safeBVM has developed the Sotair® device, a flow control valve that fits between a manual resuscitator and a patient mask, limiting airflow to prevent hyperventilation during manual ventilation. This technology addresses the high variability in breath delivery by healthcare providers, reducing the risk of complications such as lung injury and aspiration pneumonia.
Funding
$999.7K raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Manual resuscitators, while essential for emergency ventilation, often lead to inconsistent breath delivery due to variability in healthcare provider technique. This inconsistency can result in hyperventilation or hypoventilation, increasing the risk of complications such as lung injury, aspiration pneumonia, and ARDS.
Solution
safeBVM's Sotair® device is a flow control valve designed to mitigate the risks associated with manual ventilation. The Sotair® is placed between the manual resuscitator and the patient's mask or airway, limiting airflow to a safer rate. By regulating airflow, the device helps to reduce peak airway pressures, excessive tidal volumes, and breath delivery rates, thereby minimizing the potential for over-pressurization and hyperventilation. The Sotair® acts as a forcing function, guiding providers to deliver more consistent and safer manual ventilation.
Target Audience
The primary users are healthcare providers, including respiratory therapists, EMTs and other first responders, who utilize manual resuscitators for emergency ventilatory support.
Features
- Flow control valve that connects between a manual resuscitator and patient mask/airway
- Limits airflow to a maximum of 55 LPM during manual ventilation
- Reduces the risk of over-pressurization, over-ventilation, and hyperventilation
- Constrains providers to deliver safer manual ventilation with less variability
- FDA 510(k) cleared for adult, single-patient use
- 100% activation and flow limiting testing to ensure reliable performance