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MIRACU PDO Threads and BENEV Exosome Regenerative Complex set to transform the anti-aging market

Sponsored by BENEV

MIRACU PDO Threads® (MIRACU®) and Exosome Regenerative Complex are two new products transforming thread lifting and regenerative medicine. DBM Corporation Inc. (DBM), the official U.S., Mexican and Canadian distributor of MIRACU, and BENEV Company, Inc. (Mission Viejo, Calif.), the globally-recognized FDA-registered manufacturing facility, are key players in the aesthetic space. Through MIRACU and Exosome Regenerative Complex, BENEV and DBM are re-educating both physicians and consumers about what’s possible in mini- mally invasive aesthetic medicine.

MIRACU PDO Threads

MIRACU PDO Threads, are unique in providing a pre-loaded cannula with U.S. FDA class 2 clearance for soft tissue approximation, where use of an absorb- able suture is appropriate. The product has been cleared for localized skin lifting and tightening. MIRACU PDO Threads are sold exclusively though DBM, a joint venture between BENEV and DongBang Medical Co. Ltd. (Sungnam, Korea), reportedly the largest PDO and cannula manufacturer in Korea.

According to Richard Jin, MD, PhD, who practices aesthetic medicine with a focus on regenerative aesthetics at RJ Clinical Institute in Mission Viejo and Temecula, Calif., “MIRACU has been driving the PDO industry for years. The company’s philos- ophy centers around research, develop- ment and technology that is transforming this field.”

This sentiment was echoed by Philadelphia- based plastic surgeon Richard M. Goldfarb, MD, founder of the Center for SmartLipo and Plastic Surgery. “I’ve been heavily involved in trials for other threads over the years, and what attracted me to MIRACU was that despite having a finished product they followed the path of regulatory approval, quality product development and safety. Instead of rushing to put this on the market, they took the necessary steps of achieving FDA approval, giving me the con- fidence to incorporate this into my practice.”

Building on the MIRACU family of cannulas and advanced PDO threads, the Elasty Line and Elasty Meshfill represent some of the most innovative threads to come to market. “The extensive R&D incorporated into this technology has allowed us to obtain dramatic results using less product, also enabling manipulation and contouring of portions of the face in ways we couldn’t before,” said Dr. Jin. “The tensile strength and flexibility of the threads provide the ability to shape and pull tissue without compromising their integrity.”

“The safety and ease of use with these threads means we don’t see adverse reactions from patients, and can easily place these accurately to create the result we’re working toward,” said Randy B. Miller, MD, medical director of Miller Plastic Surgery in Miami, Fla.

Featuring a double coated high polymer PDO with deep cogs and exclusive FCV cannula tip for muscle fixation, Elasty Line threads are stronger, more reliable, and more effective than alternatives, said J.D. McCoy, NMD, medical director of Contour Medical (Gilbert, Ariz.). “This is almost a thread within a thread, which is stronger and degrades more gradually as a result. I’ve been doing thread lifting since 2005 and this is my go-to because of durability, longevity and ease of use.”

“The barbs and anchor tip fix more solidly into tissue,” said plastic surgeon Diane I. Duncan, MD, who practices in Fort Collins, Colo. “The double coating also makes it last significantly longer than traditional PDO threads. MIRACU threads last two years, standard PDO threads last six months.”

“The barbs and anchor not only fix well within tissue, they are designed so that as they dissolve a secondary cone-like structure remains in its place, providing a secondary hold,” added Dr. Jin.

The great thing about threads is that you see much of the result at the time of the procedure, Dr. Miller explained. “This provides a nice payoff for patients, add to that the fact that you don’t have the significant aftercare you would see with surgery or lasers, for example, so there is very little downtime, which is important to a busy professional clientele.”

“MIRACU thought of every little detail,” Dr. Goldfarb added, “from quality control to the fact that each thread is individually sealed to preserve thread sterility.”

Elasty Meshfill is a unique two-in-one filler and thread composed of 16 mono threads interwoven to create a cylindrical hollow mesh scaffolding for volumizing, lifting and rejuvenation with and without filler. This is the first thread of its kind. Two weeks after insertion of mesh in the layer between the dermis and SMAS, soft tissue grows into the gaps of the mesh to pull and fixate. It can be used in regions such as the tear trough, nasolabial folds, bridge of the nose, deep forehead lines, and vermillion border. “This is a crazy idea, taking 16 threads and wrapping them in a cylindrical fashion to create a mesh which dissolves over time, but stimulates collagen growth,” said Dr. Jin. “And it works incredibly well.”

Medical professionals can maximize the volume effects of treatment by combining the Elasty Meshfill with filler. The scaffold design provides structural support and works to reduce the diffusion and migra- tion of filler, as well as extend the life of the filler by about 40%. “You have stimula- tion of nucleogenesis by the mesh, plus augmentation with the filler. It is ideal for difficult-to-treat areas where you may need multiple vials of filler otherwise,” said Dr. Goldfarb. He added that this con- cept works well with other products such as PRP. “This really defines what regen- erative aesthetics is all about.”

“I believe this will become the standard of care for some areas of the face, such as the nasolabial fold,” Dr. Jin added.

Shino Bay Aguilera, DO, director of Shino Bay Cosmetic Dermatology & Plastic Surgery (Fort Lauderdale, Fla.) tends to be conservative when adopting new modalities, so he was slow to incorporate threads into his practice. “I loved the concept, but was initially put off by the inconsistent results and low reliability of threads,” he said. “The use of PDO was a move forward in making this concept successful, but I still waited. Now, I’ve used a lot of PDO threads and gravitate to MIRACU because of the unique prop- erties. They fit well into my approach to facial restoration.”

“I like to use fillers that incorporate into the body rather than just occupy space, which is especially important as I envi- sion how correction will be needed for a patient over the years because you can’t just keep putting filler into the face forever without it beginning to present a subop- timal result,” Dr. Aguilera continued.

“So as I strive to maintain the youthful look and shape of the face over time, I find that fillers are not a 100% answer by themselves,” Dr. Aguilera continued. “MIRACU PDO Threads and Elasty Meshfill are a great complement to fillers because they lift, tighten and provide volume naturally. The community will use products like these more and more because they fill a niche by themselves and with existing fillers to achieve a better, more natural-looking result. And with the mesh reducing migration and diffusion of fillers, this allows me to sculpt a more youthful, natural look for my patients.”

Dr. Duncan also shied away from thread lifting initially. “I just wasn’t happy with the results for a lot of reasons. The threads were either too thick and patients could feel them, or so thin that they fragmented in the package after six months and didn’t provide the correction I was looking for. MIRACU Elasty Line threads and Elasty Meshfill are more what I was looking for.”

“Also, I’ve been looking for a small, inject- able implant for four years,” she said. “I now use Elasty Meshfill with fillers and autologous fat to fill that niche, and I’ve been very happy with the results. You can stack it to obtain different thicknesses, which makes it useful on any area of the face. It is also great for a lip lift because you can craft your correction exception- ally, even for thin, lax lips, without that obvious augmented look we want to avoid. I haven’t seen anything like this product in my travels around the world in aesthetic medicine. Plus, FDA clearance was obtained before launch, and as far as I know they’re the only company to have obtained approval for both their thread products and cannulas.”

According to Dr. McCoy, a key aspect of thread treatment is the need for existing facial volume before use. “A lot of my patients may need facial integrity and volume augmented before they are good candidates for MIRACU. But it is extremely rare that I’ll use threads alone anyway because I do a lot of combination therapies, as many of us do,” he noted.

“In my mind the art of using threads is the art of patient selection,” Dr. McCoy con- tinued. “So MIRACU goes hand-in-hand with volumizing, and as an entry level pro- cedure the Elasty Meshfill is great because with fillers it lifts and volumizes at the same time.”

Dr. Miller agreed. “Good thread lifts depend on tissue quality, volume and firm- ness, otherwise you get a poor outcome. So, you’re looking to use these to correct ptosis rather than laxity. The middle-aged patient who doesn’t yet need a facelift is an ideal candidate.”

While MIRACU products themselves are outstanding, Dr. Goldfarb believes the training system supporting their use is even more extraordinary. “MIRACU is committed to hands-on training. “When you use these in your patients for the first time the company makes certain that you are thoroughly trained and comfort- able,” he stated. “This has been a problem for other thread companies in the past. The quality of the product, the training and the support from the company make MIRACU second to none.”

The vast difference between MIRACU and competitors comes through during training as well, Dr. Jin pointed out. “When I’m training physicians, they often remark how similar these products are to what they already use, but by the time we’re finished, they see the gap between their original go-to thread and MIRACU.”

Exosome Regenerative Complex

Exosomes are extracellular vesicles produced naturally by cells, facilitating the exchange of RNA and other proteins between cells, as well as transmitting growth factors, cytokines and other genetic material. Thus, they are responsible for cell-to-cell communication and influence the micro-environment around a cell. As a worldwide thought leader in regenerative medicine, Dr. Miller gravitated to Exosome Regenerative Complex because of the way it har- nesses the power of the exosome. “It is exosomes from stem cells that trigger the therapeutic responses we are looking for in regenerative medicine,” he said.

“In aesthetic medicine we’re using these exosomes to activate the regenerative capacity of cells to make healthy, youthful new tissue.”

Exosome Regenerative Complex powered by Exo-SCRTTM is a dual action complex formulated to absorb quickly into the skin. This delivers concentrated power of more than 2 billion stem cell derived exosomes (from adipose tissue), potent growth factors, peptides, coenzymes, minerals, amino acids, vitamins and hyaluronic acid (HA). These paraben free, steroid free, hypoallergenic patented technologies and ingredients are clinically proven to rejuvenate and regenerate the skin.

Developed and designed by BENEV and ExoCoBio®, the fourth largest exosome research company in the world, BENEV holds the license to Exo-SCRT in the U.S., Mexico and Canada. Exo-SCRT is the innovative patented purification method to separate and refine 0.1 pure exosomes from stem cell conditioned media. The concentration of materials is significantly greater than can be achieved with a product such as PRP.

Studies have shown that this product increases fibroblast production by 180% and collagen production by about 300%. “The science is clearly demonstrating that exosomes are the wave of the future, not just for aesthetics, but for many other areas of medicine,” Dr. Miller stated, “and the richest source of this material, by far, is adipose tissue.”

“PRP is tried and tested and has a firm place in the armamentarium with proven therapeutic benefit for years to come, but it can be enhanced with the addition of the Exosome Regenerative Complex,” Dr. Jin indicated. “The Exosome Regenerative Complex consists of more than 50 growth factors and other active constituents, with the ability to exert a self- proliferating therapeutic effect promoting neocollagenesis plus anti-inflammatory capabilities for better outcomes.”

“BENEV lyophilizes the exosomes, stabilizing and preserving the biologic activity, maximizing topical therapeutic potential,” added Dr. Goldfarb.

Additionally, the size of the nanoparticles promotes passage through the stratum corneum, making them ideal for topical use, alone or in conjunction with the usual suspects: microneedling, ablative resur- facing, microdermabrasion and chemical peels, among others. “BENEV has done an excellent job of giving us something that delivers these compounds into the skin, and if we use other modalities to increase the number of exosomes we can deliver, we will reap even greater benefits,” Dr. Miller said.

Dr. Duncan agreed. “If you’re looking to deliver these compounds into the skin through these conditioned media, then exosomes are the thing. There are a few competitors on the market, but they’re prohibitively expensive, and I don’t know too many patients who are willing to spend that much money when we have this product available.”

“These are remarkably safe and easy to use,” Dr. McCoy said. “You can use them right after treatment for something simple or aggressive. The HA diluent is very elegant as well. It is a nice way to addi- tionally deliver HA with treatment and is a differentiator.”

BENEV’s X|RATED Exosome Facial® treatments harness the power of Exosome Regenerative Complex in conjunction with modalities such as microneedling, CO2 and other lasers, PRP, chemical peels, RF and more. The protocol is a clinically proven, non-invasive therapy for fine lines and wrinkles, age spots, redness and irritation, lesions and scars, texture and pore size, as well as overall brightness and hydration of skin. Outcomes appear incrementally over a series of five treatments. Integrating the product for at-home use three to four days after aggressive procedures, or one day after minimally invasive procedures, has been shown to soothe any inflammation and discomfort, while significantly decreasing the associated recovery downtime.

Additionally, the cost of treatment with Exosome Regenerative Complex is a fraction of that seen with the few other exosome products on the market. “I use the Exosome Complex to enhance wound healing and response to other treatments,” Dr. McCoy shared. “I’ve used multiple products such as growth factors or PRP over the years and I’m always looking for the best and most affordable; this satisfies both criteria. And I love the X|RATED Exosome Facial by itself as well. This is very easy to implement; the price point makes it accessible for patients.

“Also, other products are labeled for topical use, but employed off-label by physi- cians, whereas Exosome Regenerative Complex is labeled for its intended use.”

Dr. McCoy adds the product to lighter and more aggressive treatments, such as RF microneedling and laser resurfacing, among others. “Since implementing this as a protocol I’ve observed significant improvement in speed of healing, skin quality and comfort during recovery. And by building this inexpensive therapy into the overall cost of treatment, then explaining the role of Exosome Regenerative Complex in their protocol, I see more and more patients returning to have stand-alone treatments with the product itself for maintenance.”

In addition to safety, efficacy, affordability and utility, the shelf life of Exosome Regenerative Complex makes it appealing to physicians, Dr. Duncan expressed. “The product is lyophilized and freeze dried, so it doesn’t expire so quickly. I never got into PRP, and with this product, I don’t have to.”

“With aesthetic medicine we are talking about a very narrow focus, but these exosomes have potential applications across the field of medicine, and it is exciting to see how it will unfold,” Dr. Jin concluded.

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