Report
Teaser, summary, work performed and final results
Periodic Reporting for period 1 - RetinArt (Clinical biomarker for arterial hypertension based on micro-vascular retinal imaging)
Teaser
Cardiovascular diseases (CVDs) are the leading cause of death in industrialized countries. Despite significant medical advances, a large proportion of serious events are not predicted by traditional risk factors. In many cases, irreversible damage to organs is preceded by...
Summary
Cardiovascular diseases (CVDs) are the leading cause of death in industrialized countries. Despite significant medical advances, a large proportion of serious events are not predicted by traditional risk factors. In many cases, irreversible damage to organs is preceded by structural alterations in small blood vessels. Unfortunately, so far there has been no technique available for detecting such alterations in the clinic. To answer this need, Imagine Eyes invented a non-invasive imaging system that analyzes microscopic alterations in retinal arterioles. For the first time, physicians can easily obtain biomarkers of micro-vascular integrity. This spectacular advance has been enabled by adaptive optics, a technology derived from astrophysics. The company now intends to validate that its micro-vascular biomarker assessment technique can help to significantly reduce the morbidity and mortality caused by CVDs.
Work performed
Imagine Eyes has undertaken the RetinArt project in order to verify feasibility and define a validation program, while taking into account medical, technical, regulatory, industrial and marketing commercial aspects.
Final results
Throughout RetinArt, feedback from clinical partners has driven Imagine Eyes to develop a significantly upgraded system that was successfully tested and CE marked. A separate evaluation of the product and manufacturing process by industry specialists has enabled planning further design optimization and industrialization tasks. Exchanges with CE-mark and FDA experts have resulted in defining clear milestones for the company’s regulatory plan. A preliminary study of the reimbursement landscape has also contributed shaping the company’s market access strategy.
Pilot clinical studies have delivered substantial findings: the new assessment technique appeared reproducible, highly sensitive for tracking short-term therapeutic effects, and strongly predictive for CVDs. Moreover multiple interviews of medical experts have indicated strong interest in the cardiology and neurology areas, in addition to ophthalmology. These discussions have also led to define the investigations needed for full clinical validation.
The project results have confirmed that Imagine Eyes’ micro-vascular biomarker assessment technology has a huge potential for lifesaving applications in cardiology and neurology. The clinical validation defined in RetinArt will be a key step for establishing a new standard of care that may benefit millions of patients.