R3 Vascular

What R3 Vascular does

R3 Vascular Inc. is a privately held, pre-commercial medical device company founded in 2019 and headquartered in Mountain View, California. The company develops next-generation drug-eluting bioresorbable scaffolds (BRS) for the treatment of peripheral arterial disease (PAD), with an initial focus on below-the-knee (BTK) interventions and Critical Limb Ischemia (CLI). Its lead and only product family, MAGNITUDE®, is a sirolimus-eluting scaffold manufactured from a proprietary ultra-high molecular weight polylactic acid (PLLA) polymer with engineered amorphous and crystalline domain balance, delivering a 98-micron strut profile — the thinnest BRS tested in the BTK setting. The scaffold is designed to provide temporary mechanical support, elute sirolimus to limit restenosis, and gradually resorb, leaving more naturally functioning vessels than permanent metal stents.

The company operates a vertically integrated manufacturing model that spans polymer resin to finished device, enabling tight control over scaffold characteristics and rapid iteration. R3 Vascular is currently enrolling the ELITE-BTK pivotal trial following FDA Investigational Device Exemption (IDE) approval in November 2024, with the first patient treated in April 2025; the device remains unapproved and the company is pre-revenue. Its go-to-market plan upon PMA approval is direct enterprise sales to U.S. hospitals, academic medical centers, and specialized vascular surgery centers through a field sales organization serving interventional cardiologists and vascular surgeons.

The business model is single-product hardware sales of a Class III implantable medical device, with pricing expected to follow standard hospital procurement and group purchasing organization channels (not publicly disclosed). R3 Vascular has raised approximately $105 million across two disclosed rounds — a $17.8M round in October 2020 led by 415 CAPITAL and an $87M Series B in May 2024 backed by Deerfield Management and 415 CAPITAL — to fund pivotal trial execution and pre-commercial preparation. Senior leadership includes a CEO (Christopher M. Owens) with prior exits at IDEV Technologies and Gynesonics, plus domain depth in regulatory, clinical, manufacturing, and quality drawn from BD, Medtronic, Abbott, Cordis/J&J, Silk Road Medical, and Shockwave Medical.

Name

R3 Vascular

Legal name

R3 Vascular Inc.

Website

https://r3vascular.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

R3 Vascular is a pre-commercial medical device company developing the MAGNITUDE®, a sirolimus-eluting bioresorbable scaffold made from proprietary ultra-high molecular weight PLLA polymer, targeting peripheral arterial disease below the knee. It serves U.S. hospitals, vascular surgery centers, and interventional specialists pursuing FDA PMA approval via the ELITE-BTK pivotal trial.

Ownership category

akta.pro rank

Product category

Peripheral Vascular Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Peripheral Vascular Intervention (PAD Stents, Balloons, Atherectomy) (HLAHAFAE)

akta.pro secondary industry

Cardiovascular & Vascular Regeneration (vascular grafts, angiogenesis) (HLAAAGAJ)

Keywords

• Bioresorbable vascular scaffolds
• Peripheral arterial disease
• Drug-eluting implants
• Below-the-knee intervention
• Critical limb ischemia treatment

Headquarters

HQ city

Mountain View

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, Supply Chain

Revenue model

1. Medical Device Sales: R3 Vascular is a pre-commercial medical device company developing bioresorbable scaffolds for peripheral arterial disease. Revenue will be generated through direct sales of the MAGNITUDE BRS device to hospitals and healthcare providers upon regulatory approval and commercialization. The company completed a $87M Series B financing in May 2024 to fund clinical trials and prepare for market entry.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

R3 Vascular develops and is preparing to commercialize the MAGNITUDE® Bioresorbable Sirolimus-Eluting Scaffold, an implantable Class III peripheral vascular device made from a proprietary ultra-high molecular weight polylactic acid (PLLA) polymer for treating below-the-knee peripheral arterial disease and Critical Limb Ischemia. The product is currently in the ELITE-BTK pivotal trial under an FDA IDE granted in November 2024, with first-in-human treatment of a pivotal trial patient completed in April 2025.

Product overview

R3 Vascular develops a single product line—the MAGNITUDE® family of bioresorbable scaffolds—which are drug-eluting implants made from a proprietary ultra-high molecular weight polylactic acid (PLLA) polymer. The MAGNITUDE® scaffold is designed for treating peripheral arterial disease (PAD), specifically below-the-knee (BTK) applications. The company's vertically integrated manufacturing operations control the process from polymer resin to finished devices, enabling scaffolds with thin profiles (98-micron strut thickness), high radial strength, flexibility, and controlled bioresorption characteristics.

Differentiator

Problem solved

Functional benefit

Brands

• MAGNITUDE: Drug-eluting bioresorbable scaffold (BRS) for treating peripheral arterial disease (PAD), specifically for below-the-knee (BTK) applications

Products and services

• MAGNITUDE® Drug Eluting Bioresorbable Scaffold The MAGNITUDE® Drug Eluting Bioresorbable Scaffold is R3 Vascular's flagship implantable peripheral vascular device, made from a proprietary ultra-high molecular weight polylactic acid (PLLA) polymer that elutes sirolimus. With a 98-micron strut thickness across all usable diameters, it is the thinnest bioresorbable scaffold tested in the below-the-knee clinical setting, and is engineered for gradual and predictable absorption into the tissue while maintaining structural integrity during the clinically relevant healing period. It is intended for treating below-the-knee peripheral arterial disease (BTK PAD) and Critical Limb Ischemia (CLI) in adult patients treated by vascular surgeons and interventional cardiologists at hospitals and vascular surgery centers.

Quantifiable outcome

• 98-micron strut thickness across all usable range of diameters - thinnest BRS ever tested in this clinical setting
• +1 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Abbott Vascular: Abbott is a global leader in vascular intervention with deep peripheral and coronary stent portfolios (XIENCE, XIENCE Sierra). Comparable to R3 Vascular because Abbott previously developed bioresorbable scaffolds (Absorb) in the same therapeutic category and continues to dominate the peripheral vascular intervention market where MAGNITUDE will compete.
• Medtronic: Medtronic is the largest peripheral vascular intervention company, with the IN.PACT Admiral drug-coated balloon as a standard-of-care in BTK disease. Comparable to R3 Vascular as the dominant incumbent physician relationships, established BTK/PAD clinical evidence, and competing therapeutic modality (DCB vs. BRS) that R3 Vascular must differentiate against.
• Boston Scientific: Boston Scientific has an extensive peripheral intervention portfolio (Eluvia DES, Ranger DCB) overlapping with R3 Vascular's BTK PAD target market. Comparable as a broad incumbent competing across multiple peripheral vascular modalities, including drug-eluting stents and drug-coated balloons, against which MAGNITUDE must demonstrate advantage.

Direct peers

• Becton Dickinson (BD): BD acquired Bard Peripheral Vascular and competes in peripheral vascular intervention with drug-coated balloons (Lutonix) and vascular access devices. Comparable to R3 Vascular as a direct competitor in BTK/PAD intervention with established physician relationships and an incumbent position that a new BRS entrant must displace.
• Shockwave Medical: Shockwave developed intravascular lithotripsy (IVL) for calcified peripheral vessels, with strong adoption in complex BTK and femoropopliteal disease. Comparable to R3 Vascular as a direct competitor addressing calcified and complex peripheral arterial disease, recently acquired by Johnson & Johnson, illustrating the strategic exit opportunity for novel peripheral vascular technologies.
• Biotronik: Biotronik markets Magmaris, a bioresorbable magnesium scaffold (and previously sirolimus-eluting Orsiro), competing directly with R3 Vascular's MAGNITUDE in the bioresorbable scaffold category. Comparable as the most direct technological competitor developing bioresorbable scaffolds for vascular intervention.
• Reva Medical: Reva Medical developed the Fantom and Fantom Encore bioresorbable scaffolds for coronary applications using a tyro-derived polymer. Comparable to R3 Vascular as a pure-play bioresorbable scaffold company using proprietary polymer chemistry, illustrating both the technology path and the commercialization challenges in this category.
• Surmodics: Surmodics develops drug-coated balloon technology and coatings used in peripheral vascular intervention (acquired by Abbott in 2024). Comparable to R3 Vascular as a peripheral vascular intervention technology developer competing for the same BTK/PAD procedural volume.
• Silk Road Medical: Silk Road Medical developed the TCAR procedure for carotid disease and was acquired by Boston Scientific. Comparable to R3 Vascular as a venture-backed, novel-teology peripheral/endovascular device company that progressed from pivotal trial through commercialization and strategic exit in the same physician call point (vascular surgeons and interventionalists).
• Penumbra: Penumbra develops peripheral vascular thrombectomy and aspiration devices, including the Indigo system used in below-the-knee interventions for acute limb ischemia. Comparable to R3 Vascular as a venture-backed peripheral vascular intervention company with overlapping vascular surgeon call point and CLI treatment focus.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/r3-vascular-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds2 records

Investors2 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 R3 Vascular