What ReFlow Medical does

ReFlow Medical is a privately held medical device company founded in 2011 and headquartered in San Clemente, California, with a worldwide team of more than 135 employees and a wholly-owned European subsidiary in Germany. The company develops physician-inspired interventional cardiology and vascular devices for the treatment of complex peripheral artery disease (PAD), chronic limb-threatening ischemia (CLTI), below-the-knee lesions, chronic total occlusions (CTOs), and complex coronary artery disease including in-stent restenosis. Its core platform is the Retrievable Scaffold Therapy (RST) system, centered on a self-expanding stent with radially expandable spikes integrated with a balloon catheter; the device creates channels in the vessel wall to reduce recoil and enhance drug uptake when paired with drug-coated balloons, and is then fully removed leaving no permanent implant. The product portfolio includes the FDA-cleared Spur Peripheral Retrievable Stent System, the investigational Spur Elute Coronary Sirolimus-Eluting Retrievable Stent System, the Wingman CTO crossing catheter, the Spex and Spex LP shapeable support microcatheters, and the Cora Flex, Cora Force, and Cora Cross torqueable coronary microcatheters.

ReFlow protects its technology with more than 70 registered patents and a proprietary sirolimus drug formulation, and has built a clinical evidence base spanning six studies with more than 2,200 enrolled and planned patients, including the DEEPER, DEEPER OUS, DEEPER LIMUS, DEEPER REVEAL, and DEEPER CORONARY programs. The company operates a hybrid go-to-market model: a US direct sales force sells to interventional cardiologists, interventional radiologists, and vascular surgeons, while more than 30 distribution partners extend reach across 55+ countries in Europe, the Middle East, Asia, and Oceania. Revenue is generated almost entirely through hardware sales of single-use interventional devices to hospitals and catheterization labs, with physician training, proctor programs, and major conference participation (LINC, EuroPCR, ISET, CRT, VIVA, SIR) serving as primary marketing channels. Key recent milestones include FDA De Novo clearance and FDA Breakthrough Device Designation for the Spur Peripheral system in 2025, establishment of the European subsidiary, a clinical co-development partnership with Concept Medical combining Spur RST with the MagicTouch sirolimus drug-coated balloon, and US launch of the next-generation Cora Flex and Cora Force microcatheters in April 2026.

Name

ReFlow Medical

Legal name

Reflow Medical, Inc.

Website

https://reflowmedical.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

ReFlow Medical is a privately held medical device company developing retrievable scaffold and microcatheter technologies for the treatment of complex peripheral and coronary cardiovascular disease, sold through a US direct sales force and a network of more than 30 distribution partners across 55+ countries.

Ownership category

akta.pro rank

Product category

Cardiovascular Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Open & Minimally Invasive Surgical Instruments (Handheld, Laparoscopic, MIS) (HLAHADAA)

Keywords

• Peripheral vascular devices
• Coronary microcatheters
• Retrievable stent systems
• Cardiovascular medical devices
• Drug-coated balloon catheters

Headquarters

HQ city

San Clemente

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Sale of proprietary cardiovascular medical devices including microcatheters, crossing catheters, support catheters, and retrievable scaffold systems. Products sold through direct sales force in US and distribution partners internationally.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels7 records

Core offering

ReFlow Medical designs, develops, and manufactures physician-inspired medical devices for treating complex peripheral and coronary cardiovascular disease. Its portfolio includes retrievable scaffold systems (Spur, Spur Elute), torqueable microcatheters (Cora Flex, Cora Force, Cora Cross), shapeable support microcatheters (Spex, Spex LP), and the Wingman CTO crossing catheter. Products are sold to hospitals and interventional physicians through a US direct sales force and a global network of distribution partners.

Product overview

Reflow Medical is a medical device company developing physician-inspired solutions for treating complex cardiovascular disease. The company offers a portfolio of 4 peripheral and 3 coronary technologies. The peripheral product line includes Wingman CTO Crossing Catheter, Spex and Spex LP Shapeable Support Microcatheters, and the Spur Peripheral Retrievable Scaffold System (RST) for below-the-knee treatment of CLTI. The coronary portfolio includes Cora Flex, Cora Force, and Cora Cross Torqueable Microcatheters, plus the investigational Spur Elute Sirolimus-Eluting Retrievable Stent System. The proprietary RST platform features radially expandable spikes that create channels to modify lesion morphology and enhance drug uptake, with the device fully removed leaving nothing behind.

Differentiator

Problem solved

Functional benefit

Brands

• Spur: Retrievable Scaffold Therapy (RST) platform for peripheral and coronary interventions, including the Spur Peripheral Retrievable Stent System and Spur Elute Sirolimus-Eluting Retrievable Stent System
• Cora Catheters
• Cora Cross
• Spex
• Spex LP
• Wingman

Products and services

• Spur Peripheral Retrievable Stent System Retrievable Scaffold Therapy (RST) peripheral stent system featuring a self-expanding scaffold with radially expandable spikes and integrated dilation balloon catheter for below-the-knee (BTK) treatment of chronic limb-threatening ischemia (CLTI). Creates channels to modify lesion morphology and optimize drug uptake when used with drug-coated balloons, then is fully removed leaving nothing behind.
• Spur Elute Coronary Sirolimus-Eluting Retrievable Stent System First and only retrievable self-expanding stent with radially expandable spikes combined with an integrated balloon, both drug-coated with proprietary sirolimus formulation. Uses RST mechanism where spikes create channels to increase drug uptake while the temporary stent supports the arterial lumen before full removal; designed for coronary in-stent restenosis and complex coronary intervention.
• Cora Flex Torqueable Microcatheter Next-generation torqueable microcatheter designed for complex coronary interventions, featuring enhancements to handling, torque transmission, and navigation in challenging anatomies.
• Cora Force Torqueable Microcatheter Next-generation torqueable microcatheter designed for complex coronary interventions with improved handling and navigation capabilities.
• Cora Cross Coronary Microcatheter Coronary microcatheter product in the Cora catheter line for complex coronary interventions.
• Wingman CTO Crossing Catheter Crossing catheter designed for crossing challenging chronic total occlusions in peripheral interventions, incorporating needle-based crossing techniques.
• Spex Shapeable Support Microcatheter Shapeable Support Catheter that holds its preferred angle throughout the procedure; compatible with physician's preferred guidewire and procedural technique, designed to promote improved and predictable access to the vasculature.
• Spex LP Lowest Profile Reinforced Support Microcatheter Lowest profile reinforced support catheter designed for crossing the tightest lesions without sacrificing strength; features braid-reinforced microcatheter body for improved column strength and pushability, with three radiopaque markers for visibility.

Quantifiable outcome

• 78.0% primary patency at 12 months in DEEPER REVEAL trial (130 patients, 49 US centers)
• +9 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

One partnership is on record.

• Concept MedicalcoreStrategic or Co-development Partner · 1 March 2025Partnership involving use of MagicTouch PTA sirolimus-coated drug-coated balloon in combination with Spur RST in the DEEPER LIMUS clinical study. Concept Medical's sirolimus DCB used with Spur retrievable scaffold therapy for BTK CLTI treatment demonstrating 89.5% 12-month patency.

Scale indicators13 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Asahi Intecc: Japanese specialty microcatheter and guidewire manufacturer widely used in complex coronary and peripheral interventions. Comparable to Reflow's Cora microcatheter and Spex support catheter product lines.
• Penumbra: Vascular thrombectomy (Indigo, Lightning) and peripheral intervention franchise. Comparable as a fast-growing, physician-focused interventional vascular device company with novel mechanism products in similar cath lab channels.
• Shockwave Medical: Intravascular lithotripsy (IVL) platform for calcified peripheral and coronary lesions. Comparable as a novel mechanism-of-action device addressing complex cardiovascular disease that has scaled rapidly in the same BTK/CLTI and coronary markets.
• Concept Medical: Developer of the MagicTouch sirolimus-coated drug-coated balloon used in Reflow's DEEPER LIMUS trial. A partner-and-competitor in sirolimus DCB and coronary scaffold technology, with overlapping R&D programs.
• LimFlow: Developer of percutaneous deep venous arterialization system (LimFlow pDVA) for no-option CLTI patients. Direct competitor in the same end-stage CLTI/limb-salvage market that Spur targets.

Broad incumbents

• Abbott Vascular: Major interventional cardiology and peripheral vascular franchise (XIENCE, Absorb, Stellarex DCB, CSI orbital atherectomy). Comparable as the dominant incumbent in coronary stents and peripheral DCBs that Reflow's Spur and Spur Elute compete with.
• Medtronic: Global leader in coronary stents (Resolute, Onyx) and peripheral vascular interventions (IN.PACT Admiral DCB, HawkOne atherectomy). Competes head-to-head with Reflow in both coronary and below-the-knee indications.
• Boston Scientific: Major peripheral and coronary intervention portfolio (Eluvia, Ranger DCBs, Synergy coronary stent, Rotarex atherectomy). Directly comparable to Reflow in peripheral DCB and coronary DES markets.
• Philips (Spectranetics/Image-Guided Therapy): Peripheral atherectomy and laser lead management franchise (formerly Spectranetics) plus intravascular imaging. Comparable as an incumbent in complex peripheral intervention procedures where Reflow's Spur is used.

Emerging players

• Transit Scientific: Developer of novel low-profile catheters and scaffolds for peripheral vascular interventions including below-the-knee disease. Most direct small-cap comparable in catheter-and-scaffold engineering for the BTK segment.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

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• Facebookfacebook.com/reflowmedical
• LinkedInlinkedin.com/company/reflow-medical
• Instagraminstagram.com/reflowmedical

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries1 record

Funding overview

Funding rounds2 records

Investors

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 ReFlow Medical