A Birmingham-based biotechnology company is using recent funding from Southern Research to pursue FDA approval for a wound-healing biologic therapy.
Southern Biologic Solutions (SBS) is one of eight companies that received a portion of the $2.5 million that Southern Research allocated from its Therapeutics Development Fund.
SBS, which has an office space in Southern Research’s Station 41 biotech incubator, will use the $200,000 in funding to meet the requirements for FDA approval of its anti-microbial biologic therapy.
Wound-focused SBS was born in 2020 out of Southern Medical Solutions, which is an orthopedic sports medicine company founded in 2008.
The therapy was developed for wound healing and the prevention of infection in human and animal wounds.
SBS cofounder Frank Tomlinson said obtaining FDA approval of the therapy will be easier if they can find a similar therapy to compare it to.
We are still finalizing our predicate device for 510(k), which means if there is a device out there that (has) very similar systems, the length of time it takes to get 510(k) approval is much less than if you don't have a predicate device because you have to prove all these things,” Tomlinson said. “We think we've found our predicate device, so all of the funding will go to FDA required testing.”
Part of this testing is purchasing and using genetically altered rats who are given an infection and then given the anti-microbial therapy to see if it cures the infection. Tomlinson said infection care is a financial drive in the health care system, creating a need for more infection-related therapies in the industry.
“Ultimately, the goal is to develop a product both for wound care and orthopedics to fight infection,” Tomlinson said. “We will continue to develop biologics in this space that push the envelope of how to treat infection.”
Tomlinson said Birmingham’s health care and biotech ecosystems provide great support for small companies like SBS.
“Birmingham has this long-standing health care success ... but if I hadn't been introduced to Josh Carpenter (CEO of Southern Research) through a third party, I would have never known who to go to,” he said. “I think the public understanding what's out there is important, but I also think having the resources at UAB, especially with this new acquisition of St. Vincent's, (means) UAB can be a tremendous backbone for all these biotech companies.”
Tomlinson is confident the new Station 41 incubator will support business growth and development in Birmingham.
“It's almost like, if you build it, they will come,” he said. “It's going to be really interesting to see how this incubator program within Southern Research ... is going to affect the development in the health care space here.”
