74% of patients treated with CLARIX® FLO demonstrated clinically significant improvement at 12 months, signifying its potential in delaying Total Knee Arthroplasty (TKA)

Miami, FL – November 9, 2020 – Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today the results from a retrospective study, Intra-articular Injection of Amniotic Membrane and Umbilical Cord Particulate for the Management of Moderate to Severe Knee Osteoarthritis, published in the October 19, 2020 issue of Orthopedic Research & Reviews.

Forty-two patients with moderate to severe knee osteoarthritis (OA), defined as Kellgren-Lawrence (KL) Grade 3 or 4, received a single intra-articular injection of 100mg CLARIX FLO. Prior to the injection, median patient-rated pain was 7 out of 10 despite the majority of patients having prior treatment with oral or topical NSAIDs (n=26, 62%), intra-articular corticosteroid injections (n=24, 57%), intra-articular hyaluronic acid injections (n=20, 48%), and/or platelet-rich plasma (n=6, 14%). Three months after the injection, 86% of the patients rated their symptoms as “very much improved” or “much-improved” using the Patient Global Impression of Change (PGIC) scale.

“Study results are very encouraging. CLARIX FLO may be an option to alleviate pain and promote functional recovery for patients with moderate-to-severe knee OA and have exhausted other non-surgical treatments but are not ready to undergo TKA surgery,” said TissueTech co-founder and Chief Technology Officer Scheffer C.G. Tseng, MD, PhD. “We have long studied the anti-inflammatory, anti-scarring, and pro-regenerative properties of Amniotic Membrane and Umbilical Cord, and we’re excited about what it could mean for the many patients suffering from knee OA, which is the leading cause of physical disability in the aging population.”1

Knee OA is a degenerative joint disease affecting an estimated 14 million Americans.2 According to the National Institutes of Health (NIH), it is the most common type of arthritis. Its prevalence will continue to grow as life expectancy increases and obesity rates rise. Depending on the source, roughly 13% of women and 10% of men 60 years and older have symptomatic knee OA. Among those more than 70 years old, the prevalence reaches as high as 40%.3

“Despite the widespread prevalence of knee OA, current treatment options are limited to HA or corticosteroid injections,” said Leon P. Mead, MD, Board Certified Orthopedic Surgeon and treating physician of the 42 patients analyzed in this study. “While it varies from patient to patient, these treatments are generally limited in both efficacy and duration in advanced cases. I have found that CLARIX FLO can successfully manage patients’ symptoms for significant durations, which is particularly important in those who have failed prior therapies but are not yet ready to undergo TKA.”

About Amniox Medical, Inc.

Amniox Medical, Inc., a TissueTech, Inc. company, is a leader in the clinical application of human birth tissue-based products (amniotic membrane & umbilical cord) processed using TissueTech’s proprietary CRYOTEK® preservation technology. Established in 2011, Amniox serves an unmet need for better surgical and therapeutic outcomes for chronic and complex wounds, orthopedics, sports medicine, spine, urology, gynecology, plastics, and general surgery. Connect with Amniox on our Website, Facebook, LinkedIn and Twitter.

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and Bio-Tissue, Inc., is a scientific and market leader in the field of regenerative medicine. TissueTech manufactures a broad range of ocular, surgical, wound care, and soft tissue products that are marketed under these subsidiaries. Since the company’s inception, clinicians have performed more than 500,000 human implants of the company’s products and published more than 360 peer-reviewed studies supporting its platform technology. TissueTech is committed to an unwavering culture of integrity that places our patients’ safety and clinical outcomes above all else. Learn more at https://tissuetech.com/.

1. Guccione AA, Felson DT, Anderson JJ, et al. The Effects of Specific Medical Conditions on the Functional Limitations of Elders in the Framingham Study. Am J Public Health. 1994;84(3):351-358.
2. Lawrence RC, Felson DT, Helmick CG, et al. Estimates of the Prevalence of Arthritis and Other Rheumatic Conditions in the United States. Part II. Arthritis Rheum. 2008;58(1):26-35.
3. Hsu H and Siwiec RM. Knee Osteoarthritis. StatPearls. Treasure Island (FL): StatPearls Publishing