The company’s innovative DermaSensor device could save lives with early skin cancer detection capabilities.

With tens of thousands of deaths each year in the U.S. attributable to skin cancer, 99% of deaths from melanoma — the most deadly skin cancer — are avoidable if detected at an early stage, Cody Simmons says.

That’s where DermaSensor comes in.

With Simmons as CEO, DermaSensor develops technology that could help primary care providers spot lesions that are potential cancers before forwarding patients to a dermatologist for further evaluation, improving the ability of the healthcare system to catch skin cancers early.

The company won the MedTech Innovator Mid-Stage Companies Pitch Event at DeviceTalks Boston in May and recently raised  $10 million as it prepares for a commercial launch in the U.S.

DermaSensor’s technology could become the first device cleared by the FDA to assist primary care physicians in evaluating skin cancer.

“Nearly all of the tens of thousands of skin cancer deaths every year are completely avoidable if they are simply detected early,” Simmons told MassDevice. “That’s what’s exciting about the opportunity — and also a bit of the tragedy and frustration in this field — is that pretty much all skin cancers are curable and pretty much all skin cancers, you can literally see on the surface of the skin. At the end of the day, as [DermaSensor co-founder and Chair] Dr. Maurice Ferre says, it’s really a public health issue.” 

Simmons reinforced this in describing how preventing skin cancer deaths is “just a matter of getting patients better access to effective skin cancer checks.”

Developing DermaSensor’s technology

DermaSensor’s device uses a form of optical spectroscopy called elastic scattering spectroscopy (ESS) to take noninvasive 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.

That technology was invented by Irving Bigio, a Boston University professor and scientific advisor to the DermaSensor. Dr. Ferre and DermaSensor Director Christopher Dewey, along with a few other early investors (including Intuitive Surgical founder and major surgical robotics player Dr. Fred Moll) worked to use the technology in a 30-pound desktop spectroscopy system, which represented the early stages of DermaSensor’s founding a decade ago.

When Simmons joined as CEO in 2016 to scale their research project into a company, there were not yet any issued patents, no employees and no medical advisors. However, the promising technology, major clinical unmet need, and knowledgeable early investors proved to be a good foundation for Simmons to build upon.

“It’s been a great journey working with world-class medical device entrepreneurs, executives and investors, and I have learned a tremendous amount from them over the last six years,” he said. “We’re working toward this common goal of solving skin cancer through developing this effective, highly accessible detection tool.”

The biggest challenge came in the early days when shrinking the 30-pound, microwave-sized desktop prototype into a low-cost, handheld device that can be widely accessible and used by frontline providers. Over time, the spectral data collected during algorithm development and testing has remained consistent due to keeping the same fiber-optic probe configuration, but the rest of the device is now the size of a thick smartphone.

An advantage held by DermaSensor, according to the CEO, is that the technology isn’t taking a surface-level photo of the mole. The pointed tip of the device is placed on the lesion and five scans of a mole are taken in a “point and click” manner. After that, DermaSensor’s proprietary algorithm provides a result in seconds instead of sending the spectral data to a lab or physician for review.

Simmons also pointed to important efforts from the American Academy of Dermatology related to improving physicians’ training with and assessment of skin color. He said that photo-based technologies used in Europe (none are FDA-cleared for use in the U.S.) also have challenges with darker skin types since most image datasets for algorithm training are on lighter skin types. Because DermaSensor’s technology takes samples of tissue beneath the skin surface at a cellular and sub-cellular level, rather than using visual surface-level photos, literature suggests that skin color has no impact on the device’s performance.

“You can do a surgical biopsy of a skin lesion, genetic testing of a skin lesion, or a patient or a primary care provider can use telemedicine by taking a photo of a lesion and send that to a dermatologist for their assessment,” Simmons said. “But, there’s no FDA-cleared product available in the U.S. right now that uses any kind of photo or optical approach to do a point-of-care assessment or test of a lesion and provide that point-of-care result to help inform the doctor. That’s what we’re focused on.”

Bringing DermaSensor to market

DermaSensor followed a unique path to market with its product, which received FDA breakthrough device designation in 2021 and has regulatory authorization in Europe, Australia and New Zealand.

The company has an ongoing commercial pilot effort in Australia, as the regulatory pathway for this type of device was different abroad, with early validation studies proving sufficient as clinical evidence for use there. Simmons said DermaSensor has received valuable insights from Australia, where the commercial team members jokingly refer to themselves as the “company guinea pigs.”

One in five people in the U.S. get skin cancer in their lifetime, compared to two of three in Australia.

“It’s a major public health issue in Australia,” Simmons said. “It’s leaps and bounds higher in Australia than anywhere else in the world.”

Of course, amid the effort to launch abroad, another public health issue emerged: COVID-19. Understandably, Simmons said, focus shifted to the pandemic. But, ahead of a potential U.S. launch, DermaSensor has recently heard back on the benefits of its technology.

“It’s been challenging for us as it could have been over a year of us selling and marketing our product,” Simmons said. “However, we’ve been able to do some in-person conferences in the last few months and we’ve gotten a lot of great, excited feedback from the physicians that have been using the device on many hundreds of patients.”

What’s next for DermaSensor?

With ongoing commercial efforts overseas and a push toward regulatory authorization stateside, DermaSensor’s future looks bright.

Still, the persisting issue of undetected skin cancer remains, and the current situation leaves plenty to be desired with high wait times for dermatologists. Simmons referenced a publication that found that just 15% of Americans report receiving a full-body skin cancer check in their lifetime.

“With wait times for dermatologists already being months long, just imagine if Americans actually became compliant with getting regular skin cancer checks from dermatologists,” Simmons said. “It would go from an overwhelmed system to being completely unfeasible.”

Putting DermaSensor in the hands of primary care physicians could alleviate those wait times and provide people with potentially life-saving cancer detection.

“Primary care physicians are not dermatologists. It’s not their expertise. It’s not their specialty. And they’ll be the first ones to tell you that the majority do not consider themselves as experts in skin lesion assessment and care,” Simmons said. “Equipping them with a tool that improves their performance and improves their detection rate can help get high-risk patients to dermatologists as quickly as possible.

“We think our product can have a big impact on a lot of these important outcomes.”