FDA Approves New Formulation of Coagulation Therapy

WASHINGTON (Reuters) - Denmark's Novo Nordisk won U.S. approval to sell a new formulation of a genetically engineered protein therapy that helps the blood clot, regulators said on Friday.
The product, NovoSeven RT, can be stored at room temperature for up to two years, the Food and Drug Administration said. An older formulation had to be refrigerated.
NovoSeven RT is a genetically engineered version of Factor VIIa, a protein found in plasma that is essential for the clotting of blood.
Approved uses of NovoSeven RT include treatment of bleeding, and prevention of surgical bleeding, in certain patients with hemophilia.

Read FDA News HERE

Omrix Biopharmaceuticals Announces First Quarter 2008 Financial Results

Omrix Biopharmaceuticals, Inc. (“Omrix” or the “Company”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, today announced financial results for the first quarter ended March 31, 2008: Read more HERE

In 2003 and 2004, Omrix entered into development, distribution and supply agreements with Ethicon Inc., a Johnson and Johnson company. The partnership agreement between OMRIX and Ethicon allows each company to do what it does best: OMRIX will manufacture products and hold regulatory licenses; Ethicon will retain exclusive sales and marketing rights in the U.S. and EU to OMRIX biosurgical products in the field of hemostasis and sealing only.

Cohera Medical, Inc. Announces Closing of Insider Round of Financing for Over $7.6 Million

PITTSBURGH, May 7 /PRNewswire/ -- Cohera Medical, Inc., a rapidly growing medical device company developing a suite of wound management systems and surgical adhesives, announced today that it has closed an insider round of financing for over $7.6 Million. The proceeds of this transaction will support the growth of the company through pilot clinical trials for its lead product, TissuGlu(R), a strong, resorbable surgical adhesive, as well as pre-clinical development of Cohera's product pipeline.
"Cohera has generated significant value since our last financing and this is reflected in the strong support from our shareholders," said Patrick Daly, President and CEO of Cohera Medical. "The team at Cohera is focused on developing world class products that improve patient care and we are excited about the future of the Company."
"As Cohera's largest investor through our affiliate Kern Medical, LLC, we are delighted to once again lead its investment round," said Jay Kern, Founder and General Partner of Kern Whelan Capital, LLC, and Manager of Kern Medical II. "Strong participation by existing investors in this financing reflects the significant accomplishments that Patrick and his team have made in developing Cohera's revolutionary line of adhesive products."

TissuGlu - Unlike “Superglue” products, TissuGlu® is biocompatible and biodegradable, making it safe for internal use. Unlike “fibrin glue” products, it is strong, easy to use, and contains no human or animal product derivatives. Studies in the laboratory have demonstrated that the bond created with TissuGlu® is as strong after one hour as a normal wound is after a week of healing. It works well on planar surfaces, binding tissue layers to eliminate the potential space between recently separated tissues in which fluid accumulates (potentially reducing the need for fluid drains).

ThermoGenesis, GE Deal

RANCHO CORDOVA, Calif., May 7 --ThermoGenesis Corp. , a leading supplier of innovative products and services that process and store adult stem cells, said today that in partnership with GE Healthcare it has restructured its existing International Distribution Agreement to maximize the AXP product value utilizing each parties' respective strengths and focusing on long-term strategic goals.........more HERE

Global Blood Resources LLC

.....The UConn Health Center in Farmington began using the Hemobag more than a year ago.One of the first institutions to use the device was Salem Hospital in Salem, Ore."We've used over 800 Hemobags," said Scott Beckmann, one of the hospital's perfusionists. "We're using less blood bank products. That's been a cost savings for the hospital."Before Salem Hospital began using the device, "We used cell washers that would wash away significant and beneficial blood elements and would only give back red blood cells — red blood cells are important, but that's not all there is to it," Beckmann said. "Ethically, we would look at this waste bag full of viable elements — proteins, platelets that help plug that hole in the artery — and it was being thrown out."When the Hemobag was finally made available, we sat down with the surgeons and said, 'This looks like a helpful device.' We said 'Let's try it for two weeks,' and before the two weeks were up, we decided to use it during every surgery."...................read more HERE

Orthovita and ThermoGenesis financial reports

Orthovita Reports 2008 First Quarter Financial Results - HERE
ThermoGenesis Corp. Announces Third Quarter Fiscal 2008 Results - HERE

FDA asks ZymoGenetics to revise new product's press release

FDA Letter HERE
The U.S. Food and Drug Administration says ZymoGenetics omitted important facts when announcing the launch of its first commercial product, Recothrom, and it asked the company to revise the press release.
The Seattle company's product is a genetically engineered form of thrombin, a protein that helps control surgical bleeding. In a Jan. 17 press release, ZymoGenetics said its product was shown to be as effective as a competitor derived from bovine blood, and had a "lower incidence of antibody formation."
In a letter posted on the FDA's website Wednesday, the agency called that statement "false or misleading," because it suggested that bovine thrombin's antibodies are less safe than Recothrom. In clinical trials, the agency noted, the antibodies did not lead to adverse events in patients treated with the bovine product. Both products had similar instances of adverse events, the FDA said.
In response to the FDA letter, ZymoGenetics added a three-sentence footnote with the missing information. The information is already present in the company's promotional materials, said spokeswoman Susan Specht. "This will not change the sales materials," she said.
The FDA action underscores the fierce competitiveness of the medical market — and how closely federal regulators watch over it. ZymoGenetics has asserted that genetically engineered products, also called recombinant, are less risky than those derived from bovine or human blood, which could contain impurities.
The company said Tuesday that its Recothrom sales had reached $1 million in the first quarter of its launch.
"We believe the launch is going well, and we're seeing strong interest in the marketplace, reflecting an appreciation for the advantages of a recombinant topical hemostat," said Chief Executive Bruce Carter.
Kevin DeGeeter, an analyst with Oppenheimer & Co, said in a note that Recothrom adoption is "taking longer than previously thought," and called the launch "soft."
Many hospitals targeted by ZymoGenetics are stocking both Recothrom and its bovine competitor made by King Pharmaceuticals.
McAdams Wright Ragen analyst Paul Latta cut his 2008 sales outlook to $18 million from $30 million, but said the product's long term potential remained unchanged.
"We're still seeing a $300 million to $400 million product in three to five years," Latta said. "But clearly it will take a while to get there."
Source:Seattletimes.com

ZymoGenetics says first product is meeting expectations

ZymoGenetics says first product is meeting expectations
ZymoGenetics' executives said Tuesday that the company's first commercial product, a synthetic protein to control bleeding during surgery, has brought in nearly a million dollars in sales since its launch in mid-January ?an amount they said met their expectations.
However, analysts cautioned that it was too early to tell how much market share ZymoGenetics' product, Recothrom, would ultimately capture from King Pharmaceuticals, which has dominated the market for treatments to control bleeding during surgery for more than a decade.
ZymoGenetics claims that Recothrom avoids complications associated with King's animal-derived product, which is sold with a warning regarding the potential for abnormalities, including severe bleeding.
Although the Recothrom sales numbers were below several analyst's estimates, analysts said that the early figure was largely inconsequential.
Because Recothrom is bought by hospitals, committees at those institutions have to meet in order to decide whether to add the treatment to the selection of products that doctors can choose from to use. The process can take six months or more.
"Everybody wants to read a lot of information into the first data point you get. But it's the first one you get," said Kevin DeGeeter, an analyst at Oppenheimer & Co., who has repeatedly questioned Recothrom's prospects because ZymoGenetics has priced Recothrom at a 20 percent premium to King's product. "My concern ultimately remains the same."
DeGeeter had estimated that Recothrom would bring in $3.3 million during the first quarter. "There's nothing here to suggest this is jumping off the shelves," he said.
Hanzhong Li, an analyst at Stanford Group, expected Recothrom to bring in $2 million but said the figure was largely a "placeholder," noting that ZymoGenetics had long said that most of Recothrom's sales would take place during the second half of this year. He estimates that Recothrom sales will reach $35 million for the year.
Of the 60 hospital committees that have reviewed Recothrom so far, 22 have decided to buy the product exclusively, while another 27 more have added it, in addition to the King product, said ZymoGenetics CEO Bruce Carter during a conference call. The other committees have not yet made decisions. An additional 100 committee meetings will take place this month alone.
Carter said that ZymoGenetics has enlisted the support of more than 2,000 surgeons and 1,000 pharmacists to ask that their institutions add Recothrom to the selection of products that they could use.
"It will take time for our efforts to bear fruit," he said during the conference call, which was held to report the company's first-quarter earnings. "We do expect that work to pay off in the second half of the year."
For the quarter, ZymoGenetics said that its total revenue increased to $13.5 million, compared to $5.2 million during the same period a year earlier, due in part to milestone payments associated with treatments in its pipeline. The company also posted a net loss of $40.9 million, or 60 cents per share, compared with a net loss of $33.3 million, or 49 cents a share, during the first quarter of 2007.
As of March 31, ZymoGenetics had $155 million in cash and short-term investments.
During the conference call, ZymoGenetics CFO James Johnson said that the company was working on a "financing transaction" to raise additional funds this year. He said the company could potentially use its inventory of Recothrom in order to raise money.
DeGeeter of Oppenheimer & Co. said Johnson's remarks probably meant that the company would issue debt, backed in part by its inventory. But he said the company would probably eventually also have to issue more stock to raise funds.
"You have a company that in the first quarter that lost $41 million," he said. "How quickly can they grow sales to get that number down to something more manageable? Because $41 million is not manageable. We'll see."
May 6, 2008 3:26 p.m. View more HERE

Gecko-Inspired Bandage May Heal Surgical Incisions

Elizabeth Dougherty, Harvard-MIT Division of Health Sciences and TechnologyFebruary 18, 2008
MIT researchers and colleagues have created a waterproof adhesive bandage inspired by gecko lizards that may soon join sutures and staples as a basic operating room tool for patching up surgical wounds or internal injuries.
Drawing on some of the principles that make gecko feet unique, the surface of the bandage has the same kind of nanoscale hills and valleys that allow the lizards to cling to walls and ceilings. Layered over this landscape is a thin coating of glue that helps the bandage stick in wet environments, such as to heart, bladder or lung tissue. And because the bandage is biodegradable, it dissolves over time and does not have to be removed.
The team is led by MIT Institute Professor Robert Langer and Jeff Karp, an instructor of medicine at Brigham and Women's Hospital and Harvard Medical School. Both are also faculty members at the Harvard-MIT Division of Health Sciences and Technology (HST). Their colleagues include several other researchers from MIT, as well as from the University of Basel, Switzerland. In addition, Dr. Jeff Borenstein and David J. D. Carter from Draper Laboratory fabricated the nanomolds involved in the work, and Jay Vacanti and Cathryn Sundback performed all animal experiments with colleagues at Massachusetts General Hospital.
The work is described in the Feb. 11 online issue of the Proceedings of the National Academy of Sciences.
"There is a big need for a tape-based medical adhesive," said Karp. For instance, a surgical adhesive tape made from this new material could wrap around and reseal the intestine after the removal of a diseased segment or after a gastric bypass procedure. It could also patch a hole caused by an ulcer. Because it can be folded and unfolded, it has a potential application in minimally invasive surgical procedures that are particularly difficult to suture because they are performed through a very small incision.
Gecko-like dry adhesives have been around since about 2001 but there have been significant challenges to adapt this technology for medical applications given the strict design criteria required. For use in the body, they must be adapted to stick in a wet environment and be constructed from materials customized for medical applications. Such materials must be biocompatible, meaning they do not cause inflammation; biodegradable, meaning they dissolve over time without producing toxins; and elastic, so that they can conform to and stretch with the body's tissues.
The MIT researchers met these requirements by building their medical adhesive with a "biorubber" invented by Karp, Langer and others. Using micropatterning technology--the same technology used to create computer chips--the researchers shaped the biorubber into different hill and valley profiles at nanoscale dimensions. After testing them on intestinal tissue taken from pigs, they selected the stickiest profile, one with pillars spaced just wide enough to grip and interlock with the underlying tissue.
Karp then added a very thin layer of a sugar-based glue, to create a strong bond even to a wet surface. The resulting bandage "is something we never expect to remove," said Karp. Because of that difference, he continued, "we're not mimicking the gecko"--which has sticky feet but can still lift them up to walk--"we are inspired by the gecko to create a patterned interface to enhance the surface area of contact and thus the overall strength of adhesion."
When tested against the intestinal tissue samples from pigs, the nanopatterned adhesive bonds were twice as strong as unpatterned adhesives. In tests of the new adhesive in living rats, the glue-coated nanopatterned adhesive showed over a 100 percent increase in adhesive strength compared to the same material without the glue. Moreover, the rats showed only a mild inflammatory response to the adhesive, a minor reaction that does not need to be overcome for clinical use.
Among other advantages, the adhesive could be infused with drugs designed to release as the biorubber degrades. Further, the elasticity and degradation rate of the biorubber are tunable, as is the pillared landscape. This means that the new adhesives can be customized to have the right elasticity, resilience and grip for different medical applications.
"This is an exciting example of how nanostructures can be controlled, and in so doing, used to create a new family of adhesives," said Langer.

Iran invents extremely sticky nanoglue

Iranian scientists have employed nanoparticles in an innovative way, inventing a new generation of tension-resistant tissue glue.
The 'nanoglue' made of branched biopolymer is characterized by its high adhesive and tension-resistant quality. Its effect becomes apparent in less than a minute.
Scientists say because it is rich in fibrinogen, extracted from the patients own blood, allergic reactions are rarely reported when used.
The glue also contains high amounts of fibronectin, which facilitates the conjunction of biological agents to a cellular scaffold, improving the tissue repair process.
Shahid Beheshti University scientists claim the glue has been successfully tested in repairing intestines, trachea, fallopian tubes and brachial plexus on dogs.
They add that the intestinal repair process, considered as one of the most sophisticated operations, can be simplified using the new glue.
According to the scientists, the glue has also shown promising results in repairing fallopian tubes, helping the treatment of infertile couples.
source: presstv