The Netherlands-based Xeltis, a clinical-stage medical device company, announced on Tuesday that it has raised €15M in a Series D2 round of funding.
The investment came from China-based Grand Pharmaceutical Group. The deal, which primarily focuses on the aXess restorative hemodialysis access device from Xeltis, also covers additional novel hemodialysis products created on the same technological foundation.
Grand Pharmaceutical will also have exclusive rights of development, production and commercialisation, as well as pre-emptive negotiation rights for Xeltis’ products developed in other indications in the Greater China region.
Grand Pharmaceutical’s CEO, Frank Zhou, says, “Grand Pharma is building interventional diagnosis and treatment platform for cardiovascular and cerebrovascular diseases in China. Xeltis’ aXess device would represent an excellent addition to the scope of our broad portfolio and is expected to bring significant clinical impact in China.”
What is aXess?
Xeltis claims aXess is a restorative cardiovascular access graft for hemodialysis-dependent patients with chronic kidney disease (CKD). China has the largest number of CKD patients in the world, accounting for about 130 million people – around 580,000 are currently on hemodialysis. The number of people on hemodialysis in China is projected to increase by 15 per cent in the next five years.
The aXess graft functions similarly to some of the ePTFE synthetic hemodialysis access grafts that are currently in the market in that it allows early puncturing or dialysis to begin. Additionally, like an arteriovenous fistula, it is intended to develop into the patient’s own living blood vessel.
The patient’s own tissue gradually colonises the biocompatible, porous microstructure of the implant after implantation, taking over the operation before the original device is absorbed by the body. The term for this procedure is endogenous tissue restoration (ETR).
Xeltis CEO, Eliane Schutte, says, “Grand Pharma’s commitment to invest in Xeltis brings global validation of aXess’ commercial potential from one of the largest Chinese life sciences companies, from the country with the largest need of hemodialysis access globally. It confirms the strength of our technology platform and clinical evidence to date, and supports our goal of providing potentially more durable, transformative restorative devices for patients worldwide.”
Brief about Xeltis
Xeltis was formed through the merger of two Dutch/Swiss university spin-offs in 2006. The company has developed a polymer-based restorative device for cardiovascular treatment. “The devices are made of supramolecular polymers shaped, through a process called electrospinning, into a microstructure that allows tissue restoration,” says the company.
The restorative devices comprise heart valves and small diameter blood vessels for coronary artery bypass graft (CABG) surgery and for hemodialysis vascular access. The company’s restorative heart valves enable the patient’s own body to naturally form a new heart valve through a therapeutic approach called Endogenous Tissue Restoration (ETR).
With ETR, the patient’s natural healing system develops tissue that pervades Xeltis’ heart valve, forming a new, natural, and fully functional valve within it. As ETR occurs, Xeltis implants are gradually absorbed by the body.
Currently, the company has initiated the development of three types of cardiovascular implants: pulmonary heart valves, coronary artery bypass graft, and hemodialysis access grafts.