Amplio Spine announced that it has completed the asset acquisition of the KeyLift Expandable Interlaminar Stabilization System from FloSpine. The deal includes the full intellectual property portfolio, FDA 510(k) clearance, finished inventory, and established distributor relationships tied to KeyLift. Financial terms were not disclosed.
Amplio Spine is a founder-led and founder-funded medical device company based in Boca Raton, Florida. The company said it is now launching the national commercialization of KeyLift following the acquisition.
KeyLift is an FDA-cleared expandable interlaminar stabilization system indicated for supplemental fusion of the non-cervical spine. The device is intended for use as a posterior, non-pedicle supplemental fixation device at a single level in the non-cervical spine from T1 to S1.
The device is intended for plate fixation and attachment to the spinous processes and lamina for supplemental fusion in conditions including lumbar spinal stenosis, degenerative disc disease, spondylolisthesis, trauma, and tumor. It is intended for use with allograft or autograft bone and is not intended for stand-alone use.
Amplio Spine said the acquisition strengthens its focus on FDA-cleared posterior non-pedicle supplemental fixation. The company said KeyLift is designed to support a minimally invasive approach while offering a fixation strategy tied to the spinous processes and lamina.
The KeyLift platform is being commercialized in two configurations under FDA 510(k) K232484. KeyLiftXL is sized for lumbar anatomy, while KeyLiftXS is a slim-profile configuration sized for lumbosacral anatomy, including L5-S1. Across the two configurations, KeyLift ships in eight cleared sizes.
Amplio acquired the KeyLift platform from FloSpine and has assumed responsibility for national commercialization, distributor onboarding, inventory deployment, and clinical training. KeyLift was developed at FloSpine under the engineering and clinical direction of the late Peter Harris, a spine engineer and named inventor on the foundational KeyLift patent family.
The company said its distributor network has been deployed, its field team has been trained on the device’s Indications for Use, and inventory is now in market.
KEY QUOTES:
“The surgical world of spine treatment has progressed through the years from what one might describe as maximally invasive to minimally invasive. The KeyLift technology is perhaps among the most secure minimally invasive spinal fusion developments. I believe, when appropriately applied by both well-trained surgeons and interventionalists, it will rise quickly to a preferred technique.”
Stephen H. Hochschuler, MD, Chairman of Texas Back Institute, Founding Board Member of Global Spine Initiative, and Advisory Board Member of Amplio Spine
“KeyLift is cleared by FDA as a posterior, non-pedicle, supplemental fixation device for plate fixation/attachment to the spinous processes/lamina at a single level in the non-cervical spine, T1-S1, for the purpose of achieving supplemental fusion. That is the Indications for Use, and that is the claim we will run on. The peer-reviewed anatomic record explains why spine specialists may find that target useful; the clinical conclusion belongs to the spine specialists who use it.”
Joshua Lambert, Founder and CEO of Amplio Spine
“Our distributor network is deployed, our field team is trained on the IFU, and our inventory is in market. We are not making noise — we are making cases. Our job is to put the cleared label and the supporting literature in front of the right spine specialists and let procedural experience compound from there.”
Blake Boesel, Chief Revenue Officer and Co-Founder of Amplio Spine
