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DermaSensor gains FDA clearance for its AI-powered skin cancer detection device

Nancy Dahlberg
Nancy Dahlberg
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It’s the first medical device aimed at improving skin cancer detection in primary care offices for the most common skin cancers.

By Nancy Dahlberg

It’s been a long journey, but the road to the US market is now full speed ahead for Miami-based healthcare technology company DermaSensor. Today, the startup announced it has received FDA clearance for its real-time, non-invasive skin cancer evaluation system.  

This means that DermaSensor’s AI-powered, handheld medical device can now be used by the country’s 300,000 primary care physicians to detect and evaluate all three common skin cancers for their patients right in their offices.

“This is a long-standing unmet clinical need. This is something very well recognized from a population health standpoint. Primary care providers that are assessing suspicious lesions can really provide a lot of benefit to all healthcare stakeholders – patients, clinicians, payers, etc.” said Cody Simmons, DermaSensor’s CEO and co-founder, in an interview with Refresh Miami.

Cody Simmons, CEO and co-founder of DermaSensor

The device, which combines the power of artificial intelligence with patented spectroscopy technology, is the first real-time skin cancer device designed for primary care physicians and the only one that can detect melanoma, basal cell carninoma and squamous cell carinoma, the three most common forms of the cancer, Simmons said. It’s also a point and click solution that is the only currently available automated skin cancer device that is completely non-invasive.

The need

Skin cancer afflicts one out of five Americans by the age of 70, and there are about 5.5 million new cases each year. But 99% of skin cancers – including the most deadly of them, melanoma – are curable if detected early, yet access to dermatology is challenging, particularly in rural areas.

While dozens of companies have attempted to address this problem in recent decades, “our focus is on better equipping the non-specialist, the primary care physicians, to better assess and detect skin cancer,” Simmons explained. “And that’s really the population health opportunity because only 8% of at-risk Americans report recently receiving a skin exam.”

The road to FDA clearance for the other 92% has been an eight-year endeavor for Simmons, who came aboard as CEO in January of 2016 after leading business development for a Silicon Valley medical device startup and before that worked at Genentech. It’s been an even longer journey for Miami medtech serial entrepreneur Maurice Ferre, who started it all, believing that early detection of skin cancer is a public health issue because not enough people have access to dermatologists.

DermaSensor’s patented technology was pioneered at Boston University and University College London, and the device had been undergoing development since around 2012 starting with collaborations with dermatologists in Florida. Through the years the device evolved from a 30-pound desktop system the size of a microwave to the hand-held device it is today.

Over those years, DermaSensor underwent 13 clinical studies, six of which provided the principal support for the FDA clearance, through which thousands of diagnosed skin lesions were assessed.

The FDA pivotal study of over 1,000 patients, led by the Mayo Clinic across 22 study centers to validate device performance, found that the device had a sensitivity of 96 percent across all 224 skin cancers and a negative result had a 97 percent chance of being benign for all skin cancers, the company said. A companion study with 108 physicians was found to decrease the number of missed cancers by half, from 18 percent to 9 percent.

With this FDA clearance, primary care physicians can use DermaSensor’s device to help determine whether to refer a patient to a dermatologist for further evaluation.

Going to market

The company has raised about $27 million in venture capital to bring the product to market, including a $10 million round of financing in 2022. Investors include Ferre, Fred Moll, Ceros Capital and others.

“Achieving this medical milestone is a testament to the 12 years and tens of million of dollars our company has invested in research and development to bring this powerful technology to market. We are incredibly grateful to the FDA for the collaboration and dedication to this area starting with our first FDA pre-submission in 2016,” said Ferre, co-founder and chairman of DermaSensor who is also CEO and chairman of Insightec.

The next step is US commercialization (the device is already available in Europe and Australia). Simmons plans to start rolling the device out in two states – Florida and Pennsylvania and then hoping to quickly expand access to the device nationally next year. The team will be selling its solution to primary care physicians and private practices as well as large health care systems. They are also aiming to equip walk-in clinics and urgent care centers.

DermaSensor, now a team of 12, has begun assembling a go-to-market team. A chief marketing officer has been hired, a chief medical officer and a couple of commercial specialists are coming aboard next month, and a full sales team will be in place around mid-year, Simmons said.

“Eight years, $25 million in research and development, yeah, it’s been a long road,” said Simmons. “We’re very excited about what’s to come and very relieved all of that did not go to naught.”

https://youtu.be/SX3J_D7rd8E

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