Eden Prairie med-tech firm to lay off 13% of employees after FDA approval delay

Surmodics made the move after a letter from the Food and Drug Administration requesting more information and data about the company's new drug-coated balloon device.

February 3, 2023 at 10:24PM
Gary Maharaj, CEO of Surmodics, which is laying off staff after a delay in approval of one of its devices. (Surmodics/The Minnesota Star Tribune)

Med-tech company Surmodics Inc. said Friday that it plans to cut about 13% of its workforce to reduce its use of cash. The move is in response to a recent request from the U.S. Food and Drug Administration for more information about a device submitted for approval, slowing the approval process.

As of the end of September, Eden Prairie-based Surmodics had 447 employees. If that is still the case, a 13% cut would translate into 58 jobs. The cuts were disclosed on Friday in a filing with the U.S. Securities and Exchange Commission. The company said they started on Monday.

Surmodics disclosed on Jan. 19 that it received a letter from the FDA stating that its application for pre-market approval of a drug-coated balloon was "not currently approvable." The company's stock dropped 29% on the news that day.

In Friday's filing, Surmodics noted that the FDA's request on the premarket approval application for the SurVeil drug-coated balloon led the company "to reassess the timing of a potential related milestone payment that would be due following approval and subsequent commercial revenue related to its distribution of the product."

The milestone payment would come from med-tech giant Abbott, which has partnered with Surmodics on the SurVeil device.

Surmodics also has operations in Ireland. The company's specialty is coating technologies for intravascular medical devices.

Surmodics stock closed at $29.95 on Friday, up 13.5% from its drop two weeks ago. The document disclosing the job cuts was filed after the market closed.

The company's Friday filing indicated that the company planned to take $1 million to $1.2 million in restructuring charges for its second fiscal quarter.

about the writer

about the writer

Burl Gilyard

Medtronic/medtech reporter

Burl Gilyard is the Star Tribune's medtech reporter.

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