The quest for a spinal implant that is porous, strong and bioactive has had elusive results, with most products offering only one or two of these attributes in support of fusion. HAPPE Spine’s mission is to accomplish all three with a porous, hydroxyapatite-reinforced PEEK interbody.
HAPPE (pronounced “happy”) is an acronym for HydroxyApatite Porous PEEK—a clever nod to a positive outcome. The startup is rethinking the way that PEEK and hydroxyapatite (HA) are manufactured together, so that the interbody maintains the strength necessary for load-bearing spinal applications, while being porous enough to facilitate osteointegration and radiolucent for imaging purposes.
“The body likes HA, the body likes PEEK, but it's how those are put together that’s important structurally,” said David Blue, Chief Commercial Officer of HAPPE Spine. “There’s a lot of nuance and differentiation that separates us.”
Building on HA-PEEK Innovation
The genesis of HAPPE Spine’s technology began in the early 2000s with Ryan K. Roeder, Ph.D., whose research interest focused on ways that materials interact, integrate and replace bone in an implant.
Dr. Roeder expanded on Invibio’s HA-enhanced PEEK concept to address porosity and strength in addition to the bioactive benefits of HA-reinforced PEEK. He worked with his graduate students at the University of Notre Dame to create a porous structure similar to trabecular bone tissue using HA whiskers.
“Fiber reinforcement is done in many different technologies,” said Doug Snell, Engineering Program Director for HAPPE Spine. “This is that similar concept where the HA is not only present to increase the bioactivity, but it also strengthens the material and provides more exposure. You get more opportunity for bioactivty with HA whiskers molded with our proprietary process than you do with powdered HA and today's extrusion molding or sprayed application.”
HA whiskers are dispersed throughout the implant on the surface of the pores. They are interconnecting strands that cross-link to provide a strong, porous structure ideal for implant-to-bone fusion. The technology lends itself to customize how much porosity is in the molded structure.
HAPPE has conceived a manufacturing method to densify certain regions of the implant, giving it a structural skeleton within the implant in the same footprint that supports the biological loading. The implants are manufactured to have the porosity where it is most important and where bony ingrowth is required for effective fusion within the graft.
“The design of the implant is made such that the skeleton is put where it’s needed most, and the porosity, the osteoinductive material, is placed where it is needed most,” Snell said. “HAPPE technology gives you the opportunity to have a single molded construct that has both dense supported material where you want it, and porous material where it’s best served.”
HAPPE implants are made utilizing a proprietary molding method that leverages traditional processes, making the manufacturing practical and economical, according to the company.
“In today’s environment, you can’t bring something to market that’s not cost-competitive,” Blue said. “We execute this manufacturing process with standard, traditional methods, so we have the opportunity for it to be cost-competitive. It’s really great because now you are bringing all of the features and benefits of these three goals of porosity, strength and bioactivity to accomplish that, but to do it cost-effectively is really an important piece in today’s environment.”
The technology also leverages surgeons’ current processes, meaning that there isn’t a learning curve.
“It doesn’t change putting in an implant from a surgical standpoint,” Blue said. “It doesn’t change physicians’ behavior, which is important. And the nice thing is that we’re not introducing some strange material to anybody; it’s well adopted and embraced in the marketplace.”
Genesis Innovation Group formed HAPPE in 2018, and in April 2019 provided the company with a second round of financing from with investments from its cultivate(MD) Capital Funds I and II. HAPPE plans to submit a cervical implant for FDA clearance during 2019.
Image courtesy of HAPPE Spine
Heather Tunstall is an ORTHOWORLD® Contributing Editor.