Cardionovum

What Cardionovum does

Cardionovum GmbH is a privately held German medical device company headquartered in Bonn, founded in 2010 by Dr. Michael Orlowski, who introduced the first CE-marked drug-coated balloon (DCB) catheter in 2007. The company develops and markets next-generation drug-coated balloon catheters and drug-eluting stents for the interventional treatment of coronary artery disease, peripheral artery disease, and hemodialysis vascular access stenosis. Its portfolio spans five core devices: LEGFLOW (peripheral DCB for SFA and below-the-knee lesions), APERTO (the world's first high-pressure DCB for hemodialysis shunt stenosis), RESTORE DEB and RESTORE PLUS (coronary DCBs for in-stent restenosis, small vessel disease, and complex/tortuous lesions), and the XLIMUS sirolimus-eluting coronary stent with biodegradable polymer and 71 μm thin struts. All DCBs are built on the proprietary SAFEPAX third-generation paclitaxel matrix coating technology, which the company markets as providing the lowest wash-off rates and highest coating stability in the category.

The firm operates an enterprise field-sales motion targeting hospital interventional cardiology, vascular surgery, and nephrology departments, supported by a distribution network spanning more than 40 countries across Europe, Latin America, and Asia, with regional distributor partnerships (e.g., Aquilant in the UK) supplementing direct sales. Pricing is quote-based and negotiated with healthcare institutions; no public price list exists. Go-to-market is reinforced by an event-driven marketing architecture — major cardiology and vascular congresses (LINC, EuroPCR, CIRSE, GISE, Charing Cross), physician-to-physician workshops hosted at teaching hospitals (Hospital Universitari de Bellvitge, IRCCS Policlinico San Donato), the Cardionovum Academy education program, and peer-reviewed clinical publications stemming from an ongoing program with more than 1,300 patients enrolled.

Cardionovum has secured CE marking, plus NMPA approval in China (for both APERTO and RESTORE), ANVISA approval in Brazil, and COFEPRIS approval in Mexico, and reports more than 22,000 cumulative patients treated with LEGFLOW. Its products are not commercially available in the United States. Revenue mechanics are pure medical-device hardware sales to institutions; the company discloses no revenue, has no identified parent or external institutional investors, and has not publicly disclosed any funding rounds, leaving its commercial scale inferable only through employee count (11–50), country count, and cumulative treatment volume.

Name

Cardionovum

Legal name

Cardionovum GmbH

Website

https://cardionovum.de

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Short description

Cardionovum GmbH is a privately held German medical device company that develops drug-coated balloon catheters and drug-eluting stents for the interventional treatment of coronary artery disease, peripheral artery disease, and hemodialysis vascular access, selling direct and via distributors to hospitals in more than 40 countries.

Ownership category

akta.pro rank

Product category

Interventional Cardiovascular Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Coronary Stents & Drug-Eluting Technologies (HLAHAFAA)

akta.pro secondary industry

Peripheral Vascular Intervention (PAD Stents, Balloons, Atherectomy) (HLAHAFAE)

Keywords

• Drug-coated balloons
• Drug-eluting stents
• Cardiovascular medical devices
• Interventional cardiology
• Peripheral artery disease

Headquarters

HQ city

Bonn

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Sale of cardiovascular medical devices including drug-coated balloons and drug-eluting stents to hospitals and healthcare providers worldwide through direct sales and distribution network.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels5 records

Core offering

Cardionovum develops, manufactures, and sells drug-coated balloon (DCB) catheters and drug-eluting stent (DES) systems for the interventional treatment of coronary artery disease, peripheral artery disease, and hemodialysis access stenosis. Its portfolio of paclitaxel-coated and sirolimus-eluting devices is built on the proprietary SAFEPAX third-generation drug coating technology and is sold to hospitals and interventional specialists worldwide.

Product overview

Cardionovum offers a portfolio of next-generation drug-coated balloons (DCBs) and drug-eluting stents (DES) for cardiovascular therapies. The product lineup includes peripheral DCBs (LEGFLOW for SFA/BTK, APERTO for hemodialysis shunts) and coronary DCBs (RESTORE DEB and RESTORE PLUS), plus the XLIMUS sirolimus-eluting stent. All products incorporate the proprietary SAFEPAX drug coating technology, which provides superior coating stability with minimal drug crystallization. The company focuses on paclitaxel-based therapies for peripheral artery disease, coronary artery disease, and hemodialysis access management.

Differentiator

Problem solved

Functional benefit

Brands

• LEGFLOW: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter for SFA and BTK lesions
• APERTO
• RESTORE
• RESTORE PLUS
• XLIMUS
• SAFEPAX

Products and services

• LEGFLOW RX/OTW Paclitaxel Releasing Peripheral Balloon Dilatation Catheter for the treatment of superficial femoral artery (SFA) lesions and dilatation of artery lesions below the knee (BTK). Targeted at interventional radiologists and vascular surgeons performing peripheral vascular interventions.
• APERTO OTW Paclitaxel Releasing Hemodialysis Shunt Balloon Dilatation Catheter, the world's first high-pressure paclitaxel-releasing shunt DCB for treatment of hemodialysis access stenosis and recanalization of arteriovenous shunt grafts. Targeted at nephrologists and vascular surgeons managing dialysis vascular access.
• RESTORE DEB Paclitaxel Releasing Coronary Balloon Dilatation Catheter for treatment of coronary in-stent restenosis (ISR), side-branch dilatation, and small vessel lesions. Targeted at interventional cardiologists.
• RESTORE PLUS Paclitaxel Releasing PTCA Balloon Catheter specifically designed for treatment of the most complex lesions and tortuous anatomies with improved delivery performance platform. Targeted at interventional cardiologists.
• XLIMUS Sirolimus Eluting Coronary Stent System with fully biodegradable drug elution and 71 micrometer thin strut thickness, designed to treat complex coronary artery disease with optimal deliverability and crossing profile. Targeted at interventional cardiologists.
• SAFEPAX Drug Coating Technology Third-generation paclitaxel matrix coating technology with lipophilic and polymeric excipient that minimizes wash-off rate, prevents drug crystallization, and provides homogeneous non-crystalline coating for improved drug transfer and highest coating stability. Marketed as the platform technology underlying Cardionovum's DCB portfolio.

Quantifiable outcome

• Procedural success rates >98% in both ISR and SVD patients in controlled trials
• +6 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Hospital Universitari de BellvitgecoreStrategic or Co-development PartnerCollaboration on international physician workshops on drug-coated balloons in interventional cardiology. Brought together more than 30 physicians from across the globe for sharing clinical experience and discussing advances in DCB therapy.
• IRCCS Policlinico San DonatocoreStrategic or Co-development PartnerHost partner for physician-to-physician workshops advancing innovation together. Workshop brought together over 40 participants from around the world to exchange clinical experience and insights in DCB interventional cardiology.
• Aquilant (Healthcare 21 Company)minorChannel Partner/ Reseller/ DistributorUK distribution partner for Cardionovum products. Participated together at BSIR (British Society of Interventional Radiology) exhibition with booth presence.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Concept Medical: Concept Medical is an emerging DCB specialist with sirolimus-coated balloon platforms (MagicTouch) targeting coronary and peripheral indications, directly competing with Cardionovum's paclitaxel-based DCB franchise on the 'leave nothing behind' positioning that defines the category.
• Acotec Scientific: Acotec Scientific is a Beijing-based developer of drug-coated balloons including peripheral and coronary DCB platforms (e.g., AcoArt Orchid and Tulip), the closest direct DCB-native competitor in the China and emerging-market corridors where Cardionovum is also expanding.
• Biotronik: Biotronik is a German-headquartered private cardiovascular device company with a directly overlapping portfolio including Pantera Lux paclitaxel-coated balloons (coronary DCB) and Orsiro DES — making it the closest geographic and product-line comparable to Cardionovum's DCB/DES franchise.
• iVascular: iVascular is a Spanish private medical device company specializing in drug-coated balloons (including paclitaxel-coated peripheral DCBs like Freeway and coronary DCBs) and peripheral/coronary interventional devices — a near-pure-play competitor to Cardionovum's DCB portfolio in similar mid-sized private market segments.

Broad incumbents

• Medtronic: Medtronic competes through IN.PACT Admiral and IN.PACT AV paclitaxel DCBs (peripheral and dialysis access) directly against Cardionovum's LEGFLOW and APERTO platforms, and also fields the Resolute Onyx DES against XLIMUS, giving it overlapping technology breadth Cardionovum lacks at scale.
• Becton Dickinson (BD): BD acquired BTG and now markets the Lutonix DCB portfolio for peripheral vascular disease, placing it as a direct DCB competitor to LEGFLOW while leveraging a much broader medical device portfolio and global hospital sales infrastructure than Cardionovum commands.
• Abbott: Abbott's Xience DES franchise is the dominant comparator in Cardionovum's own RESTORE SVD China non-inferiority data, and Abbott also fields coronary and peripheral devices that bracket Cardionovum's coronary and vascular intervention segments through a large established sales network.
• Boston Scientific: Boston Scientific is the global DCB market leader via the ELUVIA and Ranger paclitaxel peripheral DCB franchises, and competes with Cardionovum's LEGFLOW in SFA/BTK and across coronary DCB indications, but as part of a much larger interventional cardiology portfolio rather than a DCB-focused business.
• Philips (Spectranetics): Through its Spectranetics/Laser atherectomy and interventional cardiology franchises, Philips competes with Cardionovum's peripheral intervention products (LEGFLOW) in the same cath-lab and hybrid-OR procedures, even though its core technology is mechanical rather than drug-coated.

Emerging players

• SurModics: SurModics provides proprietary paclitaxel and sirolimus drug-coating technology used by other DCB manufacturers and is developing its own Sundance DCB platform, making it an adjacent technology competitor to Cardionovum's SAFEPAX third-generation coating IP in the DCB enabling-tech layer.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/irccs-policlinico-san-donato

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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 Cardionovum