- What is SPAS System's primary focus?
- SPAS System is focused on the development and commercialization of a stent positioning assistance system (SPAS) for safer and faster percutaneous coronary intervention (PCI) procedures.
- What is the purpose of the SPAS device?
- The SPAS device is a torque-like accessory designed to allow accurate, mm-precise stent positioning, minimize geographical misses, and enable stent manipulation and placement without impairing the PCI workflow.
- What is the classification of the SPAS device?
- SPAS is classified as a class 2a medical device.
- Has the SPAS device undergone clinical validation?
- Yes, SPAS has been validated on-bench, in silico as the angio system for Simbionix, and in multiple clinical settings by industry leaders in Europe, Israel, and Russia. A 55-patient first-in-human multicenter clinical study in Israel reported no device-related adverse events.
- What were the results of the first-in-human clinical study for SPAS?
- A 55-patient first-in-human multicenter clinical study conducted in Israel returned no device-related adverse events. All five investigators reported that SPAS improved their ability to control stent deployment and achieve better accuracy in positioning, with high overall mean operator SPAS accuracy and satisfaction scores.
- When was SPAS System founded?
- SPAS System was founded in February 2019.
- What is the current employee count for SPAS System?
- SPAS System has 1-10 employees.
- What is SPAS System's current funding stage?
- SPAS System is currently in the Pre-Funding stage.
