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OBJECTIVES

OBJECTIVES

  1. Design of a scalable clinical RSOM prototype
  2. Validation of the RSOM ability to clinically resolve novel diagnostic and theranostic morphological and spectral features
  3. Quantitatively measure improvements in disease detection and monitoring
  4. Development and update of an exploitation plan for RSOM market introduction

TECHNOLOGY BREAKTHROUGHS

  • High-resolution optical imaging, deeper (~5 mm) than all-optical imaging methods
  • Unique label-free optical absorption contrast mechanisms
  • High-contrast imaging of vascularization / angiogenesis
  • Quantification of  tissue, lesion and individual blood vessel oxygenation / deoxygenation
  • Imaging of micro-vessel blood flow; imaging of blood-volume

INNOVATION CHALLENGES

RSOM technology utilizes non-ionizing safe technology which has already been applied to humans. Today more than 200 volunteers and patients have been scanned across Europe using (low-frequency) optoacoustics without any adverse effects or indications. A smaller number of volunteers have been also scanned with RSOM without any adverse indications. INNODERM wishes to reach a technological maturity that will drive RSOM into the clinics and showcase the value drivers of the technology to key stakeholders (physicians, cancer lobby groups, hospital administrators, private care enterprises, insurance companies, dermatology industry) after validation in real-settings. RSOM will operate within the safety limits established by ANSI for human use. Therefore, we do not anticipate regulatory barriers beyond the regulatory approval process typical in the use of electromechanical devices in clinical settings as determined by CE markings. Nevertheless, we will inspect for effects of light on tissue (toxicity, other). In addition, provisions are taken to receive advice from notified bodies (e.g., TÜV), in order to ensure developments according to European and medical safety regulations for a medical technology, as it associates to market approval and safety.