SCONE Medical Solutions Inc Receives FDA Emergency Use Authorization (EUA) for Self-Contained Negative Pressure Environment (SCONE™)
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PHOENIX, Dec. 21, 2020 /PRNewswire/ -- 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.
SCONE™ has received FDA EUA and is designed for use during triage, transport, AGPs, 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 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 received FDA Emergency Use Authorization for the SCONE™ device on December 19, 2020, roughly 18 weeks after their first submission request. And with no predicate for this type of device, plans to move toward a full FDA approval for SCONE™ are already in the works. Mike Adams, Chief Executive Officer, says "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 4 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. Chris Lyons, Chief Strategy Officer, says "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. And make no mistake, winter is coming. Protecting the health of our doctors and nurses, managing patient flow efficiently during times of high-risk high-demand, and keeping patients and their families together must remain a top priority. The SCONE™ device is the 'next big thing' for PPE solutions in healthcare. SCONE™ is available for commercial sale at www.sconemed.com or through Authorized Distributors nationwide. Mike Adams
SOURCE SCONE Medical Solutions Inc |
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