Farapulse, Inc.

Boston Scientific’s electrophysiology business stumbled as competition from Medtronic, Johnson & Johnson, Abbott, and others in the pulsed-field ablation (PFA) space intensified. Marie Thibault, a BTIG analyst, wrote, “The closely watched electrophysiology segment missed consensus by $33 million, confirming investor fears.” Because of the sales miss, BTIG analysts readjusted their forecast for the electrophysiology segment. “We reduce our electrophysiology revenue forecast and increase our ICVT outlook,” Thibault wrote. “We now model 17% year over year worldwide sales growth for EP, reflecting estimates for 13% U.S. year-over-year EP sales growth and 25% OUS year-over-year EP sales growth.” Thibault also wrote, “Boston Scientific has dazzled investors in the past with its one-two punch of Farapulse and Watchman, but we think that era is likely behind us.” Mike Mahoney, Boston Scientific’s CEO, addressed the electrophysiology segment falling shy of expectations during the company’s earnings call last week. “I think we've been pretty consistent with our messaging on electrophysiology,” he said, according to a Seeking Alpha transcript of the call. “We do think the market is 18% to 20%, like we said. I think some may have overshot the market growth in Q4. When you're the highest market share leader in PFA, and competitors are coming out, we planned, and we do expect to lose some share given the competitive launches that are coming out and given our really dominant market share position going into 2025. So, we did anticipate that.” Boston Scientific entered the PFA market when it won a nod from FDA about two years ago for the Farapulse PFA system . The company inherited the technology when it acquired the remaining shares of Farapulse in 2021. Boston Scientific’s competitors in electrophysiology Since the company won approval, Johnson & Johnson, along with Abbott Laboratories, has received FDA nods for PFA technology. Medtronic received FDA approval a few months earlier than Boston Scientific. Other companies have also emerged in the market. For example, at the AF Symposium last week, Argá Medtech announced positive clinical results from the BURST-AF  first-in-human trial for the Coherent Sine-Burst Electroporation. Data presented at AF Symposium 2026 showed 94% overall lesion durability, 100% procedural success, and an excellent safety profile using a single, stylet-driven, multi-configurable catheter. “While pulsed field ablation has transformed Afib treatment, many systems report low durability for the complex lesion sets beyond pulmonary vein isolation,” said Ante Anic, MD, Head of the Electrophysiology Lab at KBC Split Hospital and BURST-AF investigator. “In this study, the CSE System enabled efficient, single-catheter ablation across multiple lesion sets with high durability, short ablation times of 20 minutes for pulmonary vein isolation, and an additional 15 minutes for additional linear ablations. These data support sine-burst electroporation as an important next step in Afib ablation.” PFA drives the electrophysiology market “There are many new technologies coming in PFA, and with more commercial options, we expect this to be another fast year of evolution for PFA,” Thibault wrote. PFA therapies were also a hot topic during MD&M West. Don Bonitati, director of the Medical Segment at Trelleborg, spoke to MD+DI about the growing field . “When you look at the cardio-space and especially electrophysiology, you see pulsed-field ablation really driving that market – working with leaders in those OEMs that are bringing the top-level products to market is where you see that two-digit high-level growth,” Bonitati told MD+DI .

Early-stage companies will remain Santé’s primary investment target, and especially those looking to tackle areas marked by “clinical complexity, capital inefficiency or outdated care delivery models.\"\n As biotech and other sectors of the life sciences industry espouse cautious optimism for a stabler financing environment in 2026, a steady influx of new funds in the space suggests things are trending in a positive direction so far.The latest firm to top up its venture capital coffers is Austin, Texas-based Santé Ventures, which Monday announced its fifth and biggest fund to date. At $330 million, the fund has eclipsed the $300 million target Santé originally set, according to a Feb. 2 press release.Santé will direct the fund toward investments in innovative biotechnology, medtech and digitally enabled healthcare companies. The firm noted that it will continue its playbook of “thematic investing, rigorous scientific diligence and hands on company creation.”Early-stage companies will remain Santé’s primary target, and especially those looking to tackle areas marked by “clinical complexity, capital inefficiency or outdated care delivery models,” the investor said.  Many of the companies where Santé played lead investor have gone on to secure successful buyouts, such as heart implant maker Laminar, purchased by Johnson & Johnson, electrophysiology specialists Farapulse, which was acquired by Boston Scientific, and biotech AbVitro, which ultimately found its way under Bristol Myers Squibb’s wing through its buyout by Juno Therapeutics in 2016.“Fund V represents a continuation of our mission to partner with exceptional entrepreneurs driving breakthrough science and transformative healthcare solutions,” said in a statement.In tandem with the fund’s close, Santé has also appointed two new managing directors, Dennis McWilliams and Omar Khalil.Last year, Khalil said in an interview with Fierce Biotech that the industry had reached a “new normal” after the policy and financing tumult that defined the first half of 2025, noting that biotechs were learning how to better manage impacts, prepare for multiple possibilities and, in some instances, acknowledge that certain issues weren’t as severe as feared.Still, pressures from an enduring bear market, persistent layoffs and increasingly high data standards mean that, these days, Santé is investing in biotechs a bit closer to the clinic than it might have before, Khalil explained last summer.As policy uncertainties abate and the financing environment appears to be evening out, many within the industry and on the sidelines have suggested that 2026 could mark a major rebound for biotech.Adding to that sense of optimism, three other biotech-focused funds debuted near the start of January, including a $700 million tranche set aside for “Bio and Health” from Andreessen Horowitz. Around the same time, German mRNA maven BioNTech teamed up with the University of Pennsylvania and VC firm Osage University Partners to create a $50 million fund for Pennsylvania companies, while French pharma Servier formed a new fund catering primarily to European biotechs. Servier has put down an initial 200 million euros to be channeled toward oncology and neurology companies.On the flip side, European investment firm Gimv recently declared that it will no longer put funds into the life science sector as it focuses its efforts on platforms in consumer, healthcare, smart industries and sustainable cities. Curiously, the move came right on the heels of Gimv leading a 51 million euro series B round for neuropsych biotech Exciva. 

Pulsed-Field Ablation, one of the hottest and most competitive segments in medtech , was a major topic of discussion during Boston Scientific’s presentation at the J.P. Morgan Healthcare Conference earlier this week. It was also very timely, as the Marlborough, MA-based company won FDA approval for the Farapoint PFA, a day before the presentation. The firm obtained CE mark for the device in December . Boston Scientific’s Senior VP & Global CMO Ken Stein commented on immediate plans for the newly approved device, according to a Seeking Alpha transcript of the presentation. “We'll be going into limited market release in the U.S. imminently, already are in a limited market release in Europe,” he said, according to a Seeking Alpha transcript. “And you can anticipate that we'll see that scale up pretty quickly over the course of this year.” During the presentation, Boston Scientific’s President and CEO Mike Mahoney spoke about the company’s growth in PFA – noting how it was pushing the firm’s Electrophysiology business forward. “I think we're in a great position,” Mahoney said, according to a Seeking Alpha transcript of the presentation. “We'll give the results in a few weeks here, but our EP business did extremely well. [Boston Sci is] clearly the PFA market share leader. The market is undoubtedly the fastest-growing market in medtech. In '2025, the market was well in this 20% growth range, and we predict a very, very healthy, a minimum of 15% plus over the next three years. So, the market itself is growing quite quickly, much of it due to Pulsed Field Ablation and our leadership in that area.” Boston Scientific inherited its PFA technology when it acquired Farapulse in 2021 . And about two years ago, the company won FDA approval for the Farapulse PFA . Boston Scientific obtained the nod from FDA about a month after Medtronic received approval for the PulseSelect PFA system. Boston Scientific faces competition from Abbott Laboratories and Johnson & Johnson in the PFA market.