21 February 2023
Xeltis raises €32 million to drive clinical development of world’s most advanced restorative cardiovascular devices
New investors DaVita Venture Group and Invest-NL join syndicate of international investors, including Grand Pharma and EQT Life Sciences, investing from the LSP Health Economics Fund 2, in series D2 fundraise
Use of proceeds to advance Xeltis’ aXess vascular access graft into pivotal clinical trials
EINDHOVEN, The Netherlands – 21 February 2023, Xeltis, a clinical stage medtech company developing living implants that enable the body to restore cardiovascular function, announces that it has raised €32 million in a Series D2 equity fundraise. The fundraise has been backed by a syndicate of current and new investors, including Grand Pharma, DaVita Venture Group, EQT Life Sciences, Invest-NL and other international investors. This fundraising round will enable Xeltis to progress its key clinical programs into pivotal trials, as it aims to give patients around the world access to the world’s most advanced restorative cardiovascular devices.
Xeltis’ breakthrough technology is focused on restoring the body’s natural cardiovascular functions, with numerous potential applications. The Company’s proprietary endogenous tissue restoration (ETR) platform utilizes an advanced polymer-based material which triggers the body’s natural healing response to regenerate the patient’s own tissue around it, forming new, living and long-lasting vessels and valves.
Xeltis’ most advanced program, aXess, is a vascular access graft for patients with chronic kidney disease (CKD) requiring hemodialysis. Preliminary in-human clinical trial data from the Company’s ongoing aXess studies have been very encouraging. The Company is also pursuing clinical programs in pulmonary valve replacement and coronary artery bypass grafts.
Alongside the equity fundraise, Xeltis and Grand Pharma have completed a license deal, covering Greater China, for aXess and other potential hemodialysis products developed under the same technology platform. Under the agreement, Grand Pharma will have exclusive rights to develop, produce and commercialize these products in Greater China.
“The strategic support of Grand Pharma and DaVita alongside our existing investor base represents a strong validation of our technology and potential to transform the landscape of cardiovascular surgery. We remain focused on progressing our aXess clinical trials, as well as exploring our next steps in other indications,” commented Eliane Schutte, CEO of Xeltis. “Securing this financing is an important milestone for Xeltis. We are proud to have attracted such high-profile investors to our company and look forward to leveraging their respective insights – from clinical expertise to the product development lifecycle – as we continue on the next phase of growth.”
Steve Phillips, Group Vice President for DaVita Venture Group, said: “We’re incredibly energized by the progress Xeltis has made in developing a technology to improve care for patients receiving life-sustaining dialysis care. This investment is spurred by our commitment to kidney care transformation and advancing solutions that improve the quality of life for patients.”
Frank Zhou, Grand Pharmaceutical Group CEO, added: “Xeltis is leading the way in addressing the current limitations of access grafts for hemodialysis patients, using a ground-breaking approach based on its world-leading ETR platform. We believe the company’s technology has enormous potential to benefit patients and hospital care systems globally.”
Notes to editors
About Chronic Kidney Disease
Chronic Kidney Disease (CKD) affects nine percent of the population, with growing prevalence due to cardiovascular disease (diabetes, hypertension, obesity). Patients with CKD have a reduced quality of life due to living with significant constraints and restrictions brought on by disease related manifestations and side effects of treatments. Each year, three million patients with chronic kidney disease need hemodialysis and require vascular access to connect to a dialysis machine.
About the AXESS pivotal clinical trial
The EU AXESS pivotal trial is a prospective multi-center study evaluating the safety and performance of the Xeltis hemodialysis access graft in adult patients with end-stage renal disease, who plan to undergo hemodialysis and are deemed unsuitable for fistula creation. The trial is ongoing at 25 implanting centers across Europe.
Xeltis is an advanced medtech company developing next generation implants that naturally integrate into the body to restore and sustain vascular and valve function. Xeltis’ products seek to address the limitations of currently available options for the millions of people requiring access grafts or cardiovascular replacements every year. The Company’s proprietary endogenous tissue restoration (ETR) platform utilizes an advanced polymer-based material which triggers the body’s natural healing response to regenerate the patient’s own tissue around it, before gradually being absorbed and leaving new, living and long-lasting vessels and valves in place. Xeltis’ restorative devices include implantable small diameter blood vessels for hemodialysis vascular access (aXess), currently in pivotal clinical trials, and for coronary artery bypass graft (CABG) surgery (XABG), as well as a pulmonary heart valve.
Xeltis is based in The Netherlands and the USA and its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, and Ysios Capital, as well as Grand Pharma Group and several public and private investors.