San Antonio — [Corrected 4:05 p.m. See below.] For a few hours this week, the country was focused on a pair of infant twins in the South Texas town of Corpus Christi, who were conjoined below the waist. Surgeons at Driscoll Children’s Hospital successfully separated the 10-month old babies, Ximena and Scarlett Hernandez-Torres, after 12 hours of surgery on April 12.
Part of the successful operation can be traced to San Antonio. CellRight Technologies, a maker of cadaver-derived bone and tissue grafts, had some of its dermal graft flown to the hospital when surgeons realized they might need more skin to complete the operation.
In the end, some of CellRight’s Matrix IQ Dermis product was used on the twins to help repair their (now separate) abdominal walls, says CellRight CEO Jesus Hernandez. The company’s product is derived from human skin, which is put through a sterilization process that CellRight calls BioRinse, making it so the recipient’s body doesn’t reject the tissue, Hernandez says. [Updated to reflect correct spelling of product name and the placement of dermis on the abdominal wall, not skin.]
“The way we decellularize our product, we remove the DNA and the cells, so your body doesn’t recognize it (preventing rejection),” Hernandez says. [Wording changed to clarify how process prevents rejection.]
Founded in 2012, CellRight first developed a scaffold product for repairing bones. CellRight has a method of processing human bone—which comes from donated cadavers—so that it can be sterilized, without it losing a type of protein that Hernandez says is thought to help in bone grafting: bone morphogenetic proteins.
If CellRight’s scaffold, called the Matrix OI, is mixed with a patient’s stem cells—done by either soaking the scaffold in a patient’s blood or by removing cells from bone marrow—Hernandez says the proteins will stimulate the cells, spurring bone growth.
The company is certainly in a competitive market, with countless tissue and bone grafting technologies swarming the market. That includes Durham, NC-based Bioventus and its FDA-approved scaffold Silhouette, as well as Medtronic’s more controversial Infuse Bone Graft. Even something as simple as a ceramic scaffold, or as complicated as a titanium implant like that made by Mequon, WI-based Titan Spine, competes with CellRight.
It is possible for a company like CellRight to seek approval for its products as 510(k) medical devices. Hernandez says CellRight has avoided that, however, fearing the cost and that the high level of disclosure could allow competitors insight into its work. Currently, the company is registered as a tissue bank. It has registered its products with the FDA as minimally manipulated products, Hernandez says. [Corrected to reflect name of FDA registration process and updated with additional comment from Hernandez.]
Though that may limit its scalability, Hernandez is hopeful that a larger acquirer will see the potential in the tools. Even though CellRight products are not regulated as 510(k) medical devices, he says each time CellRight creates a batch of products, they are tested by two separate and independent labs to ensure safety and that the stem cells will have an environment to proliferate. [Wording changed to clarify CellRight’s position with medical device clearance, and wording added about stem cell environment.]
The ability to help in the separation of the conjoined twins (who were actually part of a rare type of triplets) makes doing business worth it, Hernandez says.
“It’s why we do what we do,” he says.