FDA OKs Cellmyx’s intelliFat BOD

Cellmyx, an autologous adipose grafting and transfer companies and developer of medtech for orthopedic physicians, pain management, and regenerative medicine, gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its intelliFat BOD, a single-use kit for macro, micro, and nano fat tissue harvesting, processing, and transfer.
 
intelliFat BOD was cleared for orthopedic, plastic, and cosmetic surgery procedures. The technology uses the patient’s adipose tissue for patient recovery and healing. It’s also sometimes used in tandem with traditional orthopedic surgery to advance outcomes.
 
The technology preserves adipose cellular and tissue micro-architecture, removing oil emulsion and blood for a tissue byproduct that is minimally manipulated in accordance with FDA guidelines. The sterile, disposable kits contain proprietary and standalone components to harvest, process, and transfer autologous fat tissue to use as an alternative and/or adjunct to surgery for filling soft tissue defects and promote healing.
 
intelliFat BOD lowers procedure times to under 30 minutes and doesn’t require incising, stitching, or scarring the patient.
 
“I began performing autologous fat derived treatments for orthopedic regenerative medicine in 2009, the first physician in New England, and among the earliest in the country,” Dr. Paul D. Tortland, D.O. FAOASM, RSMK told the press. “Over the years I’ve trialed most commercially available systems to harvest and prepare adipose for injection. I have found these systems are cumbersome to use, time-consuming, or produce suboptimal product for injection. But with intelliFat BOD Cellmyx hit the mark. Their kit is elegantly simple, fast and easy to use, and produces a superlative final product that’s easy to inject. Most importantly, I’m seeing outstanding clinical results.”
 
The clearance specifically includes procedures for neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic, cosmetic, and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, laparoscopic surgery, arthroscopic surgery, and thoracic surgery.