Svelte Medical Systems develops drug-eluting coronary stent delivery platforms, including a stent-on-a-wire Integrated Delivery System (IDS) and Rapid-Exchange (RX) platforms. The IDS incorporates Asahi wire tip technology and is designed to optimize transradial (wrist) interventions using a ‘slender’ approach to percutaneous coronary intervention. Svelte says its IDS has the lowest-crimped stent profile on the market, enabling physicians to downsize catheter sizes during procedures. The company plans to commercialize the IDS and RX platforms in Europe in the second half of 2015. Svelte is privately held and headquartered in New Providence, New Jersey. Recent financing will support ongoing operations, infrastructure expansion, and commercialization efforts. Svelte Medical Systems develops highly deliverable balloon-expandable drug-eluting coronary stents and integrated delivery systems. Its core products are the Integrated Delivery System (IDS) and Rapid-Exchange (RX) platforms, which combine wire, balloon and stent into an all-in-one system to reduce procedural steps, contrast use, fluoroscopy time, and adjunctive product costs. The platforms use low-compliant balloon material and proprietary Balloon Control Bands, and employ a bioresorbable drug carrier composed of naturally-occurring amino acids (PEAs) that is resorbed over approximately nine months via enzymolysis to reduce inflammatory response versus PLGA technologies. The company reported 0% clinically-driven MACE in its first-in-man drug-eluting stent study through 20 months. Results from the randomized, controlled DIRECT II study evaluating the IDS to support CE Mark certification will be available later this year. Headquartered in New Providence, New Jersey, Svelte is using recent capital to accelerate regulatory approvals in the U.S. and Japan, enhance operational efficiencies, and augment commercial preparation. Svelte Medical Systems develops low-profile, balloon-expandable drug-eluting coronary stent platforms including a fixed-wire Integrated Delivery System (IDS) and a conventional rapid-exchange (RX) system. Both platforms incorporate the company’s specialized low-compliant balloon with Balloon Control Bands and a high-pressure design intended to facilitate direct stenting and reduce procedure time. Its drug coating uses a bioabsorbable amino-acid-based carrier (PEAs) absorbed over approximately nine months via enzymolysis, which the company says reduces inflammatory response compared with PLGA-based coatings. The company plans commercialization of the IDS and RX platforms in Europe in early 2015 and expects results from the randomized, controlled DIRECT II study next year. Financially, Svelte closed approximately $22 million of new private financing in the latest round, bringing total invested capital to about $65 million since the company’s 2007 founding. Proceeds from the round will be used to complete the DIRECT II study, prepare for European commercialization of IDS and RX, and expand overall operational infrastructure. Headquartered in New Providence, New Jersey, Svelte is positioned to advance its clinical and commercialization milestones with the new capital. Svelte Medical Systems develops the Acrobat drug-eluting stent, now advancing a second-generation design with a low-thrombogenic surface and a dissolving drug coating intended to reduce clotting and inflammatory reactions. The company plans to initiate clinical trials for the new stent in New Zealand, Europe and South America this year and is already conducting a 30-patient trial in New Zealand. The original Acrobat received CE mark approval in Europe in 2010. Svelte has raised about $25 million in debt and equity since December and reported an additional $8 million in new investment in recent Form D filings. The company was founded by serial entrepreneurs Robert Fischell and his sons David and Tim, and is led by CEO Mark Pomeranz, a veteran of Cordis Cardiology at Johnson & Johnson. Svelte plans to expand into the peripheral artery stent market and intends to compete with large medtech firms while navigating a challenging fundraising climate for medical device companies. Svelte Medical Systems develops the Acrobat all-in-one stent system for cardiac procedures. Its first-generation Acrobat received a CE mark in the European Union last year. The company raised $17 million in a Series B round—just under half of a $37 million target—to advance its first- and second-generation stents. Management says the second-generation device will be a drug-eluting version, and the Series B proceeds are intended to support pivotal CE mark trials for that device, expand sales and marketing in Europe, and initiate U.S. clinical trials. Svelte was founded in 2007 in New Providence, New Jersey by serial entrepreneurs Robert Fischell and his sons David and Tim; Mark Pomeranz is CEO. The company plans future expansion into lower-extremity and neurovascular applications and positions Acrobat as a procedure-simplifying technology that reduces steps, costs, and radiation exposure compared with existing approaches. It faces competition from large incumbents including Medtronic, Abbott Laboratories, and Boston Scientific.

Total raised

$84M

Funding rounds

7

Latest round

Equity

Latest activity

Mar 2015