#USA #Chicago #FDA Approval #Sibel Health #Aria Sensor

Sibel Health Gains FDA Approval for Innovative Cough Monitoring Solution

Sibel Health, a Chicago-based pioneer in medical wearable technology, has recently celebrated a pivotal achievement. The U.S. Food and Drug Administration (FDA) has accepted the company's Letter of Intent (LOI) into the Clinical Outcome Assessment (COA) Qualification Program under the Drug Development Tool (DDT) framework for its novel Aria cough monitoring sensor. This significant approval represents a major step in developing a more objective and reliable means of measuring cough frequency for adults suffering from chronic refractory cough (CRC).

Chronic refractory cough, characterized by a persistent cough lasting longer than eight weeks, poses numerous challenges for patients, significantly affecting their quality of life. With an estimated 7 million adults in the U.S. affected, this condition often disrupts sleep and contributes to social isolation and emotional issues. Sibel Health's innovative approach aims to address these challenges by providing clinicians with continuous, accurate, and privacy-focused monitoring solutions.

The Aria sensor utilizes advanced acousto-mechanic sensing to capture coughing events discreetly and objectively. It is designed to adhere to the suprasternal notch at the base of the neck, recording mechanical vibrations without picking up audible voice frequencies. This feature not only mitigates privacy concerns common with traditional audio recording devices but also creates an environment for efficient monitoring in both home and clinical settings. Accompanied by an AI algorithm, the Aria sensor eliminates the need for manual labeling of cough events, streamlining the process significantly.

This recent FDA approval marks Sibel Health’s third acceptance into the COA qualification program, illustrating its commitment to advancing digital health solutions. Previous qualifications for their itch detection sensor for atopic dermatitis and a swallow sensor for Parkinson's disease have established Sibel as a leader in the development of digital health technologies. To further support their mission, Sibel has also received a $500,000 grant from the FDA for the classification of its scratch sensor as a key endpoint for clinical trials targeting atopic dermatitis, pushing their total funding from the FDA above $1 million.

Steve Xu, MD, FAAD, CEO and co-founder of Sibel Health, emphasized the importance of this FDA acceptance, stating, "This milestone validates the need for reliable and patient-friendly tools for measuring chronic cough and illustrates our dedication to elevating patient care across the board."

Benjamin Monteagudo, Senior Product Manager at Sibel Health, adds, "The implications of our sensor technology extend beyond mere cough counting. Chronic refractory cough often presents with multiple contributing factors such as asthma and gastroesophageal reflux disease (GERD). Understanding cough frequency and severity objectively can facilitate better treatment options for patients struggling with this debilitating condition."

One of the complexities of managing chronic refractory cough lies in the reliance on subjective patient-reported outcomes (PROs), such as diaries and recall surveys that can lead to inaccuracies and bias, especially in older adults. The FDA's acceptance highlights the crucial need for objective measurement as a standard in drug development contexts addressing CRC. Sibel Health’s technology positions itself as a solution, providing continuous monitoring capabilities without burdening patients and researchers, consequently aiding the development of more effective therapeutic interventions.

In line with this advancement, Sibel Health is set to submit a comprehensive Qualification Plan (QP) to the FDA, marking the next stage in its qualification journey. Kevin Dwyer, Director of Regulatory Affairs and Quality Assurance, remarked on this progression, stating that the acceptance not only validates their efforts but also outlines a clear path towards regulatory compliance and clinical application.

Ultimately, upon successful completion of the qualification process, Sibel Health aims to deploy the Aria sensor as a definitive endpoint in clinical trials for new treatments addressing chronic refractory cough. Looking ahead, the technology holds promise for a broader range of respiratory conditions, including asthma and chronic obstructive pulmonary disease, making it a pivotal development for millions of patients seeking relief from chronic cough.

In summary, Sibel Health’s FDA acceptance offers hope for many adults affected by chronic cough, paving the way for a future characterized by improved monitoring, effective treatments, and enhanced patient well-being. For additional information about Sibel Health’s innovative offerings, visit their official website or connect via LinkedIn.