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Bone Graft Product Articles & Analysis

32 news found

Empirical Spine Completes Investigational Arm Enrollment In Pivotal IDE Clinical Trial Studying LimiFlex In Degenerative Spondylolisthesis

Empirical Spine Completes Investigational Arm Enrollment In Pivotal IDE Clinical Trial Studying LimiFlex In Degenerative Spondylolisthesis

Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of enrollment in the investigational arm of its U.S. IDE trial studying the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal ...

ByEmpirical Spine, Inc.


Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis

Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis

Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of enrollment in its U.S. IDE trial studying the use of LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) ...

ByEmpirical Spine, Inc.


KLISBio to participate at 2022 IFSSH, IFSHT & FESSH Combined Congress With an abstract presentation on SILKBridge

KLISBio to participate at 2022 IFSSH, IFSHT & FESSH Combined Congress With an abstract presentation on SILKBridge

Gabriele Grecchi, CEO and co-Founder of KLISBio, Antonio Alessandrino, CTO and Founder and Gabriella Francavilla, Global Marketing Manager, will be attending the congress with the aim to cement current relationships and establish new ones with physicians and strategic partners. KLISBio’s first product in pipeline is SILKBridge®, a silk fibroin absorbable medical ...

ByKLISBio


Cerapedics Announces FDA approval of an IDE supplement

Cerapedics Announces FDA approval of an IDE supplement

In 2015, the company’s first-generation bone graft became the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine. CAUTION: In the United States, P-15L Bone Graft (i-FACTOR® + Matrix) ...

ByCerapedics, Inc.


Cerapedics Announces FDA Breakthrough Device Designation Granted for P-15L Bone Graft for the Treatment of Degenerative Disc Disease

Cerapedics Announces FDA Breakthrough Device Designation Granted for P-15L Bone Graft for the Treatment of Degenerative Disc Disease

“We look forward to working closely with the FDA through the on-going clinical trial and review processes for P-15L, with the goal of bringing this important new technology to a patient population with a significant unmet medical need.” P-15L Bone Graft is currently being studied in the U.S. in the ASPIRE study, a prospective, single-blinded, ...

ByCerapedics, Inc.


KLISBio to present SILKBridge for peripheral nerve repair and its innovative silk-based tissue-engineered technology platform at 2022 Bio€quity Europe

KLISBio to present SILKBridge for peripheral nerve repair and its innovative silk-based tissue-engineered technology platform at 2022 Bio€quity Europe

Among the most innovative MedTech emerging companies, KLISBio is keen to deal-make and establish strong relations with active investors and paramount players in the life science and regenerative medicine space, aiming to contribute to the advancement of the whole industry with SILKBridge®, KLISBio’s first product in pipeline for peripheral nerve repair. ...

ByKLISBio


KLISBio to share its leading-edge silk-based technology platform at 2022 AAOS Annual Meeting

KLISBio to share its leading-edge silk-based technology platform at 2022 AAOS Annual Meeting

KLISBio is committed to contributing to the advancement of orthopedics with SILKBridge®, its first product in pipeline intended for the surgical repair of digital nerves. ...

ByKLISBio


Synergy Biomedical Launches BIOSPHERE® Flex SP Extremities, Synthetic Bioactive Bone Graft.

Synergy Biomedical Launches BIOSPHERE® Flex SP Extremities, Synthetic Bioactive Bone Graft.

Synergy Biomedical, LLC, a developer of innovative biomaterial products, today announced the launching of BIOSPHERE® FLEX SP EXTREMITIES, Synthetic Bioactive Bone Graft. ...

BySynergy Biomedical, LLC


KLISBio to disclose state-of-the-art tissue-engineered technology platform at 2022 CG Musculoskeletal Conference

KLISBio to disclose state-of-the-art tissue-engineered technology platform at 2022 CG Musculoskeletal Conference

Among the best innovators in orthopedics, biologics and regenerative medicine participating in CG Musculoskeletal Conference, KLISBio is open to expand its network and build strong relations with investors and industry leaders, in the attempt to move forward the current standard of care in peripheral nerve repair with SILKBridge®, KLISBio’s first product in pipeline for ...

ByKLISBio


KLISBio to unveil cutting-edge silk-based technology platform at 2022 Digital RESI Conference

KLISBio to unveil cutting-edge silk-based technology platform at 2022 Digital RESI Conference

KLISBio, a clinical-stage company leading a revolution in restorative surgical procedures and tissue engineering, is willing to connect with investors and strategic partners, with the purpose of moving science forward and advancing innovation in the life science and healthcare domain with SILKBridge®, KLISBio’s first product in pipeline for peripheral nerve repair. ...

ByKLISBio


KLISBio to share innovative tissue-engineered technology at LSI 2022 Emerging MedTech Summit

KLISBio to share innovative tissue-engineered technology at LSI 2022 Emerging MedTech Summit

Among the most innovative MedTech emerging companies, KLISBio is keen to deal-make and establish strong relations with active investors and paramount players in the life science and regenerative medicine space, aiming to contribute to the advancement of the whole industry with SILKBridge®, KLISBio’s first product in pipeline for peripheral nerve repair. ...

ByKLISBio


Synergy Biomedical Announces Publication of Core Scientific Study on Its BioSphere® Bone Graft Technology

Synergy Biomedical Announces Publication of Core Scientific Study on Its BioSphere® Bone Graft Technology

Synergy Biomedical, LLC, a developer of innovative bone graft products for spine and orthopedic surgery, announced the publication of a basic science study describing the findings and scientific strategies of controlling the bone formation response of bioactive glass. ...

BySynergy Biomedical, LLC


Hyalex Orthopaedics appoints Carl Vause, orthopaedic industry veteran, as Chief Executive Officer and President; Names Mike Hawkins, PhD, Chief Technical Officer

Hyalex Orthopaedics appoints Carl Vause, orthopaedic industry veteran, as Chief Executive Officer and President; Names Mike Hawkins, PhD, Chief Technical Officer

Hyalex Orthopaedics, a privately-held medical device company developing transformational cartilage biomimetic products, today announced the appointment of Carl Vause as its new chief executive officer and president. ...

ByHyalex Orthopaedics, Inc.


KLISBio to feature engineered silk innovation at AAHS 2022

KLISBio to feature engineered silk innovation at AAHS 2022

KLISBio will introduce SILKBridge® to attendees at the American Association for Hand Surgeons Annual Meeting Jan. 12-15, 2022. SILKBridge®, a silk-based graft, is a tissue-engineered technology based on pure silk fibroin. ...

ByKLISBio


KLISBio to share innovative tissue-engineered technology at BIO Partnering with JP Morgan

KLISBio to share innovative tissue-engineered technology at BIO Partnering with JP Morgan

Among the company’s developing portfolio of products is SILKBridge®, a first-to-market, silk-based graft for peripheral nerve repair, which is anticipated to be available for clinical use in 2023. ...

ByKLISBio


KLISBio to feature engineered silk innovation at Biotech Showcase

KLISBio to feature engineered silk innovation at Biotech Showcase

Silk fibroin is also fully biocompatible and promotes cell proliferation by stimulating in-vivo tissue regeneration. The first of KLISBio’s products, SILKBridge®, is a first-to-market, silk-based graft for peripheral nerve repair. ...

ByKLISBio


Bonesupport – Supplementary Us Denovo Application Submitted

Bonesupport – Supplementary Us Denovo Application Submitted

BONESUPPORT™, an emerging leader in orthobiologics for the management of bone injuries, today announced that the company has submitted a supplementary De Novo application to the US Food and Drug Administration (FDA) to obtain a market approval for the company’s antibiotic-releasing product CERAMENT® G. ...

ByBONESUPPORT AB


SeaSpine Announces CE Mark Certification of 7D Surgical Cranial Module and Percutaneous Spine Module for Minimally Invasive Spine Surgery

SeaSpine Announces CE Mark Certification of 7D Surgical Cranial Module and Percutaneous Spine Module for Minimally Invasive Spine Surgery

CARLSBAD, Calif., Sept. 27, 2021 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced it received simultaneous CE Mark certification for its Cranial Module and Percutaneous Spine Module for the 7D FLASH™ Navigation System. This achievement expands the ...

By7D Surgical


OrthoPediatrics Announces Entry into a Distribution Agreement with SeaSpine to Exclusively Distribute the 7D Surgical FLASH Navigation Platform for Pediatric Applications

OrthoPediatrics Announces Entry into a Distribution Agreement with SeaSpine to Exclusively Distribute the 7D Surgical FLASH Navigation Platform for Pediatric Applications

Enables OrthoPediatrics to Further Address Full Patient Continuum of Care for Pediatric Orthopedic Surgeons with Market-Leading, Radiation-Free Navigation Technology WARSAW, Ind., Sept. 09, 2021 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today ...

By7D Surgical


SeaSpine Announces FDA 510(k) Clearance of 7D Surgical Percutaneous Spine Module for Minimally Invasive Surgery

SeaSpine Announces FDA 510(k) Clearance of 7D Surgical Percutaneous Spine Module for Minimally Invasive Surgery

CARLSBAD, Calif., July 07, 2021 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the FDA 510(k) clearance of its 7D Percutaneous Spine Module for minimally invasive surgery. This represents a new application and increased functionality for its 7D Flash™ ...

By7D Surgical

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