Investigator-Initiated Study
Support Request

Pre-clinical and Clinical Investigator Initiated Study Support Request Procedure

The Investigator-Initiated Study Review Committee (IISRC) considers requests for both pre-clinical and clinical study support including case studies/case reports.  The committee may award support (product, financial grants or a combination) to institutions, medical foundations, and professional societies whose mission includes public health treatment, scientific research and/or medical education.

For clinical studies, the investigator is responsible for obtaining IRB approval prior to Bioventus providing the initial product or grant support for the study.  For pre-clinical studies, the investigator is responsible for following relevant national ethical guidelines.  Both clinical and pre-clinical studies undergo an additional ethical review by the IISRC.

For new indication studies, the investigator is responsible for obtaining regulatory approval through the appropriate national body.  In the United States, approval for investigator-initiated IDE trials is provided by the FDA.

EXOGEN

  • Stress Fractures
  • Health Economic Outcomes Research (HEOR)
  • Foot and Ankle
  • Wrist/Hand
  • EXOGEN as adjunctive therapy post-surgery
  • EXOGEN in fractures with specific comorbidities
  • EXOGEN comparator studies (vs other bone stimulators)
  • EXOGEN use with bone void fillers/other biologics/biologic hardware

Hyaluronic acid 

  • Comparator HA studies
    • HA vs other HA products
    • HA vs other biologic therapies (PRP, Stem Cell)
  • Outcomes in non-indicated joints (for US, outside the knee)
  • Combination Therapies
  • Health Economics Outcomes Research (HEOR)
  • Pharmacoeconomic data
    • Adverse Event Costs
  • Duration effect and safety data
  • Safety and efficacy data of repeat dosing

Peripheral Nerve Stimulation

  • Knee Pain
    • Medial Knee Pain/Saphenous Nerve
  • Ankle and Foot Pain
  • Shoulder Pain
    • Failed Rotator Cuff Repair
    • Post-Stroke Shoulder Pain

Surgical – Bone Graft Substitutes

  • Case Studies/Reports
  • Bone Grafting – Spine Only

Surgical – Ultrasonics

  • Ultrasound Bone Cutting – Spine Only
  • Ultrasound Soft Tissue Aspiration

Each request must include:

  1. Name, address, contact information of PI
  2. Name and address of research institue/site
  3. Brief study synopsis including:
    • Product to be investigated
    • Type of support requested (product, funding, combination)
    • Estimated amount of product/funding support
    • Title of Study
    • Hypothesis/Objective
    • Type of Research (Pre-clinical, clinical)
    • Study Design
    • Estimated sample size/study population

Surgical

  1. Upon receipt of submission, if you are requesting funding, you may be requested to provide a basic budget overview

Please use link below to
Request support for a study