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Orthofix (OFIX) Wins FDA Clearance for CONSTRUX Mini Ti System

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Orthofix Medical Inc. (OFIX - Free Report) recently announced the receipt of FDA 510(k) clearance for 3D-printed CONSTRUX Mini Ti Spacer System. Notably, the CONSTRUX Mini Ti cervical spacer with Nanovate Technology is the first 3D-printed titanium interbody launched by Orthofix.

Orthofix has also marked the initial patient implant of the CONSTRUX Mini Ti Spacer System, a product designed to improve anterior cervical discectomy and fusion (ACDF) procedures.

Per Orthofix management, the company is committed to expand the wide range of cervical spine solutions with technologies like the CONSTRUX Mini Ti Spacer System, which can enhance patients’ outcome.

More in the News

Orthofix’s cervical spine offerings feature a wide collection of implants that support surgeons in restoring spinal alignment and reducing pain and nerve compression. Notably, the CONSTRUX Mini Ti Spacer System with Nanovate Technology is one of the many products with nanotechnology FDA clearance offered by Orthofix.

Performed to treat a herniated cervical disc or degenerative disc disease, the ACDF procedure involves the replacement of a patient’s damaged cervical disc with an interbody full of biologics to promote fusion to give stability and strength to the area. The CONSTRUX Mini Ti System’s optimized porosity and surface let bones to grow into and through the spacer in order to support the patient’s fusion.

The 3D-printed endplates of the implants with Nanovate Technology demonstrated a significant rise in growth factors involved in osteogenesis and osteoblast maturation, resulting in a more favorable osteogenic environment for bone ingrowth compared to solid PEEK devices.

Growth in Orthofix’s Spinal Implants

Orthofix’ global spinal implants revenues were up 9% in the fourth quarter of 2020. The primary growth driver was 11% growth in U.S. spine implant revenues on strong M6 disc sales.  

Orthofix also announced a new partnership with Neo Medical to develop and market single-use spinal instrument solutions focusing on improving patient outcomes during the fourth quarter of 2020.

Industry Prospects

Per a report by Allied Market Research, the global spinal implants and devices market was valued at $11,356.59 million in 2019 and is projected to reach $15,054.07 million by 2027, at a CAGR of 5.7%. The major factors that contribute to market growth include shift toward minimally-invasive spine procedures, rise in elderly population, surge in prevalence of spinal disorders owing to sedentary lifestyle and advancements in spine surgery.

Price Performance

Shares of the company have gained 57.2% in a year’s time compared with the industry’s growth of 36.5%.

Zacks Rank and Key Picks

Currently, Orthofix carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the broader medical space include Asensus Surgical, Inc. (ASXC - Free Report) , Cantel Medical Corp. (CMD - Free Report) and ConforMIS, Inc. (CFMS - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Asensus Surgical has a projected long-term earnings growth rate of 71%.

Cantel Medical has a projected long-term earnings growth rate of 19%.

ConforMIS has a projected long-term earnings growth rate of 42%.

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