Surmodics (NSDQ:SRDX) announced data showing that its SurVeil drug-coated balloon is non-inferior to Medtronic’s In.Pact Admiral.
Eden Prairie, Minn.-based Surmodics’ 12-month data from the Transcend clinical trial, presented at the Leipzig Interventional Course 2021 virtual event, revealed primary results that found the SurVeil DCB is non-inferior to In.Pact Admiral in both safety and efficacy while delivering a “substantially lower” drug dose, according to a news release.
Transcend is a global, multi-center, randomized, controlled clinical trial with 1:1 randomization to SurVeil or In.Pact Admiral in patients with symptomatic femoropopliteal artery disease. Both DCBs use coatings with paclitaxel — a controversial drug that could cause a higher risk for death — although In.Pact Admiral has a 75% higher drug load of paclitaxel than SurVeil, Surmodics said.
The primary efficacy endpoint for the trial was primary patency — defined as a composite of freedom from clinically-driven target lesion revascularization and binary restenosis — at 12 months. The primary safety endpoint was freedom from device- or procedure-related death through 30 days and freedom from above-ankle amputation and clinically-driven target vessel revascularization within 12 months.
SurVeil was found to be non-inferior to In.Pact Admiral in both the primary safety and primary efficacy endpoints. In total, 91.7% of subjects (222 patients) reached the safety endpoints for SurVeil, compared to 89.6% in the In.Pact Admiral arm (224 patients). SurVeil saw 81.7% efficacy compared to 85.9% efficacy in the In.Pact Admiral arm.
“We are grateful to Dr. Rosenfield, co-principal investigators Dr. Marianne Brodmann and Dr. William Gray and all the physicians and coordinators for their commitment to this important first of its kind clinical trial during a worldwide pandemic,” Surmodics president & CEO Gary Maharaj said in the release. “Transcend demonstrates that achieving clinically safe and effective outcomes with a substantially lower dose of Paclitaxel is achievable with the SurVeil DCB, which sets a new standard with its proprietary coating technology and therapeutic choice for physicians and the patients that they treat.”
Needham analyst Mike Matson wrote that analysts expect the Transcend trial to lead to FDA approval and subsequent commercialization for SurVeil, followed by added revenue for Surmodics. They expect FDA approval as soon as late 2021.
Additionally, Matson’s conservative estimate sees SurVeil as potentially worth around $10 per share to Surmodics, leading Needham to list the company as a “buy” option.