Bimini Health Tech Achieves FDA Clearance for Float PRP
Bimini Health Tech has made a groundbreaking advancement in the health technology sector by successfully obtaining the United States FDA 510(k) Class II clearance for its innovative Platelet-Rich Plasma (PRP) preparation technology known as Float PRP. This clearance marks an important milestone for the company, as it enhances their commitment to pioneering cutting-edge medical technologies.
The Float PRP system is designed to provide efficient and rapid concentration of platelets and growth factors derived from whole blood, making it applicable for immediate use at the point of care. Featuring co-polymer technology, Float PRP enables the customization of platelet concentrations, catering directly to the specific needs of healthcare providers. This advancement not only emphasizes speed and simplicity but also optimizes workflow, allowing medical professionals to perform their duties more conveniently without compromising efficacy or platelet recovery.
Bradford A. Conlan, the CEO of Bimini Health Tech, emphasized the strategic significance of the FDA clearance: "The Float PRP furthers our commitment to develop best-in-class technologies while simultaneously strengthening our existing strategic partnerships." This statement underscores the company’s ambitions to remain at the forefront of innovative health solutions.
Jeff Greiner, the Chief Commercial Officer of Bimini Health Tech, articulated the uniqueness of the Float PRP system, highlighting its ability to precisely separate red blood cell (RBC) contaminants from platelet concentrates. He stated, "The Float PRP technology is unlike any technology currently on the market with a tuned density float that enables precise separation of the RBC contaminates from the platelet concentrates without sacrificing platelet recovery. This feature addresses significant challenges faced by other tube technologies that utilize separators. The Float PRP system allows for a customization of platelet concentration levels akin to double spin systems while maintaining a straightforward workflow that gel separators are known for. This combination of advanced customization and operational efficiency is a game-changer in the field."
The implications of this landmark clearance are vast and may reshape the PRP preparation landscape significantly. Many healthcare providers will benefit from the system's innovative approach to platelet preparation, thanks to its streamlined workflow and enhanced customization capabilities, which set it apart from existing products.
About Bimini Health Tech
Founded in 2013, Bimini Health Tech has rapidly established itself as a leader in the women's health market. With decades of experience underpinning its operations, Bimini focuses on developing, acquiring, and commercializing innovative products designed to create premium solutions for both patients and healthcare professionals. The company boasts a diverse product portfolio that includes the Puregraft® Adipose Filtration Systems, the Essence Acellular Dermal Matrix™, and the Serene Breast Implants®, along with Healeon PRP®.
Backed by more than 100 patents and over 20 device clearances and approvals, Bimini's products have been used in over 1.5 million procedures globally, highlighting its substantial impact on the healthcare landscape. The latest achievement with Float PRP is expected to further bolster Bimini Health Tech’s reputation, strengthening its position as a pivotal player in the health technology domain.
For more information, visit
Bimini Health Tech.