Biomedical and Svelte Medical Systems

Through a long-term strategic partnership, Biomedical, the world’s unrivaled biomaterials expert and committed partner in driving sustainable innovation in healthcare, and Svelte Medical Systems, a privately-held company engaged in the development of highly deliverable balloon expandable stents, have revolutionized the standard for coronary stenting procedures to treat coronary artery disease (CAD).

CAD is the most common type of heart disease, caused by plaque buildup in the arteries located around the heart. With more than 125 million individuals across the globe suffering from heart disease, a variety of options ranging from lifestyle changes, medications and surgical procedures exist to treat those who are affected by CAD.

Svelte Medical Systems has redefined how patients, physicians, payers and providers approach coronary stenting through their extremely low profile, highly deliverable DES. Enhanced with DISCREET Drug Coating Technology based on Biomedical’s proprietary polyesteramide (PEA) bioresorbable polymer, the SLENDER IDS® and DIRECT RX® DES systems achieved 1.5% clinically-driven Target Lesion Revascularization (TLR) at 1 year in the OPTIMIZE Investigational Device Exemption (IDE) clinical study, the lowest ever reported with an investigational DES. With the success of the OPTIMIZE IDE clinical study reported at the end of 2021, Svelte Medical Systems received U.S. Food and Drug Administration (FDA) approval to commercialize the SLENDER IDS® fixed-wire and DIRECT RX® rapid-exchange DES systems for the treatment of coronary artery disease in the U.S.

Marc Hendriks, Vice President, Strategy and Business Development at Biomedical, commented: “The Biomedical team could not be more excited for our partner, Svelte Medical Systems, and their premarket approval for their differentiating Drug-Eluting Stent (DES) design. Undoubtedly a huge achievement in our long-lasting partnership, this milestone brings us one step closer to realizing our global vision of solving our world’s healthcare needs through sustainable science. We are proud that our PEA technology has been a key enabler of one of the most critical aspects of Svelte’s DES – the superior efficacy of controlled drug release with safe biodegradation of the polyesteramide carrier. As we look to the future, we will continue to work together through our proven partnership model by supporting Svelte’s next steps in the commercialization of their innovative device.”

Jack Darby, President and CEO at Svelte Medical Systems, stated: “OPTIMIZE was a unique study – the first of its kind to evaluate a new mode of DES delivery, a new class of drug coating, direct stenting and TRI. This not only generated outstanding data on investigational device performance, but also helped identify discrepancies between study definitions and assessments of myocardial infarction in clinical studies, which will help areas of future clinical research. Furthermore, the success of OPTIMIZE would not have been possible without our collaboration with the Biomedical team. Their innovative PEA technology and partnership have proven to be vital to our DES system design and we are looking forward to seeing our newly approved DES systems continue to deliver unmatched value to all constituents of cardiac care in the United States – patients, physicians, providers and payers.”

Biomedical’s PEA bioresorbable polymer is designed to maintain high mechanical integrity during stent delivery and promote healing as the antiproliferative drug sirolimus is delivered to the local tissue in a controlled manner.  Composed of naturally occurring amino acids, the biomaterial provides toughness and mechanical integrity necessary for direct stenting combined with enzyme mediated surface-resorption.  The unique biodegradation mechanism eliminates the risk of acidic microenvironment (citation) and promotes the vascular healing process.  The polymer coating is fully absorbed by the body over time, which allows healing to occur naturally and demonstrates consistent, safe, and durable outcomes for CAD patients.  DISCREET Bioresorbable Coating Technology is one of many examples in which bioresorbable polyesteramides available from Biomedical enable formulators to develop sustained release systems of small molecule drugs and biologics for both systemic and site-specific parenteral drug delivery.

Gina Conti, Global Senior Manager of Marketing, Drug Delivery at Biomedical added: “Collectively at Biomedical, we are delighted to celebrate this fantastic achievement with everyone on the Svelte team! Not only do we enjoy partnering with such a dynamic group of individuals, but our shared passion for positively influencing the treatment landscape for patients affected by CAD by leveraging the unique features of our PEA technology is what excites us the most. As we continue to improve the standard of care for patients across the globe together, I look forward to our continued partnership during the commercialization of Svelte's DES system."