Canadian medical device company Spiderwort’s Spinal Cord Scaffold Implant, CelluBridge, has received Breakthrough Device designation from the Food and Drug Administration (FDA).
The FDA Breakthrough Devices programme helps innovators launch their medical devices in the market faster.
Designated for new devices, the programme helps patients receive effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions, sooner.
The designation aids in expediting device development, assessment, and review without compromising on the statutory standards, consistent with the FDA’s mission to protect and promote public health.
Spiderwort CEO and co-founder Charles Cuerrier said: “While this designation is a great achievement for our team and a validation of our technology, I am most excited for the patients whose lives we will be able to change with our biomaterial.
“This designation will enable us to efficiently interact with the FDA to increase the speed, at which we will initiate our clinical trials.”
Spiderwort’s biomaterial uses a plant-based cellulose scaffolding to generate a framework that aids in healthy tissue regeneration.
The biomaterial has microchannels, which guide regenerating neurons through damaged regions of the spinal cord after a traumatic injury.
Preclinical studies have shown that this method can potentially restore motor function.
To fund its work towards clinical trials to bring the biomaterial to market, Spiderwort received $2.5m in a Series Seed financing round led by Horizons Ventures in May.
Moving closer to clinical testing, the company is planning for a Series A financing round next year.
Spiderwort also plans to work at some other applications for the technology, including soft tissue replacement or reconstruction.