Cooled RF bronchoscopic lung volume reduction

The National Heart, Lung, and Blood Institute awarded Coridea, LLC $305,365 on September 1, 2026, under the Cardiovascular Diseases Research program (CFDA 93.837) to develop cooled radiofrequency bronchoscopic lung volume reduction technology for severe emphysema patients.

The project addresses a clinical gap in lung volume reduction therapy. Current surgical options reach only a fraction of severe emphysema patients: wedge excision LVR surgery is invasive and limits candidate eligibility, while FDA-approved endobronchial valves exclude approximately 90 percent of emphysema patients due to fissure integrity requirements. Prior endobronchial steam ablation attempts generated high adverse event rates from uncontrolled thermal delivery into healthy lung tissue. This Phase I SBIR award funds development of a cooled radiofrequency approach designed to enable controlled, safer lung volume reduction in patient populations ineligible for existing treatments.

Coridea, LLC, a New York City-based small disadvantaged business, develops minimally invasive medical device technologies. The company holds prior NHLBI grants and support from the National Institute on Drug Abuse and National Institute of General Medical Sciences for related interventional and device research.

The period of performance runs from September 1, 2026, through August 31, 2027. Work is performed in New York, New York. The SBIR program evaluation criteria assess technological innovation, commercial potential, feasibility of Phase I objectives, and qualifications of the investigator team.

Abstract

In the united states, chronic obstructive pulmonary disorder (COPD), ranks fourth in the leading causes of mortality with over 140,000 deaths annually. COPD is made up of chronic bronchitis (inflammation of the bronchi resulting in increased production of mucus) and emphysema (a chronic lung condition resulting in irreversible damage of alveoli and eventual necrosis). Of the 16 million people diagnosed with COPD in 2016 (1.5% of the adult population), 3.5 million were diagnosed with emphysema. This health crisis is compounded by the estimated 8 million potential COPD cases that remain undiagnosed each year. Emphysema is a progressive disease characterized by the destruction of lung parenchyma and an irreversible increase in the size of alveolar spaces. This leads to hyperinflation, loss of lung elasticity, and reduced expiratory flow. These morphological changes in the lungs cause structural changes to in the chest wall and respiratory muscles, making IT difficult for patients to breathe. Lung volume reduction (LVR) is the only treatment method for patients with severe emphysema, but issues exist with the current options. LVR surgery done via wedge excisions is the most established and validated option, but few patients qualify due to the invasiveness of the procedure. Recently, the FDA approved implantable endobronchial valves (EBVS), which achieve LVR via permanent implantation of one-way valves. However, 90% of patients with emphysema are ineligible for EBVS due to the requirement of having intact fissures between lobes. Other attempts have been made to develop a safe LVR procedure that is a viable option for all severe emphysema patients, but none have been approved by the FDA. For example, two companies attempted LVR via endobronchial steam ablation, but this procedure had high rates of adverse events due to uncontrolled delivery of steam that quickly spread into areas of healthy lung tissue. This proposal will validate a new, minimally invasive and completely endobronchial approach to LVR that will be a safe and effective option for all patients with severe emphysema. Our innovative approach is designed to be used with currently available bronchoscopic tools for lung tumor biopsy or imaging and can also be used in conjunction with contemporary navigation systems. This procedure will allow physicians to selectively target the most diseased segments of the lung, thereby sparing the healthier tissue. Our proprietary system delivers controlled radiofrequency (RF) energy with a device completely in the airway that selectively heats diseased parenchyma and prevents ablation of healthy tissue in non-target segments of the lungs. LVR is achieved by the normal healing process after heating, which involves replacement fibrosis of the ablated tissue. To increase the radius that the delivered RF energy can reach with such a small device, our system aspirates air and then infuses hypertonic saline to increase conduction in the target zone. The size of the ablation zone is controlled via our proprietary algorithm and generator, which modulates both energy and hypertonic saline irrigation rate in response to changes in temperature and impedance. We have already developed a full length, bronchoscope-compatible prototype and custom RF generator and demonstrated proof of concept in computational models, bench and chronic preclinical studies that show our system can make significant lesions (~120 CC) without causing pneumothorax or other complications. In phase I, we plan to extend the ability of our system to make lesions up to 3X the size achieved in the preliminary studies by increasing the power, duration of ablation, and by staging the procedure. The information obtained in this grant will be used directly to guide eventual EFS-IDE submission with the FDA in a future phase of the grant.