Bimini Health Tech Receives Class III Regulatory Approval to Market Puregraft® Fat Transfer Products in Japan
February 23, 2021
SOLANA BEACH, Calif., Feb. 23, 2021 /PRNewswire/ — Bimini Health Tech (“Bimini” or the “Company”), a diversified global medical aesthetics and regenerative therapy company, announced today that it has received approval from Japan’s Pharmaceutical and Medical Device Agency (“PMDA”) to market the Company’s Puregraft family of autologous fat transfer products in Japan.
Bimini will market the complete portfolio of Puregraft fat transfer products in Japan through its local partner PRSS Japan Co., Ltd. (“PRSS”), a leading provider of surgical and medical devices in the fields of plastic and reconstructive surgery. PRSS will sell Bimini’s Puregraft products through a dedicated sales force to over 2,000 hospitals and clinics across Japan.
“This is a great achievement for Bimini Health Tech team as we drive the global adoption of our Puregraft products. PMDA approval will allow our trusted partner, PRSS, to launch the Puregraft family of products into the Japanese market, further broadening Puregraft’s global recognition as the gold-standard in fat transfer,” said Brad Conlan, CEO of Bimini Health Tech. “Plastic surgery trends are shifting towards more natural approaches like autologous fat transfer procedures and the demand for predictable, outcome-based technology has increased.” Brad continued, “Puregraft fulfills this need by providing the patient with assurance that the graft they are receiving is natural with a high retention rate post-transplant. Our commitment is to the patient, the physician, and their trust in Puregraft.”
Puregraft’s patented filtration technology selectively removes up to 97% of the contaminants from the fat (adipose) graft material, while preserving the structural integrity and regenerative properties of the tissue, leading to optimal graft composition and reliable long-term graft retention.