The INNODERM Project

The Mission

INNODERM is an EU funded project that brings together the expertise of Small and Medium Size Enterprises (SMEs) and academic partners the Technical University of Munich (TUM)Humanitas University Milan (HUNIMED)iThera Medica GmbHRayfos Ltd, and Sonaxis SA in the fields of photonic and ultrasound technologies. The goal of INNODERM has been to develop a novel Raster-Scan Optoacoustic Mesoscopy (RSOM) device to improve non-invasive diagnostics for skin cancer and other dermaological conditions. 

RSOM is based on Multispectral Optoacoustic Tomography (MSOT), a proven imaging method that generates high-resolution optical images in scattering media and dramatically improves upon conventional bio-optic barriers by enabling (1) three-dimensional high-resolution optical imaging deep inside tissues (up to several centimeters), (2) high-scalability, ranging from optical-resolution microscopy to acoustic-resolution optical mesoscopy and macroscopy, and (3) novel label-free anatomical, physiological and molecular contrast at the tissue and single-cell-level, based on spectrally-resolved optical absorption. MSOT technology is commercialized by iThera Medical for macroscopy imaging, while RSOM was developed to image features at the meso- and micro- scopic levels. 

INNODERM aimed and succeeded to design, manufacture, and validate the technical viability of a handheld, portable, scalable label-free RSOM prototype for point-of-care applications in dermatology diagnostics and skin disease monitoring. RSOM goes beyond the abilities of other current optical or optoacoustic devices and offers a paradigm shift in dermatology imaging.

Demonstration of clinical RSOM imaging system. Video courtesy of iThera Medical GmbH. 

tumor 01-1
RSOM image of tumor vasculature in a mouse model.

Objectives

INNODERM has four primary objectives, which are to:

1. Design a scalable clinical RSOM prototype;
2. Validate RSOM ability to clinically resolve novel diagnostic and theranostic morphological and spectral features;

3. Quantitatively measure improvements in disease detection and monitoring; and,
4. Develop and update of an exploitation plan for RSOM market introduction.

During the project and development of RSOM, many technological, clinical and scientific breakthroughs have occurred including the: ability to perform high-resolution optical imaging at depths not possible by other optical methods, development of unique, label-free optical absorption contrast mechanisms, ability to image high-contrast vascularization/angiogenesis, the quantification of tissues, lesions, and individual blood vessel oxygenation/deoxygenation, and ability to imaging microvascular changes for disease monitoring.

The consortium has not faced any major innovation barriers as RSOM technology utilizes non-ionizing safe technology that operates within the safety limits established by the ANSI, with which many volunteers and patients have been scanned across Europe and the world. INNODERM has already marketed RSOM as a research device and it is currently in clinics being used to showcase the value of the technology to key stakeholders (physicians, cancer lobby groups, hospital administrators, private care enterprises, insurance companies, dermatology industry) and patients. RSOM is currently in the regulatory approval process to recieve CE marking as an electromechanical devices for clinical settings.