Familial Cylindromatosis

SUFFERN, N.Y., March 6, 2024 /PRNewswire/ -- CDx Diagnostics, Inc., developer of the WATS3D AI platform for the detection and surveillance of Barrett's esophagus (BE) and dysplasia, today announced the publication of "WATS3D: An Interobserver Study of Barrett's Esophagus–Associated Dysplasia Among Gastrointestinal Pathologists" in Clinical and Translational Gastroenterology. The study provides new insights into the use of CDx's AI-powered diagnostic technology to consistently identify precancerous cells in patients with BE, thereby helping prevent the development of esophageal cancer. Continue Reading This was a collaborative study among gastrointestinal pathologists who have an interest and expertise in Barrett's esophagus. The lead author in this study was Dr. Deepa Patil of Brigham and Women's Hospital, Boston, MA. Additional contributors include: John R. Goldblum, MD (Cleveland Clinic), Gregory Lauwers, MD (Moffitt Cancer Center), Jason T. Lewis, MD (Mayo Clinic), Marie Robert, MD (Yale University School of Medicine), Mendel Singer, PhD, MPH, (Case Western Reserve University School of Medicine), and senior author, Robert D. Odze, MD (Tufts Medical Center). WATS3D Study Demonstrates Exceptional Consensus Among Pathologists. Post this The study set out to address the challenges in grading BE and dysplasia where the histopathological diagnosis of Barrett's esophagus-associated dysplasia has poor inter-observer agreement even among experienced gastrointestinal pathologists.1-3 Published estimates for the inter-observer agreement ("kappa values") for diagnosing dysplasia on forceps biopsy in Barrett's esophagus have varied between 0.15 and 0.69.1,4 Within this investigation, five GI pathologists were trained in-person and virtually on specimens from CDx's proprietary diagnostic platform, WATS3D, which leverages AI-enabled tissue analysis and 3D-imaging to reliably identify precancerous cells in the esophagus. The pathologists were then asked to evaluate digital images from 60 WATS3D cases with BE. "This study tackles a crucial clinical hurdle in gastroenterology," remarked Dr. Deepa Patil, MD, lead author. "The significant variability among pathologists assessing Barrett's esophagus poses challenges for accurate diagnosis and treatment decisions, complicating patient care." The overall mean kappa value in this study for all diagnoses for the five observers was calculated at 0.93, demonstrating remarkable consistency in interpreting both cell block and smear specimens (kappa=0.93 and 0.97, respectively). Kappa values of above 0.80 indicate nearly perfect agreement (Landis and Koch scale).5 The data represents significant improvement compared to standard histopathology in the diagnosis of BE and dysplasia where the kappa value is only considered to be "fair agreement" - 0.30. In addition, agreement was perfect (100%) regarding detection of neoplasia (either LGD, HGD, or EAC). "Our findings show a high level of accuracy and reproducibility among GI pathologists who have had no prior experience with the WATS3D platform," stated Dr. Robert Odze. "These outcomes are a testament to the effectiveness of CDx Diagnostics' approach to diagnosis. The results define a path to saving more patient lives by significantly improving diagnostic practices and delivering consistent dysplasia detection rates to more clinicians. Taken together with the fact that CDx recently processed and diagnosed its 400,000th WATS3D specimen, the study underscores the reliability and scalability of the technology." said Duane Dorn, Chief Operating Officer at CDx Diagnostics. Visit WATS3D.com to learn more. References 1. Montgomery E, Bronner MP, Goldblum JR et al. Reproducibility of the diagnosis of dysplasia in Barrett esophagus: a reaffirmation. Hum Pathol 2001;32:368-78. 2. Reid BJ, Haggitt RC, Rubin CE et al. Observer variation in the diagnosis of dysplasia in Barrett's esophagus . Hum Pathol 1988 ; 19 : 166-78. 3. Kerkhof M, van Dekken H, Steyerberg EW et al. Grading of dysplasia in Barrett's oesophagus: substantial interobserver variation between general and gastrointestinal pathologists. Histopathology 2007 ; 50 : 920 - 7. 4. Pech O, Vieth M, Schmitz D et al. Conclusions from the histological diagnosis of low-grade intraepithelial neoplasia in Barrett's oesophagus. Scand J Gastroenterol 2007;42:682-8. 5. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33:159-74. About CDx Diagnostics CDx Diagnostics' mission of Empowering Physicians with Innovative Technology to Prevent Esophageal Cancer, One Patient at a Time is accomplished through a proprietary diagnostic platform. This combination of technology synthesizes computer imaging, artificial intelligence, molecular biology and three-dimensional cytopathology to detect precancerous changes earlier and more reliably than prior methods. CDx tests require only a few minutes of practice time, are highly cost effective, widely reimbursed, and address a recognized critical gap in the current diagnostic standard of care. Routine clinical use of CDx testing has detected thousands of cancers and precancerous conditions that otherwise would have been missed. Contact: Logan Garrett 423.519.9979 lgarrett@bouvierkelly.com SOURCE CDx Diagnostics

SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (hereinafter referred to as "ESCC"). As of February 20, 2024, for the indication of esophageal cancer (EC), 9MW2821 has shown an ORR and DCR of 30% and 73.3%, respectively, in a Phase II clinical study at a dose of 1.25 mg/kg in 30 patients with advanced EC who have received monotherapy and completed at least one tumor assessment. Of those, 28 patients have undergone chemotherapy and immunotherapy. The study is still ongoing with further enrollment and evaluation. 9MW2821 is the world's first Nectin-4-targeting drug to disclose clinical efficacy data for the indication of EC. 9MW2821 is a site-specific conjugated novel Nectin-4-targeting ADC developed by Mabwell's ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first clinical stage Nectin-4-targeting ADC developed by Chinese company. The drug achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells. In addition to EC, Mabwell is conducting clinical studies for multiple indications such as urothelial cancer (UC), Cervical Cancer (CC), with monotherapy for UC entering Phase III clinical study, combination therapy with PD-1 entering Phase I/II clinical study, and monotherapy for CC entering Phase II clinical study. As of now, more than 280 patients have been enrolled. 9MW2821 is also the first to disclose preliminary clinical efficacy data for the indication of CC among drugs with the same target in the world. About EC According to the global cancer burden data released by the International Agency for Research on Cancer (IRAC), there were 604 thousand new cases of EC worldwide in 2020, with 544 thousand deaths. In 2024, the National Cancer Center published the Cancer Burden Data in China in 2022 on JNCC, showing that there were 224 thousand new cases of EC in China (167.5 thousand in men, 56.5 thousand in women), with 187.5 thousand deaths (140.4 thousand in men, 47.1 thousand in women), ranking 7th and 5th, respectively, in terms of new cases and deaths. According to the statistics from the American Cancer Society, it is estimated that there will be 22,370 new cases of EC (17,690 in men, 4,680 in women), and 16,130 deaths (12,880 in men, 3,250 in women) in the United States in 2024. In China, ESCC is the most common histological type, accounting for about 85.79% of EC cases, while esophageal adenocarcinoma (EAC) and other types account for 11.00% and 3.21%, respectively. In the United States, EAC is the most common type of EC among White population, accounting for about 70% of EC cases, with ESCC accounting for about 30%, and ESCC is more common among African Americans. Furthermore, according to IQVIA's report, in 2022, the number of prevalent patients with EC in China was 742 thousand, with approximately 70% being cases of advanced metastatic EC, of which about 80% (approximately 416,000 cases) were eligible for systemic treatment. The guidelines of the Chinese Society of Clinical Oncology (CSCO) recommends that PD-1 monoclonal antibody combined with platinum-based chemotherapy is the standard first-line treatment, and PD-1 or monotherapy chemotherapy is an optional second-line treatment. In actual clinical practice, there is a significant unmet clinical need after first-line treatment failure, since no preferred options are available. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different R&D stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 2 products have been approved and commercialized, 2 products have been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and several provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell

Quarterly EsoGuard® test volume and revenue increased 17 percent and 392 percent sequentially, respectively Conference call and webcast to be held tomorrow, November 14th at 8:30 AM EST NEW YORK, Nov. 13, 2023 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ( "PAVmed"), today provided a business update for the Company and presented financial results for the three and nine months ended September 30, 2023. Conference Call and Webcast The webcast will take place on Tuesday, November 14, 2023, at 8:30 AM and will be accessible in the investor relations section of the Company's website at luciddx.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-833-816-1418 and international listeners should dial 412-317-0511. All listeners should provide the operator with the conference call name "Lucid Diagnostics Business Update" to join. Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at luciddx.com. Business Update Highlights "I can confidently say that Q3 was the most important quarter in Lucid's history," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We crossed several critical milestones necessary to translate test volume growth into revenue and revenue growth. The initial impact that we saw in the second quarter from the upgrade to our revenue cycle management infrastructure has been sustained, driving record revenues this past quarter. Key metrics, such as the percentage of allowed claims and the average allowed payment, have held up nicely during this period. A key driver supporting in-network payor coverage engagement, along with claims history, is a solid base of clinical utility data. We went from no clinical utility data in the second quarter to over 1,500 patients across three clinical utility studies with near-perfect results—two published and one pending peer review." Highlights from the third quarter and recent weeks: Lucid's CLIA-certified clinical laboratory performed 2,575 commercial EsoGuard® Esophageal DNA Tests in 3Q23, which represents a 17 percent increase sequentially from 2Q23 and a 137 percent annual increase from 3Q22. Lucid personnel performed cell collection for 82 percent of tests in the quarter, reflecting a steady increase in Satellite Lucid Test Center activity. High-volume #CYFT testing events continue to strongly contribute to test volume growth. Gaining traction with strategic accounts at health systems and academic medical centers. For the quarter, EsoGuard revenue was $783K, which represents a 392 percent increase sequentially from 2Q23 and a 930 percent annual increase from 3Q22. Upgrade to revenue cycle management infrastructure showed sustained impact during the quarter. Allowed claims percentage and average allowed payment amount also held up well. Active pipeline of claims going through appeals with success based on medical necessity vs. guidelines. Substantial increase in clinical utility data to support in-network payor coverage engagement. Near-perfect clinical utility data (99-100 percent concordance) from three studies—CLUE, the PREVENT Registries, and the SAFD Study—totaling over 1,500 patients released during the quarter. Two manuscripts published in peer reviewed journals, and one pending peer review. Accelerating activity in Direct Contracting with employers to offer EsoGuard as a benefit. First contract signed and on-site testing has begun. New VP, Employer Markets with 30 plus years of experience in employer benefits sales starts this week. EsoGuard 2.0 with multiplexed triplicate consensus launched last week, improving already unprecedented cancer and precancer detection results. Analytical validation studies to be presented at this week's Association of Molecular Pathology Annual Meeting (AMP 2023). Upgrading NGS-sequencing platform to a higher-throughput NextSeq 1000 to accommodate increased EsoGuard testing volume. Updated assay and platform expected to significantly lower per-sample sequencing costs. Financial Results For the three months ended September 30, 2023, EsoGuard related revenues were $0.8 million. Operating expenses were approximately $11.9 million, including stock-based compensation expenses of $1.3 million. GAAP net loss was approximately $14.2 million, or $(0.34) per common share. As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company's financial results, the Company's preliminary non-GAAP adjusted loss for the three months ended September 30, 2023, was approximately $9.3 million or $(0.22) per common share. Lucid had cash and cash equivalents of $24.1 million as of September 30, 2023, compared to $32.6 million as of June 30, 2023. The unaudited financial results for the three months ended September 30, 2023, will be filed with the SEC on Form 10-Q on November 14, 2023, and available at or . Lucid Non-GAAP Measures To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company's financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA), and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense and other non-cash income and expenses, if any. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP. Non-GAAP financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from, or as an alternative to, the most directly comparable GAAP financial measures. Non-GAAP financial measures are provided to enhance readers' overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment, and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods. A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the three and nine months ended September 30, 2023, and 2022 are as follows: About EsoGuard and EsoCheck Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80 percent of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500 percent over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5 percent to 15 percent of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer. Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10 percent of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment. The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard, performed on samples collected with EsoCheck, is the missing element – the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients. An updated American College of Gastroenterology clinical practice guideline and an American Gastroenterological Association clinical practice update both endorse non-endoscopic biomarker tests as an acceptable alternative to costly and invasive endoscopy for esophageal precancer screening. EsoGuard is the only such test currently available in the United States. EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck, which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90 percent sensitivity and specificity at detecting esophageal precancer and cancer. EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect™ technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid's CLIA-certified, CAP-accredited laboratory, LucidDx Labs, for EsoGuard testing. About Lucid Diagnostics Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. 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 - the first and only commercially available tools designed with the goal of preventing esophageal cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients. For more information, please visit luciddx.com and for more information about its parent company PAVmed, please visit pavmed.com. 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 Diagnostics' 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 Diagnostics' common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid Diagnostics' products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid Diagnostics' clinical and preclinical studies; whether and when Lucid Diagnostics' products are cleared by regulatory authorities; market acceptance of Lucid Diagnostics' products once cleared and commercialized; Lucid Diagnostics' ability to raise additional funding as needed; and other competitive developments. In addition, Lucid Diagnostics continues to monitor the COVID-19 pandemic and the pandemic's impact on Lucid Diagnostics' businesses. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid Diagnostics' 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 Diagnostics' future operations, see Part I, Item 1A, "Risk Factors," in Lucid Diagnostics' 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 Diagnostics 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. SOURCE Lucid Diagnostics