Canary Medical’s Smart Lumbar Spine Pad has been designated a “Breakthrough Device” by the FDA.

• The Smart Spine Lumbar Insert is the fourth Canary Medical product to receive Breakthrough Designation under the FDA’s Breakthrough Device Program
• The lumbar cassette is Canary Medical’s first application of intelligent sensors for spine treatments

VANCOUVER, British Columbia, May 29, 2024 (GLOBE NEWSWIRE) — Canary Medical, a healthcare data company focused on the development and commercialization of its patented implantable sensor technology and complementary data and analytics ecosystem, today announced the FDA’s “Breakthrough Designation” designation devices”¹ for Canturio^® Lumbar insert (canturio^®lc) with an implanted Canary Health reporting processor (CHIRP^®) System. Kanturio^®lc is intended for use with the lumbar interbody system to fuse the lumbar spine from L1 to S1. The insert is designed to provide objective kinematic data from an implanted medical device during the postoperative treatment of a patient’s symptomatic degenerative disc disease. The transmitted data will be used to remotely monitor the progress of union and facilitate the early detection of clinically significant instability, partial union or nonunion.²

Like the now commercialized Canturio^® Extension of the tibia (canturio^®these), kanturio^®lc aims to collect a variety of kinematic measurements for at least 10 years and collect data on each of multiple parameters across the entire patient population. The Canary data platform will provide clinicians with frequent, objective, aggregated population data on each patient’s activity level and kinematics, enabling each patient’s performance to be compared to their peers based on age group, gender and time since surgery. Physicians will have access to and use daily functional information to help decide whether to improve in-office patient testing and/or update the patient’s care plan in the year after surgery.

“Canturio approval^®lc This is the fourth consecutive time that a Canary Medical product has received Breakthrough Device designation from the FDA, an unparalleled achievement in our industry. First we received breakthrough designation for our Smart Knee, then for our Hip and Shoulder App, and now for our Smart Spine App. I would like to congratulate the entire Canary team on their continued excellence,” said Bill Hunter, M.D., founding member and CEO of Canary Medical.

“This is also Canary’s first smart spine offering and the company’s first FDA breakthrough designation outside of a large shared space, which we intend to maintain. Based on the results we have seen with our current “smart” knee product, this designation is also great news for future patients with lumbar spinal ankylosis. We look forward to finding an innovative spine partner to help bring this cutting-edge technology to market,” he continued.

This news follows Canary Medical’s recent FDA approval of Canturio Smart Extension (canturio^®se), 30mm version of the smart tibial stem extension integrated with Zimmer Biomet’s Persona IQ^® – Smart knee^® for patients who the physician feels would benefit from a shorter tibial stem. Kanturio^®se will be widely available for sale in late 2024. Current Canturio 58mm^®these the stem is still available for patients requiring a longer tibial stem.

About Canary Medical
Canary Medical is a healthcare data company focused on the development and commercialization of its patented implantable sensor technology and complementary data and analytics ecosystem. In 2021, Canary Medical launched canturio^®these, the world’s first “smart knee,” an extension of the tibia that is implanted in the body, where it monitors patient activity and joint function and transmits data to the cloud autonomously, requiring almost no patient compliance or physician involvement. The company was conceived and founded with the vision that healthcare transformation requires reliable and cost-effective healthcare data and that effective monitoring and analysis of this data will deliver better patient outcomes at lower costs. Canary Medical is led by a team of experienced entrepreneurs, researchers and data analysts, globally respected for their expertise in medical device design, development and informatics.

For more information, please contact us at [email protected] or visit www.canarymedical.com. Follow Canary Medical on Twitter at @CanaryMedical.

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Canarian medicine
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Canary® Quantiles® software and services and Canary® Recovery Curves® analytics provide healthcare professionals (HCPs) with additional aggregated population data when managing post-operative care for a total knee arthroplasty (TKA) patient. Healthcare professionals can filter or select additional views based on patient demographics (e.g. age) to analyze trends and results. Canary Quantiles software and the Canary Recovery Curves analytics tool enable healthcare professionals to view aggregated data across patient populations to analyze a patient’s recovery progress and direction of outcome.

Canary® Quantiles® software and services and Canary® Recovery Curves® analysis tools do not control the functions or parameters of the Canturio® Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP®) and are not intended for active patient monitoring.

Canturio®se (Canturio® Smart Extension or CSE) with the Canary Health Implanted Reporting Processor (CHIRP®) is designed to provide objective kinematic data from an implanted medical device during a patient’s postoperative total knee arthroplasty (TKA). Kinematic data complements other physiological measurement tools used or utilized by the physician during patient monitoring and postoperative treatment.

The device is indicated for use in patients undergoing cemented TKA in whom a tibial stem extension of at least 30 mm is typically indicated.

Objective kinematic data generated by CSE with CHIRP is not intended to support clinical decision making and has not been shown to provide any clinical benefit.

CSE with CHIRP is compatible with Zimmer Biomet’s Persona® The Personalized Knee® system.

Canturio® Tibial Extension (CTE) with the Canary Health Implanted Reporting Processor (CHIRP®) is designed to provide objective kinematic data from an implanted medical device during a postoperative total knee arthroplasty (TKA) patient. Kinematic data complements other physiological measurement tools used or utilized by the physician during patient monitoring and postoperative treatment.

The device is indicated for use in patients undergoing cemented TKA in whom a tibial stem extension of at least 58 mm is typically indicated.

Objective kinematic data generated by CTE with CHIRP is not intended to support clinical decision making and has not been shown to provide any clinical benefit.

CTE with CHIRP is compatible with Zimmer Biomet’s Persona® The Personalized Knee® system.

Warning: Kinematic data obtained from this device has not been shown to provide clinical benefit. It is not intended to be used to make clinical decisions, and the data have not been evaluated by the FDA for clinical benefit.

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¹ The Breakthrough Devices Program is a voluntary program covering certain medical devices and device-based combination products that provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. The Breakthrough Program is designed to help patients gain faster access to medical devices by accelerating their development, evaluation and review, while maintaining regulatory standards for premarket approval, 510(k) clearance and De-Marketing Authorization Novo, consistent with the Agency’s mission to protect and promote public health.
² Kinematic data from Canturio^®lc it complements other tools for measuring physiological parameters used or used by a doctor when treating a patient after surgery.