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Total Revenue: $1.8 million for Q2 2026, essentially flat compared to Q2 2025.
International Revenue: $2.1 million, representing 21% year-over-year growth.
Gross Profit: Loss of $0.8 million, or negative 43.7% of revenue, compared to a profit of $0.3 million (17.6% of revenue) in Q2 2025.
Adjusted Gross Profit (non-GAAP): $0.6 million, excluding recall-related customer credits and impairment charges.
Total Operating Expenses: $13.7 million, up from $13.3 million in Q2 2025.
Net Loss: $14.3 million, or $0.17 per basic and diluted share, compared to a net loss of $13.2 million ($0.26 per share) in Q2 2025.
Cash and Marketable Securities: $30.4 million as of June 30, 2026, down from $54.2 million at the end of 2025.
Recall-Related Credit: $734,000 credit booked for the return of CGuard Prime 135 product.
Inventory Impairment Charge: $612,000 impairment charge for CGuard Prime 135 inventory no longer commercially viable.
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For the complete transcript of the earnings call, please refer to the full earnings call transcript.
International revenue grew 21% year-over-year, driven by strong demand for the CGuard stent platform.
The CGUARDIANS II trial for the CGuard Prime 80 platform reported outstanding 30-day results, with FDA approval expected in Q4 2026.
The company is advancing multiple regulatory catalysts, including the original CGuard platform for CAS and the next-generation SwitchGuard neuroprotection system.
The voluntary recall is being managed effectively, with a clear plan for design modifications and a potential earlier-than-expected market re-entry for the CGuard Prime 135 system.
The company has taken decisive actions to reduce costs, including a 20% workforce reduction, saving approximately $9 million annually.
Total revenue was flat year-over-year, with US revenue negatively impacted by customer credits and an inventory impairment charge related to the voluntary recall.
Gross profit turned negative, with a gross margin of -43.7% due to recall-related credits and a $612,000 inventory impairment.
Net loss widened to $14.3 million in Q2 2026, compared to $13.2 million in the same period last year.
Cash and cash equivalents decreased significantly to $30.4 million from $54.2 million at the end of 2025, raising concerns about financial runway.
The approval timeline for the original CGuard delivery system was pushed from Q3 to Q4 2026, reflecting regulatory delays.
Q: What is the updated timeline for the original CGuard delivery system's FDA approval, and what is driving the shift from the previously mentioned Q3 to Q4?A: Marvin Slosman, CEO, explained that the shift to Q4 is about being realistic regarding regulatory timeframes and FDA workload. He noted that required testing is complete, but they want to allow adequate time for responses to FDA and the agency's feedback on the legacy system, emphasizing a cautious approach to the approval timeline.
Q: What is left to do before submission for the CGuard Prime 135 delivery system, and how derisked is the first half of 2027 approval timeline?A: Marvin Slosman, CEO, stated that progress on the 135 Prime technical improvements is solid, with the delivery mechanism performing well in challenging anatomy. They are currently conducting design verification (DV) testing. The timeline remains first half of 2027, with long-pole items including biocompatibility testing and FDA's statutory review process. They have submitted a pre-sub dossier to FDA, and if they can eliminate some long-pole items, there is potential to pull the approval timeline in earlier.
Q: Can you provide an update on the SwitchGuard enrollment progress and confirm the timeline for US approval and launch?A: Marvin Slosman, CEO, reported that enrollments are going well, with investigators pleased with the device's performance in its first human applications. The trial expansion will depend on available resources, but they are initiating high-volume sites enthusiastic about SwitchGuard. The timeline remains on track for the back half of 2027 for US approval and launch, though enrollment progress will ultimately determine the final timeline.
Q: When will the cost-saving initiatives be fully realized, and where did the 20% headcount reduction occur within the organization?A: Michael Lawless, CFO, stated that the vast majority of actions are already in motion, with full impact expected in Q4 of this year. Q3 will see partial savings offset by restructuring costs. Marvin Slosman, CEO, added that the reduction was balanced to maintain commercial readiness for an aggressive relaunch, ensuring the field team remains strong to reestablish presence quickly.
Q: What is the key variable that could change the CGuard Prime 135 timeline, and is it within the company's control?A: Marvin Slosman, CEO, identified two key testing scenarios: biocompatibility testing, which takes time and may not be necessary, and the statutory review process. They are seeking FDA's agreement on an accelerated review under the pre-sub scenario. If FDA agrees, timelines could be pulled in significantly, but they remain conservative with a first half of 2027 guidance.
Q: How is the company thinking about the commercial strategy for the relaunch and subsequent launches, including VAT committee processes?A: Marvin Slosman, CEO, explained that they have optimized the field organization structure, focusing on high-performing territories and time-to-productivity. The new Head of Sales and Marketing has a clear playbook for the relaunch, and they are closely managing VAT committee approvals to ensure customers understand timelines. The voluntary recall provided an opportunity to refine and make the relaunch plan more efficient and aggressive.
Q: What is driving the over 20% international growth, and is it sustainable?A: Marvin Slosman, CEO, attributed the growth to the device's world-class outcomes and established standard of care in OUS markets, with over 75,000 implants sold. While the business has grown significantly, they are now focusing on fine-tuning pricing and margins to improve bottom-line contribution, indicating a strategic pivot toward higher-margin opportunities in those markets.
Q: Are physicians who used the recalled 135 delivery system still engaged, and will they re-adopt the product upon re-approval?A: Marvin Slosman, CEO, confirmed they are in touch with all customers, and the anticipation for the product's return is unanimous and palpable. The sales team has maintained relationships, and the expectation is that enthusiasm will quickly translate into revenue upon approval of both the 135 and the 80 for TCAR, with the sales organization preparing for a rapid relaunch.
Q: How important is SwitchGuard to the long-term TCAR strategy, and how does it expand the addressable market versus just the CGuard 80?A: Marvin Slosman, CEO, emphasized that SwitchGuard is fundamental to the TCAR strategy, as every TCAR procedure uses both a stent and a neuroprotection device. SwitchGuard offers improved features over current predicates, and the associated sales dollars and margins are significant. Having both the implant and neuroprotection system allows them to address the entirety of the TCAR market, benefiting from better technology and higher revenue and margin opportunities.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.