MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) today announced that it has completed the purchase of rights to a chitosan-dextran gel technology from Adelaide Research & Innovation Pty Ltd. (the commercial development company of the University of Adelaide) in Australia, Robinson Squidgel Ltd., and Otago Innovation Ltd. (a University of Otago company) in New Zealand. Medtronic is acquiring this technology for potential use in developing future products for functional endoscopic sinus surgery (FESS).
“The chitosan-dextran gel technology would enhance Medtronic’s ability to offer innovative, therapeutic products for sinus surgeons to use in postoperative patient care”
More than 525,000 FESS procedures are performed annually in the US.1 The most common complications are bleeding and adhesions,2,3 which are scars that can form at the surgical site as sinus tissues heal after FESS. These adhesions can block the sinuses, potentially causing disease to recur and requiring additional surgery.
The innovative chitosan-dextran gel has been shown in animal studies to provide hemostasis (control of bleeding) and aid in wound-healing after FESS.2 Additionally, a human trial demonstrated that the chitosan-dextran gel resulted in rapid hemostasis immediately after FESS and fewer postoperative adhesions.3
Chitosan is a polymer produced from the chitin of shellfish and squid. Its powerful hemostatic properties have been extensively studied,2-10 leading to its use in a hemostatic bandage distributed to all deployed US soldiers in Iraq and Afghanistan.11
“The chitosan-dextran gel technology would enhance Medtronic’s ability to offer innovative, therapeutic products for sinus surgeons to use in postoperative patient care,” said Mark Fletcher, president of the ENT division of the Surgical Technologies business of Medtronic. “As a leader in the FESS market, we’re pleased to have the opportunity to expand our FESS product portfolio.”
Sunday, February 27, 2011
Tuesday, February 22, 2011
Detect Patients Whose Heart Grafts Are Most Vulnerable to Clogging Soon After Bypass
A team of heart experts at Johns Hopkins has found that dual lab tests of blood clotting factors accurately predict the patients whose blood vessels, in particular veins implanted to restore blood flow to the heart during coronary artery bypass grafting (CABG), are more likely to fail or become clogged within six months. One test gauges the speed of blood platelet clumping and the other measures the level of a clumping chemical byproduct.
Researchers say the danger from such treatment failures following CABG is that the heart can return to its original state of having an insufficient blood supply. Chest pain and other symptoms may return, upping patients’ chances of requiring further surgery to bypass the newly clogged arteries or angioplasty to widen them.
Reporting in the March 1 edition of the Journal of the American College of Cardiology, the Johns Hopkins team found that a commercially available test of how fast blood-clotting platelets actually clump together, called PFA-100, reliably predicted vein graft failure in 229 people from the mid-Atlantic region who had had CABG performed within the previous six months at any one of four different hospitals. Those who ranked in the quarter with the slowest blood-clotting times had an 11 percent vein graft failure rate, while those whose blood clotted fastest had a 28 percent risk.
Tests of another highly reactive chemical whose action is normally suppressed by aspirin, urinary 11-dehydro-thromboxane B2 (UTXB), were equally linked to vein graft failure. The quarter of study participants with the lowest amounts of UTXB had a 12 percent likelihood of one or more veins occluding, while in the quarter with the highest amounts of UTXB, the rate was 29 percent.
When results of both tests were combined, patients with the “most-sticky” platelets and highest UTXB levels had a nearly sevenfold increased risk of vein graft failure, compared to those who had the “least-sticky” platelets and lowest UTXB levels.
“Now we have a particularly useful series of tests to help physicians identify patients at high risk who really need closer follow-up to check for potentially clogged grafts,” says study senior investigator and interventional cardiologist Jeffrey Rade, M.D.
The team’s ultimate goal, however, he says, is to use these tests to help develop replacement or add-on treatments to daily doses of blood-thinning aspirin, the current mainstay for warding off clot formation and subsequent vein graft failure.
According to Rade, an associate professor at the Johns Hopkins University School of Medicine and its Heart and Vascular Institute, these two tests offer physicians new tools for early detection of bypass patients at greatest risk of vein graft failure, giving them advance warning and, potentially, buying time to try drug or surgical therapies that might either slow down or reverse the narrowing and buildup of plaque and dead cells inside the grafted vein.
He says previously known risk factors were the size of the vein to be bypassed, with veins smaller than 1.5 millimeters having twice the failure rate of larger veins, and, similarly, vein grafts with slower blood flow having a two to three times greater likelihood of failing.
In CABG, blood vessels from other, readily accessible parts of the body, usually the chest wall or leg, are removed and re-attached to the heart to restore open blood flow, rerouting blood to avoid arteries blocked by underlying coronary artery disease.
Some 448,000 CABG procedures were performed in the United States in 2006, the last full year for which estimates are available. Nearly all patients took daily doses of the blood-thinning drug aspirin to prevent subsequent blood clots.
And the chances of vein graft failure need to be taken seriously. The researchers say that despite such treatment, one-third of study participants had completely occluded or blocked veins within six months of their bypass surgery.
“These numbers are extremely valuable and show us that we have to continue to work to make an already effective surgery even better,” says study co-investigator and cardiac surgeon John Conte, M.D.
Moreover, Conte notes, 19 percent of all vein grafts were completely occluded in study participants after six months, though the vast majority had no symptoms of heart failure, such as chest pain and shortness of breath, to indicate that something was wrong.
“Eventually,” says Conte, a professor at Johns Hopkins, where he is also director of the heart and lung transplantation programs at The Johns Hopkins Hospital, “pre-bypass tests may determine that some at-risk patients are better having only arterial grafts instead of vein grafts, or drug therapy without surgery, or more aggressive angioplasty instead of more bypass surgery.”
Conte says the team’s next steps are to perform both tests before patients undergo bypass surgery and to assess whether subsequent treatment helps people live longer. Plans are also under way to examine any factors that might boost or lower UTXB levels, and lower a patient’s vulnerability.
The Hopkins scientists pursued the study because aspirin is widely used and known to cut in half any risk of vein graft failure after CABG, and they wanted to assess what role, if any, aspirin resistance might play. To their surprise, aspirin resistance was quite rare, in less than 1 percent of study participants six months after surgery. So, they decided to investigate other aspects of platelet function, including thromboxane production, to see if there was any other chemical connection to vein graft failure. In all, the latest study tested nearly a dozen chemical factors involved in platelet function.
As part of the so-called Reduction in Graft Occlusion (RIGOR) study, each participant had their blood tested before and immediately after bypass surgery. Some 368, mostly men, were enrolled in the study, which took place from 2003 to 2006. Blood testing was repeated in those who survived past six months. Study participants, whose ages ranged between 34 and 88, also had an advanced CT scan, using a 64-CT multi-row detector scanner that can produce clear images of the tiniest blood vessels, letting researchers measure the extent of any blockages.
Funding support for the study was provided by the Johns Hopkins General Clinical Research Center; the National Institutes of Health Institute for Clinical Translational Research; Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership, of Bridgewater, N.J., the manufacturer and distributor of Plavix, a clot-busting drug; and by AstraZeneca, of Wilmington, Del., the manufacturer of Brilinta, another anti-clotting medication. Additional study support came from Siemens Healthcare Diagnostics, of Deerborn, Ill., which provided the PFA-100 testing kits used in the study, and from GlaxoSmithKline, of Research Triangle Park, N.C., the maker of enteric-coated aspirin.
Besides Rade and Conte, other Hopkins researchers involved in the study were Tyler Gluckman, M.D.; Jodi Segal, M.D., M.P.H.; Steven Schulman, M.D.; Edward Shapiro, M.D.; and Thomas Kickler, M.D.
The four hospitals that participated in the study were The Johns Hopkins Hospital in Baltimore, Md.; Christiana Hospital in Christiana, Del.; Peninsula Regional Medical Center, in Salisbury, Md.; and Walter Reed Army Hospital, in Washington, D.C.
For additional information, please go to:http://www.hopkinsmedicine.org/
Cryolife Q4 - Upbeat news for shareholders 10 people in the EU until 2013 to carry Medafor Divorce, Perclot-China marriage and Bioglue EU IP
Product revenues which consists primarily of BioGlue and HemoStase increased 4% in the fourth quarter and full year of 2010 compared to the corresponding periods in 2009. For the three month and full year periods HemoStase revenue increased partially offset by a slight decrease in BioGlue revenues. Fourth quarter of 2010 also included $264,000 of PerClot revenue as we began to roll out PerClot in international markets.
Total gross margins were 60% for the fourth quarter of 2010 compared to 61% for the fourth quarter of 2009. Total gross margins excluding the write off of $1.6 million for the HemoStase inventory were 60% for the full year of 2010 compared to 62% in the full year of 2009. Preservation services gross margins for the fourth quarters of 2010 and 2009 were 39% for each period and 40% in the full year of 2010 compared to 42% in the full year of 2009.
Product gross margins for the fourth quarter of 2010 were 80% compared to 82% in the corresponding period in 2009. Product gross margins excluding the write down of $1.6 million of HemoStase inventory were 81% in the full year of 2010 compared to 83% in the full year of 2009. General administrative and marketing expenses for the fourth quarter of 2010 were $12.2 million compared to $12.6 million for the fourth quarter of 2009. These expenses for the fourth quarter of 2010 included approximately $474,000 in costs related to business development activities and $268,000 in costs related to our litigation with Medafor.
General administrative and marketing expenses for the full year of 2010 were $49.1 million compared to $50 million for the full year of 2009. The full year of 2010 included a charge of approximately $1.4 million in costs related to our litigation with Medafor $1 million related to business development activities and $729,000 related to the write off of capitalized legal expenses associated with our BioGlue intellectual property rights in Germany.....
Raymond Myers – The Benchmark Company
Okay. Good. When were you targeting PerClot approval and launch?
Product revenues which consists primarily of BioGlue and HemoStase increased 4% in the fourth quarter and full year of 2010 compared to the corresponding periods in 2009. For the three month and full year periods HemoStase revenue increased partially offset by a slight decrease in BioGlue revenues. Fourth quarter of 2010 also included $264,000 of PerClot revenue as we began to roll out PerClot in international markets.
Total gross margins were 60% for the fourth quarter of 2010 compared to 61% for the fourth quarter of 2009. Total gross margins excluding the write off of $1.6 million for the HemoStase inventory were 60% for the full year of 2010 compared to 62% in the full year of 2009. Preservation services gross margins for the fourth quarters of 2010 and 2009 were 39% for each period and 40% in the full year of 2010 compared to 42% in the full year of 2009.
Product gross margins for the fourth quarter of 2010 were 80% compared to 82% in the corresponding period in 2009. Product gross margins excluding the write down of $1.6 million of HemoStase inventory were 81% in the full year of 2010 compared to 83% in the full year of 2009. General administrative and marketing expenses for the fourth quarter of 2010 were $12.2 million compared to $12.6 million for the fourth quarter of 2009. These expenses for the fourth quarter of 2010 included approximately $474,000 in costs related to business development activities and $268,000 in costs related to our litigation with Medafor.
General administrative and marketing expenses for the full year of 2010 were $49.1 million compared to $50 million for the full year of 2009. The full year of 2010 included a charge of approximately $1.4 million in costs related to our litigation with Medafor $1 million related to business development activities and $729,000 related to the write off of capitalized legal expenses associated with our BioGlue intellectual property rights in Germany.....
Raymond Myers – The Benchmark Company
Okay. Good. When were you targeting PerClot approval and launch?
Steve Anderson
I think that PerClot’s approval will be sometime towards the end of 2012 or early 2013 the clinical study that we are going to run is includes about 300 patients and will be across a number of different specialties for a number of different indications. But I would say the soonest we could get it done at the end of 2012 probably a more timely expectation is early 2013.
Raymond Myers – The Benchmark Company
And that’s for approval or for finishing this study.
Steve Anderson
That’s approval.
Raymond Myers – The Benchmark Company
And so well let’s start with the study through this to finish the 300 patient study if you would follow your IDE at the end of March when do you think you can finish the study.
Steve Anderson
It will go pretty quickly but I don’t think that we would be finished with the 300 patient enrollment until fourth quarter of 2011.
Raymond Myers – The Benchmark Company
And that leaves about a year for FDA is that your thought?
Steve Anderson
Yeah.
Raymond Myers – The Benchmark Company
Great, your HemoStase revenue was quite strong in the fourth quarter is that related to winding down the sales and a desirable push out the last of your inventory before you can’t sell it anymore or does that more represent underlying strength in the market.
Ashley Lee
I think it represents both you know I mean you know this full area of powdered hemostatic agents is rolling and that’s why we’ve made the commitment to be in it long-term with the acquisition of the PerClot distribution rights and at the same time you know as you mentioned we do have some inventory that we are trying to sell prior to our discontinuing distributing HemoStase which is going to be in late March so it’s a combination of both.
Raymond Myers – The Benchmark Company
So should we expect similar sales on Q1 as if we saw in Q4.
Ashley Lee
For HemoStase.
Raymond Myers – The Benchmark Company
Yeah.
Ashley Lee
No.
Raymond Myers – The Benchmark Company
Lower, higher?
Ashley Lee
That would be lower than the fourth quarter of 2010 and I think that our guidance for again for the full year for all powdered hemostats is between $4 million and $6 million.
Raymond Myers – The Benchmark Company
Okay, and is some of the HemoStase that you might be selling in Q1 product that is already written off?
Ashley Lee
Potentially.
Raymond Myers – The Benchmark Company
So there could be a potential of a reversal of the prior charges?
Ashley Lee
I wouldn’t say a reversal of the prior charges we could be recognizing some revenue for which there is no associated – costs associated with the revenues so not by that finish in reversal but we could have some revenue with very high gross margin on it.
Raymond Myers – The Benchmark Company
Do you expect that to be potentially meaningful to earnings in the quarter.
Ashley Lee
I wouldn’t expect it to be meaningful to earnings in the quarter.
Raymond Myers – The Benchmark Company
Okay well.
Ashley Lee
It might be meaningful to cash flow though.
Raymond Myers – The Benchmark Company
Nice your cash flow is already very good. You’ve had a share buyback consistently through 2010 do you intend to continue that in 2011?
Ashley Lee
The buyback has continued into the first couple of months of 2011 and just to give you an idea of where we are we have purchased roughly about 1.3 million to 1.4 million stock in the first two months 2011 at an average price of you know somewhere around 5.25 [ph] that’s a guess.
Raymond Myers – The Benchmark Company
So you’ve purchased $1.3 million or shares?
Ashley Lee
Dollars.
Raymond Myers – The Benchmark Company
Dollars.....
Raymond Myers – The Benchmark Company
Yeah, thank you I’m here. Ashley and Steve could you maybe start with reminding us how many sales people do you have now and what are your plans to expand that.
Steve Anderson
Steve Anderson
I think that PerClot’s approval will be sometime towards the end of 2012 or early 2013 the clinical study that we are going to run is includes about 300 patients and will be across a number of different specialties for a number of different indications. But I would say the soonest we could get it done at the end of 2012 probably a more timely expectation is early 2013.
FYI BioGlue paper, click on thumbnail.
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