Dive Brief:

• Development of Penumbra’s brain clot removal device has hit another setback, with a regulatory request to change a study endpoint delaying the program by an estimated 12 months, the company said.
• Penumbra accelerated enrollment in its study of the Thunderbolt device after a slow start, only for the U.S. Food and Drug Administration to hold up progress with a request that will increase the sample size by about 75 patients.
• The delay pushes back “a meaningful new product catalyst,” analysts at William Blair wrote in a note to investors, but the performance of Penumbra’s existing stroke devices could offset the absense of Thunderbolt sales.

Dive Insight:

Penumbra CEO Adam Elsesser discussed the changing Thunderbolt timeline in a recent interview with MedTech Dive. While investors knew the study was running behind schedule, the length of the delay was a surprise. The longer duration of the delay stems from Penumbra contending with two different problems.

“The first roughly 100 patients ... took a little longer to enroll due to the required eight-hour window, but we have seen enrollment accelerate now as the trial has progressed,” Elsesser said on a quarterly results call with investors. “The second reason, the FDA asked us to modify the safety endpoint. This request and change has not stopped enrollment in any way, but it does increase the sample size a little.”

Originally, Penumbra selected all serious adverse events in the 24 hours after the procedure as its safety endpoint. Now, the FDA has asked the company to change the safety endpoint to symptomatic intracerebral hemorrhage (ICH) at 24 hours, Elsesser said. Penumbra is still figuring out the impact of the request, but Elsesser said he thinks it “might add another 12 months or so” to the trial.

Elsesser framed the delay in the context of Penumbra’s broader stroke portfolio, telling investors that “there is a terrible misunderstanding if anyone thinks what I'm saying about Thunderbolt is a negative.” Demand for the Red 72 reperfusion catheter with SENDit Technology helped Penumbra to grow sales of neuro products by 28% to $108.8 million in the second quarter. 

With Red 72 driving growth, Penumbra reaffirmed its guidance for the next three years despite pushing back the start of Thunderbolt sales.

“Now, at face value this isn’t a positive; however, Red 72 with SENDit is performing very well and driving positive mix and gaining share,” J.P. Morgan analysts wrote in a research note. “This is the platform that Thunderbolt will work with, meaning that once it is approved, it can drive further mix and share gains again in late 2024-2025. Not the best case, but there is a silver lining.”