Elumn8 Medical—formerly known as Simpson Interventions—has announced the successful initial close of its series C financing, coinciding with the company’s rebrand.
The financing will support continued clinical development of the Acolyte image-guided crossing and re-entry catheter system, currently being evaluated in a premarket 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.
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, a press release states. It also references the eighth medical device company founded by John B Simpson, whose seminal advancements in coronary and peripheral interventions have transformed interventional cardiology, the press release adds.
“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 premarket clinical trial, which is enrolling patients at multiple sites in the USA, with up to 103 patients expected across 15 centres.
“The progress we are seeing in the Acolyte clinical programme reinforces our belief that image-guided CTO crossing and re-entry represents an important advancement for interventional cardiology,” said Simpson, who is the 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 visualise complex coronary anatomy and enable more consistent, minimally invasive treatment of CTOs.”
During coronary CTO procedures, the Acolyte System is designed to provide realtime 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 visualisation.
The Acolyte system has received US Food and Drug Administration (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.
