Surmodics has positive early results from thrombectomy system

Surmodics (Nasdaq:SRDX) today announced the successful early clinical use of its Pounce LP thrombectomy system.

Eden Prairie, Minnesota-based Surmodics designed the LP (low-profile) thrombectomy system for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. It performs this removal in vessels between 3.5 mm and 6 mm in diameter.

It introduced the original Pounce system in 2021, with the LP version receiving FDA clearance in June 2023. Pounce LP remains in a limited market evaluation and Surmodics expects a full commercial launch once it completes the evaluation.

Dr. Lucas Ferrer Cardona was the first physician to use Pounce LP. Cardona serves as a vascular surgeon at the Dell Seton Medical Center at the University of Texas Hospital. He said Pounce LP helped restore blood flow to the foot for a limb-threatened patient.

“I believe this device holds great promise in filling a major gap in our treatment algor…

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Surmodics has positive data on multiple drug-coated balloons

SurVeil drug-coated balloons [Image courtesy of Surmodics]Surmodics (Nasdaq:SRDX) today announced positive study results for two of its drug-coated balloon (DCB) technologies.

The company presented data supporting the SurVeil and Sundance DCBs at the 50th Annual VEITH Symposium in New York.

In the TRANSCEND trial, Surmodics evaluated the safety and efficacy of SurVeil versus the Medtronic In.Pact Admiral DCB. The trial evaluated the devices in the treatment of proximal popliteal artery lesions. Data came from 36 months of evaluation with 446 patients participating.

SurVeil received a long-awaited FDA approval in June of this year.

Surmodics’ SWING first-in-human study evaluated the safety and performance of the Sundance sirolimus DCB. The 35-subject study evaluated the DCB in the treatment of occlusive disease of the infrapopliteal arteries. Data came from 24 months of evaluation.

Sundance won FDA breakthrough device designation more tha…

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Surmodics launches new medical device coating technology

Surmodics (Nasdaq:SRDX) announced today that it launched its most advanced hydrophilic medical device coating technology.

Eden Prairie, Minnesota-based Surmodics designed the Preside coatings to complement its existing Serene hydrophilic coatings. Preside offers a unique, low-friction and low-particulate generation coating. It further enhances distal access for neurovascular applications and improves crossing for coronary lesions or chronic total occlusions.

Surmodics said it formulated Preside coatings to meet the challenge of achieving the right balance of lubricity and coating durability. It allows customers to leverage their existing coating processes, resulting in easy implementation in a manufacturing environment.

The company said it applies the coatings using its patented Photolink UV curing process. This process covalently bonds surface treatments to substrates at ambient temperature.

“Hydrophilic coatings are an essential feature to help …

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FDA approves Surmodics SurVeil drug-coated balloon

Surmodics (Nasdaq:SRDX) +  announced today that the FDA granted approval for its SurVeil drug-coated balloon (DCB).

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, th…

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FDA clears Pounce LP thrombectomy system from Surmodics

Surmodics (Nasdaq: SRDX) today announced that it received FDA 510(k) clearance for its Pounce low-profile (LP) thrombectomy system.

News of the regulatory nod comes just one day after Needham analysts upgraded Surmodics stock from “Hold” to “Buy.” The analysts cited positive developments pointing toward the likely approval of Surmodics’ SurVeil platform sooner than previously thought. As of March, the company expected FDA premarket approval for the SurVeil drug-coated balloon in the fourth quarter of 2023.

Mike Matson of Needham said analysts upgraded Surmodics’ stock because of the expectation for SurVeil as “a meaningful growth driver.” They predict the drug-coated balloon should bridge the gap until Sublime and the newly approved Pounce contribute to growth.

Shares of SRDX fell 1.4% at $25.95 apiece in midday trading today.

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Surmodics enrolls first patient in Pounce thrombectomy system registry study

Surmodics recently announced it enrolled the first patient in its Prowl registry study of its Pounce thrombectomy system.

Prowl is an open-label, retrospective, multi-center, U.S. registry of the Surmodics Pounce system for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. The registry aims to collect real-world efficacy and safety outcomes data for endovascular interventions. It will enroll up to 500 patients at up to 30 sites.

The first site to enroll a patient in the registry study was Baton Rouge General Medical Center in Baton Rouge, Louisiana. Dr. Sean Lyden, chairperson of the department of vascular surgery at the Cleveland Clinic, and Dr. Joseph Campbell, interventional cardiologist at OhioHealth, are national co-principal investigators.

“We are delighted to be the first site to enroll a patient in the Prowl registry,” Dr. Joseph Griffin, a vascular surgeon at the Vascular Specialty Center and Baton Rouge Gene…

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Surmodics is laying off roughly 60 workers

Surmodics (Nasdaq: SRDX) announced a restructuring that includes cutting 13% of the workforce at the Eden Prairie, Minnesota-based IVD tech developer.

In its most recent annual report, Surmodics listed a headcount of 447, which means the layoff could involve nearly 60 workers. The cost-reduction plan will save roughly $10 million to $11 million in cash for the remainder of the company’s fiscal year that ends Sept. 30, 2023, according to the company.

The move comes just weeks after the company revealed that the FDA had indicated that its Surveil drug-coated balloon was not approvable. Surmodics yesterday evening also reduced its full-year revenue guidance.

“We remain focused on making progress with respect to our regulatory strategy for the SurVeil DCB and are preparing to engage with the FDA to evaluate the appropriate path forward,” Surmodics CEO Gary Maharaj said in a news release.

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Surmodics announces regulatory delay for its SurVeil balloon
The FDA noted more information on biocompatibility and labeling is needed.

The FDA has indicated that Surmodics’ Surveil drug-coated balloon premarket approval application is not approvable.

According to an FDA letter to the company, Surmodics’ Surveil was not approved due to certain information in the biocompatibility and labeling categories. The governing agency said more information needs to be added by an amendment to Surmodics’ PMA application to place it in an approvable form.

Needham analyst Mike Matson said in an email that company management anticipated approval in the first quarter of 2023 to trigger a $27 million milestone payment from Abbott, $25 million of which would be considered revenue.

Get the full story on our sister site, Medical Tubing + Extrusion.

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Surmodics rises on mixed-bag Q1

Surmodics (NSDQ:SRDX) shares ticked up today on first-quarter results that were mixed compared to the consensus forecast.

The Eden Prairie, Minn.-based company posted losses of $274,000, or -2¢ per share, on sales of $22.3 million for the three months ended Dec. 31, 2020, for a bottom-line slide into the red on a sales decline of -1.4%.

Adjusted to exclude one-time items, earnings per share were 2¢, 11¢ ahead of Wall Street, where analysts were looking for sales of $22.4 million.

The company reached a major milestone in the quarter when 12-month data from its Transcend clinical trial showed that its SurVeil drug-coated balloon is non-inferior to Medtronic’s In.Pact Admiral.

“The entire Surmodics team is wholeheartedly pleased with the results of our Transcend clinical trial, which demonstrates comparable safety and effectiveness of our SurVeil drug-coated balloon using a substantially lower drug dose than the comparative product,” Surmodics presid…

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Surmodics’ DCB shown non-inferior to Medtronic’s In.Pact Admiral

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 a…

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