, caregivers, and physicians can track medication usage (timing and compliance) through the app, adjusting dosage and timing as needed.

The Proteus press release states that the rollout is gradual through select health plans and providers, targeting a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder. It is contra-indicated for pediatric patients and adults with dementia-related psychosis.

Abilify, developed by Japan’s Otsuka and originally marketed in the US with Bristol-Myers Squibb (BMS), has been generic since 2015. This Editor finds it interesting that Proteus would be combined with a now off-patent drug, creating a new one in limited release. Proteus’ original and ongoing tests were centered on combining their system with high-value (=expensive) drugs with high sensitivity as to dosage times and compliance–for instance, cardiovascular and infectious disease (hepatitis C, TB). Here we have a focus on managing serious mental illness and treatment. 

Editors (Steve and Donna) first noticed Proteus as far back as September 2009. Looking back at our early articles, Proteus has come a long way from ‘creepy’ and ‘tattletale’. With nearly half a billion dollars invested and a dozen funding rounds since 2001 (Crunchbase), approvals were long in coming–nine years from submission of patch and tablet sensor to the FDA (2008), seven years from the patch approval (2010), five years from the tablet sensor approval (2012), to release of a drug using the Proteus system. The only thing this Editor still wonders about is what happens to the sensors in the digestive tract. They contain copper, magnesium, and silicon–copper especially can be toxic. If the sensors do not dissolve completely, can this be hazardous for those with Crohn’s, colitis, or diverticulitis/diverticulosis?  Hat tip to Bertalan Meskó, MD, PhD, via Rob Dhoble, on LinkedIn.

Also, if you can stand it, a lengthy article from the New York Times with lots of back and forth about the existential threats of monitoring drugs, potential coercion (preferable to injected Abilify), how some with schizophrenia already manage, and Proteus as a ‘biomedical Big Brother’. (Some commenters appear to have the very vapors about any digital trackers, including AiCure and etectRx.)