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Cardiac Gene Therapy: Combination Products' Next Frontier?

This article was originally published in Start Up

Executive Summary

Orthopedic biomaterials and drug-eluting stents are only the first hint at the potentially transforming nature of combination products: device/biologic combination products that may bring a revolution to clinical therapy and to the device industry. In vascular medicine, catheter-based delivery of cardiac gene therapy may become a significant advance, yet with scant clinical evidence of efficacy and only anecdotal physician experience using catheter delivery systems, the field remains all promise. Many device executives think they see a path emerging, largely due to fundamental changes in the dynamics of their industry that are moving device business models closer to that of their pharma industry cousins.

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In Cardiac Regeneration, it's Repair, not Replace

Recent clinical trial failures in cardiac stem cell therapies have been widely reported as raising more questions than answers in a field which already had many unknowns. But those questions themselves give rise to new strategies spurring the formation of start-ups like those profiled in this issue. While the new companies are ultimately addressing heart failure, they hope to intervene much earlier in the cascade of damage and remodeling, where turning up the body's natural healing responses a notch could help it repair the damage caused by myocardial infarction or ischemia. Many cardiac cell and gene therapy companies are returning to ischemic disease, a field in which, in recent years, the success of device-based revascularization techniques appeared to present a competitive hurdle to cell and gene therapies. Microvessel disease is emerging as a large market in which cell and gene therapies might have advantages over devices.

Convergence: What's Next at the Nexus?

Convergence is the great hope of pharmaceutical and device companies hoping to enter into new high growth markets with differentiated products. Drug-eluting stents turned a stagnant product into a thriving $6 billion market, and now companies are trying to find the next large opportunity that combines devices and drugs. They're looking at many kinds of implantable devices that incorporate biomaterials and drugs to achieve site specific drug delivery, in cardiovascular disease, peripheral vascular disease, ophthalmology, orthopedics, wound healing, and anti-infection.

After Drug-Eluting Stents: Making the Heart Smaller and the Market Larger

According to a recent report by Windhover/Medtech Insight, "Emerging US Markets for Myocardial Revascularization, Repair, and Regeneration Products and Technologies," drug-eluting stents achieved sales of $1.2 billion in 2003, and sales are expected to continue to grow at a compound annual rate of 27.5% to $4.1 billion in 2008. But revascularization technologies are only one category that offer grwoth opportunities for medtech companies. Another group of players hopes to address patients trending towards heart failure, as a result of heart scar formation or the death of heart muscle cells following a heart attack. New devices and device-enabled products have the potential to intervene in both of these structural processes in ways that existing heart failure drugs, which are merely palliative, can't. Medtech estimates that two strategies-cell therapies for heart muscle regeneration and remodeling devices for the heart--will serve a market that could grow to almost $190 million by 2008.

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