We are a development stage medical device company focused on developing and commercializing our innovative customizable drug eluting stent systems for the treatment of coronary artery disease, or CAD. Our drug eluting stent systems are designed to enable physicians to customize both length and diameter of the stent at the site of the diseased section of the artery, or lesion, which we refer to as in-situ customization. Our products are designed to treat longer lesions than currently available drug eluting stents and multiple lesions with the use of a single device. Our stent systems, the Custom NX 36 and the Custom NX 60, incorporate a modular cobalt chromium stent design as well as a proprietary delivery system. In addition, our stents have a drug coating that is made up of Biolimus A9, an anti-inflammatory drug, and PolyLactic Acid, a biodegradable polymer, which in combination are intended to reduce the incidence of restenosis, or renarrowing of the previously treated artery over time. We believe our technology, if approved by regulatory authorities will enable us to compete in the approximately $5.3 billion worldwide drug eluting stent market.
Key Financial Data
From inception in June 2002 until the end of Q1, the company spent just under $34 million in operational expenses, with no revenues. OPEX grew from $3.2 to $4.2 million a quarter from Q1 05 to Q1 06. At the end of March, the company had $13 million in cash.
Notable Issues To Watch For
Market Timing: "We cannot market our products in the European Union until we receive a CE Mark or in the United States until we receive premarket approval, or PMA. We do not expect to be able to commercialize our products in the European Union until late 2007 at the earliest, if at all, or in the United States until the end of 2009, if at all."
Dependence on Occam:Occam, a subsidiary of Singaporean Biosensors International, supplies the company with the drug coating for its stents. This is a non-exclusive licensing deal. This drug has not yet been licensed for use in the US or Europe.
Shareholders: There are four VC groups invested in the company: Morgenthaler (28% pre IPO), ATV (16.6%), Latterel Venture Partners (15.6%) and St. Paul VC (15.6%).
Underwriters: Piper Jaffray, Cowen & Co., Lazard Capital Markets, RBC Capital Markets.
Offering Details: Raising up to $103 million to fund clinical trials (approximately $20 million), R&D (approximately $20 million), building out infrastructure (approximately $30 milion) and general corporate purposes.