Photo | Courtesy
Biostage CEO Jim McGorry
August 13, 2019
Biostage prepares for FDA throat implant filing
By Zachary Comeau
Holliston biotech Biostage said Tuesday it plans to file with the U.S. Food & Drug Administration in September to kick-start the company’s clinical trials of its esophagus implant.
The company has been at this for years and is now just weeks away from a major milestone. So far, 2019 has been spent preparing for those clinical trials to meet the FDA’s quality and manufacturing standards.
As such, the company did little in the second quarter aside from courting private investors to the amount of $3.3 million. However, the company had only $1.3 million in cash at the end of June.
The company lost $2.4 million in the quarter and $4.4 million halfway through the year.
The company was delisted from NASDAQ in 2017 and is now looking to re-engage with the U.S. markets after a few years of soliciting investments mostly from China, CEO Jim McGorry said in a statement.
The company’s main product is the Cellspan Esophageal Implant, which it is marketing for use in children suffering from esophageal atresia, a condition in which the esophagus doesn't reach the stomach.
So far, the implant has only been used in one human, a 75-year-old man whose esophageal tube almost fully regenerated before dying of a stroke unrelated to the device.
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