How Is Imricor Driving Growth Amid US FDA Delays and EU Approvals?
Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.
- Second-generation NorthStar and related devices approved under EU-MDR
- European hospital pipeline expands from 7 to 26 in six months
- US FDA 510(k) submission for NorthStar made, approval expected in 2025
- PMA approval for ablation catheter and RF generator delayed due to FDA reviewer change
- Clinical trial enrolment slower than expected but anticipated to improve
Regulatory Milestones in Europe
Imricor Medical Systems has achieved a significant regulatory breakthrough in Europe, securing approval for its second-generation NorthStar system, ablation catheter, and capital equipment under the stringent European Medical Device Regulation (EU-MDR). This milestone enables the company to phase out its first-generation devices and fully launch the upgraded products commercially from July 1, 2025. The impact is already visible, with the number of hospitals in the active European sales pipeline jumping from 7 to 26 over the past six months, signaling growing adoption of Imricor’s interventional cardiac magnetic resonance (iCMR) technology.
US Market Entry and Regulatory Challenges
Across the Atlantic, Imricor has submitted its NorthStar 510(k) Premarket Notification to the US Food and Drug Administration (FDA), aiming for approval within the calendar year. This approval is pivotal as it will mark Imricor’s commercial entry into the US market, allowing the sales team to engage sites and build a robust pipeline. However, the company faces delays with its Premarket Approval (PMA) process for the ablation catheter and RF generator, as the FDA reviewer for the second PMA module has been replaced. This has pushed the final clinical data submission target to the first half of 2026. Despite these setbacks, Imricor remains confident that the prioritization of NorthStar’s approval will mitigate commercial impact.
Clinical Trials and Commercial Outlook
Enrollment in the VISABL-AFL clinical trial has been slower than anticipated during the summer months in both the US and Europe, but the company expects this to pick up. Imricor’s strategic focus on launching NorthStar first is designed to accelerate iCMR lab adoption in Europe and the US, creating a larger installed base for its ablation tools. This approach aims to synchronize the sales cycle with the anticipated PMA approvals, supporting a seamless revenue growth trajectory. CEO Steve Wedan highlighted the strength of the newly expanded sales team, many with extensive electrophysiology experience, as a key driver of the growing sales pipeline momentum.
Partnerships and Market Positioning
Imricor’s progress is bolstered by collaborations with major MRI equipment vendors such as Koninklijke Philips, Siemens Healthcare, and GE HealthCare, who assist in targeting and outfitting iCMR labs. These partnerships are critical to expanding the infrastructure necessary for the adoption of Imricor’s MRI-compatible cardiac ablation technology. The company’s innovative approach, which replaces traditional x-ray fluoroscopy guidance with real-time MRI, promises safer and more effective cardiac procedures, positioning Imricor as a pioneer in this niche medical device market.
Looking Ahead
While regulatory and clinical challenges remain, Imricor’s dual-track strategy of advancing European commercialization alongside US regulatory submissions sets a promising stage for growth. The company’s ability to navigate FDA complexities and accelerate clinical trial enrollment will be critical to sustaining momentum and unlocking the full potential of its technology in the lucrative US market.
Bottom Line?
Imricor’s expanding European footprint and ongoing US regulatory efforts set the stage for a pivotal growth phase, though FDA delays warrant close attention.
Questions in the middle?
- How will FDA reviewer changes affect the timeline and certainty of PMA approvals?
- Can Imricor accelerate clinical trial enrollment to meet regulatory milestones?
- What impact will the growing European hospital pipeline have on near-term revenues?
