Outset Medical gets $76.5M to bring dialysis first to the 21st century, then to the home

Outset Medical has raised $76.5 million in a series C round led by T. Rowe Price Associates. In addition to new investor T. Rowe Price Associates, existing investors Fidelity Management & Research Company, Partner Fund Management LP, Warburg Pincus, Perceptive Advisors and The Vertical Group also participated. This round of funding bring’s the company’s total funds raised to $185.5 million.

With its flagship product Tablo, Outset is focused on innovating just about every part of the practice of kidney dialysis, a method of artificially purifying blood in patients with kidney failure.

“We’re focused on bringing dialysis into the 21st century,” CEO Leslie Trigg told MobiHealthNews. “There are a couple ways the dialysis industry looks a little bit more like the 1980s than 2017. Number one, it by and large is still a pencil and paper area of healthcare. Number two, the user experience both for patients and providers is served by technology that has not really changed in 20 or 30 years. If you think about the way that cars were designed and manufactured in 1980, imagine if the car you drove today hadn’t been updated since the 80s.”

Tablo is a unit about the size of a minifridge, which already sets it apart from larger traditional dialysis machines. Unlike current machines that have to start with purified water, which requires a massive amount of infrastructure at hospitals, Tablo can bring in tap water and purify it as part of the process. It has also been completely redesigned to be easier and faster to set up and it contains a touchscreen which displays instructions, as well as education and entertainment content.

It’s also connected. Outset recently recieved FDA clearance for a dialysis machine with two-way data communication. That means that not only can data on the treatment be sent directly to a patient’s EHR, but information about the patient that a technician used to have to enter manually to calibrate the machine can now be uploaded directly from the EHR. The two-way transmission also allows for software updates as the technology improves.

The company has attempted to identify and eliminate as many outdated parts of the dialysis process as possible.

“For example, one of the steps that’s really important in dialysis is making sure you don’t have any air bubbles in the dialyzer,” Trigg said. “Today, the method of removing air involves the technician taking the dialyzer and banging it against the side of the machine. By contrast, we have designed a proprietary algorithm that automatically removes air from both the dialyzer and the blood lines. So we’re focused on the automation of steps and elimination of steps. We were able to eliminate over 50 percent of the steps involved in setting up a dialysis machine.”

The end goal for this simplification is to have a machine operated not by a nurse or a technician, but by the patients themselves. This has already been partially realized: Although Outset needs an additional pending FDA clearance to make the device usable in the home, it has been set up in some dialysis clinics as an “in-clinic self care” offering, analogous to self-checkout stations in grocery stores.

“The consumerization of the complex has been done all over the place,” Trigg said. “If you look at a space like diabetes management, that’s a great example of something that used to be very complex for the user and has been made much less complex through consumer product design. So [one] way we’ve really updated this is through a consumer product-like experience for the user, and that would be everything from the form and function of Tablo, specifically designing it so it doesn’t look like a dialysis machine, to the graphic user interface, using a lot of pictures and videos and simple animations to show people how to do it so you don’t have to memorize anything. …  We really designed this 100 percent with the consumer in mind.”

Outset Medical also offers two mobile apps to improve that experience: a patient training app and a provider app that contains all the documentation on the device. A third app is in development.

“We are in development of a patient app that will transmit a more basic snapshot of the treatment data that’s flowing out of Tablo out to the cloud, and send that back to the patient,” Trigg said. “Because today patients don’t get any information at all about their treatment. How did it go? Did all the toxins get removed at the right rate and in the right amount? We aim to give patients a lot of information. All this is part of putting them in the driver’s seat of their own care.”

The company will use the funding to ramp up manufacturing, expand its sales and support teams, and complete more clinical trials. At least one additional trial will be required to get the clearance needed to bring the device into the home.

“The opportunity we see is to leverage the best of software and data analytics to open up the envelope on where, when, and who can dialyze at the end of the day,” Trigg said. “In addition to transforming the device, we’re aiming bigger than that. We’re really focused on technology-driven service innovation. How do we use new tech, not just because it’s newer and cooler and better, but because it can serve a larger purpose? And that purpose is both cost reduction, which is very acutely needed in the dialysis space for providers, but also — for the half a million people on dialysis — we see a future for a very different patient experience, one that really puts the patient in the center and lets them to control it and own it in ways that have been shown over and over again, in other areas of medicine, to provide better clinical outcomes over time.”

Welby launches three more apps for pharmas J&J, UCB, and Nippon Shinyaku

Japanese health app maker Welby announced three new apps last month developed in partnership with pharma companies. Welby will add to its lineup three apps available only in Japan: an app for irritable bowel disease patients with Johnson & Johnson subsidiary Janssen; an app for pulmonary arterial hypertension (PAH) patients with Japanese pharma company Nippon Shinyaku, and an app for rheumatoid arthritis patients with UCB Japan.

Welby’s approach to digital health tools is to work directly with large, global pharmaceutical companies on patient-facing apps. It was founded in 2011 and is licensed as a medical device company, but it has also been involved in a few different areas of health technology. The company makes an open platform for personal health records and data aggregation which can connect to medical devices, activity trackers and manual-input data from lab tests or prescriptions.

The IBD app is the company’s second app for Janssen — they launched an app for ADHD in March. The app, IBD Supli, is intended for patients with either Crohn’s disease or ulcerative colitis and allows patients to record data such as symptoms and information about bowel movements, then transmit that data securely to their care team or print out a record (including a QR code that leads to an online platform) to show their doctor. The app also provides a space for patients to jot down questions they want to ask their doctor on their next visit.

Welby is working with Nippon Shinyaku on its app for PAH, called PAH Care Note. The app is similar to the IBD app but has more of a focus on medication adherence. Patients can track their adherence data and also see it retrospectively in graphs and charts. The app also contains links to educational material from Nippon Shinyaku.

Finally, the rheumatoid arthritis app, with UCB Japan, is called Rheumatism Diary. It is also for tracking symptoms, such as pain and mood changes. Patients can access this data in charts and graphs that they can also share with their physician. Rheumatoid Diary also includes a medication alarm to remind patients to take their medications.

Welby works with at least 10 pharmaceutical companies altogether, making apps for lifestyle-related illnesses, chronic pain, central nervous system diseases, oncology, immunology, and rare diseases. While the company has no near-term plans to expand outside Japan (according to a March MobiHealthNews interview) successful performances might encourage the pharma companies to do similar patient engagement work in other countries.

UC Davis taps Healbe to validate caloric intake-tracking wearable band

As the saying goes, we are what we eat. But studying exactly how people consume, use and burn calories – and which foods impact them and how – has been historically difficult due to many simple reasons, including everything from inaccurate calorie counting to plain old forgetfulness or even dishonest reporting. Accordingly, a number of startups have risen up to develop wearable devices that do all that work for people. But validating whether connected devices actually can passive track caloric intake has become something of a sticking point in recent years.

Researchers at the University of California Davis want to figure out if it’s possible, and so they have initiated a five-year agreement with Healbe, makers of the GoBe 2 Smart Life Band fitness tracker. The band, which retails at $179, uses the company’s Flow technology, which claims to automatically track a range of metrics including human caloric intake, hydration and emotional state. Dr. Sara Schaefer said she was intrigued by the potential.

“I hadn’t come across any other wearable device that was designed to track caloric intake, and especially one that was made to passively track how much people consume through non-invasive technology,” Schaefer, who is the associate director of children’s health at UC Davis’s Foods for Health Institute, told MobiHealthNews. “We’ve done a lot of programs with wearable devices, but they are usually physical activity devices, and my main motivation for contacting Healbe was for the additional capabilities of not just getting metabolism, but energy intake. They are the only ones I have seen that have that ability.”

Theoretically, at least, Schaefer acknowledged. There’s still some debate about whether the device works, and Healbe has certainly taken some heat for putting the marketing horse before the validation cart. The company raised just over a million dollars on Indiegogo in 2014, and launched in early 2015, but they were subject to much scrutiny by PandoDaily, who pointed out, among other things, a lack of evidence that the device actually tracks calories or nutrition as advertised. In January of 2015, it finally launched (or at least sent out test devices to a number of journalists) to mixed reviews. Even those that proclaimed the calorie tracking function accurate found the device buggy, and others considered the calorie tracking features a total bust (in addition to finding the device buggy).

“We know it’s actually a consumer device, not a scientific research device, so we are interested in using it to see how it could be applied to scientific research,” Schaefer said. “It’s a benefit to both parties: it will let us know how these sorts of consumer wearables could be used in part of a personal management and educational tool, and it will help Healbe learn how they can make adjustments to their algorithms to be more accurate.”

According to Healbe, the company’s patented Flow technology uses three of the device’s six onboard sensors, including an accelerometer, a Piezo sensor and an impedance sensor, the latter of which sends high and low-frequency signals through the users’ skin to continuously calculate the volume of water (which is bound to glucose) entering cells within their bloodstreams. Over a 24-hour period, the process claims to determines calorie and nutrition intake, as well as energy balance and hydration levels.

“This collaboration with UC Davis is very important to us, offering not only the opportunity to continue to develop our Healbe Flow technology and future GoBe consumer devices, but to explore new approaches and applications for our health monitoring solutions,” Healbe CEO and cofounder Artem Shipitsyn said in a statement. “It is very gratifying to partner with this well-respected institution to pursue our mission to help people live healthier lives by better understanding their bodies and the consequences of their lifestyle habits.”

In that way, the five-year-long collaboration will not be carried out as a fully designed study, Schaefer said, but a research partnership that will take different forms as data is gathered and technology changes. The Smart Band will be used to collect and analyze data based on nine health parameters ­ – calorie intake, calories burned, energy balance, water balance, stress level, emotional state, heart rate, sleep quality, and steps taken per day.

“Over time, we are interested in expanding the research to focus on precision solutions for more targeted groups; different demographic groups with different metabolic parameters,” she said. “One might be athletes, one might be children, one might be people just interested in learning about calories in, calories out and protein intake. We’re looking at all the different possibilities.”

While Healbe may not be proven to be that standout consumer-tracking device that can passively collect caloric intake and expenditure data for researchers just yet, Schaefer is hopeful that such wearables will play a vital role in nutritional research.

“The way things are today, you can really look at it from a couple of different perspectives,” she said. “There is a lot of criticism as people have tried to integrate wearable devices into labs and there are questions of accuracy because these are consumer devices and it really depends on how they are being used. So we are interested in seeing how we can start to use them in ways that will reveal fluctuations and patterns, and we’re seeing how advanced capabilities that allow the market to evolve and develop are doing the same thing for science. Collaborations like these are what are going to enable devices to get better over time.”

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