Amniotic Tissue

RMG Amniotic Injectable Live 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 Benefits No 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 Options ProductSourceStem Cells Anti- Inflammatory Anti-microbial Growth Factors ToxicityPluripotency Amniotic Injectable Amniotic Tissue/Fluid Yes None Yes PRPPlateletsNoneNo YesNoneNo SteroidSyntheticNoneYesNo YesNo HASyntheticNoneNo NoneNo Adipose Derived Stem Cells Adipose TissueYesNo YesNoneYes Bone Marrow Derived Stem Cells Bone MarrowYesNo YesNoneYes Amniotic Membrane Amniotic Tissue/Fluid NoYes NoneNo

MSC Content With Aging MSCs per marrow cell 1/10,0001/100,0001/250,0001/400,0001/ 2,000,000 Donor age Caplan A. Clinics in Plastic Surgery 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