Spineology Inc

Spineology Inc. is a St. Paul, Minnesota medical device manufacturer focused on ultra-minimally invasive (ultra-MIS) spine surgery. Its core platform, OptiMesh, is a conforming, patient-specific expandable interbody implant that is inserted empty through a small portal, filled in situ with bone graft material, and deployed to full size, so that a large implant footprint can be achieved through one of the smallest insertion profiles in the lumbar interbody market. The compacted granular fill is intended to restore disc height, support alignment goals and create a biologic environment for fusion. A single implant can be used across multiple lumbar fusion approaches, including open TLIF/PLIF, MIS TLIF, ultra-MIS OptiLIF and endoscopic OptiLIF Endo.

The portfolio has been extended with OptiMesh HA Nano, which applies a nano-thin hydroxyapatite surface treatment intended to accelerate osseointegration, and OptiMesh Align, which adds real-time, in situ independent control of anterior and posterior expansion for up to 20 degrees of lordotic range. Beyond interbody fusion, company descriptions list deployable grafting, pedicular fixation, retractor, liquid tissue matrix, amniotic wound covering, spinal fixation, allograft and facet fixation systems.

The company positions OptiMesh on the strength of regulatory and clinical evidence: FDA clearance for stable vertebral body defects in 2003, an FDA De Novo grant for interbody fusion in 2020, and the SCOUT (Spineology Clinical Outcomes Trial) IDE study, whose two-year results were published in the International Journal of Spine Surgery in 2021.

Founding story

Spineology was founded by spinal surgeon and inventor Stephen D. Kuslich, M.D. (1943-2004), who had previously co-developed the BAK cage and founded Spine-Tech Inc. Seeking to deliver a larger implant through a smaller incision, he worked to miniaturize the surgical working portal even though doing so would obsolete his earlier design. The containment concept reportedly emerged when he observed a development partner holding a hackey sack in a knit glove; the team filled a cut-off glove finger with morselized bone material, demonstrating that contained bone graft could provide the structural strength needed to support fusion. Kuslich is credited with 44 U.S. patents.

Business model

Spineology designs, manufactures and distributes spinal implants and instrumentation sold for use in lumbar fusion procedures, reaching hospitals and surgery centers through a direct sales force and a distributor network; its contact page invites distributor inquiries and product demo requests.

Traction

The company reports more than 20 years of clinical experience, 20 clinical publications and more than 50,000 devices implanted. SCOUT IDE study two-year results reported 99% (95/96) fusion, 98% fusion at 12 months as evaluated by two independent radiologists, mean ODI improvement of 32.0 ± 18.5, 92% of patients rating satisfaction excellent or good, 85% with clinically meaningful back pain reduction and 75% with clinically meaningful function improvement at three months, and no device-related serious adverse events.

Latest developments

In August 2024 Spineology announced a $25 million Series AA equity financing led by SV Health Investors with participation from 1315 Capital and existing investor RC Capital, with SV Health managing partner Greg Madden joining the board. Recent announcements include the launch of OptiMesh HA Nano, the launch of OptiMesh Align, an organization rebrand, the hiring of Emory Rooney as Executive Vice President of Sales and Amanda Bloom as Executive Vice President of Marketing, and completion of enrollment in a post-market study of an expandable lateral implant. The executive team includes CEO Brian Snider, CFO Steve Nemitz and Executive Chairman Tom Patton.