Thank you, Needham & Company, for the opportunity to share our story with the executives, leaders, and investors who attended the 23rd Annual Needham Virtual Healthcare Conference.
Our CEO, Dave Marver, gave a presentation on progress towards our 2024 strategic objectives. Our highlights so far this year include:
⭐️ Our recent De Novo medical device application to the US Food & Drug Administration (FDA) for our first-of-its-kind investigational ARC-EX® System designed to restore upper limb function after spinal cord injury (SCI).
⭐️ Acceptance into the US FDA’s new Total Product Lifecycle Advisory Program (TAP), which provides us with streamlined US regulatory review for our investigational ARC-BCI™ System. We are the second brain-computer interface (BCI) company to be accepted into this prestigious program.
⭐️ We received our tenth Breakthrough Device Designation (BDD) from the US FDA for our ARC-BCI System based on clinical data from two human feasibility studies. This makes us the FIRST company in the world to receive breakthrough designation for a BCI paired with therapeutic stimulation.
⭐️ Our successful EUR 20M capital raise, led by EQT Life Sciences, Inkef, our CEO Dave Marver, and several members of our Board of Directors and Management Team.
We appreciate the opportunity to collaborate with digital health leaders and investors dedicated to supporting innovative solutions for the SCI Community.
*All ONWARD Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.
#EmpoweringMovement #SCI #Innovation
Vice President Interiors and Special Projects / Life Science at Lee Kennedy Company
2wCongratulations Peter! Way to go.