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Accelus is a privately held commercial stage medical technology company focused on accelerating the adoption of minimally invasive surgery (MIS) as the standard of care in surgical spine treatment. It has a portfolio of MIS spinal implants, leveraging its proprietary adaptive geometry technology, and a compact precision robotics platform.

The company is focused on improving procedures and outcomes, creating favorable economics, and providing broad accessibility across end markets, including ambulatory surgery centers.

Accelus is headquartered in Palm Beach Gardens, Florida, where its corporate offices, machine shop, biomechanical testing, quality, warehouse and distribution, as well as its Accelus Clinical Education (ACE) cadaver lab, is housed. Accelus’s second location in Boulder, CO, with its robotic and navigation R&D offices and lab, opened in late 2021.

Its third 5,722-square-foot Carlsbad California office opened in early 2022 and features the company’s second ACE surgical lab. The team in Carlsbad hosted their first surgical labs in late March 2022.

Accelus said it has developed a differentiated solution, combining innovative spinal implants with an affordable, easy-to-use robotic and navigation platform that creates broad accessibility by allowing surgeons to increase operative efficiencies with favorable physician and facility economics. This solution was designed to deliver improved clinical outcomes while creating immediate and meaningful cost reductions that delivers tangible benefits to providers, payers, and patients.

The company added that “Currently, the robotic market is the first-generation robotic entries, and like all first generation, you have a very kludgy, cumbersome, complex product offerings. And so, we really are coming in with something, that next generation that approximates the ergonomics in the workflow, that the current ORs are demanding.”

And the company just announced recent FDA approval of additions to it’s robotic spine surgery product lines.

On May 12, Accelus announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its FlareHawk TiHawk11 Interbody Fusion System. TiHawk11 is the latest addition to Accelus’s flagship FlareHawk® portfolio of spinal fusion cages, which are now available in a larger footprint with titanium at the bony interface.

“These interbody cages feature multi-planar expansion, adaptive geometry, and open architecture designed to facilitate safer insertion and deployment-unique properties that can minimize subsidence and maximize fusion,” said Dr. Peter Derman, a minimally invasive and endoscopic spine surgeon at Texas Back Institute who was involved in the design of TiHawk11.

Per the FDA 510(k) document, the FlareHawk Interbody Fusion System is indicated for “spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease at one or two contiguous levels from L2 to S1, following discectomy.”

And on May 20, the company announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Toro Lateral (Toro-L) Interbody Fusion System. Toro-L is a biplanar expandable lateral implant designed for a minimal insertion profile and maximum bone graft delivery directly through the inserter.

Toro-L features an insertion profile that is 14mm wide, expanding to the implant’s full width of either 21 or 24mm before further expanding to the surgeon’s desired height of up to 16mm. The implant has 3D-printed endplates, which have a roughened surface where the implant interfaces with bone due to the additive manufacturing process.

Earlier the company released it’s posterior screw line, the LineSider, and the Mongoose and the hyper-innovative Periscope screw, which is a telescoping pedicle screw.