Penumbra, Inc. (NYSE: PEN) is a global medical device company focused on developing and manufacturing innovative technologies for the treatment of vascular and neurovascular blood clots.
Adam, since we last spoke, one year ago, Penumbra has launched its newest thrombectomy device, Lightning Flash 2.0. What are its features compared to the previous model?
The medical device field typically requires significant time to update products. However, Lightning Flash 2.0 was a software-only update, which significantly expedited the process. While we still underwent the FDA clearance process for this version of the product, the faster timeframe allowed us to bring impactful improvements to market much quicker. This upgrade is part of our ongoing evolution of computer-assisted vacuum thrombectomy (CAVT) products, where regular software updates can be expected.
The key improvement in Lightning Flash 2.0 is the fidelity of the software, which controls the aspiration process with remarkable speed and precision. The software ensures that aspiration activates only when the catheter is in contact with a clot and deactivates immediately when not, minimizing blood loss. This advancement has reduced procedure times drastically, particularly for pulmonary embolism cases. Procedures which took 45 minutes to over an hour can now be completed in as little as four to six minutes, revolutionizing both patient outcomes and the physician experience.
What feedback have you had so far from Lightning Flash 2.0’s users?
The feedback has been overwhelmingly positive. For existing users of the original Lightning Flash, the transition was seamless. Beyond that, we have observed a significant shift among users of older technology who are adopting our product. This growth underscores the increasing recognition of the advantages our CAVT technology offers.
In addition to Lightning Flash 2.0, we have recently introduced new products in the CAVT family, such as Lightning Bolt 6X with TraX and Lightning Bolt 12, which cater to specific vascular needs like below-the-knee arteries and smaller veins. These innovations expand the scope of our offerings and reflect our commitment to continuous advancement in medical technology.
You have recently launched Lightning Flash 2.0 in Europe too. What does that expansion entail for Penumbra?
We have recently launched Lightning Flash 2.0 and Lightning Bolt 7 in Europe. Early feedback has been promising, with anecdotal evidence suggesting significant reductions in ICU stays, resource usage as well as overall system costs due to faster and more efficient procedures. These benefits, already demonstrated in the U.S., will now be available to patients across Europe as we build our presence.
This expansion aligns with our broader mission to deliver innovative products that not only improve patient outcomes but also reduce healthcare costs—a rare combination. The reception thus far indicates a strong appetite for our technology in international markets, setting the stage for further growth.
How has the past year been for Penumbra in terms of financial results and attracting investments?
It is clear that the current environment rewards truly innovative ideas over less differentiated products. Less than 10 percent of the estimated 1.25 million people in the US who suffer from blood clot – head-to-toe - every year receive advanced treatment. That is why innovation remains at the heart of our success. Over the past year, we have not only expanded our vascular products but also achieved CE marks for five new products in the neuro and stroke domains, demonstrating our capacity to innovate at an accelerated pace so that we can help more people suffering from conditions like stroke or pulmonary embolism.
What do you hope for Penumbra to achieve in the coming year?
Our focus is on maintaining our reputation for relentless innovation. In addition to launching new products and expanding geographically, we aim to further refine our R&D processes, ensuring we remain a leader in medical technology. Our engineers, many of them in their 20s, bring with them exceptional passion and expertise, fueling our ability to consistently deliver transformative solutions.
As we look ahead, the goal is clear: to continue improving patient outcomes through better, faster, and safer medical devices. The work excites us, and we are optimistic about what is to come.