NovaBone® Products

A diverse portfolio of osteostimulatory bone grafting products with a unique spin on delivery

NovaBone^® Products was established in 2002 with a focus on developing biomaterials that harness the body’s natural healing process. The company, headquartered in Jacksonville, Florida, with manufacturing operations in Alachua, Florida, offers diverse product lines in both dental and orthopedics, including bioactive glass, collagen wound-healing products, and composite grafts.

The synthetic dental bone graft portfolio is based upon bioactive glass at its core. The active ingredient in all NovaBone bioactive glass products is calcium phosphosilicate. This active ingredient has been shown in various studies to be osteostimulatory — meaning that the graft can assist in the proliferation and differentiation of bone-forming cells (osteoblasts). As the graft resorbs, calcium and phosphate ions are released into the wound site, which can help signal and recruit undifferentiated cells that later take on an osteoblast lineage.

“NovaBone provides an ideal environment for bone formation by acting as a very stable but also temporary scaffold in a variety of clinical applications, which is later absorbed and replaced with additional vital bone, maximizing tissue quality and function.”
— Dr. Rodrigo Neiva, DDS, MS, Chair (Periodontics) University of Pennsylvania School of Dental Medicine

The product line was expanded some years ago to include a putty form of the bioactive glass. Polyethylene glycol and glycerin are added to the bioactive glass particles to produce the putty consistency, with the bioactive glass particles still making up 70% of the putty by volume. The handling characteristics of the putty are much more desirable than a particulate graft alone as the putty can be shaped to the defect, does not wash out in the presence of blood or irrigation, and has excellent radiodensity to differentiate from the host bone in a radiograph. Initially, the putty offers a transient hemostatic effect. As the binders/additives are more quickly resorbed by the body, it leaves a matrix that is supportive of angiogenesis and ultimate bone formation. There are over 50 technical publications and over 30 clinical publications in peer-reviewed journals that demonstrate the ability for NovaBone^® Putty to regenerate bone across a range of defects, including peri-implant defects, localized ridge augmentations, extraction sockets, sinus augmentations, and periodontal defects.

The putty is available in traditional clamshell packaging as well as syringe configurations, but the real differentiator is the uni-dose cartridge configurations. NovaBone Putty is the only bone graft material that can be dispensed from a cartridge — similar to popular dental composite materials. At 1.8 mm, the cartridge cannula tip allows for precise delivery of the putty to the defect site. This is helpful when trying to place the graft in difficult to reach peri-implant defects or extraction sockets in the posterior region of the patient’s jaw. The uni-dose cartridge has also become hugely popular in the trans-crestal approach to sinus augmentation as the graft material is more easily inserted through the osteotomy to the underside of the maxillary sinus. As the putty is expressed, it creates a form of hydraulic pressure that is able to safely lift the Schneiderian membrane upward, creating an augmented dome for subsequent placement of the dental implant. This minimally invasive approach to sinus augmentation can be substantially less traumatic to the patient in comparison to the traditional lateral window approach.

In addition to its market-leading delivery system, NovaBone Putty offers other considerations for the clinician user. First, it’s a synthetic material so is not subject to the variations in quality or consistency that sometimes are associated with allograft materials based on the condition of the underlying donor. The material offers a 4-year shelf life and requires no specialized storage conditions (e.g., refrigeration).

Second, the product is resorbable with most studies demonstrating 80%-90% of the graft being resorbed by the 6-month mark. This is in contrast to many of the xenograft products that are sintered to the point of essentially creating a non-resorbable graft. That sintering is a part of the manufacturing process to ensure the elimination of any organic content in the graft that could result in disease transmission (e.g., mad cow disease). Such a process is unnecessary with NovaBone bioactive glass products as there is no organic content to remove. Finally, the NovaBone Putty has a unique osteostimulatory effect as previously described, which has not been validated to the same extent in other synthetic bone grafting materials.

Capitalizing on the success of the NovaBone Putty, NovaBone expanded the product line to include NovaBone^® Morsels. The morsels feature a larger particulate size, up to 1 mm, with interconnected porosity of 65% and pore sizes as large as 100 microns. In comparison to NovaBone Putty, the NovaBone Morsels provide more structural integrity, which some clinicians have preferred for indications to include localized ridge augmentation and the treatment of peri-implantitis defects. The morsels are a crystalline version of the same calcium phosphosilicate active ingredient found in other NovaBone graft materials. This product is currently in clinical trials at the University of Texas Health Science Center in San Antonio to assess its performance in the treatment of bone defects associated with peri-implantitis. Pre-clinical studies were encouraging and showed the material’s propensity to enhance the attachment of osteoblasts to titanium surfaces.

The NovaBone regenerative portfolio is rounded out by a series of collagen wound dressings to include tape and plug config-urations. As collagen is naturally hemostatic, these products have found a wide range of applications to include extraction sockets, repairs to a tear of the Schneiderian membrane in a sinus augmentation procedure, and short-term containment of bone grafting materials. NovaBone has a number of products in its product development pipeline that capitalize on its core competency with collagen and bioactive glass implantable biomaterials.

“We have been working on peri-implant regeneration for years, and we have found that merely osteoconductive biomaterials are not consistently adequate for regeneration in these challenging situations. Our preclinical findings with the use of calcium phosphosilicate morsels have shown that the osteostimulative properties of this graft can vastly increase the attachment of osteoblasts on implant surfaces, making it a great fit for peri-implantitis surgery.”
— Dr. George Kotsakis, DDS, MS, Associate Professor, Department of Periodontics, University of Texas Health Science Center at San Antonio (UTHSCSA)

The NovaBone bone grafting portfolio is distributed exclusively in the United States and Canada by Osteogenics Biomaterials (www.osteogenics.com).