FDA grants breakthrough status to Zimmer Biomet’s iodine-treated hip system

WARSAW - The U.S. Food and Drug Administration has granted Breakthrough Device Designation to Zimmer Biomet Holdings, Inc.’s (NYSE and SIX:ZBH) iodine-treated total hip replacement system, the company announced Tuesday. The medical device giant, currently trading at $103.12 and identified as undervalued by InvestingPro analysis, has maintained strong financial performance with $7.8 billion in revenue over the last twelve months.

The designation marks the first time a Zimmer Biomet product has received this status, which provides prioritized regulatory review and more timely feedback from the FDA. The company’s robust financial health, earning a "GREAT" rating from InvestingPro’s comprehensive analysis, positions it well to capitalize on this regulatory milestone.

The iTaperloc Complete and iG7 Hip System integrates controlled-release iodine surface treatment designed to help address infection risks in joint replacement procedures. The technology recently received approval from Japan’s Pharmaceutical and Medical Devices Agency in September, becoming the first orthopedic implant with iodine technology to receive regulatory approval.

Periprosthetic Joint Infections (PJI), which the system aims to address, occur in approximately 1% to 2% of primary total joint arthroplasty procedures and can have serious consequences, with mortality rates approaching 11%.

"The Breakthrough Device Designation from the FDA underscores the need for innovations to reduce complications that can happen with joint replacement procedures," said Ivan Tornos, Chairman, President and CEO of Zimmer Biomet, according to the press release statement. With an impressive 71.25% gross profit margin and consistent dividend payments for 14 consecutive years, the company demonstrates both operational efficiency and financial stability. For deeper insights into Zimmer Biomet’s financial health and growth potential, investors can access the comprehensive Pro Research Report available on InvestingPro, which covers this and 1,400+ other top US stocks.

The system combines Zimmer Biomet’s Taperloc Complete Hip System and G7 Acetabular System with iodine technology. Iodine is a biocompatible nutrient commonly used in medicine as an antiseptic and does not cause antibiotic resistance.

The FDA’s Breakthrough Devices Program is designed to expedite the development and review of medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

In other recent news, Zimmer Biomet Holdings, Inc. has completed its acquisition of Monogram Technologies, an AI-driven orthopedic robotics company. This acquisition adds advanced robotic technologies to Zimmer Biomet’s portfolio, with Monogram’s knee replacement system expected to be commercialized by early 2027. Additionally, Japan’s Pharmaceutical and Medical Devices Agency has approved Zimmer Biomet’s iTaperloc Complete and iG7 Hip System, the first implants with Iodine Technology designed to reduce bacterial adhesion. In the United States, Zimmer Biomet has launched the Gorilla Pilon Fusion Plating System and Phantom TTC Trauma Nail for complex foot and ankle trauma procedures. On the analyst front, Stifel raised its price target for Zimmer Biomet to $118, maintaining a Buy rating, while Rothschild Redburn initiated coverage with a Buy rating and a $130 price target. These moves reflect confidence in the company’s innovative pipeline and growth potential in the orthopedic market.

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