Ventris Medical received 510(k) clearance for its bone graft containment technology for use in spinal fusion procedures.
The Newport Beach company, specializing in orthobiologics and tissue regeneration, has developed what it has dubbed the Backpack Porous Biologic Scaffold.
Ventris Medical’s Backpack is a collagen mesh pouch filled with biomaterials that promote bone regeneration and healing.
The Food and Drug Administration clearance comes five years after the company first started developing the product.
“We have a broad line of offerings, but this one will be our new signature,” Chief Executive Russell Cook told the Business Journal.
“Backpack has a lot of room for expansion, so we have other client extension that we can create off of this.”
The company currently offers two versions of the product, the Backpack AF and the Backpack AMP.
Ventris Medical expects to begin commercialization in April or May of this year.
Damaged Shock Absorbers
Vertebrae are the bones making up a person’s spinal column.
In between these bones are discs that act as shock absorbers, Cook said.
“What happens to people that need spinal procedures is that disc becomes compromised,” he said.
When the disc is damaged, it feeds on the nerves of each segment of the spine, causing pain in the legs, arms and hands.
A spinal fusion procedure fuses vertebrae together by putting a spacer where the damaged disc used to be, then locks it in place with rods and screws.
To do this procedure, a patient’s own bone, which there’s often not enough of, requires a bone graft, according to Cook.
“The bone graft that we provide helps that infusion process between those two vertebrae to fuse together and create a construct, so that survives for the rest of the patient’s life,” Cook said.
Ventris Medical takes donated cadavers and encapsulates bone particles promoting regeneration into a bag to use in surgeries.
Backpack is touted as the first of its kind by the company, possessing an “anti-migration” feature preventing it from shifting position that’s not found in other bone graft containment technologies.
History of Selling Biologics Startups
Ventris Medical, founded in 2017, is headed by Cook who has more than 17 years of experience in developing companies focused on biologics.
Previous startups he founded include Summit Surgical and Radius Medical, which was acquired by San Diego-based medical device company NuVasive Inc. in 2007 for $16 million.
In 2015, Cook’s company Bioventus and its entire portfolio was acquired by BioStructures LLC, a developer of bone graft products for an undisclosed amount.
Ventris Medical offers other lines of allograft products for general surgery, plastic surgery and urologic and orthopedic procedures.
Cook said that the company generated $25 million in revenue for 2024 and has grown by 50% over the past two years.
“We want to continue to gain market share and offer products that not only help patients but makes the process easier for surgeons and be cost-effective for hospital facilities and the insurance companies that paid for it,” Cook said.
Ventris Medical is entirely self-funded by Cook. He said he has invested about $10 million in the company to date.
The company recently signed a six-year lease at its current address in Newport Beach and is expanding to house a larger controlled storage area and more personnel.
