Zimmer Biomet Holdings Inc. has won the FDA’s nod for its Rosa Partial Knee system for robotically assisted partial knee arthroscopy. The new system is the latest addition to the Rosa Robotics platform, which also includes the Rosa Knee system for total knee replacement and Rosa One for neurosurgical and spine procedures.

The Rosa Partial Knee system is designed to be compatible with Zimmer’s Personal partial knee. It incorporates 2D to 3D X-Atlas imaging technology and real-time, intraoperative data collection on both soft tissue and bone anatomies to ensure accurate bone cuts and improve range of motion gap analysis.

“The FDA clearance of the Rosa Partial Knee system just two years after the introduction of the Rosa Total Knee system builds on the success of our Rosa robotics portfolio, which is designed to help enhance surgical accuracy, precision and efficiency, through the use of intraoperative data that can personalize each procedure,” said Ivan Tornos, Zimmer Biomet’s COO. “As a result, the Rosa Partial Knee system empowers patients to truly get the knee that’s the best fit for their needs.”

Underutilized need

Warsaw, Ind.-based Zimmer believes its new Rosa system can fill an unmet need in patients with damage to only one side of their knee by leaving the healthy side of the knee intact. Other benefits of partial knee replacement include retention of the anterior cruciate ligament, greater range of motion, shorter hospital stays and a lower risk of postoperative complications. Yet while research shows that 50% of knee replacement patients are candidates for partial knee surgery, only 10% of those patients currently receive partial knee implants.

The company is planning a controlled launch. “Over the next several months, we will be training surgeon customers on Rosa Partial Knee to promote the best possible user experience,” Liane Teplitsky, worldwide vice president and general manager for tech and data solutions, told BioWorld. “The system is intended to be used on mature skeletal anatomy, but, ultimately, use is based on the physician’s decision on whether or not the patient would be a good candidate for robotic partial knee replacement.”

Zimmer sees a large opportunity in the partial knee space. Since launching in 2017, the Persona partial knee has become the leading implant system, and Zimmer Biomet estimates it already has about 50% of the global partial knee market. With the introduction of Rosa’s robotically assisted technique, the company stands to claim an even larger share and shift eligible candidates from total to partial knee implants.

“According to a recent report, roughly 90,000 partial knee procedures were performed in the U.S. in 2019, and this number will continue to grow over the coming decade,” Teplitsky said.

Strengthens competitive position

Zimmer’s “Rosa indication expansion strategy is taking hold,” Cowen analyst Joshua Jennings wrote in a note.

“This approval expands Rosa’s functionality and improves ZBH’s competitive position in the partial knee segment where it already holds a leading share position. Expansion into robotic partial knee procedures signals ZBH can have success building out Rosa indications with the Rosa Total Hip on tap for 2H’21.”

The Rosa Partial Knee system is the newest addition to the ZBedge connected intelligence suite of digital and robotic technologies. Intraoperative data collected by the Rosa Partial Knee system can be integrated with pre- and postoperative data collected by Zimmer’s remote care management platform, Mymobility with Apple Watch. All of that data can then be analyzed by Orthointel, using machine learning to glean clinical insights throughout the episode of care.

Last fall, Zimmer reported preliminary results showing that its Mymobility digital platform with Apple Watch demonstrated similar outcomes to traditional care models for primary knee arthroscopy while requiring fewer physical therapy visits. Patients in the Mymobility arm also had fewer emergency room visits and lower hospital readmission rates.

Zimmer launched the Rosa platform in 2019 following FDA approval for its total knee application early that year. The rollout was measured at first but is building momentum, Argus analyst David Tuong wrote in a recent research note. “Rosa placements appear to be accelerating as orthopedic surgeons prepare for the availability of the full portfolio of knee and hip applications on the platform. In 4Q20, Zimmer placed 115 Rosa units and surpassed the 300-unit benchmark for cumulative placements.”

During last month’s virtual Cowen Healthcare Conference, Zimmer CEO Bryant Hanson said he believes there are ample tailwinds associated with robotics penetration in the market, and the ability to collect and analyze data gives Zimmer an edge over competitors.

“We think that that strength in the data that we’re going to be able to have will differentiate us – not just with robotics but in the entire ecosystem and allow us to get more than our fair [market] share.”

In February, Zimmer reported plans to spin off its spine and dental businesses into a separate, publicly traded company. The move would allow Zimmer to sharpen its focus on its core businesses in knees, hips, sports medicine, extremities and trauma, and craniomaxillofacial and thoracic. With a total market of $43.5 billion, the company sees a significant opportunity to grow market share in those core businesses. In addition to Rosa and Persona knees and Mymobility, its portfolio includes the Avenir Complete hip system and Signature One surgical planner, among other products.