Biocoatings: Not Just the Icing on the Cake

The successful commercialization of drug-eluting stents (DES) has done much to pave the way for the biocoating industy. DES not only helped establish a new regulatory body to facilitate device-drug reviews, the FDA Office of Combination Products, they also proved that biocoated devices could take market share from uncoated products, command premium pricing and premium reimbursement.

Ten years ago, SurModics Inc. , one of the few sizeable "pure play" companies in the biocoating field with revenues of just abut $5 million after 15 years in business, was regarded as one of those rather prosaic industrial service kinds of company, providing chemistry services to the medical device industry. But in the past five years, the company has gone public, raising $17.25 million in 1998 [See Deal], and has enjoyed exponential sales and profitability growth. Sales have risen from $13.5 million in 1999 to $43 million in 2003. What happened? SurModics was the manufacturer of the coating for the first drug-eluting stent to hit the market—the Cypher stent of Johnson & Johnson 's Cordis Corp. division.

The clinical success of drug-eluting stents—it's tough to beat zero percent restenosis—has translated into business success. Johnson & Johnson was able to capture market share, command premium pricing for its drug-coated version of an older product, and even get premium reimbursement. Now, no stent company wants to be without a program in drug-eluting stents, and that goal has driven a spate of dealmaking around what was formerly the little-recognized biocoating segment of the medical device industry. Medical device companies that once either turned to their in-house R&D departments to tinker with biocompatibility, or for specialized applications went to the four bigger players in the field (which, besides SurModics, include Biocompatibles International PLC,Carmeda AB and AST Products Inc. ) have been increasingly turning to small companies with specialized expertise in coatings that can serve as an interface between devices and drugs. In less than a year, Guidant Corp. has spent more than $84 million to acquire the everolimus-eluting stent assets from Sun Biomedical Ltd. 's Biosensor International Pte. Ltd

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By 

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By 

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By 

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

More from Medtech Insight

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By 

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.