Advanced Bifurcation Systems, Inc. | Coronary Bifurcation Stent Delivery Manufacturer

Advanced Bifurcation Systems, Inc. | Coronary Bifurcation Stent Delivery Manufacturer

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Company Profile

Advanced Bifurcation Systems, Inc. (ABS) is a US-based manufacturer of    modular stent delivery systems for coronary bifurcation lesions, headquartered in    Livermore, California. Founded in    2010 by    Dr. Mehran Khorsandi (Chairman & CEO) and    Henry Bourang (President & COO), the privately held company employs    17 people and has raised    USD 31.8 million in total funding, including an    USD 11 million Series A (December 2020) and an    oversubscribed USD 20.8 million SAFE (December 2024). ABS is backed by institutional investors including    Cedars Sinai Medical Center and    Johnson & Johnson.

Core Products & Technologies

ABS Modular Bifurcation System

ABS MD-SBA (Side-branch Access Stenting System): Provisional side-branch stenting configuration with independently movable dual-catheter platform; daughter catheter pre-threaded through a sleeve on the mother catheter for automatic orientation and alignment
   • ABS MD-BI (Two Stent System): Mother-daughter stent (MDS) platform deploying stents in both main branch and side branch simultaneously; designed for complete carina coverage without stent deformity
   • Dual-Catheter Architecture: Modular, independently movable monorail system mitigating wire wrap; alignment, phase shift, and orientation are automatic upon inflation
   • Drug-Eluting Coating: Fourth-generation, non-durable polymer coating previously approved by the FDA; stent sizing based on Murray's law, eliminating need for additional completion balloons

Acquired Drug-Eluting Stent Portfolio (via Svelte Medical Systems)

Svelte DES Platform: Drug-eluting coronary stents acquired from Svelte Medical Systems in October 2024; includes comprehensive US and international regulatory approvals and filings
   • Regulatory Assets: US FDA Premarket Approval (PMA), Europe CE Mark, and Japan PMDA approvals for the acquired stent portfolio
   • Strategic Synergy: Combined with ABS's bifurcation-focused delivery platform to accelerate global commercial presence in interventional cardiology; acquisition completion announced April 2026

Market Position & Certifications

ABS holds a development-stage position in the dedicated coronary bifurcation device market,    competing with Tryton Medical,    Medtronic,    Vesper Medical, and    Poseidon Medical. Key strengths include:

15+ years of bifurcation technology innovation heritage
   • First-in-human validation: 10 successful human implants across 3 international centers (Sao Paulo, Ahmadabad, Caracas) with 100% procedural success and peer-reviewed publications
   • Regulatory progress: FDA Breakthrough Device Designation granted October 2023; clear pathway to full FDA approval targeted for 2027
   • Intellectual property: 75+ issued US and international patents with Freedom to Operate opinion
   • Institutional backing: Investors include Cedars Sinai Medical Center, Johnson & Johnson, Brandon Holdings, and leading cardiologists
   • Large addressable market: ~1.6 million procedures annually aggregating to ~USD 8+ billion

Corporate Timeline

2010 — Founded in Livermore, California by Dr. Mehran Khorsandi and Henry Bourang
   2018 — Completed accelerator/incubator program; advanced prototype through bench testing and animal implants
   2020 — Closed USD 11 million Series A financing
   2023 — Granted FDA Breakthrough Device Designation for bifurcation stent delivery platform (October)
   2024 — Acquired all assets of Svelte Medical Systems, adding FDA-approved drug-eluting coronary stent portfolio; completed oversubscribed USD 20.8 million SAFE financing (December)
   2025 — Named Malia Chui and Susan Yashar to Board of Directors (January); expanded board with clinical and regulatory expertise
   2026 — Announced completion of Svelte asset acquisition integration (April 27), positioning ABS among select global companies with FDA-approved drug-eluting coronary stent; targeting Series B financing to fund pathway through full FDA approval

Target Markets & Applications

Coronary Bifurcation Lesions: Primary indication for provisional and two-stent approaches in percutaneous coronary intervention (PCI)
   • Left Main Coronary Artery Disease: Specially designed stent sizes and configurations for left main bifurcation deployments
   • Complex Bifurcation Anatomy: Shallow-angle, distal, and multi-vessel bifurcations not optimally treated by conventional stent techniques
   • Interventional Cardiology Labs: Tertiary hospitals, cardiac catheterization laboratories, and academic medical centers performing high-volume PCI
   • Global Expansion: Regulatory and commercial development across the United States, Europe, Japan, and emerging markets

Contact Information

Global Headquarters

Address: 7419 Southfront Road, Livermore, California 94551, USA
   Phone: +1 877 413 5845
   Email: info@advancedbifurcation.com
   Website: www.advancedbifurcation.com

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