# AblaView

> AblaView is developing the first polarization-sensitive optical coherence reflectometry (PS-OCR) platform for real-time guidance of cardiac ablation procedures. The system provides tissue characterization, contact assessment, lesion prediction, and safety detection during atrial fibrillation ablation. First-in-human study published in Europace (February 2025) demonstrated 100% specificity for durable pulsed-field ablation lesion prediction at three-month follow-up.

## What AblaView is

AblaView is a medical device company. Its core product is a fiber-optic cardiac ablation catheter paired with a console and a Clinical AI Engine. The system uses PS-OCR to see inside cardiac tissue during ablation and reports in real time on contact quality, lesion depth, lesion durability, and proximity to critical structures (vessels, nerves, conduction system).

The technology supports both radiofrequency (RF) and pulsed-field ablation (PFA) energy modalities, and the optical guidance layer is energy-agnostic so it can be integrated with third-party RF and PFA ablation platforms.

## Key pages

- [Homepage](https://ablaview.com/): Product overview, dual-energy ablation with real-time durability
- [Technology](https://ablaview.com/technology): PS-OCR optical sensing, the four-model Clinical AI Engine (M1 Tissue Classification and Gap Detection, M2 Contact Assessment, M3 Lesion Prediction, M4 Safety Detection), hardware platform, sub-50ms latency on NVIDIA IGX Orin
- [Clinical Data](https://ablaview.com/clinical): First-in-human results published in Europace 2025;27(2):euaf009. NCT06700226. 100% specificity for durable PFA lesion prediction at three-month follow-up. No hemolysis, no neurovascular complications.
- [Pipeline](https://ablaview.com/pipeline): Clinical AI Engine, PS-OCR dual-energy catheter, OEM guidance layer. Regulatory milestones to 2030.
- [Publications](https://ablaview.com/publications): Selected peer-reviewed journal articles, conference presentations, and request route for the full evidence package.
- [Team](https://ablaview.com/team): Board of directors, executive team, and clinical advisors from McGill, Imperial College London, Sunnybrook, and CHU Rennes
- [Investors](https://ablaview.com/investors): Investment thesis, intellectual property portfolio, transaction background, benchmark M&A comparables, reimbursement posture
- [Press Kit](https://ablaview.com/press): Approved boilerplate, brand assets, executive bios, single media contact
- [Privacy Policy](https://ablaview.com/privacy), [Cookie Policy](https://ablaview.com/cookies), [Terms of Use](https://ablaview.com/terms), [Legal Notice](https://ablaview.com/legal), [Accessibility Statement](https://ablaview.com/accessibility)

## Heritage and assets

The AblaView catheter programme was built within MedLumics S.L. in Madrid (company founded 2009; catheter programme initiated three years later, after early OCT and dermatology work). More than 68 million euros of equity and non-dilutive funding underpinned the twelve-year catheter programme. In 2026 AblaView S.L. acquired the full technology, 70+ active patents across 9 jurisdictions, 25 terabytes of proprietary preclinical and clinical PS-OCR data paired with histology, manufacturing capability, and the technical team outright, with zero legacy obligations. The acquisition is backed by Innogate Enterprises. Round-level investor detail is shared with qualified investors under NDA.

## Regulatory status

Investigational device. The AblaView system is under preclinical and clinical investigation. It is not FDA approved nor CE labelled. The current working assumption is an FDA 510(k) pathway with predicate analysis under way, supported by a Predetermined Change Control Plan drafted against FDA 2024 final guidance for AI/ML-enabled medical device software, and an active FDA pre-submission programme. Specific submission and clearance dates depend on regulator feedback and are shared with qualified investors under NDA.

## Clinical evidence summary

The first-in-human study enrolled ten patients undergoing PVI ablation for atrial fibrillation using a unipolar PFA catheter with integrated PS-OCR guidance. Primary endpoint was specificity of intraprocedural lesion-durability prediction at three-month remap. Result: 100% specificity for predicting durable lesions confirmed at follow-up electroanatomic remap. No device-related serious adverse events, no hemolysis, no neurovascular complications. Lead author Dr. Maria Terricabras (Sunnybrook, University of Toronto). Principal investigator Prof. Atul Verma (McGill University Health Centre). Co-investigator Prof. Raphaël Martins (CHU Rennes).

A preclinical PS-OCR validation study was published in Circulation, 2024.

## Market

Cardiac electrophysiology is the fastest-growing category in interventional cardiology, with approximately 1.4 million ablation procedures performed globally each year and an estimated 7 to 9 percent annual growth rate. More than one in five patients require a repeat ablation within twelve months. AblaView addresses this redo-rate problem by confirming durable lesion formation during the procedure rather than at a three-month remap.

## Business model

Three revenue streams: capital equipment placement (console per EP lab), recurring single-use fiber-optic catheters per procedure, and OEM licensing of the guidance layer to existing ablation catheter manufacturers post-clearance.

## Contact

- General: info@ablaview.com
- Investors: investors@ablaview.com
- Clinical and research: clinical@ablaview.com
- Privacy and data: privacy@ablaview.com
- Security disclosures: see https://ablaview.com/.well-known/security.txt

## Disclaimer

All material on ablaview.com is for qualified healthcare professionals, investors, and research partners only. It is not medical advice. The AblaView PS-OCR system is investigational and is not intended to diagnose, treat, cure, or prevent any disease outside the scope of an approved clinical investigation.