Mediwhale announced it has secured $12 million in Series A2 funding to support its technology of artificial intelligence (AI)-based retina scans for early prevention of cardiovascular disease (CVD).
First: Mediwhale.
Founded in 2016 and based in Seoul, South Korea, the AI-powered health diagnostics company is using non-invasive retina scans to predict not just CVD but also systemic diseases (kidney and ocular) and biological age.
How it’s doing this: Via deep learning algorithms designed to detect future risk for diseases—before the onset of symptoms.
- And its technology: The company has developed a comprehensive AI diagnostic solution that provides four predictive services for those aforementioned diseases:
Now this financing.
Led by Korea Development Bank, the company’s latest round of financing involved both the issuance of new shares (where Mediwhale sells shares to investors to use the proceeds to fund its operations) as well as secondary shares (where current shareholders of Mediwhale sell their existing shares).
- Other investors: Included participation from Woori Venture Partners, IMM Investment, and Mirae Asset Securities, to name a few.
Note: This $12 million in Series A2 funding was preceded by Mediwhale raising $2 million in Series Pre-A funding in 2021 and $9 million in Series A funding in 2023.
Now to the focus of this funding.
As Mediwhale’s flagship product, the Reti-CVD is an AI diagnostic solution intended to autonomously assess the risk for future cardiovascular disease via a retinal eye scan—and, most notably, without the need for blood sampling or radiation.
- Why the eye: The eye is the only organ in the human body that enables clinicians to directly view blood vessels—which is key to disease detection.
Explain how it works.
The five-step process involves:
- Eye scanning
- One retinal image per eye is captured via a fundus camera (by an optometrist or technician)
- Uploading
- Images are submitted to the cloud for analysis, and patient information is added
- Analyzing
- Images are automatically evaluated for potential signs of CVD risk within 1 minute
- Reporting
- Personalized health screening results are generated, and the report can be downloaded
- Referring
- If needed, a clinician refers to specialists for further follow-up, suggests lifestyle changes, and advises regular check-up visits
Can I get a visual of this?
So how does Reti-CVD compare to the gold standard of CVD tests?
First: A cardiac (heart) computed tomography (CT) scan is considered the gold standard.
Comparing Reti-CVD to a heart CT scan, the company has noted:
- Similar risk stratification patterns are viewed
- Based on a retina-based coronary artery calcium (CAC) score
- No risk of radiation and no need for blood testing
- Heart scans require exposure to high-dose radiation
- Cost of Reti-CVD is similar to a retina image cost
- Heart scans typically have high costs
- Testing is available in a primary care setting
- Heart scans are not available in primary care settings
- Results take just one minute post-test
- Heart scans require multiple clinicians, from testing to results
Has it been tested in clinical trials?
Indeed it has … in fact, a 2023 study published in the Journal of the American Medical Informatics Association evaluated the efficacy of Reti-CVD for utilizing retinal images to stratify the risk for CVD.
Those findings: The test was approved by the Korean Ministry of Food and Drug Safety (K-MFDS) as a retinal image-based, personalized CVD risk scoring system (medical device) designed to assist healthcare professionals in identifying and managing current CVD risk factors as well as among asymptomatic adults with no prior CVD diagnosis.
- Most critically: The authors concluded, “These results demonstrate the ability of deep learning to bring automated CVD risk quantification which cannot be performed by humans.”
Nice! And its regulatory status?
Outside of the U.S.: Both Reti-CVD and Reti-Eye are approved under the product name DrNoon in some territories, according to the company.
- Plus: Both those products received CE approval as a Class 2a medical device in the European Union (EU) and are registered as either Class 2a or Class B medical devices in Australia, Malaysia, Singapore, Indonesia, Korea, and Thailand.
On the clinical setting side: As of August 2024, the test has been used in +7.5K patient cases in 57 medical institutions, Mediwhale reported.
How about in the U.S.?
While the test is reported to be under FDA clearance, the company intends to use this latest round of funding to support an eventual submission of Reti-CVD for FDA approval—as well as continue to develop new products for predicting CKD risk.
“We are determined to secure FDA De Novo approval by 2025, with plans to launch our product in the United States shortly thereafter,” according to CEO Kevin Choi.