HART Appoints Laura Mondano as Vice President of Regulatory Affairs To Lead HART's 2016 IND Submission For its Bioengineered Organ Implant Solutions

Mar 02, 2016, 16:26 ET from Harvard Apparatus Regenerative Technology, Inc.

HOLLISTON, Mass., March 2, 2016 /PRNewswire/ -- Harvard Apparatus Regenerative Technology (Nasdaq: HART), a biotechnology company developing bioengineered organ implants for life-threatening conditions of the esophagus, trachea and bronchus, announced today that Laura Mondano has joined the company as Vice President of Regulatory Affairs, a new position at HART.

Ms. Mondano is charged with leading the company's major 2016 milestone of submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for HART's newly developed "Cellframe" technology for the esophagus. Much of the pre-clinical work for the IND is in process. The initial key large-animal data for HART's "Cellframe" technology was announced in November 2015. In collaboration with Mayo Clinic, HART is currently anticipating a read out of additional large-animal data in May. These data are expected to positively confirm the regeneration seen in November and add to the Orphan Drug Designation and IND filings for the esophagus. 

Ms. Mondano has 20+ years of accomplishment leading regulatory affairs at significant biotechnology companies, including Genzyme Corporation where she served as Director, Global Regulatory Affairs for eight years. Ms. Mondano joins HART from Histogenics Corporation where she served as Vice President of Regulatory Affairs since 2012. She has also held regulatory management positions at Anika Therapeutics, Inc. and Boston Scientific Corporation.

Ms. Mondano has played a critical role in supporting the development, commercialization and post-approval life-cycle management of a variety of medical devices and cell therapy products. She successfully led the approval effort for Genzyme's breakthrough regenerative cell/tissue therapies for cartilage repair and severe burn care. She was also instrumental in securing orphan drug approval for the treatment of non-Hodgkin's lymphoma and multiple myeloma, as well as implants for cardiovascular disease.

HART's CEO Jim McGorry commented, "HART's new 'Cellframe' technology has been developed under the leadership of our Chief Medical Officer, Dr. Saverio La Francesca, since his arrival at the Company in 2014, and is fundamentally different from our previous product approach. Laura will be building on the body of data developed on our 'Cellframe' technology in leading our IND submission in 2016. She is a proven regulatory affairs expert in the field of combination cell therapy products. Laura has hit the ground running and already is integrated with our cell biology and materials science teams. We now have all the key resources in place for our submission of an IND in 2016."

Ms. Mondano stated, "I am very excited to join HART at this time.  The company's science-based product development efforts over the past 22 months have built a solid body of data supporting the new product technology.  I look forward to working as part of the HART team to advance our first product candidate to an IND submission with the FDA later this year."

Ms. Mondano is Regulatory Affairs Certified (RAC). She earned her B.S. degree in medical technology from the University of New Hampshire and attended the University of Massachusetts, Lowell for additional studies in mechanical engineering technology.

About HART: (www.hartregen.com)

Harvard Apparatus Regenerative Technology (HART) is developing bioengineered organ implants utilizing the recipient's own stem cells to treat life-threatening conditions. HART has developed and begun testing a new technology platform to create organ implants to replace diseased or damaged portions of the esophagus, trachea or bronchus to restore function.

HART's new "Cellframe" technology platform utilizes new scaffold materials and design, a different type and concentration of the patient's own cells certain other improvements to address the needs of affected patients . This new platform is currently being tested and developed further in a large-animal collaborative study with Mayo Clinic. HART is working to refine its new platform and to develop compelling data to pursue its goals of filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in late 2016 to initiate clinical trials for one of its three product candidates and compassionate use implantation surgeries.

Investor Relations Contact:

Tom McNaughton
Chief Financial Officer
774-233-7321

Or

Catalyst Global LLC
David Collins, Bill Jones, Helen Sun
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SOURCE Harvard Apparatus Regenerative Technology, Inc.



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