By Nancy Dahlberg

On the road to bringing its first device to market, DermaSensor, a Miami-based health-tech company designing tools to better equip primary care providers for skin cancer checks, today announced it has raised $11.5 million in a Series A Preferred Stock financing.

The round was led by Dr. Maurice R. Ferré, David Matlin, Chris Dewey and SternAegis Ventures. Ceros Financial Services acted as exclusive placement agent for a significant portion of this Series A financing. The round also included the Miami Angels. This brings the company’s total funding to date to $17 million.

With about 20% of Americans diagnosed with skin cancer, DermaSensor developed an affordable product designed to help the more than 200,000 primary care providers in evaluating patients with suspicious moles. The majority of Americans have never been checked for skin cancer.

“We expect our device, with its ability to assess a lesion in under 30 seconds using objective spectroscopy and machine learning technology, to become a standard tool of the trade in primary care,” said CEO Cody Simmons in a statement. “99% of melanoma is curable if detected early, and we want to equip primary care providers since they’re well positioned to play an important role in early detection.”

The new funding round will be used for finishing clinical submission work for the FDA, the company’s upcoming commercial efforts abroad and product development work, Simmons said in an interview with Refresh Miami.

“DermaSensor is poised for strong adoption in the market with its novel, patented technology and demonstrated, industry-leading performance,” said Ferré, DermaSensor’s chairman and a lead investor. “We’re pleased to support the next step of launching this device commercially to benefit physicians and their patients.”

A multi-center, prospective clinical study was recently published showing that DermaSensor’s automated spectroscopy and machine learning technology achieved a sensitivity of 100 percent for detecting melanoma and 94 percent for detecting non-melanoma skin cancer, Simmons said. The results are from an independent test set of 126 skin cancers and are separate from the company’s pivotal study for the FDA.

DermaSensor is preparing to submit to FDA for pre-market clearance and is near completion for the CE Mark. While the COVID crisis has slowed down some clinical studies, the company expects to pilot its flagship device commercially this summer outside of the United States. As medical devices usually are, it’s been a long road to commercialization, and the company has  has spent the last several years miniaturizing its spectroscopy technology into a hand-held device. In 2011, the technology was the size of a 30-p0und suitcase

How the product works: A physician gently touches the non-invasive device tip to a selected mole, and a spectral sensor records how dozens of wavelengths of light reflect off cells beneath the surface of the skin. A proprietary algorithm instantly analyzes the reflected photons to provide a simple “Higher Risk” or “Lower Risk” output that supports a physician’s referral decision, converging the powers of machine learning and clinical evaluation.

DermaSensor was co-founded by Ferré, a medical device industry veteran who sold MAKO Surgical and is now running  INSIGHTEC heavily backed by Koch Disruptive Technologies. Simmons worked in Silicon Valley at Genentech and a couple of health-tech startups before joining DermaSensor in 2016 as CEO.

Today, DermaSensor is a team of 11, and Simmons expects to hire a couple more people for the upcoming overseas launch. DermaSensor has a number of Miami ties. Its manufacturing work is being done  by Nikao, a Weston company Simmons was connected to through eMerge Americas, and it’s a client of the Miami-based law firm Private Advising Group. Also, Simmons was a finalist for the Rise of the Rest competition last May.

“After a decade-long clinical and product development road to now finally soon launching a product commercially and getting through the necessary hurdles with regulators, we are very excited to get this first ever cancer device developed specifically for primary care providers launched into the world,” said Simmons. “It’s all about improving access to effective skin cancer checks and we think a quick, easy to use, low cost tool with high performance like ours can be a game changer for that.”

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Nancy Dahlberg
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