DES are to BMS as BMS were to PTCA alone

Translation:  Drug-eluting stents are to bare metal stents as bare metal stents were to percutaneous transluminal coronary angioplasty alone.

In the September 1 post on the meta-analysis by researchers at Tuft Medical Center, we noted the overall findings in general terms of the value of drug-eluting stents compared to bare metal stents.  It is worthwhile to provide the slightly more detailed conclusions of the authors:

"As a new technology, drug-eluting stents have now emerged as an important innovation in reducing coronary restenosis. To provide a precise estimate of their clinical benefit and to explore sources of statistical heterogeneity, we performed a meta-analysis of randomized controlled trials involving currently available drug-eluting stents using a DerSimonian and Laird random effects model. Our meta-analysis found no significant reduction in mortality or MI-free survival from the use of drug-eluting stents. However, drug-eluting stents clearly reduced the risk of restenosis by 23% and the risk for target lesion revascularization by 11% in the primary analysis. This is similar in magnitude to the benefit found for stents compared to balloon angioplasty. The need for revascularization after DES was 3.7% that is similar to the 3.8% observed after coronary artery bypass grafting and much lower than the 21% with bare-metal stents."

I have engaged in debate (I might actually call it "baiting") wtih those who have instead favored coronary artery bypass graft (CABG) surgery, which I view as a waning procedure compared to percutaneous methods (like angioplasty with stenting) that revascularize with minimal trauma to achieve clinically competitive outcomes.   I would argue that the most minimally invasive procedure is ultimately likely to resemble a percutaneous one anyway.  Indeed, if one were to project the future evolution of CABG, it would traverse a course from thoracotomy to endoscopy (thoracoscopy) to an intraluminal procedure (which garners negative feedback from surgeons; but, of course, when speaking with surgeons, I expect their answers to be geared toward the scalpel).

By comparison, drug-eluting stents are on a course toward an analogously less invasive option, which I envision as first, atherosclerosis-reducing drugs and, probably ultimately, gene therapy that preemptively addresses the incidence of atherosclerosis.  Right now, that is fantasy, but not by much.


See also the MedMarket Diligence report #C245 on the global market for coronary stents. 

Worldwide Wound Management, 2009-2018

Wound management demands globally are as considerable as the range and diversity of therapeutic options to deal with them. Surgical, traumatic, burn, ulcer and other wound types are highly prevalent, growing in caseload and expensive when they fail to promptly heal.  epidermisNew products are steadily impacting the market, while development continues on many fronts including novel wound closure, debridement, dressings, physical therapies and others. MedMarket Diligence's 2009 report, "Worldwide Wound Management, 2009-2018:  Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World" (see link) is a thorough analysis of the current and forecast market for these products. 

See report description:

This report details the complete range of products and technologies used in wound management and wound care, from dressings, bandages, hydrogels, tissue engineered products, physical treatments and others. The report details current clinical and technology developments in this huge worldwide market with high growth sectors, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. (Continued at link.)

Drug/coating alternatives in drug-eluting stent development

In spite of arguments contesting whether bare metal or drug-eluting stents perform better, drug-eluting stents are here to stay and are still used in the majority of stent implantations. In fact, a plethora of studies have shown that DES can improve mortality rates and reduce the need for target vessel revascularization (TVR) compared with BMS.

In the largest study of its kind, researchers at Duke University Medical Center (DUMC) found that the clinical outcomes for DES patients were significantly better than for BMS patients. The researchers, led by Pamela Douglas, MD, compared outcomes in older individuals receiving DES and BMS as part of the American College of Cardiology’s National Cardiovascular Data Registry. (The study was also supported by the Agency for Healthcare Research and Quality.) The registry tracked 262,700 patients in 650 registry sites in 2004 through 2006 with procedural registry data linked to Medicare claims for follow-up. DES were implanted in 217,675 patients and BMS were implanted in 45,025 patients. The DES patients saw lower unadjusted rates of death (12.9% vs. 17.9%), MI (7.3 per 100 patients vs. 10.0), and revascularization (23.0 per 100 patients vs. 24.5) with no difference in stroke or bleeding. The results were obtained after 30 months of follow-up and across all pre-specified subgroups. The results were published online by the Journal of the American College of Cardiology (doi:10.1016/j.jacc.2009.03.005, March 28, 2009).

Drugs, coatings and other areas of focus in drug-eluting stent development are many, with multiple companies pursuing  the same or similar approaches.  There are also a wide number of unique directions being taken.

Below is a sampling of the drug/coating efforts in drug-eluting stent development: 

  • 17-beta-estradiol
  • 17-ß-estradiol (XC-121)
  • AVI-5126 (CoCr)
  • Biolimus A9
  • Deforolimus
  • Dexamethasone
  • “Drug X”
  • Dual drug: zotarolimus and dexamethasone
  • Everolimus
  • Genistein-sirolimus
  • Heparin-sirolimus
  • Melatonin/paclitaxel combination
  • Myolimus
  • Novolimus
  • Paclitaxel, bifurcation
  • Paclitaxel, rapamycin (cobalt base)
  • Paclitaxel, second generation
  • Paclitaxel, third generation, platinum chromium alloy
  • Pericardium covered stent
  • Pimecrolimus
  • Pimecrolimus bioabsorbable, CoCr
  • Pimecrolimus; biodegradable, absorbable
  • Polymer coated
  • Polymer drug delivery system
  • Rapamycin
  • Rapamycin with biodegradable polymer coating
  • Sirolimus
  • Sirolimus (CoCr)
  • Sirolimus with biodegradable coating
  • Sirolimus with biodegradable polymer coating
  • Sirolimus; bioabsorbable polymer
  • Sirolimus; biodegradable to bare metal
  • Tacrolimus
  • Tacrolimus with biodegradable polymer coating
  • Tretinoin
  • Undisclosed antiproliferative
  • Undisclosed drug, biodegradable, absorbable
  • Undisclosed; polymer-coated
  • Voclosporin
  • Zotarolimus

The status of product, company, technology and market development of drug-eluting stents (and all coronary stent types) are the subject of the May 2009 report by MedMarket Diligence.  Report #C245.

Medical Devices, Other Healthcare Driving VC Investment

According to Dow Jones VentureSource data on second quarter 2009 venture capital investment, medical devices and biopharmaceuticals are driving a boost in VC investment to $5.27 billion. While this is still down from 2Q 2008 levels, it is a 32% increase over the first quarter of 2009. From the Dow Jones VentureSource press release:

Health Care Investment Outpaces IT for First Time

According to VentureSource, the Health Care industry saw $2.23 billion invested in 184 deals completed in the second quarter of 2009, a 14% decline from a year ago when $2.60 billion was put into the same number of deals. This marks the first time on record that health care investment outpaced investment in Information Technology, which attracted $1.88 billion in the second quarter.

"Health care investment was the only sector to spring back to levels seen before the economic meltdown that began in the third quarter of 2008," said Ms. Canning. "The recovery in the biopharmaceutical and medical device sectors is driving the rebound in overall venture investments this quarter."

By sector, biopharmaceutical investment slipped 14% from $1.42 billion in 85 deals in the second quarter of 2008 to $1.22 billion put into 71 deals in the most recent quarter. Investment in medical device companies fell 26% from the $1.04 billion put into 77 deals last year to $766 million invested in 79 deals in the most recent quarter. These declines were offset somewhat by a strong quarter in the health care services sector, in which investment nearly tripled from a year ago to $145 million.

In the medical device sector alone, MedMarket Diligence has tracked over $300 million invested in July to date. See July 2009 medtech investment.

More funding added to the “equity overhang”

Foundation Medical Partners announced this week that it has raised $58.6 million toward a planned goal of $150 million for its Foundation Medical Partners III fund.   The fund invests in medical device, biopharmaceutical and predictive medicine technology sectors.

As we previously noted in "equity overhang", there is now an aggregate of approximately of $400 million raised by venture capital but not invested, while VCs (I can only presume) carefully monitor the economy, evaluate market conditions or otherwise delay their decisions to make active investments with the funds raised.  While some of that $400 million may have already been invested (indeed, see month-to-date specific medtech financings for June 2009), the new funds raised by Foundation and others subsequent to the equity overhang assessment (June 2, 2009) contribute to a large pool of funds that seed, startup, early and later stage medtech companies are clearly anxious to get their hands on during the curent cash-restricted climate. 

Nonetheless, it is encouraging to see that funds can be raised at this time and at this level.  It will be further encouraging when the funds are actually invested in those companies.