Human studies approved for lung denervation device

Graphic of doctor showing human lungs in hand.

A lung denervation device that uses an ultrasound technique to treat asthma and COPD has been approved for human trials in the country of Georgia.

AerWave Medical, Inc. has received an allowance from the Georgian Ministry of Health to initiate the study, which is expected to enroll five patients and will evaluate the safety and potential efficacy signals of lung denervation using the company’s approach.

Reinhard Warnking, AerWave medical president and chief technology officer, said the protocols are supported by extensive pre-clinical trials and data on both the safety and efficacy of dosimetry-based ultrasound denervation. He said the company’s technique holds promise for a shorter, safer and more effective clinical lung denervation procedure.

“Critically, our technology targets tissue in one energy application and is intentionally distanced from peri-esophageal nerves as a further safety enhancement,” Warnking explained. “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 and clinicians and benefit the health care system.”

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

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