Bimini Health Tech Achieves EU MDR Certification

Approval Expands the Reach of Puregraft^® and Dermapose^® Fat Transfer Product Suites in Europe

PLANO, Texas, May 13, 2026 /PRNewswire/ -- Bimini Health Tech, a global leader in medical technologies for women's health, today announced the achievement of EU Medical Device Regulation (MDR) certification for the company. The achievement marks a significant milestone in the company's continued global expansion efforts.

"We are very pleased to achieve EU MDR certification for Bimini and also expand our product approvals for both our fat transfer product families, Puregraft and Dermapose," said Brad Conlan, CEO of Bimini Health Tech. "This milestone reflects the tireless dedication of our team and our continued investment in delivering high-quality, innovative technologies to patients and physicians around the world."

The Fat Transfer Market

According to the International Society of Aesthetic Plastic Surgery (ISAPS) recent Global Survey, fat transfer procedures increased 19.2% year-over-year to 940,000+ procedures worldwide. Both Bimini Health Tech products, Puregraft and Dermapose, aim to capture a significant share of those procedures in the near term.

Bimini Fat Transfer Products

Puregraft^® is designed to support rapid, efficient large-volume fat filtration and purification through a closed-system workflow. Its patented dialyzing filtration technology gently separates viable adipose tissue from blood, oil, and waste fluid, resulting in a high concentration of healthy, viable fat cells. The Puregraft^® product suite includes the Puregraft 50, Puregraft 250, Puregraft 850, and the recent U.S. FDA 510(k)-cleared Puregraft SYNC^® technology. Puregraft products are currently available in more than 50 countries worldwide. Explore the Puregraft^® product suite and the new Puregraft SYNC^® technology.

Dermapose^® is a fat transfer technology designed for small-volume filling and rejuvenation, enabling surgeons to harvest, purify, resize, and inject micro fat within a single closed system. Engineered to support efficient adipose processing and reinjection, the Dermapose^® suite streamlines workflow while promoting procedural versatility and consistency. Following EU MDR certification, Dermapose^® is available in the United States, European Union, Japan, Brazil, Australia, Canada, and Saudi Arabia. Discover the Dermapose^® approach to fat transfer technology.

About Bimini Health Tech

Founded in 2013, Bimini Health Tech is a global leader in the women's health market. Backed by decades of experience, Bimini is dedicated to developing, acquiring, and commercializing innovative products that deliver premium solutions for patients and physicians. Our portfolio includes the Puregraft Fat Filtration Systems, Essence Acellular Dermal Matrix, and Dermapose Fat Harvest and Sizing Systems. Supported by over 100 patents, 20 device clearances and approvals, and over 25 scientific publications, Bimini's products have been utilized in over 1.5 million procedures worldwide.

Learn more at www.biminihealthtech.com

Photo - https://mma.prnewswire.com/media/2977286/Puregraft_SYNC_Adipose_Filtration_System.jpg
Photo - https://mma.prnewswire.com/media/2977287/Dermapose_Refresh.jpg
Logo - https://mma.prnewswire.com/media/2977285/BIMINI_Logo.jpg