Composite cardiovascular devices

A new heart valve for the patients today's valves fail.

Syntex is developing a polymeric heart valve for young people with rheumatic heart disease — engineered to combine the durability of a mechanical valve with the biocompatibility of tissue, without a lifetime of anticoagulant drugs.

Our technology Get in touch
The challenge

Rheumatic heart disease strikes the young — and no valve serves them well.

Rheumatic fever scars the heart valves of millions of people in low- and middle-income countries. Patients reach surgery around the age of 40, decades younger than valve patients in the West, and face a hard choice between two imperfect devices.

55M
people living with rheumatic heart disease worldwide
360K
deaths every year, mostly in lower-income countries
~40
average age at valve surgery
80%+
of cases in low- & middle-income countries
✕

Tissue valves wear out

Biological valves deteriorate quickly in young patients, forcing repeated open-heart surgery within a decade.

✕

Mechanical valves mean warfarin

Mechanical valves last, but commit the patient to lifelong anticoagulation — difficult to monitor and manage in many health systems.

Our technology

The durability of mechanical, the biology of tissue — in one material.

At the heart of Syntex is a tuneable-stiffness composite leaflet: a polymer engineered to reproduce the graded, directional mechanics of a healthy native valve. It opens and closes like living tissue, resists calcification, and needs no lifelong blood thinners.

≥50%
targeted reduction in peak leaflet stress at the commissures — where valves fatigue, crack and calcify
~10×
resulting gain in fatigue life, from the stress–life relationship — targeting well beyond 600 million cycles
4 → 0
designed against every failure mode that has kept polymer valves out of the clinic
How it works

Engineering a leaflet against the way valves fail.

◧

Graded stiffness

Spatially tuned material flattens the stress peak at the commissures, the first place leaflets fatigue and mineralise.

✛

Calcification-resistant

A biostable polymer with low leaflet strain removes the sites where mineral deposits normally take hold.

≈

Biomimetic flow

Native-like leaflet motion gives clean washout and haemocompatibility — the basis for life without warfarin.

Where we are

Early, and already de-risked.

Syntex is a pre-clinical venture advancing its valve through design, validation and the regulatory pathway, capital-efficiently and with an experienced scientific team.

Intellectual property

Patents filed

Core invention protected — PCT filed, entering national phase across eight jurisdictions.

Biocompatibility

Cytotoxicity: pass

The composite leaflet material passed ISO 10993-5 cytotoxicity testing at an accredited public institute.

In vivo

Well tolerated in vivo

Early subcutaneous implant studies in small animals showed good local tissue tolerance.

Our focus

Built for emerging markets.

Rheumatic heart disease is overwhelmingly a disease of emerging economies. We are developing Syntex for the health systems that need it most — where millions of people are affected and current devices fall short. Our aim is a valve that is not only better for young patients, but affordable at the scale these regions require.

Team & partners

The team behind Syntex.

Roberto Volpe, Co-Founder & CEO of Syntex
Co-Founder & CEO
Roberto Volpe, PhD, MBA, MEng

Senior Lecturer in Chemical Engineering at Queen Mary University of London. Roberto holds a PhD and a summa cum laude MEng in Mechanical Engineering, both from the University of Palermo (MEng 1998), and an MBA from SDA Bocconi School of Management, Milan (2003). He combines expertise in advanced materials and engineering with business and industry experience, leading Syntex's technology development and commercial strategy.

Advisory board

Guided by deep industry experience.

Joanna Tufnell, Advisor to Syntex
Advisor · Regulatory & Quality
Joanna Tufnell, LLB

Joanna has more than 40 years' experience in the pharmaceutical and healthcare industries, spanning regulatory affairs, quality management and pharmaceutical consulting. She has worked with major companies including GSK, MSD, Janssen, Celgene, Sandoz, Biogen, Elan, Sanofi-Aventis and AstraZeneca, and with start-ups including Synergen, Inflazome, Sitala and Soleno.

She was the founding Director of PharmaRegistration International, a regulatory consultancy serving biotechnology, pharmaceutical, veterinary and medical-device companies; Zenosis, an online training company for regulatory affairs; and Micropath, a medical-device company. Joanna is a Fellow of the Royal Society of Medicine, TOPRA and the Royal Society for the encouragement of Arts, Manufactures and Commerce (RSA), and holds an LLB in law.

Regulatory strategy Medical devices Drug development Compliance Pharmacovigilance
Partners
QM

In partnership with Queen Mary Innovation

Syntex is developed in partnership with Queen Mary Innovation, the technology-transfer company of Queen Mary University of London — supporting the venture's intellectual property and translation from research to clinic.

Strategic partners

Specialty-polymer and medical-device manufacturers supporting material supply and production.

Research & testing network

In-vitro, in-vivo and computational testing with partner laboratories in the UK, Switzerland and Italy.

Contact

Let's talk.

For partnership, clinical or investment enquiries, we'd be glad to hear from you.

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