PHYSICIAN BUNDLE

New Life Regenerative Medicine ®

Physician Bundle

“Enhancing the Body’s Natural Ability to Heal”

Content

Sections 1

About New Life

2

Regenerative Medicine

3

Quality Assurance

4

New Life Products

5

Conditions Treated

6

Product Preparation

7

Q & A

8

Testimonials

About New Life

New Life Regenerative Medicine ®

New Life Regenerative Medicine is an FDA registered and regulated, multi-state license tissue bank located near Tampa, Florida. New Life, having decades of combined experience, provides clinicians with the safest and most clinically effective regenerative medicine products available, while remaining cogni- zant of the rising cost of healthcare.

“Truly, the most important investment we can make with the greatest return, is in the health and duration of our lives, so that we may fully enjoy our family, iends and uits of our labor.”

Regenerative Medicine

From the young model to the aging retiree, from the elite athlete to the weekend warrior, to the immune-compromised patient and the patient with other comorbidities, clinicians continue to search for ways to control pain and accelerate the healing process. Utilizing various therapies has proven to have many profound benefits; not the least of which includes overall su- perior outcomes. Dawning on the horizon of medical advancements, these therapies hold the potent healing potential whose benefits have the power to span disciplines as diverse as hair restoration and orthopedics. These therapies harness the power and versatility of the human body to regenerate damaged skin, accelerate healing, reactivate hair follicles, heal wounds and alleviate pain.

Many people have heard of the usefulness of stem cell thera- py, but there's so much more to Regenerative Medicine than just solely stem cells, whose outcome is greatly dependent on the age of the patient that they are being harvested from, understanding that your stem cells are as old as you are. (Fig- ure 1) Equally as important are components such as collagens, cytokines, proteins, growth factors and the list goes on.

(Figure 1)

Regenerative Medicine

1

Treatments being utilized, as a stand-alone or combined, include birth tis- sues from amniotic fluid/membrane, umbilical cord tissue, umbilical cord Wharton’s Jelly and umbilical cord blood, platelet rich plasma (PRP), adipose derived stem cells (ADSC) and bone marrow aspirate (BMA). (Figure 2 and 3) .

(Figure 2)

Comparison of Stem Cells • Umbilical Cord Tissue from Wharton’s Jelly

yields the highest concentration of allogeneic mesenchymal stem cells.

• Bone Marrow ranged from 1 to 317,400 cells/mL

• Umbilical Cord Tissue ranged 10,000 to 4,700,000 cells/cm * C.T. Vangsness Jr., H. Sternberg, and L. Harris. “Umbilical cord tissue offers the greatest number of harvestable mesenchymal stem cells for research and clinical applications: a literature review of different harvest sites.” Arthroscopy, vol. 31, no. 9, pp. 1836-1843, 2015.

(Figure 3)

Regenerative Medicine

2

Regenerative medicine is a form of tissue engineering and molecular biolo- gy which deals with the "process of replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function". When injured or invaded by disease, our bodies have the innate response to heal and defend. Harnessing and enhancing the body's own regenerative powers is a medical practice at the frontier of present-day advancements whose properties may seem miraculous to those who benefit from them. The miracle, however, is the result of scientific exploration that has begun to unlock and utilize the body's extraordinary ability to heal and restore itself. Cells are the building blocks of tissue, and tissues are the basic unit of func- tion in the body. Generally, groups of cells make and secrete their own sup- port structures, called the extracellular matrix. This matrix, or scaffold, does more than just support the cells; it also acts as a relay station for vari- ous signaling molecules. Thus, cells receive messages from many sources that become available from the local environment. Each signal can start a chain of responses that determine what happens to the cell. Through medical technology we can now understand how individual cells respond to signals, interact with their environment and organize them- selves into a healing process. Scaffolds are created utilizing various Regen- erative Medicine therapies allowing for the tissue to "self-assemble".

Quality Assurance

Donor Eligibility Determination Birth Tissue is donated by healthy mothers at the time of a scheduled ce- sarean section. Expectant mothers submit their past medical and social his- tory which is prescreened by the Medical Director through an intensive and complete medical review and prenatal evaluation, including culturing and se- rological testing, prior to delivery. The recovery is performed by trained technicians utilizing aseptic technique. No harm is brought to the newborn and parents will still have the option of storing the cord blood, if desired. Our regenerative medicine products are derived from birth tissues taken from carefully screened mothers at the time of a scheduled cesarean sec- tion. Our products do not contain any fetal or embryonic tissue. All protocols followed at New Life Regenerative Medicine are in accordance with the Food and Drug Administration (FDA) and the American Associa- tion of Tissue Banks (AATB) regulations and standards.

“The Power of the Mother.”

Quality Assurance

3

Prior to the recovery of birth tissue, stringent guidelines must be met.

Eligibility for tissue donation is based on the following: • Comprehensive medical and social histories of the donors are obtained • Physical exam • Tissue retrieval possible within acceptable time limit • Patient with no known high risk for HIV or hepatitis • Patient free from transmissible disease • Patient free from active malignancy • Patient free from sepsis/systemic infection • Each donor is tested* for: o HBsAg (Hepatitis B Surface Antigen) o HBcAb (hepatitis B core Antibody) o HCV (hepatitis C Antibody) o HIV I/II-Ab (Antibody to Human Immunodeficiency Virus Types 1 and Syphilis detection test o HIV NAT (HIV Nucleic Acid Test) o HCV NAT (HCV Nucleic Acid Test) • All processing is performed in an aseptic environment in CLIA certified laboratories • All processing is performed following the guidelines of both the FDA and the American Association of Tissue Banks • In addition to serologies, culturing is performed in every step of the process • All products are retested post processing to demonstrate the ab- sence of bacterial and fungal pathogens • Once all the birthing tissue has been processed, the products are sent for additional sterilization testing and placed in quarantine • All products are tested to demonstrate the absence of bacterial and fungal pathogens and are non- pyrogenic • All testing results are reviewed by a licensed medical director • After the products have passed their 14-day quarantine, testing and medical director review, the allografts are released for use *Donors are tested in accordance with standards established by FDA requirements to minimize potential risks of disease transmission to recipi- ents. Questions? Contact Us: (844) 567-6370

New Life Products

At New Life Regenerative Medicine, we are committed to helping improve the quality of lives for those individuals suffering from pain, injuries, aging and sometimes, just from day to day living.

With New Life products, we strive to help people feel better and look better.

R ESToR New Life Regenerative Medicine ®

R ELeV New Life Regenerative Medicine ® R EV I V New Life Regenerative Medicine ®

R ENyTE New Life Regenerative Medicine ®

New Life Products

4

R ESToR New Life Regenerative Medicine ®

RESToR Product Codes

RES-050 RES-100 RES-200

.50ML 1.0ML 2.0ML

RESToR is a minimally manipulated allograft, derived from the umbilical cord tissue layer of Wharton’s Jelly and processed to maximize concentration. RESToR is for homologous use and intended to enhance the body’s natural ability to heal. Why RESToR • RESToR works by secreting powerful bioactive molecules. RESToR contains a network of scaffolding proteins, growth factors, cytokines, mesenchymal stem cells and multiple other components needed to enhance the body’s natural ability to heal. • RESToR umbilical cord tissues lack MHC-II and are therefore hypo-immunogenic, consequently there is minimal risk of an allergic reaction for the recipient. ¹ • RESToR has a higher proliferation rate when compared to autologous tissue such as adipose or bone marrow. • RESToR is less invasive when compared to other forms of regenerative medicine such as bone marrow and adipose tissue extraction; this results in less pain and rehabilitation time for the patient. • RESToR is recovered from healthy, carefully screened mothers at the time of a scheduled cesarean section. All protocols are in accordance with the FDA and American Association of Tissue Banks (AATB) regulations and standards. • RESToR is regulated as a human cell tissue product (HCT/P) under 21 CFR Part 127 and Section 361 of the Public Service Health Act. • RESToR has a strong anti-inflammatory effect reducing the expression of inflammatory cytokines. ²

1.Sabapathy V,Sundaram B,VM S Mankuzhy P,Kumar S (@014) “Human Wharton’s Jelly Mesenchymal Stem Cells PlasticityAugments Scar-Free Wound Healing with Hair Growth”PLoS One 9 (4): e93726 doi:10.137/journal.pone0093726

2.F.Gao et al.“Mesenchymal Stem Cells and Immunomodulation: Current Status and Future Prospects.”Cell Death and Disease (2016) 7.e2062:doi:10.1038/cddis.327

Potential Treatment Areas:

New Life Regenerative Medicine ®

• Aesthetics • Back Pain

• Ligament Tears • Meniscus Damage • Muscle Tears • Nerve Injury • Rotator Cuff Injury • Tendon Tears

• Cartilage Damage • Degenerated Joints • Joint Dysfunction • Knee Injuries

Office: (844) 567-6370 Fax: (813) 364-6522

RESToR Components (pg/ml)

Anti-Inflammatory IL-1ra 21.1 IL-10 4.9 HGF 125.6 TNF RII 7.9 TGFẞ-1 583.3 IL-2 9.3 IL-7 30.3 IL-15 71.3 TIMP-2 1,046.20 Lipocalin-2 441.9 ANG-1 292.2 bFGF 276.8 BMP-7 46.8 TGFẞ-1 583.3 VEGF 5.92 Growth Factors Wound Healing VEGF 5.9 TGFẞ-1 583.3 IL-6 29.2 PDGF-BB 13.2 HGF 125.6 bFGF 276.3 ANG-1 292.2 FGF-7 33.3 Homeostatic Cytokines

New Life Regenerative Medicine ® (844) 567-6370

New Life Products

4

Characterization and RESToR Characterization Diego Anguiano, Nelson Jen, Rajen Naidoo, Kevin Kong, Habib Torfi

Introduction

Regenerative medicine is changing how damaged tissues and organs are treated. Stem cells present a tremendous treatment opportunity for ag- ing-related diseases and for palliative treatment. Stem cells are unique cells that have the capacity to self-renewal and the ability to differentiate into different cell phenotypes. New Life offers cells sourced from cord blood (RECHaRG) and the Wharton’s Jelly (RESToR) of the umbilical cord. The cells are sourced from the byproducts of the birthing process and are not fraught with ethical concerns that come with human embryonic stem cells. There are three overarching types of stem cells: totipotent, pluripotent, and multipotent stem cells. Totipotent and pluripotent stem cells sourced from embryos have the potential to develop into any cell type but are not used for therapy due to ethical and medical concerns. Multipotent stem cells, which include hematopoietic stem cells (HSCs) and mesenchymal stro- mal cells (MSCs), can differentiate into several different tissue specific cell types and are found in a wide variety of tissues. MSCs are heterogenous population of multipotent cells found in a variety of tissues including adipose tissue, bone marrow, cord blood, and Wharton’s jelly. The Gold Standard for characterizing MSCs is through identification of the following in vitro characteristics: plastic adherence; potential to differ- entiate into osteoblasts, adipocytes, and chondroblasts; expression of CD105, CD73, and CD90 surface markers and a lack of expression CD45, CD34, CD14, CD19 and HLA-DR. 1 Wharton’s Jelly cells (RESToR) and cord blood stem cells (RECHaRG) pos- sess CD34 positive cells, which represent HSCs. These HSCs and MSCs work synergistically together to create a niche rich in cellular growth. Spe- cifically, MSCs create a microenvironment rich in cytokines and growth fac- tors that promotes hematopoiesis. 2

(Continued)

New Life Products 4 New Life offers two stem cell products: RESToR and RECHaRG. WJ stem cells are believed to be derived from MSCs that become embedded during embryogenesis, creating a more homogeneous population of stem cells. 3,5 CBSCs derive their stem cells from the blood circulating in the umbilical cord and placenta creating a more heterogeneous population of stem cells that includes HSCs, MSCs, and endothelial progenitor cells (EPCs). 2,4,6 In this study, viability and MSC surface markers were analyzed in RECHaRG and RESToR using a BD FACScan and analyzed using CellQuest Pro Soft- ware (n=3). Testing was done by third party Cytologistics, San Diego CA. Immunophenotype analysis by flow cytometry was performed as previously described. 7 Briefly, samples were stored at -80°C and thawed in 37°C water and centrifuged at 350 × g for 5 minutes. Cells were resuspended in flow buffer and distributed to microcentrifuge tubes. Antibodies were added at manufacturer’s suggested concentration. Cells were incubated with primary antibody for 60 minutes in the dark at 4°C. Following incuba- tion, the cells were washed with flow buffer, centrifuged at 350 × g for 5 minutes, and buffer was aspirated (repeated for two washes). Cells were resuspended in flow buffer and transferred to appropriate tubes for flow analysis. Samples were analyzed using BD FACScan (excitation: 488nm) with CellQuest Pro Software. Methods Cell staining

Results

Propidium iodide (PI) staining for cell viability was used to assess RECHaRG and RESToR each from 3 distinct donors. The average viability post-thaw for RECHaRG and RESToR was 78.17% ±0.25 and 66.91% ±3.66 respec- tively (Table 1).

Viability (%) 78.17 ± 0.25 66.91 ± 3.66

CBSC WJ

Table 1: Cell viability percentages post-thaw of RECHaRG and Wharton’s jelly cells as determined by Propidium iodide (PI) staining.

(Continued)

New Life Products 4 MSC and HSC progenitor CD (cluster of differentiation) marker expression was measured in RECHaRG and RESToR for cell surface markers CD105, CD73, CD90, CD45, CD34, CD14, CD19, and HLA-DR (Table 2). Both RE- CHaRG and RESToR expressed markers associated with both MSCs (CD105, CD73, CD90) and HSCs (CD34). MSC surface marker expression was higher in RESToR compared to RECHaRG (p<0.05, n=3). HSC progeni- tor CD34 marker was higher in the RECHaRG than RESToRr (p<0.05, n=3). RECHaRG and RESToR products are rich in MSC markers (CD107, CD73, CD90) and HSC progenitor marker CD34. Immunophenotyping and trilin- eage differentiation of cultured cells will be completed to confirm the stem cells’ functionality by evaluating the cell’s phenotypic responses. The pre- liminary data presented in this paper confirms the necessity to do follow up flow analysis with strict parameters. A comprehensive 14 parameter (HSCs) and 10 parameter (MSC) flow cytometry protocol is being devel- oped to verify cell populations and lineage verification. The rationale behind a more in-depth panel is that simultaneous expression of CD73/CD90/CD105 and lack of hematopoietic lineage markers (CD14/CD34/CD45/HLA-DR) is necessary to confirm the true percentages for MSC population. In addition, future flow data will look strictly at pheno- types representing alive single cells with strict elimination of debris and dead lives cells to avoid false positives. Discussion

Cell Type

CD90-FITC CD73-PE CD105-PE/Cy7 CD45-FITC CD34-PE CD14-PE/Cy7 CD19-FITC HLA-DR

CBSC

8.60 ± 0.40 24.95 ± 2.22 12.72 ± 0.45 48.57 ± 1.34 20.97 ± 2.38 16.74 ± 0.95 8.81 ± 0.33 19.62 ± 1.23

WJ

52.80 ± 10.74 38.63 ± 14.96 43.64 ± 9.65 22.45 ± 5.59 7.70 ± 2.33 60.05 ± 12.72 6.62 ± 0.91 31.43 ± 9.90

Table 2: MSC and HSC progenitor surface marker expression for RECHaRG and RESToR (CD90, CD73, CD105, CD45, CD34, CD14, CD19, HLA-DR)..

References

1. Dominici, M. et al. “Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement.” Cytotherapy, 2006. 8(4), 315-317. 2. Cheng, L., et al. "Human mesenchymal stem cells support proliferation and multilineage differentiation of human hematopoietic stem cells." Blood. 1998. 92(10). 3. Taghizadeh, R., et al. “Wharton’s Jelly stem cells: future clinical applications.” Placenta, 2011. 32, S311-S315. 4. Ali, H., & Al-Mulla, F. “Defining umbilical cord blood stem cells.” Stem Cell Discovery, 2012. 2(1), 15-23. 5. El-Demerdash, R. F., et al. “A comparison of Wharton's jelly and cord blood as a source of mesenchymal stem cells for diabetes cell therapy.” Regen Med, 2015. 10(7), 841-855. 6. Smith, A. R., & Wagner, J. E. “Alternative haematopoietic stem cell sources for transplantation: place of umbilical cord blood.” Br J Haemato, 2009. 147(2), 246-261. 7. Chen, G., et al. “Monitoring the biology stability of human umbilical cord-derived mesenchymal stem cells during long-term culture in serum-free medium.” Cell and tissue banking, 2014. 15(4), 513-521.

New Life Products

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R ENyTE New Life Regenerative Medicine ®

RENyTE Product Codes

REN-050 REN-100 REN-200

.50ML 1.0ML 2.0ML

RENyTE is a human tissue allograft derived from the umbilical cord and is intended for homologous use to supplement or replace damaged or inadequate connective tissue. The cushioning and structural support elements from the Wharton’s Jelly consist of a network of structural proteins, cytokines, chemokines and growth factors. Wharton’s Jelly also has a much higher concentration of hyaluronic acid, cytokines and growth factors when compared to Amniotic fluid, up to 50 times more. Hyaluronic acid is the key factor in the viscoelastic properties in synovial fluid and joints. Why RENyTE • RENyTE is less invasive when compared to others forms of regenerative medicine such as bone marrow aspirate and adipose tissue extraction. This results in less pain and rehabilitation time for the patient. • Compared to amniotic fluid therapy, RENyTE contains higher concentrations of hyaluronic acid, peptides and growth factors. • Higher concentrations of growth factors in RENyTE act as an anti-inflammatory and have been shown to prevent cell death. * RENyTE is recovered from healthy, carefully screened mothers at the time of a scheduled cesarean section. All protocols are in accordance with the FDA and American Association of Tissue Banks (AATB) regulations and standards. RENyTE is regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service Act.

*Sobolewski, K. et. al. Wharton’s Jelly as a reservoir of peptide growth factors. Plancenta. 2005 Nov; 26 (10): 747-52

Potential Treatment Areas:

New Life Regenerative Medicine ®

• Aesthetics • Back Pain

• Ligament Tears • Meniscus Damage • Muscle Tears • Nerve Injury • Rotator Cuff Injury • Tendon Tears

• Cartilage Damage • Degenerated Joints • Joint Dysfunction • Knee Injuries

Office: (844) 567-6370 Fax: (813) 364-6522

RENyTE Components (pg/ml)

Anti-Inflammatory IL-1ra 21.1 IL-10 4.9 HGF 125.6 TNF RII 7.9 TGFẞ-1 583.3 IL-2 9.3 IL-7 30.3 IL-15 71.3 TIMP-2 1,046.20 Lipocalin-2 441.9 ANG-1 292.2 bFGF 276.8 BMP-7 46.8 TGFẞ-1 583.3 VEGF 5.92 Growth Factors Wound Healing VEGF 5.9 TGFẞ-1 583.3 IL-6 29.2 PDGF-BB 13.2 HGF 125.6 bFGF 276.3 ANG-1 292.2 FGF-7 33.3 Homeostatic Cytokines

New Life Regenerative Medicine ® (844) 567-6370

New Life Products

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R ELeV New Life Regenerative Medicine ®

RELeV Product Codes

REL-050 REL-100 REL-200

.50ML 1.0ML 2.0ML

RELeV is a minimally manipulated allograft fluid with proven regenerative potential. The components in amnion are intended to maintain regenerative tissue processes.

Amniotic fluid contains growth factors, carbohydrates, proteins, amino acids and a multitude of essential molecules that are needed for tissue protection.

Why RELeV • RELeV is intended to help with inflammation and to enhance the healing process.

• RELeV is immune-privileged; the risk of rejection is extremely rare.

• For in-office procedures there is minimal, if any, down-time after treatment.

• RELeV is typically a one-time treatment compared to corticosteroids which mask the pain by shutting down the body’s nerves in a specific area. Relief with steroids does begin right away but it does not last and there are significant side-effects from long-term use. RELeV is recovered from healthy, carefully screened mothers at the time of cesarean section. All protocols are in accordance with the FDA and the American Association of Tissue Banks (AATB) regulations and standards. RELeV is regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service Act.

New Life Regenerative Medicine ®

Potential Treatment Areas:

• Aesthetics • Back Pain

• Ligament Tears • Meniscus Damage • Muscle Tears • Nerve Injury • Rotator Cuff Injury • Tendon Tears

• Cartilage Damage • Degenerated Joints • Joint Dysfunction • Knee Injuries

Office: (844) 567-6370 Fax: (813) 364-6522

Quality Assurance

RELeV™ is processed from donated amniotic uid from full-term deliveries. All donors are pre-screened and undergo comprehensive testing that includes:

• Behavioral risk assessment • Physical assessment • Donor medical history • Communicable disease testing

Testing

HBsAg HBcAb HCV HIV I/II-Ab HIV NAT

New Life Regenerative Medicine ® (844) 567-6370

New Life Products

4

R EV I V New Life Regenerative Medicine ®

REViV Product Codes

REV-050 REV-100 REV-200

.50ML 1.0ML 2.0ML

REViV is a minimally manipulated human tissue allograft derived from the amniotic fluid and the extracellular matrix of the amniotic membrane. REViV is for homologous use and is intended to regulate and maintain tissue regenerative processes. The extracellular matrix of REViV contains a high concentration of cellular scaffolding, cytokines, growth factors and proteins. The extracellular matrix (ECM) is a collection of extracellular molecules that provide the structural support needed for surrounding cells. Amniotic ECM is comprised of collagens, multi-adhesive glycoproteins, elastic, glycosaminoglycans, growth factors and cytokines. Why REViV • REViV components are intended to reduce inflammation and continue the healing process, improving, or in some cases, eliminating your pain. • REViV is typically a one-time treatment compared to corticosteroids which mask the pain by shutting down the body’s nerves in a specific area. Relief with steroids does begin right away but it does not last and there are significant side-effects from long term use. REViV is recovered from healthy, carefully screened mothers at the time of cesarean section. All protocols are in accordance with the FDA and the American Association of Tissue Banks (AATB) regulations and standards. REViV is regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service Act. Potential Treatment Areas: • REViV is immune-privileged; the risk of rejection is extremely rare. • For in-office procedures there is minimal, if any, down time after treatment.

Office: (844) 567-6370 Fax: (813) 364-6522 New Life Regenerative Medicine ®

• Aesthetics • Back Pain

• Ligament Tears • Meniscus Damage • Muscle Tears • Nerve Injury • Rotator Cuff Injury • Tendon Tears

• Cartilage Damage • Degenerated Joints • Joint Dysfunction • Knee Injuries

Quality Assurance

REViV™ is processed from donated amniotic uid and membrane from full-term deliveries. All donors are pre-screened and undergo comprehensive testing that includes: • Behavioral risk assessment • Physical assessment • Donor medical history • Communicable disease testing

Testing

HBsAg HBcAb HCV HIV I/II-Ab HIV NAT

New Life Regenerative Medicine ® (844) 567-6370

New Life Products

4

R ECHaRG New Life Regenerative Medicine ™

RECHaRG Product Codes

REC-050 REC-100 REC-200

.50ML 1.0ML 2.0ML

RECHaRG is a minimally manipulated allograft suspension, derived from umbilical cord blood (UCB), with proven regenerative potential. RECHaRG is processed utilizing a proprietary process to preserve the tissue char- acteristics and properties. Stem cells were first identified in cord blood over 40 years ago. Since then, UCB has been routinely used for hematopoietic stem cell transplantation. UCB contains a mixed population of cells including hemopoietic stem cells (HSC) and mesenchymal stem cells (MSC). These cells have the capacity to self-renew, release growth factors, and further develop into more specialized cells. These cells have also been associated with contributing to tissue homeostasis, anti-inflammatory responses, and antioxidant effects. This collection of cells can work together to provide a synergistic effect to offset the naturally occurring processes that typically derive from age and environmental factors.

Why RECHaRG

• RECHaRG is intended to help with inflammation and to enhance the healing process.

•RECHaRG - for in-office procedures there is minimal, if any, downtime after treatment.

•RECHaRG is typically a one-time treatment compared to corticosteroids which mask the pain by shutting down the body's nerves in a specific area. Relief with steroids does begin right away but it does not last and there are significant side-effects from long-term use. •RECHaRG is recovered from healthy, carefully screened mothers at the time of cesarean section. All protocols are in accordance with the FDA and the American Association of Tissue Banks (AATB) regulations and standards. RECHaRG is regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Ser- vice Act.

New Life Regenerative Medicine ®

Potential Treatment Areas:

• Aesthetics • Back Pain

• Ligament Tears • Meniscus Damage • Muscle Tears • Nerve Injury • Rotator Cuff Injury • Tendon Tears

• Cartilage Damage • Degenerated Joints • Joint Dysfunction • Knee Injuries

Office: (844) 567-6370 Fax: (813) 364-6522

Quality Assurance

Total Cell

Cell Type

RECHaRG is processed from donated umbilical cords from full-term deliveries. All donors are pre-screened and undergo comprehensive testing that includes:

8.6+0.40

CD90-FITC

24.95+2.22

CD73-PE

12.72+0.45 48.56+1.34 20.97+2.38 16.74+0.95 8.81+0.33 19.62+1.23

CD105-PE/Cy7 CD45-FITC CD34-PE CD14-PE/Cy7 CD19-FITC HLA-DR

• Behavioral risk assessment • Physical assessment • Complete medical screening • Serology testing for communicable disease*

• HBsAg • HBcAb • HCV • HIV I/II Ab • HIV NAT

• Infectious disease testing is performed at a certified laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR Part 493.

RECHaRG Concentration (pg/ml)

(844) 567-6370

New Life Products

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R ExO New Life Regenerative Medicine ®

RExO Product Codes

REX-0100 REX-0200 REX-0500

1.0ML 2.0ML 5.0ML

Why RExO Our exosome product, RExO, is comprised of tiny extracellular vesicles derived from mesenchymal stem cells. They are 40-100 nanometers in size and contain lipids, messenger-RNA, micro-RNA, signaling cytokines, and proteins to help create a regenerative response to various treatment therapies. Exosomes have a variety of reported func- tions and some of their better-documented activities are associated with a form of immune regulation. Exosomes are anti-inflammatory, anti-fibrotic, cross the “blood-brain barrier,” have minimal risk of clumping, are easy to administer, contain nearly three times more growth factors compared to adult stem cells, and influence the growth of target cells. Exosomes are primarily used in cell signaling and are found in all bodily fluids. Cells communicate with each other using cytokines. These are proteins that are excreted by one cell and tell another cell what to do. Think of an orchestra and how the conductor ensures all instruments produce beautiful music instead of noise. The conductor, in this case, is the exosome. The use of exosomes also holds the promise of being more cost-effective from the point of view of storage, logis- tics, manufacturing, and delivery. • Mesenchymal Stem Cells (MSCs) are known to play a vital role in the regeneration of injured tissue by honing in on injured or diseased cells and secreting bioactive factors, Bioactive factors secreted by MSCs stimulate resident stem cells that then construct new tissue. Exosomes have the potential to recapitulate this therapeutic function while avoiding issues associated with using whole stem cells. • Within regenerative medicine, exosome therapy is the latest treatment that is impressing doctors - many argue that exosomes may be more important than stem cells due to their unique ability to function as a “messenger” within the body, transferring information from cell to cell. Enhancing regenerative medicine therapy with exosomes is considered a superior and optimal therapy. •Due to their small size, exosomes are better able to avoid entrapment in filter organs and cross biological barri- ers than mesenchymal stem cells.

• Due to their acellular nature, there is a low risk of adverse side effects such as neoplastic transformation or eliciting an immune response.

Office: (844) 567-6370 Fax: (813) 364-6522 New Life Regenerative Medicine ®

Potential Treatment Areas:

• Aesthetics • Back Pain • Cartilage Damage • Nerve Injury

• Degenerated Joints • Joint Dysfunction • Knee Injuries • Rotator Cuff Injury

• Ligament Tears • Meniscus Damage

• Muscle Tears • Tendon Tears

Quality Assurance

RExO™ is processed from healthy, carefully screened mothers at the time of scheduled cesarean section. All donors are pre-screened and un- dergo comprehensive serological testing that includes:

HBsAg HBcAb HCV HIV I/II-Ab HIV NAT

*Infectious disease testing is performed at a certied laboratory in accor- dance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR Part 493.

New Life Regenerative Medicine ® (844) 567-6370

Conditions Treated

Sports Injuries Sports for professional and recre- ational purposes are mainstays in American society, but unfortunately so are sports-related injuries. As recent studies increasingly prove the inefficiency and harm of common- ly-used treatments like anti-inflam- matory medications and corticoste- roid injections, more injured athletes are seeking regenerative medicine therapies to heal. Regenerative medicine is now at the forefront of offering such treat- ments to help athletes overcome injuries without surgery or invasive measures.

“As a quarterback in the NFL for twenty-one years, my body has taken a lot of abuse leaving me with chronic pain, especially in my shoulder. Although now retired om the NFL, I continue to lead an active lifestyle by working out and playing golf. When the pain in my shoulder became too much to enjoy these activities, I went to my doctor who suggested I try regenerative medicine therapy, including birth tissue stem cells, provided by New Life Regenerative Medicine. Skeptical, at rst, I nally decided to move forward with the treatment and am ecstatic that I did. It has now been two months and the improvement is substantial; I am sleeping better; my golf game has improved, and the pain has substantially subsided. Overall, I would say that this treatment has improved my quality of life. Thank you, New Life, and especially thank you to the doc!” Vinny Testaverde – Retired NFL Quarterback Age 54

Conditions Treated

5

Back Pain

Today, statistics show that over 31 million Americans suffer from back pain with low back pain being the leading cause of disability worldwide. Back pain is one of the most common reasons for missed work. In fact, back pain is the second most common reason for visits to the doctor’s office, out- numbered only by upper-respiratory infections. Experts estimate that as much as 80% of the population will experience a back problem at some time in their lives. Poor Posture Puts More Pressure On Your Spine Sitting is becoming more prevalent while at work, and having a sedentary desk job can result in sitting for around 8 hours a day. This position actually increas- es the load on your spine more than standing. Spinal pressure “sits” around 140mm pressure. Americans spend at least $50 billion each year on back pain and that’s just for the more easily identified costs.

“As a retired general contrac- tor, my body has taken a beat- ing, especially my back. After an ongoing treatment program that included New Life – RENuE and New Life – RESToR, my back is virtually pain-ee and I am back on the golf course enjoying my retirement.” Tom, Retired Contractor

Conditions Treated

5

Aesthetics

In addition to baby boomers, now being an average age of sixty-three, the younger generation is feeling the pressures of today's society which has placed a tremendous focus on personal appearance. As recent as ten years ago, the average age for a woman having some type of anti-aging procedure was forty-seven; today that average age is thirty-five. Patients, both men and women, are having cosmetic treatments prior to the aging process becoming apparent in their appearance. Beauty At

Any Age

Conditions Treated

5

Sexual Health

Erectile dysfunction, commonly referred to as ED, is the inability to achieve or maintain an erection suitable for sexual intercourse. ED is most common in men 40 to 70 years old, affecting millions of men in the U.S. alone. Erectile dysfunction can cause stress, lack of self-confidence, and the inability to reproduce, all of which can lead to problems in a relationship. Failing to achieve an erection 20% of the time or less is normal and, in most cases, does not require medical attention, however, failure to achieve an erection more than 50% of the time does require medical attention. Regenerative medicine therapy, where results may last for several years, can address the basic blood flow problem that can cause ED. The procedure is done in the physician’s office with a local anesthetic used to keep pain to a minimum. Failing to achieve an erection 20% of the time or less is normal and, in most cases, does not require medical attention. However, failure to achieve an erection more than 50% of the time does require medical attention. “The First Wealth is Health” Ralph Waldo Emerson

Product Preparation

Preparation

Step 1: Open product package and remove the product vial from packaging

Step 2: Allow product to thaw (room temperature for 5 – 10 minutes or hold in hand for 2 – 5 minutes until product completely thaws) and invert (do not shake) tube several times to mix completely Step 3: After thawing, place the vial in an upright position and gently tap on a hard surface to transfer all of the contents to the bottom of the vial

Step 4: Remove cap by unscrewing the lid counter-clockwise Precautions

• Only the content of the vial is sterile • Outer vial is not sterile, do not place onto a sterile field. • Do not use if package is broken • Discard material if mishandling has caused possible damage or contamina- tion **Do not re-sterilize.**

Questions & Answers

WHAT ARE STEM CELLS?

A stem cell is a cell that has the potential to change into a very specific kind of cell. A stem cell, for example, might turn into a blood, skin, bone, or a nerve im- pulse-transmitting cell. Stem cells, with their diverse potential, are highly adaptable, self-dividing cells. Stem Cells have an essential role in the body’s growth and repair processes. Because stem cells are rich in potential, they are extremely helpful in the healing of patients who are suffering from an injury. Stem Cells, by some, are referred to as the holy grail of regenerative medicine.

HOW ARE STEM CELLS USED FOR TREATMENT?

There is research that shows stem cells show encouraging results in regenera- tive medicine. As these cells differentiate they have the ability to grow into muscle, cartilage, as well as other forms of tissue and to enhance the body’s natural ability to heal. This may provide positive outcomes for conditions such as arthritis, tendonitis, tendinopathies and many other painful issues.

WHERE DO STEM CELLS COME FROM?

Mesenchymal stem cells (MSC) can be collected from the patient’s adipose tissue (fat) in the abdomen or bone marrow (aspirated from the hip bone), but, efficacy is greatly dependent on the age of the patient. Stem cells are as old as you are and diminish as you age, losing both their abundance and their effi- cacy. As there are controversial and ethical issues surrounding the use of em- bryonic stem cells, science has now turned to stem cells obtained from birth tissues which cause no harm to the mother or her newborn.

Questions And Answers

7

HOW DOES REGENERATIVE MEDICINE WORK?

Cells are the building blocks of tissue, and tissues are the basic unit of func- tion in the body. Generally, groups of cells make and secrete their own support structures, called the extracellular matrix. This matrix, or scaffold, does more than just support the cells; it also acts as a relay station for various signaling molecules. Thus, cells receive messages from many sources that become available from the local environment. Each signal can start a chain of respons- es that determine what happens to the cell. Through medical technology we can now understand how individual cells respond to signals, interact with their environment and organize themselves into a healing process. Scaffolds are created utilizing various regenerative medicine therapies allowing for the tissue "self-assemble".

WHAT CAN REGENERATIVE MEDICINE BE USED FOR?

Regenerative medicine can be used for a multitude of conditions including, but not limited to pain management, sports injuries, spinal condition, podiatry, wound care, aesthetics, anti-aging, male enhancement, vaginal rejuvenation, hair restoration, the list goes on and on.

IS REGENERATIVE MEDICINE SAFE?

Prior to a scheduled cesarean section, consenting mothers are screened and evaluated. Within thirty days of the scheduled delivery, the mother is serologi- cally tested, per the standards of the FDA and the American Association of Tissue Banks, to rule out any transmissible diseases or other contraindica- tions. Once serology reports and donor chart is reviewed by the Medical Direc- tor or designee, the fluid is aseptically processed in a controlled environment via a gentle filtration and centrifugation cycle to remove tissue debris. Magpix analysis is performed on the final product to analyze growth factors and cyto- kine content. “Take care of your body. It ’s the only place you have to live.” Jim Rohn

Questions And Answers

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WHAT COMPLICATIONS CAN ARISE FROM USING REGENERATIVE MEDICINE? Very, very few complications exist with regenerative medicine therapy. Prod- ucts obtained from the amniotic fluid, placenta and umbilical cord are immuno- logically privileged meaning they do not cause a graft vs. host reaction (the body will not reject) and an adverse reaction is extremely rare.

WHAT CONDITIONS CAN BE TREATED WITH REGENERATIVE MEDICINE?

Due to the nature of birth tissues, regenerative medicine can be used for pain management, wound healing, surgical procedures, sports injuries, facial rejuve- nation, male enhancement and erectile dysfunction, to name a few.

HOW WILL I KNOW WHAT THERAPY WORKS BEST FOR ME?

Based on your condition or injury your physician will customize a treatment plan for you and determine what therapy, or combination thereof will work best for you.

WILL THE PROCEDURE BE PAINFUL?

In most cases, the procedure involves a simple injection and takes very little time. Guided imaging may be used depending on the area of the body being treated.

WHAT IS MY RECOVERY TIME?

Most patients experience little, if any, recovery time from the procedures. Your physician will provide you with the aftercare instructions prior to your return home.

Questions? Contact Us: (844) 567-6370

Questions And Answers

7

WILL MY INSURANCE COMPANY PAY FOR MY TREATMENTS?

Insurance coverages vary by state, but in most cases no, your treatment will not covered. We will provide you with an itemized statement, so you may per- sonally file a claim with your insurance provider. If desired, we also have arrangements with a finance company that will provide you with acceptable payment options.

WHAT IS THE COST OF TREATMENT?

The cost for regenerative medicine therapy is based on the procedure and type of product needed. The physician’s staff will sit down with you prior to your procedure and explain the cost, as well as finance options if desired.

WHY REGENERATIVE MEDICINE?

Truly, the most important investment we can make with the greatest return, is in the health and duration of our lives. Regenerative medicine therapy, under the right circumstances, may prolong or eliminate the need for a surgical pro- cedure so that you may fully enjoy your family, friends and fruits of your labor and live your life the way it was meant to be lived.

“Conquer your pain... then conquer the world!” New Life Regenerative Medicine

Testimonials

"Playing for the NFL, I was used to everyday aches and pains. However, when the pain in my elbow became too intense to ignore I chose to un- dergo amnion therapy. After one treatment, the pain was gone and I feel great!"

Jeff Demps Olympic Athlete

“I’ve been living with knee pain for years. Walking, bending, and putting extra weight on them was be- coming painfully awful. Doctors told me that I would eventually need knee replacement surgery. Corti- sone injections and more meds were my temporary option for pain. I decided to try regenerative medi- cine. I received both RESToR and RENyTE injections in both knees and the procedure was relatively quick. I began to feel better each day. No more crunching and grating in my knees! A month later I was walking a theme park all day and two months later I was walking up 344 steps at The Golden Temple in Thailand. I’m a walking testament that you can be fixed without surgery!”

Migdalia Musician

Testimonials 8

"Approaching the age of 60 very rapidly I noticed the signs of aging were catching up to me, especial- ly in the lip area, to the point I always looked as if I were frowning. Over the past decade, I have had Botox and facial fillers but none seemed to last more than a couple of months and I tended to bruise and swell substantially. During a consult with a very reputable plastic surgeon, he suggested I try RENyTE, along with a facial filler comprised of hyal- uronic acid. Willing to try this new technology I agreed. To my surprise, I experienced no swelling or bruising post treatment and my frown was turned upside down! I am delighted with the results and, after several months, I see no signs of the effects diminishing."

Vicki CEO

"As a retired contractor, my body has taken a beating, especially in my ankle. After an ongoing treatment program that included RESToR and RENyTE, my ankle is virtually pain-free and I am back on the golf course enjoying my retirement."

Tom Retired Contractor

"Being an avid tennis player, I was discouraged and obviously unhappy with my limitations due to shoulder pain. After one treatment with RENyTE, the difference is phenomenal. The pain is gone, I have resumed tennis and am even warming up with my son prior to his tournaments."

Omar Businessman

MISSION STATEMENT

New Life Regenerative Medicine ® offers patient care with trust, dignity and compassion.

Our mission is to offer innovative therapies to enhance the body's natural ability to heal through regenerative medicine.

Contact Us: (844) 567-6370 www.newliferegen.com

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