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TCT 2023: Six-Month Clinical Data from DESyne® BDS Plus Randomized Controlled Trial (RCT) Support Safety and Effectiveness of World’s First Site-Specific Antithrombotic Drug Therapy

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Elixir Medical, a developer of novel cardiovascular technologies, today announced positive six-month clinical data from the DESyne BDS Plus Randomized Controlled Trial (RCT) evaluating DESyne BDS Plus, the world’s first triple drug-eluting coronary implant with site- specific delivery of antithrombotic drugs versus a second-generation, durable polymer drug-eluting stent (DES). The study met its primary endpoint of target lesion failure (TLF) with no TLF events reported in the study arm, demonstrating safety compared to DES. The data were presented by Stefan Verheye, M.D., Ph.D., Interventional Cardiologist at ZNA Cardiovascular Center in Antwerp, Belgium and the study co- principal investigator at the Innovation Program session at the Transcatheter Cardiovascular Therapeutics (TCT) conference today in San Francisco.

“Early (<30 days) and especially acute and subacute stent thrombosis is a major catastrophic event with high rate of in-hospital mortality and myocardial infarction (MI) and a significantly increased risk of major adverse cardiac events out to 5 years. Furthermore, balancing ischemic and bleeding risk when using guideline-directed dual antiplatelet therapy (DAPT) in patients at high thrombotic risk and high bleeding risk often requires a compromise,” said Stefen Verheye, M.D., Ph.D. “These data from the DESyne BDS Plus RCT give hope that site-specific antithrombotic therapy may offer additional protection for our patients and eliminate the tradeoff decisions associated with oral antithrombotic therapy in the future.”

Clinical results

● The study’s primary endpoint was met (pnon-inferiority<0.001); TLF rate at day three or at hospital discharge, whichever came first, was 0.0% for DESyne BDS Plus versus 5.0% (95%CI, -11.8% to 1.8%) with the durable polymer DES.

○ At six months, TLF rate was 1.0% for DESyne BDS Plus and 8.2% (p=0.035; 95%CI, – 14.8% to -1.3%) for the durable polymer DES.

● No definite or probable stent thrombosis, target vessel myocardial infarction or cardiovascular deaths were observed with DESyne BDS Plus study device.

○ At six months, target-vessel myocardial infarction rates were significantly lower in the DESyne BDS Plus group (0%) compared to the durable polymer DES (6.3%).

● The secondary endpoint, in-device late lumen loss (LLL) at six-months was similar between both devices; 0.14±0.05 mm in the DESyne BDS Plus group and 0.09±0.05 mm in the durable polymer DES.

Coronary artery disease is the leading cause of death for men and women in most racial and ethnic groups in the U.S.1 While PCI has positively impacted mortality rates2, procedure and device related risks remain. Stent thrombosis after PCI is associated with large territory myocardial infarction (MI) events and poor outcomes, with death rates as high as 50% for early (<30 days) thrombosis cases3. Management of ischemic and thrombotic risk requires medication adherence, but only 60% of patients are adherent to their prescribed cardiovascular medications which can lead to an increased risk of cardiovascular events or mortality by 20% or 35%, respectively.4 In addition, 3.5% of patients undergo non-cardiac surgery within six months of PCI procedure requiring careful management of thrombotic and bleeding risk5.

“Our novel DESyne BDS Plus platform leverages triple drug site-specific antithrombotic therapy (TRx) designed to reduce clotting risk at the site of the implant without increasing the bleeding risk associated with systemic oral antithrombotics, thereby simplifying the complexity of patient management, and potentially improving outcomes and making timely PCI therapy a safer option for more patients,” said Motasim Sirhan, CEO of Elixir Medical. “We are excited by these data from the DESyne BDS Plus RCT as we build a growing body of clinical evidence supporting all of our innovative devices.”

DESyne BDS Plus device has a bioresorbable coating with three drugs: two anticoagulants (rivaroxaban and argatroban) and an antiproliferative mTOR inhibitor (sirolimus). The coronary implant is designed to help manage thrombotic and bleeding risk for at-risk PCI patient populations.

The DESyne BDS Plus RCT is a prospective, multicenter, randomized, single-blind study of 202 patients across 14 sites. Angiographic and OCT imaging was conducted on approximately 60 patients in both arms to assess and document six-month results for late lumen loss (0.14±0.05mm in DESyne BDS Plus versus 0.09±0.05mm in the durable polymer DES) and diameter stenosis (11.3±6.2% in DESyne BDS Plus versus 12.3±6.3% in the durable polymer DES).

Preclinical studies with DESyne BDS Plus device have shown site-specific tissue therapeutic levels of anticoagulants for up to one year after device implantation while systemic blood levels of anticoagulants were sub-therapeutic. A pharmacokinetic clinical sub-study was conducted to assess the blood pharmacokinetics of sirolimus, rivaroxaban and argatroban eluted from the DESyne BDS Plus device after implantation. The sub-study validated sub-therapeutic systemic blood concentration levels of both anticoagulants confirming that the DESyne BDS Plus device with its site-specific delivery of antithrombotic drugs does not present a systemic dose risk.

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