InVivo Therapeutics Corporation Announces Froedtert & The Medical College of Wisconsin As New Clinical Trial Site For Neuro-Spinal Scaffold
CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that Froedtert & the Medical College of Wisconsin (MCW) Froedtert Hospital in Milwaukee, WI has been added as a clinical site in the company’s ongoing IDE pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). Froedtert Hospital houses the only adult Level 1 trauma center in eastern Wisconsin and receives referred spinal cord injury patients from Wisconsin, northern Illinois, and northern Michigan. Shekar Kurpad, MD, PhD, professor of neurosurgery at MCW and director of the Spinal Cord Injury Center and Spine Surgery Fellowship at Froedtert Hospital, has been named Principal Investigator at the site.
“We are very excited to be a participant in this innovative and important, first-of-its-kind study”
“We are very excited to be a participant in this innovative and important, first-of-its-kind study,” Dr. Kurpad said.
On January 22, 2015, InVivo announced enrollment of its second patient in the study at its clinical site, Carolinas Medical Center in Charlotte, NC. InVivo’s first patient was enrolled in October 2014 at the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, AZ.
Mark Perrin, InVivo’s CEO, said, “We’re very pleased to have Dr. Kurpad and MCW join our pilot study. Dr. Kurpad has extensive experience in spinal cord injury research and was the recipient of the prestigious Van Wagenen fellowship from the American Association of Neurological Surgeons. We now have seven sites that will be ready to enroll patients once we re-open enrollment.”
This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The IDE pilot study has been approved by the U.S. Food and Drug Administration (FDA) and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).
For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
About the Neuro-Spinal Scaffold
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and acts as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device designation and is currently being studied in a pilot study for the treatment of complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a pioneering biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, MD, who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011 the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "believe," "anticipate," "intend," "estimate," "will," "may," "should," "expect" and similar expressions, and include statements regarding the enrollment of additional patients in the scaffold pilot study following the reopening of enrollment and its ability to conduct a second pivotal study. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the Company’s ability to obtain FDA approval to commercialize its products; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013, as amended, and its other filings with the SEC, including the Company’s Form 10-Qs and current reports on Form 8-K. The Company does not undertake to update these forward-looking statements.
InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535