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For tissue repair, surgeons are currently limited to mechanical solutions like sutures and staples, which can cause their own damage, or meshes and glues that may not adequately bond with tissues and can be rejected by the body.
Medical startup Tissium now offers surgeons a new solution based on a biopolymer technology first developed at MIT. The company’s flexible, biocompatible polymers conform to surrounding tissues and, activated by blue light attach to repair torn tissue.
“Our goal is to make this technology the new standard in fixation,” says Tissium co-founder Maria Pereira, who began working with polymers as a Ph.D. student through the MIT Portugal Program. “Surgeons have been using sutures, staples, or tacks for decades or centuries, and they’re quite penetrating. We’re trying to help surgeons repair tissues in a less traumatic way.”
In June, Tissium reached a major milestone when it received marketing authorization from the U.S. Food and Drug Administration (FDA) for its non-traumatic solution to repair peripheral nerves. The FDA’s De Novo marketing authorization acknowledges the novelty of the company’s platform and enables commercialization of the MIT spinout’s first product. It came after studies showing the platform helped patients regain full flexion and extension of their injured fingers or toes without pain.
Tissium’s polymers can work with a range of tissue types, from nerves to cardiovascular, and the abdominal walls. The company intends to apply its programmable platform to other areas.
“We really think this approval is just the beginning,” Tissium CEO Christophe Bancel says. “It was a critical step, and it wasn’t easy, but we knew if we could get the first one, it would begin a new phase for the company. Now it’s our responsibility to show this works with other applications and can benefit more patients.”
Referencing it as a collaborative project, Pereira said, “The MIT and Harvard ecosystems are at the core of our success. From the get-go, we tried to solve problems that would be meaningful for patients. We weren’t just doing research for the sake of doing research. We started in the cardiovascular space, but we quickly realized we wanted to create new standards for tissue repair and tissue fixation.”
After licensing the technology, Tissium had a lot of work to do to make it scalable commercially. The founders partnered with companies that specialize in synthesizing polymers and created a method to 3D print a casing for polymer-wrapped nerves.
“We quickly realized the product is a combination of the polymer and the accessories,” Bancel says. “It was about how surgeons used the product. We had to design the right accessories for the right procedures.”
Recent data on meta-analysis of nerve repairs using sutures found that only 54 percent of patients achieved highly meaningful recovery following surgery. By not using sutures, Tissium’s flexible polymer technology offers an atraumatic way to reconnect nerves. In a recent trial of 12 patients, all patients that completed follow up regained full flexion and extension of their injured digits and reported no pain 12 months after surgery.
Tissium now has six products in development, including one ongoing clinical trial in the hernia space and another set to begin soon for a cardiovascular application. The company also believes its 3D-printed production process will make it easier to expand.