When you’ve got osteoarthritis in your knee or hip, there’s a good chance you may have to get that joint replaced—a costly procedure often followed by a lengthy stretch of rehab. Short of that, you may get some drugs to deal with the pain, but they don’t tackle the real cause of the problem, that the cartilage that normally cushions your joints is either damaged or gone, or the bone itself is damaged.
Cork, Ireland-based SurgaColl Technologies, a small startup recently spun out of Dublin’s Royal College of Surgeons, aims to do just that. It’s developing an implantable product it claims can essentially coax the body into repairing those damaged joints or bones, and do so just as effectively—and more safely—than competing technologies, possibly delaying joint replacement surgery for years. Now it’s got to get the regulatory and commercial backing to prove it.
As a first step in that direction, SurgaColl has already filed an application for a CE mark, the regulatory nod for medical devices in Europe, for a product called HydroxyColl, a substitute for bone grafts, that would be used as a surgical implant to stimulate bone growth and repair a fracture. Should regulators approve the product, it’d be a move into the big leagues for SurgaColl, a transition from seedling academic spinout to actual commercial-stage company, where a whole host of new challenges will begin. As CEO John Gleeson says, the company aims to parlay its first regulatory approval into a full-fledged Series A round—something in the range of $5 million to $15 million. That would give SurgaColl the type of backing it’d need to manufacture HydroxyColl on a large scale, and start running trials on a second product for cartilage repair as well.
“The next 12 months are critically important,” says Fergal O’Brien, SurgaColl’s scientific founder, and the head of tissue engineering at the Royal College of Surgeons.
The journey won’t be without its share of challenges. Even if SurgaColl gets the CE mark, it’s got to begin to prove itself commercially and find the investors willing to bet it can succeed. Though the company will try to edge HydroxyColl into a $4 billion orthopedics market, for instance, that market is already flooded with a variety of bone graft substitutes. And startups with fresh ideas, like Redwood City, CA-based SMC Biotechnology, and Waltham, MA-based Histogenics (which recently filed to go public) are also developing new technologies for bone and cartilage repair.
SurgaColl, however, is betting that its core technology stands out. The company traces its roots back about 10 years, when O’Brien won a 1.1 million euro grant from Science Foundation Ireland to set up a lab for tissue engineering at RCSI. He and a team of researchers began working on engineering advanced biomaterials, trying to make ones that would help bones repair themselves.
O’Brien and his group came up with two technologies. The first, the basis of HydroxyColl, combines two main elements of bone—collagen (a protein) and hydroxyapatite (the hard mineral stuff in your bones). The materials are layered, one on top of another, to form a small, sponge-like scaffold that contains a number of tiny, specifically-sized holes that blood and cells pass through. A surgeon would insert that scaffold into the site of a bone injury. The collagen and hydroxyapatite are combined in such a way that the scaffold can soak up blood, attract bone marrow cells to the site, and essentially tell them to regenerate tissue and form bone.
“It’s biomimetic,” meaning it imitates the natural structure of the tissue, “but it’s also bioinstructive, as in, it directs cell differentiation,” O’Brien says of the technology. “It’s the composition, it’s the stiffness of the material, it’s the makeup of the material, it’s a combination of those factors which are directing those cells to become bone forming.”
That’s a different approach than the one Medtronic uses with its Infuse product, for instance. Infuse utilizes a genetically-engineered form of bone morphogenic protein-2 (BMP-2) to stimulate bone growth. It’s used in spinal surgery as an alternative to an autologous bone graft (when a surgeon uses bone from a patient’s hip, say, as a graft).
Approved by the FDA in 2002, Infuse has been dogged by safety and efficacy questions over the past few years—it’s been linked to a potential increased cancer risk, for instance—and has seen its market share dwindle. SurgaColl believes that presents … Next Page »