Protembis
Protembis is a pre-revenue German medical device company developing the ProtEmbo Cerebral Protection System, an intra-aortic filter that shields all three cerebral arteries during TAVR procedures. It serves interventional cardiologists and structural heart teams and is currently in FDA-approved pivotal clinical trials.
- Company typePrivate
- Founded2013
- HeadquartersAachen, Germany
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Protembis does
Protembis is a privately-held medical device company founded in 2013 and headquartered in Aachen, Germany, with a US subsidiary (Protembis, Inc.) established in 2024 in Wilmington, Delaware. The company develops the ProtEmbo Cerebral Protection System (CPS), a third-generation intra-aortic filter designed to shield all three cerebral arteries from embolic debris liberated during transcatheter aortic valve replacement (TAVR) procedures. The device features a 60μm pore filter with covalently bonded heparin coating, is anchored in the left subclavian artery, and is delivered via 6F left radial access with self-positioning design enabling deployment in under 5 minutes. A companion SimplGuide guiding sheath supports device delivery. The company also develops patient and physician educational content around TAVR-related stroke and cognitive decline risk.
Protembis is pre-revenue and has not received regulatory approval for commercial sale in any jurisdiction. It is currently conducting the FDA-approved PROTEMBO IDE Pivotal Trial (NCT05873816) — an adaptive, multicenter, randomized controlled trial enrolling 250-500 TAVR patients across up to 30 sites in the USA, Germany, and Poland, comparing ProtEmbo against a hybrid control of Sentinel CEP and No Device using DW-MRI endpoints. Earlier European studies include PROTEMBO C (64 patients, met safety and performance endpoints with 94% of patients free of clinically meaningful brain lesions >350mm³) and PROTEMBO SF. The company plans to commercialize via direct hospital sales targeting high-volume TAVR centers and academic centers of excellence upon regulatory approval.
Protembis has raised approximately €50 million in total funding: a $10M Series A in October 2018 (Abiomed, Seed Fonds III, Coparion, family offices, angels), a €30M Series B in March 2024 (co-led by Segulah Medical Acceleration, XGEN Venture, TechVision Fund), and €20M in venture debt from the European Investment Bank in July 2024. The company operates with a lean team of approximately 10 employees, co-led by founders Karl von Mangoldt and Conrad Rasmus as Co-CEOs, with a Board chaired by Azin Parhizgar (former Claret Medical CEO). The addressable market is anchored by the global TAVR procedure volume, projected at approximately 430,000 patients by 2025.
Protembis firmographics
Firmographics- Name
- Protembis
- Legal name
- Protembis GmbH
- Website
- https://protembis.com
- Company type
- Private
- Founded year
- 2013
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Protembis is a pre-revenue German medical device company developing the ProtEmbo Cerebral Protection System, an intra-aortic filter that shields all three cerebral arteries during TAVR procedures. It serves interventional cardiologists and structural heart teams and is currently in FDA-approved pivotal clinical trials.
- Ownership category
- akta.pro rank
Protembis industry classification
Industry- Product category
- Cerebral Embolic Protection Devices
- NAICS
- Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451)
- SIC
- Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Thrombectomy, Embolic Protection & Stroke Intervention Devices (HLAHAFAJ)
- akta.pro secondary industry
- Peripheral Vascular Intervention (PAD Stents, Balloons, Atherectomy) (HLAHAFAE)
Keywords
Where Protembis is headquartered
LocationHeadquarters
- HQ city
- Aachen
- HQ country
- Germany
- HQ region
- Europe
Offices2 records
Markets served
Protembis business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales
Revenue model
- Medical Device Sales: Protembis is a pre-revenue medical device company developing the ProtEmbo Cerebral Protection System. The product is currently undergoing clinical investigation and has not yet been approved for commercial use by any regulatory authority. Revenue will be generated through device sales to hospitals following regulatory approval.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
Protembis product offering
Product offeringCore offering
Protembis develops the ProtEmbo Cerebral Protection System (CPS), an intra-aortic filter device designed to shield all three cerebral arteries supplying blood to the brain during transcatheter aortic valve replacement (TAVR) procedures. The system is delivered via 6F left radial artery access using a companion SimplGuide guiding sheath, and is intended to capture embolic debris liberated during TAVR to reduce the risk of stroke and cognitive decline. The company also produces the SimplGuide braided guiding sheath used to deliver the ProtEmbo device into the vascular system. Both products are currently under clinical investigation and have not yet received regulatory approval for commercial use.
Product overview
Protembis is a cardiovascular medical device company offering two integrated products: the ProtEmbo Cerebral Protection System (CPS) as its primary therapeutic device, and the SimplGuide Guiding Sheath as its companion delivery technology. The ProtEmbo CPS is an intra-aortic filter that provides complete three-vessel cerebral protection during TAVR procedures, while SimplGuide serves as the guiding sheath pathway for device delivery. Both products are designed to work together within the TAVR workflow, with SimplGuide providing the procedural access and ProtEmbo providing the cerebral embolic protection. Both devices are currently under clinical and regulatory evaluation and have not yet been approved for commercial use.
Differentiator
Problem solved
Functional benefit
Brands
- ProtEmbo: The ProtEmbo Cerebral Protection System (CPS) - an intra-aortic filter device that protects the entire brain from embolic material liberated during transcatheter aortic valve replacement (TAVR) procedures.
- SimplGuide
Products and services
- ProtEmbo Cerebral Protection System (CPS) The ProtEmbo Cerebral Protection System (CPS) is an intra-aortic filter device that shields all three arteries supplying blood to the brain (brachiocephalic, left common carotid, and left vertebral arteries) during transcatheter aortic valve replacement (TAVR) procedures. It features a 60-micron pore filter with covalently bonded heparin coating, anchors in the left subclavian artery, and is delivered via 6F left radial access in under 5 minutes. It is intended for interventional cardiologists and structural heart teams performing TAVR on patients with severe aortic stenosis.
- SimplGuide Guiding Sheath SimplGuide is a braided guiding sheath with a radiopaque tip, hydrophilic coating, and superior tensile strength, designed to provide a pathway through which therapeutic and diagnostic devices (including the ProtEmbo CPS) are introduced to the coronary or peripheral vascular system. It is intended for use in catheterization laboratory procedures alongside ProtEmbo deployment. Reference Number: 561913108.
Quantifiable outcome
- 94% of patients treated with ProtEmbo were free of clinically meaningful brain lesions >350mm3
- +9 more outcomes
Companies that use Protembis
Customer profileSegments2 records
Ideal customer profiles1 record
Protembis technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature7 records
Protembis partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core.
- Buffalo Neuroimaging Analysis Center (BNAC)coreCore MRI laboratory partner for the PROTEMBO IDE trial. Provides neuroimaging analysis services for the DW-MRI endpoint assessments.
- Cardiovascular Research Institute (CRF)coreCore angiography laboratory partner for the PROTEMBO IDE trial.
- CVPath InstitutecoreCore histopathology laboratory partner for the PROTEMBO IDE trial.
- AngioConsultcoreCore CT laboratory partner for the PROTEMBO IDE trial.
Scale indicators8 records
Recent moves7 records
Expansion highlights6 records
Protembis competitors and assessment
Company assessmentBroad incumbents
- Boston Scientific: Acquired Claret Medical in 2017 for $270M and now markets the Sentinel Cerebral Protection System, the only commercially approved CEP device in TAVR and ProtEmbo's direct head-to-head comparator in the IDE trial. Boston Scientific is the dominant entrenched competitor.
- Edwards Lifesciences: Global leader in transcatheter aortic valve replacement (SAPIEN platform) and structural heart. While Edwards does not sell a CEP device, it controls a large share of the TAVR procedures where ProtEmbo would be deployed and could bundle or block access.
- Medtronic: Major TAVR manufacturer (Evolut platform) and a participant in the broader structural heart and embolic protection landscape. Medtronic is a strategic acquirer profile and a potential channel partner for ProtEmbo adoption.
- Abbott: Markets the Navitor TAVR platform and has growing structural heart franchise. As a major TAVR incumbent, Abbott is a relevant peer for procedure economics and potential CEP partnership or competitive response.
Emerging players
- InspireMD: Develops embolic prevention and carotid stent products (CGuard). InspireMD overlaps thematically with cerebral and vascular embolic protection but targets different anatomies (carotid vs cerebral).
- Penumbra: Developer of neurovascular thrombectomy and aspiration devices. While focused on ischemic stroke intervention post-event, Penumbra is adjacent to the embolic protection space and a potential consolidator of cerebral vascular medtech.
- Inari Medical: Specialist in venous thromboembolism and mechanical thrombectomy devices. Inari operates adjacent to the embolic protection theme and represents the type of growth-stage acquirer that could pursue complementary technology.
- Emboline: Developer of the Emboliner total embolic protection device for use during TAVR and other structural heart procedures. Emboline is the most direct emerging competitor to ProtEmbo in next-generation cerebral embolic protection.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Protembis social profiles
Digital presenceProtembis financial estimates
Financial estimateRevenue estimate
Valuation estimate
Protembis leadership team
Management profileNumber of profiles
Profiles10 records
Protembis subsidiaries and ownership
Company hierarchySubsidiaries1 record
Protembis funding detail
Funding detailFunding overview
Funding rounds4 records
Investors7 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Protembis M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Protembis
What does Protembis do?
Protembis develops the ProtEmbo Cerebral Protection System (CPS), an intra-aortic filter device designed to shield all three cerebral arteries supplying blood to the brain during transcatheter aortic valve replacement (TAVR) procedures. The system is delivered via 6F left radial artery access using a companion SimplGuide guiding sheath, and is intended to capture embolic debris liberated during TAVR to reduce the risk of stroke and cognitive decline. The company also produces the SimplGuide braided guiding sheath used to deliver the ProtEmbo device into the vascular system. Both products are currently under clinical investigation and have not yet received regulatory approval for commercial use.
Is Protembis a public or private company?
Protembis is a private company. It is classified as venture growth investor backed and is currently operating.
When was Protembis founded?
Protembis was founded in 2013. It employs 1 to 10 people.
Where is Protembis based?
Protembis is headquartered in Aachen, Germany, in the Europe region.
How does Protembis make money?
One revenue line is on record: medical Device Sales.
Who are Protembis's main competitors?
Broad incumbents on record are Boston Scientific, Edwards Lifesciences, Medtronic and Abbott. Emerging players are InspireMD, Penumbra, Inari Medical and Emboline.
Does Protembis have an API?
No public API is recorded for Protembis.
What industry is Protembis in?
Protembis's product category is Cerebral Embolic Protection Devices. Its primary akta.pro industry code is HLAHAFAJ, Thrombectomy, Embolic Protection & Stroke Intervention Devices, with a secondary code of HLAHAFAE, Peripheral Vascular Intervention (PAD Stents, Balloons, Atherectomy). Its NAICS code is 33451 and its SIC code is 3841.