ABM Respiratory Care has partnered with Delve Health to launch a multi-center home care study evaluating the impact of its FDA-cleared BiWaze Clear System in patients with bronchiectasis. The six-month study aims to demonstrate how this innovative respiratory therapy solution affects respiratory health when used in a home setting.
The BiWaze Clear System delivers a combination of lung expansion, high frequency oscillation, and aerosol therapy specifically designed to help patients mobilize and clear airway secretions. This post-market study will enroll approximately 85 patients across the United States, ranging from 5 to 85 years old, who will replace 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."
Next-Generation Respiratory Care Approach
The BiWaze Clear System represents a novel approach to airway clearance in the home care environment. This trial will validate its potential to transform treatment paradigms for bronchiectasis, a chronic condition characterized by permanent enlargement of parts of the airways, leading to excess mucus production and recurrent infections.
Bronchiectasis affects millions worldwide, with limited effective home treatment options. Current therapies often require complex equipment or assistance, creating barriers to consistent use. The BiWaze system aims to address these challenges with its integrated approach to secretion clearance.
Decentralized Trial Design
A key innovation in this study is the use of Delve Health's decentralized trial platform, which enables patients to participate remotely. This approach reduces the burden of traditional clinical trials while ensuring a diverse and inclusive participant pool. The platform's wearable integration and telemedicine capabilities will provide real-world data in real time.
Wessam Sonbol, CEO of Delve Health, emphasized the importance of this approach: "At Delve Health, we believe the future of clinical trials is decentralized, digital, and patient-first. 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."
Alignment with Healthcare Priorities
The trial aligns with the Centers for Medicare & Medicaid Services' (CMS) focus on value-based care and remote patient monitoring. It aims to demonstrate how innovative technologies like the BiWaze Clear can improve patient outcomes, reduce hospital readmissions, and lower healthcare costs.
Respiratory exacerbations in bronchiectasis patients often lead to hospitalizations, which represent a significant burden on healthcare systems. By potentially reducing these events, the BiWaze system could deliver substantial clinical and economic benefits.
Study Protocol and Safety Monitoring
The study will collect safety data throughout the six-month therapy period, with oversight and adverse event reporting managed in accordance with FDA and ICH-GCP guidelines. This rigorous approach ensures patient safety while gathering valuable efficacy data.
Patient enrollment will begin in May 2025, and the study is expected to run for 18 months. By combining ABM Respiratory Care's airway clearance system with Delve Health's agile trial infrastructure, the partnership aims to deliver actionable insights faster, potentially bringing life-changing respiratory solutions to market sooner.
Potential Impact on Bronchiectasis Management
For bronchiectasis patients, effective airway clearance is essential to break the cycle of mucus retention, infection, and inflammation that characterizes the disease. The BiWaze Clear System's multi-modal approach could potentially offer more effective secretion clearance than current options.
If successful, this study could establish the BiWaze Clear System as an important addition to the therapeutic arsenal for bronchiectasis management, potentially improving quality of life and reducing healthcare utilization for patients living with this challenging condition.
Patient enrollment will begin in May 2025, with results expected by late 2026. Healthcare providers and patients interested in learning more about the study can contact ABM Respiratory Care directly or visit their website for additional information.
