Filling the Gap In Spinal Fusion

Spinal fusion technologies remain relatively unchanged between manufacturers. While there are slight variations between them, which ultimately make them unique to a device maker, they all still essentially perform the same task in the same way while also having the same “flaw.” The design flaw that so many spinal fusion solutions share is the void that’s left once the implant is placed. The optimal contact is not made between the implant’s surface, bone graft, and vertebrae.
 
While attending the NASS meeting late in 2016, I met with a company who thinks they have the answer to “eliminate the performance gap” that’s seen with other spinal fusion solutions. Pinnacle Spine Group has developed the InFill Interbody Fusion System, which enables surgeons to deliver graft material following implant placement. The implant is not prepacked with the graft but rather added once the implant is in place.
 
Zach Sowell, president of the Pinnacle Spine Group, took some time at the event to speak with me about his company’s innovative solution to this “flaw” that’s commonly seen among other products. He provided insights on the technology and gave a forecast of what he saw for Pinnacle and the industry in the coming years.
 
Sean Fenske: Can you provide some background on Pinnacle Spine?
Zach Sowell:The Texas-based Pinnacle Spine Group was established in 2010 by Sowell & Company—a privately held investment company. I run Pinnacle alongside Russell W. Nelson, M.D., who serves as the chief medical officer. The company is dedicated to the design, development, manufacturing, and marketing of innovative, best-in-class spinal implants and instruments that offer greater opportunities for positive patient outcomes.
 
Pinnacle Spine Group was the first company to bring to market a patented spinal fusion system with integrated in situ graft delivery capabilities. We are committed to providing surgeons increased control, flexibility, and choices when it comes to implants, instrumentation, and bone graft delivery. We want surgeons to have a better experience so they can better serve their patients. We are proud to offer physicians innovative solutions that address unmet needs in the operating room. Positive patient outcomes are at the core of our mission. 

 
Fenske: What concerns did you have with the void that remains following a spinal fusion procedure that led to your technology development?
Sowell:We recognized that traditional fusion devices provided inadequate graft to endplate contact. Pinnacle Spine Group’s InFill Interbody Fusion Systems allow for in situ graft delivery, which significantly improves the contact of the grafting material with the vertebral endplates with the goal of promoting a larger fusion mass.
 
Fenske: I’m starting to better understand what you mean by the phrase, “Eliminate the performance gap.” Can you offer a little more insight into this technology solution for spinal fusion procedures?
Sowell:Pinnacle Spine Group pioneered the novel concept for filling the biologic void by placing bone graft material into an implanted device in situ for optimal bone graft volume and contact with vertebral endplates—a critical element for a successful spine fusion outcome. Pinnacle Spine’s InFill Fusion Systems include a full line of innovative interbody fusion devices engineered for easier insertion, reduced subsidence through maximum contact with the apophyseal ring, a generous bone grafting chamber, and compatibility with the InFill Graft Delivery System. The backbone of the technology is based on controlled and precise in situ placement of bone graft material. Our devices and system are safe and effective for more complex and minimally invasive surgeries as well.
  
Fenske: It sounds like a pretty unique solution, yet it seems there are competitors in the industry who could be “borrowing” your concept. What challenges are you facing regarding your device IP? 
Sowell:We have multiple patents for our innovations, but have seen other companies begin to incorporate graft delivery directly to their fusion devices. This serves as a validation of our ideas, but there is the potential that some competing fusion systems might be infringing upon our IP. We are examining the current IP landscape to assess the strength of our position.
 
Fenske: What are the next steps for you and your company? What’s ahead in the next five years?
Sowell:Come 2017, we anticipate FDA clearance to market our 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.
In addition, we are looking at advancements in 3D printing. We’re also conscious of costs impacting the industry and want to provide products that yield positive outcomes at lower costs.
 
Fenske: I appreciate you taking the time to discuss the technology with ODT. Before we close, do you have any additional comments you’d like to share?
Sowell:A recent analysis from Market Reports World suggests that the global lumbar spine fusion market is expected to grow at a compound annual growth rate of 4.9 percent between 2016 and 2020. We want to help reduce the number of complications and repeated surgeries. We are eager to hear more from the physician community about the InFill System and the importance of filling the biologic void, and want to partner with smart, forward-looking surgeons who can help us continually improve our offering. We’d also like to gather more clinical data demonstrating the pros and cons of our system and invite surgeons who are interested in this type of research to contact us.
 
The following video provides further clarification of how the system works.