The primary component of a Phase 1 submission was a concept paper (15 pages maximum) that summarized the solution and proposed experiments.
The proposed solution needed to be a targeted neuromodulation therapy that is tunable, accurate, and precise. It needed to demonstrate an ability to quantitatively assess and control multiple on-target and related off-target effects. The submission described what the proposed solution is, what is already known about the solution’s approach, why it is impactful and innovative, and how the corresponding experiments will be conducted. While they did not need to adhere to a specific structure or order, concept papers should have responded to the stated prompts within each of the following four considerations:
Detail your proposed solution’s methodology for targeting and modulating autonomic functions in the peripheral nervous system.
Describe how your solution would be capable of achieving the targets outlined in the target performance considerations with any applicable evidence you are able to provide. Describe any potential off-target effects or adverse events associated with your solution, as well as your plans for mitigating them. Detail how you aim to monitor and evaluate performance outcomes in proof-of-concept studies.
Describe the potential therapeutic applications of your solution, including the specific condition(s) it may treat, and detail the benefits to patients or clinicians. In addition, describe how the findings and mechanisms identified by your solution may advance scientific understanding of neuromodulation.
Plans for development
Describe the current state of clinical maturity and development of your solution. Provide a plan for conducting proof-of-concept studies throughout the later phases of the competition, including the steps and resources needed to advance (e.g., budgets, personnel, equipment).