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The Leading Edge of Topical Exosomes In-Office and At-Home

Article-The Leading Edge of Topical Exosomes In-Office and At-Home

Sponsored by Elevai; E-Series™ topical exosome skincare from ELEVAI Labs, Inc. (Newport Beach, Calif.) is expanding the boundaries of regenerative aesthetics. The Company’s two featured products – empower and enfinity – are safe and effective, but more than that, ELEVAI Labs is committed to their proper use as defined by the current regulations, while simultaneously driving forward the research.

Sponsored by Elevai;

Headshots_ElevaiE-Series topical exosome skincare from ELEVAI Labs, Inc. (Newport Beach, Calif.) is expanding the boundaries of regenerative aesthetics. The Company’s two featured products – empower and enfinity – are safe and effective, but more than that, ELEVAI Labs is committed to their proper use as defined by the current regulations, while simultaneously driving forward the research.

“Exosomes are the future of aesthetic medicine because they are giving the body more of what it needs to heal itself,” said dermatologist Doris Day, MD (New York City, N.Y.). “Whether the modality is ablative or non-ablative, anything stimulating neocollagenesis, or even something like fillers, will do better when provided in conjunction with the best support to optimize the expected outcome.

“I think that we, as a community of aesthetic physicians, are now gaining greater insight into the importance of adjunctive skincare around our in-office treatments, as we are better at considering how important it is to the ultimate success of the procedures we perform,” Dr. Day continued. “empower, for example, is not a barrier cream, but instead provides an abundance of compounds that the body creates for itself to maximize the healing and maintenance of tissues. E-Series exosomes provide what I believe to be the best version of that via an inoffice treatment support product in empower, and an at-home skin health topical in enfinity. I am always looking for the next level of skincare and we offer a full spectrum of topicals which we believe in, but to me the E-Series exosomes are that next level.”

“In essence, exosomes are the stem cell’s molecular carrier pigeons that signal the neighboring cells how to perform. This includes the messages that need to be transmitted to help these cells be active and support proper function, cell turnover, or differentiate,” explained plastic surgeon Hatem (Tim) Abou-Sayed, MD (San Diego, Calif.), who is also the co-founder and chief medical officer (CMO) of ELEVAI. BEforeAfter_Elevai_Article

“Exosomes are the key to how stem cells do their job of signaling to other cells, providing instructions or ‘blueprints’, ultimately influencing cells that are damaged or dying to repair or be replaced through natural cell turnover,” Dr. Sayed elaborated. “In other terms, we do not really need the actual stem cells in the topical skincare products, but rather the message content. Being able to capture an exosome-rich medium – the milieu that carries the exosome packages with their messages – and isolate, refine and deliver that topically, is the secret sauce in our exosome-based topical skincare products.”

Jordan Plews, PhD, co-founder and chief executive officer (CEO) of ELEVAI, put it this way, “Your body sends signals when there has been some injury, and these signals travel to your stem cell populations and let them know that damage has occurred. In response, the release of factors by stem cells is triggered, in the form of exosomes, which travel to the site of injury. Those exosomes are biologically and evolutionarily built to go there carrying a payload meant to ameliorate the situation and/or support the healing process. “We are more or less trying headshots_Elevai2to hijack what the stem cells do after that signal has been received,” Dr. Plews continued. “Our job in the lab is to trick stem cells into thinking the damage has occurred. And then, when they release their exosomes – which I describe as cellular mail between one cell to another – we are stealing the mail at just the right time. From there we enrich, purify, isolate and stabilize it, then we put it into a topical product.”

“The exosomes for these products are derived from human umbilical mesenchymal stem cells (hUMSC), specifically from Wharton’s Jelly in the umbilical cord, which is where we find the youngest, purest non-embryonic stem cells,” Dr. Sayed expressed. “These are the best source of exosomes because they are harvested at the most youthful point in their potential lifespan.”

ELEVAI’s proprietary process includes growth in an animal-free media at 37o C, and the final product is shelf-stable at room temperature, unlike those of current competitors, according to Dr. Plews. “What we are doing here is reverse engineering nature, which means not messing up what nature already does well.

“Different labs have different methods of preservation such as freezing or freeze drying,” Dr. Plews added. “We do not let them freeze, go above normal body temperature, or experience spikes in pressure, pH or other environmental factors. In our double walled airless packaging, they are kept sealed away from oxygen and UV light in a hyaluronic acid blend that mimics amniotic fluid and is quite viscous, helping support stabilization on a nanoscale. It ends up being like little ping pong balls suspended in gelatin.”

Currently the skincare line contains two products, empower for in-office treatment support, and enfinity for at-home use. BeforeAfter_Elevai2“They are not separate products, exactly, but more of a one-two punch,” Dr. Plews explained. “empower for the office and enfinity for continued home care.” “We have found great utility for the postprocedure product (empower) in my office for taking the red out of the skin,” noted Natalie Curcio, MD, of Curcio Dermatology in Nashville, Tenn. “We use it for a variety of laser and energy-based devices including particle-free microdermabrasion, microneedling, radiofrequency (RF) microneedling, vascular lasers and non-ablative fractional resurfacing. What I have found is that patients are absolutely willing to pay for the product, so they are not red whether it is for a few hours or a few days, depending on the treatment.

After people have tried the post-procedure product, she continued, they are very eager to try enfinity, the twice daily product for home use. “Word of mouth is a very effective means of marketing. Patients come in asking for a new cosmeceutical because their friends love it. In addition, my patients always ask me, ‘What is the newest or hottest product on the market?’ When something new or different comes out, my patients know that I will have it first and they are ready to try it because they trust me and my research implicitly.” 

While the exosomes are the same, the two products are distinct and crafted with a specific purpose. “The empower product is formulated for rapid absorption at the time of an initial treatment,” Dr. Sayed explained, “so it is really meant to be paired with treatments, to help soothe the skin. Patients report that the redness and the inflammation that they see after treatments like RF microneedling or fractional laser treatment, for example, is soothed much more rapidly. We are actively performing research to better visually quantify both of these benefits. We are using infrared and other skin analysis systems, plus at least one split-face study comparing the use of empower post-procedure to other incumbent exosome-based and non exosome-based serums.”

 enfinity then enables exosomes to become part of a patient’s daily skincare regimen, and might even replace other components they normally use, Dr. Sayed indicated. “What we know about skin is that its number one function is to serve as a barrier, and it is not designed to let a lot of things in. Thus, the idea of being able to kickstart rejuvenation by having something applied immediately after a procedural treatment, makes a lot of sense. At the time, it is simultaneously more vulnerable to absorption of topical agents, and in greater need of what our exosomes provide.”

While exosomes tend to be lumped in with popular products in widespread use such as platelet-rich plasma (PRP), there are many differences.

“When comparing exosomes with something like PRP, we need to consider the source,” Dr. Sayed commented. “Our exosomes are from newborn tissue. I have to think that a newborn’s ability to heal, or to rejuvenate, comes from a more youthful wellspring than the stem cell-derived constituents present in adult blood.ElevaiLabs_8weeks

“If my blood was drawn and processed for PRP, to concentrate and isolate some of the target components, we are limited to the best a 50-year-old man has to offer,” Dr. Sayed added. “If that was such a rich source of rejuvenation, then I would probably not look and feel like I am in my 50s; I would not have the senescence – the aging process that leads to cellular breakdown and cellular mutation – and all the other things that are part of aging. However, those processes would be slower or would be arrested if we preserved a wellspring of youthful regeneration as we age.

“That is why people have been searching for the so-called ‘Fountain of Youth’ forever,” Dr. Sayed continued. “At the end of the day, in aesthetics, we are searching for ways to preserve vitality, youthful appearance and vigor. That is why I consider human mesenchymal stem cell-based exosome technology from Wharton’s Jelly as the gold standard in terms of its regenerative or rejuvenative capabilities.”

PRP was Dr. Curcio’s first go-to for redness reduction and maximizing skin health post-procedure, but the effects lasted a few hours at most. “The fantastic thing about empower is that it is topically applied, quick, easy, painless and when the redness is gone it is gone for good!” she reported. “When I saw it on my first patient after RF microneedling, I really did not believe it would last. PRP takes more time, requires numbing, is more costly and needs open holes in the skin or to be injected to penetrate.”

Dr. Curcio also highlighted the three things which impressed her the most beyond safety and efficacy: the source of E-Series exosomes, the process of procuring them for clinical use and the stability of the products. “They have ethically sourced the youngest, purest stem cells,” she reported. “The product is manufactured in the U.S. in laboratories owned by ELEVAI, which is extremely important to me. And these products are shelf-stable at room temperature. To me this represents the ideal.”

According to Dr. Sayed the production takes place in a cGMP-quality (Current Good Manufacturing Practice) laboratory environment in the U.S., using stem cells sourced ethically from a well-established biotech company with strong academic research connections. Product stability and quality are preserved throughout the supply chain.

“This is a marriage of industry and academics,” said Dr. Sayed. “Here at ELEVAI we have assembled a team of leaders, scientists, administrators, and advisors formerly involved with major companies – household names to regular consumers – in and on the periphery of this industry and cutting-edge academia. Also, we are very pleased to have won the 2022 People’s Choice Award at the Octane Aesthetic Technology Summit (held annually in Orange County, Calif.). We think we are on a really great trajectory, and for me, it is really a privilege to learn a lot about exosome science and the skincare industry from my colleagues in the company!”

The company itself is a strong source of confidence, according to Dr. Curcio. “First and foremost, the people at the top have to know and be able – and willing – to answer questions about a remarkable but emerging technology. I have rarely met such a research-focused, education-committed group behind a product. There is a lot of conflicting information out there and ELEVAI was able to answer every single question I had so that I could make my own informed conclusions, well before I placed an order. ELEVAI is led by top people from around the industry who are passionate about exosomes and their safe use, for everyone’s benefit. I read more than 40 journal articles on exosomes and had meaningful conversations with people like Dr. Plews, who have deep experience with exosomes. When the E-Series products came out I had to jump on them because they so perfectly fit my clinical needs

“The company has also been incredibly attentive to customer service,” she added, “and it has made me very eager to partner with them. My excitement tends to create patient enthusiasm as well.

Dr. Sayed shared that the current landscape for exosome-based products on the market today looks basically like this: “Here is something that comes in a vial. This is how you reconstitute it to make it into some kind of liquid form factor you can use. What you do with it from there is your discretion, as the doctor. When I was introduced to such technology for the first time, that was what was actually offered to me by a company. I sort of scratched my head and said, ‘Well, I am not sure what to do with this. What is the right amount? Is this injectable? Am I going to be okay if I inject this? Is that really appropriate?’ Those are murky regulatory waters.”

“The FDA has been very clear on this issue,” Dr. Plews clarified. “We are a topical exosome company, and our products are not for injection. We cannot make medical claims, but we do know what exosomes do. We obtain them from the most youthful source we can, ethically, and prepare them for safe topical use.”

ElevaiLabs_16weeks“One of the best things about E-Series exosomes is that they stimulate conversations that educate patients,” Dr. Day noted. “I have supermodels, people who virtually anyone would want to trade places with when it comes to beauty, coming in thinking they do not look pretty, just like the average person on the street – I have to protect them from doing too much. Everyone benefits from understanding how to best take care of themselves, so the conversation about exosomes, and how they work, helps do two things. First, it promotes compliance because when people understand how a product works and what is in it, they will believe in it and how it fits into the overall picture. But more than that, it helps them see how many other things like nutrition, healthy lifestyle, managing stress and more, go into our total health and wellbeing. The excitement breeds understanding and compliance, as well as more consideration of the total picture. 

“And as they continue to study and develop these products, and share their new knowledge with us, we will be able to provide even more exciting news to patients about how they can take the best care of their skin, and themselves,” Dr. Day added.

“We have a lot of products in the pipeline and the hair restoration market is one that generates a lot of interest among providers, device manufacturers and us,” Dr. Sayed disclosed. “People have been seeing success combining PRP with hair restoration therapies, but as I mentioned, you are concentrating PRP from blood of the person who is losing their hair. When you consider exosomes as a vastly more powerful version of what PRP offers, the potential could be much greater. It is high among the exciting things on the exosome horizon.”

“Ultimately I see ELEVAI E-Series as an important new addition in what I call next-level skin care,” reiterated Dr. Day. “As I figure out these new advances and how to best fit them into our armamentarium, I have phased out some of the other products I had been offering that contained things like more basic growth factors, but ultimately I am looking for high-quality, lasting results for my patients.”

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