Lucid Diagnostics, Inc.

Pharmaceutical company Tolmar has partnered with direct-to-consumer telehealth company UpScriptHealth to provide telehealth consultations for Jatenzo, an oral testosterone-replacement therapy (TRT) for adult men. Tolmar, which acquired Jatenzo in 2022, is positioning the TRT treatment as suited for patients who lack testosterone or have low testosterone levels due to hypogonadism or other medical conditions. The treatment protocol for patients seeking testosterone, including Jatenzo, includes a series of lab tests to determine whether testosterone is the correct treatment for the patient. Peter Ax, founder and CEO of UpScriptHealth, told MobiHealthNews that the streamlined digital experience lets patients connect with licensed providers to receive treatment and ongoing care management from home. "By making the entire process more accessible and convenient, we expect better adherence rates for patients receiving testosterone replacement therapy," he explained. He said the collaboration with Tolmar was representative of a broader shift in how treatments for complex conditions can reach more patients. "Patients increasingly expect healthcare to fit their lifestyle, not the other way around," Ax said. "There's growing recognition that telehealth can provide more consistent monitoring and support than traditional models." THE LARGER TREND UpScriptHealth has launched more than 50 partnerships with pharma and has been expanding into rare diseases and complex care models, including on-site diagnostic testing for esophageal cancer, infusion care and the coordination of care with Alternative Sites of Care. The company works in a complicated regulatory environment, having to comply with fifty state laws and various federal laws regarding the delivery of care, patient safety and privacy, steering and other areas of regulation. "Compliance is fundamental to everything we do at UpScriptHealth," Ax said. "We have prioritized adherence since its inception and helped shape many of the regulations now guiding the industry." He explained that patient safety and data privacy are paramount and that focusing on compliance is critical in building trust with patients and partners. "UpScriptHealth’s clinicians are not incentivized to write prescriptions or to encourage the use of a specific therapy," he said. The company also offers treatments for hair loss and erectile dysfunction, and Ax noted that men who historically avoided seeking treatment due to stigma or inconvenience are now actively engaging with their health through UpScriptHealth’s platform. "Our goal is to make UpScriptHealth the comprehensive digital home for men's health, where patients can access the full spectrum of care they need with the convenience they expect," Ax said. In July, Axena Health and UpScriptHealth partnered to offer women online consultations with UpScriptHealth providers. This allows them to receive prescriptions for Axena’s Leva Pelvic Health System. The company has teamed up with medical device companies, including Spark Biomedical, to provide telehealth for its FDA-cleared opioid-withdrawal wearable, and Lucid Diagnostics, to expand access to esophageal pre-cancer testing, while it also enables telehealth consultations for Spark Biomedical's Sparrow Ascent wearable.

Veris Health, a subsidiary of PAVmed, has been awarded a $1.8 million grant from the National Institute on Minority Health and Health Disparities, part of the National Institutes of Health (NIH). The aim of the two-year grant is to fund research and upgrade and verify the Veris cancer care platform designed for medically underserved patients with cancer. PAVmed is a medical technology company in the medical device, diagnostics and digital health space. Veris Health's main product is the Veris cancer care platform. The research project, "Bridging the Gap: Enhancing Cancer Care for Underserved Populations with the Veris Health Cancer Care Platform," will center on patients with language barriers and narrow access to technology and socioeconomic inequality. "We are honored to receive this prestigious NIH grant, which recognizes the potential of our Veris Cancer Care Platform to enhance cancer care," Dr. James D. Mitchell, PAVmed's vice president of digital health and Veris's chief medical officer, said in a statement. "This grant will accelerate our efforts to expand the reach and impact of our technology, while strengthening our relationships with academic cancer centers and within the oncology community. We look forward to bringing the benefits of this technology to broader and more diverse patient populations, to improve patient outcomes, reduce healthcare costs, and increase patient access to enhanced cancer care." Dr. Lishan Aklog, PAVmed's chairman and chief executive officer, said the NIH grant provides Veris with important non-dilutive funding and comes at a pivotal time for Veris as it pursues financing to advance its commercial strategy, which includes the regulatory clearance and launch of its implantable physiological monitor. "This aligns with PAVmed's long-term strategy, which seeks to assure that its subsidiaries, such as Veris, are independently financeable but able to leverage PAVmed's shared infrastructure," Aklog said in a statement. THE LARGER TREND In September, PAVmed announced that, as part of an effort to regain compliance with Nasdaq's listing requirements, Lucid Diagnostics would be deconsolidated from PAVmed's financial statements; therefore, PAVmed will no longer report consolidated financials reflecting Lucid's operating losses. PAVmed's holdings of Lucid common stock remained unchanged and the value of the holdings will be reported going forward as an asset on its balance sheet. In June, PAVmed, announced that its subsidiary, Veris, had launched a pilot program with the Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, and enrolled the first patients on the Veris Cancer care platform.

Patent covers proprietary method using methylation of the CCNA1 gene to help detect esophageal precancer and cancer NEW YORK, Oct. 15, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company"), a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent application covering its proprietary method of using methylation of the cyclin-A1 (CCNA1) gene to help detect esophageal precancer and cancer, a key component of its EsoGuard® Esophageal DNA Test. "This patent strengthens the already robust intellectual property portfolio underlying our groundbreaking technologies and will provide strong protection for the CCNA1 methylation assay method which is at the heart of the EsoGuard assay," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "The allowance validates our strategy of focusing on the laboratory methods of our assay—a strategy we will continue to aggressively pursue for other components of the assay." EsoGuard utilizes next-generation sequencing (NGS) to assess DNA methylation at 31 sites on two genes, vimentin (VIM) and cyclin-A1 (CCNA1). Such methylation has been shown to be strongly associated with conditions along the spectrum from early esophageal precancer (non-dysplastic Barrett's Esophagus or BE), to late precancer (dysplastic BE), to cancer (esophageal adenocarcinoma). Although VIM methylation had been previously associated with gastrointestinal neoplasias, the association of CCNA1 methylation with esophageal neoplasia is novel and appears to be more specific. The technology behind EsoGuard and the EsoCheck® Esophageal Cell Collection Device was developed at Case Western Reserve University (CWRU) by faculty members Sanford Markowitz, M.D., PhD, Amitabh Chak, M.D., and Joseph Willis, M.D., with the support of research funds from the National Institutes of Health (NIH) and elsewhere. Lucid holds the exclusive worldwide license to commercialize this technology. The successful transfer of the assay from the academic research laboratory and its subsequent commercialization was the result of close, ongoing collaboration between Lucid and CWRU. About Lucid Diagnostics Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device, represent the first and only commercially available tools designed with the goal of preventing cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients. For more information about Lucid, please visit and for more information about its parent company PAVmed, please visit . Forward-Looking Statements This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid's management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid's common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid's clinical and preclinical studies; whether and when Lucid's products are cleared by regulatory authorities; market acceptance of Lucid's products once cleared and commercialized; Lucid's ability to raise additional funding as needed; and other competitive developments. In addition, Lucid continues to monitor the COVID-19 pandemic and the pandemic's impact on Lucid's businesses. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid's control. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect Lucid's future operations, see Part I, Item 1A, "Risk Factors," in Lucid's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics after its most recent Annual Report. Lucid disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. 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