SALES TRAINING
ADVANCED BIOLOGICS is the master distributor for DynaCord, LLC, the manufacturer of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes from Wharton’s Jelly.
You Don’t Need to Be an Expert to Sell Our Product
Keep in mind, you do not need to be an expert or know everything in order to effectively sell our product. When speaking with doctors, they are often eager to prove they are the smartest person in the room. However, when it comes to MSC exosomes, very few doctors actually understand what they are or how they function.
Even physicians who are illegally treating patients with stem cells often have no idea what exosomes are—which is ironic, considering exosomes are secreted by stem cells and do the actual healing. But we’ll dive deeper into that later.
Traditional methods of treating patients are becoming obsolete.
The future of medicine lies in regenerative medicine, which offers a far more effective approach to treating both minor and major medical conditions. One of the most promising advancements in this field is Mesenchymal Exosomes, which have the potential to address a wide range of health concerns both inside and outside the body.
What Is Regenerative Medicine?
Regenerative medicine seeks to replace tissue or organs that have been damaged by age, disease, trauma, or congenital issues, vs. the current clinical strategy that focuses primarily on treating the symptoms. The tools used to realize these outcomes are tissue engineering, cellular therapies, and medical devices and artificial organs.
Combinations of these approaches can amplify our natural healing process in the places it is needed most, or take over the function of a permanently damaged organ. Regenerative medicine is a field that brings together experts in biology, chemistry, computer science, engineering, genetics, medicine, robotics, and other fields to find solutions to some of the most challenging medical problems faced by humankind.
When injured or invaded by disease, our bodies have the innate response to heal and defend. What if it was possible to harness the power of the body to heal and then accelerate it in a clinically relevant way? What if we could help the body heal better?
The promising field of regenerative medicine is working to restore structure and function of damaged tissues, organs, cartilage, cells, reduce inflammation, etc. It is also working to create solutions for organs that become permanently damaged. The goal of this approach is to develop transformative healthcare solutions that will potentially cure previously untreatable injuries and diseases.
What are Mesenchymal Exosomes?
More than likely you are familiar with “STEM CELLS” or have at least heard about them and how stem cells are cutting edge in REGENERATIVE MEDICINE. Mesenchymal Exosomes are secreted by Mesenchymal Stem Cells (MSC’s). MSC Stem Cells and the Exosomes secreted by the stem cells are your bodies NATURAL HEALING MECHANISM starting the day you are born until the day you die.
When stem cells or exosomes are referenced, I am always referring to Mesenchymal Stem Cells and Exosomes.
For years scientists have studied how stem cells functioned naturally in the human body. They noticed tiny particles floating off of the stem cells and thought it was just waste. Years later scientists studied this closer and realized those are not waste particles, those are exosomes!
For your knowledge, ALL cells secrete “exosomes”. An “exosome” is a lipid bilayer (bubble) that shuttles the cargo inside of it to different areas of your body. MESENCHYMAL EXOSOMES shuttle healing cargo such as growth factors, cytokines, proteins, lipids, nucleic acid, mRNA, etc. to damaged cells, tissue, and so on.
Mesenchymal Stem Cells and Exosomes are the NATURAL healing mechanisms in all of us.
When we are born, we have the most abundant and potent MSC stem cells that were ever going to have. This is when we are at our peak health. When we are middle aged they are much less effective. When we reach our golden years our stem cells are not very effective and by the age of 60 our stem cells and exosomes have all but stopped working to repair your body.
This is why we are relatively healthy when we are young… meaning from age zero to our forties and once we get into our 50’s, 60’s, and older it’s not uncommon to get diagnosed with a variety of medical conditions such as arthritis, COPD, neurodegenerative conditions (dementia, ALS, Parkinson’s disease, cancer, neuropathy, diabetes, and so on).
HOW THEY WORK
All diseases, illnesses, and injuries start with damaged cells. Your damaged cells must be repaired to prevent you from getting a major medical condition(s). This could be damaged blood cells, liver cells, muscle cells, brain cells, skin cells, etc.. Your damage cells will send out inflammation signals throughout your body (like a cry out for help). Those inflammation signals are received by your MSC stem cells which triggers the repair process. The stem cells then load the healing contents (growth factors, proteins, etc.) into an “exosome” which again, is a lipid bilayer or tiny bubble. The Exosomes are then secreted from the stem cell and travel to the damaged cells in which they communicate, attach themselves and essentially repair the cells, rebuild organs, tissue, cartilage, reduce inflammation and so on.
As it turns out, although stem cells play an important role in this process, it’s the MSC Exosomes that are doing all of the heavy lifting… NOT the stem cell itself.
It didn’t take long for scientists to figure out that they can take the manufacturing process one step further by first, harvesting the stem cells in a controlled laboratory, trigger them to package up the exosomes, then get them to secrete from the stem cell. Once the MSC Exosomes are secreted from the stem cell, the exosomes can be separated and purified by removing all cell particles leaving you with pure isolated MSC exosomes which you can concentrate in very potent quantities.
NOTE: All “exosomes” are NOT created equal. The quality, potency, purity and safety of the exosomes has everything to do with how they are manufactured. Which we will dive into a bit later.
Exosomes reduce inflammation, repair and regenerate tissue, support your immune balance, encourage growth of new blood cells, protect cells from damage, repair damaged cells, speed up wound healing, reduce or eliminate scars, repair and rebuild organs, tissue, and cartilage.
Healing Power: They can help repair damaged tissues. For example, if you sprain your ankle, these exosomes can help the cells in your ankle start to heal faster.
Reducing Inflammation: Sometimes our body can get too inflamed, like when you have a cold. Mesenchymal exosomes can help calm that inflammation down, making you feel better.
Cell Communication: They improve communication between cells. This is important because cells need to work together, just like teammates in a game.
MSC Exosomes have the “potential” (compliant term) to reverse conditions such as neurodegenerative disorders, joint injuries, cancer, autoimmune diseases, organ failure, cardiovascular conditions, arthritis, neuropathy, Lyme disease, macular degeneration among other eye conditions, chronic conditions, inflammation, anti-aging, hair restoration, sexual dysfunction, kidney disease, among many other conditions.
Acne Scars
Anti-Aging
Dark Eye Circles
Eczema
Even Skin Tone
Herpes/Cold Sores
Improved Skin Texture and Pore Size
Improvement in Dryness and Better Overall Skin Hydration
Psoriasis
Reduction in Redness and Irritation
Reduction of Scars and Skin Lesions
Rosacea
Tighten Sagging Skin
Treats a Variety of Skin Condition
Visible Decrease in Fine Lines, Wrinkles, and Age Spots
180% increase in Fibroblasts
300% increase in Elastin
Migraines and Cluster Headaches
Neuropathy
Parkinson's Disease
Phantom Limb Pain
Post Herpetic Neuralgia
RSD
ALS
Alzheimer's
Autism
Bell's Palsy
Dementia
Improves Brain Health
Back Pain
Contribute to the Repair and Regeneration of Cartilage
Improved Joint Function
Plantar Fasciitis
Reduces Chronic Pain
Tennis/Golfers Elbow
Tissue Regeneration
Anti-Inflammation
Boosts Immune Health
Diabetes
Help Manage Degenerative Conditions
Immune Health
Liver, Kidney, Cardiovascular and Neurological Disease
Supports Metabolic Function
Treat Lyme Disease
COVID Lung
Erectile Dysfunction
Respiratory Issues
Burns
Enhances Tissue Regeneration
How Mesenchymal Stem Cells Replicate
Self-Renewal: MSCs have a special ability called self-renewal. This means they can divide and make copies of themselves. When they replicate, they create new MSCs that can still become different types of cells.
Differentiation:
Besides making more MSCs, they can also turn into other types of cells, like bone cells or cartilage cells. This process is called differentiation. For example, if you need more bone cells because of a fracture, MSCs can transform into those bone cells to help with healing.
Controlled Growth:
The body regulates the number of MSCs produced and how they differentiate, ensuring that tissues grow, and repair as needed. This is crucial for maintaining balance in the body.
Why We Are Healthier When Young
Cell Function and Regeneration: When we’re young, our cells, including MSCs, work efficiently. They can replicate and repair tissues quickly. This means if we get hurt, our body heals faster and more effectively.
Fewer Accumulated Damages:
As we age, our cells experience wear and tear from things like environmental stress, poor diet, and lifestyle choices. Over time, this can lead to damage to our DNA and cellular functions. Furthermore, when our MSC Stem Cells replicate themselves over and over they lose some of their potency and effectiveness, and there are fewer each time.
Decreased Stem Cell Activity:
As we grow older, the activity of our MSCs can decline. They may not replicate or differentiate as well as they used to. This means our bodies may not heal as quickly, and the ability to regenerate tissues diminishes.
When we reach age 50 and older, our stem cells/exosomes are not functioning well, so our damaged cells and tissue are not getting repaired. When this happens, we begin to experience the symptoms of the given medical condition.
Throughout life, our stem cells continuously replicate, making copies of themselves. However, with each replication, they lose a bit of their effectiveness, gradually diminishing their ability to repair and regenerate tissues as efficiently as they did in youth.
By the time we reach our early 30s, fine lines and wrinkles begin to appear. This happens because skin cells experience damage that is no longer being repaired as effectively as before. These early signs of aging indicate that stem cells and exosomes are already starting to decline in function.
In our youth, stem cells and exosomes operate at full capacity, rapidly repairing damaged cells—including skin cells—keeping us vibrant and resilient.
As we enter our 40s, we may notice subtle changes: moving a bit slower, experiencing more stiffness, or feeling occasional joint discomfort.
By our 50s, 60s, and beyond, age-related conditions become more common. Many people develop arthritis, diabetes, or Parkinson’s disease, and the risk of cancer, dementia, and COPD increases. In contrast, young individuals—such as children, teenagers, or even those in their 20s—rarely develop these conditions. This is because their stem cells are still functioning optimally, ensuring rapid and efficient cellular repair.
As we age, cellular repair slows down or even stops altogether, allowing diseases to take hold. We often attribute these changes to “getting older,” but the reality is that our stem cells and exosomes have replicated so many times that they become fatigued, less effective, and forget how to function properly. This decline weakens the body's ability to heal, increases vulnerability to disease, and accelerates the aging process.
Understanding this fundamental shift in cellular function highlights why regenerative medicine plays a crucial role in restoring, maintaining, and enhancing overall health as we age.
These are UNDISPUTED FACTS:
ADVANCED BIOLOGICS distributes ONLY Mesenchymal Exosomes that are LEGALLY permitted to be sold and used for research and investigational use.
Our product is the only one legally permitted to be administered via IV Infusion for Therapeutic Treatments, Direct Site Injection to help with Joint Pain and injuries, Torn Ligaments, Arthritis, etc., and Nebulization to help with Lung Issues such as COPD and Pulmonary Fibrosis, as well as Dementia, Alzheimer’s, PTSD among other Neurocognitive Issues. Scalp Injections for Hair Restoration, topically after Microneedling and Laser Treatments for Skin Therapy, or Topically as a cosmetic.
We are the only ones with a Drug Master File with the FDA and our product is the only one registered as a drug with the FDA.
Our product is the only one categorized as a 351(a) by the FDA. ALL other suppliers and manufacturers are categorized as a 361 HCP/T product which is only legal to use as a topical cosmetic on unbroken skin. No different than any face cream you can buy at a beauty supply store.
The only time a 361 biologic product is legal to inject is if the stem cells/exosomes are pulled from the patient and injected back into that patient OR if the donated cells come from a first or second-degree blood relative. Donated cells derived from the umbilical cord or anyone other than a first or second-degree relative is illegal (a felony).
NOTE: EVERY OTHER MANUFACTURE OR EXOSOME SUPPLIER’s product is without a doubt ILLEGAL to use for clinical purposes. That means it is illegal to inject into another human. It’s a felony and the doctor could lose their medical license. There are hundreds of suppliers and they are all categorized as a 361 cosmetic with the FDA… except for us.
3rd Party Lab Testing
Aside from compliance, more importantly we ship 25% of our final product to a third-party Laboratory called Eurofins.
Eurofins is one of only two labs that has the capabilities to be able to perform the types of testing that are required by the FDA.
Once they have completed the testing, they send the results directly to the FDA which is a few terabytes worth of information. The FDA then takes about 7 to 10 days to review the information and not until they give us the green light are we permitted to bottle it up, dilute it with saline and offer it for sale.
We provide the 3rd Party Certificate of Analysis with every order. No other supplier even has their product tested.
We abide by all regulatory guidelines to ensure that we meet the purity, potency, consistency, and safety standards. Our EXOSOMES contain a high potency of lipids, proteins, and nucleic acids such as RNA, cytokines, and microRNAs. Furthermore, our exosomes have over 700 Growth Factors which are a key component and at least 25 times more than any other MSC exosome product I know of.
We are currently performing over 13 clinical studies hosted by LSU Medical School and have several more starting soon.
We have a United States Patent on the process of manufacturing Shelf Stable Human Mesenchymal Exosomes for Topical Applications (this pertains to our topical products). So, if you see an “exosome” product that is stable at room temperature that is in a bottle combined with a gel, serum, or cream you know it’s not real exosomes because they would be violating our patent. It’s either plant based exosome which work great if you are a plant but not as a human because plant based exosomes cannot communicate with human cells. Or it’s “conditioned media” which is a hodgepodge of different cellular particles that surround stem cells and exosomes.
We have performed very extensive Safety Studies on our exosome product which concluded that our product is 100% safe, has ZERO side effects, zero adverse events, and it’s impossible to overdose.
LSU School of medicine is a 5% equity owner with our manufacturer. This is a fantastic relationship because it enables us to be able to utilize their team of attorneys, incredible scientists, State of the Art laboratories, ISO 5 clean rooms, and their women’s hospital which is where we get our umbilical cords from. All donors are Extensively tested for all diseases whether current or if they have ever had a disease in their past. Every mother is screened for mental health conditions, and we make sure all our donors have never taken the covid vaccine.
This gives us a major advantage over other manufacturers because we can get the umbilical cord right when the baby is born and take it directly over to our state-of-the-art laboratory and begin harvesting the stem cells immediately while it is fresh.
At the time of birth, you either need to begin harvesting the stem cells immediately or you need to freeze the umbilical cord. None of the other manufacturers have the ability to harvest fresh stem cells. They get their umbilical cords from a tissue bank which are frozen for years before use.
When you freeze the umbilical cord, it causes damage to the cells, growth factors cytokines, exosomes, and all of the components that are necessary to repair your body. Our scientists have studies how stem cells behave after they have been frozen and found they do not behave the same as they do naturally in the human body or when they are harvested fresh.
So, harvesting our stem cells immediately with a fresh umbilical cord is our first step in developing a superior product.
Next, we allow the stem cells to mimic the same process that your body does naturally in that once we harvest the stem cells, we will allow them to replicate up to three times, but we stop before the 4th generation. The reason we do that is because after testing our product when we went to the 4th generation, we found that we would have to file for a whole new drug category if we went to the 4th generation.
So, we stop at 3 generations, separate the exosomes, then use a proprietary process to upregulate our product to where we have over 700 growth factors which is more than 25 x’s any other manufacturer we have found.
We also have proprietary methods to modify and program our exosomes.
At this point we perform a series of different tests on our product, we lice the exosomes to make sure they are the right type and perform a series of tests to ensure that the proteins, growth factors, cytokines, etc. are consistently potent so we will meet the FDA’s 351(a) Consistency standards for potency.
Our product is Wharton’s Jelly-derived Mesenchymal Stem Cell (MSC) Exosomes—a cell-free biologic that we package in two variants. One of these is a sterile, aseptically filled saline solution containing 20 billion exosomes per cc.
Processing & Harvesting
Once we receive an umbilical cord, we immediately transfer it to our ISO-5 Clean Room for processing. We only harvest stem cells from fresh umbilical cords—never frozen. This is crucial because freezing bulk tissue can damage cells, alter stem cell behavior, and make them difficult to work with.
After harvesting the MSC stem cells, we conduct CNC (characterization and control) testing as well as performative analysis to confirm that the cells are indeed Mesenchymal Stem Cells and to assess their responsiveness and mechanism of action.
Our goal is not just to produce exosomes—but to produce exosomes with high concentrations of key growth factors and anti-inflammatory factors. Additionally, we ensure that the exosome structure is optimized to effectively target damaged and inflamed tissue.
Quality Control & Optimization
Before proceeding, we conduct preliminary testing to determine the responsiveness and behavior of the stem cells. Based on these results, we select whether to use the first, second, or third passage of the cell line.
Every time stem cells are expanded and cultured, their responsiveness and potency gradually decline. To maintain the highest quality and potency, we never use cells beyond the third passage—ensuring optimal performance based on measurable characteristics.
Once the ideal passage is selected, we establish a Master Cell Bank, which is sent for third-party laboratory testing. After the Master Cell Bank passes all quality and safety tests, we move into full-scale production.
Manufacturing & Consistency Standards
To ensure a consistently potent product with every batch, we:
✅ Stimulate the stem cells daily using a specialized, xeno-free culture media (free of animal products or foreign substances).
✅ Prevent cells from multiplying, dividing, or differentiating while in bioreactors.
✅ Measure stem cell production daily and adjust the nutrient and stimulation factors accordingly.
✅ Ensure compliance with FDA 351(a) consistency standards, allowing us to reproduce the same drug today and 30 years from now, even with different tissue sources.
As a result, our final product consistently maintains the highest potency possible, with superior concentrations of key growth factors and anti-inflammatory factors per exosome—significantly outperforming standard market products.
Final Processing & Testing
Once the production cycle is complete, we:
-
Concentrate the solution 1,000-fold and send it for batch virology testing.
-
After passing safety checks, we move into final product manufacturing, where we achieve a 20 billion exosome per cc concentration in standard 0.9% saline.
-
Send 25% of our product for finished lot analysis via a third-party laboratory, ensuring compliance with the highest safety and efficacy standards.
The third-party laboratory conducts:
✔ Sterility, endotoxin, and mycoplasma testing to confirm safety.
✔ Proteomics, mRNA sequencing, and lipid analysis—examining both free-floating and exosome-loaded content.
✔ Particle size analysis to quantify exosome count.
✔ Protein analysis to assess exosome type and function.
We measure not only the total concentration of therapeutic compounds in the vial but also the precise amount encapsulated within each exosome, ensuring a highly effective and scientifically validated product.
All biologic manufacturers have a CHOICE… they can take the 351(a) pathway which is very complex, expensive, and takes a minimum of 5 years and upwards of 10 years. This is the only pathway if you want to get your product FDA approved. It’s the same pathway that all pharmaceutical manufactures must take to get their drug approved by the FDA.
351(a)
What does the FDA require to become categorized as a 351(a) biologic DRUG?
-
You must provide very extensive EFFICACY DATA to show that your product is effective and that it “works” when treating various medical conditions.
-
You must perform PRE-CLINICAL STUDIES to back up #1.
-
You must perform very extensive SAFETY STUDIES to prove that your product is “safe”. Our safety studies concluded that our MSC exosome product is 100% safe, there are ZERO SIDE EFFECTS or adverse events, and you cannot overdose on our product.
It took us 7 years to meet the criteria required by the FDA and cost over $100M. Once you are categorized as a 351(a) biologic drug the FDA requires the manufacturer to have each batch tested by a 3rd party laboratory (they recommend Eurofins so that is who we use for testing). The tests that the FDA require are extensive and it costs the manufacturer $800k per batch. If the test shows the batch is even ONE exosome below 100 billion with our 5mL skew, we must dispose of that batch. We don’t get a “do-over”. The FDA requires us to make consistently POTENT, PURE, and SAFE product with every batch. Therefore, we are REGULATED by the FDA as we wait for our official clinical studies to conclude, and we will then have the first and only FDA-approved human-derived mesenchymal exosome product available.
361
What does the FDA require to get categorized as a 361 product? NOT MUCH. It’s easier to list what you are NOT required to do as compared to 351(a).
-
You are NOT required to provide efficacy data (so you don’t have to prove it’s effective).
-
You are NOT required to perform pre-clinical trials.
-
You are NOT required to perform safety studies (so you don’t have to prove that it is safe).
-
You are NOT required to have your product tested by a 3rd party laboratory (so you have no idea if the product you are using has what is stated on the label or no exosomes at all. No idea if it is contaminated, what types of growth factors, proteins, etc.)
-
Cost: $0
-
It takes about 45 minutes to complete the online application process.
Considering you are NOT required to prove that it’s effective, safe, or have it tested to confirm the contents and that it is free of contamination, 361 products are categorized as topical cosmetics and are permitted to be used on top of UNBROKEN SKIN only.
Again, ALL other MSC exosome products (there are hundreds of them) that you will run across are categorized as a 361 and are illegal to inject and treat medical conditions.
The pricing depends on the provider’s location. In affluent areas such as Dallas, Miami, Fort Lauderdale, high-end cities in California, Houston, Austin, Scottsdale, Phoenix, North and South Carolina, and New York, providers typically charge around $10,000 per 5mL vial. This price includes the exosomes, office visit, consultation, and administration (IV).
In less affluent areas, pricing tends to be lower, ranging from $7,000 to $9,000. However, providers ultimately set their own prices—we do not determine that for them.
Important Note: Providers are not technically supposed to mark up the price of ancillary products. They should sell exosomes at the same price they purchase them for, while billing patients separately for the office visit, consultation, and administration. The total cost should reflect whatever is customary for those services, in addition to the cost of the exosomes.
-
"Supports" (e.g., Supports cellular health and function)
-
"Promotes" (e.g., Promotes tissue regeneration and repair processes)
-
"Aids in" (e.g., Aids in natural recovery mechanisms)
-
"Enhances" (e.g., Enhances cellular communication and signaling)
-
"May assist with" (e.g., May assist with reducing inflammation markers)
-
"Contributes to" (e.g., Contributes to overall skin rejuvenation)
-
"Encourages" (e.g., Encourages the body's natural repair response)
Example Compliant Phrasing:
❌ Non-compliant: "Exosomes treat joint pain."
✅ Compliant: "Exosomes may support joint health and mobility."
❌ Non-compliant: "Exosomes cure inflammation."
✅ Compliant: "Exosomes help regulate inflammatory responses."
❌ Non-compliant: "Exosomes regenerate damaged tissue."
✅ Compliant: "Exosomes promote the body's natural regenerative processes."
General Compliance Tips:
-
Stick to structure-function claims (i.e., how exosomes support normal biological functions).
-
Use "may" or "supports" to avoid definitive health claims.
-
Avoid mentioning specific diseases unless referring to published research (and always with a disclaimer).
-
When referencing studies, ensure they are properly cited and framed as ongoing research rather than definitive claims.
Since mesenchymal exosomes fall under FDA 351(a) biologic drug regulations, you must avoid language that implies curing, treating, diagnosing, or preventing diseases unless you have specific FDA approval for those claims. Instead, here are some compliant alternatives that stay within regulatory guidelines:
Replace "Cure" and "Treat" with:
The FDA is very particular about marketing so be sure to be compliant with any mass marketing which includes any emails when being sent to someone unsolicited.
You are not allowed to use “FDA” or to reference the FDA including our status with the FDA to help persuade or sell a product.
NEVER use the word “APPROVED” in any situation until our product is officially approved. The correct way is to say, “Our MSC Exosome product is the only one that is legally PERMITTED to be sold and used for RESEARCH and INVESTIGATIONAL USE.”
Be sure to let the doctor or patient know that “currently, no exosome products are FDA Approved.”
You can follow that up with, “however, our exosomes are legally permitted to be used systemically and can be administered via IV Infusion, with joint injections, etc.”
Any emails or any marketing that anyone can access you can make references without saying “FDA” and the same point will get there. For example, you can say, “we abide by all regulatory guidelines.”
You can say, “we are categorized as a 351(a)” leaving out “with the FDA”. When you say, “legally permitted” without mentioning the FDA that leaves it open and doesn’t specify who it’s legally permitted by.
Of course, NEVER use terms such as “cure”, “heal”, etc. You need to be more broad using terms like “potential” or “have shown promise to… “ or “Potential Benefits Include…”. A lot of the time I will say, “we have seen a lot of success with _____ condition”. Saying “a lot” is a matter of opinion and not factual and people define “success” differently. You may hear me say, “I haven’t had a single patient yet who didn’t get their “desired results” as long as they took the recommended dosage and followed the protocols.” This is a true statement. Notice I didn’t say “cure”, etc.
When marketing to the masses or when doctors market on their website you are not supposed to use the term “exosomes” or “stem cells”. However, you can say, “Regenerative Medicine” or “The most advanced regenerative medicine.”
FROM ChatGPT
When marketing MSC-derived exosomes in compliance with FDA regulations, it is important to use FDA-compliant terminology to avoid regulatory scrutiny. The FDA does not allow the term "exosomes" in marketing materials, as it implies an unapproved drug or biologic product. Instead, here are alternative compliant terms that align with regulatory standards:
FDA-Compliant Terms for Marketing:
✅ Extracellular Vesicles (EVs)
✅ MSC-Derived Extracellular Vesicles
✅ Biologic Nanoparticles
✅ Regenerative Nanoparticles
✅ Signal-Cell Derived Vesicles
✅ Stem Cell-Derived Signaling Vesicles
✅ MSC-Derived Secretome
✅ The most advanced regenerative medicine
These terms focus on the natural cellular communication function of exosomes without making unapproved drug claims.
Key Compliance Guidelines:
-
Avoid disease claims (e.g., "treats arthritis" or "cures neuropathy"). Instead, use phrases like "supports regenerative function" or "promotes cellular communication."
-
Do not imply FDA approval unless explicitly stating compliance within investigational use (e.g., "Our product is FDA-compliant as a 351(a) biologic drug with a Drug Master File").
-
Use scientific, non-therapeutic language, focusing on structure and function (e.g., "supports tissue health" instead of "regenerates cartilage").
What does it mean when you say, “legally permitted to be sold and used for research and investigational use”?
As long as the doctor or patient is buying/using our product for “research” it’s legal for us to sell to anyone… anywhere. The “research” is private research and none of the data needs to be submitted to the FDA nor to the manufacturer.
What’s required to be compliant?
The provider needs to have the patient read and sign the informed consent form which states that the patient understands the product is not an FDA “Approved” medical treatment, they understand the other options available to them, outlines any side effects, and that they are getting treated with the exosomes voluntarily. Then the provider needs to enter the soap notes in their EMR system and state why they treated the patient, the medical condition, dose and administration method. Last, they need to enter follow up notes the next time they see the patient. That’s it.
To date, none of our providers have ever been audited and if they were they would just need to show those documents.
To place an order the provider or patient simply submits their order through the online order form.
There are 3 payment options:
-
Wire Transfer (preferred)
-
Credit or Debit Card (we have to pass the 3.5% processing fees to the customer)
-
Cashier’s Check – they must send the check overnight express
When they submit the order, the client will receive an order confirmation via email with payment instructions. If they selected to pay via credit or debit card we will send them an invoice through PayPal with a payment link.
I strongly suggest the client submits the order themselves as opposed to you filling it out for them. There are a couple reasons why...
-
Address mistakes - if you happen to type even one digit wrong on the zip code it will cause delays with FedEx which could cause dry ice to melt before it gets delivered and the exosomes could go bad. If this happens, you will need to pay for the replacement vials.
-
Terms and Conditions - there are terms and conditions that the client must acknowledge which states that they understand we cannot accept any returns or exchanges andn that all sales are final. It also states that they understand that they must put the exosomes in their freezer upon delivery. If you fill out the order form that means they are not agreeing to the terms and conditions and they can claim they were not aware of this so the liability falls on you.
SHIPPING
We ship our medical grade injectable exosomes overnight express on dry ice Monday through Thursday. Any orders placed on Friday will ship the following Monday for Tuesday delivery unless they request Saturday delivery.
Our topical exosomes are shipped Monday through Friday via 2-day air.
We provide tracking for each order. Once their order is delivered, the recipient needs to put the injectable exosomes in their freezer as soon as it is delivered. If there are any delays with FedEx, it’s typically not an issue. The dry ice will last at least 48 hours up to 72 hours.
REFUNDS AND EXCHANGES
We cannot accept any returns or exchanges per the FDA so all sales are final. However, if something were to happen to the product while in transit, we would replace the order. The customer must document the issue with pictures and or videos upon recognizing the issue. We will provide our FedEx account number to have their order shipped back and we will send the replacement immediately.
You can do your own research when someone asks if our product works for [incert medical condition]
ChatGPT is your friend www.chatgpt.com
Type the following:
“Explain how Mesenchymal Exosomes help in the treatment of __________.”
If you want ChatGPT to “dumb it down” for you type: “Explain how Mesenchymal Exosomes help treat _______ at an 8th grade reading level.”
EXAMPLE:
“Explain how human umbilical cord mesenchymal stem cell derived exosomes help reverse late stage kidney disease at an 8th grade reading level.”
Human umbilical cord mesenchymal stem cells (MSC) are special cells that can be found in the umbilical cord of newborn babies. These cells are really good at healing and repairing tissues in the body. They can make tiny packages called exosomes, which are like little "messenger" bubbles.
Exosomes carry important information, like proteins, lipids, and genetic material, that can help cells communicate with each other. When exosomes from umbilical cord MSCs are used to treat kidney disease, they help in several ways:
-
Repairing Damaged Cells: The exosomes carry helpful signals that encourage the kidney cells to repair themselves. They can also help new, healthy cells grow to replace the damaged ones.
-
Reducing Inflammation: In kidney disease, inflammation (swelling and irritation) can make things worse. Exosomes help reduce this inflammation, which is good for the kidneys.
-
Improving Blood Flow: Exosomes help the blood vessels in the kidneys work better, which is important for kidney function. Better blood flow helps the kidneys filter waste more effectively.
-
Helping Kidneys Heal: In later stages of kidney disease, the kidneys struggle to heal on their own. Exosomes from stem cells encourage the kidneys to heal and work better.
In short, exosomes from umbilical cord stem cells have the ability to help heal, reduce damage, and improve how the kidneys work, which is why they may be helpful in treating late-stage kidney disease.
BUTTERFLY PUSH
PROTOCOLS
EXOSOME IV INFUSION
PROTOCOLS
EXOSOME EYEDROP
PROTOCOLS
NEBULIZE EXOSOMES
PROTOCOLS
"P" and "O" SHOT
PROTOCOLS
MICRONEEDLE EXOSOME
FACIAL
EXOSOME IV INFUSION
INFORMED CONSENT
EXOSOME FACIAL REJUVENATION INFORMED CONSENT
HAIR RESTORATION
PRE & POST TREATMENT
PROTOCOLS
Frequently asked questions