Introduction to SmartX

Transcription

1 New Solution for Stem Cell Therapy Introduction to SmartX DongKoo Bio&Pharma Co.,Ltd.

2 01 Definition What is a Stem Cell? Stem cell is capable of differentiating into various cell types of organs or tissues, so called Undifferentiated cell Differentiation Self-renewal Embryonic Stem Cell : Derived from embryos that develop from eggs that have been fertilized in vitro. Adult Stem Cell : Have been identified in many organs, tissues, bone marrow, fat, etc. It can renew itself and can differentiate into some or all of the major specialized cell types of the tissue or organ.

3 02 Stem Cell Extraction Basic Process Extraction procedure of stem cell : Liposuction Enzyme Processing(type 1 Collagenase) Centrifugation Enzyme Washing Process Filtering Debris SVF Extraction (over 30% Stem cell)

4 03 Indications Clinical Use of Stem cell Applications of stem cell - Therapeutic area: Pain relief, wound repair, immune reconstitution, enrichment of hair follicles, treatment of chronic disease such as heart disease, diabetic mellitus, etc. - Cosmetic or plastic surgery: Augmentation of breast or face, wrinkle smoothness, whitening effect. Stem Cell Therapy Lipotransfer for Plastic Surgery

5 03 Indications Clinical Use of SmartX Applications of SmarX - Plastic Surgery (16 GHs, a hundred Clinics in GangNam-gu, Seoul) - Orthopedic Surgery (Samsung Hospital) - Chronic Diseases (16GHs) - Anti-aging (twenty Clinics in GangNam-gu, Seoul) Plastic Surgery SVF Assisted Lipotransfer(SAL) - Breast Augmentation - Face Fat Graft Aesthetics SVF Topical therapy for Aesthetic - Wrinkle smoothness - Whitening - Dark Circle SVF therapy for Hair loss Chronic Diseases DM FOOT(Chronic Inflamation) Wound repair Osteo Arthritis Raynaud s Phenomenon Anti-aging IV for Anti-aging therapy - Immune Modulation - Anti-Inflammation & Angiogenesis - Parkinson s Disease, AD, Stroke

6 04 SmartX Feature Product Summary SmartX is the First Registered Disposable Kit for Extracting SVF Cells (as a medical device) 1. Registered in MFDS class3 as a class III medical device registered in CE(II-a), listed FDA. Authorized medical device for SVF operation 2. The world s first divided device as a type of kit. 3. Powerful IP registered in 5 countries(usa, JAPAN, CHINA,EU) including Korea. 4. Typical protocol of SmartX Enzyme Safety (Filtered, Sterile) RBC Lysis Buffer Infuser for IV Therapy SVF (Stromal Vascular Fraction) : SVF of adipose tissue is a rich source of pre-adipocytes, mesenchymal stem cells (MSCs), endothelial progenitor cell, T cells, B cells, mast cells as well as adipose tissue macrophages.

7 04 SmartX Feature Product Line-up SmartX is the New Solution For Stem Cell therapies SmartX Kit : Body + Pressing Unit + Filter SmartX Collagenase : 25mL * 4EA SmartX Stations : Shaking Incubator(L), Centrifuge(R) SmartX IV Infuser

8 04 SmartX Feature Unique Characteristics SmartX is a product with 7 advantages originated from 4 core technologies The world s first extraction kit for medical care. Multi-Function separation, washing, Legality extraction, filtration Reproducibility Class III medical device in MFDS for extraction of SVF cell Convenience Skilled person isn t required Optimized to medical use Filtrati on (Filtration of impurities) Sepera tion (Separation of ingredients) 4 core technolo gies Washi ng (Washing enzyme) Kit type : minimum loss Minimum operating bias High Performance Maximum Cell yield and Cell viability Minimum cell loss and damage Economy Lowest operational and initial investment cost Extrati on (extraction of cell) Safety Minimum contamination from air and during operation Minimum residual enzyme

9 04 SmartX Feature Differentiation Usage frequency of extraction type : manual type> manual set type > auto-station type SmartX has advanced manual type (Lowest Cost, Moderate Convenience, High Performance + Safety) Classification Manual type Manual set type auto-station type SmartX Market share 70% 20% 10% Initial Investment cost Operational cost Class III medical device in MFDS 10 ~ 20mil. KW 40 ~ 100mil KW 50 ~ 200mil KW 5 mil. KW low More than 0.5mil. KW 0.5~2 mil. KW 0.5 mil. KW Cost effectiveness Low in operational cost High cost for skilled human resource Similar to manual type High initial investment and operational cost Cost effectiveness in initial and operational cost Convenience Hard to operate Hard to operate Safety High risk of contamination from air or during operation High risk of contamination from air or during operation Making up convenience Possible contamination due to long circuit Easy to operate Closed system, Short circuit Minimum infection and contamination Residual enzyme=0 Extraction capacity comparing to manual type Depends on skill Depends on skill Maximum 80% 150~200% good

10 04 SmartX Feature Patented SmartX 3 typical Patents are needed the best of Technology to isolate Fresh, Healthy SVF cells. Type of Up & Down Type of Concave Plunger Maximum efficiency(minimum cell loss) Nucleated cell is 1.5 times greater than one of manual type Minimize cell shearing and thermal effect Visual identification of pellet on Plunger Up & Down : Securing convenience of extraction, separation and washing, efficiency, and safety using gentle method without specific pressure Type of Kit to Syringe The world first introduced Kit type Closed System Secure safety and efficiency

11 04 SmartX Feature Patented SmartX 8 IPs and brand name registered in Korea: own source proprietary technologies through R&D Registration of IPs and brand name in USA, Japan, china, and EU(UK, Germany, France, Italty) KIPO USA, CHINA, JAPAN, EPO

12 04 SmartX Feature SmartX Pre-clinical trial Protocol Outcome 1. Purpose : SmartX (SVF extraction Kit performance evaluation) 2. Period: April 16, 2014 ~ November 14, Subjects: fat extracted from the inside of thigh or the abdominal region in 20s to 30s female 4. Total N = 11 persons 5. Research Center: RMS team of Cefo-bio 6. Test items(mfds mandatory performance test) 1 Cell Yield : comparison of Nucleated cell Yield between SmartX and manual type 2 Cell viability : Survival cell/total extracted cell. 3 Residual Enzyme : residual type 1 Collagenase detection 1. SmartX is a kit characterized by low cell loss and damage, as well as by easy to use 2. Cell Yield : Smart X s Nucleated cell yield is 1.5 to 2 times greater than Manual method (significant deference) 3. Cell Viability : 98.5% of Smart X vs. 98% of Manual method(equal ideal) 4. Washing rate : Residual type 1 Collagenase is 0 after washing 3 times with NS 5. Safety : contamination minimized through closed system 6. Extracted stem cell : present characteristics of mesenchymal stem cell after extraction by SmartX 7. Comparison with competitors : Comparing to A Product, Cell viability was 165% higher and fresh cell was identified after extraction

13 04 SmartX Feature SmartX Pre-clinical trial Data

14 04 SmartX Feature SmartX Pre-clinical trial Data MFDS result Plastic surgery center B * Cell counting comparison result(right) with a researcher in B Plastic clinic. 1.5 times more cell count was observed comparing with manual methods Operation time was reduced to 1 hour which is 30mins shorter than manual method. * More than 1.5 times of the cell count was achieved with MFDS approval. K Univ. hospital (21/12) K Univ. hospital (30/12) * It is a micrograph of SVF haemocytometry collected from K Univ. hospital in 30 December. 1.3x10^7 was confirmed.(1.2x10^7 was confirmed in 21 December) It is 5~10 times more result than an usual result.

15 04 SmartX Feature SmartX Pre-clinical trial Data Cautions when you choose SVF extraction device yield or recovery ratio Viability Healthy cell Injured or dead cell Efficacy and Result : Unexpected complication : Extravasation of cytoplasmic material such as RNA, DNA etc. The nature of extravasated materials is so sticky. Hence sticky materials can congregate surrounding cells easily. Congregated cells do not play roles effectively. The viability of the final output is a very important clinical factor because nonviable cells provide no therapeutic value and can potentially lead to excess localized inflammation in the treatment site due to excessive cellular debris. Viability standards in most clinical protocols have typically been set at greater than or equal to 70% in terms of lot release criteria. Although this number is arbitrary, it is a good standard to go by. Although all of the platforms measured were able to achieve single isolation viabilities greater than 70% viable, there were a notable number of isolations which were below this mark.

16 04 SmartX Feature Before & After : Fat Grafting using by SmartX Facial Fat Grafting Initial 3 Years later Initial 1 year later Breast Augmentation Initial 2 times / 1 year later Initial 2 times / 1 year later

17 04 SmartX Feature Before & After : DMFU using by SmartX K University plastic surgery Amount of fat : 30cc, Cell count 40M cells, Cell viability rate : 90% Operation method : intramuscular, result : wound healing, regeneration of cell tissue Pre-injection 1 st day 25 th day 55 th day

18 04 SmartX Feature Before & After : IV therapy using by SmartX Atopic dermatitis Psoriasis Initial 5 weeks later Initial 2months later Initial 3weeks later Initial 3weeks later

19 04 SmartX Feature Before & After : IV therapy using by SmartX Xeroderma Scalp chronic inflammation (eczema) Alopecia Initial 3days later Initial 3weeks later 3month s later Initial 3 months later 1 year later

20 04 SmartX Feature SmartX Protocol

21 05 SmartX Users SmartX Heavy Users General Hospital Seoul National University hospital Seoul National University hospital (Bundang) Yonsei Severance Hospital Yonsei Severance Hospital (Gangnam) Asan Medical Center Korea University An-Am Hospital Seoul Catholic University Hospital Konkuk University Hospital Chungnam National University Hospital Kyungpook National University Hospital Catholic Guangdong International hospital Plastic Clinic DA Plastic clinic YouJin Plastic clinic JW Jung Won Plastic clinic Unique Plastic clinic Taesung Plastic clinic Touch Yousung Plastic clinic Well Plastic clinic Saemyeung Plastic clinic Kaios Plastic clinic Woojin Plastic clinic Plus up Plastic clinic

22 05 SmartX Users Clinical Trials Institution Department Title Seoul National University Hospital Plastic Surgery Graft survivals of adipose-derived stem cells enriched autologous fat grafts in patients after mastectomy and implant-based breast reconstruction: A randomized-blind placebo-controlled trial Seoul Catholic University Hospital Plastic Surgery/Rheumatology Efficacy of autologous adipose-derived SVF in wound healing of patients with Systemic sclerosis Kyungpook National University Hospital Chungnam National University Hospital Bucheon Catholic Hospital, Konkuk University Hospital, Hanyang University Hospital, Dongsan Medical Center Plastic Surgery Plastic Surgery Plastic Surgery 1. Impact of autologous adipose-derived SVF on Breast Cancer Cell Growth and Fat Retention during fat grafting 2. Impact of adipose-derived SVF on graft survivals during autologous fat grafting of patients that had received mastectomy & breast reconstruction using LD Flap or Oncoplastic breast surgery Clinical effect of SVF on scar Safety & efficacy assessment of autologous adipose-derived SVF injection in diabetic foot ulcer patients Yonsei Severance Hospital Plastic Surgery A study of efficacy of SVF injection on aesthetic improvement of lower eyelid Asan Medical Center Plastic Surgery An analysis study using 3D camera on graft survivals of autologous free fat grafting using SVF injection