An Ottawa biotech firm is hoping that special status from U.S. health regulators will speed up its bid to gain approval for its revolutionary “biohacking” technology.
Spiderwort, which is developing a process of regrowing body parts such as spinal cord tissue using plant-based materials, said this week its CelluBridge spinal cord implant has been designated a “breakthrough device” by the U.S. Food and Drug Administration.
The Breakthrough Devices program targets equipment or technology that offers more effective treatments and diagnosis for patients with life-threatening or debilitating conditions. It aims to speed up the FDA’s assessment and review process in a bid to fast-track approvals and get products to market quicker.
“This designation will enable us to efficiently interact with the FDA in order to increase the speed at which we will initiate our clinical trials,” Spiderwort CEO Dr. Charles Cuerrier said in a statement.
The company has its roots in Dr. Andrew Pelling’s lab at the University of Ottawa, where students experiment in “biohacking.” Earlier this year, it landed US$2.5 million in seed funding from a group of local and international investors and expects to raise a series-A round in 2021 as it moves closer to clinical testing.
Spiderwort, which moved most of its staff to a state-of-the-art research facility and business accelerator at La Cité last year, has attracted major attention with its groundbreaking scientific efforts. Assent Compliance CEO Andrew Waitman, another early investor in the startup, called Spiderwort’s approach to regrowing limbs “life-changing.”
Cuerrier said earlier this year the 10-person company has no definitive timeline for when it hopes to start clinical trials on humans. He said the startup is still years away from gaining regulatory approval that will allow the treatments to go to market.
Life sciences companies generally must raise significant funding to finance the years of clinical trials needed to certify technologies and processes as safe for commercial use in the tightly regulated health-care field. Ottawa-based cancer-fighting startup Turnstone Biologics, for example, has raised more than $50 million in recent years to sustain its operations.
Cuerrier told Techopia last year the company got its initial runway through government grants and support from uOttawa and Invest Ottawa.