In conversation with Praxis SCI Incubate cohort member Spiderwort

Spiderwort CEO & Co-Founder Dr. Charles M. Cuerrier and Business Development Director Dr. Stephen Hanson, MBA, on their cellulose scaffolding that promotes regeneration after SCI.

 

What led you here in terms of education, experience, and people you met along the way?

Charles M. Cuerrier: I always sensed I would create my own business. I come from an entrepreneurial family. My great-grandparents owned a hotel, my grandparents owned a grocery store, and my father is also an entrepreneur. I was the outsider, pursuing sciences and a doctorate in pharmacology, but the entrepreneurship root is in my genes.

During my postdoc at the University of Ottawa, Andrew Pelling, Daniel Modulevsky and I were working on a new strategy to regenerate tissues using cellulose extracted from plants. We were trying different things to see how structures were organized, and we had good results using cell cultures. Then we started animal studies and saw how well our biomaterial integrated into the body. We knew we had something important on our hands. We showed the results to pathologists – people trained to analyse this type of data – who confirmed we were working on something amazing that could change the regenerative medicine sector and create a new tool in the surgeon’s toolbox.

At that point, I knew I could not let someone else bring this technology to the clinic. I had to lead that process. We obtained a patent with the University of Ottawa and, in 2015, we pushed this innovation into a company called Spiderwort.

Stephen Hanson: My passion for business began while pursuing my PhD in Medical Sciences at McMaster University. I became involved with several businesses at the university, and realized combining science and business as a career made sense. There are a limited number of people that understand both, and I could be a conduit to move innovation from the lab into the market.

I pursued an MBA with a focus on commercializing biotechnology. While completing an internship at the Technology Transfer Office at the University of Ottawa in 2016, I met Charles and learned about Spiderwort’s great potential. I knew I wanted to be part of it and officially joined the team three and a half years ago.

I am proud of the important financing, technology and regulatory milestones we have achieved. The start-up stage for any business is hard work, and Spiderwort is no exception. A large focus has been raising money. In 2018 we had a Friends and Family funding round that raised $500,000 CAD. In October 2019, we closed a Series Seed round of financing with $2.5 million USD. Now we are aiming to raise $15 million. We need that much money because clinical studies cost millions of dollars per trial. Despite the hard work, the start-up stage has also been extremely rewarding and motivating, and we are surrounded by amazing people.

CelluBridge™ provides the scaffolding that works with the body’s own cells to provide a framework for the functional growth and regeneration of neurons.

 

Tell me about your customers and potential customers?

Charles: Our initial target customers are those classified under the American Spinal Injury Association Impairment Scale as Grade A, which means complete sensory or motor function loss below the level of injury, and we are specifically focusing on their acute phase of treatment. Grade A injuries represent roughly a third of the 19,000 new spinal cord injury (SCI) cases in the United States and Canada each year. Eventually, we hope to expand to those with incomplete injuries – classified as Grade B and C – as well as into the chronic phase of SCI treatment.

Stephen: We are working to bring this solution to customers as soon as possible. Realistically, it will take some time to get there. We are currently undertaking preclinical animal studies. In 2019, we received a “Breakthrough Device Designation” from the FDA, which accelerated our pace to move into clinical trials. That being said, the R&D to develop technology like this is very complex. The biomaterial is long-lasting technology that is actually implanted into patients. We need to have the right results in place to show it is safe.

Spiderwort’s spinal cord scaffold implant, CelluBridge™, has been designated by the FDA as a Breakthrough Device.

What specific solution/technology is your company providing, and how are you validating this?

Charles: Our technology promotes the repair and regeneration of neural circuits within the spinal cord to bring about incremental improvements. This could mean regaining motor control or regaining feel and touch, bladder control and sexual function. Our lead product – CelluBridge^TM – is a cellulose scaffold that is implanted in a patient’s spinal cord within 96 hours after injury. This array of microchannels, or small tubes, guide the regenerating neurons to repair the injury.

We are focusing on the acute phase because of our current understanding about how to help the body, in those early hours, use its own healing mechanisms to regenerate tissue. During the acute phase, the healing process is already activated. The chronic phase, on the other hand, involves different surgeries and protocols.

Some of the challenges we need to overcome include quality control and manufacturing. CelluBridge^TM is being evaluated as a medical device by the FDA and Health Canada. As Stephen mentioned earlier, this is a long, complex process involving substantial preclinical testing. We need to know in advance what the regulator bodies will request from us, and it is a challenge to be aware of all those small things. These regulations of course are important to be sure our product is safe.

Stephen: Patient recruitment is another big challenge. Because the scaffold is implanted in the first 96 hours, we need to be ready to recruit patients as soon as they arrive at the hospital. We are setting up across North America so we can enroll patients from a large range of trauma and rehabilitation centres. This may include the Rick Hansen SCI Registry (RHSCIR) sites across Canada, as well as sites in the United States.

What differentiates your company from the competition, and who are you looking for in terms of partnerships?

Charles: The key difference between our scaffold and those being developed by competitors is our technology is made of non-resorbable material. This allows the material to integrate with the body’s own cells and become a living part of a patient for long-lasting support as the axons regenerate.

Stephen: We are now in the process of seeking a range of top-tier partners, including clinician-researchers, contract research organizations and other service providers. We are also looking for investors who have experience in the medical device space and can help bring our technology to the clinic. Companies developing pharmacological agents or stem cells to reverse the effects of SCI may also be potential partners if their strategies complement Spiderwort’s approach.

 

What do you hope to get out of SCI Incubate?

Charles: The direct interaction with people with lived experience of a spinal cord injury is critical.

We believe strongly in having representation from individuals with lived experience during the development process. They live with the consequences of this type of injury every day. They need to be part of the process so our solution is meaningful to them. That is one of the main reasons we wanted to be part of SCI Incubate – to have broader exposure to this community.

Stephen: Absolutely. We are excited to work directly with people who live with an SCI. We believe we have a solution that will bring meaningful improvements to their lives – that will, in fact, greatly enhance their lives.

 

Learn more about the Praxis SCI Incubate Program.