From product debuts and approvals, here are four key updates from orthobiologic companies since June 4.
1. Ossium Health's OssiGraft Prime was used in its first successful case. The first case was an arthroscopic ankle fusion, according to a news release. OssiGraft Prime is derived from donors with a median age of 35 and a maximum age of 55, and it has a high composition of cancellous bone to promote faster bone regeneration.
2. SurGenTec earned FDA 510(k) clearance for its B-Man bone marrow aspirate kit. It uses a centrifuge-free method for collecting aspirate with minimal contaminants. It has a diamond-tip trocar that works with CELLect filtration technology to reduce bone spicules and other impurities.
3. Vericel earned FDA approval for a supplemental Biologics License Application, which will expand the company's Maci label to include arthroscopy, according to an Aug. 26 news release. The expanded label approves Maci in knee arthroscopy to repair symptomatic single or multiple full-thickness cartilage defects up to 4 cm. Maci Arthro is a less invasive technique compared to the standard approach and lets surgeons deliver the implant through small incisions.
4. LifeNet Health, in partnership with Johnson & Johnson MedTech, launched the PliaFX Pak bone allograft in the U.S. The bone graft includes a proprietary formula of bone chips and demineralized cortical fibers processed with PliaFX's fiber technology. It can be moldable once rehydrated without the need for a carrier, and it has numerous contact points for platelet attachment.