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Remote Patient Monitoring in Kidney Care
Alio, Proton Intel, CloudCath and the road to continuous monitoring in CKD and ESKD
If you read Signal 02, you know early diagnosis and treatment are two of our most pressing challenges (and opportunities) in kidney care. But what about for individuals who do advance to kidney failure? Welcome to our next frontier.
More than 800,000 Americans are living with end stage kidney disease today, 70% of whom are on dialysis.1
The dialysis patient journey is harrowing. Around 360 people start that journey every 24 hours— that's more than 125,000 people per year. Beyond the crucible of their prescribed treatments, dialysis patients spend an average of 11 days in the hospital annually, often due to issues like vascular access and fluid management.2
In 2017, a retrospective study revealed that nearly three-quarters of 30-day dialysis patient readmissions could potentially be avoided. That’s a massive opportunity, considering these unplanned visits cost Medicare a staggering $14 billion per year.3
What if we could help clinicians and care teams monitor patients between dialysis treatments and blood draws, and do so without asking patients and care partners to change their routines or take on additional care burden? That's where novel monitoring solutions enter the fold, paving the way for a healthier, safer and more cost-effective future for dialysis patients.
Let’s meet today’s companies.
IN THIS ISSUE
Alio becomes the World's First Non-invasive Potassium Monitor
FDA clears CloudCath peritoneal dialysis at-home patient monitor
Proton Intelligence takes aim at hyperkalemia management
Why it matters and what’s next in this space
1. Alio becomes the World's First Non-invasive Potassium Monitor
Alio is a FDA cleared, non-invasive, and multimetric remote patient monitoring platform consisting of the wearable SmartPatch™, hub, and clinician-facing portal. Their first focus area is end-stage kidney disease, or ESKD.Product: While patients go about their daily lives, Alio’s technology captures clinical-grade data and wirelessly transmits actionable insights, predictive analytics, and notifications to clinical care teams. The SmartPatch™ captures novel metrics including potassium, hematocrit, hemoglobin, auscultation, and skin temperature.
News: Last week the company announced the release of a new feature to address gaps in acoustic data from a patient’s vascular access site. Now clinicians can monitor vascular access remotely instead of needing manual readings— a massive win considering vascular access-related complications account for nearly one-third of hospital admissions for dialysis patients.4
Partners: Commercial partners include Carium, Lifeline Vascular Care, and Premier Dialysis. Recent clearances, features and funding are paving the way for broader commercial efforts in 2024.
Milestones: Alio has raised $50 million to date, including its latest $18 million Series C in December of 2022.
2. FDA clears CloudCath peritoneal dialysis at-home patient monitor
CloudCath is a medical device company advancing real-time fluid analytics and remote patient monitoring of peritoneal dialysis. Stanford Biodesign alums Aly and Eric co-founded the company to drive innovation in home dialysis at the intersection of biology, machine learning, and remote monitoring.Product: The company’s lead product is CloudCath Connect™ PD, a remote monitoring device for patients undergoing peritoneal dialysis (PD). The devices combines optical analysis with Internet of Things (IoT) to detect real-time changes in the turbidity (cloudiness) of discarded dialysate fluid. (Today this is done visually: patients are instructed to read written text through a bag of spent dialysate and seek medical attention if the fluid is too cloudy.)
News: Last year the company received FDA clearance for its CloudCath System, then added Dr. Don Williamson as its Chief Medical Officer and EVP of Clinical Services.5 The company also added Stanford nephrology chief Dr. Glenn Chertow to lead its clinical advisory board, who you might remember from a study featured in my last Signal on cost-effective CKD screening.6
Impact: CloudCath partnered with American Renal Associates (ARA) to conduct its Pre-Market clinical study of the platform. ARA operates 239 dialysis clinics in 27 states and serves more than 17,000 patients with ESKD.7 The company estimates its sensor could help catch infections early and potentially reduce three-quarters of related hospitalizations.
Milestones: CloudCath closed its $12 million Series A in February, 2020. The round was led by Capital Integral with additional backing from FundRx, The Capital Partnership, Coconut Tree Investments and Stanford University’s StartX.8
3. Proton Intelligence takes aim at hyperkalemia management
ProtonIntel is developing the first-ever wearable continuous potassium monitoring platform to transform the lives of people living with hyperkalemia (high potassium). They are taking one of the hardest biomarkers to monitor and turning it into something actionable for clinicians and patients.Product: Founder and CEO Sahan Ranamukhaarachchi recently sat down to share the company story with MedTech Innovator and give us a better idea of the need for the patch the are actively developing between Vancouver and Melbourne.
Evidence: The Proton Intel team and colleagues presented findings of a cost-utility analysis at last year’s ASN Kidney Week. They compared the cost and quality of life linked with use of a real-time potassium monitoring device in patients on hemodialysis vs. usual care. Their findings suggest a continuous monitoring device could help avoid up to 50% of all hyperkalemic events in the population, resulting in lower costs and improved quality of life.9
Market: Their initial target market is ~500,000 Americans Stages 4-5 kidney disease (CKD) with a history of dangerous hyperkalemia (K+ > 5.5 mM) who need to get their potassium under control to prevent crashing into dialysis (representing a ~$4B realizable market potential). Then, they will expand upstream in CKD and Heart Failure (13M population, >$24B TAM) while adding further continuous electrolyte monitoring capabilities.
Partners: The company has already attracted the attention of top investors and partners focused on early stage “deep tech” and medical devices, including Boost VC and MedTech Innovator. The latter is the largest accelerator of MedTech companies in the world, with over 500 alums representing 200 FDA approvals & clearances, and $6.8 billion in follow-on funding.10
Milestones: The company is at an exciting inflection point and has a roadshow planned that includes AdvaMed (OCT 9-11 in Anaheim), ASN Kidney Week (NOV 2-5 in Philly), and MedTech Strategist (NOV 14-16 in SF).
“Solving hyperkalemia starts with monitoring potassium, where anything short of direct, accurate and real-time monitoring will not enable life-saving decision making. Only ProtonIntel can deliver that.”
Why It Matters
Chronic conditions are a global challenge, impacting over one in three people. The key to better management lies in extending care beyond clinical settings.11
In kidney care, remote patient monitoring holds the promise of increasing home dialysis utilization, alleviating burdens, enhancing patient experiences, and reducing hesitancy towards at-home care. These are game-changing possibilities that the companies we've explored are actively pursuing—whether it's shortening the 11 days per year spent in the hospital, detecting peritonitis four days sooner, or halving hyperkalemic events.
What’s Next
The world of kidney care is changing faster than ever, thanks to seismic shifts in policy, care delivery and innovation. Back in 2019 the AAKHI Executive Order set an ambitious goal for 2025 – 80% of new ESKD patients getting dialysis at home or a transplant— one giant leap indeed.
Here’s how we might get there:
Medicare Advantage growth: More ESKD patients are moving from Fee For Service (FFS) to Medicare Advantage (MA) plans, with enrollment growing by +51% following the 21st Century Cures Act.12
Public-Private Partnerships: KidneyX, a partnership between HHS and ASN, is fostering innovation with over 70 winners like Alio, Relavo, Venostent, Outset, Qidni Labs, and dozens more.13
Reimbursement: Evolving remote patient monitoring (RPM) and telemedicine coding and reimbursement are opening doors for these technologies. However, generating evidence and demonstrating outcomes are still necessary to unlock the full potential of RPM.14
Closing
Companies like Alio, CloudCath, and Proton Intel are pioneering innovations that could transform kidney disease from a "silent killer" into a new gold standard for metabolic health and quality of life for billions worldwide.
Which signals are you following? What did we miss, and what else should people know? If you’re building something in this [space], I’d love to meet you. Leave a comment or connect with me on LinkedIn.