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SCONE Medical Awarded Emergency FDA Authorization for Self-Contained Negative Pressure Environment

SCONE Medical Awarded Emergency FDA Authorization for Self-Contained Negative Pressure Environment

Product evacuates contagious aerosols from the environment surrounding a patient during aerosol-generating procedures.

By PR Newswire01.15.21
SCONE Medical Solutions Inc., a Phoenix-based MedTech startup, has pioneered a new strategy for PPE in healthcare facilities, aimed at reducing the risk of aerosol transmission of contagious diseases to healthcare workers (HCWs), other patients, and hospital visitors. The Self-Contained Negative Pressure Environment (SCONE) is a low-cost, disposable, active barrier protection device that uses negative pressure technology to evacuate contagious aerosols from the environment surrounding a patient during aerosol generating procedures, ER triage, facility transport, family visits, and end of life care.
 
The SCONE was developed as a collaboration between ER doctors at major medical institutions, medical device engineers, and a number of clinical device experts, in response to the massive demand for barrier protection during AGPs like intubations at the start of the COVID-19 pandemic. Together, they took the simple "Intubation Box" acrylic barrier concept to the next level by adding negative pressure technology and expanding its indications for use. Recently, the U.S. Food and Drug Administration (FDA) revoked its blanket EUA for "passive" acrylic boxes, encouraging the use of "active" barrier protection devices like SCONE that use negative pressure instead.
 
SCONE Medical Solutions Inc. has received FDA Emergency Use Authorization for the SCONE device. And with no predicate for this type of device, plans to move toward a full FDA approval for SCONE are already in the works.
 
CEO Mike Adams said, "I'm so proud of our team and the amount of time and effort that has gone in to creating the SCONE device. From initial concept to full-scale manufacturing launch in less than four months, this has been no small feat. We are eager to see the immediate impact SCONE™ will have in healthcare related to COVID-19 and many other types of infectious diseases that carry risk of aerosol transmission in the future."
 
The small-capacity clear chamber of the SCONE is placed around the patient's upper body, attaches to the hospital bed to accommodate various angles, and is designed to maintain an air exchange rate 5x greater than the average hospital isolation room. Negative pressure isolation rooms are very expensive to retrofit, can't meet the demand during high patient flow, and can't protect HCWs against larger size infectious droplets. In addition, the massive amount of PPE and resulting shortages have also put HCWs at high-risk of nosocomial infection.
 
The SCONE bridges this gap by adding an extra layer of barrier protection while actively removing pathogenic aerosols into the hospital's main air filtration suction lines.
 
Chief Strategy Officer Chris Lyons said, "SCONE is going be a huge contribution to positive healthcare economics during a time when the system needs it most. To give doctors, nurses, and other healthcare workers peace of mind as they safely and effectively serve their patients without concern, is the power of what SCONE brings to healthcare."
 
As healthcare continues to find its bearings in this new pandemic era, SCONE becomes a smart, safe, low cost solution to contain and control the virus-size particulates that transmit diseases like COVID-19 to others.
 

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