Miami, Florida-based DermaSensor’s $10 million fundraising accompanies news that the company met all primary endpoints for two FDA pivotal studies, setting it up to potentially offer the only FDA-cleared, automated skin cancer detection tool on the market that uses any kind of imaging or optical technology.
The DermaSensor device received FDA breakthrough device designation in 2021, and the company expects it to become the first device cleared by the FDA to assist PCPs in evaluating skin cancer.
According to a news release, the device uses a form of optical spectroscopy (called elastic scattering spectroscopy, or ESS) to take non-invasive samples of tissue, capturing cellular-level information from the skin lesion using hundreds of wavelengths of light in a manner similar to how sonar uses sound.
It provides output directly to the user without the need for a laboratory or another physician to analyze the spectral data, with the proprietary algorithm set up to immediately assess the data and provide results in seconds.
The technology could help general practitioners better spot lesions that are potential problems before forwarding their patients to a dermatologist for further evaluation — boosting the ability of the healthcare system to catch skin cancers early.
Last month, the mid-stage company won the MedTech Innovator Mid-Stage Companies Pitch Event, beating out 1,000 applicants, more than 20 of which competed at DeviceTalks Boston. DermaSensor earned a cash prize and admission to MedTech Innovator and its benefits.
DermaSensor said the oversubscribed $10 million financing was led by existing investors, including Ceros Capital Markets. With the newly secured funding, the company is hiring for a range of roles, including chief commercial officer.
“This $10 million in additional capital is a clear vote of confidence, from both existing and new investors, in our strong clinical evidence and in the potential of our product to greatly improve the detection of skin cancer by PCPs,” DermaSensor CEO Cody Simmons said in the release. “This could provide major public health benefits since skin cancer is the most common cancer and there are more primary care physicians than any other specialty.”
Additionally, the company’s Derm-Success FDA pivotal clinical study of more than 1,000 patients across 22 centers around the world, met both of its primary endpoints. DermaSensor’s second pivotal study, which involved more than 100 physicians and showed that the use of the device’s test results improved the detection of skin cancer, met both primary endpoints.
The company also recently published another prospective study (Derm-Assess III) that enrolled more than 500 lesions suspicious for melanoma across 10 dermatology study centers. The study demonstrated DermaSensor’s effectiveness in detecting melanoma while ruling out benign lesions.
“In addition to five other previously completed clinical studies, we have also now successfully completed three of the largest prospective clinical validation and clinical utility studies ever done for regulatory clearance for any kind of skin cancer detection tool,” Simmons said. “And having already complied with regulatory requirements in Europe, Australia and New Zealand, we look forward to working with the FDA through the premarket review process.”