Spectral MD Holdings, Ltd. (“Spectral MD” or “Company”) has achieved ISO 13485 Certification for its AI-powered DeepView® Wound Imaging System

On August 14, 2023, Spectral MD Holdings, Ltd., a company specializing in artificial intelligence (AI) for enhanced medical diagnostics to expedite and improve precision in wound care treatments, is pleased to announce the attainment of ISO 13485 certification. This certification pertains to the manufacturing and supply of its AI-powered DeepView® Wound Imaging System. Moreover, this innovative system offers swift, precise, and categorical assessments for wound treatment in the cases of burns and diabetic foot ulcers (DFUs).

ISO 13485 is a globally acknowledged standard that guarantees the excellence of medical device creation, evolution, and manufacturing. Organizations must demonstrate their commitment to Medical Device – Quality Management Systems (MDQMS) to acquire certification. Moreover, they must deliver high-quality medical devices that adhere to rigorous customer and regulatory demands. Spectral MD’s attainment of ISO 13485 certification comes after an extensive evaluation of the Company’s QMS conducted by an Independent Registrar earlier this year.

The receipt of ISO 13485 confirms Spectral MD’s status as a global provider of medical devices that meet the highest standards of quality, reliability, and safety. We believe that this acknowledgment reflects Spectral MD’s commitment to fostering a culture of continuous improvement, validates the robust sourcing and operational framework we have created, and provides an important competitive advantage as we continue our regulatory submission initiatives and advance towards product commercialization,” said Niko Pagoulatos, Chief Operating Officer of Spectral MD. 

Spectral MD’s DeepView Wound Imaging System, a Breakthrough Device Designation by the U.S. Food and Drug Administration (“U.S. FDA”) for its Burn indication in 2018, seamlessly combines optical technology with AI-driven algorithms. This amalgamation leverages a proprietary database comprising over 263 billion clinically-validated data points, enabling it to delve deep beneath the skin’s surface to differentiate between healthy and damaged tissue. The primary objective of the DeepView platform is to fulfill a substantial, unmet clinical requirement by furnishing an immediate, well-informed, and definitive AI-driven assessment of wound healing. This assessment greatly aids physicians in ascertaining whether a burn will naturally heal or necessitate surgical intervention.

About Spectral MD

Spectral MD is an AI-driven predictive healthcare company enhancing medical diagnostics to enable quicker and more precise treatment decisions in wound care, encompassing burns, diabetic foot ulcers (DFUs), and future clinical applications. Our dedicated team at Spectral MD comprises visionary individuals committed to transforming wound care management through our innovative DeepView® Wound Diagnostics System, a model of our mission to “See the Unknown”®.

The DeepView® platform developed by the company serves as a predictive diagnostic tool, delivering clinicians an impartial and immediate assessment of a wound’s potential for healing before any treatment or medical intervention takes place. Moreover, the system is powered by advanced algorithms and is designed to improve the existing standard of care in the future. Spectral MD’s diagnostic platform aims to provide swifter and more accurate insights into treatment options, ultimately enhancing patient care while concurrently reducing healthcare costs.

On April 11, 2023, Spectral MD Holdings announced its intention to merge with Rosecliff Acquisition Corp I (“Rosecliff”), a notable acquisition company listed on Nasdaq, under a business combination agreement.

Additional Information and Where to Find It

The press release is an informative document and pertains to a proposed business combination involving Spectral MD, Rosecliff, Ghost Merger Sub I Inc. (a wholly-owned subsidiary of Rosecliff), and Ghost Merger Sub II LLC (another wholly-owned subsidiary of Rosecliff), collectively referred to as the “Transaction.” Moreover, in connection with this proposed Transaction, Rosecliff has submitted a registration statement on Form S-4 to the U.S. Securities and Exchange Commission (the “SEC”).

This registration statement, which includes a preliminary proxy statement/prospectus (subject to amendments as necessary), is a comprehensive source of information about the Transaction. Rosecliff’s shareholders, investors, and other interested parties must review this Registration Statement with any other documents that have been or will be filed with the SEC. These documents contain crucial details regarding Rosecliff, Spectral MD, and the proposed Transaction.

The SEC has not yet declared the Registration Statement effective. If and when the SEC announces its effective, the proxy statement/prospectus and other pertinent documents regarding the proposed Transaction will be sent to Rosecliff’s shareholders as of a specified record date established for the Transaction vote. Furthermore, Rosecliff investors and shareholders will have access to copies of the proxy statement/prospectus and other SEC-filed documents at no cost once they become available.

Participants in the Solicitation

The SEC regulations, Rosecliff, Spectral MD, and specific individuals within their respective organizations, including directors, executive officers, management members, and employees, might be considered participants from Rosecliff’s shareholders concerning the proposed Transaction.

For more comprehensive details about the identities and interests of Rosecliff’s directors and officers concerning the proposed Transaction, investors and security holders can refer to Rosecliff’s submissions with the SEC. Moreover, this information is available in Rosecliff’s definitive proxy statement, the Registration Statement, and additional documents filed with the SEC. The Registration Statement also contains information regarding Spectral MD’s directors and executive officers and their roles in the proposed Transaction.

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