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AI Medical Technology reports highly promising results from clinical study in primary care facilities to validate Dermalyser – an AI-driven support tool for diagnosing melanoma skin cancer

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First prospective study of its kind conducted in primary care settings, shows remarkable diagnostic performance: 95% sensitivity and 86% specificity, outperforming primary care physicians and dermatologists. 

Stockholm, Sweden, February 7, 2023. Swedish start-up AI Medical Technology today announces results from a clinical trial conducted at 37 Swedish primary care facilities with Dermalyser, a diagnostic decision support system empowered with advanced artificial intelligence (AI). A total of 240 patients seeking primary care for melanoma-suspected cutaneous lesions were included in the prospective, pivotal, confirmatory, multi-centre, non-interventional clinical investigation. Dermalyser (a mobile application) showed remarkable diagnostic performance: 95% sensitivity and 86% specificity, outperforming primary care physicians and dermatologists. 

“Today, we are delighted to be able to report Dermalyser's outstanding performance as a support tool for diagnosing melanoma skin cancer”, says Christoffer Ekström, CEO of AI Medical Technology. “The remarkably high sensitivity and specificity levels demonstrate the clinical performance and benefit of Dermalyser, particularly since the study was conducted in a real world, primary care setting representing different demographics, personnel, and geographical location. We now look forward to finalising the CE marking and preparing for market launch in Europe in Q4, 2023. Simultaneously, we plan to engage US-based clinics in upcoming clinical trials as part of our US market entry strategy”.

Olle Larkö, Professor in Dermatology & Venereology and former Dean at Sahlgrenska University, comments: ‘’Indeed exciting results, these numbers show potential of not only improving future visual diagnostic accuracy, but also decreasing the amount of workload that dermatologist too often are dealing with in their daily practice. Nevertheless, additional studies are necessary to confirm the positive results. Human–computer collaboration is here to stay and I’m looking forward to its implementation in the field of skin cancer and dermatology in general. 

Magnus Falk, Associate Professor in General Practice and Principal Investigator, Department of Health, Medicine and Caring Sciences, Linköping University, comments: “In addition to the primary objective, i.e., the diagnostic precision of the device, we also determined the usability and applicability of Dermalyser in clinical practice. Results from the study will be reported in a clinical publication, but already the clear impression is a high acceptance of Dermalyser as a diagnostic support tool among the medical personnel involved”.

More information on the study: https://clinicaltrials.gov/ct2/show/NCT05172232?term=AI&cond=Melanoma&draw=2&rank=1 

For more information, please contact:

Christoffer Ekström, CEO AI Medical Technology

Email: christoffer@aimedtech.org  

Cell phone: +46 72 1748339


Melanoma skin cancer

According to Cancer Today, every 4 minutes, a person dies of skin cancer. In 2020, the incidence of new melanoma cases was over 320,000 worldwide. With a growing trend, patient cases are expected to reach almost 500,000 by 2040. Statistics further show that as many as 99% of the cases are curable if they are diagnosed and treated early enough, thus underscoring the importance of continuous self-examination and visiting your doctor in the case of a suspected skin lesion. Hence, early and accurate diagnosis is vital for saving more lives. (https://gco.iarc.fr/today/home)

About Dermalyser

Dermalyser is a mobile application empowered with artificial intelligence (AI) that can provide diagnostic decision support for medical professionals in clinical settings. Dermalyser enables fast and direct diagnostic decision support with high accuracy when diagnosing skin cancer such as melanoma of the skin. The application is used with a dermatoscope mounted in front of the smartphone camera. The Medical professional takes an image of the patient's skin lesion and, within a few seconds, receives a diagnosis from the AI in return. In this way, fewer cancers are missed, fewer patients will undergo unnecessary excisions of benign skin lesions, meanwhile saving more patients' lives. With Dermalyser, healthcare can become more efficient while costs are reduced.

About AI Medical Technology

AI Medical Technology is a company operating in the interdisciplinary fields of data science, software development, and medicine. The company is dedicated to developing AI-powered diagnostic solutions that enable frontline healthcare practitioners to make easier, faster and more reliable diagnoses for their patients. Following the second funding round in 2022, the team is now focused on bringing the first product, Dermalyser, a clinically validated decision support tool for diagnosing skin cancer through clinical trials and to the market. www.aimedtech.com

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Artificial Intelligence decision support tool malignant melanoma cancer diagnostics

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According to Cancer Today, the incidence of new melanoma cases was over 320,000 worldwide and the trend is growing. As many as 99% of cases can be cured if diagnosed and treated early enough. Thus, early and correct diagnosis and treatment saves lives. Today, the results from a clinical trial conducted at 37 Swedish primary care facilities with Dermalyser, a diagnostic decision support system empowered with advanced artificial intelligence (AI). Dermalyser (a mobile application) showed remarkable diagnostic performance: 95% sensitivity and 86% specificity, outperforming primary care physicians and dermatologists.
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Today, we are delighted to be able to report Dermalyser's outstanding performance as a support tool for diagnosing melanoma skin cancer. The remarkably high sensitivity and specificity levels demonstrate the clinical performance and benefit of Dermalyser, particularly since the study was conducted in a real world, primary care setting representing different demographics, personnel, and geographical location. We now look forward to finalising the CE marking and preparing for market launch in Europe in Q4, 2023. Simultaneously, we plan to engage US-based clinics in upcoming clinical trials as part of our US market entry strategy.
Christoffer Ekström, CEO of AI Medical Technology
Indeed exciting results, these numbers show potential of not only improving future visual diagnostic accuracy, but also decreasing the amount of workload that dermatologist too often are dealing with in their daily practice. Nevertheless, additional studies are necessary to confirm the positive results. Human–computer collaboration is here to stay and I’m looking forward to its implementation in the field of skin cancer and dermatology in general.
Olle Larkö, Professor in Dermatology & Venereology and former Dean at Sahlgrenska University
In addition to the primary objective, i.e., the diagnostic precision of the device, we also determined the usability and applicability of Dermalyser in clinical practice. Results from the study will be reported in a clinical publication, but already the clear impression is a high acceptance of Dermalyser as a diagnostic support tool among the medical personnel involved.
Magnus Falk, Associate Professor in General Practice and Principal Investigator, Department of Health, Medicine and Caring Sciences, Linköping University.