Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine, announces that its "InBreath" bioreactor was used for the world's second successful transplantation of a synthetic tissue-engineered windpipe at the Karolinska University Hospital in Stockholm, Sweden. The patient, Mr. Christopher Lyles, is making a good recovery. This transplant follows the world's first synthetic trachea transplant in June 2011, for Mr. Andemariam Beyene, which was reported in a peer- reviewed article in The Lancet on November 24, 2011 at http://www.thelancet.com/. The tracheas in both procedures were grown in Harvard Bioscience's bioreactors that were produced in its regenerative medicine device business.
Mr. Lyles, a 30-year old U.S. citizen, had been suffering from late-stage tracheal cancer that would have been inoperable before this transplantation surgery became possible. He is recovering well, is not taking immunosuppressive drugs and is expected to be discharged from the hospital within a month. To view a news segment on Mr. Lyles prior to his trip to Sweden and learn about his story, visit: http://www.wbaltv.com/r/29778764/detail.html. To see pictures of the procedure that was used for Mr. Lyles' transplant, visit:http://www.digitalbucket.net/browse/d399e20e41851bf7/Lyles%2520Transplant%2520Static%2520Images and to view a short video of the procedure visit: http://vimeo.com/32527358. The password in both cases is stockholm11. Mr. Lyles progress can be followed at: www.facebook.com/regeneratelife.
The operation was performed on November 17, 2011 at Karolinska University Hospital in Stockholm, by Professor Paolo Macchiarini of Karolinska University Hospital and Karolinska Institutet, and colleagues. Professor Macchiarini led an international team including Nanofiber Solutions of Columbus, Ohio, who designed and built the nanofiber tracheal scaffold, and Harvard Bioscience, who produced a specifically designed bioreactor used to seed the scaffold with the patient's own stem cells. The cells were grown on the scaffold inside the bioreactor for two days before transplantation into the patient. Because the cells used to regenerate the trachea were the patient's own, there has been no rejection of the transplant, and the patient is not taking immunosuppressive drugs.
David Green, President of Harvard Bioscience, commented: "We would like to congratulate Dr. Macchiarini and his team for successfully completing the world's second synthetic trachea transplant. This proves that the procedure is not a 'one off' but can be repeated. This is a significant achievement for regenerative medicine, and we are honored to participate with the use of our 'InBreath' bioreactor. It is important to note that although this is the second successful trachea transplant, it is the first procedure on a U.S. patient and with a U.S.-made scaffold. This was made possible thanks to our collaboration with Nanofiber Solutions. With the success of these procedures, it is rewarding to see science fiction turned into medical reality, and we look forward to further progress in regenerative medicine."
Ross Kayuha, CEO of Nanofiber Solutions, commented: "We wish to congratulate Dr. Macchiarini and his surgical team. It is an honor to contribute to this life-saving procedure, and we wish Mr. Lyles good health and a long life. Successfully implanting a synthetic trachea using a patient's own stem cells is a significant milestone for regenerative medicine, and we look forward to participating in the space through our collaboration with Harvard Bioscience."
Harvard Bioscience Regenerative Medicine Strategy:
Harvard Bioscience's strategy in regenerative medicine is: to create devices, not discover pharmaceuticals, as this reduces risk compared to a therapeutics company; to build these devices using its existing technologies and brands, as this reduces the investment needed to get to market; and to develop devices with a significant disposable revenue stream, as this is both clinically desirable and allows Harvard Bioscience to participate on a per-procedure basis and not just on the sale of an instrument. The company estimates that the nascent market for regenerative medicine devices could potentially grow to hundreds of millions of dollars annually.
Harvard Bioscience's regenerative medicine tools can be found at: http://www.harvardbioscience.com/regenMed.cfm
Note that both Harvard Bioscience's and Nanofiber Solutions' regenerative medicine products are currently for research use only, and are not for use in humans unless proper local investigational device regulations have been followed.
About Harvard Bioscience
Harrvard Bioscience ("HBIO") is a global developer, manufacturer and marketer of a broad range of specialized products, primarily apparatus and scientific instruments, used to advance life science research and regenerative medicine. We sell our products to thousands of researchers in over 100 countries primarily through our 850 page catalog (and various other specialty catalogs), our website, through distributors, including GE Healthcare, Thermo Fisher Scientific and VWR, and via our field sales organization. HBIO has sales and manufacturing operations in the United States, the United Kingdom, Sweden, Germany and Spain with additional facilities in France and Canada. For more information, please visitwww.harvardbioscience.com.
The Harvard Bioscience, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6426
The statements made in this press release that are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You can identify these forward-looking statements by our use of such words as "will," "guidance," "objectives," "optimistic," "potential," "future," "expect," "plans," "estimates," "continue," "drive," "strategy," "crucial," "potential," "potentially," "growth," "long-term," "projects," "projected," "produce," "intends," "believes," "goals," "sees," "seek," "develop," "possible," "new," "enabling," "emerging," "opportunity," "pursue" and similar expressions that do not relate to historical matters. Forward-looking statements in this press release may include, but are not limited to, statements or inferences about the HBIO's or management's beliefs or expectations, the field of regenerative medicine, opportunities or potential opportunities in the field of regenerative medicine, HBIO's business strategy, the positioning of HBIO for growth, the market demand and opportunity for HBIO's current products or products it is developing or intends to develop, and HBIO's plans, objectives and intentions that are not historical facts.
These statements involve known and unknown risks, uncertainties and other factors that may cause HBIO's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Factors that may cause HBIO's actual results, performance or achievements to differ materially from those in the forward-looking statements include, but are not limited to, HBIO's failure to successfully expand its product offerings, introduce new products or commercialize new technologies, including in the field of regenerative medicine, decreased demand for the HBIO's products, including products in the field of regenerative medicine, due to changes in our customers' needs, our ability to obtain regulatory approvals, including FDA approval, for our products, including any products in the field of regenerative medicine, the current size or anticipated size of the regenerative medicine market, the existence and size of opportunities in the regenerative medicine market, our financial position, plus risk factors set forth under the heading "Item 1A. Risk Factors" in HBIO's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 or described in HBIO's other public filings. HBIO's results may also be affected by factors of which HBIO is not currently aware. HBIO may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the federal securities laws to update and disclose material developments related to previously disclosed information.
Harvard Bioscience, Inc.
David Green, President
Chane Graziano, CEO
Tom McNaughton, CFO
508 893 8999
Fax: 508 429 8478