dijous, 31 de març del 2016

Harvard Apparatus rebrands as Biostage

BiostageHarvard Apparatus Regenerative Technology (NSDQ:HART) said today it is rebranding as Biostage, Inc. and shifting its Nasdaq symbol to “BSTG”, effective April 1.

The company said the brand shift “reflects the company’s broad commitment and expertise in pioneering the development of bioengineered organ implants for the esophagus, bronchus and trachea.”

“The Biostage name change reflects the evolution of our focus from commercializing bioreactors and research tools to the pioneering development of bioengineered organ implants for the esophagus, bronchus, and trachea. We have changed our company name to Biostage to better communicate and differentiate our new Cellframe technology and strategic direction,” CEO Jim McGorry said in a press release.

Holliston, Mass.-based Biostage said the new name integrates both its biotechnology focus on implants that provide staging for the body’s innate healing utilizing its Cellframe technology platform.

The company’s Cellframe tech platform features biocompatible scaffolds that are seeded with a patient’s stem cells to create Cellspan implants for treating conditions of the esophagus, trachea and bronchus.

“Cellframe employs a process in which the patient’s own stem cells are taken from a simple adipose/fat tissue biopsy, the cells are first isolated, expanded and then seeded onto a proprietary biocompatible scaffold that mimics the natural dimensions of the damaged organ. After incubation in our proprietary bioreactor, the Cellspan implant is ready to be implanted. Cellspan implants are designed to deliver the necessary cues for triggering, guiding, and modulating the regenerative process,” McGorry said.

Biostage said it plans to file an investigational new drug app with the FDA in late 2016 as it seeks to initiate clinical trials of its tech pltform in humans. The company is expanding the preclinical testing of its Cellspan esophageal implants in collaboration with the Mayo Clinic to support its IND app.

“Biostage is the result of a nearly two-year corporate transformation that centered on people, research, and technologies. We put in place a deeply experienced management team and board of directors to effectively lead our team of cell biology experts, materials scientists, and engineers to develop and pursue a clearly-defined set of research, regulatory, and commercialization goals. Biostage has also expanded its research partnership base to cost-effectively add technology resources critical to our success. Collectively, these efforts allow Biostage to pursue a new approach to restoring function to damaged organs for patients who deserve better clinical solutions and improved outcomes,” McGorry said.

The company said it expects to update on its preclinical research collaborations in the middle of the 2nd quarter of 2016.

Last November, Jim McGorry, CEO of Biostage, said he’s ready to right the ship by expanding its regenerative trachea tech into both the bronchus and esophagus.

McGorry has been the CEO of Biostage for 4 months, and told the Boston Business Journal he’s preparing to turn the company’s stock slide around.

The reins were passed to McGorry from former CEO David Green earlier this year as the company said it was seeking a chief exec had the experience to guide the company through clinical trials and product launches.

The post Harvard Apparatus rebrands as Biostage appeared first on MassDevice.



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