Thunderstuck: Penumbra's Thunderbolt Launch Delayed

Penumbra investors have been anticipating the launch of the Thunderbolt stroke treatment device like a storm chaser driving through Tornado Alley in May. But CEO Adam Elsesser took the wind out of their sails during the company's second-quarter earnings call when he said the clot removal device could be delayed by 12 months due to trial enrollment challenges. He emphasized, however, that the Thunderbolt is just one of several potentially paradigm changing stroke treatment technologies in Penumbra's pipeline.

One reason for the delay is that the first 100 or so patients took longer to enroll than initially predicted, although he said enrollment has accelerated as the trial has progressed.

"The second reason, the FDA asked us to modify the safety end point from 'all serious adverse events of 24 hours' to 'symptomatic ICH at 24 hours.' This request and change have not stopped enrollment in any way, but it does increase the sample size a little by about 75 patients, “Elsesser said. "This request was not related to anything specific to our trial or device but seems to be made in order to make our trial consistent with other stroke trials that are currently being run. And to our knowledge, those trials have also been pushed out for potentially similar reasons."

Elsesser disclosed the update informally during the question-and-answer portion of the earnings call, rather than in his prepared marks about the quarter. He said the company will formally update investors on the thunderbolt launch once details are finalized with FDA.

"But it might add another 12 months or so," he said.

As if to lighten the blow, the CEO emphasized that the delay allows the company to better penetrate the market with its Red 72 and Sendit devices. These represent the premium aspiration catheter and is as differentiated an innovation for the front end of the stroke intervention as Thunderbolt could be for clot removal once the catheters track to the face of the clot.

"The most important thing, again, I really, really want to stress this. ... the performance of our neuro business is not waiting for Thunderbolt," Elsesser said.