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Series A, €25M, FDA Target 2030

The case is built on evidence, not projections.

12 years and €68M+ of prior R&D built the hardware, the 25TB clinical dataset, and the 70+ patents. A first-in-human study then confirmed 100% specificity for durable PFA lesion prediction in Europace. €25M Series A reaches AI Engine 510(k) clearance Q4 2026 and IDE start Q2 2028.

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The thesis in four lines.

100% specificity
Durable PFA lesion prediction, first-in-human, published Europace February 2025. Peer-reviewed, zero device-related SAEs.
€68M+ absorbed
12 years of prior R&D, hardware platform, manufacturing, and technical team acquired outright in 2026. Clean entity, zero legacy obligations.
70+ patents, 25TB
Patents owned outright across 9 jurisdictions. 25TB of PS-OCR clinical data paired with histology. No competitor holds comparable data.
€25M Series A
Reaches AI Engine 510(k) clearance in Q4 2026 and IDE clinical study start in Q2 2028. FDA target 2030.

A 15-Year Head Start.

AblaView® is the continuation of a 15-year, €68M+ optical-ablation program originated at MedLumics (founded 2009). €52M of equity and €16M of non-dilutive funding and grants were absorbed before 2026, when AblaView® acquired the full technology, 70+ patents, 25TB of clinical data, manufacturing, and team outright. Clean entity, zero legacy obligations.

  • ✓ 70+ Patents & Exclusive Licenses
  • ✓ Certified Medical Device Manufacturing
  • ✓ Proprietary Histological Dataset (860+ Ablations)
  • ✓ Clean Chain of Title. All Prior Rights Assigned.
Consolidated Asset Base
Prior R&D Absorbed €68M+
Equity / Non-Dilutive €52M / €16M
Patent Portfolio 70+ Filings
Histological Dataset 860+ Ablations
Chain of Title Verified Clean
Time to Market Accelerated
$10B+
Global EP Market
Cardiac electrophysiology. Growing at 7 to 9% per year. 1.4M global ablation procedures in 2023, rising past 1M per year.
100M+
Patients with AFib (Global)
Approximately 10M in the US and 10M in the EU, rising to 170M globally by 2050. Source: ESC and AHA epidemiology.
$26B
Annual AF Cost, US Alone
More than 1 in 5 patients require a repeat ablation within 12 months. Incomplete lesion sets and untreated gaps are the primary clinical driver.
Series A and Use of Funds

€25M. Reaches AI Engine clearance and IDE start.

The €25M Series A is sized to carry AblaView® through the 510(k) clearance of the Clinical AI Engine (target Q4 2026) and the IDE clinical study start (target Q2 2028). Prior investment absorbed the technology and clinical risk, so more than 85% of new capital is deployed directly into regulatory, clinical, and manufacturing work.

Allocation

Regulatory and Clinical52%
Engineering and Manufacturing35%
Operations and Working Capital12%
Commercial Preparation1%

Revenue Model

  1. 1.
    Capital Equipment
    Console and guidance system placed per EP lab. Standard medtech upfront contract familiar to hospital procurement.
  2. 2.
    Single-Use Catheters
    Fiber-optic catheter consumed per procedure. Recurring revenue that scales predictably with lab volume.
  3. 3.
    OEM Licensing
    Platform licensed to existing catheter manufacturers at scale post-clearance. The guidance layer is modality-agnostic (RF, PFA, laser), giving any major ablation OEM a direct path to plug it in.
Market Context

A $10B+ market built on blind procedures.

Cardiac electrophysiology is the fastest-growing procedure category in interventional cardiology, growing 7 to 9% per year. 1.4 million ablation procedures are performed globally each year, every single one without real-time optical confirmation of tissue contact or lesion formation. More than 1 in 5 patients require a repeat ablation within 12 months.

1.4M
Procedures per year
Global cardiac ablations performed annually. Every one is performed without real-time optical confirmation.
No. 1
Fastest-growing category
Interventional cardiology. Growing faster than structural heart, coronary, and peripheral.
OEM path
Every major medtech is a buyer
Any company selling ablation catheters has a direct commercial interest in a guidance layer that makes their catheter more effective.

AblaView® is modality-agnostic. Pure-PFA platforms (Farapulse, PulseSelect, Affera) currently dominate ablation growth but cannot confirm lesion durability. A guidance layer with real-time optical feedback plugs into every energy modality (RF, PFA, laser) and sits upstream of the catheter-as-commodity dynamic.

Reimbursement Posture

Coverage & coding.

The ablation procedure itself is already reimbursed in every major market. AblaView® is delivered inside an existing reimbursed procedure, so no new code is required to achieve hospital economics. An add-on or category III code pathway is an accelerator, not a gating item.

Market Procedure Code Hospital Payment Status for AblaView®
United States CPT 93656 (PVI) DRG 273 / 274 • ~$22k–$29k inpatient Bundled • add-on cat. III pathway
Germany OPS 8-835.32 + EBM DRG F50B • ~€9k–€13k Bundled • NUB application eligible
France CCAM DEPF002 GHM 05K06 • ~€7k–€11k Bundled • LPPR add-on assessed
United Kingdom OPCS K62.1 HRG EA36Z • ~£5k–£9k Bundled • MedTech Funding Mandate candidate
Japan K595 PVI DPC • ~¥1.6M–¥2.2M Bundled • C1/C2 application planned

Full health-economic model (including hospital ROI per installed system, DRG uplift analysis, and budget-impact by market) available under NDA.

Transaction Background

€68M and 12 years of prior investment. Acquired outright.

The AblaView® program was built as MedLumics S.L. from 2009 through 2025. In 2026, AblaView® S.L. acquired the full technology, 70+ patents, 25TB of clinical data, manufacturing, and the team outright. Zero legacy obligations. Every new euro goes to commercialization.

2009

MedLumics S.L. founded in Madrid

Optical coherence tomography research platform. DemaLumics SL spun off in 2014 for the dermatology application.

2011

€3.5M Equity Raised

Lead investors: Ysios Capital, CriteriaBioVentures, CaixaCapitalRisc. Use of proceeds: OCT imaging and dermatology application.

2017

€16M Equity Raised

Investors: Andera Partners, Innogest, Seroba, Boston Scientific. Pivot into cardiac electrophysiology.

2020

€34.5M Equity Raised

Investors: Asabys, VIPartners, Kurma Partners, Innvierte. Funded the FIM study, PS-OCR catheter, and the 25TB clinical data asset.

February 2025

First-in-Human Result Published

100% specificity for durable PFA lesion prediction at three-month follow-up. Europace 27(2):euaf009. No hemolysis, no neurovascular complications.

2026

AblaView® S.L. Acquires Outright

Series A, €25M, backed by Innogate Enterprises.

Full technology, 70+ patents, 25TB of data, manufacturing, and the technical team acquired outright. Clean entity, zero legacy obligations, single cap table.

Q3 2026 → 2030

Path to Commercial

510(k) submission Q3 2026, AI Engine clearance target Q4 2026, IDE trial approval Q2 2028, PMA and commercial launch 2030.

Intellectual Property and Data

70+ patents. 25TB. Neither can be replicated quickly.

70+ active patents across 9 jurisdictions, owned outright with no licensing obligations. 25TB of proprietary data accumulated over 15 years of R&D and clinical work, paired with histology. A competitor starting from zero would need 10+ years and €60M+ minimum to build a comparable dataset.

70+
Active Patents
9 jurisdictions. Owned outright. No licensing obligations.
25TB+
Proprietary Data
Bench, preclinical, and first-in-human. Paired with histology.
FTO
Opinion On File
Independent counsel, refreshed annually.

Granted US Patents

  • US 11,523,740 and US 12,285,237 ,Lesion prediction
  • US 11,331,142 and US 12,232,807 ,Optical fiber tips
  • US 12,239,363 ,Patterned catheter

Pending (select)

  • Gap detection
  • Ablation model sync (EP granted, US pending)
  • Real-time lesion assessment
  • Long-coherence optical

Coverage spans hardware, optics, software, and AI application layers.

Chain of Title

All rights originated at MedLumics S.L. were formally assigned to AblaView® S.L. in 2026 under a notarized deed of assignment. Recordations filed at USPTO, EPO, JPO, and other relevant offices. Clean entity, zero legacy obligations.

Freedom to Operate

Independent FTO opinion on file, refreshed annually. Covers the RF, PFA, and PS-OCR combination against the patent landscape of Abbott, Biosense Webster, Medtronic, Boston Scientific, and published academic prior art.

Benchmark Transactions

The largest medtech companies have spent billions acquiring this space. None solved optical tissue visualization. That gap remains.

Acquirer Target Technology Value Year
Abbott St. Jude Medical EnSite mapping, ablation, cardiac rhythm management. Largest EP acquisition in history. $30.7B 2017
Johnson & Johnson Auris Health Robotic navigation and precision guidance for minimally invasive procedures. $3.4B 2019
Medtronic Affera Next-gen mapping and ablation platform. Sphere-9 catheter. $925M 2022
Boston Scientific Farapulse PFA energy delivery. Pre-revenue at acquisition. $295M+ 2021
Boston Scientific Rhythmia Medical High-density cardiac mapping. Real-time signal fidelity and lesion tracking. ~$225M 2017
Medtronic CardioInsight Non-invasive cardiac mapping. Strategic value of visualization outside the cath lab. ~$93M 2014
Johnson & Johnson Biosense Webster (CARTO) 3D cardiac mapping. Dominant mapping platform globally, billions in cumulative EP revenue. N/A 1997+
Partnership Thesis

Why the Big Four will want this.

AblaView® is the guidance layer each of the four dominant EP players is missing. Below, each acquirer is mapped to the comparable transaction that makes the valuation logic legible and to the specific gap AblaView closes.

Medtronic (Affera)
$925M, 2022

Acquired the Sphere-9 mapping and ablation platform to compete in the EP guidance arms race. Still cannot confirm lesion durability during the procedure. AblaView® closes the optical gap in the next-generation Affera stack.

Boston Scientific (Farapulse)
$295M+, 2021

Leads PFA adoption globally. Has the largest durability-credibility problem in the category because electrical signals are biased by cellular stunning. AblaView® is the only published system that confirms lesion formation in real time.

Johnson & Johnson (Biosense Webster)
CARTO, 1997+

Dominant 3D cardiac mapping platform with billions in cumulative EP revenue. Owns the mapping layer but has no real-time tissue sensing. AblaView® plugs directly into the CARTO footprint.

Abbott (St. Jude / EnSite)
$30.7B, 2017

Largest EP acquisition in history. Owns EnSite mapping depth and full cardiac rhythm management. Has no catheter-level optical guidance. AblaView® completes the stack and the dual-energy story.

Each of these transactions covered an adjacent gap. None solved real-time optical tissue visualization. That gap is the AblaView® thesis.

Latest News

January 17, 2025
Dr. Atul Verma Presents AblaView® Technology at AFS Boston
January 10, 2025
Europace Journal Accepts AblaView® Clinical Validation Paper
December 15, 2024
First-in-Human Trial Completed with 100% Safety Profile

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