Winston-Salem | Dr. Khalil Bitar
They’ve been great to work with and they’re nice people too. John is always coming up with ideas for the next step.
ABOUT CELLF BIO This bioengineering startup, still in the research phase, is developing a cure for incontinence. Cellf Bio uses the patient’s own neuro-progenitor cells to grow a sphincter, which means virtually no risk of the body rejecting the new part. After 10 years, Dr. Khalil Bitar is embarking on the last stages of research and approval before their product goes to market. The sphincter is just the first in a line of products possible using this science.
HOW DID YOU COME UP WITH THIS IDEA? We had the idea over 10 years ago at the University of Michigan. I’ve been funded in neuro-gastroenterology since my thesis back in 1976. We were interested in the effects of aging on the intestine and colon and incontinence comes with that. I know there are more glamorous organs. We could bioengineer a heart, but you can already transplant a heart; there’s a solution for that. There’s no solution for incontinence besides adult diapers, and that’s not really a solution. And the need for a solution is huge, the market for adult diapers in the United States is actually larger than for young children. Someone once told me that it is the sphincter of civilization, and I think that’s true. It becomes a societal problem. Half of the people in nursing homes are there because of this issue.
HOW DOES IT WORK? Essentially, you take a biopsy from the gut of the patient and isolate smooth muscle cells and neural stem cells. Using those, we bioengineer the tissue construct. We do extensive quality control testing before surgically implanting it in the patient. Typically, the whole thing takes approximately six weeks. We have five animals that have recuperated their function nicely. The science is solid, we have the whole team set up and ready to go for the first procedure. I even have a list of people who have contacted me interested in being first.
WHAT HAS BEEN YOUR BIGGEST CHALLENGE? Funding, certainly. That’s why the SBIR and NIH grants are so important for people who need the capital but are years away from generating revenue. Helping with funding is where the SBTDC has been extremely helpful. The research is expensive, but there are still a lot of things not covered by the grants. So, we’re also looking for investors, but I would have to know their intentions. I take it to heart that this is first and foremost something that helps people.
WHAT HAS THE SBTDC BEEN ABLE TO HELP YOU WITH? They’ve been great. I met John and Chris at the start of the SBIR grant process and they helped fine tune my proposals. The first round, we received a very favorable review with the suggestion to try again. We did and we were funded. They were also completely committed to the NIH grant process and worked with me to establish Cellf Bio as a business, including hiring a COO. John was actually tracking down other clients to see how to make the process smoother. Without those grants, I don’t know where we would be today. They’ve been great to work with and they’re nice people too. John is always coming up with ideas for the next step.
WHAT DOES THE FUTURE LOOK LIKE FOR CELLF BIO? Right now we’re starting to think beyond the science. We have to come up with packaging for transportation and longer storage times in the event that the surgical implantation procedure is delayed. But we’re thinking long-term too. We have two other projects in the pipeline and plan to develop a whole line of products. The goal is to have a service line in every hospital, so patients can go in and have their biopsy and we’ll bioengineer their needed tissue. This is the future, using your own cells so there is no risk of rejection.
This story was originally published in the SBTDC 2015-2016 Annual Report. View the entire report here.
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The SBIR grant assistance is the most valuable thing the SBTDC has provided. Receiving the SBIR funding is what allowed us to move forward and we’ve actually been able to win three grants, although we had to turn one down. They have provided much needed advice on business development and we have also paired up with several student interns for marketing analysis.
The SBTDC takes the fear away. Now I look at my financials and I understand them. Similar to my kayaking analogy, I can now hit my roll and plot my downriver course with confidence. I’m by no means a pro, and I still have a lot of questions. But I’m in there every month, and I know where I’m going to be at the end of the year. We’ve already hit our projections for the end of 2016; our gross revenues are up 20%. And we’ve just added two new employees.