[nanoPost] Passive, nano-film hydroxyapatite coating

Company Canada

Nano-film Coating Technology

The Company’s lead product in development is a passive, nano-film hydroxyapatite coating.  In parallel, the Company is developing a multi-layer nano-film coating with drug-eluting capabilities to facilitate therapeutics and treatments for localized drug delivery systems.

The coating is naturally found in bone and tooth enamel and is rapidly integrated into the human body.  Numerous results from clinical tests and surgical practice have shown that in addition to its demonstrated biocompatibility, this new generation of advanced biocompatible coatings is non-toxic and does not induce thrombogenicity, allergic or inflammatory reactions, therefore making it a potentially solid candidate as a coating for coronary stents and other implantable medical devices.

The coating technology has demonstrated that it can meet the stringent technical requirements for use on cardiovascular stents.  The coating technology has successfully progressed through a comprehensive range of animal and mechanical trials required for CE Mark and FDA approvals in both Europe and the US. 

These include thrombogenicity (blood clotting), cytotoxicity, and demanding fatigue life testing for its nano-film coated coronary stent. The results support the expectation that the HAp-coated stent may be considerably safer than currently available bare stents.

Drug-Eluting Stents
 

Since patients receiving stents remain at risk for the aforementioned problems, doctors continue to explore more efficient and longer-lasting stenting solutions. One of the more effective methods involves employing stents that are covered with medicines that can be released once inside the body.  These are called drug-eluting stents.

The company appears to be in a solid position to enter the lucrative drug-eluting stent market using two product development approaches:

Nano-film coating with sufficient capacity to carry adequate quantity of anti-inflammatory drugs, which can reduce post-procedural trauma; and

Porous coating, which is in an advanced development stage and can be loaded with considerable quantity of drugs, including anti-inflammatory, immune system depressants, or with the new generation of antithrombotic and/or antirestenotic drugs.

This technology has applications in cardiovascular and non-cardiovascular drug/device combination products, including peripheral stents, biodegradable implants, gene therapy, and delivery systems for release of chemotherapeutic agents.

Drug-eluting stents countermeasure post-deployment inflammatory reactions and considerably reduce the incidence of restenosis to only approximately 8% from 25% with bare stents. Drug-eluting stents have become, after approximately one year on the market, the most widely used modality for coronary revascularization. This has resulted in a paradigm shift in clinical practice that has quickly become the standard of care, despite the fact that drug-eluting stents cost approximately $2,600—three to four times the price of a bare metal stent.

Market Opportunity
 

The nano-film coating technology has been developed to offer an attractive alternative to the bare-metal stent and should provide significant benefit to those who cannot afford drug-eluting stents.  The passive nano-film coating has the capacity to carry sufficient anti-inflammatory drugs, which can reduce post-procedural trauma.

The Company’s second product candidate, the multi-layer stent coating, is being developed to treat cardiovascular disease with an emphasis on inhibiting restonosis as well as localized drug delivery to other diseased organs of the body.  The multi-layer, porous coating can be loaded with considerable amounts of drugs including anti-inflammatory, immune system depressants or with anti-thrombotic and/or antirestenotic drugs.  The proprietary drug-eluting coating technology is natural in composition and has the potential to become the coating of choice for drug delivery systems on medical devices.

Coronary stenting is a key component of interventional cardiology.  This is a rapidly growing clinical specialty and one characterized by the ready adoption of new products. The coronary stent market recorded worldwide sales of USD$3 billion in 2003 and is estimated to show significant growth from the introduction of drug-eluting stents, with sales reaching USD$7 billion in 2007.  

Additionally, through the diversification of its product/technology portfolio, the company hopes to also capitalize on new applications of its technology in order to access the USD$200 billion market of drug/device combination products.  The market for drug-eluting stents is one of the fastest growing segments within the medical device arena, with annual growth approaching 25%.

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