Lucius Partners, LLC Portfolio Company AerWave Medical, Inc. Announces Approval to Move into First in Human Studies

Studies are supported by extensive pre-clinical trials and hold promise for safer, shorter and more efficacious lung denervation procedures for Chronic Obstructive Pulmonary Disease and Asthma patients

NEW YORK, April 2, 2024 /PRNewswire/ -- Lucius Partners, LLC ("LP") today announced that its portfolio company, AerWave Medical, Inc., has received an allowance from the Georgian Ministry of Health to initiate its first in human studies of the Company's unique ultrasound technique for lung denervation.

The study will evaluate patients undergoing lung denervation utilizing AerWave's novel device to treat asthma and chronic obstructive pulmonary disease (COPD). The study is expected to enroll five patients and will evaluate the safety and potential efficacy signals of lung denervation with the Company's innovative, time saving approach. The protocols are supported by extensive pre-clinical trials and data on both the safety and efficacy of dosimetry-based ultrasound denervation. The Company's approach holds promise for a shorter, more efficacious, and safer clinical lung denervation procedure.

"Our team is thrilled to have the opportunity to move our platform into proof-of-concept human trials," said Reinhard Warnking, AerWave Medical President and Chief Technology officer. "Critically, our technology targets tissue in one energy application and is intentionally distanced from peri-esophageal nerves, as a further safety enhancement. Further, as our procedure requires no rotation of the catheter, unlike current denervation technology using RF that requires catheter rotation and can cause collateral damage to the smooth muscle, we believe we can confer significant safety advantages to patients, clinicians, and benefit the healthcare system."

The benefits to various stakeholders could be significant, as COPD leads to 133,575 deaths, 10.3 million physician office visits, 699,000 hospitalizations annually, while asthma leads to approximately 4,000 deaths, 12.8 million physician office visits, and 1.8 million emergency room visits annually in the US.  Up to 15 percent of asthma patients and 25 percent of COPD patients are unresponsive to treatment.  These addressable markets represent 4 million COPD patients and 2.5 million asthma patients in the United States alone.  

"The ability of AerWave Medical's ultrasound device to treat patients' lungs in the secondary bronchi versus the primary bronchus greatly reduces the likelihood of dangerous esophageal side effects, a primary concern of clinicians," said Patrick Gallagher, Director.  "Further, due to non-rotation of the catheter, we believe the procedure could require only approximately 20-30 minutes - a tremendous improvement over existing modalities. This trial was designed to provide supportive data for these unique advantages."

In addition to the platform's potential safety and speed advantages, its access to secondary bronchi affords multiple pipeline opportunities, including tumor ablation.

"We are in a very exciting time of value creation at Lucius Partners," said James Ahern, Founding Partner of Lucius Partners and Managing Partner of Laidlaw & Company.  "Achieving the first in human milestone is a testament to the AerWave team's focused and thoughtful efforts continue to advance our lung denervation platform.  This is a major step toward helping patients and physicians have an efficacious solution for treating the cause - not the symptoms - of COPD and asthma."

About AerWave Medical, Inc.

AerWave Medical is dedicated to creating and advancing medical devices to address unmet medical needs in Pulmonary medicine and beyond, using proprietary ultrasound technology developed by our highly accomplished scientists. For more information, please visit AerWave Medical. 

About Lucius Partners, LLC

Lucius Partners is a consultancy that provides a broad suite of services to help healthcare companies grow, achieve milestones, and generate value for their shareholders. Learn more about Lucius Partners here.

Contact
Patrick Gallagher
Managing Partner, Lucius Partners, LLC
[email protected]

SOURCE Lucius Partners, LLC