Eden Prairie, Minnesota–based Surmodics may now market and sell SurVeil in the U.S. for percutaneous transluminal angioplasty. Use follows appropriate vessel preparation or de novo or restenotic lesions in femoral and popliteal arteries. These arteries feature reference vessel diameters of between 4 mm and 7 mm.
Shares of SRDX rose more than 11% to $28 apiece by late morning trading today on the news. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly.
SurVeil received CE mark in Europe in June 2020. However, regulatory approval proved harder to achieve in the U.S. In January, the FDA indicated that Surmodics’ SurVeil PMA application was not approvable. The company received formal feedback from the agency in March, then gave the FDA a proposed approach to submit an amended premarket approval application. Surmodics said at the time that it targeted approval in the fourth quarter of 2023.
Analysts just last week upgraded Surmodics stock to a “Buy” rating as rumblings of the coming approval grew louder. The company also picked up FDA 510(k) clearance for its Pounce low-profile (LP) thrombectomy system.
Needham’s Mike Matson pointed out that the FDA did not require additional testing, enabling Surmodics to submit its amended application in May. He said the Needham team expects SurVeil to “be a meaningful growth driver and to help bridge the gap until the Sublime and Pounce products materially contribute to growth.”
“Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history,” said Gary Maharaj, president and CEO of Surmodics. “It represents a major milestone in our efforts to develop next-generation products to help millions of people affected by peripheral artery disease and the physicians that treat them. I would like to thank our internal SurVeil DCB team and our external advisors, investigators and partners for their multi-year efforts to make this achievement possible.”
More about the Surmodics SurVeil DCB
SurVeil utilizes best-in-class technology to treat peripheral artery disease (PAD). It includes a proprietary drug-excipient formulation for a durable balloon coating, according to Surmodics. The company says it manufactures the system using an innovative process that improves coating uniformity.
Abbott holds exclusive worldwide commercialization rights for SurVeil. Surmodics will manufacture and supply the product, realizing revenue from product sales to Abbott. It also receives a share of profits from Abbott’s third-party sales.
Surmodics said its agreement with Abbott includes the receipt of a $27 milestone payment now that the FDA approved SurVeil. The company expects approximately $24 million to $24.5 million in revenue related to that payment in the third quarter.
“Building on our recent progress, Surmodics remains focused on supporting Abbott and its exclusive worldwide commercialization rights for the SurVeil DCB,” Maharaj added. “We’ll discuss details on the developments and update our fiscal year 2023 financial guidance during our third quarter earnings call.”
The size of the global drug-eluting balloon catheters market could nearly quadruple to $916 million by 2028, according to Global Market Insights. Medtronic and Boston Scientific are among a host of companies active in the space.
SurVeil holds up against market leader
Surmodics said 24-month clinical trial results demonstrated SurVeil’s sustained durability in safety and efficacy outcomes. It also remained non-inferior to the market-leading In.Pact Admiral from Medtronic. The company noted that SurVeil features a “substantially lower drug dose.”
At 24 months, 81.8% of subjects treated with SurVeil met the secondary safety endpoint. That was defined as a composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically driven target vessel revascularization (CD-TVR). In.Pact Admiral saw 83.2% of subjects reach that endpoint.
Less than 15% of patients in both arms required repeat revascularization procedures. One patient in the In.Pact group required major leg amputation, Surmodics said.
Primary patency for SurVeil totaled 70.8%, compared to 70.4% for In.Pact Admiral.
Both DCBs use paclitaxel drug coatings, Surmodics said. In.Pact Admiral features a 75% higher drug load than SurVeil (3.5 µg/mm² vs. 2.0 µg/mm²). Surmodics says it designed SurVeil to provide a more uniform drug distribution, better efficiency of drug transfer and fewer downstream particulates and downstream emboli.
