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Lipocast Biotech UK Lipogems Equine and Canine Presentation 2017 v.1.2

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This presentation is a short preview of the translated technology. It outlines the science behind the concept and explains some of the misconceptions of tissue graft technology. The preview also contains extensive links to online published research papers and retrospective studies.

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Lipocast Biotech UK Lipogems Equine and Canine Presentation 2017 v.1.2

  1. 1. A Presentation from Lipogems Equine & Lipogems Canine
  2. 2. Revolutionising Regenerative Equine Veterinary Medicine Lipogems® is an easy to use, rapid and cost effective technique for harvesting and processing adipose tissue derived Mesenchymal Stromal Cells. In the equine veterinary market conditions treated to date include lesions of the superficial and deep flexor tendons, suspensory ligament desmitis (proximal, body and branch lesions), check ligament injuries, and osteoarthritis affecting distal interphalangeal, fetlock and stifle joints, sacroiliac injuries and kissing spines. 20,000+ human patients have been worldwide This patented technology produces micro-fragmented adipose tissue with an intact stromal vascular niche with a high regenerative capacity. Lipogems® has been used in more than 20,000 human patients worldwide. A growing bibliography documenting the scientific basis for its regenerative capacity in general, orthopaedic, aesthetic and oral-maxillofacial surgery. Intra-articular and lesional injection has been used to treat knee, ankle, hip and shoulder osteoarthritis, degenerative spinal disc disease, and injuries to tendons, ligaments and menisci.
  3. 3. Lipogems is not a stem cell therapy The Lipogems® system is a sterile single-use medical device intended for the closed-loop processing and transferring of autologous adipose tissue in a single surgical step. Lipogems® is a non-expanded and micro- fragmented adipose tissue graft that is injected into damaged areas of the body in order to provide a cushion and structural support while promoting a healing environment. The Lipogems® process preserves the natural healing properties of adipose tissue by maintaining the fat’s Vascular Stromal Niches. The micro-fragmentation of the tissue is key to the treatment process as it triggers the bodies own damage response mechanism. Lipogems has been directly translated from human application to veterinary application - No lab culturing - No cell isolations - Lipogems is a complete tissue structure graft There are no other comparative treatments that trigger the bodies own damage response mechanism in a single step non-enzymatic procedure that is completed in under an hour either in surgery for small animals or in a stable for equines.
  4. 4. Lipogems is not a stem cell therapy Mesenchymal Stem Cells vs Mesenchymal Stromal Cells Mammalian MSC from selected species: Features and applications. Uder C1, Brückner S1, Winkler S1, Tautenhahn HM1, Christ B. “Mesenchymal stromal/stem cells (MSC) are promising candidates for cellular therapy of different diseases in humans and in animals. Following the guidelines of the International Society for Cell Therapy, human MSC may be identified by expression of a specific panel of cell surface markers (CD105+, CD73+, CD90+, CD34-, CD14-, or CD11b-, CD79- or CD19-, HLA-DR-). In addition, multiple differentiation potential into at least the osteogenic, adipogenic, and chondrogenic lineage is a main criterion for MSC definition. Human MSC and MSC of a variety of mammals isolated from different tissues meet these criteria.” Click here to read the abstract and download the paper. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Dominici M1, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Prockop Dj, Horwitz E. “the Mesenchymal and Tissue Stem Cell Committee of the International Society for Cellular Therapy proposes minimal criteria to define human MSC” Click here to read the abstract and download the paper.
  5. 5. Why is Lipogems Different? Stromal fraction transplantation is enriched by active pericytes. Exosome activation means there is cell communication Exosomes are vesicles that are secreted by cells to carry information to other cells: • Encapsulated messages released by cells • Contain proteins and genetic material • Affects cell behavior Click below to watch the video
  6. 6. Bone and cartilage formation in the embryo and repair and turnover in the adult involve the progeny of a small number of cells called Mesenchymal Stem Cells (MSCs). These cells divide, and their progeny become committed to a specific and distinctive phenotypic pathway, a lineage with discrete steps and, finally, end- stage cells involved with fabrication of a unique tissue type, e.g., cartilage or bone. Local cuing (extrinsic factors) and the genomic potential (intrinsic factors) interact at each lineage step to control the rate and characteristic phenotype of the cells in the emerging tissue. The study of these Mesenchymal Stem Cells, whether isolated from embryos or adults, provides the basis for the emergence of a new therapeutic technology of self-cell repair. The isolation, mitotic expansion, and site-directed delivery of autologous stem cells can govern the rapid and specific repair of skeletal tissues. PMID: 1870029 [PubMed - indexed for MEDLINE]. Caplan A. Mesenchymal Stem Cells. J Orthop Res. 1991 Sep;9(5):641-50 A New Therapeutic Technology of Autologous Self-cell Repair What is Tissue Engineering?
  7. 7. Responsibly Providing Cutting-edge Treatment for the Veterinary Community Accreditation All our accredited vets are listed on our website following the provision of kits and attendance at one of our training days with either a lead or consultant Lipogems Vet. Not all vets are accredited after training. Responsible Use of Lipogems We are committed to making sure our technology is used responsibly, by the right vets, for the right cases for the right results. Lipogems Equine selectively train veterinarians around the world in the use of Lipogems. Kits are only provided to those practices that have completed training with Lipocast Biotech UK and signed the Terms and Conditions of Accreditation. Follow Up Support We offer substantial support and follow up advice following training to all our vets.
  8. 8. Worldwide Registrations and Certificates CE Certificate of the system of quality assurance CE Certificate of the system of quality management Lipogems® listed on the Australian Register of Therapeutic Goods managed by the Therapeutic Goods Administration FDA - Section 510(k) premarket notification FDA - Summary final Israel Lipogems® License Kingdom of Saudi Arabia Lipogems® License To view or download these certificates please click here. Or visit www.lipogems.eu/certifications.html
  9. 9. Where is the evidence? Autologous and micro-fragmented adipose tissue for the treatment of diffuse degenerative knee osteoarthritis: https://jeo-esska.springeropen.com/articles/10.1186/s40634-017-0108-2 Adipose Tissue and Mesenchymal Stem Cells: State of the Art and Lipogems® Technology Development: https://doc.co/5EQPA2 Angiogenic and anti-inflammatory properties of micro-fragmented fat tissue and its derived mesenchymal stromal cells: https://doc.co/cG1SPT Lipogems Product Treatment Increases the Proliferation Rate of Human Tendon Stem Cells without Affecting Their Stemness and Differentiation Capability: https://www.hindawi.com/journals/sci/2016/4373410/ref/ Non-Responding Knee Pain with Osteoarthritis, Meniscus and Ligament Tears Treated with Ultrasound Guided Autologous, Micro-Fragmented and Minimally Manipulated Adipose Tissue: http://www.lipogems.eu/docs/news/Knee-osteoarthritis_Striano-2017.pdf Microfractured and Purified Adipose Tissue (Lipogems™ system) Injections for Treatment of Atrophic Vaginitis: http://www.lipogems.eu/docs/pubblicazioni/urology-3-1073.pdf Low back pain treated with disc decompression and autologous micro-fragmented adipose tissue: a case report: http://www.lipogems.eu/docs/pubblicazioni/Black_disc_Grossi-2016.pdf Injection of autologous micro-fragmented adipose tissue for the treatment of post-traumatic degenerative lesion of knee cartilage: a case report: http://www.lipogems.eu/docs/pubblicazioni/Knee_cartilage_Franceschini- 2016.pdf
  10. 10. Where is the evidence? Con. Microfractured Lipoaspirate May Help Oral Bone and Soft Tissue Regeneration: a Case Report: http://www.lipogems.eu/docs/pubblicazioni/Oral%20bone%20tissue%20regeneratio_Benzi%202015.pdf Non-Responsive Knee Pain with Osteoarthritis and Concurrent Meniscal Disease Treated With Autologous Micro- Fragmented Adipose Tissue Under Continuous Ultrasound Guidance : http://www.lipogems.eu/docs/pubblicazioni/Knee_osteoarthritis_Striano-2015.pdf Recovery of Function in Anal Incontinence After Micro-Fragmented Fat Graft(Lipogems®) Injection: Two Years Follow Up of the First 5 Cases: http://www.lipogems.eu/docs/pubblicazioni/Giori-2015.pdf ADIPOSE MESENCHYMAL STEM CELLS AND “REGENERATIVE ADIPOSE TISSUE GRAFT” (LIPOGEMS™) FOR MUSCULOSKELETAL REGENERATION: http://www.lipogems.eu/docs/pubblicazioni/Tremolada-2014.pdf Radioelectric Asymmetric Conveyed Fields and Human Adipose-Derived Stem Cells Obtained With a Nonenzymatic Method and Device: A Novel Approach to Multipotency: http://www.lipogems.eu/docs/pubblicazioni/Maioli- 2014.pdf Differences in exosome content of human adipose tissue processed by non-enzymatic and enzymatic methods: http://www.lipogems.eu/docs/pubblicazioni/Garcia-Contreras-2014.pdf Lipogems, a New Modality of Fat Tissue Handling to Enhance Tissue Repair in Chronic Hind Limb Ischemia: http://www.lipogems.eu/docs/pubblicazioni/Bianchi-2014.pdf Micro Fractured and Purified Adipose Tissue Graft (Lipogems®) Can Improve the Orthognathic Surgery Outcomes Both Aesthetically and in Postoperative Healing: http://www.lipogems.eu/docs/pubblicazioni/Raffaini-2014.pdf
  11. 11. Where is the evidence? Con. Characteristics and Properties of Mesenchymal Stem Cells Derived from Micro-fragmented Adipose Tissue: http://www.lipogems.eu/docs/pubblicazioni/Carelli-2013.pdf Mesenchymal Stem Cells from human adipose tissue Characterization and Immunomodulatory Properties of Tissue and Cellular Products: http://www.lipogems.eu/docs/pubblicazioni/Messaggio-2013.pdf ADIPOSE-DERIVED STEM CELLS AND TISSUE REVASCULARIZATION: ENHANCING ISLET SURVIVAL AND PERFORMANCE FOR DIABETES CARE: http://www.lipogems.eu/docs/pubblicazioni/Olivi-2013.pdf A New Nonenzymatic Method and Device to Obtain a Fat Tissue Derivative Highly Enriched in Pericyte-Like Elements by Mild Mechanical Forces From Human Lipoaspirates: http://www.lipogems.eu/docs/pubblicazioni/Bianchi-2013.pdf A new nonenzymatic method and device to obtain a fat tissue derivative highly enriched in pericyte-like elements by mild mechanical forces from human lipoaspirates: https://www.ncbi.nlm.nih.gov/pubmed/23051701 Adipocyte transplantation and stem cells: plastic surgery meets regenerative medicine: https://www.ncbi.nlm.nih.gov/pubmed/20444320 New Prospective, Randomized Controlled Study Compares The Safety And Performance Of A Next Generation Adipose Tissue Technology (Lipogems®) Vs. Platelet Rich Plasma In Patients With Knee Osteoarthritis: http://www.lipogems.eu/docs/news/New-Prospective-Randomized-Controlled-Study-Compares-The-Safety- And%20Performance-Of-A-Next.pdf
  12. 12. Lipogems Treatment Steps 1, 2 & 3 for Equine and Canine Step 1 – Harvest the adipose tissue – For equines this can be done under sedation in stocks or restrained at the owners yard. Dogs will be under general anaesthetic. Step 2 – Process the tissue with the Lipogems canister, Processed tissue is collected ready for injection into the injury site Step 3 – The lipoaspirate is then injected into the pre-prepared injury site SOP’s Hard and digital copies of our Standard Operating Procedure is given to all accredited veterinarians, complete with demonstration videos.
  13. 13. Performance Horse Injury Treatment With over 300 cases done in the UK to date, a variety of injuries have been treated. It is estimated that 20% of all horses training for sporting or performance events are unable to compete due to injury The conditions treated are: • Flexor tendon injury – superficial and deep • Suspensory ligament – proximal body and branch leisons • Check ligament desmitis • Degenerative joint disease – fetlock, stifle and interphalangeal joints Additional applications: • Non-healing wounds • Lumbosacral pain
  14. 14. Canine Injury Treatment With over 300 cases performed to date the main application for Lipogems Canine is to repair soft tissue in and around inflamed joints. Diseases treated: Vascular (Legg-Calve-Perthes disease) Immune mediated arthritis (OA) Traumatic injury (Cr ligament and meniscus rupture, joint fractures) Hereditary/developmental (UAP, FCP, OCD, IOHC – incomp. ossif. Of humeral condyle) Degenerative Joint Disease Joints treated: Hip, stifle, elbow, shoulder, carpus and tarsus.
  15. 15. What do the Canine Veterinary Surgeons say? Dr Zeira was the first veterinary surgeon to take this technology and directly translate it in a pioneering move from the human medical world for canine application. “Whoever deals with regenerative medicine use stem cells, whoever deals with stem cells should use Lipogems. This is the shortest answer, yet the most complete and truthful, when colleagues ask me - why Lipogems? The longer answer is that Lipogems is a concept, a method and a device, all in one. The concept - instead of using pure stem cells that should be cultivated and expanded and therefore are high cost, we use a true mini habitat containing a scaffold, stem cells precursors, numerous anti-inflammatory factors, trophic mediators and others. The method - using mild mechanical forces in a completely closed system, with no enzymes, additives and other manipulations, avoiding complex regulatory issues. The device - single-use medical device for the processing of lipo-aspirated adipose tissue. It is very friendly and straight forward device. I am happy to say that in my hospital, 70-80% of all cases treated with stem cell, has been shifted from bone marrow cultivated material to Lipogems, which we can use immediately on our patients. In the case of dog’s muscles, tendons and articular diseases, 100% of the cases is treated by Lipogems. The results are amazing, dogs that suffered severe lameness, managed to walk with nearly no lameness within 5-6 days. Also, the effect’s duration of this treatment is unique, it last for 10-12 months after a single treatment, sometimes even longer.” Dr Offer Zeira, Director of San Michele Veterinary Hospital, Milan, DVM PhD Field of Study Veterinary Orthopaedics and Neurosurgery
  16. 16. “While the science behind Lipogems is exciting, the results are even more remarkable than this promise suggests. Having used the procedure in a range of sites and pathologies, we are seeing healing at a rate and of a quality that you simply don’t see with bone marrow-derived stem cell or platelet-rich plasma therapies. Also, as the technique is fine tuned we are now collecting 20- 30ml of Lipogems in a single harvest.” Dr Tim Watson BVM&S PhD MRCVS, Waterlane Equine Vets What do the Veterinary Surgeons say? “Lipogems is a new regenerative therapy for use in horses, utilising fat tissue derived Mesenchymal Stromal Cells taken from the tail head of the patient and prepared using a stable-side kit, enabling the treatment to be carried out on site and without delay… It is proving to be a revolutionary new mode of treatment for a group of injuries that have previously been difficult to treat and often with an unfavourable outcome… This has great potential in many equestrian disciplines such as racing, eventing and polo.” Dr Clive Hamblin BVET MED MRCVS, National Trainers Federation (NTF) Veterinary Advisor

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