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Thru-Fuze Spinal Fusion Device

Incubated by IntuitiveX


SUMMARY

Delivering improved spine patient care through novel, minimally invasive, tissue-sparing and biomechanically optimized device technologies and surgical techniques.

Nearly 200,000 lumbar spinal fusion procedures are performed per year in the US alone, the vast majority with bilateral pedicle screw instrumentation. The Thru-Fuze technology is a fusion device that may reduce surgery time and cost, while achieving faster biomechanical fusion.

Intellectual Property was sourced from researchers at the University of New South Wales, with two patent families filed in key countries worldwide to date. The technology has been validated through preclinical animal testing and is now ready for human trials. Aevitas Spine was formed to finalize development and to commercialize Thru-Fuze. The New South Wales government has given a grant of AUS$1.6MM to fund first-in-man testing.

 

THE PROBLEM

Modern minimally invasive surgery (MIS) of the spine was introduced in the 1990’s. MIS of the spine is an alternative to traditional open spine surgery and provides many benefits such as smaller incisions, less soft tissue damage, faster recovery time, shorter hospital stay and reduced blood loss. Although many patients are attracted to MIS, the lack of technology has limited its growth. Currently, the majority of spine surgery patients are treated with traditional open and invasive techniques.

Spine Surgery with Bilateral Pedicle Screw Fixation
Pedicle screws are inserted into the vertebral pedicles with connecting rods to achieve stability and improve alignment.

  • Often times this technique is time consuming

  • The screws protrude outward (about 15mm2 from the bone) and therefore may cause friction to surrounding tissue

  • Can result in construct that are difficult and partially dangerous to revise and/or extend

 

OUR SOLUTION

Aevitas’ Thru-Fuze Spinal Fusion Device (Thru-Fuze) is a revolutionary pedicle-sparing, true zero-profile (nothing protrudes from the bone) fusion system. It is a simple, less surgically intensive alternative to fusion that can produce better outcomes and patient experience for patients with lower back pain.

  • Single-piece construction

  • Immediate stabilization

  • Reliable fusion

  • Simple surgical technique

  • Anthropometric-driven

The Thru-Fuze device allows for more consistent, stable and faster bone fusion which ultimately results in faster recovery for the patient. Using MIS techniques, the Thru-Fuze device is inserted between two vertebrae at the transverse process. This provides stability to the spine to allow the bones to grow and fuse. The Thru-Fuze device is designed so that bone fusion occurs at the ends of the device. Fusion occurs as a result of the bone growing thru and on the ends of the device, securing the bridge between the two vertebrae. During animal testing, fusion occurred in 6-12 weeks. In contrast, when using pedicle screws and rods, the bone growth and fusion must occur from one end of the transverse process to the other to create a bridge-like connection. This process may take several months.

Benefits

  • Less time in surgery

  • Immediate stabilization

  • Enhanced safety with faster biomechanical fusion

  • True zero-profile (minimally disruptive to tissues; pedicle-sparing)

  • Quick and easy to implant and revise/extend

  • Lower implant cost

  • Less radiation

 

INVESTMENT

Raising $250,000 Pre-Seed investment to lead to a $1M Seed for:

  • Refine device and complete product development

  • Initiate First-in-Man trial in Australia and obtain 6- and 12-month results data

  • Conduct biomechanical testing to support regulatory submissions

  • Submit for regulatory approvals

    • U.S. FDA 510(k)

    • Australia TGA

    • European CE Mark

  • Broaden patent portfolio to cover additional developmental work

 

THE TEAM

President & CEO: Joseph Ross

Chief Medical Advisor: Jeffrey Roh, MD

Chief Technology Advisor: Bill Walsh