Bioengineered Organ Implant Developer HART Reviews Progress and Q4 2015 Results


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Holliston, MA, March 17, 2016 – Harvard Apparatus Regenerative Technology, Inc. (HART), announced its financial results for the fourth quarter and year ended December 31, 2015 and reviewed its corporate and research progress and plans.


HART is a biotechnology company developing bioengineered organ implants based on the Company’s new Cellframe ™ technology. HART’s new Cellframe implant technology is comprised of a biocompatible scaffold that is seeded with the recipient’s own stem cells. It is being developed to treat life-threatening conditions of the esophagus, trachea or bronchus with the hope of dramatically improving the treatment paradigm for these patients. HART continues to build on the positive animal data it released in November.


“HART has made significant progress over the past twelve months,” said Jim McGorry, CEO of HART. “We have fundamentally reshaped our research and development and our entire company in improving and optimizing our new bioengineered organ implant technology. Our new Cellframe technology aims to optimize the interaction and signaling of the scaffold and the patient’s own cells to improve regeneration and remodeling. Initial results from large-animal studies have been encouraging and in many ways suggest that our technology is an entirely new and innovative approach to restoring organ function.”


“We are now advancing the development of our platform in collaborative large-animal studies with Mayo Clinic,” continued Mr. McGorry. “We expect to provide an update on our progress in mid-second quarter 2016. During this past year, we have also enhanced our management team and our Board of Directors, and formed a Scientific Advisory Board to guide our progress. We have added experienced industry team members to execute on our new vision and I believe we are on a solid footing to the future.”


HART is working to refine its new platform and to develop compelling data in support of its goal of filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in late 2016, seeking to initiate clinical trials. Based on its existing preclinical data, HART has selected life-threatening conditions of the esophagus as the initial clinical application for advancing its Cellframe technology through the IND process.

Key large-animal data for HART's Cellframe technology was first announced in November 2015, and HART currently anticipates providing an update on its ongoing large-animal research collaboration with Mayo Clinic mid-second quarter 2016.


The following information was filed by Biostage, Inc. (BSTG) on Thursday, March 17, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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