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    NIH grants support Kessler Foundation scientists to advance research on neglect dyslexia and autism

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    Processing speed influences memory rehabilitation outcomes in TBI patients

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    Two more universities set to join IUCRC BRAIN at University of Houston to advance neurotechnology

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    New online course helps personal care assistants better understand spinal cord injury

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    New review looks at the impact of robotic exoskeletons on recovery of ambulation among individuals with acquired brain injury

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    Kessler Foundation researchers receive $1.7 million in grants to improve lives of TBI patients

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    Improving treatment outcomes for individuals with acute spinal cord injury

    Improving treatment outcomes for individuals with acute spinal cord injury

    Multipronged gene therapy restores walking in mice after complete spinal cord injury

    Multipronged gene therapy restores walking in mice after complete spinal cord injury

    NIH grants support Kessler Foundation scientists to advance research on neglect dyslexia and autism

    NIH grants support Kessler Foundation scientists to advance research on neglect dyslexia and autism

    Processing speed influences memory rehabilitation outcomes in TBI patients

    Processing speed influences memory rehabilitation outcomes in TBI patients

    Two more universities set to join IUCRC BRAIN at University of Houston to advance neurotechnology

    Two more universities set to join IUCRC BRAIN at University of Houston to advance neurotechnology

    New online course helps personal care assistants better understand spinal cord injury

    New online course helps personal care assistants better understand spinal cord injury

    New review looks at the impact of robotic exoskeletons on recovery of ambulation among individuals with acquired brain injury

    New review looks at the impact of robotic exoskeletons on recovery of ambulation among individuals with acquired brain injury

    Kessler Foundation researchers receive $1.7 million in grants to improve lives of TBI patients

    Kessler Foundation researchers receive $1.7 million in grants to improve lives of TBI patients

    Novel tool could help neuroscientists crack the secrets of spinal cord

    Novel tool could help neuroscientists crack the secrets of spinal cord

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    Progress for paralyzed patients: First implanted device is placed to restore arm, hand and finger movement

    Progress for paralyzed patients: First implanted device is placed to restore arm, hand and finger movement

    For autoimmune disease sufferers, ginger may ‘play a critical role’ in controlling inflammation, study finds

    For autoimmune disease sufferers, ginger may ‘play a critical role’ in controlling inflammation, study finds

    As amoxicillin shortage continues, prescriptions have plummeted, study finds: ‘Immediate, sweeping effect’

    As amoxicillin shortage continues, prescriptions have plummeted, study finds: ‘Immediate, sweeping effect’

    Bruce Willis’ FTD battle: Expert shares warning signs and what to know about the condition

    Bruce Willis’ FTD battle: Expert shares warning signs and what to know about the condition

    Depression risk spikes for those who eat these unhealthy foods, study finds: ‘Not a coincidence’

    Depression risk spikes for those who eat these unhealthy foods, study finds: ‘Not a coincidence’

    Dengue fever: What you need to know about the mosquito-borne illness sweeping Jamaica

    Dengue fever: What you need to know about the mosquito-borne illness sweeping Jamaica

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    Less than half of nurses are ‘fully engaged’ at work, while many are ‘unengaged,’ new report reveals

    Jellyfish are not the ‘simple creatures’ once thought: New study may change an understanding of our own brains

    Jellyfish are not the ‘simple creatures’ once thought: New study may change an understanding of our own brains

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HAPPE Spine Announces FDA Clearance for the INTEGRATE-C™ Interbody Fusion System

admin by admin
May 9, 2023
in Spine
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HAPPE Spine Announces FDA Clearance for the INTEGRATE-C™ Interbody Fusion System

GRAND RAPIDS, Mich., Could 8, 2023 /PRNewswire/ — HAPPE Backbone, a medical machine firm targeted on bringing revolutionary supplies to orthopaedic implants, pronounces that the corporate’s INTEGRATE-C™ Interbody Fusion System has acquired 510k clearance from the FDA.

Powered by the HAPPE® platform, INTEGRATE-C™ is the primary interbody fusion cage that’s totally built-in with porosity and hydroxyapatite to offer a superior therapeutic surroundings. The interconnected, cancellous porosity promotes bone ingrowth from endplate-to-endplate. Hydroxyapatite is uncovered on all surfaces to advertise cell signaling and bone on-growth. The INTEGRATE-C™ is each radiolucent and radiovisible for superior intra-operative and post-operative imaging.

Andrew Iott, CEO of HAPPE Backbone stated, “We’re very excited to have gained 510K clearance for HAPPE’s new revolutionary know-how and sit up for launching game-changing product options within the close to future. The mixture of cancellous porosity with hydroxyapatite uncovered on all pore surfaces represents a real leap ahead in interbody fusion units.”

Dr. Stephen Smith, MD, Neurosurgeon on the Beacon Health System and a co-inventor of the HAPPE know-how stated, “Our staff at HAPPE is proud and excited to share this development with our colleagues. We’ve got achieved our objective of creating an ACDF that’s distinguished from all different current units used for interbody fusion. The HAPPE INTEGRATE-C™ delivers superior radiographic visibility, optimum biomechanical properties for each load bearing and therapeutic, and true graft incorporation.”

Dr. Daniel Riew, MD, Professor of Orthopedics and a number one skilled in cervical spine surgical procedure stated, “I sit up for using HAPPE’s revolutionary product, which has all of the radiographic and scientific advantages of an artificial cage whereas overcoming the damaging features of an inert, hydrophobic PEEK machine that can’t osteointegrate.”

The INTEGRATE-C™ system gives a mess of sizes and lordotic angles to accommodate affected person anatomy. The corporate’s commercialization technique is presently targeted on a restricted consumer launch to ascertain efficacy with scientific information.

About HAPPE Backbone:

HAPPE Backbone was based by Dr. Ryan Okay. Roeder, a Professor on the College of Notre Dame and CTO of the corporate. HAPPE Backbone LLC is a medical machine improvement firm that designs and commercializes revolutionary orthopedic and spinal implants using the patented Hydroxyapatite Porous Polyetheretherketone (HAPPE®) materials platform. HAPPE transforms polyetheretherketone from a hydrophobic, inert, and non-integrating materials right into a hydrophilic, floor energetic, and osteointegrating materials, confirmed by strong bone in-growth and on-growth in preclinical testing. In vitro efficiency or animal research will not be consultant of scientific efficiency. The HAPPE INTEGRATE-C™ interbody fusion system is the primary to supply bone-like cancellous porosity with uncovered hydroxyapatite on the pore surfaces, in addition to porosity extending throughout your complete implant peak to advertise endplate-to-endplate osteointegration. INTEGRATE-C™ is designed to advertise each load bearing and therapeutic, in addition to superior post-operative imaging. The HAPPE INTEGRATE-C™ interbody fusion system thus gives allograft-like qualities in an artificial implant which will enhance scientific outcomes in interbody spinal fusion by overcoming the issues of pseudoarthrosis, subsidence and imaging artifacts that restrict present PEEK and titanium implants.

Be taught extra about HAPPE Backbone and HAPPE® materials platform at happeortho.com.

SOURCE HAPPE Backbone

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