The invention of anesthetics is one of the most remarkable feats of mankind. This breakthrough invention completely changed the course of the healthcare industry by spurring numerous advancements in surgery and treatments. Essentially, part of the reasonthe average lifespan of human beings has steadily increased over the years can be attributed to the field of anesthesia.
In recent decades, however, there has been little to no progress in terms of improving the efficiency and delivery of anesthetics, especially outside of the traditional operating room (OR) environment. Among those areas of growing concern is the length of time that anesthetic agents stay in apatient’s body. After a number of doses, intravenously delivered anesthetic agents and sedatives, including those agents used on ventilated patients in the Intensive Care Unit (ICU), become harder to clear from the body. Additionally, patients quickly build up tolerance to these powerful drugs necessitating higher dosage levels that are often beyond the levels approved by the Food & Drug Administration (FDA).
Overmedication hasbecome an alarming issue, especially as it pertains to patients with compromised livers and kidneys. These types of patients do not metabolize medicineas efficiently as healthy individuals.It is estimated that around 40% of the ventilated patients have multiple organ failuresresultingin patients staying on ventilators for a longer period of time, resulting in longer stays in the ICU and higherassociated expenses. After 3-4 days on a ventilator, up to 75% of patients may develop delirium–the second leading cause for dementia.
First Wave Technologies, Inc., a New York-based medical device company, is striving to address these issues by developing an anesthesia system, Clarity-IA®, that promises to completely redefine the traditional way of utilizing anesthetics for the acute care and long-term care markets.
Clarity-IA® is a next-geninhalational anesthesia system that expands the use of inhaled anesthetics worldwide.The goal of Clarity-IA® is to significantly enhance the precision of sedation for apatient, therebypreventing increased dosage levels and delirium, an ailment which can last for years after the patientis discharged from the hospital. Thisintelligent anesthesia system breaks the well-established link between current sedation practices and deliriumand allows for the safe use of inhaled anesthetics in the ICU.Consequently, it improves patient outcomes and lowers healthcare costs for patients. By some estimates, delirium caused by intravenous-based sedation used today results in $140 billion of healthcare related costs.
One of the many factors that makes Clarity-IA® a revolutionary product is its smart anesthesia administering function. This intelligent anesthetic system automatically senseseven the slightest of changes in a patient’s gas requirements, adapts in real time, and ensures the desireddose of sedation is maintained.Clarity-IA®allows the clinicians and staff to direct all their energy and time toward providing optimumcare to the patients. “Our solution is to provide the required control systems in an economical andefficient way to the hospital, thereby achieving improved quality of care and reducing overall treatment costs,” stated Brian Bell, Founder, Chief Executive Officer, and Director of First Wave Technologies.
Based on a worldwide exclusivity licensed portfolio of 55 patents and applications, Clarity-IA® converts any existing ventilator into the equivalent of a $75,000 (USD) anesthesia machine with zero capital costs to the hospital. The only cost associated in upgrading an existing ICU ventilatorispurchasing aninnovative breathing circuit ($600/unit) invented by First Wave’s Chief Scientific Officer, Dr.Bradley Fuhrman, a renowned ICU physician. First Wave has filed for a 510(k) market clearance application demonstrating compliance with the international standards for an anesthetic system (ISO 80601-2-13). Additionally, First Wave will work with the Food & Drug Administration (FDA) to define and conduct a series of clinical trials focused on a combination drug/device product approval for the use of inhaled anesthetics in ICU mechanically-ventilated patients.
The huge potential and possibilities of using inhaled sedation have been highlighted by numerous clinical trials and studies over the past few years. The advantages of inhaled sedation include the possibility of reducing opioid use, providing more consistent sedation, and overall reduction of delirium.For example, as reported by Jung et. al. in Burn Care & Research, a pediatric patient with 40% bodily burns and lung damage due to smoke inhalation, required an increase of 16,000% in intravenous sedative dose over a period of 10 days.Fearing further complications, the clinical staff choose to place the child on inhaled sedatives, resulting in thepediatricpatientbeing successfullyweaned from the ventilator the very next morning. This example demonstrateswhy inhaled sedatives are potentially a valuable tool to improve the quality of ICU sedation.
First Wave’s management team and advisory board have first-hand knowledge about the benefits of inhaled anesthetics that provide better care for patients. First Wave’s expert teambrings exceptional clinical insight and anentrepreneurial culture of innovation generating one of company’s biggest strengths. This mindset and experience allowsFirst Wave to think outside the box and stay ahead of other players in the marketplace. “When you have very capable people coming together for a common goal, it is a powerful engine for change. Communication is key, and it is my job to ensure those lines are always open,” explains Mr. Bell.
When it comes to future plans, First Wave’s main focus will be to advance clinical research in the field of sedation and further refine Clarity-IA’s development and making it a simple, safe, and economically-viable solution for sedating patients. With a revolutionary product in hand, First Wave is prepared to redefine the future of sedation. “Given the significant amount of achievement already attained, our hope is to have the Clarity-IA system on the market within the next year,” statedMr. Bell.
Our solution is to provide the required control systems in a very economical and friendly way to the hospital, thereby achieving improved quality of care and reducing overall treatment costs.
Description:First Wave leverages valuable clinical insight and innovative engineering to develop and market medical devices with the goal of establishing a new standard of care.