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Classified in: Health, Science and technology
Subject: FDA

Surround Medical Systems Announces FDA 510(k) Pre-market Clearance Of The PORTRAYtm Dental Imaging System


MORRISVILLE, N.C., Aug. 10, 2021 /PRNewswire/ -- Surround Medical Systems, Inc. (the "Company") announced today that the United States Food and Drug Administration (the "FDA") has granted 510(k) pre-market clearance for the Company's patented PORTRAYtm dental imaging system. The 510(k) pre-market clearance permits the commercial sale and use of the PORTRAYtm system as a 2D diagnostic tool and allows 3D tomosynthetic and 2D synthetic imaging as adjunctive tools for producing diagnostic dental radiographs of teeth, jaw, and other oral structures. PORTRAYtm is believed to be the first dental system with a 510(k) pre-market clearance from the FDA for intraoral use by dentists that features tomosynthetic, or "3D Tomo", imaging.

For more than five decades, intraoral 2D imaging has been the typical X-ray method that dentists have used to detect caries (cavities). As compared to those traditional X-ray systems, the PORTRAYtm system gives dentists the ability to see tooth decay in its earlier stages, allows them to visually separate contacts (teeth that touch) and examine the entire volume of the tooth, revealing fractures and conditions that were previously invisible or obscured. 

The PORTRAYtm system occupies a comparable footprint and uses the same procedural techniques as 2D machines currently installed in dental offices. The PORTRAYtm system deploys multiple X-ray beams to generate imaging "slices" that are reconstructed using the Company's proprietary software to create 3D tomosynthetic and 2D synthetic images that previously have not been commercially available.

The Company's PORTRAYtm system is derived from technology discoveries made at the University of North Carolina at Chapel Hill ("UNC"). There, the work advancing X-ray sources featuring carbon nanotube technologies by the Department of Physics and Astronomy was combined with the dental imaging expertise of the Adams School of Dentistry to develop the stationary intraoral tomographic system ("sIOT") that was the prototype for the PORTRAYtm system, which has now received pre-market clearance from the FDA.

The Company expects the PORTRAYtm system to be available to dental practices in the fourth quarter of 2021. The PORTRAYtm system will be assembled at and distributed from the Company's facility in Morrisville, N.C.

Dr. Alec Parker, Executive Director of the North Carolina Dental Society, stated "North Carolina dentists are constantly on the lookout for technology to enhance their diagnostic and clinical skills. Recently, several dentists had an opportunity to see the diagnostic advantages of 3D Tomo images offered by the PORTRAYtm system. These dentists consider this new product to be a real breakthrough for clinical diagnosis." The North Carolina Dental Society is an investor in the Company.

David LaVance, the President and Chief Executive Office of the Company, stated, "Dentists have been waiting for a major improvement to intraoral dental imaging for more than two decades. The PORTRAYtm system provides dentists with an intraoral 3D dental imaging system that will allow the dentists to provide a higher level of care for patients by detecting cavities and fractures that would otherwise go undetected by current 2D intraoral dental imaging systems. The PORTRAYtm system has the potential to substantially change and improve dental techniques and provide patients better outcomes and improved health."

About Surround Medical Systems, Inc.

Surround Medical Systems, Inc., is a privately-held corporation headquartered in Morrisville, NC. The Company has the exclusive worldwide rights to develop and market medical and dental systems utilizing carbon nanotube-based X-ray technologies discovered at and patented by the University of North Carolina at Chapel Hill. The Company's first product is the PORTRAYtm Dental Imaging System featuring 3D intraoral tomosynthesis. To learn more about the Company, please visit our website at www.surroundmedical.com.

Forward-Looking Statements

Statements about the Company's future expectations and all other statements in this press release other than historical facts are forward-looking statements. Such statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from expected results. Among these risks, trends and uncertainties are economic conditions both generally and within the industries in which the company may participate; competition within the Company's chosen industries, including competition from much larger competitors; technological advances; available capital; regulatory approval; and failure by the Company to successfully develop or acquire products and form new business relationships. Since these statements involve risks and uncertainties and are subject to change at any time, the Company's actual results could differ materially from expected results.

Media Contact:
David LaVance
President and Chief Executive Officer
Surround Medical Systems, Inc.
Tel:  919-424-4902
Email:  dlavance@surroundmedical.com

SOURCE Surround Medical Systems


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