Last week spinal cord injury (SCI) device specialist InVivo Therapeutics Holdings Corp. gained FDA approval for use of its biopolymer scaffold technology in humans. Now it has announced the granting of an Investigational Device Exemption (IDE) which will allow the company to begin human studies.
Founded in 2005, InVivo Therapeutics Holdings Corp. uses polymers as a platform technology to develop treatments to improve function in individuals paralyzed from traumatic spinal cord injuries. In 2011, the company earned the prestigious David F. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine.
The IDE approval comes on the back of Humanitarian Use Device (HUD) approval, this designation being reserved for devices designed to treat rare diseases or conditions. InVivo received this designation for the treatment of recent complete spinal cord injury (no motor or sensory function) that does not involve penetrating injury or complete severing of the spinal cord. The HUD designation and clinical trial data are required to support a Humanitarian Device Exemption (HDE) application to the FDA with the goal of commercializing the scaffold in the United States sooner than a Pre-Market (PMA) approval would allow.
There are currently no treatment options approved by the FDA, or in clinical trials, to intervene directly in the spinal cord following SCI, making this approval of a first-in-man study a step forward. InVivo intends to commence its clinical study in the next few months, aiming to test safety and performance of its biopolymer scaffold in five patients. The trial will be conducted at multiple U.S. hospitals and is expected to occur over approximately 15 months.
“It’s heartbreaking for all of us for it to take even a minute longer than necessary to begin human studies, and we’ve all heard of, or experienced, treatments that have proven to be unsafe, but when conducting a first-in-man study, it is imperative to take the time to get it right, because any mistakes can lead to years of lost time for the scientists and patients that follow,” said Frank Reynolds, InVivo Chief Executive Officer.
“Everyone knows my obsession with safe FDA studies. Over the next month or so, we plan to finalize the details of our study, and we expect to have all data to the FDA by the end of 2014. We will be conducting an open label study, and so we look forward to keeping the public aware of its progress. As a historical first-in-man study, this trial marks the next phase in our corporate growth and begins our mission to maintain a collaborative relationship with the FDA. We’ve built a framework to optimize speed-to-market for our pipeline of technologies, and we’ll be working to commercialize over fifteen products in the next five years while remaining focused on mitigating patient risk and maximizing patient safety and benefit.”
Source: InVivo Therapeutics Holdings Corp., Business Wire