First Wave Technologies leverages valuable clinical insight and innovative engineering to develop and market medical devices with the goal of establishing a new standard of care.
First Wave Technologies is a medical device company developing products for the acute care and long-term care markets. The company’s focus is to significantly enhance healthcare innovation by focusing on products that, historically, have not seen meaningful change. Its suite of medical devices is centered around improving the ease and accuracy of pharmaceutical delivery and providing a better healthcare experience for both patients and caregivers.
First Wave identifies innovative medical device opportunities originating out of universities in the Northeast area. The company believes that many non-traditional markets have been overlooked by the majority of venture capitalists who typically target higher-profile centers of excellence for emerging innovation. At First Wave, emphasis is placed on addressing meaningful patient care issues significantly impacting today’s healthcare landscape.
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 patients, thereby preventing increased dosage levels and delirium, an ailment that can last for years after the patient is discharged from the hospital. This intelligent anesthesia system breaks the well-established link between current sedation practices and delirium and 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 make Clarity-IA® a revolutionary product is its smart anesthesia administering function. This intelligent anesthetic system automatically senses even the slightest of changes in a patient’s gas requirements, adapts in real time, and ensures the desired dose of sedation is maintained.Clarity-IA®allows the clinicians and staff to direct all their energy and time toward providing optimum care to the patients. “Our solution is to provide the required control systems in an economical and efficient 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 with upgrading an existing ICU ventilator is purchasing an innovative 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 and 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 the pediatric patient being successfully weaned from the ventilator the very next morning. This example demonstrates why 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 team brings exceptional clinical insight and an entrepreneurial culture of innovation generating one of the company’s biggest strengths. This mindset and experience allow First Wave to think outside the box and stay ahead of other players in the marketplace.
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.
“First Wave’s management, board of advisors, and scientific teams have experience in: medical device development, venture capital, clinical research, manufacturing, business development, and sales and marketing.”
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