Joshua Woolley

About Joshua Woolley

Medical device leader who shapes the future of cardiac care by uniting clinicians…

Experience

1. Vice President Clinical and Regulatory Affairs

   Aria Cv, Inc

   Jun 2023 — Present

   The Aria Compliance System is a novel implantable device for the treatment of pulmonary hypertension, a $10B market. The device restores compliance to the pulmonary artery, reducing right ventricular afterload and increasing cardiac output. The increased blood flow improves pulmonary hypertension symptoms decreases heart strain. The Aria CV ASPIRE PH trial treats patients in WHO Groups 1, 2 and 3. This is the only implantable pulmonary hypertension device, creating a new field of therapy- Develop and execute innovative clinical and regulatory strategies to support the success of the restarted FDA EFS trial and upcoming pivotal trial. Employ deep knowledge of EFS trial and early stage company strategy to drive site engagement and patient enrollment- Primary interface with Aria CV Board of Directors for clinical and regulatory strategy- Lead all FDA EFS clinical trial activities, including budget responsibilities, team building and development, KOL engagement and site interactions. Design upcoming clinical studies through to execution, working with product development to ensure success. Utilize extensive clinical experience to lead physician training and device implants in order to improve the lives of patients suffering from pulmonary hypertension- Develop and execute the company\'s regulatory strategy to achieve commercialization and physician acceptance. Align trial design and endpoints with reimbursement and market strategy.