Elumn8 Medical, Inc., formerly known as Simpson Interventions, announced the successful initial close of its Series C financing and a corporate rebrand reflecting its broader vision for image-enabled coronary interventions.
The Series C financing will support continued clinical development of the Acolyte Image-Guided Crossing and Re-Entry Catheter System, which is currently being evaluated in a pre-market clinical trial for the treatment of coronary chronic total occlusions. Chronic total occlusions, or completely blocked coronary arteries, remain one of the most persistent challenges in interventional cardiology.
The company said the rebrand to Elumn8 Medical better represents its evolution and focus on advancing image-enabled technologies aimed at improving the precision, predictability, and safety of complex coronary interventions. The new name also references the eighth medical device company founded by Dr. John B. Simpson, whose prior innovations in coronary and peripheral interventions have helped shape interventional cardiology.
Elumn8 Medical continues to advance its Acolyte pre-market clinical trial, which is evaluating the safety and performance of the system in patients undergoing CTO percutaneous coronary intervention. The trial is enrolling patients at multiple sites across the United States, with up to 103 patients expected to participate across as many as 15 centers.
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 beyond the lesion. The company believes integrating optical coherence tomography imaging directly into a crossing and re-entry catheter could 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, highlighting its potential to address an unmet need in coronary CTO treatment.
The device remains investigational and is limited by United States law to investigational use. It is not available for sale in any geography.
KEY QUOTES
“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. 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.”
Joe Knight, Chief Executive Officer, Elumn8 Medical
“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. 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.”
Dr. John B. Simpson, Founder And Chief Medical Officer, Elumn8 Medical
