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:

  • Converts any existing ventilator into the equivalent of a $75,000 anesthesia machine WITH ZERO CAPITAL COSTS to the hospital.

  • Self-regulation technology adapts in real time to changing conditions, ensuring accuracy of dosing and reducing staff work load.

  • 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.

  • Platform technology lends itself to deliver an array of inhaled drugs.

  • 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

Clarity Gas Delivery System
Inhalational anesthesia

510K

In Process

Agreement Signed

Clarity-IA® Next-Gen
ICU sedation

PMA/505(b)(2)

Pre-Clinical

Identified

IsoVENT™
Combo anesthesia & ventilator

510K

Pre-Clinical

No

Other Inhaled Drugs
Misc.

License

In Development

No