What remains to be done before submission for the CGuard Prime 135 delivery system, and how derisked is the H1 2027 approval timeline?

The technical improvements for the 135 system are solid, and the company is confident in the solution. Currently, DV testing is underway. The H1 2027 approval remains realistic, but potential for earlier approval exists if FDA agrees to accelerate review of changes and if biocomp testing is deemed unnecessary. “The progress on the 135 technical and the Prime system on the 135 Prime technical improvements is really solid, Adam. In fact, we feel confident that we've not only solved the delivery challenges, but produced a solution that performs exactly as we anticipated.”

Can you provide an update on enrollment progress for the SwitchGuard study and confirm the H2 2027 U.S. approval and launch timeline?

Enrollments have gone very well, with investigators pleased with the device's performance. The company has initiated high-volume sites. The H2 2027 timeline is still being called, though enrollment progress will ultimately determine the exact timing. “The enrollments thus far have gone very well. We don't take any of that for granted. Obviously, this is the first time SwitchGuard has been used in human applications.”

When will the cost savings from the workforce reduction be fully realized, and what will the refreshed operating expense run rate look like?

The vast majority of cost saving actions are in motion. The full impact of savings should be visible in Q4, with some partial savings in Q3 offset by restructuring costs. The company is balancing cost reduction with maintaining commercial readiness for relaunch. “I would expect that we should see the full impact of that -- those cost savings in Q4 of this year. There will be some partial savings in Q3, but there will be also some offsetting costs associated with restructuring.”

NSPR

InspireMD (NSPR) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 17, 2026

Source: earnings call transcript

Executive summary

InspireMD Q2 FY26 — Strategic Realignment Amidst Recall, Focus on Regulatory Milestones

InspireMD navigated a challenging quarter marked by a voluntary recall of its CGuard Prime 135 system, which significantly impacted reported financials. Despite this, the company demonstrated resilience with strong international growth and made meaningful progress on multiple regulatory fronts, including advancing its TCAR and CAS platforms towards anticipated Q4 FDA approvals. Management has also taken decisive actions to streamline its cost structure and organization, positioning the company for a strategic U.S. market re-entry and long-term growth.

Highlights

International revenue grew 21% year-over-year to $2.1 million, reflecting strong demand for CGuard.
CGuard Prime 80 platform for TCAR showed outstanding 30-day results from CGUARDIANS II trial, strengthening pending FDA submission.
Workforce reduction of almost 20% is expected to save approximately $9 million annually, improving financial flexibility.

Concerns

Total revenue was flat year-over-year at $1.8 million, impacted by a voluntary recall.
Gross profit was a loss of $0.8 million or negative 43.7% of revenue, down from 17.6% in Q2 FY25, due to recall-related credits and inventory impairment.
Net loss increased to $14.3 million or $0.17 per share, compared to $13.2 million or $0.26 per share in Q2 FY25.
Cash and cash equivalents and marketable securities decreased to $30.4 million as of June 30, 2026, from $54.2 million at the end of 2025.

Guidance & targets

Category	Target	Timeline	Confidence
CGuard Prime 80 platform for TCAR approval	Q4 2026 high materiality	Q4 · FY26	High
Original CGuard platform for CAS approval	Q4 2026 high materiality	Q4 · FY26	High
Redesigned CGuard Prime 135 CAS delivery system market reentry/approval	H1 2027 high materiality	H1 FY27	Medium
SwitchGuard neuroprotection system U.S. approval and launch	H2 2027 high materiality	H2 FY27	Medium
Restructuring charge	$0.9M-$1.2M medium materiality	Q3 · FY26	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
International Growth driven by continued demand for the CGuard stent platform; foreign exchange rates were immaterial.	$2.1M	21%	—	—

Risks & headwinds

Voluntary recall of CGuard Prime 135 carotid stent system Q2 FY26

$734,000 customer credits; $612,000 inventory impairment charge

Mitigation:Identified design modifications, initiated validation and performance testing, submitted pre-sub dossier to FDA for H1 2027 re-entry (potential for earlier).

Increased net loss Q2 FY26

Net loss of $14.3 million ($0.17 per share) in Q2 FY26, compared to $13.2 million ($0.26 per share) in Q2 FY25

Mitigation:Workforce reduction initiated in Q3 FY26 to save approximately $9 million annually and align cost structure.

Cash burn H1 FY26

Cash and cash equivalents and marketable securities decreased to $30.4 million as of June 30, 2026, from $54.2 million at the end of 2025

Mitigation:Proactive actions to reduce cost structure and improve financial flexibility and operational efficiency, including workforce reduction.

Restructuring charge Q3 FY26

$900,000 to $1.2 million

Mitigation:This charge is a one-time cost associated with the workforce reduction, expected to lead to annual savings.

Regulatory timeline delays Q3-Q4 FY26

Original CGuard platform for CAS approval shifted from Q3 to Q4 2026

Mitigation:Management is being realistic about regulatory timeframes, including required testing and FDA's workload. They are working closely with the FDA and have submitted pre-sub requests to potentially accelerate timelines for the redesigned CGuard Prime 135.

What to watch in Q3 FY26

CGuard Prime 80 for TCAR FDA approval

Q4 FY26

Current Pending Q4 2026 decision

Target Approval decision

Why it matters

This approval would significantly expand the addressable market for TCAR procedures and is a key catalyst for U.S. re-entry.

all signals point to potential approval in the fourth quarter, as we previously indicated.

Find out whether NSPR delivers this. Inve re-checks your case every morning.

Q&A highlights

Why has the U.S. approval timing for the original CGuard system shifted from Q3 to Q4, and what are the interactions with the FDA like?

The shift to Q4 is due to being realistic about regulatory timeframes, including required testing and FDA's workload. Interactions remain constructive, and the company is on top of all necessary details.

“I think the wiggle, as you mentioned it, is we're just trying to be realistic about the regulatory time frames as always, request from FDA and just general time frames.”

asked by Adam Maeder · answered by Marvin Slosman

2 min read 5 chapters

Detailed narrative

Voluntary Recall and Remediation Progress

The second quarter was significantly impacted by the voluntary recall of the CGuard Prime 135 carotid stent system. This led to a $734,000 customer credit and a $612,000 inventory impairment charge. Management has identified required design modifications for the delivery system, initiated validation and performance testing, and submitted a pre-sub dossier to the FDA.

The company is optimistic about a market re-entry in the first half of 2027, with potential for an earlier approval if the FDA agrees to an accelerated review.

Regulatory Advancement for U.S. Market Re-entry

InspireMD is actively pursuing multiple regulatory catalysts to re-establish its U.S. market presence. The CGuard Prime 80 platform for TCAR is anticipated to receive FDA approval in Q4 2026, following outstanding 30-day results from the CGUARDIANS II trial. A decision for the original CGuard platform for CAS is also expected in Q4 2026.

These approvals would allow the company to address the approximately 75,000 annual U.S. stenting procedures.

International Business Strength

Despite U.S. market challenges, the international business demonstrated robust performance, growing approximately 21% year-over-year to $2.1 million. This growth reflects continued physician adoption and strong demand for the CGuard stent platform in international markets. The company plans to fine-tune pricing and margin assumptions in these markets to improve bottom-line contribution, leveraging its experience with over 75,000 OUS implants.

Cost Structure Alignment and Workforce Reduction

The company undertook decisive actions to align its organization and cost structure with near-term priorities. A workforce reduction initiated in Q3 2026 will reduce the number of positions by almost 20%, leading to approximately $9 million in annual savings. A restructuring charge of $900,000 to $1.2 million is expected in Q3.

These measures aim to create a leaner, more efficient organization while maintaining commercial readiness for U.S. relaunch.

SwitchGuard Neuroprotection System Progress

Enrollment has begun for CGUARDIANS III, the pivotal study evaluating the next-generation SwitchGuard neuroprotection system. This system is considered fundamental to the company's overall TCAR strategy, as it aims to provide both the implant and a neuroprotection device. The company is tracking towards a U.S. approval and launch in the second half of 2027, with investigators reportedly pleased with the device's performance in human applications.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.