Proxima works with emerging biotech and medical device companies across all phases of development.
As a contract research organization, we organize our team in two distinct areas: early stage advisory consulting and all-inclusive clinical trial services. The service you need. The speed you want. The attention you deserve.
Proxima Helps Puzzle Medical Receives U.S. Food and Drug Administration (FDA) Breakthrough Device Designation
Puzzle Medical's focus is to improve patient quality of life and reduce the global economic burden related to heart failure. Puzzle Medical is developing a proprietary transcatheter heart pump associated with minimal trauma to the blood components, allowing for safe and efficient heart support without open-heart surgery.
Proxima was instrumental to our success in getting breakthrough device designation for our product! The team was very knowledgeable and responsive and set us up for success. They made the FDA process easy to go through and prepared us for future interactions with FDA.
"Proxima has been attentive to a variety of our regulatory related needs. From coordinating studies with aggressive timelines to assisting with sales aid approvals, they have always delivered. As we launched our first in class/disease product, we needed a high touch clinical research and regulatory partner, and Proxima has provided that for us."
Founder & CEO
"Proxima staff understood the needs of our company and took a vested interest in supporting our clinical trial’s aggressive timeline while safeguarding our goals and objectives. Proxima has been a true partner for our early stage medical device startup!"