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Bone Generation Articles & Analysis

6 news found

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.


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 team of clinical and basic science collaborators, and ...

BySynergy Biomedical, LLC


Cerapedics Announces Canadian Approval of its next-generation bone graft

Cerapedics Announces Canadian Approval of its next-generation bone graft

Cerapedics, a private ortho-biologics company, today announced the Health Canada approval of the company’s next-generation bone graft called i-FACTOR+ Matrix, making it the first market to approve the commercial launch of this product. “We are excited to announce Canadian regulatory approval of our next-generation product, based on P15 osteogenic cell-binding peptide , i-FACTOR+ ...

ByCerapedics, Inc.


Stem Cell Agency Awards Almost $4 Million to Develop a Treatment for Spinal Degeneration

Stem Cell Agency Awards Almost $4 Million to Develop a Treatment for Spinal Degeneration

Today the governing Board of the California Institute for Regenerative Medicine (CIRM) awarded $3.9 million to Ankasa Regenerative Therapeutics for a promising approach to treat a degenerative condition that can cause chronic, progressive back pain. As we get older, the bones, joints and ligaments in our back become weak and less able to hold the spinal column in alignment. As a result, an ...

ByAnkasa Regenerative Therapeutics


Pinnacle Spine Group Announces Launch of InFill V2 Lateral Interbody Device for Lumbar Spinal Fusion Surgeries

Pinnacle Spine Group Announces Launch of InFill V2 Lateral Interbody Device for Lumbar Spinal Fusion Surgeries

Pinnacle Spine Group, LLC, a developer of innovative spinal fusion solutions engineered to deliver optimal bone graft volume and graft-to-endplate contact, today announced the launch of its InFill® V2 Lateral Interbody Device. The innovative InFill V2 Lateral Interbody Fusion device features a larger, single graft chamber and a large load-bearing surface area, which helps restore and maintain ...

ByPinnacle Spine Group

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