NuVasive's (NUVA) PRECICE System Gets Expanded FDA Approval

 | Oct 12, 2017 09:03PM ET

NuVasive, Inc. (NASDAQ:NUVA) has been in the news of late for the receipt of expanded FDA 510(k) approval for its advanced magnetic and non-invasive limb lengthening technology — PRECICE.

Falling under NuVasive Specialized Orthopedics (NSO), PRECICE can now be used to treat open and closed fracture fixation, pseudoarthrosis, malunions, nonunions and bone transport. Notably, this product was earlier allowed for use in limb lengthening procedures to elongate the femur and tibia. The approval is expected to considerably drive Nuvasive’s customer base.

The PRECICE platform comprises an intramedullary device that on being implanted uses an external remote controller in order to non-invasively compress and distract long bones. Per the company, the key to the PRECICE platform is the magnetic interaction between the external remote control and PRECICE intramedullary nail.

Notably, NSO operates as a wholly owned subsidiary of NuVasive since the acquisition of Ellipse Technologies in 2016. NuVasive continues to gain share in its NSO portfolio, which includes MAGnetic External Control (MAGEC) for early-onset scoliosis and PRECICE technology, both built on the MAGEC technology platform.

Through this latest development, NuVasive expects to gain traction in the fast growing limb reconstruction and trauma market. A report from Allied Market Research published by Ortho Spine News on the global extremity reconstruction market substantiates this view. Per the report, the global extremity reconstruction market is expected to reach a value of $3,041 million, at a CAGR of 7.5% between 2016 and 2022.

We believe unhealthy lifestyle resulting in several joint disorders, rapidly ageing population, rising awareness, technological advancement and increased spending in healthcare by government and individuals will continue to drive the limb reconstruction and trauma market. Thus, NuVasive’s latest FDA approval will likely help it to cash in on the bountiful opportunities in the niche market.

Share Price Movement

NuVasive has been trading below the broader industry over last. The stock has lost 11.9% in comparison to the broader industry’s decline of 0.1%. We believe this latest development will help the company boost investors’ sentiments and reverse the downtrend.