Conference Day 2


9:25 am Chair’s Opening Remarks

  • Ken Mariash Chief Executive Officer, Sinpatica Therapeutics

Advancing Bioelectric Medicine Development & Adoption by Mitigating Against Reimbursement Barriers

9:30 am Tackling & Assessing Coverage


  • Understand customer’s needs: What do doctors need to see?
  • Determining the data required to demonstrate to insurers
  • Navigating the future landscape for coverage following the move towards efficiency

10:00 am Step by Step Approach to Position Bioelectric for Optimum Fundraising


  • De-risking bioelectric to be better suited for capital investment from real investors 
  • What is the clinical, regulatory, and commercial strategy so bioelectric medicines are more recognized? 
  • Comparing and contrasting implantable Vs non-implantable  

10:30 am Morning Break & Networking

11:30 am Roundtable Discussion: Reflecting on Experiences with Insurers to Establish Solutions


  • What is the process and reimbursement strategy for devices that don’t qualify as breakthrough?
  • Delving into devices which improve procedural workflow and enhance profitability but lack strong reimbursement qualifications
  • Payments out of DRGs Vs insurance companies

Reimagining Clinical Trial Design & Determining the Role of RWE to Maximize Device Development & Increase Likelihood of Approvals

12:00 pm Maximizing Impact of Data by Leveraging Clinical Studies & Real-World Evidence


  • Understanding nuances in different devices, mechanisms of action and intended use cases
  • Evaluating optimal dosing
  • Reviewing previous data and identifying lessons learned

12:30 pm Lunch Break & Networking

1:30 pm Lessons from the Front: Use of RWE in Indication Expansion for Devices


  • Reviewing FDA checklists for RWE
  • Determining the role of RWE for bioelectric medicine
  • Challenges in outcome selection: Comparator Group
  • Delving into the regulatory learnings using reflections and current processes

2:00 pm Roundtable Discussion: Optimizing Clinical Trials to Reduce Costs & Reduce Time Taken


  • Modifying trials for faster approval
  • Maintaining the integrity of the devices by not altering the parameters
  • Demonstrating robust models that could be leaned into to demonstrate proof of the clinical aspects

2:30 pm Afternoon Break & Networking

3:00 pm Approach Towards Designing Non-Invasive Bioelectric Medicine Studies for Alzheimer’s Disease


  • Discussing the combination of clinical and biomarker outcomes to demonstrate efficacy and proof of biology
  • Demonstrating target engagement
  • Highlighting the results of early human studies that helped establish elements of a larger pivotal trial

3:30 pm Roundtable Discussion: Clearly Defining the Disease Indication for Each Neuromodulation Device


  • Specifying the category within the ICD that the device fits under
  • How to approach the CDC to establish a new category?

4:00 pm Chair’s Closing Remarks

  • Ken Mariash Chief Executive Officer, Sinpatica Therapeutics