Advocated stronger transparency and predictability, and inclusion of diagnostics, in federal proposals to improve equitable access to innovative lifesaving technologies
Highlighted EsoGuard's life-saving potential, and unprecedented early detection results of a recently posted NCI-supported EsoGuard study
NEW YORK, July 19, 2023 /PRNewswire/ -- PAVmed Inc. (NASDAQ: PAVM, PAVMZ) ("PAVmed"), a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, and its majority-owned subsidiary Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid Diagnostics" or "Lucid"), a commercial-stage cancer prevention diagnostics company, announced that PAVmed and Lucid's Chairman and Chief Executive Officer, Lishan Aklog, M.D, testified yesterday at the U.S. House of Representatives Energy and Commerce Committee, Subcommittee on Health, hearing entitled "Innovation Saves Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology".
Dr. Aklog, who serves on the Executive Committee of the Board of Directors of AdvaMed, the world's largest medical technology association, and as the inaugural chair of its committee focused on health equity, vigorously advocated for stronger transparency and predictability, and the inclusion of diagnostics, in two related federal proposals to improve equitable access to innovative technologies such as Lucid's EsoGuard® Esophageal DNA Test ("EsoGuard)—the Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691) and the proposed Center for Medicare and Medicaid Services ("CMS") Transitional Coverage for Emerging Technologies (TCET) pathway.
Dr Aklog testified, "Although medical technology innovation has saved millions of lives, the arduous process of translating innovation into life-saving products lacks transparency and predictability…America remains the world's engine for medical technology innovation. Most of this innovation, fueled by our entrepreneurial spirit, occurs in small companies…Government, including Congress, must keep pace and adjust…This Committee's work on H.R.1691 and TCET can help establish a transparent and predictable path to transitional Medicare coverage to ensure equitable access to life-saving technologies." During questioning, he vigorously argued that there is no justification for TCET to exclude molecular diagnostic testing which lies "…at the leading edge of innovation." Multiple Committee Members concurred.
Dr. Aklog used the opportunity to inform the Committee of the devastating impact of highly lethal esophageal cancer and EsoGuard's potential to save lives by detecting esophageal precancer, before it progresses to cancer, consistent with the goals of the Administration's Cancer Moonshot. He highlighted two recent studies, including a multi-center National Cancer Institute-supported study recently posted as a preprint, which demonstrated unprecedented early cancer detection results—with EsoGuard detecting 100 percent of esophageal cancers and over 80 percent of precancers.
EsoGuard's life-saving potential was brought into human focus through the powerful story of an elderly man who requested an EsoGuard test after reading a #CheckYourFoodTube educational poster in his doctor's office. EsoGuard successfully detected a very late stage esophageal precancer, for which he successfully underwent curative ablation treatment to prevent progression to cancer.
About PAVmed and its Subsidiaries
PAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors. Its majority-owned subsidiary, Veris Health Inc., is a digital health company focused on enhanced personalized cancer care through remote patient monitoring using implantable biologic sensors with wireless communication along with a custom suite of connected external devices. Veris is concurrently developing an implantable physiological monitor, designed to be implanted alongside a chemotherapy port, which will interface with the Veris Cancer Care Platform. Its other majority-owned subsidiary, Lucid Diagnostics Inc. (NASDAQ: LUCD), is a commercial-stage cancer prevention medical diagnostics company that markets the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device—the first and only commercial tools for widespread early detection of esophageal precancer to prevent esophageal cancer deaths.
For more and for more information about PAVmed, please visit pavmed.com.
For more information about Veris Health, please visit verishealth.com.
For more information about Lucid Diagnostics, please visit luciddx.com.
This press release includes forward-looking statements that involve risks 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 PAVmed's and 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, PAVmed's inability to regain, or subsequently maintain, compliance with Nasdaq's listing standards; volatility in the price of PAVmed's and Lucid's common stock; PAVmed's Series Z warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance PAVmed's and Lucid's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed's and Lucid's clinical and preclinical studies; whether and when PAVmed's and Lucid's products are cleared by regulatory authorities; market acceptance of PAVmed's and Lucid's products once cleared and commercialized; PAVmed's and Lucid's ability to raise additional funding as needed; and other competitive developments. 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 PAVmed's and Lucid's future operations, see Part I, Item 1A, "Risk Factors," in PAVmed's and 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 PAVmed or Lucid after its most recent Annual Report. PAVmed and Lucid disclaim 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 PAVmed Inc.