FDA orphan drug status for Cellspan Esophageal Implant by Biostage
Release Date: 19-Jan-2017
Biostage Inc., a biotechnology company focused on producing bioengineered organ implants to treat cancers and other life-threatening conditions of the esophagus, bronchus and trachea declared that US Food and Drug Administration has granted orphan drug designation to Cellspan Esophageal Implant to restore the structure and function of the esophagus subsequent to esophageal damage due to cancer, injury or congenital abnormalities.
Cellspan esophageal implants is expected to have the potential to offer improved outcomes for patients by reducing post-operative complications and providing an improved quality of life, by prompting regeneration of the patient's own esophagus.
Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. The OOPD provides incentives for sponsors to develop products for rare diseases, which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers.
For Orphan Drug Clinical Insight Reports Contact: email@example.com
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