Amniotic Tissue

RMG Amniotic InjectableLive cellular product cryopreserved to maintain viability and potency

Anti-inflammatory and Anti-microbial actions

Promotes bone/cell growth

Preserves highest activity of Collagens, Fibronectin, Laminin, Hyaluronic acid, Proteoglycans, cytokines and essential growth factors

Can be safely mixed with bone, PRP, adult MSC’s, membrane, lidocaine, HA or any structural matrix to attract and promote cellular activity

Additional BenefitsNo recovery procedures required

No additional equipment of staff needed

Fast: Procedure takes minutes to administer

Safe: Over 100,000 injections since 2005

Immune Privileged

Safety Profile

• Obtained from live, healthy, thoroughly screened donors

• Human allograft regulated by the FDA under 21 CFR part 1271 and section 361 of the Public Health Service Act

• Used in medicine for over 100 years:

No documented severe adverse events (SAEs)

No noted graft-host rejections have been documented with products with amniotic tissues

No demonstrated amplification of existing disease related to infection, inflammation NOT TUMOR FORMING

Recovery and Processing

Recovery:Amniotic tissue donated by healthy mothers at the time of scheduled cesarean section. Medical and social history is prescreened by the Medical Director through an intensive and complete medical review and pre-natal evaluation prior to delivery. The recovery is performed by American Association of Tissue Bank (AATB) accredited technicians utilizing aseptic technique.

Processing:Processed at AATB accredited facility. Tissue is tested at the time of collection, prior to processing, and again after preparation. All processing is performed following the Food and Drug Administration's Tissue Reference Group (FDATRG) guidelines. From initial recovery to final processing, protocols and procedures have been implemented to meet or exceed all applicable industry standards for use of human tissue products.

FDA Regulatory:Regulated by FDA as human tissue under 21 CFR Part 1271 and Section 361 of the Public Health Service Act. FDA considers use of amnion for void fill and wound covering to be homologous use.

Alternative Treatment OptionsProduct Source Stem Cells Anti-

Inflammatory

Anti-microbial Growth Factors

Toxicity Pluripotency

Amniotic Injectable

Amniotic Tissue/Fluid

Yes Yes Yes Yes None Yes

PRP Platelets None No No Yes None No

Steroid Synthetic None Yes No No Yes No

HA Synthetic None No No No None No

Adipose Derived Stem Cells

Adipose Tissue

Yes No No Yes None Yes

Bone Marrow Derived Stem Cells

Bone Marrow Yes No No Yes None Yes

Amniotic Membrane

Amniotic Tissue/Fluid

No Yes Yes Yes None No

MSC Content With Aging

MSCs per marrow cell

1/10,000 1/100,000 1/250,000 1/400,000 1/ 2,000,000

Donor age

Caplan A. Clinics in Plastic Surgery 1994.Estimates obtained by CFU-F assay.

Clinical Uses of Amniotic Tissue

Due to the unique characteristics of amniotic tissue and its designation as an allograft for

homologous use, the practicing physician can use the product in any way that he/she deems medically appropriate without the challenges of medical devices/drugs that often come with the “on/off label” stigma

Clinical Applications (Injectable)Ortho/Sports: Cartilage injuries, partial ligament tears,

tendinosis/tendinitis, arthritis, fractures, bone bruises, knee/ hip/shoulder arthritis, wrist/forearm/elbow tendinopathies, post-op pain

Podiatry: Tendinopathies, Plantar Fasciitis, arthritis, post-op pain/arthropathy

Spine: Intradiscal and facet injection procedures, fusion surgery, disc disease, annular tears

Wounds: Diabetic, traumatic, vascular, pressure

Plastics: Skin rejuvenation, scar therapy

Target Practices Offices currently selling PRP

Offices currently selling HA

Orthopedics/Sports Med

Podiatry practices

Spine practices

Pain management practices

Wound practices/centers

Ophthalmology practices

Plastic/cosmetic surgery centers