WALTHAM, Mass., July 23, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, announced that Stephen Kennedy, Executive Vice President & Chief Operating Officer, has been appointed to the BioFabUSA Leadership Advisory Council and Technology Advisory Subcommittee (TASC) of the Advanced Regenerative Manufacturing Institute (ARMI).
ARMI is a new public-private Manufacturing USA initiative that brings together a consortium of nearly 100 organizations from industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cell and gene-based therapies.
“Innovation and the implementation of cutting-edge manufacturing process technologies has been a critical component of Histogenics’ development of NeoCart, and we know first-hand the importance of such technologies to realize the promise of restorative cell therapies,” said Mr. Kennedy. “I am pleased that ARMI has recognized Histogenics’ achievements in enabling this transformative therapeutic modality and grateful to have the opportunity to collaborate with other leaders in the cellular therapy field. The diverse backgrounds and perspectives of TASC’s members will help to ensure the development of manufacturing processes and technologies that support the clinical and commercial success of a broad array of cell therapies.”
Stephen Kennedy joined Histogenics in 2013 and has more than 30 years of experience in biological manufacturing and process development, including 18 years at Genzyme Corporation. He has also served as Executive Director of the Novartis/MIT Center for Continuous Manufacturing at the Massachusetts Institute of Technology. Stephen holds a B.S. from the University of Michigan, an M.S. from the University of Rochester and an M.B.A. from Boston University.
“We are delighted to have Steve Kennedy join the ARMI | BioFabUSA Leadership Advisory Council and Technology Advisory Subcommittee,” said inventor Dean Kamen, ARMI’s chairman. “His intelligence, experience and collaborative attitude are exactly what we need to bring engineers and scientists together to move this industry forward.”
About Advanced Regenerative Manufacturing Institute
The Advanced Regenerative Manufacturing Institute (ARMI), headquartered in Manchester, NH, is the 12th Manufacturing USA Institute. It brings together a consortium of nearly 100 partners from across industry, government, academia and the non-profit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs. ARMI will work to organize the current fragmented domestic capabilities in tissue Biofabrication technology to better position the U.S. relative to global competition. For more information on ARMI, please visit www.ARMIUSA.org.
About Histogenics Corporation
Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and may prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. Histogenics completed enrollment of its NeoCart Phase 3 clinical trial in the second quarter of 2017 and expects to report top-line, one-year superiority data in the third quarter of 2018. NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.
Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others, the timing and success of Histogenics’ NeoCart Phase 3 clinical trial and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov. Additional factors may be set forth in those sections of Histogenics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, to be filed with the SEC in the third quarter of 2018. In addition to the risks described above and in Histogenics’ Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.
There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
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