Nelitolimod

HealthCare Industry Veterans William Valle and Gary Gordon, M.D. add Strategic Expertise in Medical Devices, Reimbursement, and Pancreatic Cancers DENVER--(BUSINESS WIRE)--Feb. 3, 2025-- TriSalus Life Sciences® Inc. (Nasdaq: TLSI), a biomedical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies and its investigational immunotherapy, today announced the appointment of two distinguished HealthCare Industry veterans to its Board of Directors. Mr. William J. Valle and Gary B. Gordon, M.D., Ph.D., joined the Company’s Board of Directors, effective as of January 29, 2025. “We are thrilled to welcome William Valle and Dr. Gary Gordon to our Board,” said Mats Wahlstrom, Chairman of TriSalus. “Bill brings exceptional expertise in medical device commercialization and reimbursement, honed over a distinguished career with Fresenius, while Gary is a visionary in oncology drug development, having helped to establish AbbVie’s oncology franchise and guide a multibillion dollar oncology program to regulatory approval over the past 25 years. Together, they bring complementary insights into the medical device and oncology landscapes, which will be instrumental in advancing our mission. We look forward to their leadership and the invaluable perspectives they bring to TriSalus.” “TriSalus’ technology with its Pressure-Enabled Drug Delivery™ (PEDD™) method represents a disruptive innovation in drug delivery, offering transformative potential in the ability to improve therapeutic delivery to solid tumors,” said Mr. Valle. “I’m excited to collaborate with Mats, Gary, and the rest of the Board to unlock the full potential of this innovative technology.” “The TriSalus Pancreatic Retrograde Venous Infusion (PRVI™) System, designed to deliver high concentrations of therapeutics directly to the pancreatic tumor site, offers a promising potential solution to the significant challenges of treating pancreatic cancer,” said Dr. Gary Gordon. “I am excited to collaborate with Bill, the Board, and the leadership team to advance the integration of this technology with nelitolimod and other therapeutic approaches, driving toward potentially better outcomes for patients facing this difficult-to-treat disease.” William Valle most recently served as Chief Executive Officer of North America at Fresenius Medical Care Management AG, General Partner of Fresenius Medical Care AG & Co. KGAA from 2017 to 2023. He was also a member of the Company’s Management Board. Prior to this role, Mr. Valle served as Executive Vice President and President of Fresenius Kidney Care at Fresenius Medical Care Holdings, Inc. He previously held key leadership positions at Fresenius, including Executive Vice President of Fresenius Medical Services (FMCNA) and President of Fresenius Medical Services (FMS), where he oversaw the management of over 2,400 outpatient facilities, 1,400 inpatient programs and 800 home dialysis programs across the U.S. serving approximately 187,000 dialysis patients. As President of Fresenius Medical Care Integrated Renal Services, Mr. Valle led the integration of several critical business functions, including Fresenius Vascular Care, FreseniusRx, Spectra Laboratories, FMS Business Development, FMS Inpatient Services and FMS Real Estate and Construction Services into a high performing renal network focused on improving patient outcomes and reducing the cost of renal disease management. With 22 years’ experience in the dialysis industry, holding executive positions at several dialysis companies including Gambro Healthcare, Inc, he serves as Director at Fresenius Medical Care US Finance II, Inc. Dr. Gary B. Gordon is an accomplished pharmaceutical executive and strategic business leader with a proven track record in drug development, spanning from first-in-human studies to approval and commercialization. Since 2018, Dr. Gordon has been a member of the Global Coalition of Adaptive Research (GCAR), an organization that brings together physicians, clinical researchers, advocacy groups, biotech and pharma companies, health authorities, and other healthcare stakeholders to accelerate the discovery and development of treatments for rare and life-threatening diseases. Previously, Dr. Gordon served as Vice President of the Oncology Department at AbbVie (a spin-off of Abbott), where he played a pivotal role in developing AbbVie’s oncology franchise, driving its expansion and solidifying the Company’s leadership in oncology. His work included overseeing the approval of venetoclax, leading major acquisitions, and fostering critical collaborations. He was also part of the AbbVie-Genentech team that received the 2017 Prix Galien Award for Best Pharmaceutical Product. Before his time at AbbVie, Dr. Gordon was Chief Scientific Officer and Vice President of Clinical Affairs at Ovation Pharmaceuticals from 2001 to 2003. He began his pharmaceutical career in 1995 with the G.D. Searle division of Monsanto, which later became part of Pharmacia. About TriSalus Life Sciences TriSalus Life Sciences® is an oncology focused medical technology business providing disruptive drug delivery technology with the goal of improving therapeutic delivery to solid tumors. The Company’s platform includes devices with a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach to deliver a range of therapeutics: the TriNav® Infusion System for hepatic arterial infusion of liver tumors as well as other solid tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. PEDD is a novel delivery approach designed to address the anatomic limitations of infusion into solid tumors. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to limit delivery to normal tissue, creating the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via PEDD may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by PEDD are commonly present as well. Nelitolimod delivered by PEDD will be studied across several indications in an effort to address immune dysfunction and overcome drug delivery barriers in the liver and pancreas. In partnership with leading cancer centers across the country – and by leveraging deep immuno-oncology expertise and inventive technology development – TriSalus is committed to advancing innovation that improves outcomes for patients. Learn more at trisaluslifesci.com and follow us on X (formerly Twitter) and LinkedIn. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this report, including statements regarding the potential benefits of the Company’s technology and Nelitolimod and the value and contributions that Mr. Valle and Dr. Gordon will bring to the Company’s Board of Directors and operations, are all forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “expect,” “may,” “potential,” “should,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, the risk that the Company’s technology and Nelitolimod will not provide the potential benefits described in this press release, and that Mr. Valle’s and Dr. Gordon’s value and contributions to the Board of Directors and operations will be less than anticipated, and other risk factors described in the Company’s filings with the Securities and Exchange Commission, including the section titled “Risk Factors”. See the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 14, 2024 and other filings made with the SEC for a discussion of important factors that may cause the Company’s actual results to differ materially from those expressed or implied by the Company’s forward looking statements. Moreover, the Company operates in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for the Company’s management to predict all risk factors nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Furthermore, if the Company’s forward-looking statements prove to be inaccurate, the inaccuracy may be material. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20250203900558/en/ For Media Inquiries: Jeremy Feffer, Managing Director LifeSci Advisors 917.749.1494 jfeffer@lifesciadvisors.com For Investor Inquiries: James Young Chief Financial Officer 847.337.0655 james.young@trisaluslifesci.com Source: TriSalus Life Sciences