Market Opportunity

Clinical Need

It is a shocking reality that a vital sign as important as respiration is often not directly or continuously monitored in the clinical setting. Respiratory rate is the best predictor of deterioration and according to published journal papers, breathing monitors currently on the market have inaccuracies or delayed responses (Source, Source, Source).

The "Silent Crisis" in the NICU

While neonatal care has evolved, the lack of accurate respiratory information remains a critical barrier.

70% of Apnea Events Missed: Current NICU monitoring often fails to detect critical events.
50% Prevalence: Half of all babies born before 32 weeks suffer from Apnea of Prematurity.
Lifelong Impact: Hypoxia events can lead to permanent neurodevelopmental impairment and increase lifetime care costs by up to $350,000.
Burden on Care: Ineffective management leads to an average of 5.7 excess days in the NICU.

Current Standard Monitors Are Inadequate

PULSE OXIMETRY

lagging indicator
6% accurate (Prodigy Trial)

CAPNOGRAPHY

prone to motion artifacts
18% accurate (Prodigy Trial)
unreliable in dark-skinned individuals

Solution

The Makani Science device offers a wireless, non-invasive monitoring system designed to identify, classify, and document respiratory events in neonates.

We believe that because of our unique sensor design and small form factor, the Makani Science monitoring system has the potential to help improve the current state of the art in neonatal respiration monitoring.

System Components:

Wearable Patch: A small, easy-to-apply wireless device.
Monitoring Platform: An app/monitor for real-time clinician feedback.
Cloud Analytics: A secure platform for longitudinal data capture and decision support.

Differentiators:

Unrivaled Accuracy: 96% correlation with the gold standard (spirometry).
Faster Response: 30–60 second improvement in response time compared to pulse oximetry.
Comprehensive Vitals: Continuous monitoring of respiration rate, volume, waveform, blood oxygen, and cardiac function.

Total Addressable Market

$1.3 Billion

U.S. neonatal respiratory care and monitoring market, which is a subset of the $115.6 billion respiration monitoring and disease management market.

Respiration monitoring and disease management (2023)

Market Potential

Respiratory problems are common in pediatric patients. Issues begin as early as birth where apnea with intermittent lack of oxygen (Hypoxia) can result in retinopathy of prematurity, hyperactive airways and neurodevelopmental delays when a child is older. Later in life, children have issues such as SIDS, bronchiolitis, asthma, croup and pneumonia. The small, wireless size and its stability with motion make the Makani Science Respiratory Monitor ideal for children where the medical device market is anticipated to grow by 8% per year ( Source ).

BEYOND THE PEDIATRIC PATIENT The Makani Continuous Respiration Monitor will create a significant disruption in this market. Its ability to measure multiple respiratory parameters coupled with other biometric information will give clinicians, researchers and patients insight into data that was previously inaccessible. This creates an opportunity to predict, prevent and intervene before disease deterioration occurs due to respiratory disorders. Patient populations that could benefit from improved respiratory monitoring are apnea, COPD, and asthma among others. These large patient populations are reflected in size of the market, with the global respiratory monitoring device market predicted to reach $43.3 Billion by 2035 (Source).