Our journey at Alio began with a commitment to creating the singular remote monitoring device for people living with chronic conditions. This vision became a reality this past year through FDA clearances, commercial partners and customers, legislative discussions, and clinical studies. Last year was a particularly memorable year for Alio, and the milestones shared in this blog post were essential in shaping our journey and providing momentum as we step into our commercial phase this year.
FDA Clearances
We kicked off the year with a monumental achievement – the announcement of our second FDA clearance, which added hematocrit, hemoglobin, and potassium to our platform. This development established the Alio SmartPatch as the world’s first non-invasive potassium monitor. Prior to this clearance, there was little advancement in care management or innovative solutions for patients on dialysis and their care teams. With Alio, patients no longer need to depend solely on monthly in-clinic blood draws to monitor their key metrics. Non-invasive, remote monitoring ensures clinicians have continuous and daily insight into their patients’ conditions between visits. Additionally, with the Alio Platform, individuals living in remote locations can receive consistent and high-quality care. With Alio’s significant technological advancements, the SmartPatch can cover this gap in care by remotely and painlessly taking readings on a daily basis and immediately notifying clinical teams about any potential issues.
Vascular-access-related complications account for almost one-third of hospital admissions among hemodialysis patients. Until now, clinicians relied on a quarterly diagnostic assessment or a physical exam to know whether or not a patient’s vascular access was open and functioning. We further expanded our platform capability in Q4 and became the first platform with a remote stethoscope function for monitoring the health of an access. For the first time ever, a clinician can now get notified of an issue in a patient’s access in real-time, rather than relying on an in-person physical assessment.
Commercialization
Upon securing our second FDA clearance, we soft-launched with our initial customers. To accelerate our go-to-market in 2024, we announced our strategic partnership with Carium, which focused on refining our clinician portal and expanding our distribution channels through Carium’s existing relationships with major healthcare systems. Carium is a Care Experience Platform (CXP) delivering one, cohesive ecosystem, and a personalized and efficient end-to-end care journey for care teams and the people they serve. Partnering with Carium, a well-respected organization with an established ecosystem, accelerates Alio’s go-to-market strategy and allows Alio to reach more patients at a faster pace.
This year brought our first two commercial customers – Quantify Remote Care and Premier Dialysis. Quantify deployed Alio’s remote monitoring technology to provide clinical teams with 24/7 remote access to key metrics for their dialysis patient population. Similarly, Premier Dialysis began using Alio’s portal for all of its patient data while deploying the Alio SmartPatch for its burgeoning home hemodialysis population.
Expanding Global Operations
We expanded our commercial operations beyond the United States to enter the Gulf Cooperation Council (GCC) countries through the first of many strategic partnerships in the region with the Al-Redwan Medical Service Company in the Kingdom of Saudi Arabia. Through this partnership, Al-Redwan will deploy Alio’s remote monitoring platform to monitor their 3,000+ End-Stage Kidney Disease (ESKD) patients for whom they provide dialysis. As Alio’s local partner on the ground, Al-Redwan also enables the distribution of Alio products to other hospitals, providers, and partners in the Kingdom.
At the end of the year, we announced a strategic partnership with GulfDrug, one of the top medical suppliers in the United Arab Emirates (UAE), further expanding our presence in the GCC. Through this partnership, GulfDrug will be distributing the Alio SmartPatch to the ESKD patients they serve, which encompasses the majority of the country’s ESKD population.
With partnerships in Qatar coming soon, Alio will have a substantial presence in the Middle East as a pioneering medtech company enabling remote patient monitoring (RPM). It has been incredibly exciting to see how quickly these countries embrace technology and innovation to improve care delivery and quality of life for their population. This provides Alio with opportunities to become a key partner to hospitals, providers, and Ministries of Health in the region in the coming year.
Value and Impact of Working with Alio
Our customer base is diverse because our solution addresses a number of pain points while also filling considerable gaps in technology and care. Current remote patient monitoring solutions are often just for one metric, each with their own dashboard, and regularly require troubleshooting or calibration. As a result, patients are left with a collection of devices which serve as singular point solutions, and clinicians are left without continuous access to important metrics and therefore lack a comprehensive view of a patient’s condition.
For customers like Premier, working with Alio expands their total addressable market by increasing the number of hemodialysis patients they are able to remotely monitor and therefore serve. For Premier’s existing Peritoneal Dialysis (PD) patients, the Alio Platform provides clinicians with an easy-to-use dashboard displaying important patient metrics all in one place. By leveraging the Alio Platform, Quantify can make quality care more accessible and better serve patients in remote locations as the SmartPatch provides clinicians with daily access to key metrics and timely notifications all without requiring an in-clinic visit.
Working with Alio also makes these organizations more attractive to patients and clinicians alike because it delivers a better experience. The platform is easy to use and delivers insights and predictive analytics where there previously weren’t any. With less time spent on troubleshooting and without multiple devices and portals to manage, Alio’s platform increases efficiency for already overburdened clinical teams so they can spend more time practicing at the top of their license.
For Al-Redwan and GulfDrug, Alio provides an innovative solution for the management and monitoring of their own patients while enabling scalability. In the Kingdom of Saudi Arabia in particular, Chronic Kidney Disease (CKD) is the fourth leading cause of death. Al-Redwan recognized the tremendous impact Alio’s technology can have in improving quality of life, reducing hospitalizations, driving down costs, and even avoiding potentially fatal complications altogether. For both Al-Redwan and GulfDrug, deploying one wearable device which monitors multiple metrics relevant to not only ESKD but also CKD and Heart Failure, they’re able to monitor and address a number of other comorbidities common among those with compromised renal function.
Government Support
Another highlight was the visit of Congresswoman Brittany Pettersen to our headquarters in Broomfield, CO. The congresswoman has established herself as a champion for innovative companies within her district, recognizing their crucial role in advancing progress in healthcare. Our team met with the congresswoman to shed light on the challenges dialysis patients face and how we are working towards providing peace of mind for patients and their family members and improving their care management through RPM.
We also urged the Congresswoman to join the Kidney Caucus, a bipartisan congressional group formed to raise awareness and encourage early detection and prevention of kidney disease. During the conversation, we also emphasized the transformative impact health tech companies, including Alio, can have on the wellbeing of constituents in her district. This sentiment was reinforced by Terry Litchfield, a member of Alio’s board of directors and a tireless advocate for kidney patients, as she shed light on her personal experience and the patient perspective more broadly.
Clinical Studies
In 2023 we also launched the first U.S. site of our WEAR study at the country’s largest nephrology practice – Nephrology Associates of Northern Illinois and Indiana (NANI). The WEAR study is a global, multi-center, interventional study designed to understand how Alio will impact health economics and key health metrics for patients with ESKD. We are proud to report patient enrollment in the study is underway, marking a significant step forward in improving wearable technology.
Additionally, we launched the JEM study in collaboration with the Alkhansa Hospital’s Jordan Center of Pharmaceutical Research (JCPR). The study aimed to assess if the SmartPatch can be placed on non-hemodialysis patients (without an arteriovenous [AV] access) and take accurate, non-invasive readings of hematocrit and hemoglobin. The initial findings of the study are promising and demonstrate the SmartPatch can serve Chronic Kidney Disease (CKD) and Heart Failure (HF) patients, in addition to ESKD.
Loss of a PFAC Member
While this year has been filled with triumphs and advancements, we must also take a moment to remember and honor our PFAC member Nieltje Gedney, who passed away. She helped design our product, provided amazing feedback, and encouraged our team on countless occasions. Her voice, enthusiasm, and advocacy for dialysis patients will be dearly missed.
Looking Ahead
We are especially grateful for our initial partners, Alio’s early adopters who truly believe in the value of RPM and have become the springboard for us to expand our footprint across the globe. Our successes and developments are a testament to the unwavering support from our community of doctors, clinical and commercial partners, and investors.
As we step into 2024, we already have a number of exciting developments underway that will come online and further support our vision of becoming the singular wearable to non-invasively and remotely monitor all chronic conditions. We look forward to embarking on another year of delivering transformative advancements and peace of mind for patients around the world.
