Full preclinical study
Fresh-frozen anatomy, the complete procedure in the Cadaver Lab, OCT, IVUS and micro-CT, core-lab analysis and a publication-ready report. For CE and FDA dossiers and preclinical phases.
First-in-human, before the first patient.
ERIDAN tests coronary devices on fresh-frozen human hearts and reads the result with micro-CT, intravascular imaging and histology. An Anatomy & Imaging Hub in Torino, founded by interventional cardiologists.
From clinical intuition to industrial evidence.
A device idea usually reaches the bench late and the patient early. ERIDAN puts a human coronary artery in between. The same team designs the study, runs it on the ex vivo bench, images the result and returns data an engineer can use.
Study design
Protocol, endpoints, sample size and the ethics dossier, written by the clinicians who will run the bench. Kick-off with your R&D team, signed protocol as the output.
Ex vivo bench
Fresh-frozen human hearts selected by CT angiography. Coronary segments with native calcium, real bifurcations, real tortuosity. Devices deployed as in the cath lab, on a bench that reproduces pressure and flow.
Micro-CT
30 µm voxels on the treated segment, before and after: fracture mapping, strut apposition, calcium morphology. Mechanical tests under continuous scanning when the question is dynamic.
Intravascular imaging
OCT and IVUS pullbacks read mm by mm: lumen, external elastic membrane, struts, calcium arc and thickness, fused with the micro-CT volume.
Histology
Sections read by a university hospital pathology unit and matched frame by frame to the imaging.
Data, models, evidence
A publication-ready report with raw data and video, and a device digital twin trained on the measurements, so the next design and the next technique start from numbers.
From the cath lab to the bench.
Every field is run by the same people who perform PCI every week. Pick a field: the plate changes and the list of what we do in it opens.
- Study coordination between industry, cath labs and university departments in Torino
- Regulatory data packs under MDR (EU) 2017/745, ISO 13485, ISO 10993, ISO 14155 and GLP
- Tissue custody and traceability under Italian Law 10/2020; pseudonymised clinical and imaging data under GDPR art. 9
- Multicentre registries: design, eCRF, statistical analysis plans
- Contract research with milestone budgets and a single clinical interlocutor
- Hands-on courses on ex vivo coronary models and anatomical dissection
- Product launch events with a live bench for sales teams and key opinion leaders
- Masters and fellowships in intravascular imaging and calcium modification
- 3D and XR anatomy library built from micro-CT datasets
- Fresh-frozen human hearts selected by CT angiography
- Isolated coronary segments with native calcium
- Pulsatile perfusion bench reproducing pressure, flow and temperature
- Deployment of lithotripsy, atherectomy, balloons and stents under imaging
- Micro-CT at 30 µm before and after treatment; 4D scanning under load
- Fracture mapping, dose–response, histology matched to the frames
- Structure–activity relationships, docking and virtual screening
- ADME and toxicity prediction, hit selection
- Antiproliferative, anti-inflammatory and antithrombotic candidates for combination devices
- Carrier matrices and coatings for drug-coated balloons and stents
- Formulation of supplements and therapeutics
- Evidence reviews with dose ranges and human-equivalent doses
- 3D device models from technical specifications
- Finite-element and CFD models of device, plaque and vessel
- Digital twins trained on study data, to refine designs and test new deployment techniques
- In-silico trials before the bench
- 3D-printed multi-material phantoms and patient-specific simulators
- XR environments for procedure planning
- OCT and IVUS analysis mm by mm: lumen, EEM, struts, calcium arc and thickness
- Multimodal fusion of micro-CT, OCT and IVUS on the same segment
- Micro-CT quantification of fractures and strut apposition
- Angiographic core lab
- Inflation-resolved balloon indices
- Registry statistics: propensity methods, causal inference, survival models
- Neural network and model development for medical applications
- Segmentation and measurement models for OCT, IVUS and micro-CT
- Predictive models from registries and ex vivo data
- Device digital twins learned from bench measurements
- Validation, calibration and documentation for regulatory use
- Patents, licensing and Testing-as-a-Service for what the bench teaches us. The eighth field is the one a partner brings: write to us with the device, the molecule or the question.
Four ways to work with us.
Every engagement is modular. A start-up with a first prototype and a multinational strengthening a CE or FDA dossier buy different pieces of the same bench.
Predictive report
A computational model of your device in variable anatomical scenarios, built with bioengineering partners. Usually added to a full study.
Proof of concept
A half-day feasibility test for an early prototype: basic mechanics plus one imaging acquisition, before investing in a full study.
Regulatory data pack
Micro-CT images, statistics and histomorphometric cross-sections formatted as a dossier ready to attach to a CE or FDA submission.
And beyond testing
Product launch events and master courses in the Academy; redesign consulting, rapid prototyping and licensing when a study shows how a device could be better; molecular design when the question is the drug on the device.
How a study runs
- Scientific kick-off: endpoints, device, anatomical scenarios, signed protocol
- Anatomical procurement: fresh-frozen preparation, cold chain, Cadaver Lab preparation
- Experimental set-up: perfusion system, OCT and IVUS calibration, micro-CT geometry, baseline pilot
- Experiment: your device, imaging before, during and after, full video; remote participation possible
- Micro-CT and histomorphometry: high-resolution scan, 3D cross-sections, histology if requested
- Core-lab analysis: dissection, expansion, plaque modification, release uniformity, statistics
- Delivery and debrief: report, raw data and video; one hour with your R&D team
FRACTAL
FRACTure Analysis after Lithotripsy
Ex vivo study · protocol stage · 2026
Lithotripsy fractures calcium, and the fracture pattern decides how the vessel yields. FRACTAL maps that pattern on micro-CT, fracture by fracture.
- Design
- Ex vivo, two arms: intravascular lithotripsy versus a non-compliant balloon, on calcified human coronary segments from fresh-frozen hearts.
- Primary readout
- Circumferential fracture map from micro-CT: number, depth and angular position of calcium fractures, with dose–response across pulse counts.
- Secondary readouts
- OCT and IVUS lumen gain and fracture visibility; histology of the treated segment.
- What the partner receives
- A fracture atlas per lesion, the dose–response curve, and a device digital twin trained on the measurements.
Device digital twin
Schematic twin of a lithotripsy balloon in a calcified segment: inflation, pressure pulses, fracture propagation and post-dilatation, with a magnified view of the contact between membrane and calcium. The sequence runs on its own. Geometry, forces and fracture count are schematic; study data will replace them.
Inflation
- Pressure
- 0.0 atm
- Pulses
- 00 / 10
- Fractures
- 0
- Lumen gain
- +0%
Fig. 06 · Device digital twin, schematic simulation. Study data will replace geometry, forces and fracture count.
Torino, 45°04′N.
Two hours from Milano, three from Lyon, four from Zürich. A university hospital with a cath lab and a pathology unit, a molecular imaging centre with a micro-CT, a polytechnic with a bioengineering department, and an additive-manufacturing competence centre, all within the same city.
- Micro-CT
- 30 µm voxels at a university molecular imaging facility
- Histology
- University hospital pathology unit
- Cath labs
- Interventional cardiology units of the Torino area
- Engineering
- Bioengineering and additive manufacturing partners
Start a study.
Tell us the device or the molecule and the question you need answered. We reply with a first design and a realistic timeline.