In May 2024, Atraverse Medical received U.S. FDA 510(k) clearance for its HOTWIRE RF Guidewire, enabling zero-exchange left-heart access. In August 2025, the HOTWIRE RF Generator received FDA 510(k) clearance, creating the first fully integrated transseptal access system with impedance-guided automatic energy shutoff. By April 2026, the system had been used in nearly 3,000 clinical procedures by nearly 100 cardiac electrophysiologists and interventional cardiologists. On April 24, 2026, Johnson ＆ Johnson (NYSE: JNJ) announced a definitive agreement to acquire Atraverse Medical, with the transaction expected to close in the second quarter of 2026.
Company Profile (Updated April 2026)
Atraverse Medical, Inc. is a privately held medical device company headquartered in Encinitas, California, USA (San Diego area). The company was founded in July 2022 by Dr. Steven Mickelsen, John Slump, and Eric Sauter—the identical founding team that created FARAPulse, the pioneer of pulsed field ablation (PFA) technology acquired by Boston Scientific (NYSE: BSX) in June 2021 for over USD 800 million. Atraverse Medical is dedicated to advancing next-generation transseptal access technology for the USD 1 billion-plus left-heart access market, which encompasses over 1 million annual electrophysiology and structural heart procedures worldwide. The company currently employs 32 people.
Development History:
- July 2022: Founded in Encinitas, CA, by the FARAPULSE founding team
- February 2023: Closed initial seed financing of USD 5 million
- November 2023: Raised additional seed funding of USD 7.5 million, bringing total to USD 12.5 million
- May 2024: Received U.S. FDA 510(k) clearance for the HOTWIRE RF Guidewire (K240506)
- July-August 2024: First clinical use performed by Dr. Devi Nair at St. Bernard's Heart and Vascular Center; limited market release commenced
- May 2025: Raised USD 53 million in seed funding to expand commercialization and product development
- August 2025: Received U.S. FDA 510(k) clearance for the HOTWIRE RF Generator (K252083), completing the fully integrated transseptal access system
- January 2025: Clinical data presented at the 30th annual AF Symposium in Boston, validating safety and efficacy
- April 2026: Entered into definitive acquisition agreement with Johnson ＆ Johnson; transaction expected to close in Q2 2026
Core Mission: To improve efficiency, control, and safety in left-heart access procedures by replacing traditional needle-based transseptal puncture with an innovative RF guidewire platform, thereby streamlining workflows and enhancing patient outcomes across electrophysiology and structural heart interventions.
2026 Breakthrough: Johnson ＆ Johnson Acquisition
Definitive Acquisition Agreement (April 24, 2026)
Transaction Overview:
- On April 24, 2026, Johnson ＆ Johnson (NYSE: JNJ) announced it had entered into a definitive agreement to acquire Atraverse Medical, Inc.
- Expected Closing: Second quarter of 2026, subject to customary closing conditions
- Financial Terms: Not disclosed
- Strategic Rationale: HOTWIRE will strengthen J＆J's cardiac ablation portfolio, complementing its electrophysiology solutions for atrial fibrillation and other cardiac arrhythmias
Core Product: HOTWIRE Transseptal Access System
HOTWIRE RF Guidewire (FDA Cleared May 2024)
- Design: A novel radiofrequency (RF) guidewire that enAbles zero-exchange left-heart access while serving as a rail for catheter-based therapies
- Universal Sheath Compatibility: Compatible with multiple sheath models and brands, allowing physicians to maintain preferred workflows
- Proprietary Tip Architecture: Enhances intracardiac echocardiographic visualization by 25% compared to conventional designs
- Rail Stiffness: Reinforced core wire and polymer jacket provide twice the rail stiffness of leADINg competitors, enabling controlled advancement of large-bore sheaths
- Clinical Use: Used in nearly 2,000 procedures by December 2025; nearly 3,000 procedures by April 2026
HOTWIRE RF Generator (FDA Cleared August 2025)
- Impedance-Guided Shutoff: The first and only left-heart access system with impedance-sensing technology that automatically halts RF energy delivery upon transseptal crossing, minimizing unnecessary RF exposure in the left atrium
- Sterile Field Activation: Enables user-controlled energy activation within the sterile field, giving clinicians precise procedural control
- Integration: Creates a fully integrated, end-to-end, sheath-agnostic transseptal access solution when combined with the HOTWIRE RF Guidewire
Clinical Evidence and Outcomes
- First-in-Human Experience: Dr. Devi Nair at St. Bernard's Heart and Vascular Center performed the initial clinical cases and presented data at the AF Symposium
- Adoption: Nearly 100 cardiac electrophysiologists and interventional cardiologists have used HOTWIRE in clinical practice
- Procedural Volume: Nearly 3,000 left-heart access procedures performed by April 2026
Financial and Funding History
Funding Rounds
- Seed Round (Feb 2023): USD 5 million
- Seed Round (Nov 2023): USD 7.5 million; cumulative raised USD 12.5 million
- Seed Round (May 2025): USD 53 million to scale manufacturing, expand team, and invest in new product development
- Total Funding Raised: Approximately USD 69.6 million
- Investor Base: Includes physicians, reputable venture investors, successful medtech entrepreneurs, angel investors, family offices, New York Angels, Band of Angels, HBS Alumni Angels of Greater New York, and MEDA Angels
Valuation and Exit
- Status: Private (pre-acquisition)
- Expected Exit: Acquisition by Johnson ＆ Johnson, expected to close Q2 2026
- Transaction Value: Not disclosed
Company Leadership and Team
Executive Team
John Slump - CEO, President ＆ Co-Founder:
- Serial medtech entrepreneur with over USD 1 billion in total M＆A transaction value across three exits
- Co-Founder and former CFO of FARAPULSE (acquired by Boston Scientific for up to USD 800M-plus)
- Co-Founder/CFO of Attune Medical (acquired by Haemonetics for USD 160M)
- CFO of Surgical Innovation Associates (acquired by Integra LifeSciences for up to USD 140M)
Dr. Steven Mickelsen - Chief Translational Science Officer ＆ Co-Founder:
- Practicing cardiac electrophysiology physician at Scripps (San Diego, CA)
- Pioneer of pulsed field ablation (PFA); Co-Founder and inventor of FARAPULSE
- Former executive at Acutus Medical (NYSE: AFIB)
Eric Sauter - COO, Co-Founder ＆ Co-Inventor:
- First named inventor of HOTWIRE technology
- Former first employee at FARAPULSE; prior roles at Abbott, Teleflex, Access Point Technologies
- Over 10 years of medtech development and marketing experience in EP / cardiac therapy
Jay Kelley - Chief Marketing Officer:
- Promoted from VP Marketing in 2024; 20-plus years in cardiac EP device R＆D and commercialization
- Prior experience at Medtronic, J＆J, Ablation Frontiers (acquired by Medtronic for USD 225M), and Filmetrics
Brandon Allen - Vice President of Sales:
- Joined May 2024; 20-plus years in cardiac EP sales
- Former VP Sales at Acutus Medical; prior experience at Biosense and Guidant / Boston Scientific
Charles Yang - SVP Quality ＆ Regulatory Affairs:
- 20-plus years of cardiovascular device regulatory experience; previously at Blockade Medical, Ablation Frontiers, and Edwards Lifesciences
Global Market Position and Competition
Market Landscape
Left-Heart Access Market:
- A USD 1 billion-plus market segment encompassing over 1 million annual electrophysiology and structural heart procedures globally
- Transseptal puncture is a critical step in atrial fibrillation ablation, left atrial appendage closure, mitral valve interventions, and other left-heart catheter-based therapies
- Traditional needle-based access carries risks of uncontrolled needle advancement, cardiac tamponade, and radiation exposure from fluoroscopy
Primary Competitors
- Boston Scientific ProTrack RF Anchor Wire: Cited by Atraverse as the predicate device in its 510(k) submission; established competitor in RF transseptal access
- Traditional Needle-Based Systems: Brockenbrough needle and fixed-curve sheath systems remain widely used
Competitive Advantages
- Impedance-Guided Safety: First and only system with automatic energy shutoff upon transseptal crossing, reducing risk of uncontrolled RF delivery in the left atrium
- Zero-Exchange Workflow: Eliminates the need to exchange needles for guidewires, streamlining procedural steps
- Sheath Agnostic: Universal compatibility allows integration with existing physician preferences and institutional inventory
- Enhanced Visualization: Proprietary tip design improves echocardiographic visibility by 25%
- Superior Rail Support: Twice the stiffness of competitors for stable large-bore sheath advancement
- Proven Entrepreneurial Team: Founders have collectively generated over USD 1 billion in medtech exits
Clinical Implementation Cases
St. Bernard's Heart and Vascular Center, Jonesboro, Arkansas (July-August 2024)
- Milestone: Site of the first clinical use of HOTWIRE in the world
- Physician: Dr. Devi Nair, Director of Cardiac Electrophysiology
- Procedures: Initial cases Included atrial fibrillation ablations and left atrial appendage closures, using multiple transseptal sheath models
- Significance: Demonstrated real-world sheath-agnostic compatibility and immediate clinical utility
Multi-Center Commercial Rollout (2024-2026)
- Adoption: Nearly 100 cardiac electrophysiologists and interventional cardiologists adopted HOTWIRE
- Procedure Volume: Nearly 3,000 left-heart access procedures performed by April 2026
- Success Rate: Strong procedural success and safety profile demonstrated in clinical practice
2026 Outlook and Strategic Priorities
Johnson ＆ Johnson Integration
- Portfolio Synergy: HOTWIRE will be integrated into J＆J's cardiac ablation and electrophysiology portfolio
- Global Scale: Leverage J＆J's commercial infrastructure to accelerate worldwide adoption
- R＆D Expansion: Continued investment in next-generation left-heart access innovations under J＆J MedTech
Technology Roadmap
- Expand HOTWIRE platform applications beyond AFib ablation to structural heart interventions
- Develop additional catheter-based therapy integration tools
- Continue clinical evidence generation through real-world registries and randomized studies
Contact Information
Headquarters
Address: Encinitas, California, USA (San Diego area)
Website: www.atraversemedical.com
Investor Relations (Pre-Acquisition)
Status: Private company; acquisition by Johnson ＆ Johnson pending (expected Q2 2026)
Corporate Website: www.atraversemedical.com
Keywords: Atraverse Medical, HOTWIRE, transseptal access, left-heart access, RF guidewire, radiofrequency, atrial fibrillation, AFib, Steven Mickelsen, John Slump, Eric Sauter, FARAPULSE, Boston Scientific, Johnson and Johnson, JNJ, acquisition 2026, FDA 510(k), cardiac electrophysiology, structural heart, zero-exchange, sheath-agnostic, Encinitas, San Diego, medical device, impedance-guided, Devi Nair, St. Bernards Medical Center
