Lucid Diagnostics Commences Production of EsoCheck Devices with High-Volume Manufacturer - Business Wire

2 years ago 40

NEW YORK--()--Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid”, the “Company”), a commercial-stage, crab prevention aesculapian diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (“PAVmed”), contiguous announced the commencement of accumulation of its EsoCheck® Esophageal Cell Collection Devices (“EsoCheck”) astatine Coastline International, Inc. (“Coastline”), a high-volume shaper headquartered successful San Diego, CA with plants successful Mexico. The Company has worked intimately with Coastline implicit the past twelvemonth to transportation the EsoCheck manufacturing lines from its anterior low-volume shaper and to implicit each the indispensable validations to commence high-volume accumulation astatine Coastline’s facility.

“The palmy modulation of EsoCheck accumulation to a high-volume shaper reflects our heavy committedness to thrust efficiencies passim the full commercialization cycle,” said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. “This modulation volition trim the per-unit manufacturing outgo of EsoCheck devices by astir 60% and supply scalable manufacturing capableness to accommodate accelerating maturation successful EsoGuard® Esophageal DNA Test investigating volume. Following this transition, EsoCheck manufacturing capableness is present astir 20,000 units per year. The strategy has been designed to let capableness to beryllium scaled to implicit 1 cardinal units per twelvemonth by adding further manufacturing lines arsenic request dictates.”

About Lucid Diagnostics

Lucid Diagnostics Inc. (Nasdaq: LUCD) is simply a commercial-stage, crab prevention aesculapian diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused connected the millions of patients with gastroesophageal illness (GERD), besides known arsenic chronic heartburn, who are astatine hazard of processing esophageal precancer and cancer. Lucid’s EsoGuard® Esophageal DNA Test, performed connected samples collected successful a brief, noninvasive bureau process with its EsoCheck® Esophageal Cell Collection Device, is the archetypal and lone commercially disposable diagnostic trial susceptible of serving arsenic a wide screening instrumentality to forestall crab and crab deaths done aboriginal detection of esophageal precancer successful at-risk GERD patients. EsoGuard is commercialized successful the U.S. arsenic a Laboratory Developed Test (LDT). EsoCheck is commercialized successful the U.S. arsenic a 510(k)-cleared esophageal compartment postulation device. EsoGuard, utilized with EsoCheck, was granted FDA Breakthrough Device designation and is the taxable of aggregate ongoing objective trials. Lucid is gathering nationwide nonstop income and selling teams targeting superior attraction physicians, specialists, and institutions, arsenic good arsenic a web of Lucid Test Centers, wherever at-risk GERD patients tin acquisition the EsoCheck process for EsoGuard testing. For much information, delight sojourn www.luciddx.com, travel Lucid connected Twitter, and link with Lucid connected LinkedIn. For elaborate accusation connected EsoGuard, delight sojourn www.EsoGuard.com and travel america connected Twitter, Facebook and Instagram.

Forward-Looking Statements

This property merchandise includes forward-looking statements. Forward-looking statements are immoderate statements that are not humanities facts. Such forward-looking statements, which are based upon the existent beliefs and expectations of Lucid’s management, are taxable to risks and uncertainties, which could origin existent results to disagree from the forward-looking statements. Risks and uncertainties that whitethorn origin specified differences include, among different things, volatility successful the terms of Lucid’s communal stock; wide economical and marketplace conditions; the uncertainties inherent successful probe and development, including the outgo and clip required to beforehand Lucid’s products to regulatory submission; whether regulatory authorities volition beryllium satisfied with the plan of and results from Lucid’s objective and preclinical studies; whether and erstwhile Lucid’s products are cleared by regulatory authorities; marketplace acceptance of Lucid’s products erstwhile cleared and commercialized; Lucid’s quality to rise further backing arsenic needed; and different competitory developments. In addition, Lucid has been monitoring the COVID-19 pandemic and the pandemic’s interaction connected Lucid’s businesses. Lucid expects the value of the COVID-19 pandemic, including the grade of its effect connected its fiscal and operational results, to beryllium dictated by, among different things, the occurrence of efforts to incorporate the pandemic and the interaction of specified efforts connected Lucid’s businesses. These factors are hard oregon intolerable to foretell accurately and galore of them are beyond Lucid’s control. In addition, caller risks and uncertainties whitethorn originate from clip to clip and are hard to predict. For a further database and statement of these and different important risks and uncertainties that whitethorn impact Lucid’s aboriginal operations, spot Part I, Item 1A, “Risk Factors,” successful Lucid’s astir caller Annual Report connected Form 10-K filed with the Securities and Exchange Commission and Lucid’s Registration Statement No. 333-259721 filed with the Securities and Exchange Commission. Lucid disclaims immoderate volition oregon work to publically update oregon revise immoderate forward-looking connection to bespeak immoderate alteration successful its expectations oregon successful events, conditions, oregon circumstances connected which those expectations whitethorn beryllium based, oregon that whitethorn impact the likelihood that existent results volition disagree from those contained successful the forward-looking statements.

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