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Sernova Corp. is a clinical-stage biotechnology company focused on developing therapeutic cell technologies for chronic diseases like insulin-dependent diabetes, thyroid disease, and hemophilia A. The company's lead asset, the Cell Pouch System, is an implantable medical device that creates a natural vascularized tissue environment for long-term survival of therapeutic cells. Sernova's technology aims to provide a 'functional cure' for diabetes and other chronic conditions by releasing essential factors to address deficiencies in patients' bodies. The company is also working on shielding therapeutic cells from immune system attacks and developing an off-the-shelf iPSC-based islet replacement therapy in partnership with Evotec. In addition, Sernova is progressing programs for hypothyroid disease and hemophilia A using its Cell Pouch System.
Sernova Corp. (OTCQB:SEOVF) announced that an abstract will be presented at the American Diabetes Association 83rd Scientific Sessions from June 23-26, 2023, in San Diego, CA. The abstract titled "Islet Allotransplantation into Pre-vascularized Sernova Cell Pouch" will be delivered on June 24 at 5:15 PM PT. This significant presentation showcases early results from the University of Chicago concerning Sernova's innovative Cell Pouch System, which aims to provide a functional cure for insulin-dependent diabetes. The study may impact future treatment approaches and is part of Sernova's broader strategy to develop cell therapies for chronic diseases.
Sernova Corp. (OTCQB:SEOVF) announced its first pre-clinical data presentation regarding the Cell Pouch with Evotec’s iPSC-derived islet-like clusters for type 1 diabetes (T1D). The presentation is set for April 24, 2023, at the 4th International Pancreas and Islet Transplant Association Summit in Cambridge, Massachusetts. This collaboration aims to develop a scalable process for manufacturing insulin-producing cells from induced pluripotent stem cells (iPSCs) for cell therapy. Sernova’s ongoing Phase 1/2 study demonstrates the potential of the Cell Pouch System as a functional cure for T1D.
Sernova Corp. (OTCQB:SEOVF) announced the implantation of the third patient with its advanced 10-chamber Cell Pouch in a Phase 1/2 trial for type 1 diabetes treatment. The company expects to report interim data from the second patient cohort in Q4 2023.
The new cohort includes up to seven patients, and the protocol is designed to optimize islet transplant efficacy. The 10-channel Cell Pouch offers over 50% more capacity than previous models, aiming to reduce severe hypoglycemic episodes and insulin dependency. The interim results from this trial phase are highly anticipated, as they may indicate pivotal advancements in diabetes treatment.
Sernova Corp. (OTCQB: SEOVF) announced its participation in two major conferences: the 35th Annual Roth Conference from March 12-14, 2023, and the Oppenheimer 33rd Annual Healthcare Conference from March 13-15, 2023. Dr. Philip Toleikis, CEO, will engage in one-on-one investor meetings and present a fireside chat on March 13, 2023, at 4:00 PM PT. Additionally, Sernova revealed that 20,136,918 warrants expired unexercised on March 1, 2023, leaving 303,332,686 shares outstanding. The company focuses on developing a 'functional cure' for insulin-dependent diabetes through its Cell Pouch System.
Sernova Corp. (OTCQB: SEOVF) has announced promising results from a preclinical study showing that thyroid auto-transplantation into its Cell Pouch can restore hormone production post-thyroidectomy. This advancement aims to eliminate the need for lifelong hormone replacement therapy in patients who have undergone thyroid removal, which affects over 150,000 individuals annually in the U.S. The company is now engaging with regulatory authorities to initiate clinical trials, highlighting a significant step toward offering a new treatment option for hypothyroidism.
Sernova Corp. (OTCQB: SEOVF) announced advancements in its collaboration with Evotec SE, focusing on a pioneering off-the-shelf cell therapy for Type 1 Diabetes (T1D). The combination of Evotec’s iPSC-derived islet-like clusters with Sernova’s Cell Pouch aims for a 2024 regulatory filing for clinical trials. Key achievements include scalable islet cluster manufacturing and successful T1D preclinical model results, showcasing long-term insulin independence. The partnership aims to provide a potential functional cure for insulin-dependent diabetes, reducing patient reliance on daily insulin.
Sernova Corp. has announced a leadership transition, with Dr. Philip Toleikis stepping down as CEO to become Chief Technology Officer. The company is actively searching for a new CEO to guide its next growth phase, particularly as it aims to expand in US capital markets. Dr. Toleikis has led the firm for 13 years, developing its Cell Pouch System for treating chronic diseases like diabetes. The transition aims to ensure continued advancements in the company’s technology and therapies. The executive search firm Slone Partners is assisting in the recruitment process.
Sernova Corp. (OTCQB:SEOVF) announced significant advancements in its clinical trial for type 1 diabetes. With the recent implantation of the 10-channel Cell Pouch in the second cohort of its Phase 1/2 study, the company enhances capacity and aims for optimized dosing. Patient recruitment has surged due to a new strategy, and interim data is expected in 2023. This trial aims for key efficacy endpoints, potentially paving the way for a pivotal Phase 3 program. The Cell Pouch System aims to provide a functional cure for diabetes, targeting insulin independence for patients.
Sernova Corp. (OTCQB:SEOVF) announced its participation in the Stifel Healthcare Conference on November 15-16, 2022, in New York. Dr. Philip Toleikis, President & CEO, will present on November 15 at 9:45 AM. Sernova is focused on developing regenerative cell therapeutic technologies for chronic diseases, primarily through its Cell Pouch System, aimed at providing a 'functional cure' for insulin-dependent diabetes. The company is also involved in partnerships to enhance its therapies, including a strategic collaboration with Evotec for iPSC-based beta cell replacement.
Sernova Corp. has made significant progress in its Phase 1/2 clinical trial of the Cell Pouch System for type 1 diabetes, receiving approval for a protocol amendment from the University of Chicago IRB. This allows for the testing of a second cohort of patients using an enhanced 10-channel Cell Pouch, which offers 50% greater islet capacity. Interim results from the initial cohort have informed dose optimizations, and rapid enrollment is expected due to engagement with a clinical trial recruitment agency. Further results may lead to a pivotal study design for a future BLA submission to the FDA.
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