Class III Medical Device · Cardiac Surgery · MDR Pathway
Autologous Cardiac Regeneration for the 64 Million Living with Heart Failure.
Heart failure affects more than 64 million people globally (American Heart Association, 2025). CardYograft develops an autologous cardiac patch — tissue from the patient, prepared in the operating room, applied during coronary artery bypass surgery. The technology is industrialised on the ISO 13485 platform of HBW Rigenera, an established medtech manufacturer with fifteen years of regulatory experience and distribution reaching more than seventy markets. A development roadmap targets less invasive, transthoracic delivery in the next decade.
Indication
Heart failure · CABG adjunct
MECHANISM
Autologous · paracrine
Regulatory class
Class III · EU MDR
Industrial base
ISO 13485 · 70+ markets
Clinical stage
Randomised, double-blind controlled clinical investigation · ongoing
Target CE-mark
2029 - 2030
01 - TECHNOLOGY
An Intraoperative Autologous Patch for the Failing Ventricle
PROCEDURE
Tissue harvest. A small fragment of right atrial appendage is collected during coronary bypass surgery — a routinely accessible source of autologous cardiac tissue, requiring no separate procedure.
Processing
Intraoperative preparation. The tissue is processed into vital micrografts using a CE-marked, ISO 13485-manufactured device platform with over a decade of clinical use in regenerative medicine across more than seventy markets, adapted by Cardyograft to the cardiac application. The micrografts are then seeded onto a biocompatible scaffold directly within the operating theatre, eliminating the logistical burden of off-site cell expansion.
Application
Epicardial placement. The patch is applied directly to the epicardial surface of the beating heart at the conclusion of the bypass procedure. Application adds approximately 15 — 20 minutes to standard CABG.
Mechanism
Predominantly paracrine. The autologous micrografts release signalling factors that act on resident cardiac cells, supporting ventricular thickness wall at the graft site in the months following surgery.
Regulatory pathway
Medical device, not ATMP. CardYograft is developed as a Class III device under EU MDR — a deliberate strategic choice that avoids the operational complexity of centralised cell-therapy manufacturing.
Schematic — intraoperative application of the autologous patch on the epicardial surface, concurrent with coronary bypass grafting. Illustrative only; not to clinical scale.
02 - EVIDENCE
Early Clinical Signals from the First-in-Human Series
+1.0 mm
Viable wall thickness gained at the graft site, versus −1.4 mm lost in controls · p = 0.0085 · CMR at 6 months · first-in-human series
n = 6
50 Patients
70+
Endpoints and outcomes from a small first-in-human series. Pivotal evidence remains to be established in the planned randomised controlled trial. Figures are illustrative and do not constitute claims of clinical efficacy.
03 - PIPELINE
From Open-Chest Adjunct to Minimally Invasive Delivery
Class III certification and commercial launch in Europe and selected international markets via the established distribution network.
2021
First-in-human series
6 patients treated, 5 controls · 6-month follow-up · Investigator-led, Northern Europe · Nummi et al., Front Cardiovasc Med 2021
COMPLETED
2026 - 2027
Technology transfer & QMS
ISO 13485 integration. Component validation. Sterile kit configuration. Design freeze & validation roadmap definition.
IN PROGRESS
2027 -2029
Pivotal RCT
a. Two-phase clinical protocol with early stopping to improve cost efficiency and patient safety.
b. 300-patient multi-centre randomised trial. Primary endpoint: LVEF and scar burden at 12 months.
PLANNED
2030 →
Less-invasive delivery
Thoracoscopic, robot-assisted, percutaneous needle-based application on the patch.
PLANNED
04 - IP & R&D
A Decade of Academic Research, Consolidated into an Industrial Asset
CardYograft’s intellectual property was developed through research conducted at a Northern European university spin-off and is exclusively held by the company.
Regulatory pathway: Class III medical device according to Article 22 MDR 2017/745.
05 - TEAM & PARTNERS
Academic Origin Paired with Industrial Medtech Infrastructure
CardYograft’s intellectual property originates from research conducted at a Northern European university spin-off and is held by the company through an exclusive transfer agreement. The portfolio covers device composition, processing workflow, and surgical application.
Academic spin-off origin
Autologous micrograft processing
The core technology was developed over a decade by a research group at a Northern European university spin-off, in collaboration with cardiac surgeons. Founding scientists remain involved as shareholders and technical advisors.
Industrial partner · majority shareholder
ISO 13485 manufacturing backbone
An established medtech company with fifteen years of regulatory experience, ISO 13485 quality management system, internal manufacturing capabilities, and a distribution network reaching more than seventy countries.
Clinical leadership
Cardiac surgery expertise
CardYograft works with cardiac surgeons and cardiologists actively engaged in heart failure and bypass programmes, supporting study design, KOL relationships, and clinical site coordination.
Institutional capital
Seed investors
The company is backed by institutional seed investors with established track records in medtech and life sciences. A Series A round targeting specialised European life-sciences funds is in preparation.
06 - LEGAL & CONTACT
Corporate Disclosure and Points of Contact
CardYograft S.r.l. is registered in the special section of the Italian Companies Register dedicated to Innovative Start-ups, pursuant to Decree-Law 179 of 18 October 2012, article 25 and subsequent amendments.
- Legal name
- CardYograft S.r.l.
- Registered office
- Corso Galileo Ferraris 63, 10128 Torino (TO), Italy
- VAT / Tax code
- 13468300010
- Share capital
- € 10.000€
- Certified email
- cardyograft@pec.it
- Special section
- Innovative Start-up · Chamber of Commerce of Turin
Contact CardYograft
For partnership, clinical, regulatory, or investor enquiries.
The information contained on this website is intended for general corporate communication purposes. It does not constitute medical advice, an offer to sell securities, or a solicitation of investment. The product described is in clinical development and is not yet authorised for commercial use.