GlobeNewswire by notified

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

Share

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 8,500 FlareHawk devices have been implanted in more than 6,000 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.

Media Contact: Brandy Craig
305-676-1679
bcraig@integrityimplants.com

A Media Snippet accompanying this announcement is available by clicking on the image or link below:

To view this piece of content from ml.globenewswire.com, please give your consent at the top of this page.


To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Iveco Group signs a 150 million euro term loan facility with Cassa Depositi e Prestiti to support investments in research, development and innovation11.6.2024 12:00:00 CEST | Press release

Turin, 11th June 2024. Iveco Group N.V. (EXM: IVG), a global automotive leader active in the Commercial & Specialty Vehicles, Powertrain and related Financial Services arenas, has successfully signed a term loan facility of 150 million euros with Cassa Depositi e Prestiti (CDP), for the creation of new projects in Italy dedicated to research, development and innovation. In detail, through the resources made available by CDP, Iveco Group will develop innovative technologies and architectures in the field of electric propulsion and further develop solutions for autonomous driving, digitalisation and vehicle connectivity aimed at increasing efficiency, safety, driving comfort and productivity. The financed investments, which will have a 5-year amortising profile, will be made by Iveco Group in Italy by the end of 2025. Iveco Group N.V. (EXM: IVG) is the home of unique people and brands that power your business and mission to advance a more sustainable society. The eight brands are each a

DSV, 1115 - SHARE BUYBACK IN DSV A/S11.6.2024 11:22:17 CEST | Press release

Company Announcement No. 1115 On 24 April 2024, we initiated a share buyback programme, as described in Company Announcement No. 1104. According to the programme, the company will in the period from 24 April 2024 until 23 July 2024 purchase own shares up to a maximum value of DKK 1,000 million, and no more than 1,700,000 shares, corresponding to 0.79% of the share capital at commencement of the programme. The programme has been implemented in accordance with Regulation No. 596/2014 of the European Parliament and Council of 16 April 2014 (“MAR”) (save for the rules on share buyback programmes set out in MAR article 5) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the Safe Harbour rules. Trading dayNumber of shares bought backAverage transaction priceAmount DKKAccumulated trading for days 1-25478,1001,023.01489,100,86026:3 June 20247,0001,050.597,354,13027:4 June 20245,0001,055.705,278,50028:6 June20243,0001,096.273,288,81029:7 June 20244,0001,106.174,424,68

Landsbankinn hf.: Offering of covered bonds11.6.2024 11:16:36 CEST | Press release

Landsbankinn will offer covered bonds for sale via auction held on Thursday 13 June at 15:00. An inflation-linked series, LBANK CBI 30, will be offered for sale. In connection with the auction, a covered bond exchange offering will take place, where holders of the inflation-linked series LBANK CBI 24 can sell the covered bonds in the series against covered bonds bought in the above-mentioned auction. The clean price of the bonds is predefined at 99,594. Expected settlement date is 20 June 2024. Covered bonds issued by Landsbankinn are rated A+ with stable outlook by S&P Global Ratings. Landsbankinn Capital Markets will manage the auction. For further information, please call +354 410 7330 or email verdbrefamidlun@landsbankinn.is.

Relay42 unlocks customer intelligence with a new insights and reporting module, powered by Amazon QuickSight11.6.2024 11:00:00 CEST | Press release

AMSTERDAM, June 11, 2024 (GLOBE NEWSWIRE) -- Relay42, a leading European Customer Data Platform (CDP), is leveraging Amazon QuickSight to power its new real-time customer intelligence, reporting, and dashboard module. Harnessing the breadth and quality of customer data, the new Insights module empowers marketing teams to dive deep into customer behaviors and gain invaluable insights into the performance of their marketing programs across all online, offline, paid, and owned marketing channels. Preview of the Relay42 Insights module, in pre-beta version Key capabilities of the Relay42 Insights module include: Deep insights into customer behaviors: With the Relay42 Insights module, marketers can ask unlimited questions about their data and gain a deeper understanding of how to serve their customers more effectively. Simplicity with AI-powered querying: Marketers can use artificial intelligence to query their data using natural language search, reducing the reliance on data scientists. Us

Metasphere Labs Announces X Spaces Event on the Topic of Green Bitcoin Mining and Sound Money for Sustainability11.6.2024 10:30:00 CEST | Press release

VANCOUVER, British Columbia, June 11, 2024 (GLOBE NEWSWIRE) -- Metasphere Labs Inc. (formerly Looking Glass Labs Ltd., "Metasphere Labs" or the "Company") (Cboe Canada: LABZ) (OTC: LABZF) (FRA: H1N) is thrilled to announce an engaging Twitter Spaces event on Green Bitcoin mining, energy markets, and sustainability on July 3, 2024 at 2 p.m. ET. Follow us on X at MetasphereLabs for updates and to join the event. What We'll Discuss Bitcoin Mining Basics: Understand the fundamentals of Bitcoin mining.Energy Market Dynamics: Explore how Bitcoin mining interacts with energy markets.Sustainable Innovations: Learn about our efforts to promote sustainability in Bitcoin mining.Sound Money: Discover how tamper-proof currency can enhance stability.Efficient Payment Rails: See how fast, neutral payment systems support humanitarian projects.Carbon Footprint: Compare Bitcoin's environmental impact with traditional banking. "We're excited to host this event and dive into the critical topics of Bitcoin

World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye