• Series C financing supports continued clinical development of the Acolyte™ Image-Guided coronary chronic total occlusion (CTO) platform, an FDA Breakthrough Device
• Company rebrands as Elumn8 Medical™ to better reflect expanded vision for image-enabled coronary interventions
• Progress continues in the Acolyte™ pre-market clinical trial

Elumn8 Medical, Inc., formerly known as Simpson Interventions, today announced the successful initial close of its Series C financing and the company’s rebrand to Elumn8 Medical, Inc. The financing will support continued clinical development of the Acolyte™ Image-Guided Crossing and Re-Entry Catheter System, currently being evaluated in a pre-market clinical trial for the treatment of coronary chronic total occlusions (CTOs). Chronic total occlusions, or completely blocked coronary arteries, represent one of the most persistent challenges in interventional cardiology.

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Elumn8 Acolyte System

The rebrand reflects the company’s evolution and its focus on advancing image-enabled technologies designed to improve the precision, predictability, and safety of complex coronary interventions. It also references the eighth medical device company founded by Dr. John B. Simpson, whose seminal advancements in coronary and peripheral interventions have transformed interventional cardiology.

“We are excited to secure the initial close of our Series C financing and to introduce Elumn8 Medical as the next chapter in our company’s growth,” said Joe Knight, Chief Executive Officer of Elumn8 Medical. “This funding strengthens our ability to execute on our clinical and regulatory strategy. We are grateful to the investors who have demonstrated confidence in our vision for this important therapeutic option.”

Elumn8 Medical continues to make progress in its Acolyte pre-market clinical trial, which is evaluating the safety and performance of the Acolyte Image-Guided Crossing and Re-Entry Catheter System in patients undergoing CTO percutaneous coronary intervention (CTO-PCI). The trial is enrolling patients at multiple sites in the United States, with up to 103 patients expected across as many as 15 centers.

“The progress we are seeing in the Acolyte clinical program reinforces our belief that image-guided CTO crossing and re-entry represents an important advancement for interventional cardiology,” said Dr. Simpson, Founder and Chief Medical Officer of Elumn8 Medical. “Further, I am thrilled by our rebranding to Elumn8 Medical, as it better captures our mission to visualize complex coronary anatomy and enable more consistent, minimally invasive treatment of CTOs.”

During coronary CTO procedures, the Acolyte System is designed to provide real-time intravascular imaging to support controlled guidewire true-lumen crossing and targeted re-entry into the correct channel for blood flow distal to the lesion, which remains an area of persistent technical challenge for interventional cardiologists. By integrating optical coherence tomography (OCT) imaging directly into a crossing and re-entry catheter, Acolyte intends to improve procedural efficiency, predictability, and safety by enabling wire delivery during concurrent fluoroscopy and OCT visualization.

The Acolyte System has received FDA Breakthrough Device Designation and has been accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP), underscoring its potential to address an unmet need in the treatment of coronary CTOs.

CAUTION – Investigational device. Limited by United States law to investigational use. Not available for sale in any geography.

About Elumn8 Medical

Elumn8 Medical is a medical technology company dedicated to advancing image-enabled solutions for complex coronary interventions. The company’s technologies are designed to enhance visualization, control, and procedural confidence in minimally invasive percutaneous treatments, with an initial focus on coronary chronic total occlusions.

For more information, visit www.elumn8medical.com.

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