DermaSensor Inc.'s CE Marked, FDA Breakthrough device was cleared by FDA in January 2024 as the first skin cancer detection device in the U.S. that provides physicians with any form of immediate, objective risk assessment for all three common skin cancers. With $32M raised to date and supported by pioneering entrepreneurs Dr. Maurice Ferre and Dr. Fred Moll, our system has been used to assess thousands of diagnosed skin lesions across 15 clinical studies. The company's FDA pivotal validation study was conducted with 22 study centers (led by Mayo Clinic) and enrolled 1,005 patients and 1,579 lesions. This study found that the likelihood a lesion was cancerous ranged from 3% to 61% for the device result range of 0 to 10 (I.e. 3% for a result of 0, 61% for a result of 10). The companion FDA pivotal clinical utility study with 108 PCPs found that device use decreased their missed skin cancers (i.e. false negative referrals) by half while also increasing their overall accuracy.

DermaSensor will provide clinicians with additional information about a lesion for them to consider in their referral decision. DermaSensor™ does not definitively determine whether or not cancer is present, specify what type of cancer may be present, nor make any decision for the user.

1. Identify lesions suggestive of skin cancer on the patient

2. Apply handheld DermaSensor device to the lesion and initiate first recording

3. Five spectral recordings are taken from the skin lesion to complete one scan

4. DermaSensor’s algorithm analyzes spectral data and delivers assessment in seconds