Clarity-IA®
A next-generation anesthesia system expanding the use of inhaled anesthetics worldwide.
Clarity-IA® is based on a worldwide exclusively licensed portfolio of 58 patents and applications.
Unique platform technology:
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Converts any existing ventilator into the equivalent of a $75,000 anesthesia machine WITH ZERO CAPITAL COSTS to the hospital.
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Self-regulation technology adapts in real time to changing conditions, ensuring accuracy of dosing and reducing staff work load.
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Disposable component allows the device to isolate airflow between each patient and the ventilator, thereby increasing patient safety by eliminating the risk of inhaling cross-contaminated air.
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Platform technology lends itself to deliver an array of inhaled drugs.
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Initial Indication: Intended for the delivery and maintenance of inhaled medical gases for patients weighing between 80-330 lbs and requiring inhalation anesthesia and sedation during mechanical ventilation under the care of a trained healthcare professional.

Clarity-IA® addresses the widely recognized link between sedation practices and incidence of delirium in patients requiring life support (i.e. breathing on a ventilator).

Delirium Focus
Delirium is common with approximately 75% of patients on mechanical ventilation (or life support),* resulting in an estimated $140 billion per year in post-hospital care.**
First Wave’s Clarity-IA® next-gen system breaks this cycle by improving the precision of sedation and anesthesia.
Inhaled sedatives and anesthetics clear faster, reducing tolerance buildup in comparison to IV sedation.
Additional benefits include:
Lowering IV sedation dosing and duration outside approved labels
Reducing risk of delirium and pneumonia
Minimizing the cost and time spent in the ICU
Sources:
* Girard, et. al., (2018). Clinical phenotypes of delirium during critical illness and severity of subsequent long-term cognitive impairment: a prospective cohort study. The Lancet, 6(3), 213-222. https://doi.org/10.1016/S2213-2600(18)30062-6
** Leslie, DL & Inouye, SK, (2011). The importance of delirium: economic and societal costs. Journal of the American Geriatric Society, 59(S2), S241-3. https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/j.1532-5415.2011.03671.x
Clinical Overview
Program | Regulatory Pathway | Stage | Industry Partner |
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Clarity Gas Delivery System
| 510K | In Process | Agreement Signed |
Clarity-IA® Next-Gen
| PMA/505(b)(2) | Pre-Clinical | Identified |
IsoVENT™
| 510K | Pre-Clinical | No |
Other Inhaled Drugs
| License | In Development | No |