US-based Svelte Medical Systems has raised $22m of new capital to complete DIRECT II study, a pivotal clinical study, and prepare for the European commercialisation of its two drug-eluting coronary stent platforms in early 2015.
Proceeds from this round of financing will also be used to expand overall operational infrastructure.
Along with participation by current investors, the round was led by CNF Investments and New Science Ventures, taking its total raise to approximately $65m since 2007.
Svelte Medical Systems president and CEO Jack Darby said: "There are no products presently in the coronary stent market specifically designed to facilitate the trans-radial approach and direct stenting.
"The low profile of our system, coupled with specialised balloon and drug carrier technologies designed to reduce arterial injury and inflammation, will enhance patient outcomes to address this unmet need."
The company plans to use the amount to complete its DIRECT II study, a randomised, controlled study, which the results of will be released next year.
Svelte Medical also plans to commercialise two drug-eluting coronary stent platforms: a fixed-wire integrated delivery system (IDS), which navigates the vasculature similar to a traditional guidewire, and a conventional catheter-based rapid-exchange system.
IDS’s lowest crimped stent profile is suitable for use with the trans-radial approach, and has even been used in interventions using 4 and 5 French diagnostic catheters.
Both platforms will incorporate the specialised Svelte balloon and drug coating technologies.
It also includes proprietary balloon control band technology (BCBs) providing uniform and controlled balloon growth, even at high pressures, to safely facilitate direct stenting and use of the system for post-dilatation.
The Svelte drug-eluting stent system is designed to couple the benefits of procedural time and cost savings realised through an IDS with the low restenosis rates associated with the latest generation drug-eluting stents.
Non-inflammatory and non-thrombogenic bioabsorbable drug carrier composed of naturally-occurring amino acids (PEAs) offers high mechanical integrity and a reduced inflammatory response compared with competitive (PLGA) technologies.
The drug coating is absorbed over approximately nine-months via enzymolysis (enzymatic digestion), rather than hydrolysis (water-based digestion) to avoid bulk degradation and pH change, two common causes of inflammation and activation of the complement cycle found with current-generation technologies.
New Science Ventures managing partner Somu Subramanium said: "Under the guidance of its experienced management team, Svelte’s highly differentiated technologies present a unique opportunity to significantly impact the very large and well-established coronary stent market."