PRNewswire. | July 03, 2023
Cresilon, Inc. a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for Cresilon Hemostatic Gel™ ("CHG™").
This marks Cresilon's first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company's global mission to transform wound care.
CHG™ utilizes Cresilon's proprietary hemostatic gel technology that rapidly controls bleeding when applied to a wound ‒ without the need for manual pressure. In addition to its versatility, the plant-based gel is easy-to-use and works instantaneously to both stop and control bleeding at the point of care
"The combination of these unique attributes will allow our technology to fill a critical unmet medical need while creating a significant and positive impact in helping to save lives and dramatically improving the standard of care in wound treatment." said Cresilon CEO and Co-Founder Joe Landolina. "The FDA clearance sets the predicate for our advanced technology and marks Cresilon's first step towards actualizing our long-term goal of expanding our technology within the broader human health market."
CHG leverages Cresilon's in-house manufacturing capabilities, advanced engineering, and focused research teams. CHG is for prescription use only. As the first product in the Cresilon portfolio approved for human use, CHG is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions. For additional important safety information, please see the CHG Instructions For Use.
Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology. The company's plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives.
Businesswire | July 26, 2023
SQZ Biotechnologies Company announced that Roche has determined that it will not exercise its option for HPV 16 positive solid tumors under the SQZ-APC-HPV program. SQZ Biotechnologies will regain full clinical development and future commercialization rights for its programs targeting HPV 16 positive tumors. The Company intends to explore potential strategic partnerships to support the advancement of its oncology programs and platforms.
The Company has completed a review of its portfolio and highlights the following achievements. SQZ® antigen presenting cells (APC) candidate was well tolerated in a Phase 1 trial and provided a significant survival benefit to a subpopulation of patients with enhanced tumor T cell infiltration. SQZ® enhanced antigen presenting cells (eAPC) candidate has completed enrollment of the highest dose monotherapy cohort in a Phase 1/2 trial, and initial data are anticipated in the second half of 2023. In addition, the low dose monotherapy cohort from the Phase 1 trial utilizing the Company’s Activating Antigen Carriers (AAC) candidate has demonstrated a confirmed complete response in one patient and an overall best response of stable disease in the other two patients. The high dose monotherapy cohort in this trial is currently enrolling, and initial data are anticipated in the fourth quarter of 2023. Finally, development and testing of the Point of Care Manufacturing system continue to advance and could significantly reduce the time and cost of cell therapy manufacturing and potentially make cell therapies more broadly accessible for patients.
“We have made meaningful progress across all our platforms this year and the management team and Board of Directors are enthusiastic about the power of Cell Squeeze® technology and the potential of the Company’s therapeutic programs,” said Howard Bernstein, Interim CEO and Member of the Board of Directors at SQZ. “As we move into the second half of this year, we are committed to assessing all of the Company’s potential strategic alternatives in an effort to advance our programs.”
About SQZ Biotechnologies
SQZ Biotechnologies is a clinical-stage biotechnology company focused on unlocking the full potential of cell therapies. The Company’s proprietary Cell Squeeze® technology offers the unique ability to deliver multiple biological materials into many patient cell types to engineer what the Company believes can be a broad range of potential therapeutics. The Company’s goal is to create well-tolerated cell therapies that can provide therapeutic benefit for patients and improve the patient experience over existing cell therapy approaches. With production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, the Company believes its approach could change the way people think about cell therapies.
Medical, Industry Outlook
Businesswire | July 24, 2023
Massive Bio, an AI-powered platform connecting patients with clinical trials and CureMatch, a healthcare technology company leveraging Knowledge Representation & Reasoning (KRR) AI for precision medicine support for oncology, and have announced a transformative partnership aimed at revolutionizing cancer treatment through advanced genomics, artificial intelligence, and expansive clinical trial accessibility.
Massive Bio and CureMatch will leverage their cutting-edge technologies to provide oncologists and their patients unprecedented access to potentially lifesaving clinical trials, personalized cancer treatments, and comprehensive reports on the most effective therapies based on individual patients' profiles.
Selin Kurnaz, CEO and Co-Founder of Massive Bio, highlights the potential of this alliance: "This partnership with CureMatch combines the power of precision medicine with the most advanced AI-driven clinical trial matching. It disruptively accelerates the drug development process, offering faster access to advanced therapies for patients."
Navid Alipour, CEO of CureMatch, also emphasized the transformative potential of the partnership. "CureMatch is thrilled to join forces with Massive Bio. By integrating our personalized oncology platform with their AI-driven clinical trial matching system, we can reach more patients and provide the best possible treatment options. Our mission is to improve the quality of life for countless patients and contribute to the global fight against cancer."
In this game-changing alliance, CureMatch will harness its distinctive platform to identify patients who stand to benefit most from groundbreaking clinical trials, thereby magnifying the reach and impact of Massive Bio's trials. Simultaneously, Massive Bio will employ its cutting-edge AI capabilities to process a wealth of patient clinical health data, including variables such as cancer type, demographics, geographic location, and historical data. By weaving this intricate data mosaic with CureMatch's customized reports, Massive Bio will expertly determine potential matches for appropriate clinical trials. This pioneering approach not only streamlines patient identification but also propels drug development and fortifies personalized treatment strategies. As a result, this transformative partnership presents a highly compelling opportunity for similar future partners looking to fuel the future of precision oncology.
Dr. Arturo Loaiza-Bonilla, Co-Founder of Massive Bio, believes the collaboration will not only contribute to cancer treatment innovation but will also play a vital role in reducing disparities in clinical trial participation. "This partnership addresses a critical gap in oncology research, providing an opportunity for all patients, regardless of their geographical location, to access cutting-edge treatments."
By leveraging the expertise and technological capabilities of both organizations, the partnership aims to facilitate the referral of patients to clinical trials, thus increasing access to potential therapies for cancer patients. As a result, patients worldwide stand to benefit from advanced precision medicine delivered locally, improving health outcomes and reducing healthcare costs.
About Massive Bio
Massive Bio is at the forefront of empowering cancer patients to discover their optimal treatment options. Utilizing AI to enhance equitable access and precision targeting for clinical trial matching, drug matching, and drug development, Massive Bio is committed to breaking down barriers in clinical trial enrollment, fostering value-based oncology decisions, and facilitating data-driven cancer treatment. Serving over three dozen pharmaceutical companies, contract research organizations, and hospital networks, Massive Bio has earned recognition from the National Cancer Institute with an SBIR contract. Founded in 2015 by a team of clinical, technology, and M&A executives, Massive Bio boasts a global presence with nearly 100 people across 12 countries. For further details, please visit www.massivebio.com, https://askfiona.ai, https://drarturo.ai or interact with us on our social media channels.
CureMatch, Inc. is a digital health company focused on personalized medicine and combination therapy in oncology. CureMatch's Decision Support System guides oncologists in the selection of cancer drugs that are personalized for individual patients based on their molecular tumor profile.
Medical, Industry Outlook
Businesswire | August 11, 2023
TriSalus Life Sciences® Inc. an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, today announced the completion of its previously announced merger with MedTech Acquisition Corporation (Nasdaq: MTAC) (MedTech). 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, 2023.
“Completing our merger with MedTech marks an important milestone in our efforts to bring to market innovative approaches to treating liver and pancreatic tumors,” said Mary Szela, President and CEO of TriSalus. “Over the last several months we have advanced our device business and generated positive clinical data that supports the potential of our immunotherapeutic program. We are moving forward with the financial resources needed to grow our commercial organization and fund our key milestones through mid-2024. We believe that we are poised to create shareholder value as we continue our work to bring hope and improved treatments to the lives of patients. Finally, I want to especially thank our MTAC and TriSalus shareholders for trusting us to create value for them. I also want to thank our employees, interventional radiologists, and clinical investors and particularly our patients for their unwavering support that has been instrumental in helping us to achieve this milestone.”
“We are excited to complete this merger with TriSalus and support the growth of its innovative devices and treatments,” said Chris Dewey, CEO of MedTech. “We believe that TriSalus has significant near and long-term value creation opportunities through its commercialization strategy and the potential to deploy SD-101 into multiple indications across several lines of therapy. We have full confidence that Mary and the experienced TriSalus team will continue working to meet significant unmet medical needs and delivering value to shareholders.”
The Company’s new board of directors consists of Mats Wahlstrom, Mary Szela, Sean Murphy, Kerry Hicks, Dr. Anil Singhal, Dr. Andrew C. von Eschenbach, Kelly Martin, David J. Matlin and Dr. Arjun (“JJ”) Desai.
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 million and $12.4 million in net sales in 2021 and 2022, respectively, and is on track to generate approximately $19.2 million in 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 2023 and 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 MedTech trust account, along with cash on hand, provides a cash runway through mid-2024 to fund key milestones.
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.