With support from Combat Casualty Care Research Program and MTEC, NuShores Biosciences, LLC has developed an automated Factory in a Box (FIAB) that is capable of manufacturing it’s lead product, NuCress™ Bone Void Filler (BVF). 

While the existing manufacturing operations rely heavily on labor-intensive methods, NuShores endeavored to create a compact, automated, FIAB system. The vision for this innovative unit would be to convert raw materials into fully packaged, sterilized, and validated medical products. This type of portable and automated manufacturing unit could be used in various military settings, from field hospitals to naval medical bays, enabling the on-site production of medical devices. The ability to produce such items on-demand and in close proximity to where they are needed would be invaluable in conflict zones or remote military operations where logistics and supply chains are often disrupted. A cGMP compliant FIAB system would ensure that high standards of quality and safety are met, even in challenging environments. This aligns with the military’s need for rapid, reliable, and flexible medical support in diverse and sometimes austere locations. 

 The NuCress™ Bone Void Filler streamlines bone healing and regeneration for orthopedic, dental, and spine care by minimizing the need for additional surgeries and donor tissue. Transitioning to an automated FIAB system from the current fabrication process has the potential to mitigate risks, reduce costs, and increase production. The ultimate vision for this product is to create a mobile, automated unit that can serve military medical needs ensuring cGMP compliance and high-quality, safe medical products under any conditions at the closest possible point of care.  Over the course of the project, NuShores successfully researched and designed multiple iterations of an automated production platform, which culminated in the construction of a prototype FIAB. This working prototype integrates multiple complex engineering systems controlled by in-house customized software, resulting in a final product that satisfies the rigorous quality requirements. 

In the future, NuShores will continue to enhance the FIAB with miniaturization through advanced intelligent manufacturing. This transition from manual to automated methods of NuCress™ production promises increased efficiency, quality, cost-effectiveness, superior data analytics for process optimization, and the reallocation of human resources to more complex tasks, increasing overall productivity. 

The research project award recipients were selected from the respondents to MTEC’s Request for Project Proposals soliciting medical technological solutions related to MTEC’s Technology Focus Areas (Solicitation #MTEC-20-07-QualRegen).   

About NuShores Biosciences LLC:  NuShores Biosciences LLC, established in 2014, is an R&D firm specializing in innovative tissue regeneration technologies, licensed from the University of Arkansas at Little Rock. With support from the DoD and NIH, NuShores has developed the NuCress™ Bone Void Filler – a device known for its consistent bone formation, flexibility, and adaptability in surgical settings, with the goal of reducing the need for additional surgeries or donor tissues. With robust preclinical study data, the technology has shown to promote safe and reliable bone regeneration for orthopedic, dental, and spine uses with the goal of minimizing the need for additional surgeries and donor tissue.  

NuShores is also gearing up for human clinical trials, leveraging standardized production processes for cost-efficiency and is well-positioned to serve military and civilian markets through strategic partnerships. Our mission is to improve the life of people with severe tissue regeneration needs and conditions safely and effectively. Transitioning to an automated ‘Factory in a Box’ system has the potential to mitigate manufacturing errors, reduce costs, and increase production. The ultimate vision for this product is to create a mobile, automated unit that can serve military medical needs ensuring cGMP compliance and high-quality, safe medical products under any conditions at the closest possible point of care.