NovaBone Products Secures Approval of CE Mark for Collagen Devices

NovaBone Products, a private biologics medical device company, has received CE mark approval for NovaTape and NovaPlug, dental wound dressing products.
 
NovaTape and NovaPlug are pure collagen-based products designed for management of soft tissue oral wounds and sores, including dental sores, oral ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical and traumatic wounds. Since 2015, NovaBone Products has led industry development of collagen-based products for the medical community, according to the company.
 
“The CE mark approval is a major milestone for our company and a benefit to physicians and dentists in the European Union,” said Art Wotiz, president of NovaBone Products. “NovaTape and NovaPlug are exceptionally user-friendly and proven to be effective for a range of indications. It is important to note that NovaBone now has comprehensive capabilities to produce intuitively-designed bioactive collagen composites and collagen-only products that meet the demands of medical professionals.”

NovaBone is a calcium phospho silicate composed of elements naturally occurring in the body. The technology platform has the proven ability to signal genetic pathways to accelerate natural bone growth. Within the field of orthopedics, NovaBone is indicated for use as an osseous defect filler capable of inducing new bone formation.This technology is available in a variety of formulations and delivery options—each developed based on surgeon preference and procedure type. 

NovaBone’s formulation is engineered to react and release ions as soon as it is exposed to an osseous defect. When implanted, it delivers a controlled release of ions over time that enhance cell signaling. Within hours of implantation, Ca and P ions, along with soluble silica, are released forming a silica-gel and hydroxycarbonate apatite layer creating an ideal environment for cellular attachment and for protein and growth factor absorption.

The formation of the reaction layers and the absorption of these organic molecules results in the signaling and recruitment of osteoprogenitor cells (mesenchymal stem cells) to the site and their early attachment and proliferation at the material surface. The continued Ca and Si ion release modulates the differentiation of the cells, resulting in a population of osteoblasts and precursor cells that have the potential to become bone forming cells, ultimately upregulating the bone forming process.

This bone formation continues on an accelerated path as multiple families of genes directly involved with the proliferation and differentiation of osteoblasts and precursor cells are regulated:

• Transcription factors – direct stem cells to osteoblasts
• Growth factors (IGF-II, VEGF) – direct osteoblast mitosis
• DNA synthesis and repair – correct cell synthesis
• Apoptosis regulators – control cell death; regulate functional osteoblasts
• Cell surface antigens (CD44) – control osteocyte differentiation

This accelerated early healing response results in bone formation on NovaBone surfaces at rates equivalent to autograft, with particle absorption keeping pace with bone remodeling.

NovaBone is a privately held company based in Jacksonville, Fla., since 2002. NovaBone developed the first bioactive synthetic bone graft offered to the orthopedic community and has been at the forefront of bioactive glass bone graft devices. More recently, NovaBone established core competency in developing collagen devices. NovaBone provides seven devices within the field of orthopedics and six for dental indications providing the medical community with the widest range of choices in bioactive graft devices.