Wednesday, May 7, 2008

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

Tuesday, May 6, 2008

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.

Sunday, May 4, 2008

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

Saturday, May 3, 2008

ANNOUNCEMENT - Medical Hemostat Forum

I have added a new forum for readers HERE the aim is providing a place where those with an interest may share ideas, discuss technology, network and ask questions. The forums are anonymous and you are able to communicate with others freely (within the boundaries of "good taste"). I hope it maybe a useful meeting point for manufacturers, distributors and medical professionals. Currently the forums will be somewhat of a testing ground based on use, so if you feel it maybe a useful resource I encourage you to REGISTER and have your say!

Thursday, May 1, 2008

Covidien Introduces the VascuSeal


Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced that its Surgical Devices business unit has introduced the VascuSeal™ Vascular Sealant System throughout Europe and in select Middle East markets. VascuSeal™ offers surgeons a unique advanced hydrogel that provides an immediate, blood-tight seal that is effective intraoperatively and throughout the critical healing period. VascuSeal™, which is CE-Marked, is intended for use as a surgical sealant during arterial and venous reconstructions to seal suture lines.
Unlike a hemostatic agent, a vascular sealant can seal blood leaks and does not depend on either the time for the blood to clot or the strength of the blood clot to perform successfully. The VascuSeal™ Sealant System offers surgeons a valuable tool to reduce bleeding from the suture line in vascular bypass procedures, and reduces post-operative complications associated with suture line bleeding.
The VascuSeal™ sealant technology is a patented synthetic, absorbable hydrogel delivered by a dual syringe applicator. The device can be stored at room temperature and prepared in less than two minutes. VascuSeal™ sealant polymerizes within seconds when sprayed on the suture line and is blue in color which provides the vascular surgeon visualization of coverage and thickness of the material upon application. Postoperatively, VascuSeal™ sealant continues to seal the suture line as healing progresses under the gel. After several days, the hydrogel breaks down into water-soluble molecules that are absorbed and cleared through the kidneys.
“The VascuSeal™ Vascular Sealant System represents another innovative product in the BioSurgery marketplace,” said Scott Flora, President, Surgical Devices, Covidien. “We expect VascuSeal™ to be well-received by surgeons looking to improve patient outcomes, save time and reduce blood loss during surgical procedures,” added Flora.

Wednesday, April 30, 2008

Clottocytes: Artificial Mechanical Platelets

While to some Robert A. Freitas Jr.'s clottocyte technology may resemble science-fiction recent developments in the hemostasis field lend his ideas more credibility.............The artificial mechanical platelet or clottocyte may allow complete hemostasis in as little as ~1 second, even in moderately large wounds. This response time is on the order of 100-1000 times faster than the natural system. Our baseline clottocyte is conceived as a serum oxyglucose-powered spherical nanorobot ~2 microns in diameter (~4 micron3 volume) containing a fiber mesh that is compactly folded onboard. Upon command from its control computer, the device promptly unfurls its mesh packet in the immediate vicinity of an injured blood vessel — following, say, a cut through the skin. Soluble thin films coating certain parts of the mesh dissolve upon contact with plasma water, revealing sticky sections (e.g., complementary to blood group antigens unique to red cell surfaces) in desired patterns. Blood cells are immediately trapped in the overlapping artificial nettings released by multiple neighboring activated clottocytes, and bleeding halts at once.......................................Read more HERE

Who else is interested in Nanotech? ........Hemcon, Alltracel


HemCon's acquisition of Alltracel gives access to Alltracel's joint venture with Elmarco and its proprietary nanotechnology manufacturing process called Nanospider®. HemCon will seek to leverage this process to aggressively grow its market share in acute wound care products developed from chitosan.

Elmarco is a specialist R&D and manufacturing company that has developed, in conjunction with the Technical University of Liberic, a novel proprietary & patented process for spinning polymers into nano-scale fibres for a range of industrial, chemical, micro-electronic and bio-medical applications. This proprietary technology branded Nanospider", represents a major breakthrough in the mass production of nanofibre materials and is now deployed in a number of markets including medical products.
NANOPEUTICS headquartered in Liberic in the Czech Republic and operating internationally has been assigned the relevant woundcare and Nanospider(TM) intellectual property and patents and has already been in advanced discussions including successful product testing with a number of existing consumer and professional woundcare companies.

Nanoparticle Laden High-Tech Gauze Looks To Save Lives


Nanoparticles are one of the hottest fields of studies. These tiny molecules promise to revolutionize everything from medicine, to computing, to power, to water purification. The diverse uses being discovered are only limited by the difficulties in bringing this incredibly promising technology to market.
Now the scientific community is enthralled by a perhaps unexpected new use of the particles -- high-tech gauze. By using a special gauze fabric, permeated with Kaolin clay which is rich in aluminosilicate nanoparticles, scientists have discovered they can dramatically inducing clotting that is nothing short of a medical miracle.
The gauze bandage is easy to apply and greatly improves clotting in hard to apply regions such as the neck or groin. This makes it ideal for the battlefield. In recent conflicts, such as the Iraq war, many of the casualties have been due to blood loss. The new gauze could soon be saving lives.
Richard McCarron, head of trauma and resuscitative medicine at the Naval Medical Research Center in Maryland stated, "We are currently testing bandages because hemorrhage is a leading cause of death in military trauma patients. The recent tests with Combat Gauze indicate that it decreased blood loss and improved survival."
Z-Medica, a medical products company located in Connecticut, manufactures the high tech gauze. Z-Medica CEO Ray Huey says the new gauze has already saved two lives. Huey describes his company's start, stating, "In 2002, following the September 11 attacks, the military was looking at new technologies to stop bleeding."
The company easily won the Navy's test of high-tech medical products, according to Huey, when Z-Medica debuted its first product, QuikClot, a special powder dumped on wounds to induce clotting. The powder is currently in use in Afghanistan and Iraq. However, despite saving lives QuikClot had some nasty side effects. During the clotting process, the powder heated up enough to cause burns, which many of the soldiers complained of. While burns were better than dying, Z-Medica went back to work looking for a better solution.
A leading materials researcher Galen Stucky led a team of several graduate students and collaborated with Z-Medica to solve the problem. Stucky's solution was to instead use a material frequently used in medical testing -- Kaolin Clay. The clay's nanoparticles trigger clotting.
Graduate student April Sawvel explains, "Kaolin clay has been used since the 1950s as an activating agent for a clotting test that medical doctors routinely perform. We tested it against the original granular QuikClot and discovered that it worked just as well, but without the large heat release associated with the original QuikClot formulation."
While some nanoparticles are thought to possibly be hazardous, there is little known risk from aluminosilicate nanoparticles, which have been frequently which mankind has been in contact with since its early days. Further, the nanoparticles are trapped by the clot at the site of the injury, so should have little chance of traveling into the body.
Having found the new material the team found that it was much easier to use it, when it was added to gauze, instead of a powder. Huey describes, "We immediately started looking at ways to impregnate gauze with this material. We very quickly prototyped some material. When I say very quickly, I mean within less than two weeks."

The video below shows the original Quikclot.