Company History

As two leading entrepreneurs and investors in health technology companies, Dr. Maurice Ferre (Co-founder and Chairman) and Christopher Dewey (Co-founder) came to believe that skin cancer is primarily a public health issue that could be addressed by improving access to quality skin cancer care. Due to the limited number of dermatologists, their goal was to use cutting-edge spectroscopy and machine learning technologies to improve frontline providers ability to detect skin cancer early.

They founded DermaSensor in 2009 following discussions with Dr. Irving Bigio, Professor of Biomedical Engineering at Boston University and one of the top spectroscopy researchers in the world. Dr. Bigio is the original inventor and patent holder for Elastic Scattering Spectroscopy (ESS), a key technology employed by the DermaSensor device.

Since Professor Bigio's invention of ESS in 1994, there have been several hundreds of publications on ESS and over 30 publications on the use of ESS in clinical studies. DermaSensor began its own skin-specific studies using this technology in 2011 and began its first study on the current commercial device in 2018.

DermaSensor Device History
The DermaSensor technology has significantly improved over the last twelve years, from the ten kilogram, second-generation system pictured at left to the current one kilogram, fourth-generation commercial product pictured at right

DermaSensor Development History

1994
ESS invention by collaborator Professor Bigio
2009
Company founded
2011
Start of algorithm training study for melanoma with 30-pound 1st-gen devices
2015
Start of algorithm training study for all skin cancers with 2nd-gen devices
Raised cumulative $5.5M
2018
Completion of 4th-gen devices, start of DERM-ASSESS II validation study for CE Mark
Raised cumulative $17M
2020
CE Mark, TGA and WAND listings; Start of FDA pivotal study
2021
Completion of DERM-ASSESS II utility study, DERM-ASSESS III, and PATIENT-SELECT validation studies
2022
Completion of FDA pivotal study with over 1,000 subjects

Strong Results from Five Recent Clinical Study Readouts

1

97% skin cancer detection sensitivity1,2


DERM-ASSESS II Clinical Validation Study

169 cancers

2

3X as many cancers missed without device use3


DERM-ASSESS II Clinical Utility Study

57 physicians

3

98% Negative Predictive Value (NPV)2,4,6


DERM-ASSESS III Validation Study

88 melanomas

4

99% NPV, 60% PPV for high spectral scores2,5


PATIENT-SELECT Validation Study

156 subjects

5

96% skin cancer sensitivity2


DERM-SUCCESS FDA Pivotal Study

224 cancers

Optical Spectroscopy

Building a Groundbreaking
Device

DermaSensor was founded in 2009 to improve patient access to effective skin cancer assessments. By harnessing the power of elastic scattering spectroscopy (ESS) we created the world's first skin tissue sampling system that uses hundreds of different wavelengths of light to painlessly and non-invasively scan skin lesions. We use the light to detect properties consistent with malignancy at a cellular and subcellular level. It's like an ultrasound, but using light instead of sound.

When it was first developed, ESS technology was the size of a microwave oven. Today, thanks to a decade of our team's engineering advancement, you can hold it in the palm of your hand.


Algorithmic Analysis

Harnessing the
Power of AI

Even with cutting-edge ESS technology, there was no way to assess lesions objectively and efficiently. That's why we developed an algorithm using machine learning. To build it, we collected thousands of dermatopathology-confirmed malignant and benign tissue samples. Then we compared the spectral data to the pathology report, testing and fine-tuning the algorithm in a process that continues today, as we constantly indentify and analyse new data, providing ongoing updates to our DermaSensor users.

Today, thanks to our proprietary DermaSensor algorithm, our device processes spectral data in a matter of seconds, rather than waiting days for a physician or labratory to return results.

1Benvenuto-Andrade C, Manolakos D, Cognetta AB. Safety and Effectiveness of Elastic Scattering Spectroscopy and Machine Learning in the Evaluation of Skin Lesions. Poster Presentation, World Congress of Teledermatology, Dec 5-7th 2021.

2Algorithm v3.0 results have not yet been published for this study, Data on file, DermaSensor Inc.

3Tepedino K, Tablada A, Barnes E, Da Silva, T. Clinical Utility of a Handheld Elastic Scattering Spectroscopy Tool and Machine Learning on the Diagnosis and Management of Skin Cancer by Primary Care Physicians. Poster Presentation, SDPA Fall Conference, Nov 4-7, 2021.

4Melanoma sample size includes highly atypical melanocytic nevi

5PPV for spectral score group 8-10.

6DA III- Hartman, R. Tepedino, K., Fung, MA., McNiff, JM., Grant-Kels, J. Clinical Validation of a Handheld Elastic Scattering Spectroscopic Device in the Evaluation of Lesions Suggestive of Melanoma, Presentation at the American Academy of Dermatologists Annual Meeting, Mar 24-28th, 2022.

Learn more about our groundbreaking device.

80-0006.5 v2

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