Pulse 2.0 | Septemeber 21, 2023 

Mediwhale is an AI-empowered health diagnostics company that uses non-invasive retina scans to help prevent heart and kidney diseases. And Mediwhale’s Reti-Intelligence suite of services uses deep learning algorithms to detect disease risks even before symptoms appear. The company has been dedicated to making preventative care more affordable, accessible, safe, and convenient since being founded in 2016 in South Korea. Mediwhale has product approvals in eight territories in Europe and Asia (including EU, UK, Australia, and Korea), and is undergoing the FDA approval process. Pulse 2.0 interviewed Mediwhale CEO, Kevin T. Choi.

Kevin Choi’s Background

At the age of 24, Choi was diagnosed with glaucoma, losing 40% of his vision. Choi said:

“I didn’t fully realize the extent of the symptoms I was experiencing, and once I received my diagnosis, the glaucoma had already advanced significantly. This personal experience motivated me to make it my mission to find diseases early and so I founded Mediwhale in 2016. By using deep learning algorithms in combination with a large data set of retina images, we can detect disease risk before symptoms start to appear.”

Formation Of Mediwhale

How did the idea for Mediwhale come together? Choi shared:

“I met Dr. Tyler Rim in a very casual setting, and he kindly offered me to do an eye check-up. This was the moment I was diagnosed with severe glaucoma, which is quite rare among young people. I realized the importance of early detection and now believe that it is more important than treatment.”

Favorite Memory

What has been your favorite memory working for Mediwhale so far? Choi reflected:

“When I started Mediwale, the doctors I went to for advice didn’t take me seriously because I wasn’t a doctor myself. They ignored my ideas and shut me out. Instead of giving up, their treatment of me fueled my determination to prove what I could do. This experience also showed me how resistant the medical community can be to new ideas and how important it is to have extensive evidence to convince them. After a lot of hard work and research, I’ve earned the respect of doctors, especially influential cardiologists. They have seen our strong research and validation and are willing to use our product in real-world settings. The shift from being dismissed to now being  valued by doctors is a significant achievement for me.”

“Finally, in June 2023, Mediwhale achieved a significant milestone when it received reimbursement in Korea, becoming the first medical device AI company to earn reimbursement for outpatients. This ground-breaking moment marked a major achievement for both me and the company.”

Challenges Faced

What challenges has Choi faced in building Mediwhale? Choi acknowledged:

“The main challenge for our business is doctors not taking us seriously. Medical processes rely on solid research and evidence, which is essential for saving lives and keeping people healthy. Doctors are naturally cautious about new methods as untested approaches have too many risks. So, there’s only one solution: Establishing strong clinical proof that doctors can believe. And this is our focus:  we have gathered comprehensive medical data from diverse populations around the world, trained and verified our AI system using this data, and then shared our findings in respected medical journals. Our efforts were recognized by the European Heart Journal as a leading digital health innovation for cardiovascular disease in 2021. We also had articles published in the Lancet Digital Health and presented research at the American Heart Association’s Scientific Session in 2022. Our ongoing goal is to continue bolstering our clinical evidence and earning the trust of doctors.” 

Core Products

What are Mediwhale’s core products and features? Choi explained:

“Mediwhale is a SaMD (Software as a Medical Device) company, and all the products we offer are solely software.”

“The product name is a combination of Reti (retina) and the disease it prevents. For instance, the product to detect future cardiovascular disease (CVD) risk through retina scan & AI analysis is named Reti-CVD. Similarly, we have Reti-CKD (chronic kidney disease), Reti-Eye, and Reti-Age products. Our primary focus at this point is Reti-CVD followed by Reti-CKD.”

“Reti-CVD provides comparable accuracy with coronary artery calcium score derived from cardiac CT scan in predicting future cardiovascular disease risks. It is a safe (no radiation risk), accessible (available at primary care), and reasonably priced (compared to CT) tool in prediction.”

“Similarly, Reti-CKD showed even better efficacy than traditional methods such as blood test-based eGFR (estimated glomerular filtration rate) or urine test, even for those who have preserved kidney function.”

“To take retina pictures, you simply need a fundus camera. However, the cameras are not Mediwhale hardware, and we are compatible with most of the existing fundus cameras.”

Evolution Of Mediwhale’s Technology

How has Mediwhale’s technology evolved since launching? Choi pointed out:

“I want to focus on why I founded Mediwhale in the first place: to make it easier to diagnose disease risk early using the eye as a biomarker. Although Mediwhale began focused on eye disease, we have since evolved into something far greater.  Our current focus is cardiovascular disease, which is a starting point for many blood vessel diseases. We understand what cardiologists need to prevent heart problems; they have recognized our efforts in following traditional cardiovascular methods and processes. Mediwhale is transforming the way cardiovascular disease risk is detected by using a simple retina scan. 

Significant Milestones

What have been some of Mediwhale’s most significant milestones? Choi cited:

“As a medical device company, product approvals and reimbursement have been the most significant milestones Mediwhale achieved so far.”

“From 2021 to 2022, Mediwhale gained Reti-CVD product approvals in 8 territories, including EU, UK, Australia, Korea, Singapore, Indonesia, Malaysia, and Thailand. In all 8 territories, we were the first and only company with the concept of predicting CVD risk using eye scans. We have been pioneers in this field and will soon enter the US market through  the FDA approval process.”

“In June 2023, Mediwhale received reimbursement in Korea, becoming the first medical AI company to receive reimbursement for outpatient services. Even in the US, reimbursement cases for medical AI devices are rare. Reimbursement is the real base of generating revenue from hospitals and clinics, making it the most significant recent milestone.” 

Customer Success Stories

Upon asking Choi about customer success stories, he commented:

“Yonsei Severance Hospital, a leading medical institution in Korea with over 130 years of history and 2,400 beds alone, has been the research partner from the foundation of the company. It will also be the first hospital customer to utilize Reti-CVD in its ophthalmology and cardiology departments. We completed the internal coding process of Yonsei Severance Hospital, and the revenue is expected to be generated later this year.”

Funding

In terms of funding, Mediwhale closed a $9 million Series A funding round in March 2023.

 Differentiation From The Competition

What differentiates Mediwhale from its competition? Choi affirmed:

“Mediwhale possesses unique AI technology and a wealth of clinical evidence. Since 2016, I’ve been committed to tackling this health problem, and as a result, we have amassed the largest and most comprehensive data sets in the world. Mediwhale’s deep learning algorithm has been rigorously trained and verified using this data and has been subjected to strict scrutiny of traditional medical standards. We have also published numerous research articles in esteemed medical journals, and our commercial products have been launched and approved in APAC and the EU. These reasons are why Mediwhale is a global standout when it comes to retina scan-based diagnosis.”

Future Company Goals

What are some of Mediwhale’s future company goals? Choi concluded:

“The short-term goal is to have strong revenue growth in Korea and prepare market readiness in the U.S. in terms of regulatory clearance, reimbursement, and go-to-market.”

“The long-term goal is to bridge the gap in healthcare systems. We are dedicated to solving the gap in the healthcare system by streamlining the patient journey and improving healthcare outcomes through our advanced retinal AI scans. With our solution, we empower healthcare providers and patients with a non-invasive, efficient, and reliable approach that optimizes preventive care and enhances overall well-being.”