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Value of Exosomes in Amniotic Fluid Products

Dissecting Ads for Regenerative Therapies: The Selling of Amniotic Fluid Products – Part Two

The focus of the previous post was on reviewing statements I found puzzling that appeared in an ad for an amniotic fluid product offered for sale by Apex Biologix. I explained that amniotic fluid without viable cells or micronized tissue is considered by the FDA to be excluded from 21 CFR 1271, much like blood, blood...
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Ads Selling Amniotic Fluid Products

Dissecting Ads for Regenerative Therapies: The Selling of Amniotic Fluid Products – Part One

Recently, I received an ad from Apex Biologix sent via email. Their ad focused on a product made from amniotic fluid collected from donors in the USA. The ad covered the composition of their product, how it was produced and what it might be used for. Since the ad made a number of statements that...
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Method of Ratios and PLT

Comments from Physicians on the Arthrex Angel Lemon/Lemonade Posts Highlight the Utility of the Method of Ratios – Part Two

In the previous post, I had shared a couple of comments from physicians (Drs. Sairam Atluri and Dr. Edward Marcheschi) that had been made on the trio of posts on the Arthrex Angel in which I concluded that the Arthrex Angel system was a lemon as a PRP/BMC processing technology. In exploring aspects of the...
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Arthrex Angel and Method of Ratios

Comments from Physicians on the Arthrex Angel Lemon/Lemonade Posts Highlight the Utility of the Method of Ratios – Part One

The posts that I write are available on the Greyledge website and are also distributed on LinkedIn. I would like to share a couple of LinkedIn comments from physicians who responded to the last three posts that have covered this question: Is the Arthrex Angel PRP/BMC processing system a lemon or has Arthrex’s marketing group made...
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Arthrex Angel System

Is the Arthrex Angel System a Lemon or Have They Made Lemonade? Part Three

In the previous two posts (Part One and Part Two), I have reviewed aspects of the performance of the Arthrex Angel system, which is being marketed to orthopedic surgeons to produce PRP and BMC for therapeutic treatments. I have covered the basics of the system and reviewed data from a publication that compared the cellular...
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Is the Arthrex Angel System a Lemon or Have They Made Lemonade? Part Two

In the previous post, I referred to comments that surgeons had shared with me at the AOSSM conference in early July about the Arthrex Angel system, which Arthrex markets to produce hematocrit (Hct)-specific PRP and BMC preparations. None of the surgeons I asked was able to provide any evidence that specific Hct levels were of...
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Arthrex Angel System Hct

Is the Arthrex Angel System a Lemon or Have They Made Lemonade? Part One

Recently, I staffed Greyledge’s booth at the AOSSM meeting held in San Diego, CA in early July. And I have to say it was an interesting experience due to the number of enquires I fielded from physicians who wanted to know if the Greyledge manual processing method in a biological safety cabinet with hemoanalysis of...
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Press Release Lipogems

Does Lipogems Want Orthopedic Surgeons to Think It’s Okay With the FDA to Use Fat-derived Fuzz Balls to Treat Orthopedic Conditions Like Knee Osteoarthritis? Part Two

Physicians in the regenerative medicine community were startled to read a press release issued on July 5th  by Lipogems, which seemed to suggest that the FDA had reversed or at least modified the prohibition on using adipose tissue to treat musculoskeletal conditions the Agency just released in a Guidance on Minimal Manipulation and Homologous Use last...
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Lipogems Press Release

Does Lipogems Want Orthopedic Surgeons to Think It’s Okay With the FDA to Use Fat-derived Fuzz Balls to Treat Orthopedic Conditions Like Knee Osteoarthritis? Part One

While I hadn’t seen anything new recently on the fuzz balling front (e.g., using mechanical methods to beat up adipose tissue for lipofilling procedures), imagine my surprise to see a press release dated July 5th with the following headline: FDA Clears The Way: Lipogems’ Receives FDA Clearance For Microfragmented Adipose Tissue System Utilizing Body’s Own...
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Misunderstanding BMA, Minimal Manipulation

Misunderstanding BMA and a Regulatory Framework for Thinking About Combination Cell-Based Therapies – Part Four

In a paper published by Gassman, et al., the authors have made a number of groundless and puzzling statements, which I have been covering over the past few posts. Misunderstanding BMA and a Regulatory Framework for Thinking About Combination Cell-Based Therapies Series: Part One | Part Two | Part Three I will provide in this...
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