The Development of Next-Generation Drug-Eluting Coronary Stents

Coinciding with the BIO International Convention held in San Diego CA, NanoInterventions introduces the "Mouse Stent Model" for rapid screening of new coronary stent therapeutics. The model, complete with a mini-stent of spectacularly small size and its ability to replicate the human diseased vessel, represents a new starting point in the development of next-generation drug-eluting coronary stents. The company, NanoInterventions, emerged from the strategic global partnership of Minnesota-based The Integra Group of Brooklyn Park and Nanocopoeia of St. Paul, along with Stentome, with operations in Palo Alto CA, Galway, Ireland and Oxford, UK, and the University of Western Ontario, in London ON.

The Twin Cities is already home to two of the three largest stent manufacturers and one of the largest clusters of medical device companies in the world. With its local headquarters and base of operations, combined with its global network of partners, NanoInterventions is ideally positioned to speed the development of these life saving devices. The new starting point for testing new stent-delivered therapies brings the customer many novel benefits, including: establishing efficacy much earlier in the process, speeding development-the experimental model requires 28 day cycle versus a 180 day average cycle-and exploring molecular mechanisms of action in the setting of a stented, diseased vessel. NanoInterventions' managing partner, Robert A. Hoerr, MD, PhD, who is Nanocopoeia's CEO, stated, "Our position within the heart of Minnesota's world-class medical device community enabled us to build strategic relationships with the talent and technology needed to launch this new development pathway for therapeutic coronary stents. We fully expect that our position at this new starting point for stent development will create a family of new, high-value cardiovascular devices."

The Mouse Stent Model is a fast, predictive model of how a new therapeutic will affect the diseased human artery when implanted as part of a drug-eluting stent. This high-throughput system provides the ideal method to screen therapeutic leads advancing from pharmaceutical and biotech companies as well as university laboratories. Many of these have not had ready access to the specialized tools or expertise needed to evaluate the potential value of their leads for interventional cardiology applications.

The market release coincides with BIO, because the biotech and pharmaceutical companies participating in the international meeting this week in San Diego, CA represent ideal users of the new testing model. NanoInterventions can assist BIO community stakeholders assess the potential value of their therapeutic discoveries for device-delivered treatments and chart a path for further development, thereby enhancing the value of their intellectual property and creating a justification for the later, more costly development program required to advance a cardiovascular combination device toward regulatory approval -- and potentially licensing rights to or selling the newly enhanced asset.

The wide-ranging expertise within the Minnesota-based partnership can guide combination drug/devices from concept through clinical trials and regulatory approval. The Integra Group anchors the development operations with its extensive experience in early stage cardiovascular research and managing complex development programs, beginning with non-human testing and extending to approval-pathway clinical trials. Nanocopoeia, an innovator in producing nanoengineered drug coatings for medical devices, incorporates the candidate drugs or biologics into the mini-stent coating. Coating the mini-stent is a special challenge for which its ElectroNanospray(TM) process is uniquely suited. Stentome, a partnership of cardiovascular scientists and bioengineers, led design of the mini-stent developed its current microfabrication process in Galway; and devised the complex surgical procedure for implanting the stent. Its scientific team contributes cutting edge expertise in cardiovascular medicine and molecular biology derived from ongoing, active research programs at Oxford and Stanford Universities. The University of Western Ontario, one of Canada's leading research-centered universities, contributes its robust drug-eluting polymer platform, which can be flexibly configured to deliver a broad range of drugs and biologics.

"We are thrilled to bring our operational and regulatory development expertise to this exciting venture and helping to establish it as a key new tool for the medical device, pharma/biotech and academic communities," commented Chris Pulling, CEO of The Integra Group. "NanoInterventions' synergistic technology and core competencies of research and engineering will save time and resources to bring more affordable, life-saving therapies to our health care system."

NanoInterventions is a featured company in the Positively Minnesota pavilion in the BIO International exhibition hall, from June 17-20, 2008.

For more information on this partnership or the medical device development process in general, please contact Ottar Schmitz at (763) 746-8899.

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