What Xeltis does

Xeltis B.V. is a privately held, clinical-stage medical device company founded in 2006 and headquartered in Eindhoven, Netherlands, that develops restorative cardiovascular implants based on its proprietary Endogenous Tissue Restoration (ETR) platform. The ETR technology employs supramolecular polymers — a chemistry rooted in Nobel Prize-winning breakthroughs by Professor Jean-Marie Lehn — fabricated via electrospinning into microstructured implants that are gradually absorbed by the body and replaced by the patient's own living tissue. The company's lead product, aXess, is a restorative vascular access conduit for hemodialysis patients that demonstrated 100% secondary patency and 0% infection at 12 months in first-in-human trials and 79% secondary patency in the EU Pivotal Trial; it received CE Mark and FDA Breakthrough Device Designation. Two additional pipeline products — XABG (a small-diameter restorative coronary artery bypass graft) and Xplore 2 (a pediatric pulmonary heart valve) — extend the ETR platform to other cardiovascular indications.

Xeltis targets approximately 3 million hemodialysis patients globally per year and roughly 1 million CABG patients per year, addressing well-documented failure modes of existing solutions including thrombosis, stenosis, calcification, infection, and the surgical burden of saphenous vein harvesting. The business model is hardware sales of regulated implantable devices to hospitals and specialized dialysis centers via a direct enterprise field sales motion, supplemented by a Greater China licensing partnership with Grand Pharmaceutical Group. The company is pre-revenue with commercialization in Europe and the US anticipated in 2026.

Xeltis has raised over €150 million across multiple funding rounds from a syndicate including the European Investment Bank, European Innovation Council Fund, EQT Life Sciences, DaVita Venture Group, Invest-NL, VI Partners, Ysios Capital, Kurma Partners, and Grand Pharmaceutical Group. The leadership team is led by CEO Eliane Schutte (appointed 2018, two-time Top 50 Healthcare Technology CEO) and includes CTO Rob Eyers, CMO Paulo Neves, COO Luciën van Os, and CFO Alexander Goemans, supported by an advisory board anchored by Nobel Laureate Jean-Marie Lehn. The company operates clinical programs across 9 European countries and the US, with the FDA-approved US pivotal trial enrolling up to 140 patients alongside the completed EU pivotal trial of 120 patients.

Name

Xeltis

Legal name

Xeltis B.V.

Website

https://xeltis.com

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

11–50 employees

Short description

Xeltis is a clinical-stage medtech company developing restorative cardiovascular devices — including the aXess hemodialysis conduit, XABG coronary bypass graft, and Xplore 2 pulmonary valve — based on a proprietary supramolecular polymer platform that enables implants to be gradually replaced by patients' own living tissue.

Ownership category

akta.pro rank

Product category

Cardiovascular Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

Vascular Access & Closure Devices (Sheaths, Guidewires, Closure Systems) (HLAHAFAK)

akta.pro secondary industries

Coronary Stents & Drug-Eluting Technologies (HLAHAFAA), Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation) (HLAHAFAL)

Keywords

• Restorative cardiovascular devices
• Vascular access conduits
• Hemodialysis access grafts
• Coronary artery bypass grafts
• Bioabsorbable polymer implants

Headquarters

HQ city

Eindhoven

HQ country

Netherlands

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales, Infrastructure

Revenue model

1. Medical Device Sales (Pre-Revenue): Xeltis is a pre-revenue clinical-stage medtech company. Revenue will be generated through the sale of its implantable medical devices (aXess, XABG, pulmonary valves) to hospitals and healthcare providers upon regulatory approval. The company is preparing for commercialization with CE Mark recently obtained for aXess and US market approval anticipated in 2026.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Xeltis develops and manufactures implantable, bioabsorbable cardiovascular devices — primarily artificial vessels and heart valves — built on its proprietary Endogenous Tissue Restoration (ETR) platform using supramolecular polymers. Its lead product aXess is a restorative vascular access conduit for hemodialysis patients, and the company is also advancing XABG (coronary artery bypass graft) and Xplore 2 (pediatric pulmonary heart valve). The company is preparing for commercialization with CE Mark obtained for aXess and FDA Breakthrough Device Designation granted in the US.

Product overview

Xeltis is a medtech company developing transformative vascular implants based on its proprietary Endogenous Tissue Restoration (ETR) platform. The company offers a portfolio of restorative cardiovascular devices: aXess (vascular access conduit for hemodialysis), XABG (coronary artery bypass graft), and Xplore 2 (pulmonary heart valve). These implants are designed to be gradually replaced by the patient's own living tissue, reducing risks of thrombosis, stenosis, calcification, and infection associated with conventional vascular grafts and valves.

Differentiator

Problem solved

Functional benefit

Brands

• aXess: Restorative vascular access conduit for hemodialysis patients that enables creation of new, permanent, living vessels for vascular access
• XABG
• Xplore 2
• RestoreX

Products and services

• aXess Vascular Access Conduit Restorative arteriovenous vascular access conduit for hemodialysis patients who cannot receive an AV fistula; combines AV fistula safety and patency with AV graft speed to treatment, designed to become the patient's own living vessel via the ETR platform. Targeted at vascular surgeons, nephrologists, dialysis centers and hospitals in the EU and US (CE Mark obtained; FDA pivotal trial underway, up to 140 patients).
• XABG Coronary Artery Bypass Graft Restorative synthetic small-diameter (4mm diameter, 15cm length) coronary artery bypass graft designed to turn into a living blood vessel when colonized by the patient's own tissue via the ETR platform; intended as an alternative to saphenous vein harvest in CABG surgery. Preclinical data showed unprecedented one-year patency in large-animal models. Targeted at cardiac surgeons and cardiac surgery centers.
• Xplore 2 Pulmonary Heart Valve Conduit Restorative pulmonary heart valve conduit for pediatric patients requiring pulmonary valve replacement, built on the ETR platform; designed to integrate with the patient's growing tissue and potentially reduce repeated replacement surgeries. Early outcomes from Xplore-1 and Xplore-2 trials demonstrate excellent safety and performance. Targeted at pediatric cardiac surgeons and congenital heart disease centers.

Quantifiable outcome

• 79% secondary patency at 12 months in EU pivotal trial, significantly higher than conventional AV grafts
• +4 more outcomes

Named customers6 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators14 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Humacyte: Humacyte develops bioengineered human acellular vessels for vascular access (dialysis) and vascular trauma indications — the most direct peer to Xeltis' aXess program. Both companies are pursuing regenerative vascular graft approaches to displace ePTFE grafts in hemodialysis, and Xeltis' VP of US Clinical Affairs previously worked at Humacyte.
• W. L. Gore & Associates: Gore is the dominant incumbent in synthetic vascular grafts (GORE-TEX) used for hemodialysis vascular access and peripheral vascular reconstruction. Xeltis' aXess is explicitly positioned to displace this standard of care. Gore also acquired InnAVasc Medical in 2022, where Xeltis' current US VP of Clinical Affairs previously served.
• LeMaitre Vascular: LeMaitre Vascular specializes in vascular grafts, patches, and carotid shunts used in vascular surgery — directly overlapping with Xeltis' vascular access and reconstructive vascular indications across EU and US hospitals.
• Artivion: Artivion (formerly CryoLife) is a leader in preserved human tissues and mechanical heart valves for cardiac and vascular surgery, making it a direct peer to Xeltis' Xplore 2 pulmonary valve and broader cardiac surgery applications.

Broad incumbents

• Edwards Lifesciences: Edwards is a global leader in heart valve replacement and hemodynamic monitoring, with established transcatheter and surgical valve franchises. It is a broad incumbent in cardiac surgery — the same clinical specialty where Xeltis' Xplore 2 and future valve indications will compete.
• Medtronic: Medtronic operates across the cardiovascular device spectrum — including CABG and heart valve products — and is the broader incumbent against which Xeltis' XABG and valve programs will compete. Xeltis' COO previously led international cardiovascular development at Medtronic.
• Abbott: Abbott manufactures cardiovascular devices including surgical valve and coronary intervention products. Xeltis' CMO has prior consulting experience with Abbott, and Abbott represents a broad incumbent in the CABG and heart valve categories Xeltis targets.
• Boston Scientific: Boston Scientific is a major cardiovascular device incumbent with peripheral vascular and structural heart franchises. Xeltis' CTO Rob Eyers previously served as R&D Director at Boston Scientific, and the company's broad portfolio competes with Xeltis' peripheral and cardiac indications.
• BD (Becton Dickinson): BD is a broad incumbent in vascular access and dialysis-related medical devices, supplying catheters and access products to the same nephrology and vascular surgery channels where Xeltis intends to commercialize aXess.

Emerging players

• CorMatrix Cardiovascular: CorMatrix develops bioengineered ECM-based materials for cardiac and vascular repair, representing an emerging adjacent peer in regenerative cardiovascular implants. It pursues overlapping indications (pericardial repair, vascular reconstruction) with Xeltis' ETR platform.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/xeltis
• Facebookfacebook.com/Xeltis
• LinkedInlinkedin.com/company/xeltis

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds12 records

Investors11 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Xeltis