CAMBRIDGE, Mass. (AP) -- InVivo Therapeutics Holdings Corp. said Friday that the Food and Drug Administration will allow it to start human trials of an experimental product that is intended to treat spinal cord injuries.
InVivo said it plans to start a trial of the device, called a biopolymer scaffold product, in the next few months. The company wants to study the device in five patients and said the initial study will last about 15 months.
The Cambridge, Mass., company said there are no FDA-approved treatments that intervene directly in the spinal cord following an injury.
On Thursday the FDA awarded the scaffolding a humanitarian use device exemption. Given to products intended to treat conditions that affect fewer than 4,000 people a year, the exemption could speed up approval of a product and reduce the amount of testing a company has to do. InVivo is trying to get a second exemption, a humanitarian device exemption, which would allow it to get marketing clearance if the FDA agrees the product's probable benefits outweigh its risks and that it doesn't pose a significant risk of illness or injury. InVivo would not have to prove the scaffolding is effective, although it would still have to run clinical tests.
- Pharmaceuticals & Drug Trials
- Food and Drug Administration