January 15, 2016

HART and Mayo Clinic Collaborate on Regenerated Trachea, Esophagus and Heart Valve

By lmulvihill
Press Release: Wed Jan 7, 2015 

Collaboration Aims to Bring These Solutions to Patients at Mayo Clinic and Worldwide

Harvard Apparatus Regenerative Technology, Inc., (NASDAQ: HART), or HART, has signed a joint development agreement with Mayo Clinic with the intent of developing and improving regenerative medicine treatments for severe diseases.

David Green, CEO of HART, stated “This new collaboration is an important development for our company. It indicates significant progress in HART’s strategy of moving forward with major American and European medical institutions to bring new products to the clinic. We are very excited to expand our relationship with Mayo Clinic, one of the world’s great medical institutions, and to work with them on co-developing regenerative medicine solutions for the trachea, esophagus and heart valve and bringing those solutions to patients at Mayo Clinic and worldwide.”

Dennis Wigle, M.D., Ph.D., thoracic surgery, Mayo Clinic, stated, “Regenerative medicine is a focus area for Mayo Clinic and will be a vital component of medical and surgical practice in the coming years. Through regenerative medicine, it is possible to actually heal diseased, injured or congenitally defective tissues and organs that today are beyond repair.” Mayo Clinic and HART have collaborated for the past two years in Mayo Clinic’s program to develop a synthetic human heart valve. The relationship has grown between the two groups and this collaboration is designed to foster work on additional organs such as the airway and the esophagus. Patented inventions made during the course of the collaboration may be licensed by HART and HART will pay royalties to Mayo Clinic.

Dr. Wigle added, “This relationship is important because the new directions for medicine are so complex that they require cross-collaboration to bring the benefits to patients. HART brings a unique set of skills in physiology, scaffolding and bioreactors as well as translation from invention to clinical use that we find extremely valuable in moving our regenerative medicine program forward.”

By working together, HART and Mayo Clinic intend to turn promising laboratory discoveries into proven treatments and make them available to patients. HART’s expertise in the design and construction of regenerative medicine-related devices will be coupled with Mayo’s expertise in regenerative medicine.

About Harvard Apparatus Regenerative Technology

Harvard Apparatus Regenerative Technology makes regenerated organs for transplant. Our first product, the HART-Trachea, is intended to replace or repair a trachea that has been severely damaged by either trachea cancer or physical trauma. Our HART-Trachea product has been used in six human trachea transplants to date approved under compassionate use exemptions, but none of our products are yet approved by a government regulatory authority for marketing. The trademark “Harvard Apparatus” is used under a sublicense agreement with Harvard Bioscience, Inc., which has licensed the right to use such trademark from Harvard University.

Forward-Looking Statements

Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements in this press release include, but are not limited to, statements relating to the success with respect to any collaborations and related development efforts pertaining to regenerated tracheas, esophagi and heart valves and related intellectual property; and clinical trials and other regulatory approval efforts, commercialization efforts and marketing approvals of HART’s products as well as the success thereof, including our HART-Trachea product and any other HART products, which such success or approvals may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, factors described under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2013 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. HART expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

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