Le Lézard
Classified in: Health, Science and technology
Subject: FDA

CyMedica Orthopedics Announces FDA Clearance for IntelliHabtm, a Novel Drug-free, Non-invasive Modality for Treatment of Knee Osteoarthritis Pain


SCOTTSDALE, Ariz., June 9, 2021 /PRNewswire/ -- CyMedica Orthopedics, a leading therapy-based digital health innovator, today announced the U.S. Food and Drug Administration (FDA) has cleared the submission of its latest technology for the management of knee osteoarthritis pain, IntelliHab. With this clearance, IntelliHab is the only neuromodulation strengthening therapy indicated to treat pain associated with the debilitating osteoarthritis disease.

The IntelliHab System, a home-based therapeutic and digital health ecosystem, introduces a non-opioid, non-invasive treatment for patients seeking pain relief from knee osteoarthritis, while remotely connecting providers to progress data in real-time. IntelliHab is strongly supported by a recent randomized, sham-controlled, double-blind, multicenter study designed to evaluate the efficacy and safety of IntelliHab in knee osteoarthritis patients. FDA 510(k) clearance was based on the highly positive data from this rigorous level one clinical trial, including significant pain reduction and improved mobility.

"CyMedica recognizes the current standard of care for managing knee osteoarthritis pain presents a significant gap in available treatment options," said Rob Morocco, President and Chief Executive Officer at CyMedica. "With the regulatory clearance of IntelliHab, we can provide a bridge between conservative management to more invasive treatment options, allowing patients to treat their pain comfortably at home while reducing opioid exposure."

Vinod Dasa,  MD, Professor of Clinical Orthopaedics and Director of Research, LSU Health Sciences Center and one of the participating Principal Investigators of the CyMedica study added, "our goal as physicians is to provide patients with a menu of modalities to break the cycle of pain and stiffness caused by knee osteoarthritis. IntelliHab's clinical evidence demonstrates the ability to strengthen the quadriceps muscles resulting in decreased pain and improved function. The product regulatory clearance offers an advanced tool for early and late stage treatment of this complex disease."

This advancement is the company's first approved solution to treat pain associated with knee arthritis. The regulatory clearance of IntelliHab, on the heels of the successful clinical trial, further drives CyMedica's focus on evidence-based medicine and the dedication to helping patients manage OA symptoms to live their best, active lives.

CyMedica Orthopedics, Inc. received 510(k) clearance from the Food and Drug Administration (FDA) for the IntelliHab System in June of 2021. The product will be commercially available in the United States in the fall of 2021.

About Osteoarthritis (OA) of the Knee
Symptomatic knee osteoarthritis (OA), also known as degenerative joint disease, affects more than 14 million Americans1 and accounts for more than $24 billion in annual expenditures2. More than half of all people with symptomatic knee osteoarthritis are younger than age 65 and will live for three decades or more after diagnosis1. The prevalence of OA is expected to continue to increase as a result of aging, obesity and sports injuries. Coupled with increasing knee osteoarthritis prevalence, the rising costs of health care may inflict a tremendous societal economic burden in the future3.

About CyMedica Orthopedics and IntelliHabtm
CyMedica Orthopedics has developed a therapy-based, pain management digital health platform designed to provide at-home pain relief for patients suffering from knee osteoarthritis. The groundbreaking IntelliHab ecosystem is the only FDA-cleared pain management and patient engagement technology delivering comfortable, individualized muscle stimulation to reduce muscle weakness, while keeping patients proactive in therapy through an intuitive app-driven interface. The IntelliHab app connects patients to healthcare providers by communicating critical data in measuring progress to a secure portal, where providers can remotely monitor and motivate patients in real-time. Clinically proven to reduce knee pain associated with osteoarthritis and improve function, IntelliHab offers patients a non-invasive, non-opioid pain management solution.

Media Contacts
Erin Hart
erin.h@cymedicaortho.com
(602) 421-7043

References

  1. Deshpande BR, et al. Number of Persons with Symptomatic Knee Osteoarthritis in the U.S.: Impact of Race and Ethnicity, Age, Sex and Obesity. Arthritis Care & Research. 2016. 68(12):1743-1750.
  2. Losina E, et al. Lifetime Medical Costs of Knee Osteoarthritis Management in the United States: Impact of Extending Indications for Total Knee Arthroplasty. Arthritis Care Res (Hoboken). 2015; 67: 203-215.
  3. London NJ, et al. Clinical and Economic Consequences of the Treatment Gap in Knee Osteoarthritis Management. Med Hypotheses. 2011.

SOURCE CYMEDICA ORTHOPEDICS


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