ew Technology Enables Rapid Growth of Regenerative AestheticsN

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he regenerative medicine market is expanding into the medical aesthetic field at a rapid pace, primarily due to the growing capabilities of cell-based therapies to replace

or regenerate human cells and tissues. For physicians wanting to break into this emerging, but evolving regenerative aesthetics arena, the question is how to best perform clinically viable treat-ments via autologous tissue transplants, biologic products and related approaches, including the use of platelet-rich plasma (PRP) solutions, adipose tissue stromal vascular fraction (tSVF) and adipose cellular stromal vascular fraction (cSVF).

One enterprising firm, Healeon Medical (Newbury Park, Calif.) has taken the lead towards simplification, automation and mass commercialization by pro-actively developing next-generation, point-of-care tools for extracting, processing and delivering autologus fat- and tissue-derived aesthetic treatments.

As an example, in partnership with the third-party service provider Regeneris Medical (North Attleboro, Mass.), Healeon offers the CENTRIcyte 1000 specimen processing centrifuge system for cell isolation from a variety of autologous tissues. This unit offers a point-of-care ability to isolate stem / stromal cells in a closed system while maintaining a sterile chain environment.

Regeneris Medical also provides research-based solutions for IRB clinical trials for cell enrichment protocols and patient reg-istry tracking, and has facilitated Healeon’s ongoing registered clinical trials focusing on neurological, pulmonary, autoimmune, musculoskeletal and medical aesthetic options.

In addition, Healeon has joined with Nouveaux Medical (Newbury Park, Calif.) to market the ALMI™ (autologous lipocyte micronized

injection) brand. Nouveaux Medical’s proprietary protocols provide a growing list of regenerative treatments, which include an autologous dermal filler and protocols for other skin rejuvenation procedures, including solar damage repair and hair regrowth.

The ALMI protocols utilize micronized fat that is unadul-terated. “I love natural solutions and I am a big believer in our

New Technology from Healeon Medical Enables Rapid Growth of Regenerative AestheticsBy Jeffrey Frentzen, Executive Editor

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THE Aesthetic Guide September/October 2017 www.miinews.com

To achieve a total skin rejuvenation effect, the ALMI procedure places micronized fat with its extracellular matrix and stem/stromal cell components in all layers of the tissue from the dermis to the epidermis, followed by placement of autologous platelets that plump the tissue and stimulate new collagen, as well as a blood supply.

Edward Zimmerman, M.D. Cosmetic Surgeon

Las Vegas, NV

Robert W. Alexander, M.D., D.M.D., F.I.C.S.

Aesthetic and Reconstructive SurgeonChief Clinical Scientific Officer

Healeon MedicalNewbury Park, CA

Tess Mauricio, M.D. Dermatologist

Beverly Hills, CA

Ryan Welter, M.D., Ph.D.CEO and Medical Director

RegenerisNorth Attleboro, MA

William Philip Werschler, M.D., F.A.A.D., F.A.A.C.S.

DermatologistAssistant Clinical Professor of

Medicine / DermatologyUniversity of Washington

School of MedicineSeattle, WA

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body’s ability to heal itself,” expressed Tess Mauricio, M.D., a dermatologist in Beverly Hills, Calif. “Regenerative aesthetics and regenerative medicine are an extension of this philosophy. I find that when patients are educated and understand regenerative technologies, they get excited about them.”

ALMI’s appearance on the scene can also be traced to increasing practitioner acceptance of fat transfer and PRP use in fillers and other applications.

According to Edward Zimmerman, M.D., a cosmetic surgeon in Las Vegas, Nev., the ALMI protocols represent a significant para-digm shift, particularly in the world of fillers. “We now have a filler that rejuvenates along the way. You don’t have to pull a syringe off the shelf or out of the refrigerator, because many people have a good quality filler that they bring with them – namely their own adipose tissue,” expressed Dr. Zimmerman. “Even on patients who are fairly slim, I am able to extract a pretty good amount of fat and put it in the scalp, or in the face. The extracted fat is micronized, so that you can inject with the same size needle and cannula you would use to inject a traditional filler. This really makes a difference.”

According to Robert W. Alexander, M.D., D.M.D., F.I.C.S., an aesthetic and reconstructive surgeon and chief clinical scientific officer at Healeon Medical, “Advancements in the preparation of these stromal cells and the emulsified tissue derived from fat, used in conjunction with targeted placements of platelet-rich plasma concentrates, have led to develop-ment of the unique ALMI protocol.”

A patient’s fat is micronized via an autologous cellular matrix (ACM) device, in which the fat is sized via a 2.4 and then a 1.2 luer to luer transfer. This extract is pushed through the ACM, which has a 600-micron screen / filter on one side and a 400-micron screen on the other side. After

emulsifying the adipose tissue, autologous biocellular components can be added.

These filters act like small sieves that capture the mesenchymal stem cells in the fat, stated William Philip Werschler, M.D., F.A.A.D., F.A.A.C.S., assis-tant clinical professor of Medicine/Dermatology at the University of Washington School of Medicine (Seattle, Wash.). “They’re also capturing portions of the stromal vascular fraction (SVF), and those ingredients act as the activator for PRP, growth factors and so forth. When injected, it is possible to regen-erate tissue, stimulate hair follicles and encourage the growth of collagen. It can also act as a filler, can be applied topically like PRP for use with microneedling,

penile enlargement, and for feminine rejuvenation as an alternative to energy-based devices.”

As stated by Dr. Alexander, “Advanced aesthetic and reconstructive surgeons have long understood that growth factors and signal proteins were of utmost importance in wound healing and regeneration of tis-sues. For more than 25 years, use of these factors derived from platelets have contrib-uted to the speed and quality of repair.” With the advent of additional platelet factor concentrates, methods of combining the cellular sources derived from microcapil-laries have proved of great worth, he noted.

“The term I use now is biocellular regen-erative therapy,” Dr. Alexander continued. “By adopting aseptic closed protocols to

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Before Tx

Five months after ALMI TxPhotos courtesy of Tess Mauricio, M.D.

Two months after ALMI TxPhotos courtesy of Edward Zimmerman, M.D.

Before Tx

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isolate the non-fat cell components known as stem / stromal cells, a number of thera-peutic applications and treatment of sys-temic disorders have become reality. The use of platelet-derived factors and tissue derived from fat offers a value larger than either of these components when given alone.”

For aesthetic practitioners seeking to introduce regenerative aesthetics proce-dures, Healeon offers a novel and effective solution, stated Dr. Mauricio. “I was an early adopter of regenerative medicine pro-cedures and Healeon was the only company that provided practical, affordable solutions for a solo practitioner like me,” she said. “In addition, over the years Healeon has led the industry in introducing cutting edge regen-erative devices with the practicing physician in mind, from PRP, to tSVF and cSVF, they have it all.”

Years earlier, Dr. Mauricio had stopped offering traditional fat transfer procedures altogether when longer lasting dermal fillers came on the market. “I stopped doing fat transfer mainly because of issues with predictability of transferred fat volume and downtime for patients,” she noted. “The ALMI micronized fat protocol finally allowed me to feel comfortable recom-mending fat transfer to patients again. The fat is a smooth, homogenized liquid. We are not just transferring fat for volume we are grafting our patient’s tSVF, which is enriched with growth factors.”

Dr. Zimmerman combines micronized fat with other biocellular components. “We use it in combination with other fillers. If I’m working on a divot in the buttock area, then I may combine it with Sculptra. So, I’ve got fat and an activator working in the same place,” he said. “It works well with anything that activates or grows.”

Injecting is smooth and consistent, Dr. Mauricio added. “I can place it in deep or

superficial planes to truly create a master-piece each time, with predictable results and very little downtime for patients. ALMI protocols using micronized fat enriched with stem cells and its native extracellular matrix can be used on the scalp for hair loss, to correct volume defects and scars on the breast, thighs, abdomen and essentially any area of the body. And beyond aesthetic applications, we can use it directly on injured joints or for sexual health.”

Likewise, Dr. Zimmerman treats all body areas with great success. “Injecting autologous micronized fat stimulates rejuvenation of the tissue, as well as pro-vides volume. We combine our treatments with autologous platelets and this process signals the release of mesenchymal stem

cells, pericytes and preadipocytes. These cells can basically evolve into whatever is needed in the area being treated, and that’s the difference between using micronized fat transfer and other fillers,” he said.

The ultimate test is the affordability of ALMI’s protocol for micronized fat pro-cedures. “The nice thing for patients is that this fat is pennies on the dollar compared to the hundreds of dollars that patients are looking at when opting for standard fillers,” explained Dr. Zimmerman.

Patient satisfaction is based on man-aging expectations and choosing the appropriate regenerative technique to achieve desired results. “Micronized ALMI fat is now one of my five different

4THE Aesthetic Guide September/October 2017 www.miinews.com

After face-lift, peel and ALMI injectionPhotos courtesy of Frank Barone, M.D., F.A.C.S.

Before Tx

Three months after ALMI TxPhotos courtesy of Edward Zimmerman, M.D.

Before Tx

Six months after cSVF TxPhotos courtesy of Ryan Welter, M.D., Ph.D.

Before Tx

choices of ‘rejuvenative’ medicine,” Dr. Zimmerman added. “Patients appreciate these treatments because they are long lasting and actually cost less.”

As reported by Dr. Mauricio, “Patients are blown away by the results. They truly get excited that they are using their own fat and are quite happy to get some of the unwanted fat sculpted away. They like using this unwanted fat to treat many problems and areas in a single visit.”

The procedures are very quick and require no general anesthesia because most of the time we are taking one to two table-spoons of fat through a microcannula, Dr. Mauricio added, “Which makes them very safe even for older patients. In fact, I just treated a 79-year-old patient a few days ago with an ALMI protocol for his scalp and for regenerative therapy after harvesting fat from his chest. He was so impressed with the results of his 68-year-old fiancée’s pre-vious ALMI facial rejuvenation treatment that he decided to get it done on himself.”

A practice can make a strong business case for incorporating Healeon products, as well, said Dr. Zimmerman. “Consider the patient that receives 25 cc to 35 cc of volume using a long lasting dermal filler, which could cost around $700 to $1,000 per syringe. That’s a lot of money. The ALMI approach makes less impact on my patients’ pocketbooks, with the average patient ini-tially spending somewhere between $4,000 and $8,000 to get full facial correction.”

The availability of a very friendly, biological volumizing and rejuvenation agent is exciting, stated Dr. Werschler. “I think this is just the beginning, and we’re going to see an increasing number of aesthetic and medical uses. It should lead into an improved use of tSVF and cSVF where you only have to remove a small amount of fat.”

Patients come in for a face-lift and find that they have more money than they have time, said Dr. Zimmerman. “These are great candidates because with these new technologies we can get them through treatments quickly, and there is still time to give them some additional anti-aging work before we let them go. For instance, we might remove an extra 20 cc to 30 cc in order to volumize the face, giving them SVF through an I.V. while they’re in recovery. This seems to cut the downtime in half.”

While the potential of Healeon’s plat-form is clear, the importance of tracking the safety and efficacy has become a key component for consumers and the FDA according to Ryan Welter, M.D., Ph.D., CEO and medical director of Regeneris.

Dr. Welter founded Regeneris Medical as a way to support and protect new regenera-tive medicine products and services while navigating the FDA’s regulatory environ-ment. “While the FDA ultimately is doing good, they are still trying to understand the best way to regulate this new field of regen-erative medicine. As they propose their reg-ulatory guidance it is just as important for physicians and clinicians who are equally concerned about safety to propose their own standards of care. It is better to self-regulate than be regulated,” he expressed.

To further the progression and safety profile of Healeon's CENTRIcyte in the marketplace, Regeneris got directly involved. “The whole idea behind Regeneris was to get physicians together and develop a network for research pur-poses and to develop and set the clinical

5 THE Aesthetic Guide September/October 2017 www.miinews.com

Three months after ALMI TxPhotos courtesy of Regina Fearmonti, M.D.

Before Tx

24 hours after laser Tx with ALMI InfusionPhotos courtesy of Barbara Mack, M.D.

Patient received ALMI Infusion immediately post laser Tx

standard for using cellular SVF. We have set protocols and guidelines that all of our physicians use for good clinical prac-tices, for recording data, for obtaining the cSVF and how it is used.”

“We teamed up with Healeon because they have a great device in the CENTRIcyte,” Dr. Welter added. “It is very easy to use and it is very reproducible, so we can replicate the data easily and achieve standard outcomes.”

Since processed cells may be carefully isolated, opportunities to study general-ized body disorders are now a reality and the government wants to ensure uniform safety, stated Dr. Alexander. “The Institutional Review Board (IRB) established guidelines to track and report clinical safety and effectiveness of using these cells via intravascular introduction.”

In Dr. Zimmerman’s practice patients are very grateful for receiving ALMI and cSVF treatments with the CENTRIcyte. “In addi-tion to addressing aesthetic and cosmetic issues, we’re using micronized fat injections

to help patients recover and for treating aches and pains. We place SVF into joints success-fully, especially using the cellular SVF to treat lateral epicondylitis, rotator cuffs, knees and hips,” he said. “The sky seems to be the limit with this approach.”

Dr. Mauricio employs the CENTRIcyte 1000 to process the harvested adipose specimens. “I routinely do a single harvest and treat patients with ALMI protocols for scalp, face and regenerative therapy with cSVF via an all-in-one visit utilizing Healeon’s products and technologies.”

So, where is all this work heading? In Dr. Mauricio’s view, “The future of aesthetics is providing holistic therapy. When we use our patient’s ALMI fat and/or SVF we are not only volumizing; we are truly reversing aging in that body area,” she expressed. “I routinely combine ALMI protocols and regenerative I.V. therapy with cSVF from the CENTRIcyte for my own skin rejuve-nation procedures. Patients heal so much faster and the results are magnified. Now, when I discuss anti-aging with patients the

discussion covers the whole body – their hair, skin, joints and sexual health.”

Dr. Werschler agreed. “The future is in holistic, head to toe, inside and out thera-pies. The ALMI program has expanded my cosmetic dermatology practice and gives me new tools to treat my patients in a more complete way.”

In addition, the future of facial aesthetics will likely revolve around products and protocols like the ALMI, Dr. Werschler added. “One day we’re going to have tech-nologically advanced methods where we can stimulate the growth of collagen, fat, elastic fibers and other tissues in any com-bination that we want. It is not going to be just another chemical filler of some sort, it is going to be a biologic injectable that amplifies tissue growth or performs other aesthetic functions. Healeon is at the fore-front of these developments.”

Unquestionably, the stem / stromal cell revolution in medical aesthetics is going full steam, concurred Dr. Mauricio. “I am so excited to share my expertise on regen-erative aesthetics with my colleagues via lectures and workshops. I know they will be amazed at how much ALMI, regen-erative medicine with cSVF, and regen-erative aesthetics overall will expand their practice and how offering these procedures will go a long way in making patients look and feel young again.”

Dr. Welter echoed these sentiments. “Healeon continues to lead our industry by providing innovative technologies that physicians will find scientifically sound, affordable, turnkey and manageable for their operations. Nouveaux Medical and its ALMI protocols allow progressive practices the opportunity to expand their treatment offerings while providing new solutions for problems their patients need help with,” he concluded.

6THE Aesthetic Guide September/October 2017 www.miinews.com

Six weeks after ALMI ManShot Tx post lipoPhotos courtesy of Edward Zimmerman, M.D.

Before Tx

Six weeks after ALMI ManShot TxPhotos courtesy of Edward Zimmerman, M.D.

Before Tx

Six months after cSVF TxPhotos courtesy of Ryan Welter, M.D., Ph.D.

Knee before Tx

autologous lipocyte micronized injection ALMI

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