Press Release: September 14, 2021

Accelus Announces Addition of TiHawk9 Titanium-Bonded Multidirectional Implant to its FlareHawk® Family of Expandable Interbody Fusion Cages

TiHawk blends features of PEEK with titanium for a modulus more similar to bone that permits fluoroscopic visualization

 

PALM BEACH GARDENS, Fla., September 14, 2021 (GLOBE NEWSWIRE) – Accelus, a privately held medical technology company focused on accelerating the adoption of minimally invasive surgery (MIS) as the standard of care in spine, today announced the introduction and commercial availability of the TiHawk9 expandable interbody cage, the latest addition to its FlareHawk® family of spinal fusion cages, now featuring titanium at the bony interface. 


“TiHawk represents an encouraging evolution in interbody cage design by integrating the desirable features of both PEEK and titanium,” said Sravisht Iyer, M.D., a spine surgeon specializing in minimally invasive surgery at Hospital for Special Surgery (HSS) in New York. “TiHawk’s innovative application of titanium means I now have the surface characteristics I desire without the fear of surface delamination or undermining my ability to easily assess fusion through the cage after surgery.”


TiHawk features a uniform non-porous 0.5-micron-thick layer of titanium applied through a high-vacuum, low-temperature, ion beam-assisted deposition process. Unlike conventional physical vapor deposition coatings, the concurrent ion bombardment intermixes the titanium and PEEK atoms at the interface providing a strong physical bond and a resulting layer of titanium that provides the desired surface characteristics yet is thin enough not to impair radiographic visualization of implant placement and assessment of fusion. Standard titanium-coated implants often generate a ghost artifact under fluoroscopic imaging, which require patients to get costly, time-consuming and high radiation-generating CT scans to confirm fusion.


“I have used the FlareHawk cage with great success and welcome the titanium-bonded version as a treatment option for my patients,” said Lee Tan, M.D., Assistant Professor of Neurological Surgery at UCSF Medical Center in San Francisco, who performed the first TiHawk case. “In addition to providing radial expansion and endplate conformability from its multimaterial construct, TiHawk features titanium at the bony interface. It also improves the radiographic visibility of the cage shell which helps surgeons to better assess the cage position intraoperatively and post-operatively.”


The first-of-its-kind FlareHawk family of implants utilize a PEEK shell and internal shim, providing a small insertion profile to minimize neural retraction during insertion and then allowing expansion in height, width and lordosis to potentially reduce subsidence, restore foraminal height and re-establish sagittal balance. Peer-reviewed clinical studies have demonstrated FlareHawk’s adaptive geometry as a potential contributor to its positive fusion rates, as well as to the absence of observed subsidence1-3–a concern with monolithic titanium cages that present a mismatch in the modulus of elasticity between the implant and the bone. To date, over 10,500 FlareHawk cages have been implanted in more than 9,000 patients.


“Surgeons loved what they were seeing from our PEEK FlareHawk device and its ability to conform to the vertebral endplates; however, they also desired a titanium option since titanium is recognized for potentially enhancing bone fixation,” said Chris Walsh, Co-founder and CEO of Accelus. “We are thrilled with the final TiHawk device, as it features a layer of titanium that still allows for a surgeon to assess fusion radiographically in the office, as well as the same minimal insertion profile, multidirectional expansion, and maximum bone graft delivery that surgeons have come to expect from FlareHawk interbody devices.”


About FlareHawk Expandable Lumbar Interbody Fusion System

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 (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 Accelus 
Accelus is committed to accelerating minimally invasive spine surgery through its procedure-enabling technology with broad accessibility to previously underserved markets. Founded in 2021 through the combination of Integrity Implants and Fusion Robotics, the company is focused on providing its proprietary Adaptive Geometry technology with pragmatic and economical navigation and robotic solutions with broad clinical use in spine surgery. 

1. Tan LA, Rivera J, Tan XA, Le VP, Khoo LT, Berven SH. Clinical and Radiographic Outcomes After Minimally Invasive Transforaminal Lumbar Interbody Fusion-Early Experience Using a Biplanar Expandable Cage for Lumbar Spondylolisthesis. Int J Spine Surg. 2020 Dec;14(s3):S39-S44. doi: 10.14444/7125. Epub 2020 Oct 29. PMID: 33122185; PMCID: PMC7735467.

2. Coric D, Roybal RR, Grubb M, Rossi V, Yu AK, Swink IR, Long J, Cheng BC, Inzana JA. Bidirectional Expandable Technology for Transforaminal or Posterior Lumbar Interbody Fusion: A Retrospective Analysis of Safety and Performance. Int J Spine Surg. 2020 Dec;14(s3):S22-S30. doi: 10.14444/7123. Epub 2020 Oct 29. PMID: 33122186; PMCID: PMC7735440.

3. Cheng BC, Swink I, Yusufbekov R, Birgelen Michele, Ferrara L, Coric D. Current Concepts of Contemporary Expandable Lumbar Interbody Fusion Cage Designs, Part 2: Feasibility Assessment of an Endplate Conforming Bidirectional Expandable Interbody Cage. International Journal of Spine Surgery. https://www.ijssurgery.com/content/14/s3/S68. Published December 1, 2020. 

# # #

Media Contact:

Brandy Craig

305-676-1679

bcraig@accelusinc.com


TiHawk Press Release, final.pdf

Press Release: August 17, 2021

Accelus Launches Ultra-Low Profile FlareHawk7™ Expandable Cage Implant and Innovative Instruments to Support Endoscopic, MIS Lumbar Fusion Procedures

New 7mm insertion profile, combined with company’s proprietary Adaptive Geometry™ technology, are designed to respect patients’ neural, vascular, bony and soft tissue anatomy both during and after insertion to promote long-term stability

 

PALM BEACH GARDENS, Fla., August 17, 2021 (GLOBE NEWSWIRE) – Accelus, a privately held medical technology company focused on accelerating the adoption of minimally invasive surgery (MIS) as the standard of care in spine, today announced the launch of FlareHawk7, a multidirectionally expandable lumbar fusion device that is inserted at an ultra-low profile of 7mm to help minimize neural retraction before expanding in both the cranial-caudal and medial-lateral planes to provide sagittal and coronal correction, foraminal height restoration, and the stability to promote fusion.


The FlareHawk7 platform also features a suite of instruments designed to facilitate surgeons’ technique preferences. For endoscopic TLIF procedures, surgeons can leverage access with instruments to allow direct visualization of disc preparation and implant delivery. For MIS procedures, surgeons are provided access to the disc space through Kambin’s triangle while also preserving the patient’s normal anatomy. And in a “mini-open” procedure, the need for neural retraction can be minimized thanks to the smaller insertion footprint that is similar in profile to a No. 2 pencil.


“FlareHawk7 enables me to do fully endoscopic interbody fusion as outpatient surgery, with the best endplate prep and great clinical results,” said Jian Shen, M.D., PhD, a world-renowned leader in endoscopic spine surgery. 


FlareHawk7 permits concurrent expansion in height and width to restore disc height without sacrificing stability. It enters the disc space with a compact 7mm x 7mm profile and then expands up to 11mm x 12mm—a 57% increase in width and 72% increase in height—with 0° and 6° lordosis options. This provides a larger surface contact area to distribute load with the goal of reducing subsidence in weak, osteoporotic bone. The implant’s open architecture design also allows significant graft delivery through the implant and into the surrounding disc space. 


“FlareHawk7 is a game changer,” said Jason Huffman, M.D., a recognized leader in minimally invasive spinal fusion and Director of the Huffman Clinic in Napa, Calif. “It enables me to quickly and effectively perform a thorough discectomy and interbody fusion with a kick-ass, multiplanar-expandable, structured cage while utilizing a minimally invasive, percutaneous approach through Kambin's triangle.”


Dr. Paul Houle, M.D., board-certified neurosurgeon with Cape Cod Healthcare Neurosurgery in Hyannis, Mass. agrees. “Historically, my surgical options were greatly limited when patients presented with scarring,” Dr. Houle said. “However, FlareHawk’s narrow insertion profile means I can treat these patients from a single position posteriorly – something not offered by other products currently on the market.”


The first-of-its-kind FlareHawk® family of implants utilizes a PEEK shell and internal shim, providing a small insertion profile to minimize neural retraction during insertion and then allowing expansion in height, width and lordosis, designed to reduce subsidence, restore foraminal height and re-establish sagittal balance. Peer-reviewed studies have suggested FlareHawk’s Adaptive Geometry to be a potential contributor to the implant’s positive fusion rates, as well as to the absence of observed subsidence1-4, a concern with monolithic cages that present a mismatch in the modulus of elasticity between the implant and the bone. To date, over 10,500 FlareHawk cages have been implanted in more than 9,000 patients.


“No other implant represents our philosophies of Adaptive Geometry and Access Without Compromise™ as well as FlareHawk7 with its ultra-low 7mm insertion profile expanding to 11mm, a full 2mm wider than the average 9mm TLIF implant. This allows for less neural retraction yet more footprint than current devices,” said Chris Walsh, CEO of Accelus. “We refuse to be dogmatic in our approach, as FlareHawk7 enables endoscopic, percutaneous, mini-open, and two-implant open PLIF procedures—all benefiting from Accelus’s Access without Compromise promise.”


About FlareHawk Expandable Lumbar Interbody Fusion System

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 (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 Accelus 
Accelus is committed to accelerating minimally invasive spine surgery through its procedure-enabling technology with broad accessibility to previously underserved markets. Founded in 2021 through the combination of Integrity Implants and Fusion Robotics, the company is focused on providing its proprietary Adaptive Geometry technology with pragmatic and economical navigation and robotic solutions with broad clinical use in spine surgery. 

1.    Cheng BC, Swink I, Yusufbekov R, et al. Current Concepts of Contemporary Expandable Lumbar Interbody Fusion Cage Designs, Part 1: An Editorial on Their Biomechanical Characteristics. International Journal of Spine Surgery. https://www.ijssurgery.com/content/14/s3/S63. Published December 1, 2020. Accessed July 27, 2021.

2.    Cheng BC, Swink I, Yusufbekov R, Birgelen Michele, Ferrara L, Coric D. Current Concepts of Contemporary Expandable Lumbar Interbody Fusion Cage Designs, Part 2: Feasibility Assessment of an Endplate Conforming Bidirectional Expandable Interbody Cage. International Journal of Spine Surgery. https://www.ijssurgery.com/content/14/s3/S68. Published December 1, 2020. Accessed July 27, 2021.

3.    Coric D, Roybal RR, Grubb M, et al. Bidirectional Expandable Technology for Transforaminal or Posterior Lumbar Interbody Fusion: A Retrospective Analysis of Safety and Performance. International Journal of Spine Surgery. https://www.ijssurgery.com/content/14/s3/S22. Published December 1, 2020. Accessed July 27, 2021.

4.    Tan LA, Rivera J, Tan XA, Le VP, Khoo LT, Berven SH. Clinical and Radiographic Outcomes After Minimally Invasive Transforaminal Lumbar Interbody Fusion-Early Experience Using a Biplanar Expandable Cage for Lumbar Spondylolisthesis. International Journal of Spine Surgery. https://www.ijssurgery.com/content/14/s3/S39. Published December 1, 2020. Accessed July 27, 2021.

# # #

Media Contact:

Brandy Craig

305-676-1679

bcraig@accelusinc.com


Accelus Launches Ultra-Low-Profile FlareHaw7 Expandable Cage Implant and Innovative Instruments to Support Endoscopic MIS Lumbar Fusion Procedures.pdf

Press Release: July 6, 2021

Integrity Implants and Fusion Robotics Merge to Form Accelus

Accelus to Offer Procedure-Enabling Technology with the Goal of Making Minimally Invasive Surgery (MIS) the Standard of Care in Spine

 

PALM BEACH GARDENS, Fla., July 6, 2021 (GLOBE NEWSWIRE) – Integrity Implants Inc., a privately held medical device company focused on Adaptive Geometry™ technology designed to enable MIS spine surgery, and Fusion Robotics, LLCa privately held medical technology company focused on efficient and cost-effective navigation and robotic targeting solutions for spine surgery, today announced that they have consummated a merger combining the two companies. The combined company will be re-branded as “Accelus” and is uniquely positioned to accelerate the adoption of minimally invasive surgery as the standard of care in spine.

 

“Accelus will create opportunities for wide-scale adoption of robotics in spine surgery—both in hospitals and ambulatory surgery centers (ASCs)—by addressing previous constraints related to cost and efficiency,” said Chris Walsh, who will serve as the CEO of Accelus. “Both Fusion Robotics and Integrity Implants have built enabling technology platforms that create a force multiplier for spinal care. Our products and culture create accessibility to fit each patient’s anatomy, each surgeon’s preferred approach, and each healthcare facility’s space and budget limitations, embodying our core principle of access without compromise.”


Although the benefits of MIS have been recognized for decades, broad adoption in the spine market is still constrained relative to other orthopedic and interventional procedures. The combination of Fusion Robotics’ efficient, compact and scalable robot with Integrity Implant’s unique Adaptive Geometry implants enables the rapid acceleration of MIS adoption.

 

“We believe Accelus is poised to be the next dominant player in the spine market,” said Alex Lukianov, who will serve as Chairman of the company’s Board of Directors. “Accelus will uniquely accelerate penetration of MIS while fostering a culture of outstanding performance together with an unparalleled product development engine to continually simplify surgical procedures. Our growth prospects are tremendous. Onward and upward!”

 

Integrity Implants’ flagship FlareHawk® Lumbar Interbody Fusion Device received FDA clearance in 2016 and CE mark approval in 2021, and to date more than 10,500 FlareHawk devices have been implanted in more than 8,000 patients. Integrity Implants also holds FDA clearances for its LineSider® Spinal System, FlareHawk TiHawk Interbody Fusion System and Toro-L Interbody Fusion System. Fusion Robotics received a 510(k) clearance for its initial product offering and started performing spine procedures in the U.S. market earlier this year.

 

"This combination of teams and technology represents a transformative opportunity to accelerate innovation in spine,” said neurosurgeon Kevin Foley, M.D., Chief Robotics Officer of Fusion Robotics. “The implant portfolio is complementary to the robotics platform, and with the rapid strides we are making in robotics development—specifically related to our fluoroscopy-based robotics system—the synergies will become even more robust in the coming months." 

 

Accelus’ corporate office, R&D, distribution and Accelus Clinical Education (ACE) surgeon training facility will be headquartered in Palm Beach Gardens, Fla. Additional ACE labs and R&D centers will be located in Boulder, Colo. and San Diego, Calif.

 

The company’s Executive Management Team will consist of leaders from both Integrity Implants and Fusion Robotics, who bring decades of experience and leadership across spine, navigation and surgical robotics. Accelus’s Board of Directors will be composed of Fusion Robotics’ founders Alex Lukianov and Brad Clayton; Integrity Implants’ founders Chris Walsh and Wyatt Geist; and current Integrity Implants Directors Nate Ward, Ned Lipes and Paul Birkmeyer. 

 

“The organizational synergies go beyond products and technology, as we are pulling together the ‘A-team’ of spine,” Walsh added.

 

Accelus will be showcasing its current product portfolio during the 2021 Spine Summit meeting in San Diego this July and the 2021 Annual Scientific Meeting of the American Association of Neurological Surgeons in Orlando in August, as well as unveiling new product launches at the North American Spine Society’s 36th Annual Meeting in Boston this fall.


Piper Sandler & Co. is serving as exclusive financial advisor to Integrity Implants.

 

About Accelus 

Accelus is committed to accelerating minimally invasive spine surgery through its procedure-enabling technology with broad accessibility to previously underserved markets. Founded in 2021 through the combination of Integrity Implants and Fusion Robotics, the company is focused on providing its proprietary Adaptive Geometry™ technology with pragmatic and economical navigation and robotic solutions with broad clinical use in spine surgery. 

# # #

Media Contact:

Brandy Craig

305-676-1679

bcraig@integrityimplants.com


Integrity Implants and Fusion Robotics Merge to Form Accelus, Final.pdf

Press Release: June 23, 2021

Integrity Implants Receives CE Mark for its Novel FlareHawk® Expandable Lumbar Interbody Fusion Device

 

Spine surgeons throughout the European Union Economic Area (EEA)1 will soon have access to FlareHawk’s minimal insertion profile, multiplanar and endplate-conforming expansion, and maximum graft delivery

 

PALM BEACH GARDENS, Fla., June 23, 2021 (GLOBE NEWSWIRE) – Integrity Implants Inc., the leader in Adaptive Geometry™ technology for innovative spine surgery solutions, today announced that it has received CE mark certification for its flagship FlareHawk Expandable Lumbar Interbody Fusion Device. FlareHawk launched in the United States in August 2016 and more than 10,500 FlareHawk devices have been implanted in more than 9,000 patients to date.

 

“CE mark further validates our belief that FlareHawk is the first expandable interbody solution that will have a true global reach,” said Chris Walsh, Co-Founder and CEO of Integrity Implants. “FlareHawk’s novel design and efficient manufacturing process enable access to the EU healthcare system. We are excited to be launching in several select European countries and initiating a prospective study with FlareHawk in the coming months. Our previously published data, which helped precipitate CE Mark clearance, is very strong data compared to that currently seen in both the expandable and TLIF/PLIF spaces.”

 

The uniqueness of the FlareHawk multidirectional interbody fusion cage called for a different approach than that used by many medical device manufacturers to demonstrate equivalence to other previously approved products. Instead, Integrity Implants compiled original retrospective clinical evidence data on FlareHawk’s performance and safety, including fusion rates, patient-reported outcome scores and adverse events.

 

“This data was pivotal in establishing evidence showing the safety and effectiveness of FlareHawk’s multidirectional expanding cage,” said the study’s principle investigator, Dom Coric, M.D., Chief of Spine Division at Atrium Healthcare’s Musculoskeletal Institute and neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, N.C. “FlareHawk has provided exceptional outcomes for my patients, and I’m happy to have played a part in helping this innovative product receive approval for the benefit of many more patients throughout the European Union.”

 

The data utilized in the study followed strict inclusion criteria and was drawn from participants with comorbidities often seen in the general patient population, including high BMI, diabetes, coronary heart disease, hypertension and a history of smoking. The study also only allowed allograft or autograft to help facilitate fusion as opposed to more expensive spinal biologics like BMP, DBM or other processed biologics. Among the 129 study patients, TLIF (51%) or PLIF (49%) surgery was performed on 171 levels. A minimally invasive approach was used in 88% of the cases.

 

Outcomes were impressive, with 97.4% of levels achieving fusion based on the well-respected Bridwell-Lenke grading classification. Additionally, there were no (0%) reported device-related adverse events, no (0%) observations of cage subsidence (defined as an overlap between the vertebral endplates and the device exceeding 25% of the device height), and only one case (1.7%) of observed device migration (defined as displacement of the device relative to the position within intra-operative or immediate post-operative images). More than 70% of patients also demonstrated clinically significant improvements in VAS leg and back pain scores.

 

“Patient-reported outcomes, including ODI and VAS for leg and back pain, were significantly improved during the last patient follow-up, an extremely important benefit in the constant quest for optimal patient outcomes and satisfaction with value-based spine procedures,” said Raphael Roybal, M.D., M.B.A., Director of The Spine Institute at Chatham Orthopaedics in Savannah, Ga. and co-author of the study. “The FlareHawk device has been transformational for my practice, especially during the past year, as it has allowed me to transition many cases to an outpatient setting that is safer for my patients and staff.”

 

Mark Grubb, M.D., a minimally invasive spine surgeon at Northeast Ohio Spine Center in Akron, Ohio and co-author of the paper, agreed: “FlareHawk’s small insertion profile and multidirectional expansion means I can treat the patient minimally invasively via a single position. The open architecture of the device also allows me to deliver the bone graft through the expanded FlareHawk cage and into the intervertebral space. This is a distinct improvement over other expandable products and represents another design aspect that I believe contributes to the favorable fusion rates seen with the FlareHawk device.”

 

In addition to receiving FDA clearance and CE mark approval, FlareHawk has also received approvals in Argentina, New Zealand, Taiwan and the United Arab Emirates.

 

About FlareHawk Expandable Lumbar Interbody Fusion System

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 (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, Fla. 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. Learn more at www.integrityimplants.com.

1. The European Economic Area includes the EU: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the following countries: UK, Norway, Iceland, Liechtenstein, Switzerland and Turkey.

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

 

Media Contact:

Brandy Craig

305-676-1679

bcraig@integrityimplants.com


Integrity Implants Receives CE Mark for its Novel FlareHawk® Expandable Lumbar Interbody Fusion Device.pdf

Press Release: December 1, 2020

Safe and Efficacious Treatment of Spondylolisthesis via MIS TLIF Approach with the FlareHawk® Expandable Cage

 

IJSS-published review finds that the novel biplanar expandable cage provides effective vertebral body slip or spondylolisthesis reduction and improvement in radiographic and clinical parameters with no reported subsidence, migration, or endplate violation

 

PALM BEACH GARDENS, Fla., December 1, 2020 (GLOBE NEWSWIRE) – Integrity Implants Inc.a privately held medical device company dedicated to delivering innovative solutions for spine surgery, today announced the publication of another in a series of recent clinical articles in the International Journal of Spine Surgery (www.ijssurgery.com) highlighting its FlareHawk® expandable interbody cage. In their paper, Clinical and Radiographic Outcomes After Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) – Early Experience Using a Biplanar Expandable Cage for Lumbar Spondylolisthesis (International Journal of Spine Surgery October 2020, 7125; DOI: https://doi.org/10.14444/7125), Lee A. Tan, Joshua Rivera, Xiao A. Tan, Vivian P. Le, Larry T. Khoo, and Sigurd H. Berven demonstrate favorable vertebral body slip or spondylolisthesis reduction accompanied by an increase in segmental lordosis and positive patient-reported outcomes.

The retrospective review of 13 patients treated during a one-year period found a mean slippage reduction of 6.0mm along with an improvement in segmental lordosis, increases in foraminal and posterior disc height, as well as improvement in all radiographic parameters postoperatively. Patient-reported outcome measures including VAS back, VAS leg, and EQ5D also improved across the board. There were no findings of endplate violation, cage subsidence, or cage migration, and there were no reoperations or implant-related complications.

Lee Tan, M.D., Assistant Professor of Neurological Surgery at UCSF Medical Center in San Francisco, California, shares, “My early experience shows good short-term radiographic and clinical outcomes, with almost complete reduction of spondylolisthesis postoperatively in all cases. The absence of nerve root injury is suggestive that the biplanar expandable cage is safe and obviates the need for excessive nerve root retraction during cage insertion.”

As discussed in the article, one possible explanation for the clinical success is that the expansion of the cage in the horizontal plane increases surface area contact with the endplates to better distribute the load and reduce stress, while the multi-material cage design consisting of a titanium shim inserted into a PEEK shell allows the cage to contour to the patient’s endplates, further reducing the risk of endplate violation.

Sigurd Berven, M.D., Professor in Residence, Department of Orthopaedic Surgery at the University of California at San Francisco, adds, “A challenging aspect of the MIS TLIF procedure is inserting the cage through a relatively small surgical corridor with protection of the neural elements. Additionally, in a lordotic disc space, the posterior disc height is typically shorter than the anterior disc height, thus limiting the size of cage that can be inserted posteriorly, potentially limiting the amount of lordosis restoration. In these cases that often present with a collapsed disc space and bone-on-bone pathology, the low-profile, biplanar, and lordotically expanding FlareHawk cage is ideal for reducing risk to the neural elements on insertion of the implant, and for improving the surface area of the implant with the endplate and the restoration of segmental lordosis. After insertion, the cage and prepared disc space can be filled with allograft or autograft to optimize fusion. The results of the study are encouraging regarding the efficacy of MIS fusion using the technique.”

Dr. Tan concludes, “Remarkably, we had no cases of endplate violation or cage subsidence in this cohort. This is significantly lower than the rates reported in the current literature, which range from 6% up to 33%. I believe that the biplanar expansion is key to decreasing the likelihood of subsidence.”

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. An open-architecture titanium shim inserted within the PEEK shell produces the expansion and creates a solid-state construct that is resistant to collapse yet has shown the ability to conform to endplate anatomy to increase surface contact area and lower stresses. The Adaptive Geometry™ and advanced multi-material composition embodied in the FlareHawk device respect patient anatomy both during insertion and for long-term stability. To date, over 8,500 FlareHawk cages have been implanted in more than 6,000 patients.

Chris Walsh, Integrity Implants CEO, adds, “Last month, we shared the encouraging results of a multi-center study highlighting the favorable fusion efficacy and endplate conforming geometry of the FlareHawk cage. This work by surgeons Lee Tan, Sig Berven, and Larry Khoo represents the third peer-reviewed study of the FlareHawk cage this year. Beyond intrinsic cage design and performance, the study addresses a specific pathology solution that resonates with surgeons. It is encouraging to see published literature echo surgeon confidence in the FlareHawk cage, and documenting the application of Adaptive Geometry to the important and increasingly popular MIS TLIF approach is yet another step in confirming our technology as a compelling clinical choice for surgeons.”

 

About FlareHawk Expandable Lumbar Interbody Fusion System

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 (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.

 

Media Contact:

Brandy Craig

305-676-1679

bcraig@integrityimplants.com


FH IJSS Clinical Publication Press Release (Tan) 2020-12-01.pdf


Press Release: November 12, 2020

Clinical Evidence Shows that the FlareHawk® Multiplanar Expandable Cage Delivers Favorable Fusion and Patient Outcomes Demonstrating Conformity to Endplate Anatomy with No Observed Device Subsidence

 

IJSS-published peer-reviewed studies demonstrate the device’s respect for neural anatomy and conformability to bony endplates through Adaptive Geometry™

 

PALM BEACH GARDENS, Fla., November 12, 2020 (GLOBE NEWSWIRE) – Integrity Implants Inc.a privately held medical device company dedicated to delivering innovative solutions for spine surgery, today announced the publication of a series of articles in the International Journal of Spine Surgery (www.ijssurgery.com) that demonstrate fusion efficacy of the FlareHawk® expandable interbody device without the use of costly processed biologics. Additionally, there were no observed reports of device subsidence. Moreover, the study set provides confirmation of the cage’s ability to conform to patients’ endplate geometry.

 

The October Special Issue features several studies on FlareHawk expandable cage technology, including:

  • Bidirectional Expandable Technology for Transforaminal or Posterior Lumbar Interbody Fusion: A Retrospective Analysis of Safety and Performance, by Domagoj Coric, Raphael R. Roybal, Mark Grubb, Vincent Rossi, Alex K. Yu, Isaac R. Swink, Jason Long, Boyle C. Cheng and Jason A. Inzana in International Journal of Spine Surgery October 2020, 7123; DOI: https://doi.org/10.14444/7123

  

  • Current Concepts of Contemporary Expandable Lumbar Interbody Fusion Cage Designs: An Editorial on Their Biomechanical Characteristics, Part 1, by Boyle C. Cheng, Isaac Swink, Rachelle Yusufbekov, Michele Birgelen, Lisa Ferrara, Kai Uwe Lewandrowski and Domagoj Coric in International Journal of Spine Surgery October 2020, 7128; DOI: https://doi.org/10.14444/7128

 

  • Current Concepts of Contemporary Expandable Lumbar Interbody Fusion Cage Designs, Part 2: Feasibility Assessment of an Endplate Conforming Bidirectional Expandable Interbody Cage, by Boyle C. Cheng, Isaac Swink, Rachelle Yusufbekov, Michele Birgelen, Lisa Ferrara and Domagoj Coric in International Journal of Spine Surgery October 2020, 7129; DOI: https://doi.org/10.14444/7129

 

The articles present favorable clinical outcomes, as well as a discussion of some of the unique design features of the multidirectional expandable FlareHawk device that may contribute to its clinical efficacy.

I.

The lumbar Interbody fusion study substantiating the safety and efficacy of the FlareHawk biplanar expandable cage is presented by principal investigator Dom Coric, M.D., of Carolina Neurosurgery & Spine Associates, Chief of Neurosurgery at Carolinas Medical Center and Spine Division Chief at Atrium Musculoskeletal Institute in Charlotte, North Carolina. The study followed strict inclusion criteria including the allowance of only allograft and/or autograft to facilitate fusion and its participants represented patients with noteworthy comorbidities, including high BMI, diabetes, and current/former smokers. Among subjects with radiographs at 12 ± 3 months, nearly all (56 of 58 patients, or 96.6%, and 75 of 77 levels, or 97.4%) 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 (0%) 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 consistent with other PLIF/TLIF studies. There were no (0%) observations of cage subsidence (defined as an overlap between the vertebral endplates and the device exceeding 25% of the device height) and only one case (1.7%) of observed device migration (defined as displacement of the device relative to the position within intra-operative or immediate post-operative images). Analysis of that case reveals that the cage moved only slightly within the disc space and the patient went on to fuse.

 

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.”

 

Raphael Roybal, M.D., M.B.A, co-author of the paper and Director of The Spine Institute at Chatham Orthopaedics in Savannah, Georgia, notes, “Popular minimally invasive TLIF techniques, typically involving a unilateral approach to the disc space, may limit the amount of disc space preparation and/or bone graft delivery, thereby impeding fusion rates. Biplanar expandable spacers that support minimally invasive surgery, safer implantation, and optimal patient outcomes will be relevant in delivering value-based spine care. The FlareHawk device has transformed my practice by allowing me to transition cases to an outpatient setting that is better for my patients and staff.”

 

Mark Grubb, M.D., co-author and minimally invasive spine surgeon at Northeast Ohio Spine Center in Akron, Ohio, adds, “Most expandable spacers use complex articulation mechanisms to expand the implant profile in either in height or width, but typically do not achieve multidirectional expansion. Furthermore, these complex mechanisms can limit the space available for bone grafting. I appreciate that the FlareHawk cage features a small insertion profile and expands in footprint, height, and lordosis via an unobtrusive mechanism that allows me to deliver bone graft through the expanded cage and into the intervertebral body space. Additionally, the ability to treat my patients via a single-position, posterior surgery allows me to improve both the quality and efficiency of my practice.”

II.

Similarly, the work from Boyle Cheng, Ph.D., Professor at Drexel University College of Medicine in Pennsylvania and Director of Research at the Allegheny Health Network (AHN) Neuroscience Institute, assesses the feasibility of a bidirectional expandable interbody cage to achieve interbody fusion and discusses two novel aspects of the FlareHawk device: (1) its multimaterial, open-architecture design that provides a combined spring effect for a modulus of elasticity similar to that of bone while maintaining sufficient support and stiffness from the titanium shim, and (2) implant geometry that allows for the naturally occurring deformation of the PEEK shell to conform to each patient’s endplate configuration.

 

Dr. Cheng’s study hypothesizes that utilizing two components, each with the appropriate intrinsic material stiffness, provides both flexibility and stability resulting in a device with a composite construct stiffness more favorable to load transfer over a large contact area with the endplates. Reducing the construct stiffness is essential, not only to reduce the risk of subsidence but also to increase the load sharing and improve bone formation as a function of Wolff’s Law. As such, the multimaterial construct, open architecture, and bi-directionally expanding design of the FlareHawk cage may contribute to the positive clinical outcomes observed.

 

Additionally, the shim-in-a-shell design conforms to patient-specific endplate anatomy. Measurement of the relative position of the tantalum markers revealed that 16 of the 18 devices showed coronal plane deformation of 1.82mm (18.55%) anteriorly and 1.41mm (15.49%) posteriorly. This measured deformation correlates well with values of endplate concavity reported in the literature (1.37 - 1.90mm), suggesting that the PEEK shell is conforming to the natural endplate anatomy. This material behavior, along with bidirectional expansion, serves to increase the surface area of the bone-implant interface and may better distribute the loads across the endplate. 

 

Dr. Cheng notes, “This represents yet another design aspect potentially contributing to the favorable fusion rates seen with the FlareHawk device. In the study, all 18 devices (100%) were determined to have fused based on demonstrated bone growth evidence (average volume of 586.42 mm3) and Bridwell-Lenke classification. An interbody device with this unique combination of compliant and rigid components has the potential to conform to the interbody space while maintaining sufficient stability to achieve fusion. This represents a significant advancement not just in expandable cage technology, but in the larger context of achieving successful lumbar interbody fusion. The cage appears to conform in shape obliquely, sagittally, and coronally, resulting in adaptive implant geometry that surgeons may desire. Additionally, the lack of endplate violation suggests that the FlareHawk cage is an atraumatic implant.”

 

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 yet has shown the potential to conform to endplate anatomy to increase surface contact area and lower stresses. The Adaptive Geometry™ and advanced multimaterial composition embodied in the FlareHawk device respect patient anatomy both during insertion and for long-term stability. To date, approximately 8,500 FlareHawk cages have been implanted in more than 6,000 patients.

 

Chris Walsh, Integrity Implants CEO, shares, “The data suggests that the FlareHawk cage changes the PLIF/TLIF algorithm, enabling a single-position, reproducible, facility-friendly interbody solution that can provide surgeons significant efficiencies and latitude for their practices. There may be profound medical and economic ramifications to study in the future. Before founding Integrity Implants, Wyatt Geist and I observed, as distributors, the power of the lateral approach to transform the modern spine practice through a less-invasive technique. What we are observing with the FlareHawk device, we believe, is even greater in scale. The simple design works in inpatient and outpatient facilities, as well as international markets. This supports our thesis that Adaptive Geometry™ – the ability of an implant to change shape intraoperatively to respect the patient’s anatomy – reconciles the desire for a minimally invasive approach that yields a maximum clinical result through a variety of surgical approaches to the spine, and in a variety of clinical settings. In addition to these papers, IJSS has published Dr. Lee Tan’s Clinical and Radiographic Outcomes After Minimally Invasive Transforaminal Lumbar Interbody Fusion – Early Experience Using a Biplanar Expandable Cage for Lumbar Spondylolisthesis. We are excited about the promise of the FlareHawk expandable cage for MIS TLIF and will discuss those findings in a future release.”

 

About FlareHawk Expandable Lumbar Interbody Fusion System

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 (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.

 

Media Contact:

 

Brandy Craig

305-676-1679

bcraig@integrityimplants.com


FlareHawk IJSS Clinical Publication Press Release 2020-11-12.pdf

Press Release: March 3, 2020

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

 

Adaptive Geometry™ facilitates compact delivery through minimal insertion exposure and an enlarged form within the disc space to promote fusion

 

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

 

Media Contact:

 

Brandy Craig

305-676-1679

bcraig@integrityimplants.com


FlareHawk Data Press Release 2020-03-03.pdf