REPORT/RECOMMENDATION TO THE BOARD OF SUPERVISORS
OF SAN BERNARDINO COUNTY
AND RECORD OF ACTION
September 23, 2025
FROM
ANDREW GOLDFRACH, ARMC Chief Executive Officer, Arrowhead Regional Medical Center
SUBJECT
Title
Revenue Clinical Trial Agreement with Aveera Medical, Inc. for a Study
End
RECOMMENDATION(S)
Recommendation
Approve a Revenue Clinical Trial Agreement with Aveera Medical, Inc., including non-standard terms, for participation in the Pivotal Multi-center Trial of the Boomerang Catheter for Percutaneous Deep Vein Arterialization study, effective upon execution and continuing until completion of study-related activities.
(Presenter: Andrew Goldfrach, ARMC Chief Executive Officer, 580-6150)
Body
COUNTY AND CHIEF EXECUTIVE OFFICER GOALS & OBJECTIVES
Provide for the Safety, Health and Social Service Needs of County Residents.
FINANCIAL IMPACT
Approval of this item will not result in the use of Discretionary General Funding (Net County Cost) as this Clinical Trial Agreement (Agreement) with Aveera Medical, Inc. (Aveera) is a revenue-generating agreement. Depending on the number of participants and the durations of each visit, Arrowhead Regional Medical Center (ARMC) will receive revenue ranging from $300-$650 and up to $7,000 for initiating the study and International Review Board (IRB). ARMC is expected to receive sponsor payments over the term of the study, based on anticipated patient enrollment.
BACKGROUND INFORMATION
The Agreement with the Aveera will enable ARMC to participate as the 17th U.S. site in a multicenter clinical trial for "Assessing the Safety and Efficacy of the Chronic Limb-Threatening Ischemia (CLTI) Treatment Using the Boomerang(tm) Catheter". CLTI is a severe vascular condition caused by inadequate blood flow to the legs and feet, often leading to rest pain, non-healing ulcers, gangrene, and ultimately limb amputation.
The purpose of the clinical trial is to evaluate the safety and effectiveness of the ...
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