Clinical Study Initiated in Primary Care Facilities to Validate Dermalyser
Swedish start-up AI Medical Technology initiates clinical study in primary care facilities to validate Dermalyser – an AI-driven support tool for diagnosing malignant melanoma
Stockholm, Sweden, May 2, 2022. On the first day of this year’s Skin Cancer Awareness Month, Swedish Artificial Technology start-up AI Medical Technologies announces the start of a clinical trial at 30 Swedish primary care facilities with Dermalyser, a diagnostic decision support system empowered with advanced artificial intelligence (AI). The study is a prospective, pivotal confirmatory multi-centre, non-interventional clinical investigation with the following aims:
- Evaluate the clinical safety, performance and benefit of Dermalyser in patients with cutaneous lesions where malignant melanoma cannot be ruled out
- Examine the user-friendliness of the device itself
- Document health economics data
The trial is expected to be concluded in Q4, 2022.
Dermalyser is a decision support tool for medical professionals, from general practitioners to consultants, to classify suspected skin cancers such as malignant melanoma. The equipment consists of a mobile phone with an app on which a dermatoscope is mounted for taking pictures with the mobile phone camera. After entering patient information, the user takes a picture of the patient’s skin lesion, and a melanoma risk rating is displayed onscreen within a few seconds. The diagnostic precision and speed of results are far higher than traditional or alternative methods.
“The artificial intelligence behind Dermalyser is based on analysing an unrivalled library of 100,000 skin lesion images with the confirmed diagnosis”, says Christoffer Ekström, CEO of AI Medical Technology. “Our solution shows an outstanding performance of 95% sensitivity and 78% specificity – exceeding that of a trained dermatologist – and we now look forward to validating this with real-world data in our clinical study”.
The clinical study is a multi-centre, prospective clinical trial to assess the diagnostic performance of Dermalyser when identifying malignant melanomas in patients seeking primary care for melanoma-suspected cutaneous lesions.
Magnus Falk, specialist in general medicine and Principal Investigator, comments: “Since this study intends to study clinical applicability and diagnostic reliability, it is important to reflect the reality of primary care. Therefore, we intend to include patients from health centres representing different demographics, size, staffing and geographical location across several Swedish regions.”
For more information, please contact:
Christoffer Ekström, CEO AI Medical Technologies
Cell phone: +46721748339
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.org/.