ANNE One

The COVID-19 pandemic has led to an unprecedented strain on healthcare systems worldwide—in the U.S., the available ICU-beds numbered in the single digits for multiple states. In LMICs, the healthcare system is frailer with inherently lower capacity for both healthcare personnel and essential supplies. When we fail to "flatten the curve", the suffering is disproportionately borne by the most vulnerable—frontline healthcare workers, older adults in long term assisted living facilities, and low-income individuals who delay necessary care for other conditions.

A foundational problem is that in the face of unprecedented demand for healthcare services, traditional hospitals are easily overwhelmed. A large influx of patients present with a spectrum of mild infections better managed at home to life-threatening sepsis requiring immediate ICU-level care. Thus, there is a critical need for new technologies powered by predictive data analytics that allows for the rapid scaling of ICU-grade physiological monitoring for care anywhere. The ability to project care beyond the hospital walls allows for tracking early signs of disease in vulnerable populations (e.g pediatric orphan diseases), monitoring those infected safely in a remote setting to protect precious hospital capacity and frontline workers, and to determine adequate recovery for a safe return to work.

The ANNE One system is soft and flexible sensor that can continuously monitor clinical-grade vital signs from premature infants to adults. Advanced processing algorithm further provides unique measurements that include cough count, fall count, peripheral arterial tone. It is designed to be scalable, low-cost, comprehensive, and predictive for early infection with algorithms trained on more than 100,000 hours of data collected from COVID-19 patients. This data can be stored continuously or streamed in real-time to a wide range of ubiquitous mobile devices for both point-of-care diagnosis or store-forward analysis. Data storage and processing in Sibel's cloud server further expands the use cases into remote patient monitoring. These systems can obtain ICU-grade data without expensive medical equipment in a low-resource setting.

Pediatric Orphan Disease: Pediatric orphan disease management (e.g. spinal muscular atrophy, critical congenital heart defects, and extreme prematurity) represents an unmet area where the the use of digital health technology such as the ANNE One system can help monitor patients where the continuous monitoring of key physiological parameters is needed and lacking. Current and prior efforts have involved deploying the ANNE One system in hospitals to monitor pediatric patients affected by the diseases mentioned above. We will elucidate upon one such condition below--congenital heart defects (CHD).

Each year, 40,000 neonates are born with a congenital heart defect (CHD) with 25% having a critical CHD requiring surgical intervention within the first year of life. Despite improvements in overall survival over the past 30 years, CHD still accounts for 4.2% of all neonatal deaths. Nearly half (48%) of CHD-related deaths occur by the first year of life. Physiological monitoring in this perioperative period is critical in the management of CHD both within the neonatal/pediatric ICU and post-discharge home settings. However, existing medical device systems to monitor vital parameters such as heart rate (HR), respiratory rate (RR), temperature (T), heart rate variability (HRV), and pulse oximetry (SpO2) have exhibited limited innovation over the past several decades. These non-invasive systems are not suitable for critically ill neonates. First, the labyrinth of wires and bulky base units require the application and removal of multiple electrodes creating a physical and emotional barrier for therapeutic skin-to-skin contact and impedes even basic bedside care such as turning a baby from prone to supine. Skin-to-skin contact between newborns and their mothers has been well documented to reduce neonatal mortality, sepsis risk, and length of hospitalization. Second, these systems often cause iatrogenic skin injuries including permanent scarring from pressure-laden injuries. Adhesives from medical devices are the primary cause of skin stripping; pulse oximeters and blood pressure cuffs cause pressure ulcers. Third, these systems are not suitable for home use. For hemodynamically unstable neonates, invasive monitoring interventions (e.g. arterial and central venous lines) cause significant morbidity. We received FDA clearance in September 2021 for the ANNE One, a wireless vital signs monitoring system composed of a time-linked chest patch and limb patch (<2 mm in thickness) that employs the most advanced electrical engineering capabilities validated in the largest cohort of pre-mature neonates (as low as 28 weeks gestational age and <1500 g) ever tested with wireless monitoring systems. Our system includes a 2-lead ECG (HR, HRV), photoplethysmogram (PPG for SpO2), RR, and T. We offer advanced capabilities including the non-invasive continuous measurement of blood pressure (BP) by calculating pulse arrival time (PAT). PAT represents the time lag between the ECG R-peak and the onset of the pulse wave in the PPG and represents a strong correlative marker to BP. Additionally, our system can monitor body position, to evaluate key events such as kangaroo maternal care to ensure bonding is occurring between the neonate and mother. For CHD patients in their first year of life, there is a critical need for new validated monitoring systems that can replicate and build upon gold-standard equipment across a wider range of low perfusion and oxygen saturation states, offer advanced capabilities to reduce the need for invasive interventions (e.g. arterial lines for BP), and allow for safer, patient-centric monitoring at home.

Frontline Healthcare Workers: we have already monitored more than 200 frontline nurses/doctors at multiple sites during the COVID-19 pandemic. Our sensors were used to survey for physiological signs of deterioration prior to symptom development. Furthermore, our sensors will monitor for signs/symptoms of disease as well as monitor recovery in case of infection. Our existing work in more than 200 healthcare workers show strong engagement, excellent adherence, and appreciation of the data outputs provided by the system. In doing so, we will identify COVID-19 cases early, support recovery, and prevent spread for precious FHWs in LMICs.

Nursing home residents: when deployed here, we will demonstrate the ability to virtually launch our remote monitoring system in older adults residing in nursing homes. In case of illness, these patients may be more safely monitored instead of a traditional care setting or detect COVID-19 earlier in the setting of severe staffing shortages to prevent hotspots. The target goal is to avert mortality. For some cases, we have already demonstrated the feasibility of virtually deploying our sensors in local nursing homes to monitor older adults for a continuous 2-week quarantine period with support from the National Institutes of Health and Anthem Inc (2nd largest insurer in the U.S.).

LMICs: with support from the Gates Foundation, Save the Children Foundation, Grand Challenges Africa, and the U.S.-India Science and Technology Endowment Fund, we have deployed the ANNE system in 5 LMICs (Ghana, Zambia, Kenya, South Africa, and India) monitoring more than 2,000 subjects in total to date. Remote monitoring offers the ability to rapidly expand access in the settings of a pandemic where demand skyrockets particularly in mothers/newborns where monitoring needs are the greatest. The ability to expand care with our sensors ensures other conditions do not worsen (e.g. neonatal mortality/morbidity) in the setting of a pandemic.

Mothers/newborns: Sibel has a strong background in monitoring physiological health in newborns (>250) and pregnant women. With pandemics, obstetrical and neonatal care must continue uninterrupted given the already high mortality/morbidity in these populations for LMICs. This work was recognized by Nature Magazine / Merck where Sibel was named the inaugural winner of the 2020 Nature SpinOff Prize for our work in newborns with advanced sensors.

Our leadership team brings world-class expertise in engineering, global health, and finance. 

Dhruv Seshadri PhD (team lead) has expertise in wearable technology with experiences deploying sensors worldwide. At Sibel Health, Dr. Seshadri serves as an engineering program manager leading development efforts with pharmaceutical companies to translate Sibel's technology as a novel digital therapeutic to address unmet medical needs. Furthermore, Dr. Seshadri (in collaboration with Dr. Xu) leads Sibel's efforts on the procurement of non-dilutive funding to spearhead developmental and clinical efforts relating to the ANNE One system.

Steve Xu MD MSc (team lead) is a physician-engineer, academic, and entrepreneur. As Sibel's CEO, he grew the team from 4 to 46 engineers in 2 years, launched the product in 5 continents, and executed major partnerships with numerous Fortune 500 companies. John Rogers PhD (technical lead) is one of 25 people ever named to the National Academy of Medicine, National Academy of Engineering, and the National Academy of Science. He is the Executive Director of the Querrey Simpson Institute for Bioelectronics at Northwestern University. Lou Simpson, board member of Sibel, is the former chief investment officer of GEICO and serves/previously served on the boards of AT&T, Comcast, ResMed, and Verisign. Sibel has its own IP including issued and granted patents worldwide as well as worldwide/exclusive licenses from Northwestern/University of Illinois on the core technology. Sibel is diverse with >50% of the team representing individuals of color and 40% women hailing from 6 different countries.

Sibel is a unique company. We're mission driven to deliver Better Health Data for All through advanced sensors, predictive analytics, and compatible / scalable software backends. Our technology and innovations are underpinned by decades of the most advanced engineering research conducted by the leading voice in the field of advanced wearables. Thus, we're driven towards delivering impact enabled by breakthrough technology.

The Global Challenges inspired us to apply because it is bold - and it is focused on delivering transformative impact worldwide. We believe the Global Challenges are willing to make big bold bets on promising teams to drive meaningful change. The focus is not on pilots, but real progress. Outcomes, not outputs. At Sibel, we believe we're ready - our whirlwind last 2.5 years have prepared our team of 30 strong to accelerate from our current deployments to the next level where everyday we can deliver Better Health Data for All. COVID-19 - and all of the suffering it has caused worldwide - has only inspired our team to push our technology forward.

Technology: the ANNE One system represents a major technology advancement. We believe this system represents the most comprehensive suite of advanced sensors offering ICU-grade monitoring compatible with mobile devices. Beyond capabilities for traditional vital signs (heart rate, respiratory rate, SpO2, and temperature), the unique mounting location of the sensor on the suprasternal notch allows the capture of important, clinically-relevant respiratory biomarkers impossible for wrist-mounted sensors. Here, we continuously determine respiratory sounds, cough count (a sign of infectiousness), wheezing, and sleep quality.

Practicality: unlike nearly every other wearable patch system which operate as single-use disposables, the ANNE sensors are fully rechargeable with our wireless charger. All ANNE sensors are waterproof with extended battery life (up to 7 days) allowing for ruggedized use. The reusable nature of the system (£21.8 per sensor at scale) and low cost consumables (<£0.07 per consumable at scale) make this system orders of magnitude less expensive compared to traditional systems.

Differentiation: while there are other groups developing wearable sensors and patches-they do not offer the same level of comprehensive monitoring as the ANNE system. Furthermore, these systems lack significant clinical validation in vulnerable populations such as neonates and pregnant women, and in LMIC settings.

Algorithms: our machine learning algorithm (submitted to the FDA for EUA) has the ability to detect early COVID-19 infection prior to symptom onset validated in a clinical trial of n=325 subjects funded by the U.S. Department of Defense.

• Number of ANNE One sensor kits deployed (currently more than 2000)

• Number of patients monitored (currently more than 4000)

•  Number of patients monitored who represent vulnerable populations (currently ~50%)

• Number of monitoring hours captured (currently more than 1 million)

• Deaths averted

• Serious medical illnesses averted

• Number of countries deployed in (currently 18)

• Number of LMICs deployed in (currently 5)

• Data quality per monitored hours (currently exceeds 85%)

• Adherence to wear (currently >95% for 4 days of wear per week in our large scale clinical trials)

• Number of ANNE One sensor kits deployed (currently more than 2000)
• Number of patients monitored (currently more than 4000)
• Number of patients monitored who represent vulnerable populations (currently ~50%)
• Number of monitoring hours captured (currently more than 1 million)
• Deaths averted
• Serious medical illnesses averted
• Number of countries deployed in (currently 18)
• Number of LMICs deployed in (currently 5)
• Data quality per monitored hours (currently exceeds 85%)
• Adherence to wear (currently >95% for 4 days of wear per week in our large scale

The FDA-cleared ANNE One System offers the most advanced platform for the measurement of ICU-quality vitals and advanced digital biomarkers necessary for clinical decision making. The reusable nature of the system (£21.8 per sensor at scale) and low cost consumables (<£0.07 per consumable at scale) make this system orders of magnitude less expensive compared to traditional systems. The mass manufacturability of our devices enables large-scale dissemination to populations across the world needing medical monitoring, but lack access to hospitals.

We envision the ANNE One system to be always ready for rapid scaling and deployment during pandemics with use cases that include detecting early infections in high-risk populations using predictive analytics, supporting a safe transfer of care from hospitals to homes to preserve capacity and reduce unnecessary exposure to frontline healthcare workers, and tracking recovery of the sick to ensure safe return to work. Generally, these systems can be used to not only remotely monitor patients anywhere with ICU-grade comprehensiveness, but to also alert users and healthcare providers of signs that may be suggestive of infection in an automated fashion.

The ANNE One system comprises of two time synchronized soft and flexible sensors (one worn on the suprasternal notch and the other on the limb) that continuously monitor clinical-grade vital signs from premature infants to adults. Advanced processing algorithm further provides unique measurements that include cough count, fall count, peripheral arterial tone. It is designed to be scalable, low-cost, comprehensive, and predictive for early infection with algorithms trained on more than 100,000 hours of data collected from COVID-19 patients. This data can be stored continuously or streamed in real-time to a wide range of ubiquitous mobile devices for both point-of-care diagnosis or store-forward analysis. Data storage and processing in Sibel's cloud server further expands the use cases into remote patient monitoring. These systems can obtain ICU-grade data without expensive medical equipment in a low-resource setting. We seek to disseminate our core technology to monitor pediatric patients suffering from orphan diseases. When successful, the ANNE One system will be the first wearable device capable of serving patients with orphan diseases including but limited to spinal muscular atrophy, critical congenital heart defects, and extreme prematurity.

We are highly diverse with a balance of women, under-represented minorities, and immigrants representing more than 60% of our team. We advocate and develop technologies for vulnerable populations including children, pregnant women, and those living in low- and middle-income countries.

The ANNE system has two major customer segments: (1) wholesale to medical device companies and (2) direct sales to hospital systems.

Medical Device Companies and Partnerships: we propose to offer the ANNE sensors in partnership with large medical monitoring companies as distribution channels and volume purchases of the ANNE system for resale to hospitals. We have existing partnerships with both GE and Draeger—two of the largest 5 medical monitoring companies worldwide. We have an existing technical collaboration with Philips. Moreover, GE and Draeger are two leading medical technology companies in the manufacturing of NICU incubators and warmers—both companies enjoy market domination in the two largest markets (U.S. and Europe) representing clear market access. Thus, these companies represent strong commercialization partners to sell and offer the ANNE system.

Hospitals via Medical Distributors and Direct Sales: Sibel Health will aim to introduce the ANNE sensors to neonatologists and pediatricians at hospitals directly. In 2010, there were 2977 acute care hospitals with ICU beds. In these, there were 641,395 total acute care beds with 103,900 ICU beds (16.2% ICU beds/total beds). From 2000 to 2010, the number of critical care beds in the United States increased by 17.8%, from 88,235 to 103,900. Additionally, between 2000 and 2010, the greatest percentage increases were in neonatal beds (29%), followed by adult beds (26%); there were minimal changes in pediatric beds (2.7%). Of the 103,900 ICU beds in 2010, 83,417 (80.3%) were adult, 1917 (1.8%) were pediatric, and 18,567 (17.9%) were neonatal. In total, there were 33.6 beds per 100,000 population, 35.5 beds per 100,000 adult beds (age > 18 years), 2.7 beds/100,000 pediatric beds (age 1-17 years), and 470 beds/100,000 neonatal beds (age < 1 year). We will target hospitals with NICUs and PICUs via a small, dedicated Sibel sales team as well as relationships with existing medical distributors (e.g., Henry Schein). Successful introduction of the ANNE sensors is contingent upon proof of efficacy and acceptance by NICU healthcare professionals including nurses, therapists, and neonatologists. In addition, NICU product review teams, purchasing personnel, and hospital administrators will become aware of the ANNE sensor system and its benefits through continued high impact publications. These groups represent the primary customer segments for the ANNE One and its eventual business partners. While review processes for new products vary across people and systems, most review new devices monthly and purchase new inventory continuously.

We plan to market our NICU and infant monitoring sensors leveraging our on-going partnerships with Dräger (also an investor in Sibel), and GE. Both companies represent ideal partners with a large and dominant business in incubators and warmers with global sales teams. We believe that the ANNE system offers both companies an ability to sell to hospital clients an alternative to wired sensors. We foresee the ANNE wireless sensors as a driver for further adoption of other medical monitoring equipment from incubators and warmers to monitors and ventilators. This strategy allows our sales partners to offer a unique product offering meeting a major unmet need in pediatrics to support follow-on sales. Given that medical monitoring accessories (single use disposables) currently cost $20 to $30 (e.g., cost of ECG leads and cables, oximeters, temperature probes, and BP cuffs), Sibel’s sale strategy is to offer hospitals a cost reduction of 3x to 9x to use wireless ANNE sensors instead of existing consumable wired probes. For Sibel itself, our business model enables us to achieve both an upfront payment as it relates to the sensors themselves followed by recurring revenue in terms of consumables, analytics, and cloud computing

Sibel Health recently closed a Series B investment totaling $25 from the Steel Foundation (June 2022). Sibel has received $8 million convertible note investment from Draeger Medical for hospital monitoring, a $5 million strategic investment from Anthem for RPM, $1 million strategic investment from Analog Devices, $3.5 million in grants from the Gates Foundation, and an additional $3.65 million from non-diluting funding sources including grants, sales, and joint development agreements.