As certain patients are resistant to intravenous sedation, healthcare practitioners have to either increase the dosing level or use multiple sedatives simultaneously, which leads to neurological side effects like delirium. With Clarity-IA, First Wave addresses the link between sedation practices and the incidence of delirium in patients by safely delivering a new class of inhaled sedatives.

“Intravenous sedation poses risks of delirium. Patients contracting delirium after being sedated with powerful pharmaceutical agents incur around $65,000 of extra cost of care as they have to rely on ventilators for prolonged durations. They even display symptoms post discharge,” says Bell.

Clarity-IA combines intravenous agents with inhalation anesthetics, such as Isoflurane or Sevoflurane.

This allows healthcare professionals to use a lesser amount of drugs and mitigate side effects while reducing costs and time spent on a ventilator.

First Wave is currently in the process of obtaining 510k approval for Clarity-IA as an anesthesia system. Post-approval, the company will work with the FDA to develop a well-defined clinical trial strategy. After releasing the product, First Wave envisions conducting clinical trials for the second indication to move Clarity-IA into the ICU.

First Wave plans to collaborate with key opinion leaders and engage them as principal investigators in the clinical trial process.

These leaders will support FDA submissions and help gain the confidence of other clinicians in the field, accelerating the adoption of First Wave’s products by healthcare organizations.

First Wave also offers First Crush, a one-of-its-kind automated electronic pill crusher. The product enables caregivers in hospitals and nursing homes to crush the medication with a single push of a button and deliver it diluted with water through the feeding tube. This enables patients to ingest it with ease and stay compliant with their prescriptions. The product also ensures better performance by producing a finer powder that prevents the clogging of feeding tubes.

Where Expertise Meets Excellence

What powers First Wave to positively transform medication delivery and create a better patient experience is a team of industry and technology experts, including physicians and former executives at hospital systems.

Clarity-IA is much smaller, more cost-effective, and more intelligent than traditional anesthesia machines. It perfectly fits the needs of a bronchoscopy or endoscopy suite, where maneuvering large and complex devices is tedious

Under the strategic guidance of its board of directors, including Raymond Dean Hautamaki, Gene Bauer, and Gene Burleson, First Wave is pushing the envelope of medical device innovation with its next-generation products. Drawing upon the intellectual capital and the excellent track record of its growth minded board of directors, First Wave is set to move revolutionary technologies into hospitals successfully.

Combining the clinical know how of its management team and advisory board with technological innovation, First Wave builds the right products for its clients. The company also follows good engineering practices and conducts usability tests to ensure that its technology meets user needs while mitigating any risks arising in the process.

With a zeal for excellence, First Wave is establishing a new standard of care with its innovative technology focused on improving the overall quality of sedation in the ICU and lowering the cost of care delivery for healthcare providers.