Company Profile
Reflow Medical, Inc. is a US-based manufacturer of endovascular devices for complex cardiovascular disease, headquartered in San Clemente, California. Founded in 2011 by Isa Rizk (CEO and Co-Founder) and Teo Jimenez (Senior Vice President of R＆D), the privately held company employs 45 people and partners with leading physicians to develop physician-inspired solutions for unmet clinical needs in peripheral and coronary interventions. In March 2025, the company established Reflow Medical Europe GmbH in Landsberg am Lech, Germany, to serve European, Middle Eastern, African, Latin American, and Asia-Pacific markets.
Core Products ＆ Technologies
Retrievable Scaffold Therapy (RST)
• Spur® Peripheral Retrievable Stent System: First and only retrievable stent system featuring a self-expanding stent with integrated dilatation balloon catheter on an over-the-wire system; designed with radially expandable spikes for controlled lesion penetration; FDA De Novo cleared May 2025 (DEN240048) and US launched April 2026; CE marked for restenotic BTK lesions with drug-coated balloon
• Spur® Elute Coronary Sirolimus-Eluting Retrievable Scaffold System: First and only retrievable self-expanding scaffold with radially expandable spikes combined with an integrated drug-coated balloon; designed for coronary in-stent restenosis (ISR); DEEPER CORONARY first-in-human study completed enrollment September 2025
• DEEPER REVEAL Clinical Trial: Prospective, non-randomized, multicenter study at 49 US sites with 130 patients; demonstrated 99.2% technical success and 97.0% freedom from MALE and POD at 30 days; 12-month data presented April 2026 showed 78.0% primary patency and 83.1% freedom from CD-TLR in appropriately sized vessels, with 84.3% complete paired wound healing and 80.0% symptomatic improvement by Rutherford class
Coronary Microcatheters
• CoraCatheters: Coronary microcatheter line available in the US; designed for complex coronary interventions and guidewire support
Peripheral Crossing ＆ Support Catheters
• Wingman™: Peripheral crossing catheter for navigating complex lesions
• Spex® / Spex LP: Peripheral microcatheters available in the US, CE Mark, and selected markets; designed for support and delivery in peripheral interventions
Market Position ＆ Certifications
Reflow Medical holds a specialized position in the endovascular treatment of below-the-knee (BTK) peripheral artery disease, competing with Abbott (Esprit BTK), Cook Medical, Medtronic, and Boston Scientific. Key strengths include:
• 14+ years of endovascular innovation heritage
• First-mover advantage: First and only retrievable stent system for infrapopliteal arterial disease cleared by FDA
• Retrievable Scaffold Therapy: Unique mechanical approach that leaves nothing behind, preserving future treatment options
• Regulatory compliance: FDA De Novo cleared (Class II), CE marked, and ISO certified manufacturing
• Global expansion: European subsidiary established 2025 with direct sales and distribution partnerships across EMEA, Latin America, and Asia Pacific
• Physician collaboration: Products developed through close partnership with interventional cardiologists and vascular surgeons
Corporate Timeline
2011 — Founded in San Clemente, California by Isa Rizk and Teo Jimenez
2012 — Completed Series A2 financing
2015 — Completed Series A3 financing
2018 — Completed Series B financing
2024 — Received CE Mark certification for Spur peripheral retrievable stent system
2025 — Spur Peripheral Retrievable Stent System received FDA De Novo clearance (May 29); established Reflow Medical Europe GmbH in Landsberg am Lech, Germany (March); DEEPER CORONARY study completed enrollment (September)
2026 — DEEPER REVEAL 12-month results presented at SIR 2026 (April 13); Spur officially launched in the US market (April 23); presented at AVC Frankfurt, CICE São Paulo, EuroPCR Paris, and Pittsburgh Vascular Symposium
Target Markets ＆ Applications
• Chronic Limb-Threatening Ischemia (CLTI): Below-the-knee treatment of de novo or restenotic lesions in infrapopliteal arteries
• Complex BTK Disease: Diabetic patients with severe peripheral artery disease and limited treatment options
• Wound Healing: Limb salvage procedures supporting paired wound healing and vascular quality of life improvement
• Coronary In-Stent Restenosis: Spur Elute for ISR treatment without leaving a permanent metallic implant
• Peripheral Vascular Access: Crossing and support catheters for peripheral arterial procedures
Contact Information
Global Headquarters
Address: 208 Avenida Fabricante, Suite 100, San Clemente, California 92672, USA
Phone: +1 949 481 0399
Email: jcarlyle@reflowmedical.com
Website: www.reflowmedical.com
European Subsidiary
Reflow Medical Europe GmbH
Address: Landsberg am Lech, Germany
