TriSalus Life Sciences Completes Merger with MedTech Acquisition Corporation
Advances TriSalus’ Platform Focused on Improving Outcomes for Patients with Liver and Pancreatic Cancer
Advancing SD-101 Into Phase 2 Clinical Trial in Uveal Melanoma, Phase 1 Trial in Pancreatic Cancer and Continuing Clinical Trials in HCC and Cholangiocarcinoma
Provides Cash Runway through Mid-2024 to Fund Key Milestones
TriSalus’ Common Stock Expected to Begin Trading on the Nasdaq under Symbol "TLSI" on
“Completing our merger with
“We are excited to complete this merger with TriSalus and support the growth of its innovative devices and treatments,” said
The Company’s new board of directors consists of
Szela continued, “We welcome Andy, Kelly, JJ and David to the Board and look forward to benefiting from their experience across the medical technology, pharmaceutical, healthcare and financial industries.
Innovative Device Technology Combined with Immunotherapeutic Platform Creates Significant Upside Potential
Fast-Growing Core Device Business: TriSalus' commercial stage, FDA cleared TriNav® Infusion System includes the proprietary SmartValve technology. SmartValve enables precision delivery of therapeutics to tumors using the Pressure-Enabled Drug Delivery™ (PEDD) approach. The PEDD approach has been shown to modulate pressure and flow, increasing therapeutic delivery to the tumor while decreasing exposure in normal tissue – an important goal for interventional radiologists focused on better outcomes with less toxicity. PEDD brings the potential to improve patient outcomes and also brings additional expansion opportunities through the delivery of a wide variety of therapeutics. TriNav achieved
$8.4 millionand $12.4 millionin net sales in 2021 and 2022, respectively, and is on track to generate approximately $19.2 millionin net sales in 2023.
Robust Device Pipeline: TriSalus' technology pipeline includes a range of devices that use technology expected to substantially improve therapeutic delivery. An FDA cleared delivery system for infusing immunotherapy into pancreatic adenocarcinoma patients is currently under study at
MD Anderson Cancer Center. The pipeline also includes a full suite of devices that allows interventional radiologists to optimize therapy delivery across the broad range of solid tumor types, vessel sizes, and with greater precision using intra-procedural flow dynamic data. The first new device expected in the expanded toolkit is the TriNav LV device, designed to optimally address larger vessel sizes, which received 510(k) clearance by the FDA in May 2023and is targeted for commercial launch in the first half of 2024.
To accelerate TriSalus’ strategy, James “Jim” Alecxih was recently appointed as President, Device Technology Business. Jim will oversee the development and expansion of the Company’s portfolio of innovative infusion technologies.
Therapeutic Platform in Clinical Development: TriSalus is developing SD-101, an investigational immunotherapeutic designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors – an environment that can make current immunotherapies ineffective in the liver and pancreas. SD-101 is a class C TLR9 agonist with a dual mechanism of action and a differentiated profile versus other TLR agonists. In solid tumors, the drug alters the tumor microenvironment by reducing immunosuppressive myeloid-derived suppressor cells (MDSC) while simultaneously stimulating multiple immune cell types.
Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that SD-101 delivered via PEDD may have favorable immune effects within the liver and systemically. Currently SD-101 is being studied in three clinical trials for patients with uveal melanoma with liver metastases, intrahepatic cholangiocarcinoma, hepatocellular carcinoma, and pancreatic ductal adenocarcinoma.
In the studies reported to date, SD-101 in combination with systemic checkpoint inhibition and delivered with PEDD, achieved high concentrations in the liver with minimal systemic exposure and was well tolerated based on a low SD-101 treatment related serious adverse event rate of 5%, and resulted in immune cell activation and natural killer cell expansion. The immune effects in liver metastases and the blood are consistent with broad tumor microenvironment modulation and the ability of SD-101 to deplete MDSCs in the liver. These findings were highlighted during an oral discussion session at ASCO 2023.
Additional Phase 1 data readouts for the PERIO clinical trial program are planned in the fourth quarter of 2023 and a Phase 2 trial is scheduled to be initiated in the second half of 2023.
Well Positioned with Cash Runway: Proceeds raised in connection with the merger with
MedTech, including proceeds from the recently closed private placement transaction and amounts remaining in the MedTechtrust account, along with cash on hand, provides a cash runway through mid-2024 to fund key milestones.
To learn more about the clinical trial treatment protocol and enrollment, visit http://www.periotrial.com or http://www.clinicaltrials.gov and search NCT04935229, NCT05220722, and NCT05607953.
About TriSalus Life Sciences
TriSalus Life Sciences® is an oncology company integrating novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors.
The Company’s platform includes devices that utilize 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 and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. PEDD is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. SD-101, 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 SD-101 delivered via PEDD may have favorable immune effects within the liver and systemically.
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 Twitter @TriSalusLifeSci and LinkedIn.
Certain statements in this communication may be considered forward-looking statements, including but not limited to statements regarding the Company’s revenue expectations for 2023, the Company’s expectations that the proceeds from the business combination and related transactions provide a cash runway through 2024 and the potential to deploy SD-101 into multiple indications across multiple lines of therapy. Forward-looking statements generally relate to future events and can be identified by terminology such as “aim”, “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by
+1 212 355 4449
Source: TriSalus Life Sciences