Amplifi Vascular
- Company typePrivate
- Founded2023
- HeadquartersWilmington, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
Amplifi Vascular firmographics
Firmographics- Name
- Amplifi Vascular
- Legal name
- Amplifi Vascular, Inc.
- Website
- https://amplifivascular.com
- Company type
- Private
- Founded year
- 2023
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Ownership category
- akta.pro rank
Amplifi Vascular industry classification
Industry- Product category
- Hemodialysis Vascular Access Medical Devices
- NAICS
- Surgical and Medical Instrument Manufacturing (339112), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)
- akta.pro primary industry
- Vascular Access Devices (AV Grafts, Catheters, Fistula Accessories) (HLAHAKAE)
- akta.pro secondary industries
- Peripheral Vascular Intervention (PAD Stents, Balloons, Atherectomy) (HLAHAFAE), Cardiovascular & Vascular Regeneration (vascular grafts, angiogenesis) (HLAAAGAJ)
Keywords
Where Amplifi Vascular is headquartered
LocationHeadquarters
- HQ city
- Wilmington
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Amplifi Vascular business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales
Revenue model
- Medical Device Sales: Amplifi Vascular generates revenue through the sale of its Amplifi™ Vein Dilation System to hospitals and healthcare providers performing hemodialysis vascular access procedures. As a medical device company with FDA Breakthrough Device Designation and CMS Category B assignment, the company will sell its device to healthcare systems performing dialysis procedures.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels2 records
Amplifi Vascular product offering
Product offeringCore offering
Amplifi Vascular develops and manufactures the Amplifi™ Vein Dilation System, a medical device designed for distal arteriovenous fistula (AVF) creation in hemodialysis patients. The system enables vein enlargement to facilitate fistula creation, with the goal of achieving functional AVF maturation at two weeks compared to the traditional pathway of several weeks to months. The company is currently advancing the device through the AMPLIFI-1 Pivotal Trial at Brigham and Women's Hospital under FDA IDE approval.
Product overview
Amplifi Vascular is a biotechnology company developing a single core medical device — the Amplifi™ Vein Dilation System — designed to improve vascular access for hemodialysis patients. The system enables distal arteriovenous fistula (AVF) creation with potential for functional maturation in two weeks versus traditional multi-week pathways. The company is conducting the AMPLIFI-1 Pivotal Trial to support regulatory approval, following successful first-in-human study results demonstrating safety and efficacy in 19 patients.
Differentiator
Problem solved
Functional benefit
Brands
- Amplifi Vein Dilation System: Medical device system for distal arteriovenous fistula creation in hemodialysis patients, designed to enable functional AVF maturation at two weeks compared to traditional pathway of several weeks to months.
Products and services
- Amplifi™ Vein Dilation System
Companies that use Amplifi Vascular
Customer profileNamed customers1 record
Segments1 record
Ideal customer profiles1 record
Amplifi Vascular technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature2 records
Amplifi Vascular partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core.
- Brigham and Women's HospitalcoreBrigham and Women's Hospital in Boston served as the initiating site for the AMPLIFI-1 Pivotal Trial, treating the first North American patients with the Amplifi™ Vein Dilation System. This represents a strategic clinical partnership for the U.S. clinical investigation.
- FDAcoreFDA granted Breakthrough Device Designation for the Amplifi Vein Dilation System, enabling more efficient regulatory engagement during the development and review process. This designation is supported by first-in-human clinical data from 19 patients.
- CMS (Centers for Medicare & Medicaid Services)coreCMS assigned Category B status to the Amplifi Vein Dilation System, which will facilitate reimbursement pathways and improve patient access to the device once approved.
Scale indicators6 records
Recent moves5 records
Expansion highlights5 records
Amplifi Vascular competitors and assessment
Company assessmentBroad incumbents
- W. L. Gore & Associates: Established manufacturer of vascular grafts including AV access grafts used in hemodialysis patients, with a strong incumbent position in surgical AV access that Amplifi's distal AVF technology could disrupt.
- Medtronic: Major medtech incumbent with broad vascular and cardiovascular portfolios; serves the same hospital customers that perform AV access surgery and represents a potential acquirer or competitive threat in dialysis vascular access.
- AngioDynamics: Mid-size medtech with vascular access and dialysis product lines (including ports and thrombectomy devices), overlapping with Amplifi's hospital and dialysis-center call points.
- Merit Medical Systems: Broad portfolio of vascular access and interventional devices sold to hospital systems and dialysis providers, with overlapping customers in the dialysis access workflow.
- Abbott: Diversified medtech incumbent with vascular and endovascular offerings that overlap the hospital-based dialysis access procedure market, and a logical strategic acquirer in this space.
- Teleflex: Manufactures vascular access devices and other interventional products used by dialysis centers and hospitals, overlapping with Amplifi's hospital-based call point and customer base.
Emerging players
- Advent Access: Early-stage company developing the av-Guardian technology to preserve and enable AVF access for hemodialysis, an adjacent approach targeting the same dialysis vascular access market as Amplifi.
- Laminate Medical Technologies: Developer of the VasQ external support device for AVF creation, addressing the same hemodialysis vascular access market with a complementary surgical adjunct approach.
- Artio Medical: Emerging medical device company developing vascular access solutions for hemodialysis patients, including technologies aimed at improving AVF creation and maturation—directly comparable to Amplifi's indication.
Direct peers
- Becton Dickinson (BD): BD acquired TVA Medical (WavelinQ) and Avenu Medical (Ellipsys), the two leading percutaneous AVF creation systems, making it the most direct competitor in the dialysis vascular access space where Amplifi is also positioned.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Amplifi Vascular compliance and trust
Trust signalCompliance3 records
Amplifi Vascular financial estimates
Financial estimateRevenue estimate
Valuation estimate
Amplifi Vascular leadership team
Management profileNumber of profiles
Profiles1 record
Amplifi Vascular funding detail
Funding detailFunding overview
Funding rounds3 records
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Amplifi Vascular 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 Amplifi Vascular
What does Amplifi Vascular do?
Amplifi Vascular develops and manufactures the Amplifi™ Vein Dilation System, a medical device designed for distal arteriovenous fistula (AVF) creation in hemodialysis patients. The system enables vein enlargement to facilitate fistula creation, with the goal of achieving functional AVF maturation at two weeks compared to the traditional pathway of several weeks to months. The company is currently advancing the device through the AMPLIFI-1 Pivotal Trial at Brigham and Women's Hospital under FDA IDE approval.
Is Amplifi Vascular a public or private company?
Amplifi Vascular is a private company. It is classified as venture growth investor backed and is currently operating.
When was Amplifi Vascular founded?
Amplifi Vascular was founded in 2023. It employs 1 to 10 people.
Where is Amplifi Vascular based?
Amplifi Vascular is headquartered in Wilmington, United States, in the North America region.
How does Amplifi Vascular make money?
One revenue line is on record: medical Device Sales.
Who are Amplifi Vascular's main competitors?
Broad incumbents on record are W. L. Gore & Associates, Medtronic, AngioDynamics, Merit Medical Systems, Abbott and Teleflex. Emerging players are Advent Access, Laminate Medical Technologies and Artio Medical. Becton Dickinson (BD) is listed as a direct peer.
Does Amplifi Vascular have an API?
No public API is recorded for Amplifi Vascular.
What industry is Amplifi Vascular in?
Amplifi Vascular's product category is Hemodialysis Vascular Access Medical Devices. Its primary akta.pro industry code is HLAHAKAE, Vascular Access Devices (AV Grafts, Catheters, Fistula Accessories), with a secondary code of HLAHAFAE, Peripheral Vascular Intervention (PAD Stents, Balloons, Atherectomy). Its NAICS code is 339112 and its SIC code is 3841.