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American Journal of Sports Medicine to publish results of an FDA-approved 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-approved trial for cellular implant therapy could mean a major development in the treatment of pain associated with knee osteoarthritis

An FDA-approved, 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 occurred. ...

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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-approved, 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-approved, 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 approve the design and development of controlled clinical studies. In an FDA-approved, multi-site, randomized, placebo-controlled Phase IIb clinical trial measuring the safety and efficacy...

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10/25/19

GID BIO Completes Trial of Stromal Cells to Treat Knee OA

GID BIO completed an FDA-approved, 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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08/16/19

GID BIO, a cellular medicine company, moves a step closer to potentially helping relieve the $200 billion osteoarthritis burden on the U.S. healthcare system

AMA grants two Category III CPT® codes, paving the way for reimbursement strategies GID BIO’s unique autologous cellular implant derived from adipose tissue is produced with its SVF-2 device and is injected into the knee intended to treat pain and function associated with osteoarthritis (OA). This procedure warrants two new Category III CPT® codes (Current Procedural Terminology) according to the American Medical Association. CPT codes offer doctors and health...

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01/8/19

Initial safety and feasibility of cellular medicine therapy

Companies and clinics tout the promise of cellular medicine (usually as a "stem cell therapy") backed by little more than anecdotal evidence and the hypothetical possibility of efficacy. When we launched GID BIO, we committed to ensuring that every device and procedure that bears our name is backed by sound medical research and clinically proven therapeutic results. One of the first steps to ensure that a device and therapy is...

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