PLT Health Solutions Granted Broad Ranging Joint Health and Cartilage Claims from Health Canada Based on Clinical Study Results

AprèsFlex^® 5-Day Joint Support Has Been Clinically Demonstrated to Improve Joint Comfort, Flexibility and Function as well as to Provide Ground-Breaking Cartilage Preservation and Protection

MORRISTOWN, N.J., Aug. 26, 2024 /PRNewswire/ -- PLT Health Solutions, Inc. announced that it has received an updated license from the Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada to market its ingredient AprèsFlex^® 5-Day Joint Support Ingredient to support joint health in Canada. The subject of four randomized, double-blind human clinical trials, AprèsFlex is a patented, low-dose, synergistic Boswellia serrata gum resin extract. In joint health products, AprèsFlex is used as a standalone ingredient or in conjunction with other ingredients to power some of the world's best-known joint health consumer brands.

The list of claims approved by Health Canada for AprèsFlex include:

• Provides long-term joint health benefits/support/pain relief in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps support improvements to joint comfort, stiffness and function over 6 months in persons with mild to moderate osteoarthritis of the knee.
• Helps to maintain joint space in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to maintain cartilage in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to maintain cartilage thickness/volume in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to protect (knee) cartilage in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to reduce cartilage breakdown in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to reduce key biomarkers of cartilage breakdown in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to improve joint function in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to improve/increase mobility when walking and stair-climbing in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to support joint function capacity when walking and stair-climbing in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to protect against the deterioration of cartilage in persons with mild to moderate osteoarthritis of the knee.
• A factor in maintaining healthy cartilage and/or joint health in persons with mild to moderate osteoarthritis of the knee.
• Helps protect against the deterioration of cartilage in persons with mild to moderate osteoarthritis of the knee and relieve joint pain associated with mild to moderate osteoarthritis of the knee.
• Helps to improve/increase mobility in those suffering from mild to moderate osteoarthritis of the knee.
• Helps reduce mild to moderate osteoarthritic knee joint pain when walking and climbing stairs.

According to Seth Flowerman, President and CEO of PLT Health Solutions, the granting of the latest NHP license for AprèsFlex by Health Canada is significant for what it says about the quality of science supports the ingredient. "With four gold-standard human clinical trials and counting, we are proud that AprèsFlex is one of the best substantiated joint health ingredients on the market today, powering some of the leading joint health consumer brands around the world," he said. "The combination of fast acting experiential improvements in joint comfort with demonstrated long-term efficacy, and now with the newly demonstrated claims on cartilage health – both preservation and protection – offers the industry never-before available messaging opportunities for consumer products benefiting people of all ages - and all in a single, low daily dose of 100mg. Health Canada is well known for their rigorous scientific review process and the breadth and quality of claims permitted speaks to the high quality of science on this ingredient," he said.

Groundbreaking six-month study will power innovative mobility products
In a recently completed randomized, double-blind, placebo-controlled clinical trial, eighty normal-to-overweight women and men (age 40-75) received either 100 mg/day of AprèsFlex or a matching placebo for six months.¹ Study endpoints included joint comfort (WOMAC, VAS, Lequesne Functional Index); functional capacity testing (six-minute walk, stair climb); MRI evaluation of the knee joints to assess joint space narrowing, cartilage thickness, and cartilage volume; and analysis of several biomarkers related to cartilage breakdown and inflammation.

Subjects taking AprèsFlex experienced steady improvement in joint comfort, with up to a 70% reduction in pain by the end of the study. Those same subjects experienced 25% less stiffness in the first month and a 72% reduction in stiffness at six months. AprèsFlex subjects also had a 71% improvement in physical function at six months.

MRI assessments of femoral, patellar, lateral tibial, and medial tibial cartilage thickness showed decreases in the placebo group over six months, whereas cartilage thickness and volume were maintained and even slightly improved in the AprèsFlex group at 180 days. Significant decreases compared to placebo in three biomarkers of cartilage degradation validated these cartilage-protective effects of AprèsFlex. Biomarkers of systemic and joint inflammation were also significantly improved in the AprèsFlex group compared to placebo.

For more information on this ingredient, visit www.plthealth.com/apresflex.

¹Murphy J, Salter D, Aurora D, Somepali RR, Brijesh K. A Standardized Boswellia serrata Gum Extract Promotes Chondroprotection and Improves Knee Pain, Function, and Inflammation in Adults With Mild to Moderate Osteoarthritis. Curr Dev Nutr 2024;8(Suppl 2):102213. DOI: 10.1016/j.cdnut.2024.102213

* THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE

SOURCE PLT Health Solutions