iCardio.ai Receives FDA Breakthrough Designation for Automated Detection of Aortic Stenosis.

iCardio.ai Receives FDA Breakthrough Designation for Automated Detection of Aortic Stenosis

We are thrilled to share a pivotal milestone in the journey of iCardio.ai. We have been granted Breakthrough Device Designation by the FDA for our machine-learning system used to detect moderate and severe Aortic Stenosis (AS) using handheld ultrasound devices. This achievement is not just a testament to our team's hard work and dedication but a massive step forward in the care of cardiac patients worldwide.

Why This Matters, for Patients, for Hospitals, and for Investors:

Aortic Stenosis is a grave cardiovascular condition that affects a significant portion of the aging population in Western countries. Aortic stenosis affects approximately 1.5 million Americans, with severe cases noted in about 0.4% of the population, the burden of this condition is substantial. With untreated mortality rates alarmingly high, early detection and treatment are crucial. This Breakthrough Designation underscores its potential to fill critical diagnostic gaps and offer more effective treatment pathways for patients with AS.

iCardio.ai’s ability to accurately identify moderate to severe AS has the potential to change patient trajectories dramatically. By enabling early and accurate diagnosis, iCardio.ai facilitates timely interventions, such as aortic valve replacement (AVR), which can return mortality rates to those of the general population. This is a game-changer in a field where timely diagnosis can mean the difference between life and death. 

One of the most compelling aspects of iCardio.ai we have thought about since our inception is its ability to serve as a diagnostic aid in environments where traditional echocardiography might not be available or utilized effectively. This is particularly pertinent in POCUS/handheld hardware settings for use by non-specialists, challenging the stethoscope, the traditional method of detecting this condition, which has remained unchanged for decades. This dramatically expands the reach of this life-saving technology to the primary care setting, and even further to underserved and previously unreachable patient populations. To our knowledge, this is the first Breakthrough granted by the FDA concerning the use of handheld ultrasound devices, and with our Butterfly Network partnership, we have already forged a path for massive distribution.

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The necessity to address the diagnostic and treatment gaps in aortic stenosis cannot be overstated, given the dire consequences of untreated disease. Patients with severe untreated aortic stenosis face a 50% chance of mortality within two years of symptom onset (ref; PMID:26926974).

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"This stark statistic highlights the critical role of technologies like iCardio.ai and the Butterfly probe in facilitating early detection and intervention. By providing a more accessible, accurate, and efficient screening tool, more patients can receive interventions that have been demonstrated to significantly enhance both the quality and longevity of life for individuals at risk of this life-threatening condition." - says Davinder Ramsingh MD, Vice President of Clinical Research and Product Development at Butterfly

Breakthrough Designation is a special program initiated in 2015 by the FDA to identify crucial technologies that advance the care of life-threatening illnesses. Not only does FDA Breakthrough Designation ensure a pathway towards NTAP, in which providers can be reimbursed by Medicare for the use of our technology, but there is a further commercial implication for iCardio.ai in that large tertiary centers will be incentivized to deploy our technology in which consequently will increase TAVR procedures, a significant revenue driver for tertiary centers.

Our technology also stands to reduce disparities in healthcare by providing a standardized, unbiased diagnostic tool that can be widely deployed across various healthcare settings and demographics. This aligns with the broader mission of promoting health equity and ensuring that advancements in medical technology benefit all segments of society.

And now, our commercial pathway is solidified: our path to success has never been stronger, and this recognition by the FDA validates our approach and the potential impact to investors, the world of healthcare, and patients. 

We are immensely grateful for our investors’ continued support and belief in our mission. This achievement reflects our shared commitment to improving healthcare outcomes through innovation.

"With the announcement of Breakthrough we are anticipating announcing several major partnerships with companies that have been following our story. There is a tremendous demand for our technology and we are working diligently to see our submission process through to FDA clearance." - says Joseph Sokol, CEO and Founder, iCardio.ai.

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