In the race to capitalize on patient-driven interest in stem cells, biologic solutions and “regeneration” of a more vital, healthy and functional body, there has been an explosion of offerings that lack scientific controls, validity and meaningful evidence.
With the NASS 2019 Annual Meeting approaching, it's an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. This round-up shares another entrant into the sacroiliac joint treatment arena, an implant company's first clearance for an enabling technology and additional details about some lesser-known companies to watch.
SeaSpine announced 2Q18 revenue of US $36.4MM, +6.5% vs. 2Q17, and 1H18 revenue of $69.6MM, +5.3% vs. 1H17. This is the company's highest quarterly growth rate since its spinoff from Integra LifeSciences in 2015.
Pre-clinical studies suggest that multipotent adult progenitor cells (MAPCs), such as the technology used in RTI Surgical's map3® Cellular Allogeneic Bone Grafts, exhibited a more robust angiogenic protein release profile vs. mesenchymal stem cells in vitro.
Preclinical data on adipose-derived mesenchymal stem cells in a rat model, using technology similar to AlloSource's AlloStem® Cellular Bone Allograft process, showed bone formation within a critical-sized defect in all study subjects.
MiMedx signed a definitive agreement to acquire Stability Biologics for US $10MM in cash and stock. Stability Biologics provides human tissue products for the surgical, spine and orthopaedic industries. The transaction is expected to close in early 1Q16.