CAMBRIDGE,
Mass.–(BUSINESS WIRE)–InVivo Therapeutics
Holdings Corp., a developer of groundbreaking technologies for the treatment of
spinal cord injuries (SCI), announced today that it held a meeting with the
U.S. Food and Drug Administration (“FDA”) in which they discussed the
Investigational Device Exemption (“IDE”) application previously filed by InVivo
for its biopolymer scaffolding to treat acute spinal cord injuries.
Following the meeting, the Company is expecting the
biopolymer scaffolding device to be regulated under the Humanitarian Use
Device/Humanitarian Device Exemption (HUD/HDE) pathway. Before human clinical
studies can commence, the FDA must approve the Company’s IDE filing, for which
the FDA has agreed to an open dialogue as part of the final process toward
gaining approval. During the FDA meeting, the Company addressed several points
in the FDA’s feedback including the proposed design and clinical protocol for
the study.
“This is a significant step for all patients waiting for
first in-man data using biomaterials for spinal cord injuries,” said Frank
Reynolds, InVivo’s Chief Executive Officer. “We are pleased that our core team
of multidisciplinary scientists, led by my partner, Bob Langer, has had the
opportunity to meet with the FDA to discuss our platform technology. We are
encouraged by the communication we have had with the FDA to this point, and
pending approval of the IDE, we expect the clinical trial for our treatment of
acute spinal cord injuries to commence during the second half of 2012.”
Later in 2012, the Company plans to submit hydrogel-based
applications to the FDA for the treatments of SCI and chronic pain. As the
industry of cell-based therapies advances, InVivo also intends to leverage the
Company’s acute SCI treatments to expand to chronically injured patients.
InVivo has pioneered a new treatment that uses a biocompatible polymer-based
scaffolding to provide structural support to a damaged spinal cord in order to
spare tissue from scarring while improving recovering and prognosis after a
traumatic SCI. Today, there is no effective treatment for the spinal cord for
paralysis caused by SCIs, and the market potential for acute SCI is estimated
to be over $10 billion.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is focused on utilizing polymers as a
platform technology to develop treatments to improve function in individuals
paralyzed as a result of traumatic spinal cord injury. The Company was founded
in 2005 on the basis of proprietary technology co-invented by Robert Langer,
ScD., Professor at Massachusetts Institute of Technology, and Joseph P.
Vacanti, M.D., who is affiliated with Massachusetts General Hospital.
In 2011, data from a Company study was published in the Journal of Neuroscience
Methods and won the prestigious 2011 Apple Award from the American Spinal
Injury Association recognizing excellence in SCI research. The publicly traded
company is headquartered in Cambridge,
MA. For more details, visit www.invivotherapeutics.com
