#1 Killer, Short-lived Options

Cardiovascular diseases (CVDs) are the leading cause of death globally.[1]

Today, patients with a number of cardiovascular conditions suffer repeated procedures and complications or take long term medication with potentially severe side effects.

This is especially evident in patients with artificial heart valves and in patients with vessel occlusion who undertake bypass procedures to reduce the risk of heart attack, stroke or limb loss.

Coronary Artery Bypass Graft (CABG)

Coronary Artery Bypass grafting is the gold standard for coronary artery disease treatment caused by blood vessel occlusion/narrowing[1,2,3,4,5,6]

Around 1 million patients undergo CABG surgery each year.

The CABG procedure is normally performed by harvesting patient’s own veins[7]

Progressive vein graft failure frequently occurs following CABG, limiting the long-term success of the operation.[8]

On average, around 20% of veins occlude by the end of the first year after CABG surgery.[6]

Endoscopic harvesting of saphenous veins is an alternative but also expensive option, with inferior patency of vein grafts compared to arterial grafts. Synthetic grafts are currently not available.

Heart Valve Replacement

Heart valve disease affects 2% of the population in industrialised countries, while many of them remain undiagnosed.[9,10]

Hundreds of thousands of patients undertake heart valve intervention every year.[1]

Artificial heart valves currently available can be life savers. However, all existing options involve some compromise.

Patients with biological valves may endure repeated replacement procedures. Mechanical heart valves require life-long anticoagulation treatment, with potentially severe side effects.

Fully synthetic heart valves are currently not available.

Citations

[1] Benjamin EJ, et al. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492

[2] Benedetto U, et al. Coronary surgery is superior to drug eluting stents in multivessel disease. Systematic review and meta-analysis of contemporary randomized controlled trials. Int J Cardiol 2016;210:19–24.

[3] Mohr FW, et al. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet 2013 Feb 23;381(9867):629-38

[4] Mäkikallio T, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting n treatment of unprotected left main stenosis (NOBLE), a prospective , randomised, open label, non inferiority trial. Lancet 2016, October 31. S0140-6736(16)32052-9

[5] Taggart DP, et al, A prospective study of external stenting of saphenous vein grafts to the right coronary artery: the VEST II study. European Journal of Cardio-Thoracic Surgery 0 (2017) 1–7

[6] Shavadia J. Symptomatic graft failure and impact on clinical outcome after coronary artery bypass grafting surgery: Results from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease registry. Am Heart J. 2015 Jun;169(6):833-40.

[7] Tabata M, et al. Prevalence and variability of internal mammary artery graft use in contemporary multivessel coronary artery bypass graft surgery: analysis of the society of thoracic surgeons national cardiac database. Circulation, 2009;120:935–40.

[8] Harskamp RE, et al. Saphenous vein graft failure after coronary artery bypass surgery: pathophysiology, management, and future directions. Ann Surg. 2013;257:824–33.

[9] Iung B, Vahanian A. Epidemiology of acquired valvular heart disease. Can J Cardiol. 2014 Sep;30(9):962-70.

[10] Nkomo VT, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2016 Sep. 368(9540):1005-1011

Naturally restoring cardiovascular function

Xeltis is pioneering a restorative approach in cardiovascular therapy to overcome the limitations of existing treatment alternatives.

Xeltis cardiovascular devices enable the patient’s own body to naturally restore a new blood vessel or heart valve through a therapeutic process called Endogenous Tissue Restoration, or ETR.

Xeltis’ platform is the world’s first polymer-based technology for natural cardiovascular restoration in clinical trial phase.

Fully synthetic cardiovascular devices can be developed on large-scale. By overcoming cumbersome manufacturing process, such as those of biological valves, these devices would make cardiovascular replacement potentially available more widely at a global level, even in developing countries.

Xeltis’ History

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

Regenerative Medicine

  • First tissue transplantation experiments

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

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

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

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

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

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

19TH CENTURY20TH CENTURY1930s1960s – 80s:1990sNEW MILLENNIUM2006 and 2007

Supramolecular Chemistry

  • Supramolecular chemistry postulates.
     
     
     
     
     
     
     
     
     
     
     
     
     

  • 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.

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

19TH CENTURY1960s – 80s1990s and NEW MILLENNIUM

Electrospinning

  • First electrospinning experiments.

  • Electrospinning first patented.

  • First industrial use of electrospun equipment.

  • Industrial production of electrospun filters.

  • Growth of scientific research on electrospinning.

  • Research develops on usage of electrospinning in medical applications.

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

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

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

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

  • Xplore-2 trial in US

    Xeltis Series C financing round closed

  • Small diameter blood vessels enter preclinical trial phase
    Patient enrolment completed for EFS

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.