The prestigious Orthobond Corporation has reached a significant milestone in obtaining FDA de novo approval for its state-of-the-art Ostaguard antibacterial coating technology. This exciting announcement was conveyed in a recently issued press release, representing a significant advancement in the realm of medical device innovation.
The Ostaguard technology is equipped with a non-eluting coating specifically engineered to effectively eradicate bacteria known to cause infections related to medical devices. This cutting-edge coating has been developed to furnish a crucial layer of protection in various medical applications, including joint reconstruction, neuromodulation, oncology, sports medicine, plastic surgery, and cardiology.
In addition to its medical applications, the Ostaguard technology also has the potential to be utilised for non-medical purposes, such as in textiles and consumer products. This versatility underscores the far-reaching impact and potential benefits of this innovative antibacterial coating.
David Nichols, the Chief Executive Officer of Orthobond, expressed pride in the company’s evidence-based submission to the FDA, underscoring the significance of this accomplishment. He also highlighted the potential for Ostaguard to establish a new standard of care in protecting patients from harmful pathogens, ultimately propelling transformative changes in the field of surgery and healthcare as a whole.
With FDA de novo approval now secured, Orthobond is prepared to make its pioneering technology accessible to a wide range of customers. The regulatory green light for Ostaguard represents a critical step forward in advancing patient safety and mitigating the risks associated with device-related infections.
In conclusion, the approval of Orthobond’s Ostaguard antibacterial coating technology is a momentous development with far-reaching implications for the medical industry. The potential to enhance the safety and efficacy of medical devices across various specialties is a testament to the impact and value of ongoing innovation in healthcare. This achievement serves as a powerful example of the positive outcomes that can be realised through dedication to evidence-based research and the pursuit of groundbreaking technological advancements.
Source: Orthobond Corporation