Reflow Medical, Inc. - Pioneer of Retrievable Scaffold Therapy for Complex Cardiovascular Disease

Company Profile (Updated April 2026)

Reflow Medical, Inc. is a global medical device company dedicated to developing innovative technologies that address unmet clinical needs in the endovascular treatment of complex cardiovascular disease. Headquartered in San Clemente, California, USA, the company was founded in 2011 by Isa Rizk (CEO and Co-Founder) and John Fulkerson (COO and Co-Founder). Reflow Medical partners with leADINg physicians to design devices that improve patient outcomes in peripheral and coronary interventions.

Development History:

- 2011: Founded in San Clemente, California, with a mission to develop novel endovascular solutions for complex cardiovascular disease

- 2012: Completed Series A2 funding ($500K), bringing total early-stage capital to $1.4M

- 2015: Completed Series A3 funding to advance product development

- 2016: Completed later-stage venture round to support clinical and regulatory pathways

- 2018: Completed Series B funding while generating revenue

- 2024: Spur received CE Mark approval for the treatment of restenotic lesions in below-the-knee arteries when used with a commercially available drug-coated balloon (January 2024)

- 2025: FDA granted De Novo clearance for the Spur Peripheral Retrievable Stent System (May 2025, DEN240048); established European subsidiary in Germany to build direct sales channels and distribution partnerships

- 2026: Published 12-month DEEPER REVEAL trial results demonstrating sustained wound healing and symptomatic improvement; advancing development of a drug-eluting version of Spur for coronary arteries

Core Mission: To partner with leading physicians to develop innovative technologies that address unmet clinical needs in the endovascular treatment of complex cardiovascular disease, improving patient outcomes through novel mechanical and drug-device combination therapies.

Core Technology: Retrievable Scaffold Therapy (RST)

Proprietary Platform

Reflow Medical's Retrievable Scaffold Therapy (RST) represents a paradigm shift in endovascular treatment. Unlike conventional permanent stents that remain implanted indefinitely, RST provides temporary mechanical scaffolding to support the vessel wall and facilitate blood flow, then is fully retrieved after treatment—preserving future treatment options and avoiding long-term complications associated with permanent metallic implants.

Key Mechanism:

- Radially Expandable Spikes: The Spur stent incorporates a series of radially expandable spikes that create controlled lesion penetration and modification

- Acute Luminal Gain: Spikes penetrate the lesion to increase the acute luminal diameter and modify lesion morphology

- Vessel Compliance Improvement: Changes vessel compliance and reduces vessel recoil effect—the natural tendency of an artery to collapse inward after mechanical expansion

- Full Retrieval: Following treatment, the device is completely removed, leaving no permanent implant behind

- Reusability: The device can be used up to four times during a single procedure for long or complex lesions

Core Products & Solutions

Spur Peripheral Retrievable Stent System (Flagship)

The Spur Stent System is the first and only retrievable stent system featuring a self-expanding stent with an integrated dilatation balloon catheter on an over-the-wire system. It is designed for controlled lesion penetration and treatment through radially expandable spikes.

Indications:

- Treatment of de novo or restenotic lesions following predilatation in patients with infrapopliteal arterial disease (below-the-knee, BTK)

- Adjunct to standard balloon angioplasty (PTA) for chronic limb-threatening ischemia (CLTI)

Regulatory Status:

- FDA De Novo Clearance: Granted May 2025 (DEN240048) for BTK arterial disease

- CE Mark: Approved January 2024 for restenotic lesions in below-the-knee arteries when used with a commercially available drug-coated balloon

- Breakthrough Device Designation: Received from FDA prior to De Novo clearance

Clinical Evidence - DEEPER REVEAL Trial (NCT05358353):

- Study Design: Multicenter pivotal trial conducted at 49 centers across the United States, enrolling 130 patients

- Lead Principal Investigators: Dr. Mahmood K. Razavi (St. Joseph Heart and Vascular Center, Orange, CA) and Dr. S. Jay Mathews (Bradenton Cardiology/Manatee Memorial Hospital, Bradenton, FL)

- 30-Day Results: 99.2% technical success (less than 30% residual stenosis by visual estimation); 97.0% freedom from major adverse limb events (MALE) and perioperative death (POD)

- 12-Month Results (April 2026): 84.3% complete paired wound healing; 80.0% symptomatic improvement measured by Rutherford class; significant gains in vascular quality of life; outcomes compare favorably to historical plain balloon angioplasty data

Coronary Product Line - Cora Catheters

- Cora Microcatheters: FDA-approved coronary microcatheters for complex coronary interventions

- Cora Crossing Catheters: Designed to navigate challenging coronary anatomy

- Availability: United States only

Peripheral Product Line

- Wingman™: Crossing catheter for peripheral vascular access, available in the U.S., CE Mark and CE Mark-accepting countries, and selected markets

- Spex®: Peripheral microcatheter for complex peripheral interventions, available in the U.S., CE Mark countries, and selected markets

- Spex LP: Low-profile version of the Spex microcatheter for enhanced deliverability, available in the U.S., CE Mark countries, and selected markets

Pipeline

- Drug-Eluting Spur (Coronary): Development of a drug-eluting version of the Spur retrievable stent system designed for use in the heart's coronary arteries, expanding the RST platform into the coronary space

Clinical & Market Context

Disease Burden

Chronic Limb-Threatening Ischemia (CLTI):

- CLTI represents the most advanced stage of peripheral arterial disease (PAD) and is associated with high morbidity, mortality, and limb loss

- Based on 2017-2018 Medicare data, an estimated 480,000 Americans were living with CLTI

- Among adults over age 70, PAD affects up to 15%, with CLTI representing a smaller but high-risk subset

- Without timely intervention, up to 25% of CLTI patients may die within one year, and many remain at risk for major amputation

- Standard balloon angioplasty (PTA) shows limited durability: meta-analysis data indicate treated vessels remain open in only about 63% of cases at follow-up (Primary patency), with nearly 15% requiring major amputation

Competitive Landscape:

- Abbott Esprit BTK: FDA approved in 2024 as the first dissolvable stent for BTK use; 2-year LIFE-BTK trial showed 90.3% freedom from reintervention and 48% reduction in repeat procedures vs. balloon angioplasty

- Reflow Medical's Spur RST offers a distinct retrievable (rather than dissolvable) approach, providing mechanical lesion modification without leaving any permanent implant

Financial Performance

Funding & Revenue

- Total Funding Raised: Approximately $4.82 million across multiple venture rounds (Series A through Series B)

- Annual Revenue (2025): Approximately USD 7.3 million

- Company Stage: Private, revenue-generating, post-regulatory clearance with commercial launch underway

- Funding History:

- Series A (June 2011): $900K

- Series A2 (May 2012): $500K (total $1.4M)

- Series A3 (April 2015): Undisclosed

- Later Stage VC (September 2016): Undisclosed

- Series B (August 2018): Undisclosed

Global Expansion

European Market Entry

In 2025, Reflow Medical established a European subsidiary in Germany, tasked with building direct sales channels and distribution partnerships across the continent. This strategic move leverages the Spur system's CE Mark approval (January 2024) to access European markets for the treatment of restenotic BTK lesions in conjunction with drug-coated balloons.

Company Information & Leadership

Corporate Overview

Company Full Name: Reflow Medical, Inc.

Founded: 2011

Headquarters: San Clemente, California, USA

Company Type: Private venture-backed company

Industry: Medical Devices - Endovascular / Peripheral Vascular / Interventional Cardiology

Employees: 45-63 (industry estimates)

Annual Revenue: ~USD 7.3 million (2025)

Total Funding: ~$4.82 million

Leadership Team

CEO & Co-Founder: Isa Rizk

- Led the company from founding through FDA De Novo clearance and commercial launch

- Vision: "We are fully prepared to launch our innovative technology through our dedicated sales force, ensuring it promptly reaches physicians to support patients."

COO & Co-Founder: John Fulkerson

Senior Vice President of R&D: Teo Jimenez

- Oversees product development and clinical validation; led the extensive R&D program that laid the groundwork for the DEEPER REVEAL trial

Director of Clinical Affairs: Carolyn Mascho

Media & Investor Contact: Jennifer Carlyle

- Email: jcarlyle@reflowmedical.com

- Tel: +1 (949) 481-0399

2026 Outlook & Strategic Focus

Future Development Priorities

- Commercial Launch of Spur in the U.S.: Deploy dedicated sales force to drive adoption of the Spur Stent System among interventional cardiologists, vascular surgeons, and interventional radiologists treating CLTI

- European Market Expansion: Leverage the German subsidiary and CE Mark to build direct sales and distribution across European markets

- Coronary Drug-Eluting Spur: Advance development of the drug-eluting version of Spur for coronary artery disease, expanding the RST platform into the cardiac space

- Long-Term Clinical Data: Continue follow-up of DEEPER REVEAL trial patients to generate robust real-world evidence supporting Spur's durability and cost-effectiveness

- Reimbursement Strategy: Secure favorable reimbursement codes and coverage policies for retrievable scaffold therapy in BTK interventions

- Product Line Expansion: Explore additional applications of RST technology in other vascular territories and lesion types

Contact Information

Headquarters

Location: San Clemente, California, USA
   Website: www.reflowmedical.com

Media & Press

Contact: Jennifer Carlyle
   Email: jcarlyle@reflowmedical.com
   Telephone: +1 (949) 481-0399

European Subsidiary

Location: Germany
   Established: 2025
   Focus: Direct sales channels and distribution partnerships across Europe

Keywords: Reflow Medical, Retrievable Scaffold Therapy, RST, Spur Stent System, Spur, peripheral arterial disease, BTK, below-the-knee, CLTI, chronic limb-threatening ischemia, PAD, De Novo, DEN240048, FDA clearance, CE Mark, endovascular, stenosis, restenosis, lesion penetration, vessel recoil, microcatheter, coronary catheter, Wingman, Spex, Cora, San Clemente, Isa Rizk, John Fulkerson, Teo Jimenez, DEEPER REVEAL trial, Mahmood Razavi, S Jay Mathews, drug-coated balloon, DCB, angioplasty, limb salvage, amputation prevention, vascular intervention, interventional cardiology, interventional radiology, peripheral vascular, complex cardiovascular disease, retrievable stent, temporary scaffold, wound healing, Rutherford class