Wednesday, April 28, 2010

IIT-K develops polymer to stop bleeding

Researchers at the Department of Biological Sciences and Bio Engineering of IIT-Kanpur claim to have developed a polymer which when applied to a fresh wound stops bleeding within five seconds. They believe the Natural Polymer Sponge (NPS), which has been developed from a chemical found in crab shells, would revolutionise medical treatment, as excessive bleeding has often been the main cause of fatalities.

“A polymer sponge that can promote haemostasis (the process to prevent the flow of blood from an injured body part) has not been developed anywhere else,” said Ashok Kumar Kaul, Associate Professor in the Bio-Sciences and Bio-Engineering Department. Kaul said the haemostasis creams and ointments available in the market provide only partial relief. “In fact, they are ineffective in controlling bleeding in major injuries,” he added. After conducting animal trials, the IIT-K team is now looking forward for clinical testing of the product and is also planning to apply for a patent.

The NPS is made from a substance called chitin extracted from crab shells at -20 degrees Celsius using “cryogelation technology”. The chitin is modified into another substance called chitosan. “Using dextran and other polysaccharides, chitosan is developed into NPS. The sponge has several pores which have the capacity to absorb large volumes of blood to promote haemostasis,” said Kaul.

The biodegradable NPS is in the form of a 1-mm thin sheet but can be different as per requirement. “We have designed the NPS to have a similar impact in all seasons,” Kaul said, adding that they will look for collaboration with foreign institutes for further tests if required.

Tuesday, April 27, 2010

Vascular complications after percutaneous coronary intervention following hemostasis with the Mynx vascular closure device versus the AngioSeal vascul

Abstract

We investigated the prevalence of vascular complications after PCI following hemostasis in 190 patients (67% men and 33% women, mean age 64 years) treated with the AngioSeal vascular closure device (St. Jude Medical, Austin, Texas) versus 238 patients (67% men and 33% women, mean age 64 years) treated with the Mynx vascular closure device (AccessClosure, Mountain View, California). RESULTS: Death, myocardial infarction or stroke occurred in none of the 190 patients (0%) treated with the AngioSeal versus none of 238 patients (0%) treated with the Mynx. Major vascular complications occurred in 4 of 190 patients (2.1%) treated with the AngioSeal versus 5 of 238 patients (2.1%) treated with the Mynx (p not significant). Major vascular complications in patients treated with the AngioSeal included removal of a malfunctioning device (1.1%), hemorrhage requiring intervention (0.5%) and hemorrhage with a loss of > 3g Hgb (0.5%). The major vascular complications in patients treated with the Mynx included retroperitoneal bleeding requiring surgical intervention (0.8%), pseudoaneurysm with surgical repair (0.8%) and hemorrhage with a loss of > 3g Hgb (0.4%). These complications were not significantly different between the two vascular closure devices (p = 0.77). Minor complications included hematoma > 5 cm (0.5%, n = 1) within the AngioSeal group, as well as procedure failure requiring > 30 minutes of manual compression after device deployment, which occurred in 7 out of 190 patients (3.7%) treated with the AngioSeal versus 22 of 238 patients with the Mynx (9.2%) (p = 0.033). CONCLUSIONS: Major vascular complications after PCI following hemostasis with vascular closure devices occurred in 2.1% of 190 patients treated with the AngioSeal vascular closure device versus 2.1% of 238 patients treated with the Mynx vascular closure device (p not significant). The Mynx vascular closure device appears to have a higher rate of device failure.

J Invasive Cardiol. 2010 Apr;22(4):175-8.

Perfect Storm Brewing for Plasma Stocks


Baxter International (BAX) started it with a profit warning last week, saying that its blood plasma revenues would not grow by the expected mid-single digits for 2010 and instead would decline by a damaging mid-single digits. The group fashionably included US healthcare reform as one of the reasons for the dip, but the news of its difficulties soon caused the other main players in the plasma sector to rapidly start hemorrhaging value.

While Baxter finished last week with a 17% decline in its shares to a 10-month low, the likes of Talecris Biotherapeutics (TLCR) dipped 11%, Grifols (GIFLF.PK) was down by 12% and despite CSL (CMXHY.PK) protesting it would not be revising its earnings guidance, its shares also finished the week 8% lower. The falls are perhaps so steep because, as can be seen from the table below, many had been expecting the good old days in the plasma and immune globulin market to continue and growth in the sector to continue at roughly 7% over the next seven years.

But these forecasts are almost certain to come down and if Baxter is anything to go by, could slip into negative territory, at least for 2010.



Market fundamentals

Healthcare reform, or the ramifications of it, may indeed be one of the reasons for Baxter predicting a bad 2010 for its plasma franchise, but there are other multiple and more fundamental reasons for the current weakness in the plasma market.

Looming large among the culprits is lower demand, especially at the higher and more lucrative end of the market, intravenous immunoglobulin (IVIG), typically used for people with weakened immune systems. Here it is thought that the number of people losing their jobs during the recession and therefore their health coverage may have had a bigger impact than previously thought.

Vincente Martin, healthcare analyst with Santander, estimates that the cost of IVIG treatment can range from as much as $50,000 to $90,000 a year. “In the current environment it is clear that these treatments are looking very expensive and this is the same for coagulation prices.”

Adding to the industries woes, this decreased demand in the US has coincided with a destocking by both distributors and hospitals. To obtain good discounts, hospitals and distributors are encouraged to bulk buy. As such, if their inventories are now full, orders are likely to be reduced, meaning that there could be little prospect of a recovery during 2010.

“The fundamentals in the sector are weaker than they were a year ago. If you look at the market it is growing at a lower rate in the US, 1-2% compared to 7-8% a year ago,” Mr. Martin added. “Nobody knows what is going to be the revised growth rate for the business.”

Over-stocking

Completing the ingredients for a perfect storm is the excessive supply in the market, which in turn has led some to offer bigger discounts to entice customers, which has resulted in lower pricing. Baxter, which has been losing some market share in the last few quarters to the likes of Talecris and CSL as they have cut their prices, has itself recently announced that it too will be reducing the cost of some of its products.

The glut for plasma products is a direct result in the growth in plasma collection, which has in the last three to four years been growing 15-20% a year. Demand has not kept up with this rate of supply and as such many plasma collection companies are overstocked.

Mr. Martin estimates that Grifols has 13 months of plasma supplies. The normal inventory levels are 7-8 months. If as suspected other companies are similarly overstocked, then the bad time for the industry could be set to continue for sometime as higher inventory will result in higher working capital and costs, further increasing pressure on these companies.

With the outlook for the plasma market looking so gloomy, last year’s failed merger between CSL and Talecris could now look like a blessing in disguise (CSL’s reality check sinks Talecris deal, June 9, 2009).

Source - Seekingalpha

Thursday, April 22, 2010

Cryolife may have problems beyond continued supply of Hemostase

A new non-clinical video comparing Hemostase (AKA Arista) with PerClot indicates Cryolife may have problems beyond continued supply of Hemostase. The video indicates a much stronger absorptive capacity for PerClot manufactured by SMI. The non-clinical video available HERE on Youtube appears to be an internal SMI validation of their product. Meanwhile the Medafor rejected proposal and (what appears to be imminent divorce) of the Medafor-Cryolife marriage is being thrashed out publicly in a curiously tabloid fashion.
Recently Medafor CEO Gary Shope stated "we no longer believe that CryoLife can be viewed as a trustworthy partner" and on March 18, 2010 after notifying CryoLife that it was treating the EDA as terminated, Medafor notified CryoLife that it would not fulfill their order.
Gary Shope, CEO of Medafor, has also stated, "Over the past six months, CryoLife has repeatedly breached our contract in China, Europe, Brazil and the U.S. CryoLife has also continued to insist that it is entitled to distribute HemoStase in China and Japan, despite the clear terms of the EDA to the contrary . As such, we were highly concerned about whether CryoLife was going to honor our agreement in the future, and had no choice but to insist it provide us assurance, as required by law. CryoLife ignored our request, effectively repudiating the contract and allowing us to cease all performance under the agreement.” Under the agreement, CryoLife had the exclusive right to sell the MPH product into cardiac and vascular surgeries in the United States (excluding Department of Defense facilities) and into cardiac, vascular and general surgeries in the rest of the World (except China and Japan ) excluding ENT, orthopedic, neurosurgery and topical applications.
Both Cryolife and Medafor have made no secret of their mutual dissatisfaction with each other, Cryolife has created a site dedicated to public laundering of their difficulties HERE and includes the following:
Frequently Asked Questions
While Medafor respond on their website HERE



Sorin Group Sells Angel(TM) Whole Blood Separation System and activAT(R) Autologous Thrombin Processing Kit to Cytomedix

MILAN, Italy, Apr 12, 2010 (BUSINESS WIRE) -- Sorin Group, (MIL:SRN), a global company and a leader in the treatment of cardiovascular diseases, announced today that it has completed the sale, for $7 million (EUR5.25 million) in cash paid in installments over two and a half years, of the Angel(R) Whole Blood Separation System ("Angel(TM)") and activAT(R) Autologous Thrombin Processing Kit ("activAT(R)") product lines to Cytomedix, Inc. (GTF 0.90, -0.05, -5.26%), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis. Together these products had sales of approximately $5 million (EUR3.75 million) in 2009.

Angel(TM) consists of a blood processing device and disposable products used for separation of whole blood into red cells, platelet poor plasma and platelet rich plasma ("PRP"); activAT(R) is designed to produce autologous thrombin serum from platelet poor plasma, providing a completely autologous, safe alternative to bovine-derived products.

"We are pleased to enter into an agreement to sell these non-core assets to Cytomedix, and we count on Cytomedix to maintain the same high level of customer service, support and product excellence that our customers have come to expect from Sorin", said Michel Darnaud, President, Cardiopulmonary Business Unit.

Baxter International Inc. Q1 2010

Sales in the regenerative medicine business which includes our bio surgery products totaled $119 million and increased 20%. Sales excluding foreign currency grew 14% and continue to reflect robust growth of Floseal, Coseal and Tisseel....... we expect the regenerative medicine to have sales growth exceeding 25% reflecting the ApaTech acquisition and continued double digit growth in the base business.........

Besides the existing growth vehicles of hemophilia and bio surgery and the various product categories of medication delivery like [hemostasia] and nutritionals, if you just look at kind of near-term new product launches in the various businesses, not to get off of IVIG. Let’s start with that. We have a 30 gram IVIG product we hope to get approved this year and hopefully launch in the U.S. by the end of this year. We have a 10% sub-q product without Enhance, without the Hylenex technology that we will be submitting shortly and hope to have on the market in 2011. Then of course HYQ which incorporates the Hylenex technology we are very excited about. Then new indications like MMN and the whole Alzheimer’s thing which we don’t need to get into.

So even within the antibody therapy area we have a very nice lineup of near-term and longer term things that can really I think change the game. The rest of bio science of course we just got approval for TachoSil in our bio surgery business which we will be launching. We continue to make good progress with our seasonal influenza vaccine targeting EU approval this year and hopefully approval and launch in the U.S. before too long.

I guess where we are completing a trial right now for a broader hemostasis claim which could be very helpful for the growth of that product. I mentioned in renal but Enterprise which is the next generation PD cycler we will be launching hopefully by sometime in early 2011. Our hemo next generation infusion pump platform. Then in the short-term a number of market expansion opportunities with existing products. ADVATE launches in big markets this year like Brazil and then next year Russia. Following year China. Supreme launch in Japan. I will stop there. I am getting pretty granular. We have a fairly nice array and continuous array in all of our businesses of new product launches both near-term and obviously some bigger things longer term. In addition to the existing growth platforms whether it is hemophilia or recombinant and bio surgery and so on. I covered a lot.

St. Jude Medical Inc. Q1 2010

..........Total sales of cardiovascular products for the first quarter of 2010 were $256 million, up 7% over the first quarter of 2009, including $10 million of favorable foreign currency translation. On a constant currency basis, first quarter cardiovascular products sales increased 3% versus last year. Within this category of products, sales of vascular closure products in the first quarter of 2010 were $98 million consistent with the first quarter of 2009.........

Sunday, April 18, 2010

Medafor Abandons Efforts to Deny Shareholder Status to CryoLife CEO

In November 2009, Medafor, Inc. filed a lawsuit against Mr. Anderson and Mr. Richard Zerban, the former CEO of Medafor, regarding Mr. Zerban's sale to Mr. Anderson of 1,000 shares of Medafor stock (the "Transaction"). Mr. Anderson asserted a counterclaim against Medafor and third party claims against Mr. Gary Shope, Medafor's CEO, and Mr. Gavin Thomson, Medafor's CFO, in the lawsuit regarding the Transaction.

Medafor has agreed to dismiss with prejudice all of its claims against Mr. Anderson and Mr. Zerban in the Lawsuit and has agreed to register the 1,000 shares in Mr. Anderson's name effective as of May 13, 2009. Medafor also retracts the allegations it has made on its website and elsewhere that the Transaction was wrongful.

Mr. Anderson, in turn, has agreed to dismiss with prejudice all of his counterclaims against Medafor and all of his third-party claims against Mr. Shope and Mr. Thomson.

As part of the dismissal, both parties withdraw the allegations they have made against one another in the Lawsuit. No party admits or acknowledges liability or wrongdoing in this matter. The Lawsuit was settled to the Parties' mutual satisfaction.

CryoLife was not a party to the lawsuit.

Comparison between TachoComb and TachoSil

TachoComb has frequently been used for the treatment of both venous and arterial bleeding. However, anaphylactic reactions have been reported after repeated use of hemostatic agents containing aprotinin such as TachoComb. Because aprotinin is also associated with risk of renal failure, manufacturing of a new product--TachoSil--which lacks aprotinin seems a logic evolvement. Furthermore, thrombin on the TachoSil material has been changed from bovine in TachoComb to human origin. These changes in the biochemical composition could lead to changes in the hemostatic performance. Therefore, we aimed to disclose any difference in hemostatic efficacy of the two products. METHODS: Twelve 70-kg pigs had controlled insults to the thoracic aorta with and without heparin administration. The iatrogenic lesion was randomly covered with either TachoComb or TachoSil and the time to hemostasis was measured. RESULTS: Time to hemostasis when using TachoSil compared with TachoComb was increased 14% (-13% to 48%) with heparin and 10% (-26% to 66%) without heparin (mean +/- 95% confidence interval; p > 0.05 in both). Time to hemostasis with heparin administration increased significantly in both treatments: TachoComb 80% (26%-156%) (p = 0.001) and TachoSil 75% (18%-158%) (p = 0.005). CONCLUSION: We found neither statistical nor clinical evidence that TachoComb should have better hemostatic properties than does TachoSil in arterial bleeding. Both TachoSil and TachoComb can be used with heparin administration, but significant prolongation of the time to hemostasis is to be expected for both products. TachoSil should be preferred to TachoComb due to the potential lower risk of side effects when using the former.

World Hemophilia Day


On World Hemophilia Day 2010, April 17, meet the many faces of bleeding disorders - united to achieve Treatment for All. Each year hemophilia organizations around the world celebrate World Hemophilia Day, increasing awareness of hemophilia and other bleeding disorders.

The World Federation of Hemophilia (WFH) will launch “The Many Faces of Bleeding Disorders” video podcast on World Hemophilia Day. This video podcast celebrates the whole bleeding disorders community – people with hemophilia and symptomatic carriers, males and females with von Willebrand disease, as well as rarer factor deficiencies, and inherited platelet disorders. It features the impact of these conditions through global patient perspectives and includes a call-to-action for access and improved patient standard of care.

“The goal of the World Federation of Hemophilia is that, one day, treatment will be available for all those with inherited bleeding disorders, regardless of where they live,” said Mark Skinner, WFH president. “Our vision of Treatment for All means expanding services beyond hemophilia.”


Visit www.wfh.org/whd :
for more information about World Hemophilia Day. The World Hemophilia Day website is supported by Bayer, Baxter, and Novo Nordisk. View “The Many Faces of Bleeding Disorders” video podcast, made possible with funding from Baxter Healthcare Corporation, at www.wfh.org/whd : .