Spine

Clinical Study Demonstrates Favorable Patient Outcomes with the FlareHawk® Expandable Cage

PALM BEACH GARDENS, Fla., March 3, 2020 (GLOBE NEWSWIRE) – Integrity Implants Inc., a privately held medical device company dedicated to delivering innovative solutions for spine surgery, today announced positive data from a retrospective study demonstrating favorable fusion efficacy with its FlareHawk® interbody implant. The study, “Transforaminal/Posterior Lumbar Interbody Fusion with the FlareHawk Expandable Interbody Fusion Device,” was led by principal investigator Domagoj Coric, M.D., Chief of Neurosurgery at Carolinas Medical Center and Spine Division Chief of Atrium Musculoskeletal Institute, both in Charlotte, North Carolina.

Results from the multi-site study of 129 patients validate the safety and efficacy of the FlareHawk expandable fusion device. Among 58 subjects with radiographs at 12 ±3mo, nearly all (56 patients, or 96.6%) achieved fusion based on Bridwell-Lenke grading. Among 45 evaluable subjects, 71% (32 patients) achieved clinically significant improvements in VAS leg pain, and 76% (34 patients) achieved clinically significant improvements in VAS back pain. Additionally, there were no reported device-related adverse events (AEs). Common device-related AEs associated with interbody fusion devices include, but are not limited to, subsidence, displacement, and nerve injury. The incidence rate for non-device related AEs was 14.7%, which is consistent with other TLIF/PLIF studies.

Dr. Coric notes, “This study adds to the evidence base supporting the safe and effective use of expandable interbody spacers in the treatment of lumbar spine diseases. The FlareHawk implant’s ability to expand in both cephalad-caudal and lateral-medial planes is especially advantageous for decreasing neural retraction while maximizing vertebral body endplate coverage and fusion area.”

The FlareHawk spinal implant is the flagship product for Integrity Implants and represents the first of its kind in the expandable cage market. Much like coronary stents that offer patients a less-invasive alternative to open-heart procedures, the FlareHawk expandable cage features a PEEK shell that is inserted in a compressed form that can be effectively passed through small neural pathways and, once within the intervertebral disc space, expanded to a larger footprint and height. A titanium shim inserted within the PEEK shell produces the expansion and creates a solid-state construct that is resistant to collapse. The design accommodates the delivery of appropriate bone graft material into and through the apertures of the cage. The Adaptive Geometry™ philosophy embodied in the FlareHawk device emphasizes respect for patient anatomy through implant geometry that can be optimized for both insertion and long-term stability. To date, over 6,400 FlareHawk cages have been implanted in more than 4,300 patients.

Chris Walsh, Integrity Implants CEO, adds, “Importantly, this data set was achieved without the use of any biologics other than autogenous or allogenic bone graft, further validating our thesis that minimal nerve retraction and a large footprint are design imperatives that decrease the strain on a surgeon and facility to achieve a stable fusion. From the outset, we have heard anecdotally from our surgeon user group that the FlareHawk cage can be implanted with minimal or no nerve retraction and is a ‘fire and forget’ device, so we are thrilled, but not surprised, that the data set showed no device-related adverse events. With our TLIF and PLIF platforms complete, look for Integrity to expand our Adaptive Geometry platform into lateral, Kambin’s, and anterior approaches.”

Rohit Vasan, M.D., FAANS, Chief Medical Officer for Integrity Implants concludes, “Integrity Implants is dedicated to meet head-on the widely recognized, yet paradoxically unaddressed, challenges faced by spine surgeons in daily surgical operations. The company blueprint is simple: combine yesterday’s time-honored fundamental principles of surgery with tomorrow’s technology to offer solutions that are both minimally invasive and maximally effective today. For the surgeon obsessed with patient safety and clinical outcomes above all else, preferentially choosing products designed by this philosophy is as natural as always choosing to wash your hands before a procedure.”

About FlareHawk Expandable Lumbar Interbody Fusion System

The FlareHawk Interbody Fusion System is 510(k) cleared by the FDA and 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 (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

About Integrity Implants Inc.

Integrity Implants, founded in 2016 by seasoned business partners and spine leaders Chris Walsh and Wyatt Geist, is a privately held medical device company headquartered in Palm Beach Gardens, Florida. The Company is dedicated to delivering innovative spine products and solutions to surgeons and their patients around the globe. Its proprietary Adaptive Geometry™ technology fundamentally respects a patient’s neural, vascular, bony, and soft tissue anatomy, both during and after implantation.

For more information, please visit the Company’s website at www.integrityimplants.com

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Chris J. Stewart

Chris currently serves as Chief Executive Officer of Surgio Health as well as Chief Operating Officer at Ortho Spine Partners. Prior to that, he was the assistant vice president and business unit leader of Medical Device Management for HealthTrust Purchasing Group (HPG).

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