CereVasc

What CereVasc does

CereVasc is a clinical-stage medical device company founded in 2014 and headquartered in Charlestown, Massachusetts. The company is developing the eShunt® System, an endovascularly implantable cerebrospinal fluid (CSF) shunt designed to treat communicating hydrocephalus and Normal Pressure Hydrocephalus (NPH) through a minimally invasive, percutaneous transvenous-transdural approach. The system is the first of its kind to access the central nervous system through a leg vein using X-ray guidance, eliminating the need for craniotomy, brain catheter passage through white matter, and subcutaneous tunneling across the chest and abdomen. Deployment is designed to take approximately one hour, and the company has signaled potential for outpatient day-surgery administration as an alternative to traditional neurosurgery.

The eShunt System consists of a patented implantable shunt and dedicated delivery components. CereVasc has conducted multiple clinical programs, including the ETCHES I first-in-human study at Clinica la Sagrada Familia in Argentina, an NPH pilot study across 12 sites in the US and Argentina, and the ongoing STRIDE pivotal randomized controlled trial comparing eShunt to conventional ventriculo-peritoneal shunting across 28 sites in the US, Argentina, and Canada. Published clinical results have shown 95% clinical improvement with 0% device-related serious adverse events through 90-day follow-up in 66 NPH patients, and 97% clinical improvement in pilot data.

The eShunt System is investigational and not yet commercially available; CereVasc generates no product revenue. The planned revenue model is direct hardware sales to hospitals and medical centers with interventional radiology and neurosurgery capabilities, with the STRIDE pivotal trial serving as the regulatory basis for a future FDA Premarket Approval submission. The company has also explored platform extension into CNS gene and cell therapy delivery through a research collaboration with UMass Chan Medical School. CereVasc has raised approximately $199 million across three funding rounds, with institutional and strategic investors including Bain Capital Life Sciences, Perceptive Xontogeny Venture Funds, Piper Sandler Merchant Banking, Johnson & Johnson Innovation – JJDC, and Medtronic.

Name

CereVasc

Legal name

CereVasc, Inc.

Website

https://cerevasc.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

CereVasc is a clinical-stage medical device company developing the eShunt® System, a minimally invasive endovascular CSF shunt for treating communicating hydrocephalus and Normal Pressure Hydrocephalus. The investigational device targets hospitals and patients needing alternatives to invasive neurosurgical shunt procedures.

Ownership category

akta.pro rank

Product category

Neurological Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Surgical Stapling, Suturing & Hemostasis (Staplers, Clips, Sealants, Tourniquets) (HLAHADAL)

Keywords

• Minimally invasive neurosurgery
• Cerebrospinal fluid shunts
• Hydrocephalus treatment devices
• Endovascular medical devices
• Neurological medical devices

Headquarters

HQ city

Charlestown

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Medical Device Sales (Future): CereVasc plans to generate revenue through the sale of its eShunt System following FDA regulatory approval and commercialization in the US market. The device is currently investigational and not available for sale.
2. Platform Technology Licensing (Potential): The company may explore licensing its endovascular CNS delivery platform for gene and cell therapies to biopharmaceutical partners.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

CereVasc is developing the eShunt® System, an endovascularly implantable cerebrospinal fluid (CSF) shunt delivered percutaneously through a leg vein under X-ray guidance to treat communicating hydrocephalus and Normal Pressure Hydrocephalus without invasive neurosurgery. The investigational device includes patented shunt and delivery components and is being evaluated in the STRIDE pivotal trial to support a future FDA Premarket Approval submission. Follow-on products in cerebrospinal fluid management, access, and therapy are also under development, leveraging the same endovascular delivery platform.

Product overview

CereVasc is a clinical-stage medical device company offering a focused product portfolio centered on the eShunt® System, an investigational medical device for treating communicating hydrocephalus and Normal Pressure Hydrocephalus. The eShunt System represents a first-ever, minimally invasive endovascular approach to cerebrospinal fluid drainage, designed to replace traditional invasive neurosurgical shunt procedures. The company is developing follow-on products for expanded cerebrospinal fluid management applications. The eShunt System includes an implantable shunt and patented delivery components, with the STRIDE pivotal trial serving as the regulatory pathway to FDA approval.

Differentiator

Problem solved

Functional benefit

Brands

• eShunt System: The eShunt System is an endovascularly implantable cerebral spinal fluid (CSF) shunt designed to treat communicating hydrocephalus without invasive surgery.

Products and services

• eShunt® System Endovascularly implantable cerebrospinal fluid (CSF) shunt system placed percutaneously through a leg vein under X-ray guidance to drain excess CSF into the venous system, treating communicating hydrocephalus without invasive neurosurgery, craniotomy, or subcutaneous tunneling. Investigational device for use by interventional specialists and neurosurgeons.
• Generation 2 eShunt System Improved version of the eShunt System with FDA IDE approval for expanded clinical studies in Normal Pressure Hydrocephalus patients, designed to enhance ease of use and implementation of the minimally invasive CSF shunting procedure.
• Follow-on Products (CSF Drainage) Additional products in development for cerebrospinal fluid management, access, and therapy, building on the eShunt platform technology for treating various neurological conditions beyond hydrocephalus.

Quantifiable outcome

• 95% of patients demonstrated clinical improvement with 0% device-related serious adverse events through 90-day follow-up in multi-center NPH study (66 patients)
• +4 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles2 records

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.

• UMass Chan Medical SchoolcoreStrategic or Co-development Partner · 26 August 2024Collaborated with researchers from UMass Chan Medical School on the gene therapy delivery study published in Molecular Therapy, bringing expertise in CNS drug delivery and gene therapy.
• Tufts Medical CentercoreStrategic or Co-development Partner · 6 August 2014Co-founders Dr. Carl Heilman and Dr. Adel Malek originated the eShunt device concept at Tufts Medical Center. The technology was licensed to CereVasc for development and commercialization.
• Clinica la Sagrada FamiliacoreStrategic or Co-development PartnerArgentina-based clinical site led by Dr. Pedro Lylyk for first-in-human studies of the eShunt System. Dr. Lylyk performed the first eShunt procedure and leads multiple clinical trials.
• Yale New Haven HealthcoreStrategic or Co-development PartnerUS clinical trial site led by Dr. Charles Matouk for pilot studies of the eShunt System in Normal Pressure Hydrocephalus patients.

Scale indicators10 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• B. Braun (Aesculap): B. Braun's Aesculap division manufactures neurosurgical implants including hydrocephalus shunts, directly competing with conventional VP shunts that eShunt is positioned to replace.
• Integra LifeSciences: Integra LifeSciences (Codman Neurosurgery) is the market-leading manufacturer of conventional VP shunts and other hydrocephalus treatment devices. It is the most direct competitive threat to CereVasc's eShunt in the hydrocephalus treatment space.
• Möller Medical: Möller Medical is a German manufacturer of neurosurgical devices including hydrocephalus shunts, directly competing in the same conventional VP shunt market that eShunt targets for replacement.

Broad incumbents

• Medtronic: Medtronic manufactures conventional VP shunts (Strata, PS Medical) and is also a strategic investor in CereVasc. It is both a current competitor in the incumbent shunt market and a potential acquirer or fast-follower in the endovascular space.
• Penumbra: Penumbra is a leading neurovascular device company with endovascular delivery expertise (thrombectomy, embolization). Its endovascular R&D platform and physician relationships make it a strong fast-follower candidate in endovascular CSF shunting.
• Stryker (Neurovascular): Stryker's Neurovascular division offers a broad portfolio of endovascular devices for ischemic and hemorrhagic stroke. Its neurovascular commercial channel and R&D capabilities position it as a relevant broader incumbent and potential adjacent competitor.
• Johnson & Johnson (Cerenovus): J&J's Cerenovus neurovascular division is a major player in stroke intervention devices. As a strategic investor via JJDC, J&J is a potential acquirer and could leverage its neurovascular channel to commercialize competing endovascular approaches.

Regional players

• Spiegelberg: Spiegelberg (a SHS Group company) manufactures external CSF drainage and monitoring devices used in hydrocephalus management, representing a regional European peer in the broader CSF management category.
• Natus Medical: Natus Medical has historically supplied neurosurgical products including CSF management devices. While not a primary direct competitor today, it represents a relevant adjacent player in the neurosurgical device space.

Emerging players

• Anuncia Medical: Anuncia Medical is an emerging player developing next-generation hydrocephalus treatment devices (ReduX system), sharing CereVasc's mission of replacing traditional VP shunts with less invasive approaches.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/cerevasc
• LinkedInlinkedin.com/company/cerevasc

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds3 records

Investors6 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 CereVasc