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Zimmer Biomet and Canary Medical Announce FDA De Novo Classification Grant and Authorization to Market the World’s First and Only Smart Knee Implant

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Zimmer Biomet and Canary Medical Announce FDA De Novo Classification Grant and Authorization to Market the World's First and Only Smart Knee Implant | Pharmtech Focus

Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, and Canary Medical, a medical data company, today announced U.S. Food and Drug Administration (FDA) De Novo classification grant and authorization to market the tibial extension for Persona IQ®, the world’s first and only smart knee cleared by the FDA for total knee replacement surgery. Persona IQ combines Zimmer Biomet’s proven and trusted knee implant, Persona® The Personalized Knee®, with Canary Medical’s proprietary implantable canturioTMte tibial extension sensor technology that measures and determines range of motion, step count, walking speed and other gait metrics. Persona IQ will work together with Zimmer Biomet’s remote care management platform, mymobility® with Apple Watch®, as well as other components of the ZBEdge™ Connected Intelligence Suite.

“We are excited to introduce Persona IQ, the world’s first and only smart knee implant, which offers a wealth of objective data to monitor patients’ post-operative progress,” said Bryan Hanson, Chairman, President and CEO of Zimmer Biomet. “As the newest component of ZBEdge, Persona IQ advances our vision of creating a seamlessly connected suite of digital health and robotic technologies to deliver objective data to clinicians throughout the surgical journey. Following a recent expansion of our partnership with Canary Medical, we now expect that Persona IQ will be the first in a broader portfolio of smart implant technologies in various orthopedic surgery applications.”

“After almost a decade of development and designation by FDA as a Breakthrough Device, we’re proud that our CANARY canturio™ te technology has enabled Zimmer Biomet to debut the world’s first smart knee implant. Persona IQ reflects our shared belief that automatic, reliable and accurate data collection and analysis represents the future of orthopedic care,” said William L. Hunter, MD, MSC and CEO of Canary Medical. “The launch of Persona IQ marks the start of an exciting, ongoing partnership with Zimmer Biomet designed to innovate smart implant technologies that help joint replacement patients regain and maintain their mobility with confidence.”

“Historically, surgeons relied on patient-reported metrics during intermittent post-op follow up visits to assess the quality and pace of recovery from knee replacement surgery. Now, with physiological tools to support remote monitoring technologies like mymobility, and smart implants like Persona IQ, we can actively monitor patient recovery and rely on real-world, objective data to supplement patient care,” said Peter Sculco, MD, orthopedic surgeon at Hospital for Special Surgery in New York. “In addition, providing patients with access to their own mobility data will allow them the opportunity to be engaged in their recovery in a new way.”

Once surgically implanted in the knee, Persona IQ records and wirelessly transmits a wide range of gait data to a patient’s personal base station at home. The data are then securely delivered to a cloud-based platform. Surgeons can assess post-surgery recovery progress by comparing pre-operative mobility metrics captured by mymobility, with post-operative gait metrics collected by Persona IQ. Ultimately, the data from Persona IQ will be seamlessly integrated with pre-, intra- and post-operative data collected by the ZBEdge™ Connected Intelligence Suite and analyzed by OrthoIntel Orthopedic Intelligence Platform to provide surgeons with objective data as a supplement to patient care.

“Zimmer Biomet has a strong heritage of delivering revolutionary innovations that can transform the surgical experience and enable data-supported patient care,” said Ivan Tornos, Chief Operating Officer of Zimmer Biomet. “The post-operative data captured by Persona IQ, together with the wealth of pre- and post-operative data collected by the mymobility platform, will provide surgeons with an exceptional level of objective and comparative data intelligence.”

Persona IQ features the CANARY canturio™ te Tibial Extension proprietary implantable sensor developed by Canary Medical. The sensor technology was licensed by Zimmer Biomet through an exclusive partnership agreement with Canary Medical to develop first-to-market smart orthopedic implants to support remote monitoring and tracking of patient recovery metrics. The CANARY canturioTM te uses the same material and technology found in implanted cardiac devices such as pacemakers. The sensor is powered by a battery with a lifespan of up to 10 years, so patients will not need to charge the device. In addition, as an implanted technology, data is collected passively and does not rely on daily patient compliance to ensure information is captured by Persona IQ.

Persona IQ will be available to healthcare professionals and patients in the coming months. To learn more about Persona IQ and Persona The Personalized Knee, visit http://www.zimmerbiomet.com/personaiq. Please refer to the labeling for a complete list of warnings, precautions and contraindications.

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