Cerebrovascular Accidents (CVAs), or stroke, are the top cause of disability and the second leading cause of death worldwide, posing significant threats to human health.
Unfortunately, many individuals only become aware of their condition after experiencing a stroke, missing the optimal window for early intervention and treatment.
Carotid Artery Stenosis (CAS) has been identified as a crucial factor contributing to strokes, serving as an early indicator. Therefore, early detection and treatment of carotid artery stenosis are vital measures for stroke prevention.
However, traditional methods for detecting carotid artery stenosis are limited by expensive equipment, heavy reliance on specialized medical personnel for operation and interpretation, lengthy testing procedures, and high costs, preventing widespread early detection of risk for stroke.
Through collaboration with a team of professionals from National Taiwan University, Pulxion Medical Technology has developed a non-invasive AI imaging technology for rapid screening of the risk of carotid artery stenosis, PulStroke, which breaks through traditional testing limitations.
With rapidity, standardization, and high cost-effectiveness features, the technology can significantly reduce the need for medical manpower and resources. It is poised to enhance the accessibility of early stroke screening greatly.
The limitations of traditional methods make early stroke detection challenging
Pulxion was founded by Professor Hao-Ming Hsiao from the Department of Mechanical Engineering at National Taiwan University. The co-founder is Dr. Hsien-Li Kao, a Professor in the Medicine School at the National Taiwan University and Chairman of the Cardiology Division at the National Taiwan University Hospital. Their long-term collaboration started in 2014, dedicated to addressing numerous challenges in early stroke detection, and they officially established Pulxion in 2020.
According to Professor Hsiao, the main reason for choosing the carotid artery as the topic of their research is that there are over 12 million new cases of stroke worldwide every year, which means one new case occurs every 3 seconds. It is not only a threat to human health but also significantly impacts healthcare and societal costs. There's an estimation that by 2030, the global economic burden of stroke, including post-care, will exceed one trillion US dollars.
Carotid artery stenosis serves as a critical early indicator of stroke. Existing common diagnostic methods for carotid artery stenosis include carotid artery ultrasound, Computed Tomography Angiography (CTA), and Magnetic Resonance Angiography (MRA). However, due to issues such as expensive equipment and complex operations, early screening is challenging to implement widely.
The carotid artery is the closest blood vessel to the body's surface, making it easier to observe the pulsation characteristics. Therefore, Pulxion starts with carotid artery stenosis assessment and utilizes non-invasive AI imaging technology to evaluate the risk of stroke.
Unique Screening Method: Rapid, Accurate, and Easy-to-Use
By analyzing subtle pulsation variations on the subject's skin surface, Pulxion's PulStroke can differentiate between the pulsation patterns of normal individuals and those with carotid artery stenosis. The device projects visible light onto the subject's neck and then performs the video motion analysis with AI algorithms to highlight skin surface pulsations.
Comparing these pulsations with features associated with carotid artery stenosis, a risk assessment report is generated to evaluate the subject's risk of carotid artery stenosis. The entire process is completed within 1 minute, with reports available within 5 minutes.
PulStroke possesses several key advantages. First, compared to traditional methods like carotid artery ultrasound, CTA, and MRA, the technology is non-invasive, offering a non-invasive and radiation-free screening approach for subjects.
Second, it's portable and user-friendly, with a compact size and no need for specialized operators, making it suitable for placement in small to medium-sized clinics, health examination centers, and potentially homecare and community service in the future. Third, utilizing AI algorithms and big data analysis supported by PulStroke, clinical trials have demonstrated an accuracy of nearly 90% when compared to ultrasound.
Regarding the business model, Joy Chen, CEO of Pulxion, said that PulStroke includes both hardware device and cloud platform. The hardware device can be set up in medical facilities with buyout or leasing options. The analysis reports generated on the cloud platform are billed separately and also come with several options for users.
For marketing, Pulxion will first work with health examination centers and large hospitals, with plans to participate in government disease prevention programs. The next step is to enter the community clinics with the ultimate vision of making the technology accessible to the general public and integrating it into home healthcare and nationwide health services to increase stroke screening rates and ultimately reduce stroke incidence.
Pulxion has completed its angel round funding and plans to sign an MOU with internationally renowned medical device companies this year. Pulxion also plans to file the medical device regulatory submission to the Taiwan Food and Drug Administration (TFDA) this year and is preparing to apply for the Breakthrough Devices Program of the U.S. Food and Drug Administration (FDA).
Chen said that Taiwan will be the first launch market for Pulxion, and the company will subsequently begin preparations for regulatory submission in the United States.
PulStroke enables rapid and accurate assessment of stroke risk. The company immediately attracted attention from the medical industry upon its release. Professor Hsiao believes the key driving force behind the successful commercialization of Pulxion technology is the Startup Value Creation Program promoted by the National Science and Technology Council. As he mentioned, the program activates the value of academic research by providing resources, regulatory ease, and policy support to allow professors to play significant roles in startups. It also encourages various forms of innovation matchmaking.
Pulxion has participated in the acceleration program of Mosaic Venture Lab – a TTA accelerator partner as well. The program not only organizes various activities to increase interaction opportunities with investors but also helps startups to expand their exposure. All the support for Pulxion has transformed into its competitiveness. The company will do its best to broaden the applications of its technology to other diseases, creating a healthy society in the future and fulfilling its vision of preventive medicine and home healthcare.
(Editor's note: The original article was published in TTA Magazine Issue 14. Read more startup stories in TTA Magazines.)
Pulxion PulStroke
Photo: Pulxion