Recognizing an unmet need in the spine industry, Dallas-based Pinnacle Spine Group dove into the fusion space with a novel idea — delivering graft material directly to the implant in situ.
"We're innovating beyond the implant," says Zach Sowell, president of Pinnacle. "The implant, itself, is generally acting as a scaffolding."
Noticing incomplete grafting of the entire disc space and vertebral endplates during spinal fusions, Pinnacle patented its flagship product, a direct lateral fusion device with integrated graft delivery technology to rectify the issue.
"We were able to nearly double the amount of bone graft material than can be placed in a controlled manner in the disc space," Mr. Sowell explains. "We started the company…with the idea that we were going to bring something new to the fusion industry that hadn't been commercialized yet."
And Pinnacle did just that, now possessing several issued patents and pending patent applications, providing the company with exclusionary protection for in-situ delivery of graft material directly into spinal implants. In recent years, the company has seen increasing awareness and uptake of graft delivery technology, and has entered various co-distribution agreements. Other companies have also introduced technology similar to Pinnacle's.
"We consider that as sort of a legitimizing factor for us, because we believe we pioneered this movement," says Mr. Sowell. "We filled the technology gap in the industry by filling biologic void in the disc space."
The company possesses three patents to date, with a fourth and fifth in the finalization process. In October, Pinnacle launched its InFill V2 Lateral Interbody Device, featuring a large single graft chamber with a large-load bearing surface area and an expansion of sizes and lordotic angles.
Come 2017, the company anticipates FDA clearance to market its implant systems manufactured with Invibio's PEEK-OPTIMA HA Enhanced polymer. Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, is fully integrated, not coated, into the PEEK-OPTIMA matrix, making it available on all surfaces of a finished device. PEEK-OPTIMA HA Enhanced offers all of the clinical advantages of PEEK-OPTIMA Natural including: modulus similar to bone, reduced stress shielding and artifact-free imaging.
"With the advent of the advanced materials and the science behind bone ongrowth and ingrowth, we believe this new material will be a good complement to our graft delivery technology," adds Mr. Sowell.
In the latter half of 2017, Pinnacle will focus on boosting its product offering with advancements in 3D printing as well as experimenting with titanium to achieve the maximum amount of bone graft delivery. And as the industry becomes immersed in value-based care, Pinnacle is ready with products yielding positive outcomes at low costs.
"We are making advancements, allowing surgeons to achieve very robust fusions using more basic biologics, that are not costing hospitals or patients more money," notes Mr. Sowell.
As the company does not have to answer to public investors, Mr. Sowell says they are able to focus their finances and energy on their customers' desires: "We feel we are able to address the needs of any surgeon."