Aug 17, 2026 earnings call — Voluntary recall and U.S. relaunch plan
Total revenue was $1.8 million, essentially flat year-over-year despite a voluntary recall.
Revenue $0.0B (est $0.0B) · EPS $-0.17 (est $-0.20)
Key quotes
"Since then, we've identified the required design modifications, initiated validation and performance testing and continue to work closely with the FDA as we advance these improvements with a completed early submission of our pre-sub dossier."
"In fact, our latest discussions and feedback from FDA remain constructive and interactive and all signals point to potential approval in the fourth quarter, as we previously indicated."
"Included in these efforts was a workforce reduction action initiated in the third quarter that reduces the number of positions in our organization by almost 20% and saves the company approximately $9 million on an annual basis."
Analyst Q&A 4
U.S. approval timing for CGuard systems
Q (Adam Maeder · Piper Sandler): He asked why the original CGuard 135 delivery system U.S. approval timing slipped from Q3 to Q4 and wanted color on recent FDA interactions. He also asked what remains before CGuard Prime submission and how derisked a first half 2027 approval is, plus an update on SwitchGuard enrollment and its timeline.
A: Management said the timing shift reflects being realistic about regulatory time frames, required testing and FDA requests, and that testing has been completed. For CGuard Prime they said the delivery mechanism issues are solved, DV testing is underway, and they submitted a pre-sub request to FDA; biocomp testing and the statutory review process are the remaining long poles, so first half 2027 remains their realistic guide. For SwitchGuard they said enrollments have gone very well, investigators are pleased, they have initiated high-volume sites, and they continue to enroll on the previously mentioned timeline.
"We have submitted early our pre-sub request to FDA to review all of the results to date and our anticipated response." — Marvin Slosman (CEO)
timing and distribution of cost cuts
Q (Frank Takkinen · Lake Street): He asked when the cost savings from the initiatives will be fully realized and when the refreshed operating expense run rate will be visible. He also asked where the 20% headcount reduction occurred inside the company.
A: Management said most actions are already set in motion and they expect to see the full impact of the cost savings in Q4, with partial savings in Q3 offset by restructuring charges. On the 20% headcount reduction they said they reduced layers to conserve cash while keeping commercial readiness and maintaining a strong field team, but did not give a detailed breakdown by department.
"I would expect that we should see the full impact of that -- those cost savings in Q4 of this year." — Michael Lawless (CFO)
commercial relaunch and international growth
Q (Marie Thibault · BTIG): She asked how the company plans to run the relaunch with a smaller commercial team, any strategy changes, and VAC committee considerations. She also asked what drove international (OUS) growth above 20% and whether that growth is sustainable.
A: Management said they optimized the field organization, use claims data and territory management, and have a new Head of Sales and Marketing and a refined playbook to relaunch quickly while monitoring VAC approvals. On international growth they said the OUS business has matured, physicians there view the device as a new standard, they've sold over 75,000 implants, and they are working to improve pricing and margins in those markets.
"Remember, we've been in the OUS markets now for years, sold over 75,000 implants." — Marvin Slosman (CEO)
customer feedback and SwitchGuard importance
Q (Jeremy Pearlman · Maxim Group): He asked whether the company is in contact with physicians using the recalled 135 delivery system and whether those physicians will reengage after reclearance. He also asked how important SwitchGuard is to the TCAR strategy versus just the CGuard 80.
A: Management said they are in touch with all customers and current users and that market anticipation and enthusiasm for the product's return is unanimous; the sales team has stayed engaged to convert interest into revenue once approvals occur. On SwitchGuard they said it is fundamental to the TCAR strategy: they want both an implant and neuroprotection device, believe SwitchGuard improves on the current predicate, and expect meaningful sales and margin benefits by addressing the full TCAR market.
"It's very fundamental to our overall TCAR strategy." — Marvin Slosman (CEO)