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Bone Graft Material 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

Traditional means of stabilizing the spine after decompression surgery involve lengthy, invasive procedures that use bone graft material, combined with instrumentation such as pedicle screws and rods, to fuse two or more vertebrae together. ...

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

Traditional means of stabilizing the spine after decompression surgery involve lengthy, invasive procedures that use bone graft material, combined with instrumentation such as pedicle screws and rods, to fuse two or more vertebrae together. ...

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

Milan, Italy (June 1st, 2022) – Today, KLISBio, a MedTech company challenging the status quo in regenerative medicine by leveraging a silk-based multidisciplinary technology platform, announced its attendance to 2022 IFSSH, IFSHT & FESSH Combined Congress organized by the International Federation of Societies for Surgery of the Hand and International Federation of Societies for Hand ...

ByKLISBio


Cerapedics Announces FDA approval of an IDE supplement

Cerapedics Announces FDA approval of an IDE supplement

Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for the on-going clinical trial, ASPIRE, for P-15L Bone Graft in a single level transforaminal lumbar interbody fusion (TLIF) surgery. “We are pleased to announce ...

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

Cerapedics Inc., an ortho-biologics company dedicated to enhancing the science of bone repair, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its investigational P-15L Bone Graft for the treatment of degenerative disc disease (DDD). The FDA’s Breakthrough Device designation is designed to expedite the development and review ...

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

The tissue engineered technology at the core of SILKBridge® merges a deep-rooted cultural tradition and know-how with the most advanced technologies creating a highly purified material required for biomedical applications, without the need for chemical cross-linking reactions that alter silk fibroin. ...

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 leveraging silk as a powerful and biocompatible scaffold material, targeting different clinical indications in the orthopedic, vascular and drug release markets via several technology ...

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. Using Synergy’s proprietary BIOSPHERE® Technology, BIOSPHERE® FLEX SP Extremities is a sheet putty composed of innovative spherical bioactive glass granules combined with a ...

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

SILKBridge® is expected to be available for clinical use in the US market in 2023.The tissue engineered technology at the core of SILKBridge® merges a deep-rooted cultural tradition and know-how in silk handling with the most advanced technologies creating a highly purified material required for biomedical applications, without the need for chemical cross-linking ...

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

The tissue engineered technology at the core of SILKBridge® merges a deep-rooted cultural tradition and know-how with the most advanced technologies creating a highly purified material required for biomedical applications, without the need for chemical cross-linking reactions that alter silk fibroin. ...

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

The tissue engineered technology at the core of SILKBridge® merges a deep-rooted cultural tradition and know-how with the most advanced technologies creating a highly purified material required for biomedical applications, without the need for chemical cross-linking reactions that alter silk fibroin. “KLISBio is focused on developing innovative solutions to tackle ...

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. This study was conducted by Synergy’s founder, Mark Borden Ph.D. and a ...

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

Hawkins has led an accomplished career in materials science and orthopaedic implants during his 35 years at Zimmer Holdings, where he had progressive leadership positions in R&D and product development including vice president, corporate research. He is credited with developing a wide variety of products for the global orthopaedics market spanning novel bone ...

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. This tissue engineered technology is based on pure silk fibroin that merges a deep-rooted cultural tradition and know-how with the most advanced technologies creating a highly ...

ByKLISBio


KLISBio to feature engineered silk innovation at Biotech Showcase

KLISBio to feature engineered silk innovation at Biotech Showcase

KLISBio is leading a revolution in restorative surgical procedures using engineered silk materials to heal and regenerate human tissue. Engineered silk materials provide a unique combination of outstanding biological and mechanical properties for a variety of clinical indications such as peripheral nerve injuries, peripheral vascular diseases, ...

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. The application is specified for the indication osteomyelitis (bone infection) ...

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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