DeepX Diagnostics Inc. to enter US market, having already performed over 180,000 skin lesions assessments in pharmacy and primary care to date in Europe.

Washington, DC, USA – June 6, 2023. DeepX Diagnostics Inc., the skin cancer teledermatology and diagnostics company, announced today that its digital dermatoscope DermoSight^TM received clearance from the US Food and Drug Administration (FDA) for teledermatology screening of suspect skin cancer lesions in the United States. The company is now ready to enter the US market on the back of over 180 thousand assessments in pharmacies and primary care clinics in Europe.

DermoSight is currently cleared to acquire skin lesion images for teledermatology assessment, like existing digital dermatoscopes. It is also designed for integration with an AI algorithm, empowered by proprietary optical transfer diagnosis (OTD) technology, although the FDA has yet to approve the commercial use of the OTD technology with DermoSight. OTD enables the analysis of lesions on the sub-skin level based on their light transferring properties. The technology is designed to turn dermatoscopic assessment into a robust, non-invasive and accessible AI driven tool, and to streamline and fast-track skin cancer diagnosis.

“We are delighted to announce that the FDA has cleared DermoSight for use in the United States. It will help people with skin lesions of concern receive early diagnosis and effective reatment of skin cancer,” said Christian Horn, the CEO at DeepX Diagnostics.

Teledermatology assessments in primary care clinics and pharmacies can help streamline the detection of cancerous lesions and fast-track their diagnosis, while reducing unneeded referrals and procedures for non-cancerous lesions. Today, skin cancer is mainly diagnosed by a dermatologist through a biopsy, which means long wait times and costly and invasive procedures.

“Our technology has the potential to revolutionize the way skin cancer is diagnosed, by turning the dermatoscope from a sophisticated tool for the dermatologist’s eye into a precise diagnostic instrument, comparable to biopsy in accuracy, through its future integration with an AI augmented OTD algorithm,” said dermatologist DrDavid Swanson, DeepX Diagnostics’ Chief Medical Officer and Professor ofDermatology at Mayo Clinic.

An initial study was conducted in cooperation with the Mayo Clinic using an AI integrated Dermosight prototype to analyze and diagnose skin cancer. The promising results from this study were published in the British Journal of Dermatology.[1]

“DermoSight is only the first step in our vision to make skin cancer diagnosis directly accessible in primary care and beyond, and to reduce referrals and waiting times, which we know increase cost and make early detection less likely,” said Hans Gangeskar, DeepX Diagnostics board member, and co-founder and former CEO of US telemedicine company Nurx. “We are progressing well with our AI development and may be ready for further clinical trials of an integrated DermoSight version soon.”

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Notes to editors

About DeepX Diagnostics

DeepX Diagnostics is a skin cancer teledermatology and diagnostics company working to enable early skin cancer diagnosis by integrating device technology, AI, and teledermatology. Its dermatoscope for skin cancer screening, DermoSight, is designed for future integration with an AI diagnostics algorithm empowered by Optical Transfer Diagnosis technology.

About OTD

DeepX Diagnostics' proprietary technology, OTD, allows for the assessment of deep layers of suspicious skin lesions underneath the skin surface through optical analysis. This analysis is part of our OTD augmented AI technology to diagnose skin lesions. OTD stems from NASA technology for ocean surveillance and is the brainchild of brothers and physics professors Knut and Jacob Stamnes, who are at the origin of the company.

About DermoSight

DermoSight is a digital dermatoscope device for skin cancer screening first approved for commercial use in Europe for teledermatological skin cancer screening. DermoSight is currently being used in primary care settings as part of NHS services and in community pharmacies in Europe, including the Walgreens Boots Alliance pharmacy chain Boots, in the UK andIreland. The company has so far preformed about 180 thousand teledermoscopy assessments of skin lesions through its services offered to concerned consumers and doctors.

About skin cancer

Skin cancer is the most prevalent cancer in the world, with 6.1 [2]million people treated every year in the USA alone. If detected early, skincancer can be easily treated by removing the cancerous lesions with a small surgical procedure.  If left untreated, metastatic skin cancer is fatal in most patients.[3]

[1] D.L. Swanson, R.V. Venneugues, S.Q. Vicensio, J. Garioch, M. Biryulina,G.Ryzhikov, B. Hamre, L. Zhao, F.S. Castellana, K. Stamnes, and J.J. Stamnes,Br.J. Dermatology 178, 541-546 (2018). doi: 10.1111/bjd.15898.

[2] U.S.Cancer Statistics Working Group. U.S. Cancer Statistics Data VisualizationsTool, based on 2021 submission data (1999-2019): U.S. Department of Health andHuman Services, Centers for Disease Control and Prevention and National CancerInstitute; https://www.cdc.gov/cancer/dataviz, released inNovember 2022.

[3] Sandru A,Voinea S, Panaitescu E, Blidaru A. Survival rates of patients with metastaticmalignant melanoma. J Med Life. 2014 Oct-Dec;7(4):572-6. PMID: 25713625; PMCID:PMC4316142.

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