Presentation is loading. Please wait.

Presentation is loading. Please wait.

DESolve TM : Investigational device, not available for sale in the US

Similar presentations


Presentation on theme: "DESolve TM : Investigational device, not available for sale in the US"— Presentation transcript:

1 DESolve TM : Investigational device, not available for sale in the US
Elixir Medical Corporation Biodegradable Polymer Program Motasim Sirhan, CEO Elixir Medical DESolve TM : Investigational device, not available for sale in the US DESyne ® and DESyne BD ® : CE mark approved, not available for sale in the US 1

2 Elixir Medical: Innovating Vascular Restoration
Developing drug-device therapies to improve the standard of care for vascular intervention Bilingual organization fluent in the development of drugs and devices for vascular applications Developed and patented proprietary drug, Novolimus, a metabolite of Sirolimus with high potency and known safety profile Developed highly biocompatible, biodegradable polymeric materials designed to sustain excellent long term clinical outcomes Industry’s most comprehensive portfolio of drug eluting coronary vascular therapies DESolveTM fully bioresorbable scaffold: enrolled pivotal trial for CE Mark, approval anticipated in 2013 DESyne BD® biodegradable polymer DES: CE Mark approved, launching in 2013 DESyne® durable polymer DES: CE Mark approved, beginning commercialization Leverage proprietary know-how and technologies for peripheral vascular therapies Adapting our bioresorbable scaffolds to SFA, BTK and pediatric applications where the need for improved therapies is acute and bringing them into the clinic 2

3 Elixir’s unique drug: Novolimus, a metabolite of Sirolimus
Known safety and efficacy Active metabolite of Sirolimus Binds to FKBP12, forming immunosuppressive complex mTOR inhibitor Known safety profile Patients treated with Sirolimus orally / via DES exposed to significant amount of Novolimus Potent anti-proliferative Sustained performance with low drug dose Excellent clinical outcomes Exclusive supply and manufacturing Active Pharmaceutical Ingredient (API) Developed and chemically synthesized by Elixir Exclusive supply agreement with a GMP certified API manufacturer cGMP API Drug Master File complete Proprietary drug with issued US patent Oral Sirolimus Formula: C50H77NO13 MW: 900 Drug Concentration Elixir DES & Scaffold Novolimus Exposure Time Not to scale

4 DESolve Breakthrough bioresorbable scaffold DESyne BD DESyne
Elixir has the broadest DES product portfolio in the industry for the markets of today and tomorrow DESolve Breakthrough bioresorbable scaffold DESyne BD Biodegradable polymer DES designed to reduce the duration of DAPT DESyne Workhorse DES with best-in-class safety, efficacy

5 DESolve TM: the next quantum leap in vascular repair therapy
DESolve utilizes Elixir’s advanced platform technologies … Ultrathin (< 3 µm) biodegradable polymer matrix with no primer coating Drug release provides sustained neointimal inhibition Low Novolimus drug dose of 5 µg / mm … and combines them with a scaffold that bioresorbs in about 1 year PLLA-based polymer with excellent durability, flexibility, and biocompatibility Excellent radial strength with low recoil Ability to expand in physiological conditions Proprietary fabrication and processing technology Allows visualization with MSCT Two issued US patents DESolve Breakthrough bioresorbable scaffold DESyne BD Biodegradable polymer DES designed to reduce the duration of DAPT DESyne Workhorse DES Investigational use device .Product not available for sale in the US

6 DESolveTM has several key differentiating performance characteristics
Scaffold bioresorbs in about 1 year and provides excellent low late lumen loss at 6 months Self-correcting scaffold property designed to resolve malapposition Substantial safety margin for fracture resistance Wide range of sizes to accommodate a broad range of vessel sizes and lesion lengths Achieving ease of use and performance characteristics comparable with metallic DES systems 1 2 3 4

7 DESolveTM has demonstrated success in the clinic
First-In-Man trial complete with excellent 6 month and 12 month results 16 patients across Belgium and New Zealand Primary endpoint: in-stent late lumen loss at 6 months – 0.19mm late lumen loss Principal investigators: Dr. Stefan Verheye and Dr. John Ormiston DESolve Nx CE Mark pivotal trial undergoing follow-up 126 patients across 15 sites: Europe, New Zealand, and Brazil Principal investigators: Dr. Alexandre Abizaid, Dr. Joachim Schofer, Dr. Stefan Verheye Primary endpoint: in-stent late lumen loss at 6 months; other endpoints: Clinical: MACE, stent thrombosis QCA: In-segment late lumen loss, binary restenosis, and percent diameter stenosis Subset of patients: QCA, IVUS, OCT at 6, 12 and 24 months; MSCT at 12 months Data analysis ongoing – 6 month clinical and imaging data to be presented at Euro PCR 2013 CE Mark approval anticipated in 2013

8 DESolveTM FIM 6 month angiographic results
In-scaffold Analysis n=14 (paired) RVD (mm) post-procedure 2.84 ± 0.23 at 6 months 2.78 ± 0.27 MLD (mm) 2.60 ± 0.19 2.41 ± 0.28 % Diameter Stenosis post procedure 8.05 ± 7.90 12.63 ± 11.37 Acute Recoil (%) 6.4 ± 4.6 Late Lumen Loss (mm) at 6 months 0.19 ± 0.19 Binary Restenosis (%) at 6 months 0.0

9 DESolveTM FIM 12 month MSCT results
In-scaffold Analysis 12-month Follow-up n=12 Reference Diameter (mm)  2.9 ± 0.5 Minimal Lumen Diameter (mm)  2.4 ± 0.4 Mean Diameter Stenosis (%)  15.9 ± 10.0 Mean Lumen area (mm2) 6.7 ± 3.5 Minimum Lumen area (mm2) 5.1 ± 1.2 Reference area (mm2)  7.5 ± 2.3 Mean area stenosis (%) 22.4 ± 14.2 MLD and % DS consistent between 6 and 12 months

10 post-stenting (baseline)
pre-stenting 69-yr old male hyperlipidemia hypertension former smoker stable angina post-stenting (baseline) 6M FU 6 month follow-up 6M FU 12M FU *Stefan Verheye, M.D., Ph.D., ZNA Middleheim Hospital, Antwerp, Belgium

11 CE Mark trial case presented live by Dr. A. Abizaid, Dr. D
CE Mark trial case presented live by Dr. A. Abizaid, Dr. D. Chamié at TCT 2012 demonstrates the conformability of the DESolveTM scaffold Severe lesion in proximal LAD with severe angulation (>90º) Pre-placement At placement Post-placement 97o DESolve 3,5 x 14mm DESolve (92o)

12 DESyn BD ® : CE Mark-approved biodegradable polymer DES
Ultra-thin biodegradable polylactide-based polymer that dissolves within 6 months No primer coating, allowing for a true BMS surface after biodegradation of polymer coating Uniform drug distribution in vessel wall DESolve Breakthrough bioresorbable vascular scaffold DESyne BD Biodegradable polymer DES designed to reduce duration of DAPT Advanced Co-Cr stent platform Thin stent struts with high flexibility and deliverability Optimal vessel wall coverage for uniform drug delivery Open cell design for ease of side branch access DESyne Workhorse DES Unique drug agent Novolimus Potent anti-proliferative with known safety profile Achieves sustained clinical performance with low drug dose and low polymer load

13 DESyne BD ® 6 month angiographic and IVUS results
In-Stent Analysis Novolimus Zotarolimus P value RVD. mm N(L)=119 N(L)= 38 Post-procedure 3.00±0.37 3.08±0.35 0.31 At 6-months 2.95±0.37 2.99±0.38 0.67 MLD / Late Lumen loss (LLL), (mm) Acute gain 1.87±0.42 2.01±0.43 0.09 MLD post-procedure 2.76±0.37 2.90±0.34 0.04 MLD at 6-months 2.64±0.39 2.22±0.53 <0.001 LLL at 6-months (in-stent) 0.12±0.15 0.67±0.47 < 0.001 Diameter Stenosis (%) 8.5±44 6.2±4.5 0.002 11.0±6.6 25.6±15.1 Binary Restenosis (%) (in-stent) 0.0% 7.9% 0.003 %Neointimal volume obstruction (%) 3.6±4.2 20.7±14.2 < 0.001 

14 DESyne BD ® 12 month Clinical Results
0 to 360 days, % (n) DESyne (N=112)* Endeavor (N= 31) P-Value HIERARCHICAL EVENTS DEVICE-ORIENTATED COMPOSITE 2.7% 3.2% 1.00 CARDIAC DEATH 0.0% -- TARGET VESSEL MI 0.9%§ CLINICALLY-INDICATED TLR 1.8% 0.52 Definite/Probable Stent Thrombosis §Two vessel intervention with peri-procedural enzyme rise and no further complications *Modified Intention to Treat (patients who received a study stent)

15 CE Mark-approved workhorse DES
FORMULA coating technology Thin polymer and drug matrix coating without the need for a primer coating Lowest polymer load for improved biocompatibility DESolve Breakthrough bioresorbable vascular scaffold DESyne BD Biodegradable polymer DES designed to reduce duration of DAPT Advanced Co-Cr stent platform Thin stent struts with high flexibility and deliverability Optimal vessel wall coverage for uniform drug delivery Open cell design for ease of side branch access DESyne Workhorse DES Unique drug agent Novolimus Potent anti-proliferative with known safety profile Achieves sustained clinical performance with the lowest drug dose among DES on the market

16 DESyne ® EXCELLA II 9 month angiographic and IVUS results
In-Stent Analysis Novolimus Zotarolimus P value RVD (mm) N(L)=154 N(L)= 75 Post-procedure 2.84±0.43 2.91±0.38 0.20 At 9-months 2.82±0.44 2.70±0.42 0.06 MLD / Late Lumen loss (LLL), (mm) Acute gain 1.36±0.40 1.47±0.36 0.047 Acute gain (%) 46.48±11.65 47.51±11.13 0.53 MLD post-procedure 2.48±0.39 2.57±0.37 0.10 MLD at 9-months 2.36±0.48 1.95±0.48 < 0.001 LLL at 9-months 0.11±0.32 0.63±0.42 Diameter Stenosis (%) 12±5 11±5 0.34 16±12 28±14 Binary Restenosis (%) 1.4% (2/138) 7.6% (5/66) 0.037 Volumetric Analysis N(L)=34 N(L)=15 %Neointimal volume obstruction (%) 4.5±5.1 20.9±11.3 <0.001

17 DESyne ® EXCELLA II trial long-term clinical safety data
0 to 1080 days, % (n) DESyne (N=139) Endeavor (N= 71) P-Value HIERARCHICAL EVENTS DEVICE ORIENTATED COMPOSITE 5.0% 12.7% 0.057 CARDIAC DEATH 0.0% -- TARGET VESSEL MI 2.2% 1.4% 1.00         Q-WAVE MI         NON-Q- WAVE MI 0.7% CLINICALLY-INDICATED TLR 9.9% 0.008 CI-PCI 4.2% CI-CABG NON TARGET VESSEL REVASCULARIZATION# 7.2% 5.6% 0.77 Definite & Probable Stent Thrombosis #Clinically and non-clinically indicated

18 DESyneTM and DESyne BDTM
DESyne ® and DESyne BD ® leveraging thin stent struts, low polymer load and low drug dose DESyneTM and DESyne BDTM CypherTM XienceTM & PromusTM ResoluteTM BioMatrixTM SynergyTM Strut Thickness (µm) Polymer Thickness (µm) Drug Load and release kinetics (µg) Data on File at Elixir Medical

19 Elixir is leveraging its proprietary know-how and technologies for peripheral vascular therapies Bioresorbable technologies can improve outcomes, expanding the global peripheral vascular device market Superficial femoral artery Long lesion lengths and complex biomechanics lead to Suboptimal long term patency rates with POBA and metallic BMS/DES DCB leaves behind no permanent implant, but with sub-optimal long term patency Below the knee CLI below the knee is a very severe condition with ~50% of cases resulting in death or amputation Sub-optimal patency with POBA, DCB and BMS/DES DESolve technology can overcome the limitations by offering the required radial support and leaving behind no permanent implant and potentially achieving optimal long term patency Elixir activity Entered pre-clinical testing in 2012, including pediatric indication FIM studies in 2013 Elixir activity Preclinical studies in 2013 Future DESolve application includes iliac, pudendal, renal, carotid and neural arteries…

20 Elixir technology in new clinical indications
Pediatric Applications Congenital Heart Disease Pulmonary Artery Stenosis births Coarctation of Aorta 1-10,000 births Currently treated by surgery/PTI with stenting Typically requires multiple re-intervention to re-expand stent/surgery to accommodate somatic growth DESolve technology can overcome the limitations by offering the required radial support , scaffold growth with somatic growth, followed by bioresorption and there by no repeat intervention Elixir activity Entered pre-clinical testing in 2012


Download ppt "DESolve TM : Investigational device, not available for sale in the US"

Similar presentations


Ads by Google