Points of Clarity - Clinical Programs

  • The purpose of Nu-Life clinical programs or initiatives are to demonstrate that Nu-V3 and the Nu-V3 program is comprehensive, safe, effective, simple to apply and easy to use.

  • Nu-V3 initiatives and clinical programs are Institutional Review Board (IRB) approved clinical trials and abide by all regulatory requirements and oversight by IRB, clinical principal investigators and our clinical team.

  • Although the Nu-V3 clinical programs are performed under strict regulatory standards, the clinical background and data necessary for FDA clearance has already been documented and finalized.  

The Clinical Program Design

The Nu-V3 clinical program design is . . .

Program & Initiative Objectives

The objectives for the Nu-V3 initiatives and clinical programs are . . . 

Initiatives and Regulatory

It's important to understand how the clinical programs relate to regulatory clearances.  While regulatory agencies often require clinical data to determine the safety and effectiveness of a product or technology, the Nu-V3 clinical programs are strictly designed to demonstrate how Nu-V3 works for those who are considering treatment or recommending treatment.  For Nu-Life's FDA clearance submittal, all clinical data has already been collected and finalized.

IRB Trial Guidelines 

The Institutional Review Board (IRB) that Nu-Life has engaged to approve Nu-V3 for clinical trial is licensed by FDA for the purpose of assuring patient safety and adherence to regulatory standards.  Nu-Life has a very specific IRB strategy which is designed to coincide with Nu-V3's indications for use and patient populations so the greatest number of people may be treated under our foundational regulatory approvals.

The Nu-Life regulatory strategy has been designed specifically to meet the goals and objectives for Nu-V3 in the United States as well as the regions of Europe, Japan, Latin America and Canada, all of which carry their own specific regulatory requirements.

To view our major points of clarity with regard to the Nu-Life regulatory strategy, please click below.