Research

“One Step Forward to a Former Vision”

The InRoad® of today is the culmination of well over a decade’s worth of research, development, and working towards marketability by the founding members of OsteoGene Tech. The synthetic bone graft brings a novel solution to bone defects that could revolutionize the dental industry, but this is only the beginning of a long, arduous path towards greater innovation for InRoad®. Ironically, the first step forward for OsteoGene Tech is an echo from their beginnings.

The uses of synthetic bone grafts are not, in any way, limited to the dental field, and while InRoad® is a synthetic dental bone graft, OsteoGene Tech’s initial vision for their research was directed towards a different target audience. In fact, the initial research that led to InRoad®’s development was originally intended for military personnel injured in the line-of-duty. Open fractures were and are very common in armed conflict. The use of weapons such as improvised explosive devices (IEDs), vehicle-borne improvised explosive devices (VB-IEDs), car bombs, and suicide bombers resulted in devastating extremity wounds, which often involved fragmentation of bones. Medics reported open fracture wounds for every two soldiers injured, and of these, 82% became a major source of morbidity due to infection. In a turbulent battlefield with limited resources, infection commonly led to nonunion–the failure of fractured bones to heal after an extended period of time, debilitating soldiers for years after the initial injury and, in some cases, following them for the rest of their lives.

Research efforts in this area focused on a wide range of issues including fractures, massive periarticular reconstructions, inflammation, pain management, infection prevention, and vascular reconstruction. However, recent works recognized critical-size segmental bone defects as a challenging clinical problem for which no definitive and fully satisfactory treatment exists. Segmental bone defects are bone voids that will not naturally heal and fill without third-party intervention, but while there are current solutions available, there are heavy drawbacks to utilizing them as well such as limited availability and prolonged treatments. A successful realization of the research would have an enormous impact on the lives of soldiers and veterans and reduce the cost of treatment for the military if there is a decrease in the recovery period of injured personnel. This research could lead to the elimination of the need for complex surgery, an increase in morale, fewer surgical complications, early ambulation, reduced pain, stiffness, and arthritis as a consequence of the injury, and a significant improvement in the soldiers’ quality of life.

New treatment modalities for critical-size segmental bone defects that are geared specifically towards repairing the types of injuries sustained by modern soldiers are vital to reducing casualties in armed conflict. Not only would the treatment need to be effective for combat-related injuries, but it would also need to be designed to be practical for rapid, mobile, multi-staged environments due to the nature of modern military trauma medicine. It is the hope of OsteoGene Tech that they will be able to manufacture a product that will do just that along with greater accessibility and affordability than what is currently available.

While OsteoGene Tech temporarily shelved their progress in this field of research, that is not to say that they lack compared to other competitors in research and development for this unmet medical need. Clinical trials are paramount to developing and vetting any medical device, particularly so when designed for use by governmental institutions such as the military. In 2009, Dr. Daniel S. Oh conducted and published a scientific study in which the base technology that evolved into InRoad® was tested to determine the feasibility of its application in open fracture, segmental bone defects. The researchers developed an anatomically conforming trabecular bone-like synthetic graft two centimeters in length and tested its effectiveness through application in a dog tibia. The outcomes were reported to be highly successful; however, that was only the beginning.

Successful real-world, clinical application cannot be proven with preclinical animal studies, and to this point, the concept of using InRoad®’s technology in this way is still highly theoretical and based on academic research. The current synthetic bone graft produced by OsteoGene Tech should not be utilized outside of its specified intended uses, but the corporation’s scientists are hopeful that, in the future, they may be able to provide medical devices for treatments beyond their current scope. OsteoGene Tech is looking towards the future with reconstruction of critical-sized segmental bone defects as a next goal to conquer.

References

1. US Casualty Status: Operation Iragi Freedom, Operation Enduring Freedom. Department of Defense, http://www.defenselink.mil/news/casualty.pdf, 2009.

2. Military Casualities in Global War on Terrorism (IUF and OEF combined), Sorted by reason code. Department of Defense, http://siadapp.dmdc.osd.mil/personnel/CASUALTY/gwot_reason.pdf, 2009.

3. Jun Sik Son, Jong Min Kim, Myungho Han, Seok Hwa Choi, Francis Y. Lee, Daniel S Oh. Bone Regeneration of Tibial Segmental Defect Using Isotropic-Pore Structures Hydroxyapatite/Alumina Bi-Layered Scaffold: In Vivo Pilot Study. Journal of Long-Term Effects of Medical Implants. 2011;21(2):159-67

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