What Innora Gmbh does

Innora GmbH is a Berlin-based medical technology company that develops and manufactures drug-coated balloon catheters (DCB) and drug-eluting stents (DES), with active pharmaceutical coatings based on paclitaxel and sirolimus for cardiovascular and peripheral vascular applications. Founded in 2001 by scientists from Charité Universitätsmedizin Berlin, the company operates a vertically integrated development stack that spans pharmaceutical coating research, in-vitro and in-vivo preclinical testing, analytical chemistry (HPLC, HPLC-MS/MS, DSC, UV/Vis), prototype and small-scale-series production in an ISO Class 7 / GMP Class C clean room, and — via the wholly-owned subsidiary InnoRa CRO GmbH (founded 2021) — full clinical trial coordination including study design, regulatory submissions, monitoring, and data management. The company holds a broad patent portfolio covering drug-coated balloon and polymer-free stent coating technology, and has obtained regulatory approvals in the USA and China (2014/2015), supported by ISO 13485 quality certification (since 2014).

Innora operates as a B2B contract development and manufacturing partner for medical device companies ranging from start-ups to large corporations, providing full-service development from initial concept through product approval and manufacturing. The go-to-market is enterprise field sales with direct engagement supported by scientific publications, conference presence, and a multilingual website. Innora's products have been recognized through multiple innovation awards, including the Berlin Brandenburg Innovation Award (2008), the 1st German Innovation Award for Medicine (2009), and the CIRSE Award of Excellence and Innovation in Interventional Radiology (2021). The company is integrated under InnoRa Holding (founded 2022) alongside InnoRa CRO GmbH, with founders Prof. Ulrich Speck and Prof. Bernd Hamm (Charité) and Prof. Bruno Scheller (Saarland University) retaining shareholder roles and Dr. Thomas Speck serving as CEO.

Customer payment mechanics are project-based and quote-driven, with no public pricing disclosed; revenue is generated from a mix of professional services (development, preclinical, clinical CRO) and hardware-adjacent revenue (coating and small-scale manufacturing). Customers are unnamed but described as medical device OEMs across Germany, the United States, and China. Geographic reach is global via partner and customer networks, with primary operations in Berlin.

Name

Innora Gmbh

Legal name

InnoRa GmbH

Website

https://innora.de

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

1–10 employees

Short description

Innora GmbH is a Berlin-based medical technology company developing drug-coated balloon catheters and drug-eluting stents for cardiovascular and peripheral vascular applications. It provides full-service B2B development, including coating, preclinical, analytical, clean-room manufacturing, and clinical trial services, for medical device companies globally.

Ownership category

akta.pro rank

Headquarters

HQ city

Berlin

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Others

Revenue model

1. Medical Device Development Services: Full-service medical device development from concept through approval, including research, preclinical testing, clinical trials, and manufacturing support. Services span development, preclinical, laboratories, clean room, and regulatory support.
2. Coating and Manufacturing: Pharmaceutical coating laboratory and production services for balloon catheters, stents, and medical devices. Includes prototype development, clinical samples, pilot production, and small-scale series production in clean room environment.
3. Clinical Research Organization Services: Through InnoRa CRO GmbH subsidiary, provides complete clinical trial coordination including study design, regulatory submissions, monitoring, data management, and study reporting.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Innora GmbH is a medical device development company that develops and manufactures drug-coated balloon catheters (DCB) and drug-eluting stents (DES) with proprietary pharmaceutical coatings (paclitaxel and sirolimus) for cardiovascular and peripheral vascular applications. The company provides full-service development from initial concept through preclinical testing, clinical trials, regulatory approval, and small-scale manufacturing, serving medical device companies ranging from startups to large corporations. Its services include a pharmaceutical coating laboratory, an ISO 7 / GMP Class C clean room, analytical laboratory, and clinical research organization (CRO) services through subsidiary InnoRa CRO GmbH.

Product overview

InnoRa GmbH is a German medical technology company offering a comprehensive portfolio centered on drug-coated medical devices. The core products include Drug-Coated Balloon Catheters (DCB) and Drug-Eluting Stents (DES), along with Novel Balloon Catheters and Resorbable Temporary Stents in development. Supporting these products is a full-service ecosystem including preclinical studies, clinical studies (via subsidiary InnoRa CRO GmbH), analytics laboratory services, production & coating services, and certified clean room facilities. The company operates from concept to finished product, providing development services for pharmaceutical companies and medical device manufacturers ranging from startups to large corporations.

Differentiator

Problem solved

Functional benefit

Products and services

• Drug-Coated Balloon Catheters (DCB) Drug-coated balloon catheters that enable new therapeutic options in vascular medicine, providing treatment for vasoconstrictions in heart and leg arteries. Innora uses both paclitaxel and sirolimus coatings and is considered a market leader in this category. The product line targets medical device companies and clinical applications in cardiovascular and peripheral vascular disease.
• Drug-Eluting Stents (DES) Stents with active ingredient coatings that release drugs in a controlled manner over time. Innora works with innovative polymer-free coatings, particularly for special stents and specialized applications, with controlled drug release kinetics over defined periods.
• Clinical Studies Services (InnoRa CRO GmbH) Complete clinical trial coordination services including project coordination, study design planning, regulatory submissions, monitoring, risk management, data management, and publication support, delivered through InnoRa CRO GmbH (founded 2021). Targets medical device companies conducting clinical studies for drug-coated devices.
• Preclinical Studies Services Preclinical testing services including in-vitro and in-vivo testing, efficacy evaluation, tolerability studies, GLP conditions, and large animal laboratory facilities for medical device development.
• Analytics Laboratory Services Comprehensive analytical testing services including HPLC, HPLC-MS/MS, DSC, UV/VIS spectroscopy, method development and validation, stability testing, and active ingredient characterization for drug-coated medical device development.
• Production & Coating Services Contract manufacturing services including prototype development, clinical sample creation, pilot production, and small-scale series production, performed in certified clean room by experienced coating experts with quality control. Includes pharmaceutical coating of balloon catheters, stents, and other medical devices.
• Clean Room & Laboratory Facilities

Quantifiable outcome

• Treated arteries remain open longer than with conventional uncoated balloon catheters
• +1 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Fraunhofer IPKcoreStrategic or Co-development PartnerCollaboration partner in the perKunSt project (2023-2025) for development of personalized biodegradable plastic stents. Fraunhofer IPK contributes expertise in 3D printing technology for novel stent designs. Project aims to improve patient quality of life by reducing complications following coronary stent implantation.
• Organical CAD/CAM GmbHcoreStrategic or Co-development PartnerProject partner in perKunSt public funding project. Contributing to development of 3D printing systems for production of resorbable stents with degradation gradients. Project focused on biodegradable plastic stents.
• NetPhaSol (Network for Pharmaceutical Solutions)minorStrategic or Co-development PartnerNetwork partner for pharmaceutical solutions. Part of InnoRa's partner and cooperation network for research and development activities.
• InnoRa CRO GmbHcoreStrategic or Co-development PartnerRelated company founded in 2021 providing clinical research organization services. Offers complete clinical trial coordination including study design, regulatory submissions, monitoring, and data management. Integrated under InnoRa Holding since 2022.

Scale indicators3 records

Recent moves10 records

Expansion highlights6 records

Broad incumbents

• Cordis (Cardinal Health): Cardiovascular medical device specialist with established DCB portfolio (e.g., ELUTAX) and DES products. Comparable as a focused cardiovascular device company with overlapping product categories.
• Boston Scientific: Major medical device company with DCB products (Ranger, Eluvia) for peripheral vascular disease and DES (Synergy) for coronary applications. Large incumbent competitor in DCB and DES categories.
• Medtronic: Global medical device leader with significant DCB (IN.PACT Admiral) and DES (Resolute Onyx) portfolios in cardiovascular and peripheral vascular markets. Broad incumbent competing across all vascular device categories where InnoRa operates.
• Abbott: Global healthcare company with major drug-eluting stent franchise (Xience) and expanding DCB presence. Significant incumbent competing in the same vascular medicine categories as InnoRa.
• B. Braun: German medical technology and pharmaceutical company with active DCB portfolio (SeQuent Please) and broader cardiovascular offerings. Direct regional incumbent competitor headquartered in Germany.
• Terumo: Japanese medical device company with significant cardiovascular presence, including DCB products (Kanshas, Serene) and stent systems. Broad incumbent competing in the global vascular device market.

Direct peers

• Concept Medical: Specialist developer of drug-coated balloon catheters (MagicTouch series using sirolimus) for coronary and peripheral vascular applications. Closest direct competitor to InnoRa with similar DCB-focused R&D and product strategy.
• Biotronik: German medical device company with active DCB portfolio (e.g., Passeo-18 Lux for peripheral arteries) and drug-eluting stents (Orsiro). Comparable in offering and overlapping directly with InnoRa's vascular medicine focus.
• Orchestra BioMed: Clinical-stage biomedical company developing drug-coated balloon (Virtue SAB) for hypertension treatment and partnering with established medtech firms. Comparable as a DCB-focused innovator with similar partnership-driven commercialization model.

Emerging players

• Surmodics: Provides proprietary drug-delivery coating technology for vascular devices, including DCB platforms. Relevant peer as a technology/development-stage company in the DCB coating space, though more focused on out-licensing its coating IP.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/innora-gmbh

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries2 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 Innora Gmbh