SRDX - Surmodics sinks as FDA declines to approve drug-coated balloon
- Surmodics, Inc. ( NASDAQ: SRDX ) shares approached a three-year low on Thursday after the MedTech company announced that the FDA said its premarket approval application for the SurVeil drug-coated balloon was not approvable in the current form.
- In a letter to the company, the agency recommended that certain information be added to the PMA application to make it approvable, Surmodics ( SRDX ) said, adding that the amendment would require additional testing and analysis.
- However, the FDA has not raised concerns about the human data the company has submitted nor requested additional human data.
- In light of the setback, Gary Maharaj, Chief Executive Officer of Surmodics ( SRDX ), said that the company is weighing options to cut its cash burn.
- “We are evaluating the issues raised in the FDA’s letter and plan to meet with Agency representatives regarding its contents,” Maharaj added.
- In October, Surmodics ( SRDX ) announced a five-year credit agreement with MidCap Financial to raise up to $100M in term loans and obtain a $25M revolving credit facility.
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Surmodics sinks as FDA declines to approve drug-coated balloon