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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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Harvard Apparatus Regenerative Technology, Inc. announced its financial results for Q2 2023, reporting a net loss of $2.6 million compared to $1.4 million in Q2 2022. The company activated its first clinical trial site with Mayo Clinic and contracted with IQVIA as the contract research organization. They also started a Consumer Health business in Hong Kong, planning to sell anti-aging supplements in Q3 2023.
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Biostage, Inc. (OTCQB: BSTG) has officially activated Mayo Clinic as the first site for its clinical trial in severe esophageal disease. This marks Biostage's first clinical trial in the United States for its esophageal implant technology, which aims to regenerate organs inside the body. The Phase 1, first-in-human study approved by the FDA will evaluate both safety and efficacy in up to ten patients requiring the removal of up to 6 cm of their esophagus due to cancer, trauma, or birth defects.

The study will be conducted at up to five hospitals in the U.S., with the primary endpoint being the development of a continuous biological neo-conduit at three months following implantation. This milestone represents a significant step forward for Biostage in its mission to advance organ regeneration and regenerative medicine.

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Biostage, Inc. (OTCQB: BSTG) has appointed Ron Packard as an independent director to its Board of Directors, enhancing its strategy and innovation capabilities. Packard brings extensive experience in business and finance, previously leading K12 Inc. to nearly $1 billion in revenue and guiding its IPO. His leadership will be crucial as Biostage focuses on its cell-therapy advancements, particularly the Biostage Esophageal Implant, for treating esophageal cancer. Biostage's technology has already shown promise, achieving successful regeneration of the esophagus in clinical cases. The company holds 12 U.S. patents and two orphan-drug designations from the FDA, indicating potential market exclusivity. Packard expressed enthusiasm about supporting Biostage's mission to address unmet patient needs through its innovative therapies.

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Biostage, Inc. (OTCQB: BSTG) announced a private placement raising approximately $6 million to accelerate the clinical development of the Biostage Esophageal Implant (BEI). The FDA has approved a phase one and two clinical trial for adults to repair esophageal damage caused by cancer or injury, with potential future expansion for pediatric use. The company is also exploring applications of its technology for lung cancer treatment with the Biostage Bronchial Implant. The private placement involved the sale of 1,000,967 shares at a price of $6.00 per share, with $3.6 million received so far. The announcement highlighted the company's commitment to advancing regenerative medicine technologies, specifically targeting gastrointestinal and airway disorders.

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Biostage, Inc. announced a leadership transition effective March 1, 2023. Existing board member Jerry He replaces David Green as Chairman and CEO, while Green continues on the Board to assist in the transition. Jerry He previously served as Executive Vice Chairman of Bright Scholar Education Holdings Limited and has a strong background in biotechnology and finance. Biostage develops regenerative medicine solutions for gastrointestinal and airway disorders. The company is preparing for FDA-approved clinical trials aimed at treating esophageal cancer, a condition impacting many patients with a low survival rate.

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Biostage, Inc. (OTCQB: BSTG) announces a leadership transition, appointing Jerry He as the new Chairman and Chief Executive Officer effective March 1, 2023. He replaces David Green, who will remain on the Board to support the transition. Mr. He has significant experience in the biotechnology and education sectors, previously serving as CEO of Bright Scholar Education Holdings. The company is advancing towards FDA-approved clinical trials for regenerative treatments targeting esophageal cancer. This clinical approach could significantly impact the treatment landscape, as esophageal cancer has a high mortality rate.

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On January 11, 2023, Biostage, Inc. (OTCQB: BSTG) officially appointed David Green as Chief Executive Officer by removing his Interim title. The updated employment agreement will include amendments to his existing terms. Green, a founder of the company, expressed his commitment to advancing Biostage's FDA-approved clinical trials and expanding its treatment pipeline for gastro-intestinal and airway disorders. Biostage has achieved significant milestones, including the world's first successful esophagus regeneration in 2017 and holds 12 U.S. patents along with two orphan-drug designations.

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Biostage, a biotechnology company, announced plans to initiate patient recruitment for its first clinical trial in early 2023. The company published a study in the Journal of Immunology and Regenerative Medicine, demonstrating the effectiveness of its Biostage Esophageal Implant (BEI) in stimulating tissue regeneration in nine pigs. The BEI facilitated new blood vessel growth and allowed for the regeneration of a continuous biological conduit by 28 days. This aligns with Biostage's FDA-approved clinical trial objective of achieving similar results within 90 days.

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FAQ

What is the market cap of BSTG (BSTG)?

The market cap of BSTG (BSTG) is approximately 63.9M.

What does Biostage, Inc. specialize in?

Biostage specializes in developing bioengineered organ implants to address unmet medical needs in treating life-threatening conditions such as cancer, trauma, and congenital abnormalities.

What is the Cellframe™ technology?

Cellframe™ is Biostage’s proprietary technology platform designed to stimulate the body's natural healing processes to regenerate and restore organ function using a combination of synthetic scaffolds, tissue engineering, and cell biology.

What are Cellspan™ implants?

Cellspan™ implants are organ-specific implants created using the Cellframe™ technology. They are designed for in situ tissue regeneration, providing biological signals and structural support for cell growth and differentiation.

What recent advancements has Biostage made?

Biostage recently initiated its first clinical trial in the U.S. in collaboration with the Mayo Clinic, evaluating the safety and efficacy of Cellspan™ esophageal implants.

What is the goal of Biostage's current clinical trial?

The goal is to establish the safety and efficacy of the Cellspan™ esophageal implant in regenerating a continuous biological neo-conduit in patients with severe esophageal disease.

How does Biostage’s technology benefit patients?

Biostage's technology enables patients to regenerate their own organs, potentially eliminating the need for donor transplants, animal transplants, or permanent artificial implants.

What significant achievement did Biostage attain in 2017?

In 2017, Biostage achieved the world's first successful esophagus regeneration in a patient with esophageal cancer. The procedure was a significant milestone in the field of regenerative medicine.

How does Biostage ensure market exclusivity for its products?

Biostage holds 13 issued U.S. patents, 2 issued in China, and 2 orphan-drug designations, which provide up to seven years of market exclusivity in addition to patent protections.

Where can I find the latest news and updates about Biostage?

The latest news and updates about Biostage can be found on the company's official website and social media channels such as Twitter and LinkedIn.

How can I contact Biostage for investor relations?

For investor relations inquiries, you can contact Joseph Damasio, Chief Financial Officer, at 774-233-7330 or via email at jdamasio@biostage.com.

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