Morristown, NJ 26 August 2024 – 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.

Learn more about this ingredient.

¹ Kumar B, et al. A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy of a boswellia composition SN13108F to improve joint function and cartilage protection in subjects with mild to moderate osteoarthritis of knee. [Manuscript in development.]

Morristown, NJ 28 May 2024 – PLT Health Solutions, Inc announced that a recent scientific review of clinical studies of Boswellia-based ingredients found the company’s AprèsFlex® 5-Day Joint Support ingredient (also known as Aflapin®) was most effective at helping study subjects with osteoarthritis (OA) manage pain, stiffness and overall physical function. The study, published in EXPLORE: The Journal of Science & Healing in February 2024, was a systematic review and sub-group meta-analysis study of multiple clinical trials and different brands of Boswellia serrata ingredients.1 Out of 828 studies identified, it reviewed thirteen clinical trials and nine different ingredients. The data regarding the following evaluation parameters were collected: visual analog scale (VAS) score, Lequesne’s Functional Index (LFI) score, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores for pain, stiffness, and functionality. As part of the sub-group analysis, the authors concluded: “AflapinⓇ [AprèsFlex®] supplementation showed greater reduction in VAS (MD: -16.09 vs -4.68), LFI (MD: -3.81 vs -2.01), WOMAC-pain (MD: -18.68 vs -7.07), WOMAC-stiffness (MD: -14.25 vs -3.78), and WOMAC-function (MD: -14.99 vs -8.41) scores as compared to other Boswellia serrata therapies.”

According to Seth Flowerman, President & CEO of PLT Health Solutions, this independent review provides formulators of leading joint health products additional confidence in the efficacy of PLT’s leading joint health portfolio. “Consumers are becoming increasingly aware of Boswellia serrata as a safe and effective path to supporting joint comfort and better mobility. But not all Boswellia-based ingredients are the same in composition or demonstrated efficacy. It is essential to review the clinical science that supports these ingredients, so we can offer consumers the best products with the best results,” he said. “AprèsFlex is the best studied Boswellia serrata extract on the market today, with four double-blind, placebo-controlled clinical trials. These studies demonstrate joint comfort efficacy starting at just 5 days with a very low 100 mg/day dose, along with improvements in mobility and cartilage preservation and protection not found in any other Boswellia ingredient. It’s a lineup of benefits that is unmatched in the space,” he added.

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.2 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.

According to Dr. Jeremy Appleton, Director of Medical & Scientific Affairs, at PLT the company is committed to continuing the development of clinical science to support its ingredients. “At PLT Health Solutions, we invest in understanding how our ingredients work and how they can benefit consumers. With AprèsFlex, we started out with one- and three-month long studies and have now extended our understanding to 6 months. We also extended our clinical assessments to include imaging of the cartilage and various functional tests, with results that set AprèsFlex well apart from other joint health ingredients. Our category-defining studies, with validated outcome measures and full transparency to the materials and methods used, provide credibility to the compelling claims we can make about our products’ efficacy,” he said.

Learn more about this ingredient.

1 Dubey V, Kheni D, Sureja V. Efficacy evaluation of standardized Boswellia serrata extract (AflapinⓇ) in osteoarthritis: A systematic review and sub-group meta-analysis study. Explore (NY). Published online February 10, 2024. doi:10.1016/j.explore.2024.02.001
2 Kumar B, et al. A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy of a boswellia composition SN13108F to improve joint function and cartilage protection in subjects with mild to moderate osteoarthritis of knee. [Manuscript in development.]

Morristown, NJ 6 September 2023 – PLT Health Solutions, Inc announced the completion of a six-month clinical study on its AprèsFlex® 5-Day Joint Support ingredient in collaboration with PLT innovation partner Laila Nutraceuticals (Krishna, Andhra Pradesh, India). This study validates and extends the findings of three previous double-blind studies showing that AprèsFlex provides significant improvements in joint comfort at a low 100mg dose. The new study validates the improvements in joint comfort, stiffness and physical function at the 1- and 3-month marks, and shows that those benefits continue to increase, with no plateau effect through the end of the six-month study. The study also shows long-term improvements in functional capacity for walking and stair climbing, activities of daily living most affected by those with joint comfort and mobility issues. Most impressively, these groundbreaking results demonstrate preservation of joint space and cartilage thickness compared with placebo, and significant reduction of biomarkers of inflammation and cartilage degradation.

This is the first study of a Boswellia serrata ingredient demonstrating support for cartilage preservation – a major concern for consumers and product formulators in the joint health/mobility space. This fourth double-blind, placebo-controlled human clinical study on AprèsFlex sets it apart from other ingredients in terms of its demonstrated efficacy across this broad range outcome measures. Previous studies of AprèsFlex have demonstrated improvements in joint comfort in as few as five days. All studies were completed with a low 100 mg/day dose.

According to Seth Flowerman, President & CEO of PLT Health Solutions, this study breaks new ground on the potential for the supplement industry to provide joint health and mobility support. “AprèsFlex is one of the world’s most widely used joint comfort ingredients, powering major consumer brands – because it works – and now we know that it keeps working for the long-term. Working with our innovation partner Laila Nutraceuticals, PLT designed a study that could evaluate both the long-term potential for this ingredient and its ability to address the unmet needs of joint space preservation and cartilage protection,” he said. “When you see results like a 70% improvement in comfort, stiffness, and function, and 30% improvement in functional capacity in a longer-term setting, these are not just statistics, but tangible results that can meaningfully improve people’s lives. The joint space and cartilage preservation data from this study is a game-changer for our industry.” he added.

Patented formulation combats inflammation
AprèsFlex is a patented, synergistic Boswellia serrata gum resin extract. The oral bioavailability of acetyl-11-keto-beta-boswellic acid (AKBA) from AprèsFlex has been shown to be about 52% higher than other commercially available Boswellia extracts, allowing for a lower daily dose with enhanced efficacy.

Six-month study will power innovative mobility products
In the 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. 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 analysis of several biomarkers related to cartilage breakdown and inflammation.

Measurements were made at baseline, one, two, four, and six months.

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 on Day 30 and up to a 72% reduction in stiffness at six months. AprèsFlex subjects showed a 71% improvement in physical function at six months.

Impressively, AprèsFlex subjects demonstrated substantial, significant improvements in their functional abilities including an increase in walking speed of nearly 27% and a reduction in time to ascend and descend stairs of 30%.

In first of its kind data for a low-dose joint health ingredient, MRI assessments of joint space in the knee showed AprèsFlex limited joint space narrowing, actually improving joint space, while subjects taking placebo experienced further narrowing of knee joint space. When joint space narrowing occurs, cartilage can no longer keep bones a normal distance apart, resulting in increased pressure and pain.

MRIs of femoral, patellar, lateral tibial, and medial tibial cartilage thickness showed decreases in the placebo group over six months, whereas cartilage thickness was maintained and even slightly improved in the AprèsFlex group at 180 days. Changes in biomarkers of cartilage degradation (C2C, uCTX-II, Fibulin-3) validated these protective effects of AprèsFlex against cartilage breakdown. Biomarkers of systemic and joint inflammation (hsCRP, MMP-3) were also significantly improved in the AprèsFlex group compared to placebo.

According to Jen Murphy, Director of Innovation & Clinical Development at PLT, the design of this study was developed in response to industry interest in three main indicators of joint health: fast-acting and long-lasting comfort, physical function, and cartilage protection, with the latter benefit being the most revelatory in terms of current results. “Currently, most ingredients that purport to support cartilage, like collagens, benefit from a story that relies on their compositional similarity to cartilage, but these ingredients lack human clinical data showing benefits to cartilage. The scientific evidence for structural benefits from consuming cartilage or any of its components is limited,” Murphy said. “Having previously shown that AprèsFlex was effective and fast-acting, this new study demonstrates that the improvements in comfort, stiffness and function experienced with AprèsFlex correlate with the preservation and long-term protection of cartilage,” she added.

To learn more about AprèsFlex, visit us at SupplySide West 2023 (Oct 23-27) in Las Vegas Booth #4655.

Morristown, NJ 14 August 2022 – PLT Health Solutions, Inc announced that it will begin offering new  elderberry extracts to the North American market. The PLT elderberry portfolio will include extracts standardized to 6% and 10% anthocyanins, offered in both standard and organic grades. Innovation  partner Nektium Pharma (Las Palmas, Spain) has secured long-term supply agreements with black  elderberry (Sambucus nigra) growers in Central Europe and will extract finished product at its state-of the-art facilities in the Canary Islands. Quality for these ingredients is assured by a per-batch testing  program including fingerprint analysis for identification and quantification of anthocyanins, DNA sequential  barcoding for authenticity, analysis for adulteration using the MALDI TOF technique, and standardization  of biomarkers. As non-GMO-certified, gluten- and additive-free powders, these elderberry extracts are  available immediately.

According to Steve Fink, Vice President of Marketing for PLT Health Solutions, the new elderberry  portfolio was developed as a solution to industry problems that occurred when demand for this ingredient  skyrocketed during the pandemic. “As often happens with plant-based materials when demand spikes  rapidly, there was a shortage of elderberry materials and a proliferation of sub-standard and adulterated  products entering the market. All of us have read headlines of inferior elderberry offerings in the media,”  he said “It has long been the mission of PLT Health Solutions to address industry pain points and to solve  problems. With this line of traceable, standardized and lab-tested elderberry extracts, we believe PLT and  Nektium have done that.” Our organic offering adds additional value and can help our customers  differentiate their products in the marketplace,” he added.

Traditional Immune Support, Modern Quality 

Black elderberry has a long tradition of use for immune support. The berries are high in flavonoids, such  as quercetin and rutin, with anthocyanins arguably the most important. Anthocyanins impart the  characteristic purple color to the berries, as well as much of the bio-efficacy in terms of antioxidant  activity, balancing inflammation metabolism, and supporting immune function.

Elderberry modulates immune function by multiple mechanisms, including activation of phagocytes,  supporting non-specific immune response, and promoting immune defense. The material supplied by PLT  is based on the Haschberg cultivar of Sambucus nigra, which contains a high level of naturally-occurring  anthocyanins.

According to Dr. Jeremy Appleton, Director of Medical and Scientific Affairs for PLT, the company’s new  elderberry extract portfolio offers consumer companies excellent product development and messaging  opportunities. “Elderberry and its constituent anthocyanins have been extensively researched. These new  products are both more concentrated than many other elderberry ingredients on the market today and of  higher quality, offering formulators the ability to create more effective products while building trust with  consumers and delivering greater value.”

For more information on PLT’s elderberry extract portfolio, visit https://www.plthealth.com/elderberry

Morristown, NJ 20 July 2022 – PLT Health Solutions, Inc announced the publication of a clinical study on its Boswellia serrata-based AprèsFlex® 5-Day Joint Support ingredient that provides further evidence of its ability to support joint health and function with statistically significant improvements in pain scores and biomarkers starting at only five days from initial consumption. Published in The Journal of the American Nutrition Association, the study is entitled “Efficacy and Safety of Aflapin®, a Novel Boswellia Serrata Extract, in the Treatment of Osteoarthritis of the Knee: A Short-Term 30-Day Randomized, Double-Blind, Placebo-Controlled Clinical Study”[1]  and authored by Vasu Karlapudi, Krishna Bhagavan Sunkara, Purna Rajeswari Konda, Kadainti V. Sarma, and Meher Prasanna Rokkam. Aflapin is an alternative trade name for the AprèsFlex ingredient that is marketed globally by PLT Health Solutions. This is the third double-blind placebo controlled study conducted with AprèsFlex and the second study to confirm statistically significant improvements in joint comfort beginning at five days from a remarkably low dose – 100 mg/day. The ingredient is produced by PLT innovation partner Laila Nutraceuticals (Krishna, Andhra Pradesh, India).

According to Seth Flowerman, President & CEO of PLT Health Solutions, this new study further builds on the strong existing data supporting AprèsFlex as a powerful and fast-acting, low-dose joint health ingredient. “When it comes to mobility, there can be a disconnect between what consumers want and what existing solutions deliver. Too often, natural joint and muscle health solutions require large doses that take weeks or even months to show improvements – and the science backing these ingredients doesn’t support what consumers are looking for. That is one of the reasons we continually work to understand things like mechanism of action and to develop quality science that can support strong messaging,” he said. “At PLT, we are working to deliver Mobility Solutions, and to make these solutions available for people of all ages and walks of life,” he added.

Patented formulation combats inflammation

AprèsFlex is a patented, synergistic combination of two proprietary extracts derived from Boswellia serrata gum resin, launched in 2013. The oral bioavailability of acetyl-11-keto-beta-boswellic acid (AKBA) from AprèsFlex is significantly higher than that of other commercially available Boswellia extracts, which allows for a lower daily dose, with enhanced efficacy. In joint health products, AprèsFlex is used often as a standalone ingredient or in conjunction with other ingredients to power some of the best-known joint health consumer brands in the world. It has been the subject of seven pre-clinical studies and three published human clinical trials.

Third study provides confirmation of fast-acting relief and sheds light on key biomarkers

In the newest clinical study, Karlapudi and colleagues examined the efficacy of AprèsFlex in the management of joint comfort and function in a randomized, double-blind, placebo clinical trial. Sixty-seven subjects received either 100 mg/day of AprèsFlex or a matching placebo for thirty days.

Measurements included:

• Visual Analog Score (VAS)
• The Lequesne algofunctional index (LFI)
• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
• Serum biomarkers (MMP3, TNF, hsCRP, COMP, CPII and C2C)

Measurements were done on Days 0, 5 and 30.

The study showed that AprèsFlex provided significant improvement (p<0.05) in all pain and physical function scores at five days compared to placebo. Post-trial, VAS, LFI, WOMAC pain, WOMAC stiffness, WOMAC function, and total WOMAC scores decreased in the AprèsFlex group by 45%, 40.9%, 44.4%, 66.3%, 44.4%, and 48%, respectively.

Beyond joint comfort and function improvements, AprèsFlex was also shown to offer statistically significant impact on biological markers associated with joint health and inflammation metabolism, including TNF-alpha, C-Reactive Protein (CRP), and Interleukin-6 (IL-6). It was also shown to significantly inhibit matrix metalloproteinase (MMP-3), an enzyme that breaks down cartilage, collagen, and connective tissue.

Previous studies with AprèsFlex showed 56% reduction in pain scores at 30 days. A similar study with AprèsFlex showed a 69% reduction in pain scores at 90 days.

According to Dr. Jeremy Appleton,  Director of Medical and Scientific Affairs for PLT, this new study confirms previous results with AprèsFlex and should give innovators of joint health and mobility products confidence in the fast-acting messaging supported by the science. “We now have three double-blind placebo-controlled clinical trials that validate the efficacy of AprèsFlex, and two demonstrating improvements as early as five days, at a low dose. These outcomes support our customers’ “fast-acting” claims for their products containing AprèsFlex. At PLT Health Solutions, we are continually evaluating our existing science and conducting new research that enables our customers to offer strong messaging while building trust with their own customers,” he said.

In addition to this new stand-alone study on AprèsFlex, ingredient company Bioiberica announced an open-label study in June 2022  that combined AprèsFlex with its Collavant® n2 type-II collagen complex. That study further demonstrated the five-day efficacy of AprèsFlex at 100 mg/day, when used as part of a combination formula Dr. Appleton commented, “The Karlapudi study, along with the new study announced by Bioiberica, continues to strengthen the evidence that AprèsFlex can rapidly improve people’s lives.”

To learn more about AprèsFlex, contact the company or visit the PLT website at www.plthealth.com/apresflex.
[1] Karlapudi V, Sunkara KB, Konda PR, Sarma KV, Rokkam MP. Efficacy and Safety of Aflapin®, a Novel Boswellia Serrata Extract, in the Treatment of Osteoarthritis of the Knee: A Short-Term 30-Day Randomized, Double-Blind, Placebo-Controlled Clinical Study [published online ahead of print, 2022 Feb 15]. J Am Nutr Assoc. 2022;1-10. doi:10.1080/07315724.2021.2014370