Phoenix, Arizona--(Newsfile Corp. - November 25, 2019) - The Stock Day Podcast welcomed Biostage, Inc. (OTCQB: BSTG) ("the Company"), a bioengineering company that is developing next-generation esophageal implants. CEO of the Company, Jim McGorry, joined Stock Day host Everett Jolly.
Jolly began the interview by noting that the Company's primary product is an esophageal implant called the Cellspan Esophageal Implant, or CEI. He then asked about the Company's recent IND application with the FDA. McGorry explained that this application represents a key milestone for the Company.
"It's that moment that you take all of the pre-clinical data and that clinical data, and really show that there's safety to begin a clinical trial," said McGorry. "We're really happy. It's taken years of work. This is a new-to-the-world product."
When asked why the world needs the Company's product, McGorry explained the gap in current treatments that Biostage's Cellspan Esophageal Implant aims to fill.
"There's a real unmet health need, and that need is really in children and adults that suffer from a congenital abnormality called pediatric esophageal atresia," McGorry said, adding that children born with this condition can remain in hospital intensive care for "weeks and months." Esophageal atresia involves about 1 in 4,000 patients born with a physical gap in their esophagus, such that food can't reach their stomach.
He went on to share the different approach Biostage takes over current treatments, using the patient's cells to bridge this gap.
"We are able to demonstrate now . . . that we can implant a scaffold seeded with the patient's own cells," McGorry explained. "These cells will signal other cells to regenerate that organ and fill the space. So that's why we really feel the driving force -it's all about the kids." He went on to note that after a month, the scaffold itself is removed once the organ has regenerated around it. "As the child grows, so does the regenerated portion," he said.
Jolly then asked about the Company's recently-filed application with the FDA, as well as their next steps.
"We filed at the end of October," McGorry said, explaining that the FDA has one month to respond by the end of November. "It's a combination product of both the device and cells, so we anticipate some questions," he explained, but added that the Company is prepared to manage the upcoming stages of the application. "We're excited for this moment," he said.
McGorry then explained that if the application is approved, the Company will be able to begin clinical trials in partnership with the Mayo Clinic, which has already used the CEI in a patient successfully before. He shared that the trials will begin with testing the implant in adults to ensure that the device is safe prior to its use on children. "If we get the green light with the agency and work through those areas, then we can start treating patients into 2020," he said.
To close the interview, McGorry shared that the Company is remaining focused on its current application with FDA, which if approved will allow them to begin clinical trials. He then expressed his gratitude to listeners and shareholders for continuing to show interest in the Company as they grow.
To hear Jim McGorry's entire interview, follow the link to the podcast here: https://audioboom.com/posts/7433533-biostage-inc-discusses-potential-clinical-trials-for-their-next-generation-esophageal-implants
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About Biostage, Inc.
Biostage is a bioengineering company that is developing next-generation esophageal implants. The Company's Cellspan technology combines a proprietary, biocompatible scaffold with a patient's own cells to create an esophageal implant that could potentially be used to treat pediatric esophageal atresia and other conditions that affect the esophagus. The Company's esophageal implant leverages the body's inherent capacity to heal itself as it is a "living tube" that facilitates regeneration of esophageal tissue and triggers a positive host response resulting in a tissue-engineered neo-conduit that restores continuity of the esophagus. These implants have the potential to dramatically improve the quality of life for children and adults. At Biostage, we believe the future of medicine has been inside us all along.
For more information, please visit www.biostage.com and connect with the Company on Twitter and LinkedIn.
Forward-Looking Statements
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements in this press release include, but are not limited to, statements relating to our financing activities; development expectations and regulatory approval of any of the Company's products, including those utilizing its Cellspan and Cellframe™ technology, by the U.S. Food and Drug Administration, the European Medicines Agency or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; or success with respect to any collaborations, clinical trials and other development and commercialization efforts of the Company's products, including those utilizing its Cellspan and Cellframe technology, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the Company's inability to obtain needed funds in the immediate future; the Company's ability to obtain and maintain regulatory approval for its products; plus other factors described under the heading "Item 1A. Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2018 or described in the Company's other public filings. The Company's results may also be affected by factors of which the Company is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
Investor Relations Contact
Peter Chakoutis
Vice President of Finance
774-233-7300
pchakoutis@biostage.com
About The "Stock Day" Podcast
Founded in 2013, Stock Day is the fastest growing media outlet for Nano-Cap and Micro-Cap companies. It educates investors while simultaneously working with penny stock and OTC companies, providing transparency and clarification of under-valued, under-sold Micro-Cap stocks of the market. Stock Day provides companies with customized solutions to their news distribution in both national and international media outlets. The Stock Day Podcast is the number one radio show of its kind in America. Stock Day recently launched its Video Interview Studio located in Phoenix, Arizona.
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