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  • Swedish AI Medical Technologies now receives approval to trial AI for determining actual melanoma thickness prior to surgery

Swedish AI Medical Technologies now receives approval to trial AI for determining actual melanoma thickness prior to surgery

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Dermalyser support tool has already demonstrated 100% sensitivity and 93% specificity for detecting invasive melanomas 

Stockholm, Sweden, October 22, 2024 – Swedish AI Medical Technologies has announced approval to commence a clinical trial aimed at further validating the performance of Dermalyser, its advanced AI-driven diagnostic support tool for assessing melanoma. The primary goal of this investor-led, single-center, non-randomized, parallel, double-blinded, prospective clinical investigation is to evaluate Dermalyser’s ability to accurately determine melanoma thickness using dermoscopy images. 

The trial is expected to start in Q4 2024 and be concluded in Q4, 2025. 

While melanomas are often easy to detect, determining whether they are invasive (i.e., malignant cells infiltrating in the dermis and risk for metastasis) or in situ (i.e., cells confined to the upper layer of the skin and no risk for metastasis) can be challenging based on dermatoscopic images alone. Although surgery is required regardless of melanoma depth, having a better understanding of the melanoma’s thickness preoperatively brings benefits for both surgeons and patients.

Dr. Sam Polesie, Consultant Dermatologist and Associate Professor at the Department of Dermatology and Venereology at Sahlgrenska Hospital, Gothenburg, and the lead investigator in the study, commented: “This trial seeks to determine whether AI-powered tools like Dermalyser can enhance our ability to assess melanoma thickness. Such insights can help prioritize patients for surgery, guide surgeons on optimal excision margins during the first operation and provide patients with more accurate information before surgery.”  Dr. Polesie added: “The primary goal is to identify practical applications for AI in routine healthcare that can enhance clinical decision-making. One promising use case is the preoperative assessment and profiling of lesions suspected to be melanoma, particularly in estimating their thickness. We believe this represents a strong starting point for integrating AI to support diagnostic accuracy and improve patient outcomes.”

“In a previous study, published in March 2024 in the peer-reviewed British Journal of Dermatology, Dermalyser demonstrated a high level of sensitivity and specificity when used by primary care physicians, achieving rates of 95% and 85%, respectively. These figures rose to 100% sensitivity and 93% specificity for detecting invasive melanomas,” said Christoffer Ekström, CEO of AI Medical Technologies. “I am happy to announce the approval to embark on the next study in the clinical validation program for Dermalyser as we strive for making it easier, faster and more reliable to diagnose for patients with skin lesions suspected to be cancerous.”

For more information, please contact:

Christoffer Ekström, CEO AI Medical Technology

Email: christoffer@aimedtech.com  

Cell phone: +46704027101

About the clinical study

Investigation of the Performance of the Medical Device Dermalyser in Determining Melanoma Thickness Based on Dermoscopy Images - A Single center, Non-randomized, Parallel, and Double-blinded Prospective Clinical Investigation

In this investigator-led, prospective study, a total of 300 confirmed primary cutaneous melanomas will be included from up to 300 patients (as more than one lesion per patient may be included). Since melanoma diagnoses are not known prior to screening, approximately 600–900 subjects will need to be screened in order to include 300 confirmed melanoma cases. The study will involve adult patients (aged 18 and above) with suspected primary melanomas scheduled for surgery, with lesion sizes ranging from 2 to 20 mm in diameter.

About malignant melanoma

According to Cancer Today, the incidence of new cases of malignant melanoma in 2020 was over 320,000 worldwide, https://gco.iarc.fr/today/home and every 4 minutes, a person dies of skin cancer. 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.

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. AI Medical Technology was founded by a diverse team of driven, passionate tech entrepreneurs, software developers and clinicians. Following the initial funding round in 2021, the team is now focused on bringing the first product, Dermalyser, a clinically validated decision support tool for the diagnosis of all skin cancers through clinical trials and to the market. https://aimedtech.com/

About Dermalyser

Dermalyser is a sophisticated smartphone application that leverages artificial intelligence to provide diagnostic decision support to medical practitioners in clinical environments. This application facilitates rapid and precise diagnosis of melanoma, the most aggressive form of skin cancer.

Utilising a dermatoscope, which is affixed to the smartphone camera, healthcare professionals can capture high-quality images of suspicious skin lesions. Within seconds, the AI analyses the image and delivers a diagnostic result, enabling timely intervention.

By integrating Dermalyser into their practice, medical professionals can enhance their diagnostic accuracy, thus facilitating earlier detection of skin cancer. This not only has the potential to save lives but also helps to streamline the standardised course of care for melanoma, making healthcare delivery more efficient in terms of both time and cost.

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Quotes

This trial seeks to determine whether AI-powered tools like Dermalyser can enhance our ability to assess melanoma thickness. Such insights can help prioritize patients for surgery, guide surgeons on optimal excision margins during the first operation and provide patients with more accurate information before surgery. The primary goal is to identify practical applications for AI in routine healthcare that can enhance clinical decision-making. One promising use case is the preoperative assessment and profiling of lesions suspected to be melanoma, particularly in estimating their thickness. We believe this represents a strong starting point for integrating AI to support diagnostic accuracy and improve patient outcomes.
Dr. Sam Polesie, Consultant Dermatologist and Associate Professor at the Department of Dermatology and Venereology at Sahlgrenska Hospital, Gothenburg, and the lead investigator in the study
In a previous study, published in March 2024 in the peer-reviewed British Journal of Dermatology, Dermalyser demonstrated a high level of sensitivity and specificity when used by primary care physicians, achieving rates of 95% and 85%, respectively. These figures rose to 100% sensitivity and 93% specificity for detecting invasive melanomas. I am happy to announce the approval to embark on the next study in the clinical validation program for Dermalyser as we strive for making it easier, faster and more reliable to diagnose for patients with skin lesions suspected to be cancerous.
Christoffer Ekström, CEO of AI Medical Technologies