InCytu’s Betting that On-the-Spot Body Repair Will Succeed Where Traditional Tissue Engineering Has Not

With its aim of growing replacements for injured or ailing body parts, tissue engineering is a field that at first seemed spectacularly promising. (Anyone remember the mouse with a human ear growing on its back?) But it has ended up being a bit of a boondoggle. Although researchers have made important scientific advances in areas such as skin and bladder repair, overall too few projects panned out. What’s more, the business model for tissue engineering is awkward because, in most cases, donor cells must be harvested from each individual patient. These and other challenges have sent most investors scurrying away from the field.

Lincoln, RI-based InCytu is a brand new player in the tissue engineering arena with high hopes of reversing that trend, drawing on new technology from Harvard bioengineer David Mooney’s lab. InCytu is developing a suite of “smart” materials that help the body grow new tissues and repair itself—using its own stem cells right in the body—rather than requiring that cells be harvested, treated in a lab, and then returned to the patient. InCytu won’t try at first to rebuild very complex organs or structures, however. The company’s initial aim is to create simpler products such as dressings that can coax new blood vessels to grow into skin badly damaged by diabetes and injectable gels to help repair hernias and perhaps even shrapnel or bullet wounds.

Founded in April 2007, InCytu is now part way through a Series A funding round, which is expected to close this summer. CEO Alfred Vasconcellos says he’s not ready to reveal the initial backers or how much funding the company has, but he and Mooney were brought together by Venzyme Venture Catalyst, a matchmaker for new technologies and management teams. Venzyme’s managing director, Richard Berenson, is a co-founder of InCytu, along with Vasconcellos and Mooney.

The startup already has about 20 staff on board, and it plans to hire another 23 people by the end of 2008. And those new hires will be busy; InCytu hopes to have at least one product in human studies within 18 to 24 months, and something approved by 2011.

InCytu’s technology stems from Mooney’s work on the interaction between materials and living cells, particularly stem cells—undifferentiated cells able to develop into a variety of tissues. Hoping to boost the body’s own healing process into hyperdrive, Mooney developed materials embedded with biomolecules that “talk” to cells, coaxing them toward one particular fate or another.

InCytu uses these materials to build what it calls “Cellariums”—implants, dressings, gels, and other devices that function as solariums for cells, providing each type of cell with what it needs to grow, thrive, and replicate. As Vasconcellos explains, “they hold onto the cells, amplify their numbers, amplify their functionality, and then release them in an organized pre-programmed manner.” By customizing the mix of materials and biomolecules in each type of device, InCytu hopes to be able to grow or repair blood vessels, brain tissue, tendons, spinal cords, and more. The target market numbers in the business plan are whoppers, of course, with several offering blockbuster potential.

But what makes Vasconcellos think his team can succeed in a field where so many others have failed? For one thing, the technology, part of a whole new field referred to as “bioactive medical devices,” avoids the problem of how to get the engineered tissues or organs to reintegrate with the body properly. With Mooney’s approach, the new tissue is being engineered right at the point of damage or disease, rather than in a lab—there’s no need for any re-implantation procedure.

In addition, Vasconcellos says, InCytu won’t be caught up in a service model, where it has to grow cells or tissues for each new patient. The company will be mainly selling devices, including gels and dressings, that can be stored at room temperature and transported easily. The manufacturing process is also straightforward. “We can make large batches easily,” he says.

Finally, Vasconcellos thinks his experience with another former Rhode Island startup, Cytotherapeutics (now Stem Cells Inc.), will be invaluable. “I firmly believe cells will revolutionize medicine,” he says. (InCytu is Vasconcellos’s sixth startup overall.) Another alumnus of Cytotherapeutics, Dwaine Emerich, will be on InCytu’s scientific advisory board with Mooney.

Based on my recent conversation with Harvard Stem Cell Institute’s Brock Reeve, InCytu is just one of several new companies that isn’t looking to sell cells per se, but rather is developing products that encourage certain behaviors from the body’s own cells. Another player in this game is the high-profile Seattle startup Fate Therapeutics. Vasconcellos says InCytu is not in direct competition with Fate, though. Rather, he says, “we think we can help each other.”

And with any luck, the combination of new technology and simpler business models will help investors warm back up to tissue engineering.