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Amid the COVID-19 pandemic, Kelvin Health emerged to tackle vascular issues using advanced thermal imaging and visual AI, providing a non-invasive, reliable, and accessible solution for conditions like peripheral arterial disease.
March, 2020. In the midst of health implications brought on by COVID-19, innovators across the globe channeled their attention, knowledge, and technologies to help the world deal with a crisis unseen before. It was through these challenges that Georgi Kadrev, CEO and Co-Founder of Kelvin Health, found inspiration to revolutionize medical diagnostics.
At a time when rapid COVID-19 tests were unavailable, a team of medical experts approached Kadrev’s company, Imagga. Known for its expertise in visual recognition AI, the medical experts were interested in performing advanced analysis of thermal images used in detecting COVID-19. Kadrev recounts that "we didn't know what COVID-19 really was yet, but we saw an opportunity to use our skills in a new way." This realization led to the formation of an Imagga spin-out, dubbed Kelvin Health. Recognizing the unmet need and tremendous opportunity for innovation, Kelvin Health aimed to apply the deep image recognition expertise inherited from its parent company to medical imaging – specifically, to vascular diagnostics.
The current standard of care for diagnosing vascular issues involves both non-invasive and invasive methods, each with its own limitations. On the non-invasive side, common approaches include the Ankle Brachial Index (ABI) and the Toe Brachial Index (TBI). These methods involve measuring blood pressure at the ankle or toe and comparing it to the blood pressure in the hand. Another non-invasive method is Doppler ultrasound, where a trained specialist applies ultrasound technology to scan key points in the arteries. However, these methods are limited in their effectiveness, as Kadrev points out. “The main problem with these methods is that they're not reliable enough and they depend on a specialist to be well trained," says Kadrev. they are heavily influenced by the skill of the specialist. Kadrev also mentions how these methods are particularly imprecise for patients with diabetes, due to medial arterial calcification.
Invasive methods, such as X-ray angiography, involve injecting a contrast agent and exposing the patient to significant radiation over several hours. While this method is the current gold standard, it doesn’t address the achilles heel in diagnosis. "An angiography can cost between $5,000 to $20,000 and demands a high level of specialist involvement," says Kadrev.
Kelvin Health aims to address these challenges by introducing a non-invasive, reliable, and accessible solution through its innovative thermography-based technology. Their approach seeks to provide a more efficient and patient-friendly diagnostic tool that mitigates the disparities and limitations of current methods. “Our mission is to end preventable deaths and suffering from conditions like critical limb ischemia. To achieve that, we combined the power and availability of mobile thermography and state-of-the-art visual AI to enable accessible vascular screening, especially for conditions like peripheral arterial disease,” says Kadrev.
Kelvin Health has developed a software solution that leverages the power of mobile thermography and advanced visual AI to enable accessible vascular screening. The technology uses a pocket-sized thermal camera, attached to a mobile phone or computer, to capture thermal images of the human body. By analyzing these images, the software can identify areas with potential vascular issues based on temperature variations, which indicate changes in blood flow and possible inflammation.
Kadrev explains that "local body temperature is directly related to blood flow. If there is an anomaly in temperature, this means that there is some anomaly in blood flow. There are a relatively limited number of reasons that might affect it, such as inflammation or a vascular problem, typically some type of blockage like stenosis or thrombosis."
The process begins by capturing a thermal image of the patient's legs using the specialized camera. Their proprietary software then segments the different zones of the legs and evaluates the level of perfusion in each zone, within a certain level of confidence. Kadrev explains that "we can capture the heat of the body, detect local anomalies, and notify the doctor if needed. This can be done by specialists, nurse practitioners, general practitioners, or even the patient's spouse.” The innovative approach will allow for rapid and non-invasive screening of conditions like peripheral arterial disease (PAD).
Kelvin Health’s technology offers several advantages over traditional diagnostic methods. Unlike the Ankle Brachial Index (ABI) or Doppler ultrasound, which require specialized training and equipment, their solution is non-invasive, user-friendly, and does not depend on the operator's skill. This makes it particularly useful for screening patients with diabetes, who often present diagnostic challenges due to medial arterial calcification.
The technology is not only applicable in specialist contexts but can also be used in primary care settings. "We are focused on building Kelvin Health as a vascular diagnostic assistive device that is non-invasive, non-operator dependent, rapidly applicable, and potentially usable in remote patient contexts in the future," says Kadrev. By optimizing part of the workflow, Kelvin Health aims to save time for clinicians, reduce costs for hospitals, and ultimately improve the quality of life for patients.
Kelvin Health is in the preclinical stage, having conducted multiple observational studies with over 1,300 patients across Europe and Argentina. With a database of more than 9,500 thermal images, their machine-learning models have achieved high sensitivity and specificity, both above 96 percent. Encouraged by the positive response from specialists and the potential applications in primary care, Kelvin Health is currently preparing for regulatory clearance processes in Europe and the United States.
They are also raising funds to accelerate this process and prepare for commercialization. "We are currently raising $4.8 million to speed up the regulatory clearance process and to prepare for commercialization. About one-third of it is already soft-committed by European investors," Kadrev shares.
Accurately and effectively identifying critical limb ischemia (CLI) and critical limb threatening ischemia (CLTI) is crucial to improving the quality of life in patients with peripheral arterial disease (PAD). Of the more than 200 million adults with PAD, 10 percent of these patients have CLTI. Patients with CLTI are at increased risk of amputation and death. The gold-standard for treating patients that have progressed to more severe forms of PAD is revascularization through bypass or endovascular procedures.
According to LSI’s Global Procedure Volumes database, global peripheral vascular procedures are projected to increase at a compound annual growth rate (CAGR) of 4.1 percent from 2023 to 2028. With nearly 6 million procedures performed annually, only a small fraction of the overall patient population are receiving appropriate interventions needed to save their limbs and lives. One of the most prominent challenges gating these interventions is accurate and early identification.
In spite of advancements in interventional technology and approaches, PAD remains a challenging disease state. Patients undergoing revascularization ultimately face high mortality and morbidity rates, and nearly 25 to 40 percent of patients are ineligible for revascularization due to medical comorbidities or physiological limitations.
This is where better diagnostic tools can truly revolutionize patient management. Early identification of disease can improve the effectiveness of intervention, and of conservative management, including lifestyle changes and pharmacological therapy.
Kelvin Health’s journey from an AI-based visual recognition company to a pioneering medical diagnostics startup highlights their innovative spirit and adaptability. Their technology addresses critical gaps in vascular screening, offering a non-invasive, accessible, and reliable solution. As they move towards regulatory approval and wider clinical application, we are excited to see how their work will impact healthcare delivery.
Georgi Kadrev has been selected to present at LSI Europe ‘24 this September 16th to 20th in Sintra, Portugal. Join us at the event where he will share the latest updates on Kelvin Health.
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