TYRX has a novel device - an antibiotic-impregnated envelope designed to prevent infections in CRM implants - that could create signifcant opportunities, not just for itself, but also for large CRM companies looking to differentiate their devices in a flat, crowded market. Convergence has fallen on hard times recently, but TYRX hopes to succeed where others have failed by stripping risk out of drug/device convergence.
TYRX: Is This the Model for Drug/Device Convergence?
Article preview from IN VIVO- May, 2010
TYRX has a novel device to prevent infections associated with CRM implants, built on a proprietary polymer and antibiotic cocktail. And there are other applications for the technology in cosmetic surgery and treating surgical site adhesions.
The company's rapid progress toward commercialization was built on an opportunistic 510(k) strategy, and with 510(k) reform imminent, that regulatory strategy has likely created high barriers to entry for any company hoping to follow. TYRX is hoping to find gold where few device companies have to date – in the field of drug/device convergence, with a platform technology that has multiple applications.
But TYRX's success will come from building its own blockbuster products, but by creating value of some very large and very mature product lines – in effect, a scaled back drug/device convergence.
In the early 2000s, there was, arguably, no hotter topic in medical devices than drug/device convergence. Riding the great success of drug-eluting stents, which were creating the first multibillion dollar product lines in devices, everyone wanted to figure out how to combine drugs and device technology to create products with enhanced therapeutic benefit.
But who talks much about convergence anymore? By the late 2000s, the enthusiasm around convergence had clearly begun to wane. The great debate and controversy over the role drug-eluting stents play in late stent thrombosis – a debate which arose in 2006 and was all but over two years later – wasn't so much the cause of the disenchantment as a kind of denouement of convergence's hyped potential.
Indeed, even before the controversy hit, many device executives – and in the case of start-ups, the VCs that backed them – had begun to see the dark side to convergence's enormous promise. Steep development costs, difficult regulatory cycles, and a cultural struggle with the drug component of combination products made the small, but potentially powerful, clinical risks of convergence products pale by comparison.
As the scales fell from their eyes, more than a few device executives had come to believe that the risk/reward of convergence products was more about risk than reward – that the blockbuster potential was too elusive. But maybe the problem with early convergence products was that they dreamt too big – maybe the real opportunity lay in the capacity of drug combinations not to create compelling new products, but to help established products perform better. That is the bet made by New Jersey-based TYRX, developers of an innovative anti-infective device that is being applied first to the cardiac rhythm management (CRM) market. TYRX's products, valuable though they are, may never be blockbusters in their own right. But that doesn't mean they can't create a lot of value for TYRXs partners and investors.
A Lesson LearnedTYRXwas founded just over a decade ago, based on some research done by Joachim Kohn, PhD, a scientist teaching at Rutgers University in New Jersey, which resulted in the development of a modified polyester based on the amino acid tyrosine, known as polyarylate, which showed some unique properties in its ability to serve as a medium for drug delivery or release. Rutgers eventually licensed Kohn's technology to a group of angel investors, led by Arikha Moses, PhD, one of TYRXs founders and the company's current CSO.
Though TYRX's focus today is on cardiovascular markets, specifically implantable devices used in cardiac rhythm management, the company's first target was surgery and, specifically, the pain and infection that are common post-operative morbidities. But in looking for early licensing partners, TYRX officials struck a deal with Boston Scientific Corp. which saw a potential application using the TYRX technology to address the risk of late stent thrombosis (LST) associated with drug-eluting stents. "There was some thought that the problem was the non-resorbable [drug] carrier which makes it difficult to predict how long it would take for the drug to be fully released from the stent," recalls William McJames, TYRX's VP of product development.
Even before the LST controversy that erupted at the European Society of Cardiology meeting in 2006 – TYRX's licensing deal with BSC was an exclusive deal signed in 2005 – researchers at drug-eluting stent companies, BSC and others, had begun to worry about a correlation between the incidence of LST and the degradation of the polymer – especially since most interventionalists were limiting their patients' anti-platelet regimen to six months. "Boston came to us and said, 'We want you to match the release curve of the paclitaxel on our current product, but we want the polymer carrier to be gone in six months,'" notes McJames. "We developed a library of around 100 different variants of the original tyrosine polyarylate from which BSC selected several for animal testing, some of which generated positive data out to one year." But when Boston Scientific in 2007 acquired Guidant, the TYRX program fell by the wayside, along with a host of other similar programs Boston had taken on over the previous several years.
- David Cassak
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