A novel approach to non-invasive and personalized skin cancer diagnosis

Project Information

OCTAV

Grant agreement ID: 850006

DOI

10.3030/850006

Project closed

EC signature date 24 April 2019

Start date 1 September 2019

End date 31 August 2022

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 485 857,00

EU contribution

€ 2 400 000,00

Coordinated by

DAMAE MEDICAL
France

Periodic Reporting for period 3 - OCTAV (A novel approach to non-invasive and personalized skin cancer diagnosis)

Reporting period: 2021-09-01 to 2022-08-31

Summary of the context and overall objectives of the project

French SME-company DAMAE Medical is facing skin cancer worldwide issue by developing the deepLive™ Project, a new approach to dermatological diagnostic based on a disruptive Line-field Confocal Optical Coherence Tomography (LC-OCT) technology, in a novel hand-held imaging device.
deepLive™ is designed to capture in situ images of the skin layers with a cellular resolution. It is used in conjunction with dermoscopy to provide more accurate diagnosis, leading to fewer biopsies of benign lesions and earlier detection of melanoma and non-melanoma skin cancers. It may also guide the surgery to provide more accurate presurgical margins, preventing unnecessarily large scars and reducing the risk of recurrence.
Correlatively, DAMAE is developing a full software solution, based on a data storage cloud-platform, a computer-aided software designed to assist dermatologists with deepLive™ image interpretation, as well as telepathology and patient services. deepLive™ device will initially be used by clinicians as a routine easy-handling diagnostic device in public practices. Implementation of deepLive™ software will enable its adoption by a much larger market, consisting of private practices dermatologists. The approach will contribute to the development of skin cancer risk patient awareness, while changing the current paradigm through a timely, performant, and non-invasive approach, and releasing the financial burden on the healthcare system.
Project deepLive™ has successfully completed in 2017 a feasibility phase covered by the SME Instrument Phase 1, resulting in a TRL6 prototype of the technology and a first consolidated atlas of skin cancer clinical images. The main objective of this Phase2 is to scale-up the deepLive™ solution to TRL9 through industrialization activities and by achieving a definitive market assessment, the clinical validation and the regulatory approval, before deploying the approach worldwide.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Following scientific demonstration of the concept in 2014, years of research and development was conducted by DAMAE Medical multitalented team of experts – in biophotonics science; optics, mechanics and system engineering; user experience and industrial design; software development and image processing. A close collaboration with Key Opinion Leader expert dermatologists allowed to perform iterative end-users clinical testing, to deliver a device that is suitable for an easy integration into hospitals, clinics and dermatology practices. A last run of industrialization activities led to the CE-marking of deepLiveTM device in 2020. DAMAE Medical is currently scaling-up its production activities to support the first step of commercialization to clinicians, in academic centers.
deepLive™ is a Class I medical device according to the directive EC 93/42/CEE and is indicated for the imaging and characterization of multiple skin conditions in human adults. With the combination of 3 imaging modes – vertical, horizontal, and 3D – deepLive™ enables the dermatologist to visualize the epidermis and dermis in real-time; and get a better understanding of skin pathologies at the cellular level, thus accelerating their management, and facilitating access to non-invasive diagnostics and treatments.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

DAMAE Medical's strategic objective is to provide tools that will help reduce the financial and societal impact of skin. It is implementing a new approach and new models that will initiate a real shift in the way skin cancer is diagnosed.
Multicentric clinical trials are being conducted with expert dermatologists throughout Europe, who are using deepLive™ to assess and validate performances of LC-OCT-based skin pathologies diagnostics. Clinical results were and will continue to be published in dermatology journals.
Moreover, 3D imaging capabilities at this level opens the way for leveraging from the potential of the finest image analysis technologies, providing access to robust algorithms for segmentation and quantification of skin microstructures, thus facilitating LC-OCT-based therapeutic decisions of non-expert dermatologists.

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