Tempe, Arizona–based Nectero designed its EAST system to treat patients with abdominal aortic aneurysm (AAA). These AAAs have a maximum diameter of 3.5 cm to 5 cm. The company plans to initiate a randomized, controlled Phase II/III clinical trial to evaluate its safety and effectiveness.
Nectero EAST features a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG). It delivers PGG locally into the aneurysmal wall where it binds to elastin and collagen. This strengthens the aortic vessel wall and potentially reduces the risk of further degradation.
The procedure requires no specialized tools and takes less than an hour to complete. It leaves behind no permanent implant and doesn’t preclude any future interventions.
Fast track designation enables companies developing novel technologies to engage in more meetings with the FDA. This ensures appropriate data collection, enables eligibility for accelerated approval and priority review and supports rolling review.
According to Nectero President and CEO Jack Springer, current available therapies only apply to patients in the highest-risk category.
“This designation reinforces Nectero Medical’s belief that the Nectero EAST system has the potential to address a large segment of patients who suffer from a serious progressive disease with no proven treatment options,” said Springer. “We are proud to be advancing a treatment that has the potential to impact so many lives and are extremely pleased that FDA acknowledged this through our designation.”
Nectero brings with it the backing of one of medtech’s major companies. In 2021, the company raised a $19.5 million Series C with Boston Scientific leading the round.
