Company Description
Biostage, Inc. (OTCQB: BSTG) is a trailblazing biotechnology company at the forefront of developing bioengineered organ implants. These implants cater to critical needs in treating life-threatening conditions such as cancer, trauma, and congenital abnormalities, specifically targeting the esophagus, bronchus, and trachea. Central to Biostage's innovation is its proprietary Cellframe™ technology platform. This platform stimulates the body's innate signaling pathways and natural healing processes, fostering the regeneration and restoration of organ function.
The breakthrough Cellframe™ technology combines a synthetic scaffold with tissue engineering and cell biology to produce organ-specific Cellspan™ implants. These implants are strategically designed to facilitate in situ tissue regeneration by providing both stem cell-derived biological signals and three-dimensional structural support for cell growth and differentiation. A testament to its potential, recent large animal studies have shown promising results, notably in esophageal applications.
In an exciting development, Biostage has initiated its first clinical trial in the United States in collaboration with the Mayo Clinic, focusing on severe esophageal disease. This Phase 1, first-in-human study, approved by the FDA, aims to evaluate the safety and efficacy of the Cellspan™ esophageal implant in up to ten patients across five hospitals. The trial seeks to establish a continuous biological neo-conduit at three months post-implantation.
Biostage's commitment to advancing regenerative medicine is further emphasized by its robust intellectual property portfolio, which includes 13 issued U.S. patents, 2 issued in China, and 2 orphan-drug designations. These designations provide seven years of market exclusivity, reinforcing Biostage's competitive advantage.
The company's long-term vision is to provide next-generation solutions for organ restoration, eliminating the need for donor or animal transplants and avoiding the use of permanent artificial implants. This vision was notably realized in 2017 when Biostage successfully regenerated the esophagus in a patient with esophageal cancer, a milestone procedure that was later published in the Journal of Thoracic Oncology Clinical and Research Reports.
For the latest updates, Biostage regularly shares news on its website and through its social media channels, providing stakeholders with current advancements and financial performance.
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