EU Pricing Pressure Sure To Impact Hemostasis Market

"European governments grappling to reduce large budget deficits are focusing their cost-cutting on a large spending item - pharmaceuticals," The Wall Street Journal reports. "Several countries in recent weeks, including Spain, Germany and Italy, have proposed or enacted reductions in what they will pay or taken other cost-control measures for various drugs. ... In Europe, state healthcare systems pay for the bulk of drug purchases. European governments have long been known for their frugality when negotiating prices with drug companies, but the latest cuts are more severe than usual. Europe is the second largest market after the U.S. for many drug companies."
The European Federation of Pharmaceutical Industries and Associations, the industry's main lobbying body in Europe, is warning of the economic consequences. In a statement, the group said the cuts would "sharply diminish revenues to manufacturers...with an impact on their R&D investments. This in turn will impact European economic recovery and employment"

The dollar's climbing value threatens to pressure sales in coming quarters for U.S. medical-device and drug makers that are big exporters to Europe.
The greenback's rise--it's up about 15% against the euro this year--compounds worries already brewing that cash-strapped European governments, pressured by a debt crisis on the continent, will cut back on health-care spending.

For device companies, Piper Jaffray analyst Matt Miksic called the currency impact "manageable for most" because of hedging plans. He sees a 1% to 2% earnings impact this year.
The currency effects can be very complex. Many companies routinely give sales estimates that exclude the currency impact so that the business' performance isn't shrouded. Also, they typically employ a mix of natural and financial hedges to protect earnings, even if sales take a big hit.
Natural hedges can include overseas manufacturing capacity, which can put the cost of production in the same currency as sales. For big multinational companies doing business around the globe, currency values in different countries can sometimes have an offsetting effect. Then there are foreign- exchange contracts companies can enter to manage risk.
But the dollar's strength still adds strain. JPMorgan noted a trend over the past decade of device stocks performing better than the broader market when currency rates add to sales, but worse when currency is a negative factor. "In short, MedTech stocks seldom outperform in the face of an FX headwind," analyst Michael Weinstein said.
Some of the dollar's gains have come since companies reported first-quarter results in April; however, device-maker Medtronic's recent report offered some fresh perspective. The company, which posted sales of $15.8 billion for its year ended April 30, said exchange rates at Monday's level would dent sales by $400 million to $500 million in the new fiscal year.
But the company also said its hedging strategy should mostly shield earnings.
The backdrop to currency concerns is the threat European sales also will decline because of government spending cuts. But some big companies have downplayed this risk.
This is "spooking investors," Abbott Laboratories (ABT) Chief Executive Miles White said at a recent conference. He explained that Abbott factored pressure in Europe into its 2010 financial forecasts and that he doesn't plan to change them directly due to European woes.

Baxter's Profit Drops 8.9%

Baxter International Inc.'s second-quarter earnings fell 8.9%, including a charge, as it faced macroeconomic headwinds and individual product issues. The Deerfield, Ill., based maker of products for conditions such as hemophilia and kidney failure, tightened its 2010 earnings guidance and backed sales expectations, but warned that issues in key markets will continue. "Clearly 2010 has been a challenging year," said Robert Parkinson, Baxter's chairman and chief executive, noting pressure from U.S. health-care reform, economic pressures, and softness in its plasma protein-based business.

Notably, Mr. Parkinson said the company continues to operate "through a transition period in the plasma proteins environment."
The slowdown in the plasma-based business has been a source of uncertainty for investors, as it is a key component in Baxter's largest business unit. For the remainder of the year, Mr. Parkinson projected plasma protein sales to decline in the mid-single digits, and antibody therapy sales to decline about 10%.
In its last earnings call in April, Baxter cut its 2010 outlook and said there was a surprising slowdown for plasma-based medical products.
Mr. Parkinson said that Baxter has implemented some new commercial strategies to counteract market share loss in sales of a plasma-based drug called Gammagard. He said that there are "some early positive signs" that the company's share position, and the U.S. market as a whole, are stabilizing.
Looking ahead, the company narrowed its 2010 adjusted earnings guidance to $3.93 to $3.98 a share, from a previous view of $3.92 to $4.00 a share. It projects sales growth of 1% to 3%, which amounts to $12.7 billion to $12.9 billion.
Baxter also forecast third-quarter earnings of 96 cents to 99 cents a share on revenue growth of 1% to 3%.
Earnings for the three months ended June 30 dropped 9% to $535 million, or 90 cents a share. The company recorded a $22 million write-down related to an expected settlement with the Greek government. Excluding items, the company earned 93 cents a share.
Sales in the period rose 2.3% to $3.2 billion, with the change primarily coming from the effects of currency exchange.
The company's biggest business unit, bioscience, reported a 4% revenue drop to $1.4 billion, mostly because of increased Medicaid rebates required by the U.S. health-care overhaul in the spring, as well as lower revenue derived from antibody therapies, vaccines, and some international hemophilia products.
Sales in the medication delivery unit rose 9% to $1.2 billion, helped by its intravenous and injectable therapies, along with sales of the Sigma Spectrum infusion pump.
The company is in the process of recalling about 200,000 Colleague brand drug-infusion pumps in the U.S. while offering customers either refunds or replacement devices over the next two years.
Problems with the pumps, typically found bedside at hospitals where they deliver intravenous fluid and drugs, have been a long-running issue for Baxter amid problems linked to reports of patient injuries and deaths.
Baxter is offering Spectrum brand pumps from a private company called Sigma International, in which Baxter has a 40% ownership stake. On Thursday, it said it continues to work with Sigma to increase manufacturing capacity to meet expected demand.
The ability to meet demand is key, as the company faces competition from rival pump makers CareFusion Corp. and Hospira Inc.
Mr. Parkinson said it is too early to tell how the company's market share for the products will change, but it will have a better view by the end of the year.
Baxter's renal unit, which includes products for managing advanced kidney failure, saw sales rise 6% to $585 million.
In the quarter, the company repurchased 15.2 million shares for about $677 million.

Use Your Own Blood In Transfusions During Emergency Operations

A new report in the July issue of Archives of Surgery, now provide information that a person using their own blood during transfusions is possibly now cost effective.
Trauma injuries is the leading cause of death in persons between the ages of one and forty four, a major player in this cause is major blood loss this is obtained from the background facts in the report. This seems to hold especially accurate in deaths which happen in the operating room or twenty four hours after the trauma had occurred. Patients that go into shock due to hemorrhaging need a transfusion, usually with packed red blood cells and plasma. Any transfusion of blood from another person (allogeneic) is linked to an array of problems which include having a reaction to the transfusion, infectious diseases being transmitted and being susceptible to antigens according to researchers. Additionally, transfusions of allogeneic blood products in trauma patients have solely been linked to heightened morbidity and mortality, specifically when using blood that has been stored awhile.
Dr. Carlos V. R. Brown, of the University Medical Center Brackenridge, Austin, Texas, and associates had examined forty seven adult trauma patients that had undergone an emergency operation and had been given intraoperative cell salvage, a method in which shed blood is gathered and prepared in order for red blood cells to be transfused back into the patient in 2006 or 2007. In everyone of these patients the researchers had chosen a corresponding patient who was the same age, sex, same system and identical severity of injury and had the same operation but did not have savage cells.
Patients that were in the savage cell group displayed an average intraoperative blood loss of 1,795 milliliters, and averaged a return of 819 milliliters of their own blood. They also had been given less intraoperative and total units of allogeneic packed red blood cells the associated group (two vs four units in surgery and four vs 8 in total units) and also had received less total units of plasma.
The amount from blood product transfusion which includes the complete cost of cell salvage, was lower in the group who had receive this particular procedure ($1,1616 vs. $2,584). The groups had alike of duration of stay in the intensive care unit (eight days for both) and in the hospital (18 for salvage group and 20 in comparison group), there was no dissimilarity in death ratios (6 in the salvage group and 10 in comparison group).
In closing, this current cohort study adjoins with the already present literature in reference concerning the benefit of outcomes in intraoperative cell salvage andautolgous transfusion in patients of trauma who undergo emergency surgical mediation according to the researchers writings in this study. They furthermore state that further studies are warranted to positively substantiate the safety of transfusing contaminated blood to per-operative determined patients that would get the greater advantages from autologous transfusion and also to maximize cost effectiveness. Meanwhile the centers that have avenues to a cell salvage program should frequently use autologous transfusion as a role in their intraoperative resuscitation. Most critically, centers that do not use intraoperative cell salvage and autotransfusion should establish and take away blockades to putting in use this life saving technique.

Johnson & Johnson Q2 2010 with commentary on EU Pricing Impact

Ethicon worldwide sales grew operationally by 8.2% with the U.S. up over 12.65%, and sales outside the U.S. up 5% operationally. Growth was driven by sutures, biosurgicals and Mentor products. Additionally, the acquisitions of Acclarent this year, contributed to the growth in the quarter. Ethicon Endo-Surgery achieved operational growth of 6.6% in the second quarter of 2010, with the U.S. sales growing 3.7% and sales outside the U.S. up with an operational basis by 8.8%. Growth was driven by of the Advanced Sterilization, Endo and HARMONIC products.

Frederick Wise – Leerink Swann LLC

OK, thank you. Next, Dominic, obviously, you're talking about the increased EU price pressures. Maybe I missed it, but during the Medical Device Day in early June, it seemed like you all hadn't seen it yet. Can you give us a little more color on what you're seeing, how you're seeing it? And obviously you're talking about the sort of an accelerating impact for the rest of this year, is this something we should be concerned about accelerating further into 2011 and beyond?

Dominic Caruso

Right, Rick. That's a great question. So, let me just be clear on the EU pricing pressure that we're seeing. They're much more significant in the Pharmaceutical business than they are in the Medical Device business. If you've been – I'm sure you've been following the various governmental austerity programs that include price reduction; those price reductions are specifically directed towards Pharmaceutical products where those governments have much more of an active role in pricing in those types of products.

With respect to the Medical Device business, that business is characterized quite differently than the Pharmaceutical business. It's characterized by largely a DRG system and largely a tender system. So, we have not yet seen much of an impact at all on pricing and medical devices. We do expect that it may begin to show up later in the year or into next year. But of the estimates that I gave you earlier of approximately $200 million from increased acceleration of pricing pressures in Europe, that is largely in the Pharmaceutical business, not in the Medical Device space.

Warm Ischemia Worsens Partial Nephrectomy Outcomes, Study Finds

Warm ischemia during partial nephrectomy (PN) on a solitary kidney is associated with an increased risk of acute renal failure (ARF) and CKD, according to researchers.
Consequently, they concluded, “PN with no ischemia should be used when technically feasible in patients with solitary kidney.”
R. Houston Thompson, MD, of Mayo Clinic in Rochester, Minn., and collaborators studied 458 patients who underwent open PN (411 patients) or laparoscopic PN (47 patients) for a renal mass in a solitary kidney. The researchers excluded patients treated with cold ischemia. They explained that no ischemia was used if a tumor was sufficiently exophytic or in a position where regional compression could provide sufficient hemostasis during tumor enucleation.
No ischemia was used in 96 patients (21%), whereas 362 patients (79%) had a median of 21 minutes of warm ischemia (achieved with hilar clamping). Compared with the no-ischemia patients, warm ischemia patients had a significant twofold increased risk of ARF and a fourfold increased risk of having a glomerular filtration rate (GFR) below 15 mL/min/1.73 m2 in the post-operative period, the investigators reported in European Urology (published online ahead of print).
In addition, of 297 patients with a preoperative GFR of 30 or higher, those treated with warm ischemia had a significant 2.3 times increased risk of new-onset stage IV CKD during a mean follow-up of 3.3 years.
“We do not submit that clamping should be avoided at all costs but rather support the use of no clamping in select patients with a tumor that is amenable to manual compression,” the researchers noted.
Dr. Thompson's group noted that their study is limited by its retrospective design. In addition, they pointed out that their study had a significant selection bias. Patients managed with no ischemia were likely to have more exophytic and smaller tumors that presented a lower risk of complications.

FDA Warns on Fibrin Sealant Problem

Air embolisms can occur with some gas- or air-pressurized spray devices used for applying fibrin-based bleeding control products when used improperly during surgery, the FDA warned.
At least seven types of fibrin sealant sprayers were associated with air or gas embolisms, which appear to have occurred when pressure settings were too high or the sprayer tip was too close to the bleeding site.
The FDA emphasized that clinicians should follow manufacturers’ recommendations for pressure control settings and the minimum distance for applying the sealants.
“Although rare, the reports describe air embolisms that are life threatening and include one fatality,” the FDA said.
The bureau listed seven product series that have been affected:
EasySpray and spray set used with Duploject system (Baxter Healthcare)Tissomat and spray set used with Duploject system (Baxter Healthcare)Evicel application device (Omrix Medical)FibriJet Aerosol Applicator (MicroMedics)HemaMyst Surgical Applicator System (Haemacure)MicroMyst Applicator and Air Pump Models 20-5000 and AP-A-6063 (Confluent Surgical)Vitagel Hemostat Spray Set (Orthovita)
Label instructions for all fibrin sealants have been rewritten to note the risk of air embolismsassociated with improper sprayer use.
In addition to following the listed recommendations for pressure settings and proper distances for application, clinicians should be sure to monitor patients’ blood pressure, pulse, oxygen saturation, and end-tidal CO2 levels for signs of embolism, the FDA noted.
The sprayers should also be maintained and tested regularly, the bureau said.

Department of Defense Funding Shows Continued and Bi-Partisan Support for STB® Lifesaving Technologies' Products

ROCKVILLE, Md., July 7 /PRNewswire/ -- For the third consecutive year the Department of Defense demonstrated its commitment to help save the lives of our troops by providing STB Lifesaving Technologies® with $2.85 million of funding.
The award is to further advance the development of STB®'s Fibrin Adhesive STat (FAST®) dressing, designed to be effective against the full spectrum of blood loss, including severe arterial and venous bleeding. Fifty percent or more combat-related deaths are attributable to uncontrolled hemorrhaging, and with products such as this, thousands of military and civilian lives could be saved.
"We are most appreciative of the support we have continued to receive from the Department of Defense and members of both the Senate and House. This funding is not only invaluable; it serves as a strong statement of their belief in our Fibrin Adhesive STat (FAST®) dressing and their commitment to help us bring our products to the battlefield, emergency responders and operating rooms," said STB® CEO, Richard Moscarello.
Funding for the grant was included in the FY2009 U.S. Department of Defense appropriations bill and received bipartisan support from Senators Richard Burr (R-NC), Ben Cardin (D-MD), Barbara Mikulski (D-MD), Charles Schumer (D-NY) and former Senator Elizabeth Dole (R-NC) and Representatives Bob Etheridge (D-NC), David Price (D-NC) and Chris Van Hollen (D-MD).
"We've all been encouraged by the pre-clinical studies, but it's particularly gratifying that support for our science is backed with significant monetary commitments as well," said STB®'s Moscarello.

About STB®

Founded in 2005, STB Lifesaving Technologies® (STB®) is a privately held, pre-clinical stage, biotechnology development company located in Rockville, Maryland. STB® which stands for "stop the bleeding", is focused on developing a comprehensive suite of products to stop serious and life threatening bleeding in trauma and surgical settings. With a strong proprietary position using its all-natural protein technology with five patents and one provisional patent pending, STB®'s products will be indispensable to both the military and civilian medical markets.

Ethicon, Inc. Expands Hemostasis Product Portfolio with Approval of the Company's First Synthetic Internal Use Sealant

SOMERVILLE, N.J., July 7, 2010 /PRNewswire via COMTEX/ -- Ethicon, Inc., a worldwide leader in surgical care, announced today the introduction of ETHICON(TM) OMNEX(TM) Surgical Sealant, ETHICON(TM) Biosurgery's first synthetic sealant designed to achieve adjunctive hemostasis (stoppage of bleeding) in vascular reconstructions by mechanically sealing areas of leakage. The US Food and Drug Administration (FDA) recently granted approval of the Premarket Approval Application (PMA) for ETHICON(TM) OMNEX(TM) Surgical Sealant.

ETHICON(TM) OMNEX(TM) creates a strong, flexible physical seal independent of the body's clotting mechanisms. It is proven in an ex-vivo model to be two-to-four times as strong as other surgical sealants, is ready for use in less than 30 seconds, and proven to seal to ePTFE grafts and bond securely to friable vessels.(1)

"A basic rule of patient safety and excellent outcomes is to prevent unnecessary bleeding during and immediately after surgery," said Alan B. Lumsden MD, Medical Director of the Methodist DeBakey Heart & Vascular Center and the Chairman of the Department of Cardiovascular Surgery at The Methodist Hospital in Houston.* "The availability of an effective surgical sealant such as ETHICON(TM) OMNEX(TM) provides surgeons with a valuable new tool that is clinically proven to decrease the time it takes to seal the surgical site, including ePTFE grafts, and prevent leakage from occurring."ETHICON(TM) OMNEX(TM) is clinically proven to significantly decrease time to hemostasis based on clinical trials conducted to support its safety and effectiveness. Specifically, results from a pivotal, randomized, controlled, open-label, multi-center trial of 151 patients at 13 centers in the United States and European Union demonstrated that ETHICON(TM) OMNEX(TM) provided hemostasis three times faster than oxidized regenerated cellulose at a rate of 1.99 minutes vs 6.73 minutes, with 54 percent of the ETHICON(TM) OMNEX(TM) patients receiving immediate hemostasis.(2) There were no significant differences in adverse events compared to oxidized regenerated cellulose during the study time period and 4+ year follow-up analysis.(2)

ETHICON(TM) OMNEX(TM) Surgical Sealant has proven efficacy in a broad spectrum of vascular reconstructive procedures including arteriovenous access, aortobifemoral bypass, femoral popliteal bypass, endarterectomy, abdominal aortic aneurysm and aortotomies.(1)

ETHICON(TM) OMNEX(TM) Surgical Sealant is contraindicated in patients with known hypersensitivity to cyanoacrylate or formaldehyde. The device is not for intravascular use. ETHICON(TM) OMNEX(TM) Surgical Sealant is intended for use as an adjunctive sealant and is not to be used in place of sutures, staples, or mechanical closure.

Hemostase - Medafor states CryoLife Press Release is Misleading and False

Please click the thumbnail to read.

PS - Happy Independence Day!

Hemostase: Medafor says its off...CryoLife its on.......

NOT SO FAST, MY FRIEND!

The continued quagmire that is the CryoLife/Medafor relationship appears set to continue according to This latest Press Release from CryoLife.

Background

After a failed takeover bid by CryoLife they encouraged Medafor shareholder's to withhold their votes at a recent Medafor shareholder meeting. This was rejected by 95% of the 70% of attendee's and one disappointed shareholder will no doubt be Jim Karerchersuch who commented "I say get rid of CryoLife and let investors make some money,".

Expenses in the tussle continue to escalate for both companies with Medafor CEO Shope stating... "The real problem for Medafor is the distraction and expense stemming from CryoLife's takeover bid and continuing litigation, Shope said. Had it not been for the $1.2 million the company shelled out for legal expenses last year, Medafor would have been profitable, ."

and another online source stating ...."Anderson, who launched the hostile takeover attempt of Medafor in 2009 and chose several public venues to prosecute his case, spent approximately $6 million in the effort."

Conclusions

For those on the sidelines this extremely public battle has been an intriguing insight. Lately barely concealed personal attacks are now appearing in certain news articles relating to CryoLife CEO Steven Andersons, age and absence from the shareholder meeting despite his residence in MN. Meanwhile Medafor management were brought under the spotlight with the CryoLife claim "that Medafor's CEO and chief financial officer earned a combined $700,000 last year." Medafor management also denied any issues related to the fact that Medafor senior executives, and Pennsylvania residents Shope and Pasquale don't live in Minnesota, where the company's 21 employees are based. With Pasquale claiming it isn't necessary to live locally.

Investors and Distributors must be feeling unsettled by the lack of clarity in terms of supply, and without any public statement from Medafor or the courts (where both companies appear more comfortable communicating) the status quo appears confusing.

One positive indication from this mess is that plant-based hemostatic technology is certainly worth fighting for. Medafor partner Orthovita must have an eye on these occurences, as will other key China manufacturer Starch Medical.