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iCardio.ai

Echocardiography is the most prominent cardiac imaging modality and there is (1) a projected labor shortage of MDs and sonographers (2) missed revenue-generating underdiagnosed conditions. We solve both problems by automatically generating a preliminary echo report using AI.

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One Liner

One Liner
Echocardiography is the most prominent cardiac imaging modality and there is (1) a projected labor shortage of MDs and sonographers (2) missed revenue-generating underdiagnosed conditions. We solve both problems by automatically generating a preliminary echo report using AI.

What Problem We are Solving

Problem
Ischemic heart disease and stroke are the leading causes of death worldwide, with a combined 17.9 million deaths in 2016 and a projected 40.5% of the US population having some form of cardiovascular disease by 2030. Echocardiography is the most widely used modality for the diagnosis, management and follow-up of heart diseases, with an estimated 27 million exams performed each year in the US alone. However, there is a growing gap in expertise and consistency of interpretation, which is projected to increase due to the growing demand for cardiologists. This gap leads to inefficiencies in patient outcomes. iCardio.ai is a venture that aims to build the OpenAI of ultrasound for automated interpretation of echocardiography. There is a host of implications for this technology across healthcare, however, one of the primary areas of interest is in the concept of pairing automatic echo interpretation with handheld ultrasound devices, enabling increased access, quality and outcomes. This combination of super-human AI and POCUS is considered to be the "stethoscope of the future." Additionally, there is a gap between patients who would benefit from cardiac drugs and devices and those who receive them, which is due to inconsistency in echo reads between institutions and poor dissemination of clinical guidance to physicians. To solve these problems, iCardio.ai aims to provide a platform for accurate and consistent interpretation of echocardiograms through the use of AI, thereby improving patient outcomes and reducing the gap in expertise. 

About Us

About Us
iCardio.ai is a Los Angeles-based deep learning startup automating the interpretation of heart ultrasounds (echocardiograms). There are more than 30M echos performed each year in the US, and represent one of the most ubiquitous imaging exams in medicien. iCardio.ai has created an AI system to automatically interpret echos, trained on its proprietary dataset of over +200 million images. iCardio.ai has teamed with some of the largest Ultrasound vendors, including GE Healthcare, Butterfly Network, UltraLinQ and Viz.ai, to deliver its technology to clinicians around the globe. In February of 2024, iCardio.ai received Breakthrough Designation by the FDA. 

Venture Highlights

Highlights
2019-2020:

Joseph Sokol co-founded iCardio.ai in 2019 with cardiologist Dr. Joshua Penn and later brought on co-founder Dr. Roman Sandler to lead development of AI algorithms. Dr. Penn brought his large echocardiographic dataset with patient diversity representative of the United States and significant heterogeneity in image quality across decades of ultrasound technologies, which is essential to creating a generalizable AI for echocardiography.

2021:

iCardio.ai closed a multi-year partnership contract with GE Healthcare, the world’s leading ultrasound manufacturer with 31% market share. Later, iCardio.ai raised $1M from BSD Enterprises to expand AI capabilities. iCardio.ai also participated in Jerusalem Venture Partners’ #PlayBeyondBio program to accelerate their growth and exposure for commercialization strategy with partners AstraZeneca, Jerusalem Venture Partners Fund, Accenture, Amazon Web Services, and others. 

iCardio.ai continued to work on improving diagnostic capability of their algorithms; in July 2021, they outperformed a landmark paper with previously state-of-the-art performance in predicting aortic diameters. They improved on ultrasound interpretation challenges due to inter-operator variability, and significantly improved on existing research. 

2022

iCardio.ai continued to work on predictive capabilities, expanding to objective scoring of heart imaging to produce a predictive measure of mortality. They also expanded their engineering team by onboarding selected top talent in AI and ML. Notably, they brought on Markos Muche as an AI Scientist after he won Ethiopia’s top AI competition and achieved the highest score on Ethiopia University’s entrance exam. Muche brings in a global perspective and demonstrates iCardio.ai's commitment to sourcing diversity in talent. 

iCardio.ai was selected as one of five ventures to be accepted to HeartX accelerator program powered by Healthech Arkansas and MedAxiom. They received $150,000 of investment and access to hospital resources to execute pilot projects. 

iCardio.ai continued to grow its engineering team by bringing on Aleksandar Stojmenski, a PhD candidate in computer science from North Macedonia’s Faculty of Computer Science and Engineering. Stojmenski has published over 25 academic papers and had previously worked with CEO Joseph Sokol on their now-exited Fintech company.

2023

iCardio.ai applied for FDA 510K clearance in June and began a number of collaborative relationships. They also joined NVIDIA Inception to build out AI uses with NVIDIA Clara Holoscan. NVIDIA’s software development kit provides libraries, pretrained AI models, and reference applications to build out high-performance streaming AI applications. A new collaboration was established with Tufts University Professor, Dr. Benjamin Wessler to demonstrate feasibility of predicting Aortic Stenosis with ML from echocardiography.

In November, iCardio.ai joined Butterfly Garden, the AI marketplace launched by Butterfly Network, Inc. (NYSE: BFLY). This landmark collaboration brought iCardio.ai into the world of handheld, point-of-care ultrasound (POCUS) capability.

2024

iCardio.ai received FDA Breakthrough Designation on February 21, 2024 for their automated ultrasound interpretation for Aortic Stenosis. 

In addition, they have been expanding on established distribution partners. iCardio.ai began a partnership in January with UltraLinQ, a major medical imaging software provider in the current clinical ultrasound workflow. In February, they announced a partnership with European AI algorithm distributor in healthcare, deepc. iCardio.ai is exceptionally well-positioned for accelerated growth and became a revenue-generating company this year by integrating as an educational component in UltraLinQ. As of this update, iCardio.ai's latest announcement was a partnership with Viz.ai, the largest AI distributor in the world. SignifyResearch, a global research firm on emerging tech within radiology, has published that iCardio.ai is "quickly becoming one of the most accessible AI solutions [for Ultrasound]." 


Business Model

Business Model

Business Model and Revenue Streams

iCardio.ai will earn revenue by providing AI-powered, automated echocardiogram interpretation services in partnership with point-of-care ultrasound (POCUS) hardware distribution companies. Further, they have a compelling opportunity to sell aggregated data to pharmaceutical companies to inform the need for regional targeted sales. 

10.1 - Distribution

iCardio.ai has a highly diversified distribution portfolio and have begun partnerships with large providers of portable, point-of-care ultrasound devices such as Butterfly Network (2023), Clarius (2022), and GE Healthcare (2021). In particular, Butterfly Network (NYSE: BFLY) is the first mover in POCUS, and has a global fleet of 145,000 handheld ultrasound devices serving their user base of over 100,000 providers. This partnership grants iCardio.ai access to the largest POCUS customer base today. AI compatibility with Butterfly in particular drastically increases the global scalability of their automated interpretation services. 

iCardio.ai has established relationships with a growing list of PACS (Picture Archiving and Communication System) companies operating in the ultrasound services space; their AI interpretation service can currently be utilized at UltraLinQ, HeartLab, deepc, and Viz.ai. Once FDA 510K clearance is achieved, they will distribute with Butterfly (NYSE: BFLY), GE Healthcare, Clarius, Vave, and Ferrum.

10.2 - Revenue Streams

Pre-FDA clearance, iCardio.ai has in February 2024 begun collecting minimum revenue payments of iCardio.ai partnered with UltraLinQ in 2024, a platform used by over 2,000 institutions worldwide. The company currently has 40,000 end customers and is paying iCardio.ai $6,000 per month to access iCardio.ai’s product for educational use. Through this partnership, iCardio.ai’s interpretations are pushed through to all UltraLinQ users, amounting to 30,000 scans monthly. 

iCardio.ai has been working closely with the FDA to achieve their recent FDA Breakthrough Designation, the first of its kind for POCUS/handheld ultrasound. Given this designation, they are confident in the pathway forward to achieving FDA 510K clearance within 6 months conservatively, and within 2-4 months with minimal processing issues (initial submission June 8th, 2023). Once clearance is achieved, they will take advantage of the New Technology Add-on Payment (NTAP), which is the first reimbursement directly related to use of handheld ultrasound in the primary care setting. Importantly, this form of FDA designation is often chronological, meaning iCardio.ai has true first mover advantage and the company’s algorithm will be inducted into standard of care. Following competitors would need to exhibit clinically significant improvement in order to achieve the same designation for aortic stenosis.

Post-FDA 510K clearance, established revenue streams will be as follows:

  1. Service Fees (Base + Charge Per Scan)

iCardio.ai will engage in revenue sharing in accordance with agreements with each distributor. Distributors will charge clinical providers (medical centers, clinics, community hospitals, etc.) a tiered pricing base charge of $6,000-15,000 per month for providing POCUS and AI interpretation. In addition, there will be a price per scan charged at a minimum of $2-4 per scan (and current access to 500K scans/month via existing distribution partners). 

Distributor agreements are as follows:

  1. UltraLinQ: 50/50 revenue split
  2. Butterfly Network: 60/40 revenue split (60% to iCardio.ai)
  3. Clarius: likely 70/30 revenue split (70% to iCardio.ai)
  4. Others to be negotiated: starting at 70/30 revenue split (70% to iCardio.ai)

Rationale: NTAP reimbursement is $100 per scan. In addition, iCardio.ai and its partners agree that increased diagnosis resulting from such screening can result in upwards of $100,000 per diagnosed AS patient (further indications to come in future). These fees consist of the TAVR procedure, AS diagnosis and associated referrals, cardiologist visit, CT scan, and more. From the impact and payor standpoint, accessible screening efforts would improve patient outcomes by diagnosing early. This will avoid costly hospital stays for severe conditions diagnosed at a late stage.

  1. Monetization of Aggregated Data

Demand for POCUS with AI interpretation exists from all stakeholders, including providers, payors, medical device developers/distributors, and pharmaceuticals. In particular, iCardio.ai’s ability to diagnose puts them in an intensely data-rich position within the clinical workflow. A future and significant potential revenue stream involves informing pharmaceutical companies of demand for their medications. 

iCardio.ai intends to provide regional data on diagnoses numbers to pharmaceutical companies, who will not only gain real-time data on demand, but also pinpoint targeted sales regions. Ultimately this can positively impact physicians and patients who would benefit from new therapeutics. 

As an example, iCardio.ai has engaged in multi-stakeholder conversations between Butterfly and Bristol-Myers Squibb. There is demonstrated interest and use case with multiple pharmaceutical and medical device companies. Further agreements will solidify after FDA 510K clearance and subsequent progress made in clinical adoption. They have also engaged in conversations with AstraZeneca and Abbott.



Competitive Advantage

Quote
We differentiate ourselves from other offerings in the market via three means:
  1. Comprehensive report: Only iCardio.ai aims to replicate the full cardiologist’s report, including over 30 pathologies and a dozen metrics. Other competitors only do small subsets of the report such as Aortic Sclerosis (EchoAI), ejection fraction (Caption), coronary artery disease (Ultromics EchoGo Pro), volumetric and doppler measurements (US2.ai).
  2. Data: we have full commercial access to a dataset of over 150k echo studies with full clinician annotations. This dataset is growing at a rate of >15k studies per year. To our knowledge, this is the largest private echo database in the US. It has been independently valued at between $7.5M-$10M. 
  3. AI Platform: We have developed a sophisticated AI platform to train and manage AI models at scale. This platform can be used to seamlessly pivot to other medical imaging modalities/domains. 

Revenue

Revenue To Date
N/A
MRR
N/A
Revenue YTD
N/A
Burn Rate
$30K

Go-To Market Strategy

Business Strategy
To expedite the long hospital sales cycle, we will work directly to integrate our initial product, the iCardio.ai Brain v1, into downstream systems already behind the hospital firewall. These include ultrasound manufacturers and PACS systems. To that end, we have already established a revenue-sharing agreement with Clarius, one of the largest POCUS manufacturers with a 12k install base. The agreement specifies a 70%-30% revenue split (70% to iCardio.ai). We also have a 5 year R&D contract with GE and are working to integrate our product into their EchoPAC system. On the PACS side, we are working to integrate with HeartLab and are in talks with several others. By integrating into these systems, we will substantially lower the IT burden of onboarding our product and thus shorten the sales cycle. We will also offer a browser-based version of our software designed for direct use by cardiologists. 

Additionally, we plan to leverage our network of hospital systems and offer six-month free trials to demonstrate value and increase hospital revenue. Our sales team will identify and target hospitals with high volumes of echocardiograms and underserved populations, offering them the opportunity to test our product with no financial risk. The trial will include access to our full suite of features, including our AI-driven detection of missed revenue-generating conditions such as aortic stenosis. During the trial period, our team will work closely with the hospital's physicians and IT staff to ensure smooth integration and provide training on how to use our software. 

By offering a free trial, we can demonstrate the value of our product and its potential to improve patient care and hospital revenue. We anticipate that hospitals will see a significant increase in revenue by identifying and treating previously missed conditions such as aortic stenosis. After the trial period, we will work with the hospital to determine the best pricing model based on the volume of studies processed and the value created.

Overall, our go-to-market strategy will focus on leveraging our network of hospital systems, integrating into existing ultrasound and PACS systems, and offering feasibility trials to demonstrate the value of our product. By doing so, we aim to establish iCardio.ai as a leading provider of AI-driven cardiac analysis and improve patient care and hospital revenue.

Competitive Analysis

Competitive Analysys
We differentiate ourselves from other offerings in the market via three means:
  1. Comprehensive report: Only iCardio.ai aims to replicate the full cardiologist’s report, including over 30 pathologies and a dozen metrics. Other competitors only do small subsets of the report such as Aortic Sclerosis (EchoAI), ejection fraction (Caption), coronary artery disease (Ultromics EchoGo Pro), volumetric and doppler measurements (US2.ai).
  2. Data: we have full commercial access to a dataset of over 150k echo studies with full clinician annotations. This dataset is growing at a rate of >15k studies per year. To our knowledge, this is the largest private echo database in the US. It has been independently valued at between $7.5M-$10M. 
  3. AI Platform: We have developed a sophisticated AI platform to train and manage AI models at scale. This platform can be used to seamlessly pivot to other medical imaging modalities/domains. 
Competitor Website
Egnite egnitehealth.com
US2.ai us2.ai
Ultromics www.ultromics.com

Networking

Networking
We are open to meeting up to grab a coffee, or just to chat. We would really enjoy your feedback and insight into our venture and would be happy to discuss anything that you are currently working on to see if we can be of service!

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Capital

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Name Amount
Amount Left $999,997.00
Amount Raised (This Round) $1,000,002.00
Amount Raise To Date $1.4M
Type of Raise Equity

Valuation
$20M
Friends & Family
$600K
Preseed
$800K

TAM SAM SOM

TAM
N/A
SAM
N/A
SOM
N/A

Business Stage

Business Stage
Seed

Business Type

Business Types
Investor-Backed

Categories

Healthcare

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