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01/17/20

Physicians: advancing the future of evidence-based cellular therapy could increase quality of life for 14 million US adults suffering from knee osteoarthritis

Over the past three decades cardiothoracic procedures have significantly shifted to minimally invasive techniques with new technology, training of physicians and an ecosystem for workforce development. Orthopedics is on the forefront of a similar shift. Fourteen million U.S. adults suffer from knee osteoarthritis and professional athletes are driving a demand for alternative treatments to surgery, despite many being unsupported by data and lacking proof of success. This level of patient...

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01/14/20

Leaders come together for the first time to advance the field of cellular medicine and its treatment of pain and function associated with knee osteoarthritis

A first-of-its kind meeting brought leaders from eight orthopedic, sports medicine, pain management and regenerative medicine advocacy organizations together to discuss advancing cellular medicine in the U.S. The group of physicians, lawyers, engineers, PhDs, and CEOs from American Medical Society for Sports Medicine, Arthritis Foundation, Arthritis National Research Foundation, BoneSmart, Interventional Orthopedics Foundation, Regenerative Medicine Foundation and Regenerative Outcomes, realized the potential of combining forces to address: evidence-based data, FDA...

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01/10/20

Device and cellular therapy could lead to a major development in the treatment of pain and function associated with knee osteoarthritis for 14 million US adults

Individuals who overuse their joints, such as athletes, military members and people working physically demanding jobs are at a high risk of developing knee osteoarthritis (OA), according to the Arthritis Foundation. Unfortunately, there is no cure on the market for the 14 million US adults suffering.  Industry experts say patients undergo 966,000 total knee replacement surgeries (TKR) annually, millions of hyaluronic and corticosteroid injections, and take millions of pain medications...

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01/10/20

GID BIO aims to make treatment for pain and function associated with knee osteoarthritis accessible to millions with a single-use device and point-of-care therapy

Osteoarthritis (OA) of the knee is a painful disease that impacts 14 million U.S. adults. With no surgical or pharmaceutical treatment existing to cure the disease, industry experts say patients undergo 966,000 total knee replacement surgeries (TKR) annually, millions of hyaluronic and corticosteroid injections, and take millions of pain medications. The average cost of a TKR with included basic inpatient fees is around $57,000. This figure does not include pre-...

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01/9/20

Precision medicine could improve treatment for 14 million U.S. adults with knee osteoarthritis

Precision medicine — commonly referred to as personalized medicine — is widely recognized as the future of U.S. healthcare. Innovative treatment approaches can lead to affordable, minimally invasive therapies that lead to patients’ recovery from chronic conditions such as knee osteoarthritis, which affects 14 million US adults and is the main factor in 966,000 total knee replacements annually. For a chronic degenerative disease like osteoarthritis, reparative cells found in the...

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01/6/20

American Journal of Sports Medicine to publish results of a clinical trial

Trial measures safety and efficacy of device and point-of-care therapy; first to meet endpoints for reducing pain and improving function in osteoarthritic knees   In a shift toward minimally-invasive treatments for orthopedics, an influx of misinformation about stem cells leaves patients vulnerable to treatments that haven’t been approved by the Food and Drug Administration (FDA) and that promote false promises and potentially risky outcomes. American Journal of Sports Medicine (AJSM),...

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12/14/19

Device and point-of-care therapy intended to treat pain and function could soon help knee osteoarthritis patients

About 30 million U.S. adults suffer from osteoarthritis (OA). Many of these patients put up with pain in the hopes of avoiding surgery, time recuperating and costs. Patients suffering from knee OA have few options when it comes to pain management because there is no cure for the disease. Some turn to corticosteroid injections, which come with risks and can speed up progression of the disease, or hyaluronic acid injections,...

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12/13/19

FDA compliant trial for cellular implant therapy could mean a major development in the treatment of pain associated with knee osteoarthritis

An FDA compliant, multi-site, randomized, placebo-controlled Phase IIb clinical trial measuring safety and efficacy of our single-use SVF-2 device and point-of-care (POC) therapy, intended to improve function and reduce pain associated with knee osteoarthritis (OA), met all endpoints at one year. Eighty-eight percent of subjects responded greater than placebo and reported a median 87 percent improvement in pain, stiffness and function. At two years, no serious or device-related adverse events...

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12/12/19

6 Orthobiologic Companies Move Clinical Trials Forward

Multiple orthobiologic companies have engaged in clinical trials in 2019, seeking to demonstrate the efficacy of their cell-based products.... GID BIO completed an FDA compliant, multi-site, randomized, placebo-controlled Phase IIb clinical trial using autologous stromal cells in the treatment of knee osteoarthritis (OA), successfully meeting endpoints and two-year safety results... Read more via BONEZONE.  

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12/10/19

GID BIO aims to close a healthcare gap with the launch of a cost-effective treatment for those suffering from osteoarthritis

Osteoarthritis (OA) is the most common form of arthritis due to the increasing number of U.S. adults 65 and older developing the disease and the increase of injuries to athletes of all ages. The chronic disease, typically diagnosed by the destruction of articular cartilage and structural changes in underlying bone, affects 27 million Americans. Cells that make up diseased tissue are unable to achieve full regulation of the healing process...

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11/18/19

GID BIO’s results in FDA compliant, multi-site, randomized, placebo-controlled Phase IIb clinical trial support an evidence-based, data-driven approach to treat pain-management caused by osteoarthritis of the knee

While minimally invasive treatments transformed cardiology decades ago, advancements in orthopedic medicine are introducing potential alternatives to traditional surgery by applying cellular medicine therapies. GID BIO is focused on using a data-driven approach when introducing cellular medicine therapies. Our team has worked with the FDA to make sure the design and development of controlled clinical studies is compliant with their regulations. In an FDA compliant, multi-site, randomized, placebo-controlled Phase IIb...

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10/25/19

GID BIO Completes Trial of Stromal Cells to Treat Knee OA

GID BIO completed an FDA compliant, multi-site, randomized, placebo-controlled Phase IIb clinical trial using autologous stromal cells in the treatment of knee osteoarthritis (OA), successfully meeting endpoints and two-year safety results... Read more via ORTHOWORLD: https://www.orthoworld.com/index.php/publications/orthoflash/gid-bio-completes-trial-of-stromal-cells-to-treat-knee-oa

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