A Grand Rapids medical device startup aims to launch into the market in early 2023 with a new material for spinal and orthopedic implants.
HAPPE Spine LLC expects to clear U.S. Food and Drug Administration review within two or three months, enabling it to begin selling the porous, bioactive material that encourages new bone growth in patients.
In anticipation of receiving FDA clearance in early 2023, HAPPE Spine has been building inventory through a contract medical device manufacturer in Indiana, founder and Chief Technology Officer Ryan Roeder said.
After clearing FDA review, the company will move into the market slowly, targeting sales to hospitals, ambulatory surgical centers and orthopedic practices.
“The plan is to start slow, and not overextend ourselves, because we’re still a little company, and grow from there,” Roeder said. “We’re starting with what we’re calling a ‘micro-commercialization.’ We’re not going out and trying to create a lot of revenue with this launch. Our goal is to get it on the market (and) safely prove it out. We want to start with baby steps and then grow it after we’re comfortable that our entire operation is ready to go.”
Formed in late 2018 by Genesis Innovation Group in Grand Rapids, HAPPE Spine uses a material that Roeder developed in his research work at the University of Notre Dame. The material allows for the full or partial construction of artificial bone applications.
HAPPE Spine this year reopened a Series A capital round that initially netted $3.35 million from investors in 2021. The company closed this fall on another $2 million raised from 41 investors, according to a filing to the U.S. Securities and Exchange Commission. The regulatory filing indicated that HAPPE Spine seeks to raise another $2 million in the equity offering that has a $7.35 million goal.
The capital round will support HAPPE Spine through regulatory approval, commercial product launch and through the next year and a half, said Jenna Hollern, the company’s head of finance and operations.
Launching the new material first for spines is the “most logical, call it a beachhead market if you want, where we’re targeting” because “it’s the most ripe for innovation with this material,” Roeder said. HAPPE Spine is “already planning what our next implant launch would be” beyond spinal fusions, he said.
“We expect that, from there, we will have the opportunity to grow to other spinal indications (and) other orthopedic indications with this platform that better integrates with bone than traditional metal and plastic devices,” he said. “We view it as a material platform that can be used across a number of different indications in orthopedics. It could be used in sports medicine, it could be used in trauma, fracture repair. There’s a whole host.”