Baxter International raises outlook after third-quarter earnings beat expectations

Baxter International Inc.’s third-quarter earnings beat Wall Street expectations Thursday, propelled by a jump in sales in the company’s IV solutions business. After the company’s earnings release, Baxter’s stock price rose by more than 3 percent.
The Deerfield-based medical supply and pharmaceutical company posted earnings of $594 million, or $1.01 per diluted share, in the quarter ended Sept. 30, besting Wall Street’s consensus projections of 97 cents.  Net income rose 12 percent from the same quarter in 2009, when the company earned $532 million, or 87 cents per diluted share.
In the 2009 quarter, the company incurred a one-time charge of $27 million for the retirement of a syringe pump.  Without that cost, 2010 third-quarter earnings would have been 1 percent lower than 2009.
Still, the company raised the floor of its 2010 annual forecast from $3.93 to $3.96 per diluted share, and now expects 2 percent to 3 percent annual sales growth. Its previous forecast called for growth in the range of 1 percent to 3 percent.  The top forecast figure remained at $3.98.
“We continue to aggressively manage general administrative and discretionary spending across the company,” Robert Parkinson, Baxter’s chairman and chief financial officer, said in a Thursday morning conference call.  “We’re selectively investing in several key promotional activities aimed at demand creation, new product launches and driving future growth of our higher margin products.”
Baxter’s third-quarter revenue grew by 3 percent to $3.2 billion from last year’s $3.1 billion.  The medical delivery sector, which manufactures intravenous solutions and sets, intravenous nutritional products, medical pumps and drug manufacturing products, spurred much of the company’s third-quarter momentum by racking up $1.2 billion dollars in sales, up 2 percent globally and 12 percent domestically.
The company’s bioscience division also is outperforming analysts’ expectations, led by developments in critical-care blood plasma replacement therapeutics. Sales at the division did not grow significantly during the quarter but have grown 3 percent so far this year, totaling $3.4 billion.
“We view this commentary, quarterly results, and outlook as all positives for the company and encourage investors to revisit what should be a core holding in the healthcare space,” said Daniel Owczarski, a financial analyst with Avondale Partners LLC.
In the first nine months, Baxter has earned $1.1 billion, or $1.79 per diluted share, down 35 percent from the same period last year, when the company earned $1.7 billion, or $2.66 per diluted share. Revenue, rose 3 percent to $9.3 billion, compared with last year’s $9.1 billion.  

King Pharma Disappoints

King Pharma's branded Pharmaceuticals segment declined 43.3% with revenues coming in at $160.8 million. Revenues of almost all key products declined from the year-ago period.
Thrombin-JMI sales declined 25.9% to $32.2 million. We expect Thrombin-JMI sales to continue declining due to tough competition in the form of Bristol-Myers Squibbs’ Recothrom and Johnson & Johnson’s Evithrom.

Seven U.S. Medical Centers Commence Study to Change Femoral Artery Cath Lab Access

REDWOOD CITY, Calif., Nov. 8, 2010 /PRNewswire/ -- Arstasis is pleased to announce that patient enrollment has begun in the RECITAL (A Patient Registry Evaluating Closure Following Access with the Arstasis One Access System) Study.  The non-randomized, prospective, post-approval study is anticipated to enroll up to 500 patients in at least seven U.S. hospitals.  The goal of the study is to observe the clinical safety and effectiveness of the Arstasis One Access System in patients undergoing diagnostic angiography procedures through the femoral artery.
The first patient was enrolled at La Paz Regional Medical Center inParker, Arizona.  "We've begun performing Arstaotomy procedures routinely in our cath lab because they make femoral artery access safer for our patients, easier for me and my staff, and less expensive for our hospital compared with closure devices or manual compression," said Dr. Frank Kresock, chief of interventional cardiology at La Paz Regional Medical Center, the physician who performed the procedure.
Since 1959, physicians have been using the Modified Seldinger Technique (or "Seldinger Technique" for short) to insert flexible catheters into the femoral artery of patients for the purpose of performing procedures in the patient's arterial-vascular system.  The most prevalent such procedure, angiography, is thought to be performed more than half a million times per month worldwide.  At the end of every such case, each patient is left with a substantial hole in his/her femoral artery (upper inner thigh) which typically takes significant effort and cath lab resources to get to stop bleeding.  With the Arstasis One Access System, however, physicians may create a shallow-angle needle pathway through the wall of the femoral artery.  At the end of the procedure, when the sheath is withdrawn, the shallow-angle pathway collapses from the normal pressure of the patient's femoral artery blood flow from below and approximately 3-4 minutes of mild, non-occlusive finger-pressure from above, resulting in a quickly sealing access site.
"The Arstasis One femoral artery access system marks the beginning of a new approach to heart catheterization," commented Zoltan G. Turi, MD, the Director of the Vascular Center at Cooper University Hospital and Professor of Medicine at Robert Wood Johnson Medical School in Camden, New Jersey, and the national principal investigator of the RECITAL study.  "We hope to show that patients who participate in this study benefit from femoral artery closure that has advantages over regular manual compression", Dr. Turi continued. "We are also interested in this technology because Arstasis facilitated closure, unlike vascular closure devices, does not result in any foreign materials being implanted."
The study will also assess patient satisfaction due to reduction of pain and discomfort as well as early mobility.  In non-U.S. clinical trials the resulting closed access site was typically so secure that a patient could get up from his/her bed and begin walking hours sooner than would be the case with a standard femoral arteriotomy, sometimes as soon as those patients receiving Vessel Closure Devices.
"This procedure over the Angioseal, in my opinion, was 100% better because of the recovery time, less swelling and bruising. This is much better, I'm glad I got the Arstaotomy," said Russell McKenzie, Dr. Kresock's 75-year old patient at La Paz Regional Medical Center who was the first to enroll in the RECITAL study.
Detailed information about the Arstasis One, and the Arstaotomy procedure, is available at www.arstasis.com.

ABOUT ARSTASIS, INC.
Arstasis, Inc., headquartered in Redwood City, California, is a medical device manufacturer dedicated to bringing innovative access devices to cardiologists, interventional radiologists, their staffs, and patients.  The company's first product, the Arstasis One, was cleared for U.S. commercialization by the FDA in 2010.  The device is used in the Arstaotomy? procedure, a new way to gain access to the femoral artery that improves upon the Seldinger Technique and that some physicians believe results in a more pleasant and efficient cath lab and post-procedure experience for clinician and patient alike.

New Surgical Applicator

Researchers invent inkjet that prints out living skin

This is no horror movie, this is part of a recent presentation at the American College of Surgeons Clinical Congress, where Wake Forest Institute for Regenerative Medicine researchers had a super fun time showing off their results from a printer that uses living cells instead of ink. Fluid based inkjet technology used in the very printers you’ve got in your home or office is used to lay down cells, printing large sections of living tissue down on cut up or damaged areas of the body. These fine folks from the Institute note that “any loss of full-thickness skin of more than 4 cm in diameter will not heal by itself,” and that with this device, (refined and tested extensively, of course,) skin that might have been otherwise damaged horrifically can now be patched up to a much higher level of healthiness. Testing has occurred on mice revealing advanced healing by the second and third week of recovery and complete closure of the skin by the end of week three on wounds that would otherwise still be open to infection.
The printer works with two heads, one that dispenses skin cells mixed with fibrinogen (a blood coagulant) and type I collagen (connective tissue’s main component in scars), the other which sends out thrombin (another coagulant.) Together these create a chemical reaction and form fibrin, another protein that works on the clotting of blood. On top of this is one more layer printed by the printer: keratinocytes – the outer layer of skin we’ve all got right this moment.

Future research will be done on the pigs who, if you know your Gangs of New York lore, are great to practice stabbing on because they’ve got skin that very closely resembles human skin. Will this device ever hit your local wartime hospital or town hospital? Who can tell?

CryoLife Slips To Loss In Q3

(RTTNews) - CryoLife Inc. (CRY: News), an implantable biological medical device and cardiovascular tissue processing company, Thursday reported a loss for the third quarter, compared to a profit last year, mainly reflecting higher expenses.
CryoLife's net loss for the quarter was $3.03 million or $0.11 per share compared to a net income of $1.86 million or $0.07 per share last year.
For the recent third quarter, the company recorded charges of $3.7 million for acquired in-process research and development related to the Starch Medical transaction, $3.6 million related to the impairment of its investment in Medafor common stock and $1.6 million related to HemoStase inventory that the company does not believe that it will be able to distribute.
Excluding these charges, adjusted net income for the quarter was $2.6 million or $0.09 per share. On average, three analysts polled by Thomson Reuters expected the company to earn $0.09 per share in the quarter. Analysts' estimates typically excludes special items.
The Kennesaw, Georgia-based company's total revenues improved slightly to $28.44 million from $28.22 million in the comparable quarter last year. Three analysts were looking for a revenue of $29.30 million.
Total gross margins decreased to 54% from 60% last year, mainly due to the charge related to the write-off of the HemoStase inventory.

Effects of an absorbable polysaccharide hemostat PerClot(r) on fracture healing of the cranial bone

EU Protocol for the use of CryoLife BioFoam

CryoLife protocol for EU rollout of BioFoam, Click Thumbnail to view.

ARCHIVE
On 10/27/09, CryoLife (NYSE: CRY) announced that the FDA has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam Surgical Matrix protein hydro-gel technology. BioFoam will be used to help seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemo-static agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial. CryoLife is currently conducting a 60-patient controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. Upon successful completion of the feasibility study, and subsequent FDA and DoD approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study will be conducted. It is currently anticipated that the pivotal investigation will enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites.

Tenaxis Medical, Inc. Announces 'Fileable' Status of PMA

MOUNTAIN VIEW, Calif., Oct. 25 /PRNewswire/ -- Tenaxis Medical submitted its PMA to the FDA on July 27, 2010 and has now received confirmation from the FDA that "we have made a threshold determination that the PMA is sufficiently complete to permit a substantive review and is, therefore, suitable for filing."
In the pivotal study designed to demonstrate superiority, the ArterX Surgical Sealant was compared to a thrombin soaked gelatin-sponge hemostat to reduce or eliminate suture line bleeding.  President & Chief Executive Officer, David Smithcommented, "We are delighted that the FDA has made the determination to substantively review the PMA. We are continuing to prepare for our US launch and this was an important milestone."
About Tenaxis Medical, Inc.
Incorporated in 2004 and located in Mountain View, CA, Tenaxis Medical, Inc. is a privately held company. It develops novel, high performance sealants for use in vascular and general surgery.  In addition to the ArterX Surgical Sealant, the company is developing a second high performance sealant for use throughout the gastrointestinal tract, and an anti-adhesion agent that can be delivered laparoscopically to help prevent or reduce pelvic and abdominal adhesions.
CONTACT: Ronald Dieck, +1-650-691-9016, ext. 110, for Tenaxis Medical, Inc.

Study shows use of superglue in chest surgery cuts recovery time in half

Victor Haddad used Krazy Glue in his woodworking shop for years to mend his accidental wounds. Then last year, as he awaited a heart operation, he discovered on the Internet that a Calgary doctor was using a superglue to fuse bones together after chest surgeries.
The minute he read about the experimental procedure, he says, “I wanted it.”
He became a patient of Paul Fedak, a cardiac surgeon who pioneered the technique in 2009 at Calgary’s Foothills Hospital Medical Centre. In June of this year, Dr. Fedak replaced Mr. Haddad’s aortic valve and joined his sternum using steel wire, and then sealed the bones with a sticky paste called Kryptonite.
Mr. Haddad was out of the hospital in seven days. Within six weeks, the 59-year-old resident of Milk River, Alta., was back to work as a real-estate broker. Mr. Haddad didn’t bother to fill his prescription for pain meds, he says. “I’ve been pain free since before I left hospital.”
His surgery was standard except that Dr. Fedak took a few minutes to apply adhesive to the ends of the chest bones before stitching up the soft tissue. According to Dr. Fedak, breastbones heal much faster when secured with wire as well as Kryptonite glue.
Instead of it taking six to eight weeks for the bone to fuse back together, “we do it in 24 hours.” The glue makes it rock solid within a day.
A study released Sunday suggests the use of adhesive in chest surgery reduces the normal recovery time by half. Patients have less physical disability in the first six weeks after surgery and can breathe deeply sooner, Dr. Fedak reports. He adds that patients are able to cough with less discomfort and require significantly less medication such as narcotics to manage pain.
No complications or side effects from the glue were reported among the 55 patients in the randomized controlled trial.
The procedure has the potential to improve post-operative care for an estimated 1.4 million open-chest surgeries performed worldwide each year, according to the Heart and Stroke Foundation of Canada.
Dr. Fedak has applied to the Canadian Institutes of Health Research to fund a larger clinical trial involving 2,000 patients throughout North America, which should start in six months, he says.
Although medical adhesives are widely used in hip replacements and other procedures, most bone cements contain toxic ingredients that are dangerous for use in the chest, notes Dr. Fedak. In contrast, Kryptonite is an adhesive polymer composed of calcium carbonate and fatty acids derived from castor bean oil. It is “bio-compatible” and turns into a porous bonelike substance as it cures, he says.
Dr. Fedak doesn’t recommend the adhesive for patients at high risk for internal bleeding and other complications after surgery, because doctors might need to re-enter the breastbone and the procedure would take longer if the breastbone is well-bonded. Otherwise, he says, “you could use this on almost any patient.”
Regulators in Canada and the United States have approved the use of Kryptonite, which is made by the Doctors Research Group in the United States.
The glue is expensive, adding $700 to $1,000 to the cost of performing surgery. The need for public funding is a barrier to routine use, Dr. Fedak says. But he suggests that using Kryptonite could result in net savings to the health-care system by reducing recovery time and major post-op complications, including breastbones that separate after surgery.
“If a patient leaves the hospital a day early, that would be thousands of dollars of savings,” he points out.
Patients from around the world have contacted him, seeking repairs to sternums that didn’t heal properly after surgery, Dr. Fedak says. Although he is cautious about expanding the use of Kryptonite prematurely, he adds, reconstructions to damaged sternums “work very well.”
Mr. Haddad says he’s been the envy of his friends since he was glued back together with Kryptonite. He mentions a neighbour who took more than six months to bounce back after recent heart surgery.
“He is absolutely annoyed that he wasn’t in the [Kryptonite] study.”

Vascular Solutions Announces Record Third Quarter Results. Edited

Vascular Solutions, Inc. (Nasdaq: VASC) today reported financial results for the third quarter ended September 30, 2010. Highlights of the third quarter include:
Achieved record net revenue of $19.9 million, an increase of 15% from the third quarter of 2009.
Highlighted the clinical success of the GuideLiner® catheter at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington D.C. in September, with GuideLiner catheter sales increasing by 37% sequentially from the second quarter of 2010.
Achieved net income of $1,464,000, or $0.09 per diluted share.
Issued guidance for 14% to 16% revenue growth to between $20.8 million and $21.2 million in the fourth quarter of 2010 and net income of between $0.94 and $1.00 per share (including $14.3 to $15.0 million, or $0.83 to $0.87 per share, of income tax benefit as the result of the Company's potential recognition of its remaining net operating loss carryforwards as a deferred asset in the fourth quarter).
Commenting on the results, Vascular Solutions' Chief Executive Officer Howard Root said: "Contrary to what many companies in our sector are reporting, we are pleased to report 15% revenue growth in the third quarter to a new record quarterly level, resulting from substantial new product launches and continued sales expansion of our existing products. Of special note, our GuideLiner catheter has generated unprecedented interest in a Vascular Solutions' product since its U.S. launch less than a year ago, and that interest is translating into broader sales opportunities and increased visibility at major medical meetings. With a full pipeline of internally-developed new products in development, along with acquisition and product distribution candidates in evaluation, we are very optimistic about our ability to continue with our consistent sales growth and success.".....
Net sales of hemostat products (primarily consisting of the D-Stat® Dry, D-Stat Flowable and D-Stat Radial products) were $6.1 million in the third quarter, a decrease of 5% from the third quarter of 2009. "During the third quarter one of our primary competitors in the patch market was subjected to an injunction preventing their sales in the U.S. as the result of a patent infringement verdict initiated by another competitor, but that injunction was quickly subjected to an administrative stay while the case is presented to the Federal Circuit. We expect that administrative stay to be subject to a substantive decision by the Federal Circuit very soon, which, if the injunction or judgment is allowed to stand, would open up approximately 15% of the patch market to our sales force," commented Mr. Root.....