Miami Tech & Startup News

DermaSensor raises $10M, completes pivotal FDA studies for its skin cancer detection device

DermaSensor raises $10M, completes pivotal FDA studies for its skin cancer detection device

By Nancy Dahlberg

Most Americans forgo an annual skin exam even though the vast majority skin cancers aren’t deadly if detected early. DermaSensor is on a mission to improve outcomes and save healthcare costs by broadening access to effective skin cancer checks. The Miami-based health-technology company has built a non-invasive tool to better equip primary care physicians to detect skin cancer.

Today, DermaSensor is announcing that it has closed a $10 million round of financing, led by existing investors including Ceros Capital Markets. In addition to serial medtech entrepreneur Maurice Ferre, DermaSenor’s chairman, other investors from the Miami area include Ernest Bachrach and Alberto Beeck, both of whom are on the Endeavor board.

The funding  comes as the startup is also announcing today that it has successfully met all primary endpoints for its two FDA pivotal studies. DermaSensor is beginning to prepare for an expected U.S. launch, which could make DermaSensor the only FDA-cleared, automated skin cancer detection tool on the market that uses any kind of imaging or optical technology.

“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. 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,” said DermaSensor CEO Cody Simmons.

DermaSensor’s hand-held 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, similar to how sonar uses sound. The DermaSensor platform provides output directly to the doctor, without the need for a laboratory or another physician to analyze the spectral data. The proprietary algorithm immediately assesses the data and provides a result in seconds.

The DermaSensor device is already on the market in Australia and is cleared for sales in New Zealand and Europe. “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,” Simmons said.

DermaSensor announced the successful completion of the two required pivotal studies for the FDA. One was a clinical validation study basically showing the performance of the device in a  blinded study with over 1,000 patients and conducted by 22 primary care study centers globally, including Mayo Clinic. The second pivotal study, which involved over 100 physicians, showed that their use of the DermaSensor test results improved their detection of skin cancer.  These studies mark the first ever successful FDA pivotal studies for any type of skin cancer device for primary care physicians, Simmons said in an interview with Refresh Miami.

Despite advances in AI and phone technology, there’s no app that can do what DermaSensor’s device does. “We’ve shown that the device improves doctors’ detection of skin cancer, and that’s key,” Simmons, said. “We’re big believers in empowering doctors for in-person assessments.”

It’s been a long road. For a decade, DermaSensor has been working on developing and then miniaturizing the product from a 30-pound microwave-sized box to a one pound hand-held device. In total, the company has raised about $27 million in venture capital to bring the product to market.

Dr. Leffell, Chief of Dermatologic Surgery and skin cancer researcher at the Yale School of Medicine and a medical advisor to DermaSensor, agrees. He said published studies have already shown the potential for ESS to identify cancer using large spectroscopy systems.

“Miniaturizing that technology into a hand-held, point-and-click tool significantly improves its accessibility and utility for time-constrained physicians, who commonly must make quick referral decisions for skin lesions,” Leffell said in a statement. “And, most importantly, we hope the use of our tool will help clinicians identify skin cancer sooner, since 99% of skin cancers are curable if detected early.”

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