Richmond biotech Cellf Bio LLC is set to begin human trials on an innovative fecal incontinence product after gaining clearance from the Food and Drug Administration.
Founder Dr. Khalil Bitar is a gastrointestinal researcher who conducted the majority of his work at the University of Michigan. Dr. Jaime Bohl, chief of colon and rectal surgery at the Virginia Commonwealth University School of Medicine, connected with Bitar and began working to develop its BioSphincter Implant product. That led Bitar to relocate to the VA Bio+Tech Park in Richmond last year and found the company.
The company helps people who do not have a strong sphincter muscle. The product cultures cells within the patient’s body and implants them back into the colon. Cellf Bio COO Rayana Marker said about 30% of patients do not receive much help through today’s standard of care and can benefit from the company’s treatment.
She said the early research on the product has been positive, and the company is partnering with VCU surgeons to test the product on humans.
“We are enrolling our first patient right now,” Marker said. “We are taking patients who will come to VCU.”
The process of getting the product to market will be complicated. Marker expects a six-year timeline to approval if trials are successful.
“This will have a pretty long regulatory pathway because it’s pretty cutting edge,” Marker said.
Up until now, the research has been funded through grants from the National Institutes of Health. The company also received a Small Business Innovation Research grant from the Small Business Administration for the phase 1 clinical trials. Marker said Cellf Bio is looking to also raise private funds for clinical trials, but did not divulge how much money the company is seeking.
Cellf Bio has just four employees. Marker said the company’s lab space at the Bio+Tech Park has been a good fit. It gives the company access to surgeons at VCU and the lab has the types of cleanroom facilities necessary for human trials.
“For a small company, where you can’t put out the kind of capital to build your own facility, this fits for us,” Marker said.
Marker said one in 12 people suffer from incontinence and the problem increases with age. The company estimates a $2 billion market exists for its product.
“Our early trials show that it works every time,” Marker said.