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TIGR® Matrix Surgical Mesh Launched in the United States

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TIGR® Matrix Surgical Mesh Launched in the United States ® SURGICAL MESH CORPORATE - timeline The history of Novus Scientic - a journey of innovation RadiPlast founded Radi Medical Systems AB founded. PressureWire® methodology ‘Fractional Flow Reserve’ (FFR) conceived. on the basis of using Novus Scientific founded. intelligent plastic Radi grows it’s international presence globally with nine regional offices. TIGR® mouldings to avoid RadiPlast becomes RadiPlast sold to to CR Bard. available injuries to children. agent for ACS (Advanced Employees around the world swell to 350. in EU. Catheter Systems). Radi acquired by St Jude Medical Inc. Later the company First PressureWire® sold. TIGR® turns its’ hand to available PressureWire® (Radi Sensor) First FemoStop® sold. First Femoseal® sold. selling catheter kits. in USA. concept conceived. Work starts on TIGR™ project. Polymer research starts in earnest at the Radi research facility in Uppsala. 03 011 1978 2004 1979 2005 1980 2006 RadiPlast 1981 MEDICAL SYSTEMS 2007 1982 2008 1983 2009 1984 1978 1985 Engstrom runs radiology product company 1986RadiPlast AB. 1987 1982 1988 Engstrom secures distribution rights to Advanced Cardiovascular 1989 Systems Inc. (ACS > Guidant Inc). 1990 1988 1991 Engstrom sells RadiPlast AB to CR Bard Inc. and founds Radi Medical Systems 1992 AB. 1993 1988 – 2008 1994 1995 Radi pioneers some of the world’s leading devices for interventional cardiology, hemostasis 1996 management, and radiology. 1999 1997 1998 Engstrom sets up a resorbable biomaterials R&D department in Sweden. 1999 2003 2000 2001 Engstrom invests heavily in clean room production facilities on the island of Phuket. 2002 2004 20 ® Resorbable polymer matrix project group established - 1st patent filed for what would become TIGR Matrix Surgical Mesh. 2005 Engstrom honored at Ernst and Young ’ World Entrepreneur of the Year’ awards. 2008 2010 Radi Medical Systems sold to St Jude. Inc. / Novus Scientific founded and established into 2009. 2 2010 TIGR® Matrix Surgical Mesh launched in the United States. 2011 TIGR® Matrix Surgical Mesh launched in selected European countries. TIGR® Matrix Surgical Mesh - indications for use for use in reinforcement of soft tissue where weakness exists In January 2010 the US Food and Drug Administration (FDA) gave the company 510(k) clearance to market TIGR® Matrix Surgical Mesh for use in reinforcement of soft tissue where weakness exists. In July 2011 Novus Scientific’s Quality Management System was certified by BSI to ISO 13485:2003 for the following scope: Design, control of manufacture and supply of sterile resorbable synthetic surgical mesh for reinforcement of soft tissue. In August 2011 Novus Scientific received CE Mark approval for TIGR® Matrix Surgical Mesh in Europe. TIGR® Matrix Surgical Mesh PRODUCT - key features dual-stage resorption long-term absorbable % Strength Retention * TIGR® Matrix Surgical Mesh ** Polyglactin 910 100 *** GTMC * Novus Scientic, Data on File. FAST ** Chu, C. C. A comparison of the eect of pH on the biodegradation of two synthetic absorbable sutures. Annals of Surgery 1982;195(1):55-59 *** Katz et al. New synthetic monolament absorbable suture made from polytrimethylene carbonate. Surgery, Gynecology & Obstetrics 1985;161(3):213-222. 50 SLOW 0 10 20 30 40 50 60 WEEKS strong when you need it gone when you don’t wound healing phase remodeling phase INCREASING MECHANICAL COMPLIANCE DECREA SING MECHANIC ® AL S TRE NG TH SURGICAL MESH 100% synthetic increasing mechanical compliance TIGR® Matrix Surgical Mesh PRODUCT - design ® SURGICAL MESH ◆ Unique, patented dual-fiber construction (dual-stage mechanics) ◆ Strong in the acute wound healing phase ◆ Gradually increasing mechanical compliance over time ◆ Pore size of approx. 1mm at time of implantation increasing to approx 1 x 2mm at 4 months ◆ Warp knitted to prevent unravelling TIGR® Matrix Surgical Mesh PRODUCT - materials 0 days 6 months 3 years Fast-resorbing fiber = copolymer of glycolide, lactide and trimethylene carbonate. strong for 1-2 weeks, gone in 4 months Slow-resorbing fiber = copolymer of lactide and trimethylene carbonate. strong for 6-9 months, gone in 3 years TIGR® Matrix Surgical Mesh PRODUCT - strength comparison Suture retention Burst Strain at Tear resistance, strength, Thickness Product strength 16N/cm parallel/perpendicular parallel/perpendicular (mm) (N/cm) (%) (N) (N) TIGR® 86.5 7.0 45.8 / 59.0 32.0 / 33.3 0.51 Matrix 10 Physiologic 32 15-25 ? - - requirement - Ultrapro™ 35.5 16.2 15.1 / 16.7 10.5 / 5.1 0.50 Parietex Composite 38.9 6.5 28.2 / 36.3 19.7 / 16.2 0.76 ™ C-Qur™ 50.5 13.2 22.3 / 33.8 19.4 / 18.35 0.28 Lite “Small” Proceed™ 52.6 7.25 34.1 / 41.6 19.8 / 20.2 0.57 Gore 97.8 10.2 65.2 / 73.0 30.5 / 41.3 1.20 Dualmesh™ 10 Parietex Flat Sheet 112.9 3.5 51.4 / 58.4 32.7 / 28.6 0.52 TEC™ Prolene™ 156.6 5.3 61.2 / 70.5 33.7 / 39.3 0.53 Bard 157.7 10.8 50.8 / 66.8 46.8 / 38.4 0.73 Mesh™ Physiomechanical Properties of Permanent Meshes compared to TIGR® Matrix Physiomechanical Properties of Permanent Meshes compared to TIGR® Matrix Deeken CR, et al. J Am Col Surg. 2011;212:68-79. Deeken CR, et al. J Am Col Surg. 2011;212:68-79. Deeken CR, et al. Surg Endosc. 2011;25:1541-52. Deeken CR, et al. Surg Endosc. 2011;25:1541-52. Data on file: Novus Scientific For six months TIGR® Matrix Surgical Mesh maintains mechanical integrity equivalent to a lightweight polypropylene mesh and initially is twice that strong. High strength is crucial in the initial wound healing phase. Beyond that the increasing mechanical compliance of TIGR® Matrix is designed to promote remodelling of native tissue. TIGR® Matrix Surgical Mesh PRODUCT - strength retention comparison 350 % Strength Retention 317 * TIGR® Matrix Surgical Mesh 300 ** Polyglactin 910 100 *** GTMC 253 250 * Novus Scientic, Data on File. ** Chu, C. C. A comparison of the eect of pH on the biodegradation of two synthetic absorbable sutures. Annals of Surgery 1982;195(1):55-59 200 *** Katz et al. New synthetic monolament absorbable suture made from polytrimethylene carbonate. Surgery, Gynecology & Obstetrics 1985;161(3):213-222. 50 150 Max Force (N) Force Max 100 89.6 37 50 30 35 23 20 14 0 10 20 30 40 50 60 WEEKS 0 Veritas™ Alloderm™ Permacol™ 0 Months 1-­‐12 Months max 1-­‐12 Months min TIGR® Matrix Strength Retention compared to other Resorbable Synthetics Biomechanical Characteristics of Biologic Meshes Deeken CR, et al .J Am Coll Surg 2011;212:880-888 TIGR® Matrix Surgical Mesh retains 50% of its mechanical strength for at least 6 months. TIGR® Matrix Surgical Mesh is stronger for much longer than other synthetic absorbable meshes and is designed to have gradually increasing mechanical compliance. VicrylTM (Polyglactin 910) for example degrades in a matter of 2-3 weeks. The long-term resorption of TIGR® Matrix gives the recipient tissue time to respond to the increasing mechanical load. TIGR® Matrix Surgical Mesh THE CONCEPT OF MECHAnotrANSduction* Muscles and tendons become stronger in response to repetitive loading. “Tendons adapt to changes in mechanical loading, and numerous animal studies show that immobilization of a healing tendon is detrimental to the healing process.” “collagen networks are mechanosensitive in that they are stabilized by mechanical strain.” *mechanotransduction is the physiological process where cells sense and respond to mechanical loads Br J Sports Med 2009;43:247-252 doi:10.1136/bjsm.2008.054239 TIGR® Matrix Surgical Mesh PRODUCT - time dependent mechanical characteristics wound healing phase remodeling phase required physiological elasticity in vertical stretching (25 ± 7 %) INCREASING MECHANICAL COMPLIANCE 20 19 16.2 DECREA SING MECHANIC 15 AL S 13.2 TRE NG 10.8 TH Strain at 16N/cm (%) 10.2 (day 0) (day Parietex Composite Parietex Prolene (day 277) (day (day 182) (day 7.3 (day 28) (day 7 6.5 Parietex Flat SheetTEC 5.3 3.5 Bard Gore Dualmesh Proceed C-Qur Lite Small Ultrapro Matrix Matrix ® TIGR Matrix ® TIGR Matrix ® TIGR Matrix ® TIGR DAY 0 Physiomechanical Properties of Permanent Meshes compared to TIGR® Matrix The increasing mechanical compliance results in a Deeken CR, et al. J Am Col Surg. 2011;212:68-79. gradual transition of load from the mesh to the patient. Deeken CR, et al. Surg Endosc. 2011;25:1541-52. Junge K, et al. Hernia (2001) 5: 113-118. Data on file: Novus Scientific. TIGR® Matrix Surgical Mesh was developed The elasticity of TIGR® Matrix Surgical Mesh based on the hypothesis that soft tissue increases over time, reaching normal positively remodels in response to the physiological levels after 6 months. stimulus of increased mechanical load. TIGR® Matrix Surgical Mesh PRODUCT - why long-term resorbable /absorbable? Wound healing is a long-term process. In particular, the time taken to regain 50% of normal tissue strength is typically 3 months, after which about 80% of normal tissue strength is ultimately achieved. The time scale can be significantly longer in some patients. Approximate times of the different phases of wound healing, with faded intervals marking substantial variation, depending mainly on wound size and healing conditions. (Image does not include major impairments that cause chronic wounds.) TIGR® Matrix Surgical Mesh PRODUCT - benefits 0 days 6 months 3 years strong gone when when you you need it don’t for 6 months in 3 years TIGR® Matrix Surgical Mesh is: 100% resorbable / absorbable 100% synthetic Strong for 6 months, gone in 3 years (dual-stage mechanics) Easy to handle CE marked TIGR® Matrix Surgical Mesh DEFCET CREATION - 3 year sheep study This is a summary of the results ® from a 3 year implantation study SURGICAL MESH of TIGR® Matrix Surgical Mesh in the abdominal wall of sheep.
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