Pioneering a Restorative Approach

Heart valve disease is a serious condition. In industrialized countries, it affects around 2% of the population and many patients remain undiagnosed.

In these countries, hundreds of thousands of patients undertake heart valve intervention every year. This figure is expected to rise substantially due to aging of the population and better diagnosis of pre-existing heart valve disease.

Biological and mechanical heart valves can be life savers. However, all existing options involve some compromise. Patients with biological valves may endure repeated replacement procedures. Mechanical valves require long-term medication, with potentially severe side effects.

Xeltis is pioneering a restorative approach in heart valve therapy to overcome the limitations of existing options.

Xeltis’ heart valves enable the patient’s own body to naturally restore a new heart valve through a therapeutic approach called Endogenous Tissue Restoration (ETR).

Xeltis’ history is the culmination of substantial developments in regenerative medicine, supramolecular chemistry and electrospinning.

Regenerative
Medicine

19TH CENTURY:

First tissue transplantation experiments

20TH CENTURY:

cardiovascular restoration

First cultivation of cells outside of the body and organ ‘culture’ by Alexis Carrel – Nobel Prize laureate for his transplantation work

1930s:

cardiovascular restoration

First bioreactor created by unique engineering medicine cooperation: Carell and world-famous pilot Charles A. Lindbergh

1960s – 80s:

Fundamental in vitro tissue growth work with first dermal cell culture on a scaffold from Massachusetts General Hospital and Boston MIT collaboration

 

1990s:

Tissue engineering: mouse with subcutaneous artificial scaffold works as bioreactor for cell in-growth. Harvard at the center of the heart-valve tissue-engineering

 

NEW MILLENNIUM:

Cardiovascular tissue engineering takes off with University of Zurich (UZH) collaborating with Frank Baaijens’ team at Eindhoven University of Technology (TU/e)

2006 and 2007:

cardiovascular restoration

Xeltis and QTIS founded respectively as spin-offs of UZH and TU/e to develop tissue-engineered heart valves

 

 
Supramolecular
Chemistry

19TH CENTURY:

Supramolecular chemistry postulates

 

1960s – 80s:

cardiovascular restoration

Fundamental science of supramolecular chemistry established with 1987 Nobel Prize for Chemistry awarded to Jean-Marie Lehn, Donald J. Cram and Charles J. Pedersen for their supramolecular chemistry work

1990s and NEW MILLENNIUM:

cardiovascular restoration

New supramolecular building blocks’ development by Bert Meijer at Eindhoven University of Technology

 
Electrospinning

19TH CENTURY:

First electrospinning experiments

cardiovascular restoration

20TH CENTURY:

Electrospinning first patented

1930s:

First industrial use of electrospun equipment

1940s – 60s:

Industrial production of electrospun filters

 

1990s:

Growth of scientific research on electrospinning

 

NEW MILLENNIUM:

Research develops on usage of electrospinning in medical applications

 

2008 ONWARDS:

Research on tissue regeneration, supramolecular polymers and electrospinning join with Frank Baaijens’ group starting research on ‘in situ tissue engineering’, now called ETR.

cardiovascular restoration

2011:

Xeltis and QTIS merge, abandon tissue engineering to focus on ETR and to develop the RestoreX technology platform.

2013:

First patients implanted with Xeltis bioabsorbable blood vessels (pulmonary conduit) and patches.

2016:

First patient implanted with Xeltis bioabsorbable pulmonary heart valve in clinical trials, with Thierry Carrel as Principal Investigator.

cardiovascular restoration

Xeltis International Medical and Scientific Advisory Boards established.

Xeltis bioabsorbable aortic valve in preclinical trials

 

2017:

Xplore-II trial in US

Xeltis Series C €45M financing

Xeltis is carrying the legacy of hundreds of years of research made by incredible visionaries and scientists.

Most of the (contemporary) people named are today involved with the company.

Scientific Literature

  1. The Journal of Thoracic and Cardiovascular Surgery (JTCVS): Total Cavo-Pulmonary Connection with a New Bio-Absorbable Vascular Graft First Clinical Experience VIEW
  2. Biomaterials: In Situ Heart Valve Tissue Engineering Using a Bioresorbable Elastomeric Implant – From Material Design to 12 Months Follow-up in Sheep VIEW
  3. Science Translational Medicine: 50 Shades of Red VIEW
  4. EuroIntervention Restorative valve therapy by endogenous tissue restoration: tomorrow's world? VIEW
  5. EuroIntervention Mid-term performance of a novel restorative pulmonary valved-conduit: preclinical results VIEW
  6. EuroIntervention Acute performance of a novel restorative transcatheter aortic valve: preclinical results VIEW

Academic Partnerships

Xeltis is actively involved in research collaborations with leading academic partners. Scientific research projects enable Xeltis to increase our knowledge of ETR, by leveraging the deep scientific understanding achieved at an academic level, and to contribute to our robust knowledge of technology application in the field.

Xeltis Academic Partnerships include among others:

  • RegMed XB:

    The RegMed XB Institute brings together multiple health foundations, leading scientists, entrepreneurs and government institutions to cooperatively tackle ambitious challenges in regenerative medicine.

  • ImaValve:

    The ImaValve Consortium, led by Professor Bouten from Eindhoven University of Technology (TU/e), aims at using intelligent materials to develop innovative solutions for the challenging research field of in situ cardiovascular restoration. The ImaValve is made of a slowly degrading elastomeric polymer that can be inserted with minimally invasive surgery.

  • iValve-II:

    The iValve-II project is a continuation from the BMM iValve project, with a public-private consortium led by Professor Bouten from TU/e. The focus of this academic collaboration is on using restorative approaches to repair or replace damaged tissues and organs.

  • InSiteVx:

    The InSiTeVx Consortium, led by Professor Dankers from TU/e, is investigating whether the understanding on cardiovascular restoration from previous projects can be translated to develop an off-the-shelf, synthetic, biodegradable vascular access graft for dialysis.