TriSalus Completes MedTech Merger, Outlines Clinical Program

August 10, 2023—TriSalus Life Sciences Inc., an oncology company integrating its delivery technology with immunotherapy to treat patients with liver and pancreatic tumors, announced the completion of its merger with MedTech Acquisition Corporation. TriSalus’ common stock and warrants are expected to commence trading on the Nasdaq Global Market under the ticker symbols TLSI and TLSIW, respectively, on August 11. The company also outlined its current clinical program in the press release.

To accelerate TriSalus’ strategy, James “Jim” Alecxih was recently appointed as President, Device Technology Business. Mr. Alecxih will oversee the development and expansion of the company’s portfolio of infusion technologies.

In November 2022, the company announced it had entered into a definitive merger agreement with MedTech (Nasdaq: MTAC), a publicly traded special purpose acquisition company focused on the medical technology industry in the United States and other developed countries.

According to TriSalus, its commercial-stage, FDA-cleared TriNav infusion system includes the company’s SmartValve technology, which enables precision delivery of therapeutics to tumors using the pressure-enabled drug delivery (PEDD) approach.

The company noted that the PEDD approach has been shown to modulate pressure and flow, increasing therapeutic delivery to the tumor while decreasing exposure in normal tissue. PEDD has the potential to improve patient outcomes and offers expansion opportunities through the delivery of a wide variety of therapeutics.

TriSalus’ technology pipeline includes a range of devices for improving therapeutic delivery. An FDA-cleared delivery system for infusing immunotherapy into pancreatic adenocarcinoma patients is currently being studied at MD Anderson Cancer Center in Houston, Texas.

Additionally, a full suite of devices that optimize therapy delivery across the broad range of solid tumor types, vessel sizes, and with greater precision using intraprocedural flow dynamic data.

The first new device expected in the expanded toolkit is the TriNav LV device, which is designed to address larger vessel sizes. TriNav LV received FDA 510(k) clearance in May 2023 and is targeted for commercial launch in the first half of 2024.

TriSalus advised it is developing SD-101, an investigational immunotherapeutic designed treat 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 toll-like receptor 9 (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.

According to TriSalus, patient data generated during the 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.

The company stated that 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. The SD-101 treatment-related serious adverse event rate was 5%, and treatment 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, noted the company.

These findings were presented during an oral discussion session at ASCO 2023, the American Society of Clinical Oncology’s annual meeting held June 2-6 in Chicago, Illinois.

Additional phase 1 data readouts for the PERIO clinical trial program are planned in the fourth quarter of 2023. A phase 2 trial is scheduled to be initiated in the second half of 2023.

More information is available on the PERIO clinical trial program’s website, www.periotrial.com.

The three trials are in the FDA Clinical Trials database:

• Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma (NCT04935229)
• Pressure-Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors (NCT05220722)
• Pressure-Enabled Intrapancreatic Delivery of SD-101 With Checkpoint Blockade for Locally Advanced Pancreatic Adenocarcinoma (NCT05607953)