ABM Respiratory Care Launches Homecare Study

EAGAN, Minnesota—ABM Respiratory Care, a provider of respiratory therapy solutions, announced the initiation of a multi-center homecare study in collaboration with Delve Health, which specializes in decentralized clinical trial technology, to evaluate the impact of its BiWaze Clear System in patients living with bronchiectasis. The study will assess how the BiWaze Clear System affects respiratory health over a six-month period.

The Food & Drug Adminstration (FDA)-cleared BiWaze Clear System delivers a combination of lung expansion, high frequency oscillation and aerosol therapy designed to help patients mobilize and clear airway secretions. This post-market study will enroll approximately 85 patients across the United States, ages 5 to 85, replacing their existing airway clearance therapy with the BiWaze Clear System.

“Our goal is to demonstrate that BiWaze Clear can significantly reduce pulmonary exacerbations in bronchiectasis patients and improve their quality of life when used in the home setting,” said Leah Noaeill, vice president of marketing and clinical affairs at ABM Respiratory Care. “We’re excited to partner with Delve Health to capture meaningful data through remote monitoring, making it easier for patients and physicians to track therapy effectiveness in real time.”

Key Study Highlights:

• Patient-Centric Innovation: Delve Health’s decentralized trial platform enables patients to participate remotely, reducing the burden of traditional clinical trials while ensuring a diverse and inclusive participant pool. Wearable integration and telemedicine capabilities will provide real-world data in real time.
• Supporting CMS Priorities: Technologies like the BiWaze Clear can improve patient outcomes, reduce hospital readmissions, and lower healthcare costs.
• Accelerating Impact: The study will also collect safety data throughout the six-month therapy period, with oversight and adverse event reporting managed in accordance with FDA and ICH-GCP guidelines.

“At Delve Health, we believe the future of clinical trials is decentralized, digital and patient-first,” said Wessam Sonbol, CEO of Delve Health. “Partnering with ABM Respiratory Care on this trial allows us to bring that vision to life while supporting the development of a device that has the potential to revolutionize respiratory care and align with CMS’s goals for improved patient outcomes and cost efficiency.”

The study is expected to run for 18 months.