CARDIONOVUM GmbH Am Bonner Bogen Bonn Germany. CARDIONOVUM Sp. z o.o. ul. Panska Warsaw Poland

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1 CARDIONOVUM GmbH Am Bonner Bogen Bonn Germany Phone: +49 (0) Fax: +49 (0) info@cardionovum.eu CARDIONOVUM Sp. z o.o. ul. Panska Warsaw Poland Phone: Fax: cardionovum@epoczta.pl CARDIONOVUM Inc Canwood Street Suite 202, Agoura Hills, CA USA Rev. no.: L-04007EN

2 FACTS ON DEBs LEGFLOW RX/OTW PACLITAXEL RELEASING PTA BALLOON DILATATION CATHETER. WITH UNIQUE SAFEPAX DRUG COATING TECHNOLOGY

3 SUCCESSFUL PREVENTION AND TREATMENT OF RESTENOSIS AFTER PERIPHERAL INTERVENTION. 02

4 LEGFLOW RX/OTW Paclitaxel Releasing Peripheral Balloon Dilatation Catheter THE LEGFLOW BALLOON DRUG COATING QUALITY IS A MAJOR STEP BEYOND CONTEMPORARY FIRST AND SECOND GENERATION DEB COATINGS. Effective DEB PTX drug-transfer LEGFLOW SAFETY: Only the smallest PTX crystals appear safe enough to bear no risk of adverse embolic or thrombotic effects or obstructing the smaller distal vasculature. LEGFLOW ensures a high patient safety by non-visible 0.1µm smallest PTX particles leapfrogging ahead of µm large Paclitaxel crystals on most other DEBs. THE UNIQUE LEGFLOW INNOVATION: The step beyond contemporary first and second generation DEB coatings which had to compromise on vulnerable balloon coating mixtures out of a high water soluble drug excipient with relatively large PTX crystals. LEGFLOW COATING INTEGRITY: The indestructible, structural balloon coating integrity, combined with a protective drug coating finesse, does not require the use of an extra insertion tool. LEGFLOW SAFEPAX PERFORMANCE: Consistent and predictable drug delivery to the artery lesion site results in a homogenous and maximized drug absorption into the arterial tissue. LEGFLOW PROTECTIVE BALLOON COATING: The LEGFLOW Paclitaxel balloon surface coating cannot be wiped or fall off the balloon during catheter preparation, insertion or manipulation. LEGFLOW prevents endangerment of cathlab personnel, and guarantees a safe and predictable drug delivery to the target lesion site. 03

5 LEGFLOW RX/OTW 0.1µm UNSURPASSED INVISIBLY SMALL TRANSLUCENT PTX PARTICLES. Paclitaxel transfer into the vessel wall for clinically effective antiproliferative restenosisprevention. Paclitaxel inhibits SMC proliferation and significantly reduces neointimal hyperplasia. The LEGFLOW RX/OTW is indicated for the treatment of: critical limb ischemia (CLI) de-novo and restenotic lesions of the SFA popliteal artery and BTK (Below-The-Knee) artery lesions 04

6 The Paclitaxel particle size matters! DEB SAFETY FIRST! MINIMIZING THE RISK OF MICRO EMBOLIZATION. Minimizing the risk of thrombotic effect LEGFLOW SAFEPAX technology utilizes the clinically important, nanocrystalline PTX particles. Even if PTX particles would broke free they would be too small to cause any embolic or thrombotic effect. When invisibility equals safety! 1. LEGFLOW PTX coating of 0.1µm appears translucent under light reflection. 2. Other DEB`s with unstable and brittle balloon coatings, consisting of large (visible) PTX particles, bear a risk for physicians and patients. 1 2 Microscopy of the LEGFLOW balloon surface showing no visible PTX particles Stable vs. unstable DEB PTX coating 05

7 More than patients successfully treated. NO DRUG COATING PITFALLS BUT ONLY HIGH PERFORMANCE. SUPERIOR PATIENT RESULTS. For the safest SFA & BTK revascularization therapy. 06 NO Paclitaxel debonding from the LEGFLOW balloon surface before or during catheter DEB manipulation. NO PTX breaks from a brittle coating during balloon inflation. The LEGFLOW PTX coating translates into a stable, smooth and elastic, balloon surface. NO thrombotic or embolic adverse effects caused by large PTX crystals of µm adhering to the vessel wall or caused by washed off PTX embolization. LEGFLOW s SAFEPAX technology is based on invisible nano crystalline PTX particles of only 0.1µm. NO risk of PTX contamination of the cathlab environment and personnel by detached and free PTX crystals as LEGFLOW provides a stable PTX balloon coating. NO PTX-associated adverse effect potential LEGFLOW s SAFEPAX coating controls the PTX particle dimension, distribution and release. NO hidden risk from the drug-release matrix: LEG- FLOW SAFEPAX consists of a novel and innovative Shellolic Ammonium salt composition. NO uncontrolled and unpredictable drug wash-off effect during balloon inflation and manipulation as LEGFLOW s moderate hydrophobic drug coating limits PTX wash-off and ensures sufficient reproducible drug delivery to the lesion site.

8 LEGFLOW RX/OTW PROVEN! OPTIMAL THERAPEUTIC DRUG- IN-TISSUE BIOAVAILABILITY RESULTING IN MAXIMAL CLINICAL EFFICACY. Paclitaxel in tissue concentration ng/mg Hours post dilatation * LEGFLOW reliable performance even in long and occluded lesions. Preliminary results of the randomized RAPID trial (LEGFLOW vs. POBA) reveal: LEGFLOW shows greatest effectiveness in reducing neo-intimal hyperplasia also in high-risk patients with challenging lesions. The randomized European multi-center RAPID clinical trial compares LEGFLOW Paclitaxel releasing PTA balloon dilatation catheter with stent placement vs. POBA with stent placement in the treatment of extraordinary-long superficial femoral artery (SFA) lesions of > 15 cm up to 25 cm length and a total occlusion rate of 80%. (Data on file at Cardionovum GmbH) LEGFLOW: No signs of vessel toxicity were found. No other safety concerns were noted in animals studied for up to 90 days.* A short-term balloon-to-vessel wall contact time of sec. is sufficient to inhibit SMC proliferation sustainably for up to 150 hours. Pre-clinical results confirm no noticeable embolization results similar to POBA. Pre-clinical study results confirm a most effective drug delivery into the vascular tissue, showing a sustained drug effect of up to 28 days. Cardionovum s DEB shows great effectiveness in neo-intimal growth reduction in diseased vessels. *Source: Report on pre-clinical studies performed at CV-PATH Institute (R. Virmani MD), Gaithersburg USA 07

9 LEGFLOW RX/OTW PRELIMINARY RAPID STUDY RESULTS. Extraordinary SFA lesion length >15-25cm at high 80% occlusion rate results in 95% patency and freedom of TLR. (Data on file at Cardionovum GmbH) More patient case reports and LEGFLOW presentations at LINC (Leipzig Interventional Course) + Veith Symposium New York, USA available on file at Cardionovum GmbH. Case 1: Pre-dilatation SFA lesion 15 cm long with a 12 cm occlusion. Severe calcification. 08 Case 1: Final result Single shot of LEGFLOW balloon inflated at 16 atm.

10 HIGH CLINICAL EFFICACY. OUTSTANDING CLINICAL PERFORMANCE AND EXCELLENT LONG-TERM PATIENT RESULTS. Case 2: Pre-dilatation Case 2: Final result SFA lesion 15 cm long with a 6 cm occlusion length. After LEGFLOW pre-dilatation optimal stenting result without residual stenosis. 09

11 THE WIDEST SELECTION OF BALLOON SIZES. LEGFLOW OTW Technical data Shaft material Polyamide Balloon material Polyamide Usable catheter length 135 cm or 80 cm (S) Max. recommended guidewire 0.035" Tip length 5.0 mm Rated burst pressure Introducer sheath size Paclitaxel coating S - ordersymbol 16 bar for Ø 4.0 Ø mm (length 60 mm) 14 bar for Ø mm (length > 60 mm) Ø mm (length 60 mm) 12 bar for Ø mm (length > 60 mm) Ø mm 5 F Ø 4.0 (length 60 mm) 6 F Ø 4.0 (length > 60 mm) 6 F Ø 5.0 to 6.0 mm 7 F Ø 7.0 to 10.0 mm 3.0µg/mm² 80 cm catheter length LEGFLOW OTW Order information Balloon length (mm) Balloon Ø (mm) OTW Catheter length 800mm (LS) or 1350mm (L) 4.0 mm 5.0 mm 6.0 mm 7.0 mm 8.0 mm 9.0 mm 10.0 mm 20 mm L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW 40 mm L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW 60 mm L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW 80 mm L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW mm L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW mm L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW mm L OTW LS OTW L OTW LS OTW L OTW LS OTW L OTW LS OTW

12 LEGFLOW RX/OTW Technical data OTW RX Shaft material Polyamide Stainless steel Balloon material Polyamide Polyamide Usable catheter length 150 cm 140 cm Max. recommended guidewire 0.014" Tip length 3.5 mm 3.5 mm Rated burst pressure 16 bar for Ø mm 14 bar for Ø mm 16 bar for Ø mm (length 40 mm) Ø 4.0 mm (length 20 mm) 14 bar for Ø mm (length > 40 mm) Ø 4.0 mm (length > 20 mm) Introducer sheath size 4 F 4 F Ø mm, 5 F Ø 4.0 mm Paclitaxel coating 3.0µg/mm² 3.0µg/mm² LEGFLOW RX/OTW Order information Balloon length (mm) Balloon Ø (mm) OTW Catheter length 1500 mm, RX Catheter length 1400 mm 2.0 mm 2.5 mm 3.0 mm 3.5 mm 4.0 mm 20 mm L RX L OTW L RX L OTW L RX L OTW L RX L OTW L RX L OTW 40 mm L RX L OTW L RX L OTW L RX L OTW L RX L OTW L RX 60 mm L RX L RX L RX L RX - 80 mm L RX L OTW L RX L OTW L RX L OTW L RX L OTW L RX 100 mm L RX L RX L RX L RX mm L RX L OTW L RX L OTW L RX L OTW L RX L OTW L RX 150 mm L RX L OTW L RX L OTW L RX L OTW L RX L OTW mm L RX L RX