DermaSensor (skin cancer detection device)

2023: DermaSensor Proven Skin Cancer Detection

On March 17, 2023, at the annual meeting of the American Academy of Dermatology (AAD), DermaSensor released data from two clinical studies that evaluated the effectiveness of its device for detecting skin cancer.

DermaSensor provides non-invasive tissue sampling. The technology uses hundreds of wavelengths of light to obtain information at the cellular level. This allows primary care physicians to promptly identify malignant skin lesions and refer patients to a dermatologist for a more detailed examination.

DermaSensor System

As part of the Derm-Assessment III and Derm-Success clinical trials, more than 2,000 suspect lesions were biopsied at 32 sites, it said. The results suggest sensitivity at 94% for the correct classification of 338 high-risk lesions and a 23% specificity score for the correct classification of 1,681 low-risk lesions.

Results from the Derm-Assess III study in 10 centers showed a 96 percent sensitivity of the system when melanoma was detected. In addition, sensitivity was demonstrated at 91% for all high-risk melanocytic lesions. The instrument classified 32.5% benign lesions (specificity) during biopsy when melanoma was suspected.

At the same time, the Derm-Success study, conducted at 22 primary health care centers, demonstrated a 96 percent sensitivity of the device to all skin cancers. Specificity was 21% for proper classification of benign lesions at biopsy. In both studies, as noted, every sixth lesion with a positive test result turned out to be malignant. No security issues were identified when using the system.^[1]

2022: Start production of portable skin cancer detection device in a couple of seconds

On June 15, 2022, it became known that the production of a portable device for detecting skin cancer in a couple of seconds began in the United States. We are talking about the DermaSensor device, for the commercial launch of which the manufacturer attracted $10 million in investments.

The fundraising of the amount is accompanied by the news that the company has reached all primary endpoints in two central studies from the Food and Drug Administration (FDA). This will enable the company to offer on the market the only certified automated skin cancer detection tool using any imaging or optics technology. DermaSensor said the financing was led by existing investors, including Ceros Capital Markets. Thanks to the funding received, the company recruits employees in various positions, including the chief commercial officer.

Production of a portable device for detecting skin cancer begins in a couple of seconds

Previously, the DermaSensor device received FDA certification as a breakthrough device, and the company expects it to be the first such device to help doctors assess skin cancer. According to the press release, the device uses optical spectroscopy called elastic scattering spectroscopy. The technology is needed for non-invasive tissue sampling, obtaining information about skin damage at the cellular level using hundreds of wavelengths of light, similar to how sonar uses sound.

The technology issues the result directly to the user without having to go to a laboratory or other doctor to analyze spectral data, and the patented algorithm is set to immediately evaluate the data and provide the results within seconds.

health care The system could help GPs better identify potentially problematic lesions before referring their patients to a dermatologist for further screening, increasing the system's ability to detect skin cancer early. In May 2022, DermaSensor, which is in the middle stage of development, won the MedTech Innovator Mid-Stage Companies Pitch Event, beating 1,000 applicants, more than 20 of whom participated in the competition for DeviceTalks Boston.^[2]

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