InnAVasc Medical

What InnAVasc Medical does

InnAVasc Medical, Inc. is a Durham, North Carolina-based medical device company founded in 2013 that designs and develops the InnAVasc Arteriovenous Graft (IG), an investigational implant intended to provide vascular access for patients undergoing hemodialysis. The company operates as a wholly-owned subsidiary of W. L. Gore & Associates, leveraging the parent's infrastructure, capital, and commercial reach while maintaining a focused R&D effort on a single core product.

The InnAVasc Graft is a physical implant differentiated by three proprietary features: cannulation pods protected by puncture-resistant backplates on the side and back walls, pod materials engineered to self-seal after needle removal, and raised target stick zones designed to improve cannulation accuracy. Together these features target three recurring problems in hemodialysis access: back and side wall injury from dialysis needles, excessive bleeding after needle removal, and lack of cannulation confidence. The product is currently limited by U.S. law to investigational use and is being evaluated in the CSP-2002 clinical study, with the company explicitly stating the device is not yet commercially available.

InnAVasc's business model is a conventional pre-commercial medical device model: capital is raised through equity, exempt securities offerings, and non-dilutive grants (NSF, NC Biotechnology Center) to fund clinical development, with future revenue expected from hardware sales to healthcare providers (surgeons, interventionalists, dialysis centers) upon regulatory approval. The company has a headcount of 1-10 employees, no disclosed commercial revenue, and no public pricing; distribution is currently restricted to U.S. clinical study sites only.

Name

InnAVasc Medical

Legal name

InnAVasc Medical, Inc.

Website

https://innavasc.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

InnAVasc Medical is a Durham, NC-based medical device company developing the investigational InnAVasc Arteriovenous Graft for hemodialysis access, featuring proprietary backplate, self-sealing, and raised stick-zone technologies. It is a wholly-owned subsidiary of W. L. Gore & Associates.

Ownership category

akta.pro rank

Product category

Vascular Access Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Medical Equipment and Supplies Manufacturing (3391)

SIC

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

akta.pro primary industry

Vascular Access Devices (AV Grafts, Catheters, Fistula Accessories) (HLAHAKAE)

akta.pro secondary industry

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

Keywords

• Vascular access devices
• Hemodialysis grafts
• Arteriovenous graft
• Medical device innovation
• Dialysis access solutions

Headquarters

HQ city

Durham

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, Operations, Marketing or Sales, Personnel

Revenue model

1. Medical Device Sales (Future): InnAVasc is currently pre-revenue as the InnAVasc Arteriovenous Graft is under clinical investigation. Upon regulatory approval, the company expects to generate revenue through sale of its medical device to healthcare providers for hemodialysis access.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

InnAVasc Medical designs and develops the InnAVasc Arteriovenous Graft (IG), an investigational medical device for hemodialysis vascular access. The graft features two cannulation pods with puncture-resistant backplates, self-sealing materials, and raised target stick zones designed to reduce needle injury, bleeding, and cannulation difficulty. The product is currently in clinical investigation and is not yet commercially available.

Product overview

InnAVasc Medical offers a single core product: the InnAVasc Arteriovenous Graft (IG). This investigational device is designed specifically for hemodialysis access and incorporates three key technological innovations: protective backplate technology on the side and back walls to prevent needle injuries, self-sealing pod materials that re-seal after needle removal to prevent bleeding complications, and raised target stick zones to improve cannulation confidence. The device features two cannulation pods designed for easy identification and access during dialysis treatment.

Differentiator

Problem solved

Functional benefit

Products and services

• InnAVasc Arteriovenous Graft (IG) Investigational medical device for hemodialysis vascular access. Incorporates two cannulation pods with protective backplates resistant to dialysis needle puncture on the side and back walls, self-sealing pod materials engineered to re-seal after needle removal, and raised target stick zones for safe cannulation. Designed for surgical implantation by vascular access surgeons and subsequent cannulation by dialysis care providers.

Quantifiable outcome

• Potential to prevent bleeding from accidental injuries and allow patients to go home sooner following dialysis sessions
• +1 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators1 record

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• W. L. Gore & Associates: Parent company of InnAVasc and an established manufacturer of ePTFE vascular grafts (including GORE-TEX-based AV access grafts) for hemodialysis; the most direct competitor once InnAVasc's product reaches market, and the entity that ultimately controls InnAVasc's commercial fate.
• BD (Becton, Dickinson and Company): Through its Bard acquisition and broader vascular access portfolio, BD offers dialysis catheters and access products; a broad incumbent with overlapping presence in the hemodialysis vascular access workflow.
• Medtronic: Diversified medical device major with vascular and dialysis-related products; competes broadly in the vascular surgery ecosystem surrounding hemodialysis access.
• Abbott: Major vascular device manufacturer with overlapping presence in dialysis and vascular access; potential competitor and ecosystem player in the hemodialysis access space.

Direct peers

• Getinge: Through its Maquet and Intervascular heritage, Getinge markets vascular grafts used in dialysis access; competes in the same AV graft category that InnAVasc targets with its novel cannulation-pod design.
• LeMaitre Vascular: Specialty vascular device manufacturer offering a portfolio of vascular grafts and patches used in dialysis access procedures; competes for the same surgeon and interventionalist customers.
• Artivion: Cardiovascular and vascular surgery company with vascular graft product lines relevant to hemodialysis access; an incumbent competing for the same hospital vascular access budget.

Regional players

• Fresenius Medical Care: Largest global dialysis services provider and a major buyer of vascular access devices; relevant peer because it influences which grafts are adopted across its clinic network, even though it is not a graft manufacturer.

Emerging players

• Humacyte: Clinical-stage regenerative medicine company developing bioengineered vascular conduits with potential dialysis access applications; comparable as a development-stage vascular access innovator with a single core product focus.
• Vascular Genesis: Emerging developer of vascular access solutions for hemodialysis; comparable as a small, focused vascular access innovator targeting the same clinical workflow.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/innavasc-medical-inc-

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds7 records

Investors4 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 InnAVasc Medical