Pleural Dynamics, Inc. today announced positive results from a prospective, multicenter study evaluating its Automatic Continuous Effusion Shunt (ACES) device for the management of symptomatic recurrent pleural effusions. The study, presented at the CHEST 2025 Annual Meeting, demonstrated that implantation of the ACES device resulted in a 53% median reduction in pleural effusion volume at 30 days, with no adverse events related to fluid diversion to the abdomen reported.

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Unlike current approaches that require frequent outpatient drainage through an externalized catheter or prolonged hospitalization for invasive pleurodesis procedures, Pleural Dynamics' Automatic Continuous Effusion Shunt (ACES) device is designed to automatically drain pleural fluid to the peritoneum using the patient’s natural breathing motion, eliminating the need for additional hospital stays for pleural effusion management.

The ACES study (NCT06210685) evaluated the safety, feasibility, and efficacy of the fully internalized ACES pleuroperitoneal shunt in patients with non-infectious recurrent pleural effusions. Unlike current approaches that require frequent outpatient drainage through an externalized catheter or prolonged hospitalization for invasive pleurodesis procedures, ACES is designed to automatically drain pleural fluid to the peritoneum using the patient’s natural breathing motion, eliminating the need for additional hospital stays for pleural effusion management.

A total of 25 patients were enrolled across leading U.S. academic centers including Johns Hopkins University, the University of North Carolina, Vanderbilt University, and Memorial Healthcare System. Median hospital discharge time was only one day, highlighting the potential for streamlined recovery and reduced healthcare burden.

The study met its primary endpoint with a 53% median reduction in pleural effusion volume at 30 days (n=23, p<0.001). The ACES device had a 96% rate of implantation success with 80% of patients requiring no additional drainage out to 60 days. Additionally, patient-reported outcomes demonstrated trends toward reduced shortness of breath and improved quality of life, and when asked 84% of patients would recommend ACES to others.

“These findings support the potential of ACES as a safe and effective alternative for managing recurrent pleural effusions without repeated drainage or inpatient procedures,” said Jeffrey Thiboutot, MD MHS of Johns Hopkins University. “The procedure is easy to perform and well-tolerated by patients, and we are pleased to have ACES as a new option for patients suffering from recurrent pleural effusions.”

"We are excited to have this data reinforcing the strong safety profile and clinical effectiveness of the ACES device, demonstrating clinically meaningful and statistically significant reductions in pleural effusion volume and resulting in lower rates of repeat drainage procedures for patients,” said Martin Mayse, MD, Chief Executive Officer of Pleural Dynamics. “With this supporting evidence and the recently issued reimbursement code from CMS, we are well positioned to bring this transformative therapy to patients suffering from recurrent effusions who are in need of a better treatment option, all across the U.S.”

About Pleural Dynamics, Inc.

Pleural Dynamics is a Minnesota-based medical device company, founded in 2020 by pulmonologist Dr. Martin Mayse and medtech veteran John Streeter. Frustrated with the current costly, cumbersome, and decades-old technologies to treat debilitating pleural diseases, Pleural Dynamics seeks to revolutionize care by bringing effective treatment options to patients and providers that reduce the overall cost of care through reductions in hospital stays, decreased caretaker labor and reduced infection rates. https://www.pleuraldynamics.com/

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“These findings support the potential of ACES as a safe and effective alternative for managing recurrent pleural effusions without repeated drainage or inpatient procedures,” said Jeffrey Thiboutot, MD MHS of Johns Hopkins University.