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Globus Medical (GMED) Gets FDA Nod for Excelsius3D

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Globus Medical, Inc. GMED recently announced the receipt of FDA’s 510(k) clearance for its Excelsius3D, an intelligent intraoperative 3-in-1 imaging system. The Excelsius3D combines 360-degree cone-beam computed tomography (CT), fluoroscopy and high-resolution digital radiography into one unified solution. It eliminates the need for multiple imaging systems during a single procedure.

Excelsius3D is designed for 2D fluoroscopy, 2D digital radiography and 3D imaging of adult and pediatric patients. The system’s images are compatible with image-guided systems such as ExcelsiusGPS.

The Excelsius3D is the company’s first imaging system 510(k) to be filed with the FDA’s Office of In Vitro Diagnostics and Radiological Health. The recent regulatory go-ahead for Excelsius3D is expected to enable Globus Medical to expand into a new product space that is the intraoperative imaging system market.

More in the News

Excelsius3D functions as a standalone imaging unit or as an extension to the Excelsius ecosystem. The system’s precise motion, omnidirectional wheels and intelligent maneuverability offer unmatched imaging capability. Its agility and efficiency is amplified by a compact footprint and elimination of a separate viewing station.

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The company at present is accelerating the production of the Excelsius3D as it prepares for a commercial release in the fourth quarter.

Industry Prospects

Per a report published in MarketsandMarkets, the global intraoperative imaging market size is expected to see a CAGR of 5.2% by 2025. Factors such as technological advancements, growing incidence of surgeries, increased funding and public-private investments are driving market growth. The higher incidence of chronic diseases coupled with higher death rates in developing economies such as India, China, Brazil, South Korea, Turkey, Russia and South Africa showcases the need for early detection and thereby is expected to drive market growth further.

Given the market prospects, the recent regulatory authorization of Globus Medical’s Excelsius3D seems well-timed.

Notable Developments

In its earnings call for second-quarter 2021, Globus Medical noted the launch of HEDRON L in the reported quarter. This new 3D-printed spacer adds to the RISE-L, ELSA, CORBEL and TransContinental to create the most comprehensive suite of lateral inter-body solutions available in the market at present. This broad product portfolio enables surgeons to perform lateral access surgery utilizing multiple expandable options, multiple static spacers and integrated plate-spacer solutions.

In July 2021, Globus Medical announced that its ExcelsiusGPS Robotic Navigation system has been utilized to perform more than 20,000 spine procedures. The number of procedures that incorporate the ExcelsiusGPS platform was recorded to be at an all-time high. The ExcelsiusGPS platform is developed to overcome the limitations associated with minimally-invasive surgery.

In April 2021, the company launched CREO ONE, the market’s first robotic screw designed for spine surgery with ExcelsiusGPS. The CREO ONE simplifies pedicle preparation while maintaining navigational accuracy and increasing pullout strength by 86% compared to traditional pedicle screws tapped to size. It is part of the company’s CREO AMP family.

Share Price Performance

The stock has outperformed its industry over the past year. It has rallied 45.1% compared to the industry’s 13% growth.

Zacks Rank and Key Picks

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

A few better-ranked stocks from the Medical-Instruments industry include IDEXX Laboratories, Inc. IDXX, Intuitive Surgical, Inc. ISRG and Semler Scientific Inc. SMLR, each sporting a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

IDEXX has a long-term earnings growth rate of 19.9%.

Intuitive Surgical has a long-term earnings growth rate of 9.7%.

Semler Scientific has a long-term earnings growth rate of 25%.

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