SCONE Medical Solutions Inc. Receives EUA for Self-Contained Negative Pressure Environment
MORRISVILLE, N.C., December 21, 2020 – SCONE Medical Solutions Inc. announced today that their product, the Self-Contained Negative Pressure Environment (SCONE™) has been cleared by FDA and is available for sale to hospitals in the United States.
The SCONE™ uses negative pressure technology to create “active” barrier protection, helping hospitals reduce the risk of infectious aerosol exposure to healthcare workers. The SCONE is disposable, low cost, and easy to use. In addition to reducing the spread of transmissible diseases, the SCONE maximizes hospital throughput and improves the quality of patient care.
The SCONE™ was designed and developed by SCONE Medical Solutions in partnership with Gilero, a medical device design, development and manufacturing company, and with clinical support from Mayo Clinic. “In as little as four months, Gilero was able to refine SCONE’s original design concept and develop an innovative product that was functional, easy to use, and designed for manufacturability,” said Clayton Roberts, Director of Business Development for Gilero. “Gilero is also manufacturing this product at our facility in Pittsboro, NC. The materials needed to manufacture this device are in high demand because of COVID-19, so we had to get creative and leverage our knowledge of the supply chain to source the raw materials needed. Our team is proud to be helping SCONE produce a product that will help keep healthcare workers safe and improve patient outcomes.”
Mike Adams, CEO of SCONE Medical Solutions, commented, “Our choice to partner with Gilero for the design and development of the SCONE™ device has given us a clear advantage in our speed to market. With COVID cases on the rise in almost every state in the US, the stakes are high for hospitals and healthcare workers. The SCONE device is a new kind of PPE that provides an additional layer of protection and opens up new possibilities for hospitals to triage and transport patients safely and efficiently through the ER and ICU. We are extremely grateful for the knowledge and expertise of the Gilero team and what we have been able to accomplish in such a short amount of time. We couldn’t have done this without them.”
For more information about the SCONE™ or to contact the company, visit the SCONE Medical Solutions website at www.sconemed.com.
Gilero offers end-to-end services in design, development and contract manufacturing in the medical device and drug delivery/combination product markets. With an expanding global footprint, Gilero utilizes industry experience and in-house talent to design, develop and manufacture everything from consumable medical devices to complex electromechanical drug delivery systems.
About SCONE Medical Solutions Inc.
SCONE™ reduces the spread of transmissible diseases through the use of Self-Contained Negative-Pressure Environments. The company uses technology developed with clinical support from Mayo Clinic to help hospitals protect their health care workers. The low cost, disposable SCONE device is being manufactured in the United States for distribution beginning in December 2020.
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