Heart Tech Startup Atraverse Medical Raises $29M for FDA-Cleared Device

Atraverse Medical has closed a $29.4 million funding round to accelerate commercialization of its FDA-cleared HOTWIRE radiofrequency guidewire system. The San Diego-based startup is targeting a massive market opportunity in cardiac procedures that require precise access to the heart's left chambers.

The funding builds on a $12.5 million seed round that helped the company secure FDA 510(k) clearance for its breakthrough technology in 2024. The raise builds upon $12.5 million in prior seed investment that was used to obtain FDA 510(k) clearance and launch early commercial efforts.

Atraverse was founded in 2022 by Dr. Steven Mickelsen, John Slump, and Eric Sauter, with the same group that helped launch the pulsed field ablation company Farapulse. The team brings deep experience in cardiac device innovation to a problem that affects over a million procedures annually.

The HOTWIRE system addresses a critical bottleneck in cardiac care. More than 1 million catheter-based procedures are performed worldwide in the left heart each year, including treatments for atrial fibrillation, valve repairs, and structural heart conditions. Current methods for accessing the left heart chambers through the septum can be complex and time-consuming.

The HOTWIRE system, invented by Atraverse Co-Founders Dr. Steven Mickelsen and Eric Sauter, introduces a paradigm shift in left-heart access. Featuring universal sheath compatibility and optimized RF technology, the HOTWIRE aims to improve patient outcomes and streamline procedural workflows.

The technology enables what the company calls "zero exchange" left-heart access, meaning physicians can cross the septum and deliver therapy without swapping out multiple devices. The Hotwire provides the benefits of RF-guidewire enabled puncture - including Zero Exchange workflow - while allowing physicians to use their preferred transseptal sheath.

CEO and co-founder John Slump sees the funding as validation of the company's evolution from startup to growth-stage medtech company. "This milestone marks an important inflection point for Atraverse and underscores our evolution from a startup company to an emerging growth corporation," Slump said.

The clinical data supporting HOTWIRE has been presented at major cardiology conferences, with early results showing the system's ability to integrate seamlessly into existing workflows. "The HOTWIRE innovation is both intuitive and allows for seamless integration into current workflows - together likely to have a significant impact on electrophysiology and structural heart procedures," according to clinical presentations.

Atraverse's timing appears strategic as the cardiac device market continues expanding. Procedures like atrial fibrillation ablation, left atrial appendage closure, and mitral valve repairs are growing rapidly as populations age and minimally invasive techniques improve outcomes.

The company has already demonstrated clinical use of HOTWIRE at medical centers and plans to use the new funding to expand its commercial reach and establish additional production capabilities. "Our mission is to improve efficiency and take the guesswork out of what should be simply-executed therapeutic and diagnostic procedures," said COO Eric Sauter.

With FDA clearance secured and initial clinical validation complete, Atraverse is positioned to capture market share in the growing field of structural heart interventions. The substantial funding round signals investor confidence in both the technology and the experienced team's ability to scale commercial operations in the competitive cardiac device market.