Scientist has succeeded in producing a replica of human collagen from tobacco plants

A scientist at the Hebrew University of Jerusalem's Robert H. Smith Faculty of Agriculture, Food and Environment has succeeded in producing a replica of human collagen from tobacco plants – an achievement with tremendous commercial implications for use in a variety of human medical procedures.

Natural human type I collagen is the most abundant protein in the human body and is the main protein found in all connective tissue. Commercially produced collagen (pro-collagen) is used in surgical implants and many wound healing devices in regenerative medicine. The current market for collagen-based medical devices in orthopedics and wound healing exceeds US $30 billion annually worldwide.

Currently, commercial collagen is produced from farm animals such as cows and pigs as well as from human cadavers. These materials are prone to harbor human pathogens such as viruses or prions (mad-cow disease). Human cadaver is scarce, and for certain indications possesses serious ethical issues.

Producing human recombinant type I pro-collagen requires the coordinated expression of five different genes. Prof. Oded Shoseyov of the Robert H. Smith Institute of Plant Sciences and Genetics in Agriculture has established the only laboratory in the world that has reported successful co-expression all the five essential genes in transgenic tobacco plants for the production of processed pro-collagen. For this work, Shoseyov was one of the recipients of a Kaye Innovation Award during the Hebrew University Board of Governors meeting in June.

Shoseyov's invention on has been patented, and the scientific findings behind it were published recently in the journal Biomacromolecules. A company, CollPlant Ltd ., has been established based on patents and technology that were developed in Shoseyov's laboratory. It has raised US$15 million to establish the first commercial molecular farming company in Israel and is already manufacturing collagen-based products that have attracted collaborative commercial interest from companies in the US, Japan Europe and Israel.

Yissum, the technology transfer company of the Hebrew University, is one of the shareholders of CollPlant.. CollPlant is a public company traded in "TASE", and the potential revenue for the Hebrew University from this invention is estimated to reach into the multi-million dollar range.

The Kaye Awards have been given annually since 1994. Isaac Kaye of England, a prominent industrialist in the pharmaceutical industry, established the awards to encourage faculty, staff, and students of the Hebrew University to develop innovative methods and inventions with good commercial potential which will benefit the university and society.

Cow Products - Why ?

Bovine Neonatal Pancytopaenia (BNP) is a newly emerging disease syndrome of calves less than one-month-old which has recently been reported in Britain and Europe.
It is often referred to as calf haemorrhagic disease, haemorrhagic diathesis, bleeding calf syndrome or blood sweating disease.
The first cases of the condition were reported in Germany in 2007.Since then, reports of confirmed cases have slowly risen in a number of European countries while the first confirmed case was recently diagnosed in Ireland and there have been four cases confirmed in Northern Ireland to date.

Typically, the clinical signs in young calves can include excessive bleeding from small abrasions of the skin, or even from injection sites, and the passing of large clots of blood in the dung.

Temperature

Calves affected with the condition normally have a high temperature and become rapidly depressed. In the majority of cases, death follows within 24 to 48 hours (mortality of about 90% is commonly reported), with aggressive veterinary treatment, including blood transfusions, normally providing only a temporary respite for the animal.

The disease syndrome tends to affect single calves in a herd although multiple calves have been affected in some herds in Britain and Germany.

Affected calves tend to be found in larger well-managed herds with a large proportion of affected farms also keeping sheep as well as cattle.

Within countries that have identified cases, a geographical pattern to the occurrence of the disease has not been identified nor has any breed or gender association been established.

On post mortem examination of affected calves, significant damage to the bone marrow has been consistently reported.

The bone marrow is responsible for producing the blood cells. Red blood cells are responsible for transporting oxygen, while white blood cells play a role protecting against infection. Platelets are responsible for blood clotting.

Of these three, the platelets are most severely affected, giving rise to the typical clinical signs of poor clotting and widespread bleeding in the calf.

While the cause of the condition is unknown, there is no evidence that the condition is infectious or that it gives rise to food safety concerns.

The fact that apparently normal calves at birth can develop clinical signs rapidly after consuming colostrum has focused the attention of researchers on colostrum. It is possible that colostrum acts as a vehicle for the introduction into the calf of the agent which damages the bone marrow.

During the 24 hours that follow the birth of an animal, the intestine allows antibodies (a form of defence against disease) which are contained in the colostrum to pass from the gut into the blood stream. This is an important step in the transfer of immunity from the mother to her offspring and plays a vital role in preventing disease in the newborn calf.

It is possible that, in a very small percentage of calves, some of these antibodies target the bone marrow cells, leading to the clinical signs of the disease. Indeed, a similar mechanism is known to cause destruction of blood cells in some newborn foals and piglets. Researchers wish to ascertain whether this is the case in affected calves and, if so, to determine what has changed in the cow or her environment which has led to the occurrence of the condition.

The Department of Agriculture, Fisheries and Food's regional veterinary laboratories are available to assist herdowners and veterinary practitioners with laboratory diagnosis and investigation of any suspicious cases.

The Department has offered to provide free post mortem examinations of any young calf with clinical signs typical of the condition.

While the condition is rare, with minimal losses to date, the Department is always vigilant to the occurrence of novel diseases or novel presentations of existing diseases. Herd owners are asked to notify their veterinary practitioner of any young calves with apparent clotting difficulties.

Dangers of bleeding control in Kidney surgery

Interrupting the blood flow for more than 20 to 25 minutes during kidney cancer surgery leads to a greater risk for patients developing chronic kidney disease, Mayo Clinic researchers have found. The team’s study was published today in the journal European Urology.
Researchers analyzed outcomes of 362 patients with only one kidney who underwent surgery between 1990 and 2008 at Mayo Clinic and Cleveland Clinic for renal cortical tumors. Using a technique called warm ischemia, surgeons kept the patient’s kidneys body temperature during the partial nephrectomy. Ischemia involves cutting off the blood supply to the kidney with clamps in order to control bleeding and to keep blood from obscuring the surgeon’s view of the kidney. Ischemia can cause tissue damage from a lack of oxygen and nutrients.
Researchers found that each additional minute of warm ischemia is associated with a five-to-six-percent increase in the odds of developing acute renal failure or reduced kidney functioning and is associated with a six percent increased risk of new onset Stage IV chronic kidney disease during long-term follow-up.
“This is the largest evaluation of warm ischemia time in patients with a single kidney who are undergoing a partial nephrectomy,” says R. Houston Thompson, M.D., a urologist at Mayo Clinic and study primary investigator. “These results suggest that every minute counts when the renal arteries and veins are clamped. When planning for the surgery, surgeons should make efforts to minimize ischemia time, especially in situations where a person only has one kidney,” says Dr. Thompson.

Medafor's board gets a vote of confidence

Shareholders of Brooklyn Center-based Medafor Inc. on Thursday decisively rejected a suitor's proposal to withhold support from the company's board after it turned down a takeover bid.
The Atlanta biomedical firm CryoLife Inc., which is Medafor's top distributor and shareholder, abandoned its $2-a-share cash and stock bid for the privately held company in March. The Medafor board dismissed it as "grossly inadequate."
But the two companies continue to duke it out in federal court, most recently over Medafor's decision to sever the distribution agreement between the two. CryoLife had also proposed withholding support for the five-member board, on the grounds that it "has overseen the destruction of Medafor's business, its technology and the value of its shares."
Shareholders who control roughly 70 percent of the company's shares voted by a 95 percent margin to re-elect the board.
At the center of the dispute is Medafor's unique blood-clotting powder, called HemoStase, which CryoLife distributes in the United States and in some markets abroad. But the legal status of that agreement is now unclear: A ruling by a federal district judge on the matter is expected soon. (While sales have temporarily lapsed in those markets as a result of the dispute, Medafor says customers will continue to be served after the ruling.)
At Thursday's meeting, held at the Northland Inn in Minneapolis, Medafor's CEO Gary Shope said the company's revenue in 2009 grew 40 percent to $13.8 million. He said trends in the business are strong through the first quarter of this year.
"The Medafor of today is a revitalized company," Shope said. "We've had a few bumps in the road, but we'll get through it."
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, he said.
The meeting was attended by about 175 shareholders, who listened as Shope and Chairman Michael Pasquale tag-teamed a series of questions.
Many shareholders appeared frustrated that they haven't been able to cash out their long-held stock at a profit. "I say get rid of CryoLife and let investors make some money," said Jim Karercher, a longtime investor from Ortonville, Minn.
Some asked for salary figures for the two executives, a request that was denied. CryoLife claims the company's CEO and chief financial officer earned a combined $700,000 last year.
Another shareholder asked why Pennsylvania residents Shope and Pasquale don't live in Minnesota, where the company's 21 employees are based. Pasquale said the company is global, and it isn't necessary to live locally.
One noticeable absence from the meeting was Steven Anderson, CryoLife's CEO, who is a Minnesota native and a former Medtronic Inc. executive. Anderson had planned to attend the meeting, but was waylaid by a family emergency, according to CryoLife spokeswoman Nina Devlin.

CryoLife to Submit Bond After Seeking Preliminary Injunction Against Medafor

KENNESAW -- CryoLife Inc. (NYSE: CRY ) likely will be ordered to submit a bond for up to $500,000 after filing an emergency motion for preliminary injunction in a drug distribution dispute with Medafor Inc., according to an SEC filing.
CryoLife, an Atlanta-based maker of medical products that enable heart and blood vessel reconstructive surgery, said it opposed Medafor's demand for a bond in the range of $14 million to $40 million because any injunction would not harm the defendant.
The U.S. District Court in Atlanta said it requires a bond before issuing a preliminary injunction, and ordered the two litigants to submit proposed bond amounts by June 11. The filing states the court is considering a bond in the range of $100,000 to $500,000.
CryoLife accuses Minneapolis-based Medafor of violating a drug distribution agreement by allowing other companies to distribute Hemostase, an absorbable blood-clotting agent manufactured by Medafor, in territories and medical fields reserved exclusively for CryoLife.
Under the agreement, CryoLife said it is the exclusive U.S. distributor of the drug used in cardiac and vascular surgery, excluding those performed at Department of Defense hospitals; and the exclusive distributor internationally, except China and Japan , for all surgeries other than orthopedic and ear, nose and throat surgery.
Medafor, in turn, accuses CryoLife of violating their exclusive distribution deal by selling Hemostase in Spain for uses allegedly barred by the agreement.

Grifols to Acquire Talecris Biotherapeutics Creating a World Leading Provider of Life-Saving Plasma Protein Therapies

BARCELONA, Spain and RESEARCH TRIANGLE PARK, N.C., June 7, 2010 /PRNewswire via COMTEX/ -- Grifols (GRF.MC) a global healthcare company and leading producer of plasma protein therapies, and Talecris(TLCR 19.97, +4.06, +25.48%) a U.S.-based biotherapeutics products company, today announced that they have signed a definitive agreement through which Grifols will acquire Talecris for a combination of cash and newly-issued Grifols non-voting shares having an aggregate value today of approximately $3.4 billion (euro 2.8 billion), creating a global leader of life-saving and life enhancing plasma protein therapeutics.

The combination of Grifols and Talecris will create a vertically integrated and diversified international plasma protein therapies company, bringing together complementary geographic footprints and products, as well as increased manufacturing scale. Grifols' leading global footprint will benefit from Talecris' strong presence in the United States and Canada. Grifols' available manufacturing capacity will enable Talecris to increase production in the near term. As a result, the combined company will be better able to meet the needs of more patients with under-diagnosed disease states around the world.

In addition, upon completion of the transaction, the combined company will have:

• the ability to derive more protein therapies from every liter of plasma, enhancing access and availability for patients, and optimizing use of collected plasma;
• an established plasma collection operation capable of meeting the combined company's needs to address increasing patient demand and an accelerated path to improving the cost efficiency of the Talecris plasma platform;
• a broad range of key products addressing a variety of therapeutic areas such as neurology, immunology, pulmonology and hematology, among others;
• an enhanced R&D pipeline of complementary products and new recombinant projects that will drive sustainable growth;
• a well established clinical research program in the U.S.

Grifols Chairman and CEO Victor Grifols commented, "The acquisition of Talecris furthers our vision to better serve patients and health care professionals with innovative products, a strong clinical research capability and new research into recombinant therapies. We look forward to combining the strengths of both companies to improve the quality of the lives of patients around the world, while positioning the enlarged group for long term profitable growth."

Talecris Chairman and CEO Lawrence D. Stern commented, "We believe that Grifols' well-established reputation, know-how and expertise will enable the combined entity to meet the needs of more patients. Our employees will benefit from the opportunities available to them as part of a larger, global organization committed to the expansion of Talecris' existing business, the development of our pipeline products, and the maintenance of our culture of compliance and quality. Importantly, our stockholders will realize a compelling premium and benefit from the ability of the combined business to accelerate key gross margin improvement opportunities within Talecris."

CryoLife purchases recombinant human serum albumin and gluteraldehyde formula

ATLANTA, June 7 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company whose products include BioGlue Surgical Adhesive, announced today that it has completed the purchase of U.S. patent # 6,329,337. The patent involves the formulation and use of recombinant human serum albumin and gluteraldehyde, and now becomes part of CryoLife's protein hydrogel patent portfolio, which includes BioGlue.

"CryoLife will continue to invest in emerging and adjacent intellectual property and tools that will complement our portfolio of surgical adhesives and glues for surgeons," said CryoLife president and CEO Steven G. Anderson. "With our acquisition of this technology, we have an additional opportunity to expand and strengthen our surgical adhesive portfolio," Anderson added.

CryoLife's BioGlue Surgical Adhesive is the leading surgical adhesive used in cardiovascular surgery around the world and is used in a wide range of reconstruction procedures. Composed of purified bovine serum albumin (BSA) and gluteraldehyde, BioGlue has been used in more than 550,000 surgical procedures and has been published in more than 250 preclinical and clinical papers discussing safety, efficacy, and application techniques since its launch in 1998.

"The strength of BioGlue assures the surgeon that delicate tissues are well reinforced and assists in controlling bleeding in complex surgery. We believe that these and other properties of BioGlue Surgical Adhesive make it a leading sealant used in complex cardiac and vascular surgery," Anderson said.

Surgical Complications of bleeding, infection dehiscence and necrosis are interelated

Miami — Keeping good closures from going bad requires not only thorough patient education and surgical planning by the physician, but also patient adherence to pre- and post-surgical instructions, according to an expert who spoke at the 68th annual meeting of the American Academy of Dermatology.

Common surgical complications include bleeding, infection, dehiscence and necrosis, all of which are usually interrelated, says Emily J. Fisher, M.D., chief of cosmetic and laser dermatology, Lahey Clinic, Burlington, Mass. "It's very unlikely to have one of these without a second, third or fourth complication occurring," she says.

Typical examples include lower-leg complications, where lack of skin laxity and excess wound tension can lead to tissue ischemia and necrosis, as well as infection and dehiscence.
Bleeding risks

Bleeding and infections represent the most common types of postsurgical complications, Dr. Fisher says. "Minor hemorrhagic complications include increased intraoperative bleeding, which can be a challenge. But if you get it under control, it doesn't usually cause long-term problems," she says.

However, intraoperative bleeding also can increase the length of procedures and drive surgeons to choose less-than-optimal closures. "If the patient is having significant bleeding, performing a complicated flap or graft can be challenging and poses an increased risk of bleeding due to the amount of undermining necessary," Dr. Fisher says. "As a result, a surgeon may opt to perform a simpler closure to decrease this risk, but that may not be the best from a cosmetic standpoint.

"More worrisome complications include postoperative bleeding," she says. "That may require flap takedown and additional hemostasis." Often, Dr. Fisher's patients who experience postoperative bleeding will seek treatment at emergency rooms — even though she warns them not to — where ER physicians may make unwise or unnecessary alterations to the flap or graft. Fortunately, she says, although studies show postoperative bleeding is the most common dermatosurgical complication, it only impacts about 2 percent of patients (Cook JL, Perone JB.Arch Dermatol. 2003 Feb;139(2):143-152).

Full Article HERE

J&J comment on EU market and the US release of Fibrin Pad

Johnson & Johnson's (JNJ) big medical devices and diagnostics unit anticipates that pressure on product prices in Europe will rise over the long term but not immediately, the unit's top official said Thursday.
J&J also said it expects the portion of the $350 billion devices and diagnostics market it competes in to grow at a faster rate than the overall market.
Additionally, the company anticipates that unit will make about 80 "significant" regulatory filings between 2010 and 2010.
J&J, which is dealing with fallout from the recent recall of children's medicines, is holding an all-day review Thursday for the devices and diagnostics unit. That unit grew sales by 2% to $23.6 billion last year and became J&J's largest segment, eclipsing a pharmaceutical business that has been pressured by competition from generic drugs.
The segment derived more than half of its sales last year from outside the U.S. A big question for device and drug companies these days is how the European debt crisis will affect product prices as governments try to rein in health spending.
"I think longer term we clearly see there being increased pricing pressure," Alex Gorsky, worldwide chairman for J&J's devices and diagnostics unit, said during the meeting. But there are reasons to believe it won't be an "immediate" issue, and doesn't mirror the situation with drug prices, he said.
These reasons include the tendering systems used to purchase devices and the dynamics between hospitals and governments, he said.
Pricing in Europe remained a top issue when analysts asked questions. Gorsky told them the pricing issue is difficult to forecast. He also said J&J hasn't seen a slowdown in procedure volumes that could also impact sales, but added "we'll have to watch closely."

Healthcare company Johnson & Johnson (JNJ), Thursday revealed growth strategies and product pipeline information for its Medical Devices & Diagnostics Segment. The company said the segment was its largest, and that new products and acquisitions would help sustain its market-leading position in the $350 billion, worldwide medical device and diagnostics market.
The New Brunswick, New Jersey-based company provided information on products that have been launched already or are on the anvil for the current fiscal, from its seven global franchises.
Ethicon Endo-Surgery, a maker of surgical device solutions for minimally invasive and open surgery; and Advanced Sterilization Products is rolling out a host of new products, J&J said. They include new energy instruments as part of its HARMONIC family of technology that delivers precise ultrasonic energy to minimize thermal tissue damage to the patient, while providing surgical efficiency.
Further, Ethicon continued to focus on patient comfort and surgeon ease-of-use as it built its portfolio of hernia repair products with ETHICON PHYSIOMESH Flexible Composite Mesh and its first entry into the hernia mesh fixation market with ETHICON SECURESTRAP 5mm Strap Fixation Device.
Ethicon Endo-Surgery would make a BLA filing in the U.S for its Fibrin Pad in the fourth quarter. The product combines two biomaterials and two biologics to stop bleeding during surgical procedures.

Cytomedix to Present at Sixth Annual Noble Financial Equity Conference

ROCKVILLE, Md., June 1, 2010 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (NYSE Amex:GTF) (the "Company"), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that the Company will participate in the Sixth Annual Noble Financial Equity Conference taking place June 7-8, 2010 at the Seminole Hard Rock Hotel in Hollywood, Florida.

Martin Rosendale, President and CEO of Cytomedix, will present a corporate update on Tuesday, June 8, 2010 at 1:30 p.m. ET in which he will provide an overview of Cytomedix, including an update on the integration of its recent acquisition of the Angel® Whole Blood Separation System and the activAT® Autologous Thrombin Processing Kit from the Sorin Group.

Company management will be available for one-on-one meetings with investors participating in the Noble Financial Equity Conference. For those who would like to schedule an appointment with Cytomedix's management, please contact Anne Marie Fields, Lippert/Heilshorn & Associates, Inc., at 212-838-3777 or at afields@lhai.com or contact your Noble Financial representative.

The presentation will be video webcast live at www.cytomedix.com where it will also be archived for 90 days.

About Cytomedix

Cytomedix is a biotechnology company that develops, sells, and licenses regenerative biological therapies, to primarily address the areas of wound care, inflammation, and angiogenesis. The Company currently markets the AutoloGel™ System, a device for the production of platelet rich plasma ("PRP") gel derived from the patient's own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for separation of whole blood into red cells, platelet poor plasma and platelet rich plasma ("PRP") in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from platelet poor plasma. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is currently pursuing a multi-faceted strategy to penetrate the chronic wound market with its products. Cytomedix is also pursuing opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics, as well as actively seeking complementary products for the wound care market. The Company also seeks to monetize other product candidates in its pipeline through strategic partnerships, out-licensing, or sale. Most notably is its anti-inflammatory peptide (designated "CT-112") that has shown promise in pre-clinical testing. Additional information regarding Cytomedix is available at www.cytomedix.com.