MyStem® Autograft Preparation Kit

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Presentation transcript:

MyStem® Autograft Preparation Kit Regenerative Treatments made easy

The People Pier Ivona, IFATS Member, WOSIAM Member, Regenerative Medicine Expert, Entrepreneur Mr. Ivona has a multi year experience in Regenerative treatments and MedDev industry, His experience leads the team who developed MyStem technology

The Science - Stromal tissue - Scientific Definition: The connective tissue framework of anorgan, a gland, or other structure, as distinguished from the tissues performing the special function of the organ or part. Stroma is a broadly used term for the loose connective tissue that contains mesenchymal stem cells and other cells like fibroblasts, macrophages, adipocytes, mast cells and leukocytes. Source: The American Heritage® Stedman's Medical Dictionary

The Science - Stromal tissue – Why Adipose stromal tissue a Regenerative fraction source? Adipose tissue as a Stromal Tissue source provides regenerative components in high ratio

The Science - Stromal tissue – Adipose tissue as a Stromal Tissue source provides regenerative components in great numbers (Stromal Vascular Fraction-SVF)

The Stromal Vascular Fraction (SVF) Derived from Blood Vessels in adipose (fat) stromal tissue Capillaries are primary source (see inset below) Same-day clinical procedure Easy to harvest High cell counts Blood vessels / Capillaries Adipose (fat) cells

The Stromal Vascular Fraction (SVF) The isolated SVF contains: Adult Stem Cells Endothelial Cells Fibroblast Cells Pericytes Red Blood Cells White Blood Cells … and much more

ADSCs are Growth Factors and Cytokines factories Flt-3 ligand, granulocyte colony stimulating factor (G-CSF) granulocyte/macrophage colony stimulating factor (GM-CSF) macrophage colony stimulating factor (M-CSF) interleukin-6 (IL-6) interleukin-7 (IL-7) interleukin-8 (IL-8) interleukin-11 (IL-11) interleukin-12 (IL-12) leukemia inhibitory factor (LIF) tumor necrosis factor-alpha (TNF-α) Growth Factors epidermal growth factor (EGF) vascular endothelial growth factor (VEGF) basic fibroblast growth factor (bFGF) keratinocyte growth factor (KGF) platelet-derived growth factor (PDGF), hepatocyte growth factor (HGF) transforming growth factor-beta (TGF-β) insulin-like growth factor (IGF) brain-derived neurotrophic factor( BDNF)

The Technology - the MyStem concept - Our Vision: Providing Regenerative fraction at the point-of-care

MYSTEM® Process - Step by Step – (can be repeated several times for the same patient)

up to 10x volume reduction 1111 MYSTEM® SVF isolation Process (the process can be repeated several times for the same patient) 1.Tissue Harvesting 2.Fractioning Liquid Fraction Fat Fraction 3.Cells Separation 7.1 millions cells / harvested ml 4.Cells Concentration up to 10x volume reduction

The Technology - the MyStem device - Single-use Medical Device One-step Procedure Process time 15 min 710.000 Nucleated Cells / ml Up to 10x Concentration International Patent

Clinical use of MyStem technology Demonstrated effects in: Bone tissue repair (Published Study) Osteoarthritis (Case Report) Intervertebral Disc disease (Published Study) Tendon injury (Case Report) Severe Burns (Case Report) Soft tissue augmentation (Case Report) Wound healing (Case Report) Diabetic Foot Syndrome (Case Report) Crohns (Case Report) Fistulas (Case Report)

MyStem Factsheet MyStem Authorizations Clinical Evidence CE Mark SFDA (Saudi FDA) TGA (Australia) ANVISA (Brazil) Clinical Evidence over 1200 clinical cases done

Together..... ...helping people... ..with great results..

Thank you