Leadership
Regulatory, clinical, and operational depth behind the device.
David Barthel
Chief Executive Officer & Director
25+ years as a global C-suite executive, leading capital raises, infrastructure, and the commercialization of DuraGraft.
Amar Dhaduk
Director of Business Development & Commercial Operations
10+ years in medical technology marketing and sales distribution; strategic global partnerships.
Marco Barron
Director of Clinical & Global Operations
20+ years directing clinical operations in the US and Europe; FDA and GCP compliance.
Joe Paparella
Director of Quality Assurance & Regulatory Affairs
20+ years of QA leadership in medical device and aerospace; 21 CFR 820 and ISO 13485.
Purna Kasha
Senior Principal Scientist, Technical Operations
18+ years in sterile device and drug product development, cGMP manufacturing, FDA/EMA compliance.
Cheryl Rosenberger
Director, Technical Operations
25+ years in pharmaceutical and medical device operations; analytical testing and CRO management.