Reaching a Milestone, Preparing for What’s Next
This quarter marks an important milestone for Cadence.
We recently received approval for our Investigational Device Exemption (IDE) application and are moving ahead to finalize research agreements with our institutional partners. While there is still work ahead, this milestone reflects years of effort by an incredible team and brings us one step closer to initiating a clinical study, which we currently anticipate later this year.
To put the scope of this work into perspective, our regulatory submission alone was thousands of pages long. Behind every page are years of planning, testing, documentation, and review—all designed to demonstrate a rigorous and thoughtful development process. It represents millions of dollars of investment, countless hours of work, and a shared commitment to moving at the speed of safety.
For us, this milestone is both exciting and humbling. It is not the finish line—it’s the beginning of an important new chapter.
Thank you for following our journey and for being part of the Cadence community.
With gratitude,
Kent Leyde
Chief Executive Officer
Cadence Neuroscience
Cadence Neuroscience is developing investigational medical technologies that have not been approved or cleared by the U.S. Food and Drug Administration (FDA) or other health authorities. Any forward-looking statements reflect current expectations and are subject to risks and uncertainties. Actual results may differ materially. This information is for educational purposes only and does not constitute medical advice or investigational device promotion. Patients should consult qualified healthcare providers regarding diagnosis and treatment options.
Currently, these investigational technologies are only accessible through participation in a clinical trial. To learn more about these investigational technologies and how to access them, talk with your qualified healthcare provider or visit www.clinicaltrials.gov.