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.

Wound-Sealing, Self-Assembling, Nanoscale Technology

A super-stealthy MIT (Massachusetts Institute of Technology) spinoff is poking its head out today to announce that it has finalized a licensing agreement with the Institute. The pact gives Arch Therapeutics rights to a family of clear liquids developed by research scientist Rutledge Ellis-Behnke that stanch or prevent bleeding after an injury or during surgery.

Ellis-Behnke and his colleagues had started out working with the liquids, which are packed with tiny protein fragments, or peptides, as potential aids to the regeneration of damaged neural tissue; they discovered in the course of brain surgeries on lab animals that some of the peptides stopped bleeding—within just 15 seconds. It turned out that what was happening was the nanoscale peptides were self-assembling into a biodegradable gel that sealed the wound on contact.

Around the same time as that work was published in 2006, Ellis-Behnke founded Arch—which then went by the perhaps-too-literal Clear Nano Solutions—with healthcare investment veteran Terrence Norchi and Steve Kelly, a serial entrepreneur and founding CEO of Myomo, another MIT spinoff. (Both Myomo’s founders and Ellis-Behnke have received grants from MIT’s Deshpande Center for Technological Innovation.) The company still has yet to ink any venture financing deals; in an article in Mass High Tech written shortly after the company’s founding, Kelly was identified as the sole investor in the firm.

It’s still early days, but Arch materials might eventually be used in the operating room, on the battle field, or even in first-aid kits. Says former Cleveland Clinic head and Arch advisor Floyd D. Loop in a press release: “Discovering ways to control something so fundamental as bleeding has potentially huge implications for the medical field.”
I had trouble viewing the 2006 Pdf full description at its web location so I have made it public hosting it at http://www.adrive.com/ and it is available HERE.

Cryolife BioGlue for Abdominal Aortic Aneurysm Repair

10% of people given fibrinogen have HCV

The Yomiuri Shimbun
About 10 percent of the 7,400 or so patients who were administered the blood product fibrinogen were infected with hepatitis C, a Health, Labor and Welfare Ministry study team announced Tuesday.
The team has been investigating patient records kept at medical institutions to which fibrinogen was shipped. The product was made by Green Cross Corp., a predecessor of Mitsubishi Tanabe Pharma Corp.
An estimated 10,000 people are thought to have been infected with the hepatitis C virus after the blood product fibrinogen was used in surgical operations involving about 280,000 people. However, the results of the investigation suggest this percentage of infection, 3.6 percent, could be lower than the true figure, medical sources said.
In its interim report, the study team found 99 people infected after being treated with fibrinogen have died from hepatitis-related diseases.
Fibrin glue, used as a surgical adhesive, was the most common use of fibrinogen among patients, making up about 40 percent of cases. Direct intravenous injection of fibrinogen as a hemostat agent in operations, including parturitions, accounted for 30 percent of treatments involving the product.
The survey results prompted the ministry to renew its call for people who have had surgery to have hepatitis checkups.
Out of 6,609 medical institutions to which Green Cross delivered the product, 644 institutions that kept individual patients' records of administration of fibrinogen were surveyed at the end of February. Of them, 475 institutions provided valid responses.
According to the survey, 7,406 patients were administered fibrinogen, and 741 of them were found to have been infected with HCV. Of them, 12 also had been infected with the hepatitis B virus, while 40 others had been infected with HBV alone.
Hospitals are unsure whether 4,908 of the 7,406 patients have hepatitis. The number of people found to have been infected likely will further rise as the investigation progresses, the medical sources said.
Of patients administered fibrinogen, 1,817, or 24.5 percent, have already died. Of them, 99 died from hepatitis-related diseases.

Entegrion achieve FDA approval

Entegrion, Inc., a privately owned life sciences product development company specializing in technologies for hemorrhage control, resuscitation, and tissue repair, announced that it has received 510(k) market approval from the U. S. Food and Drug Administration (FDA) for its hemostatic medical textile technology. The first application of the technology is Stasilon FR – hemostatic wound dressings for first responders. This market includes EMS workers, police officers, emergency personnel and fire fighters. The Stasilon FR – hemostatic wound dressing was approved by the FDA for use by medical professionals under prescription and “over-the-counter” by consumers to control bleeding resulting from “minor cuts and abrasions” as well as “lacerations, punctures and incisions.” Pending acceptance of an amendment to the FDA approval, a second version of the technology will be implemented as Stasilon OR – hemostatic surgical pads.
Entegrion 510K available HERE

CryoLife to Distribute FDA-approved Hemostatic Agent Under Private Label

ATLANTA, April 17 /PRNewswire/ --
CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue
processing company, announced today that it has signed an exclusive
three-year agreement with Minneapolis-based Medafor, Inc.

Under terms of the agreement CryoLife will distribute Medafor's microporous polysaccharide hemostatic agent for use in cardiac and vascular surgery in the U.S. and for cardiac, vascular and general surgery, other than orthopaedic and ear, nose and throat surgery, outside the U.S. (excluding Japan and China). CryoLife expects to begin distributing Hemostase MPH in the U.S. in the second quarter of 2008, except to approximately 41 hospitals for which Medafor will retain distribution rights until no later than December 31, 2008. Outside of the U.S., CryoLife expects to begin distributing Hemostase MPH in Canada, United Kingdom and Germany in the second quarter of 2008, with distribution in other markets beginning in 2009. Department of Defense hospitals are excluded from CryoLife's territory under the distribution agreement, but Veterans' Administration Hospitals are included. The unique, absorbable powder hemostat, which received CE Mark approval in 2003 and FDA pre-market approval in September 2006, will be distributed by CryoLife under the private label name Hemostase MPH. Hemostase MPH is developed using Medafor's exclusive, licensed Microporous Polysaccharide Hemospheres technology (MPH(R)), which yields a plant-based, flowable powder engineered to rapidly dehydrate blood, enhancing clotting on contact. When used as directed, this highly effective hemostatic agent facilitates the formation of a resilient, natural clot within just a few minutes. Available in a convenient ready-to-use applicator, Hemostase MPH, unlike many hemostatic agents, does not require additional preparation steps in the operating room or special storage conditions thereby saving valuable operating room time and resources. Pre-clinical evaluations have shown that Hemostase MPH does not promote infection and absorbs within 24-48 hours of application at the wound site, compared to other surgical hemostats which can take 3-8 weeks or more to fully break down. "Hemostase MPH gives surgeons the ability to quickly control active surgical bleeding, making it the perfect complement to CryoLife's BioGlue(R) product line, which is much stronger and provides both tissue reinforcement and sealant capabilities," stated Steven G. Anderson, president and chief executive officer. "Hemostase MPH also allows us to compete in the surgical hemostat market, which we believe totaled approximately US$380 million in the U.S. in 2007." Gary Shope, Medafor's chief executive, said, "We are pleased to be working with CryoLife as a major distribution partner. CryoLife is a world leader in its chosen areas, and its strength in sales, marketing and distribution in the cardio and vascular fields should provide great impetus to Medafor's market penetration." The agreement allows for a three-year extension at the option of CryoLife if certain minimum purchases are met.

Orthovita Introduces VITASURE™ Absorbable Hemostat

Orthovita, Inc. (NASDAQ:VITA), a spine and orthopedic biosurgery company, announced today that it has obtained certain rights to distribute an absorbable hemostat product developed by Medafor, Inc., a Minneapolis-based medical device company. The product is approved for use as a hemostat in certain surgical procedures under a pre-market approval granted by the U.S. Food and Drug Administration in 2006 and a CE Mark granted in 2003. Orthovita plans to rebrand the product as VITASURE™ Absorbable Hemostat.

VITASURE’s hemostatic mechanism of action is based on Medafor’s exclusively licensed microporous polysaccharide hemosphere technology. Through this technology, VITASURE acts as a molecular sieve to instantly extract fluids from blood, creating a powerful osmotic action that causes the particles to swell and concentrates serum proteins, platelets, and other formed elements on its surface. The VITASURE particles and their coating of compacted cells then create a matrix for the formation of a tenacious fibrin clot. The VITASURE particles are fully absorbed and enzymatically cleared within 24-48 hours.
Under its distribution agreement with Medafor, Orthovita has the non-exclusive right to sell VITASURE in the spine and orthopedic field in the United States, and certain territories outside of the United States. Medafor has responsibility for manufacturing and maintaining regulatory approvals for the product. The initial term of the agreement is scheduled to expire in December 2013 and Orthovita has the right to renew the agreement for an additional three year period if certain purchase obligations are met during the fifth year of the agreement.

Japan - Infected Fibrin glue believed used at 550 hospitals

The Health, Labor and Welfare Ministry announced Friday that 556 medical institutions nationwide are believed to have used fibrin glue, some of which is believed to have been made with tainted fibrinogen blood-clotting agents.
The medical glue, which is manufactured using fibrinogen and other chemicals, is widely used to suture and halt bleeding during medical procedures including cardiac surgery and operations to treat bone fractures and burns. Fibrin glue made with fibrinogen manufactured by Green Cross Corp., the predecessor of Mitsubishi Tanabe Pharma Corp., is suspected of having caused hepatitis C infections.
Fibrin glue is estimated to have been used in the treatment of about 79,000 people, according to surveys by drugmakers. But the names of all the medical institutions that might have used fibrin glue have not been identified, and surveys looking to reveal this information have been delayed.
According to the documents the ministry released, the usage of the glue by large-scale medical institutions, such as university hospitals, stands out as a trend.
Breaking down the figures according to area, Tokyo ranked top with 46 institutions named in the documents, followed by Hokkaido, with 43, and Osaka and Aichi prefectures, with 39 and 28 institutions, respectively.
A ministry official said: "The list of medical institutions released this time does not comprehensively cover all the institutions that might have used fibrin glue. But we hope that people will take an examination as soon as possible to see if they have been infected on the basis of the information released."
The cases of hepatitis C infections are most likely to stem from the use of fibrin glue made using Green Cross fibrinogen between 1981 and 1987.
(Apr. 12, 2008)

Baxter's Tisseel Prep

Czech company Synthesia celebrate Gelita shipment

First oxidized cellulose left Synthesia in final medical device packaging (06.06.2007)
We shipped the first completely packed delivery of oxidized cellulose to our customer! So far deliveries have left Synthesia not finally packed, but as raw material intended for further processing. Production of finally packed product is a major milestone in Synthesia´s history.
In the future only finally packed product will be leaving Synthesia´s gates. It is packed in a primary and secondary packaging, intended for use on operating rooms, labeled by trademark of our exclusive partner and worldwide distributor company called Gelita Medical. Gelitacel is distributed directly to end users, surgeons in hospitals worldwide. Click here and find more information on oxidized cellulose.

Arista Newsclip

Saving Blood Product From Human Form Of Mad Cow Disease

Amid concern that recipients of certain blood transfusions may risk infection with a deadly protein responsible for the human form of mad cow disease, researchers in Canada now report development of a special filter that quickly and effectively removes the protein from blood. In addition to causing mad cow disease, these so-called prion proteins cause a variant form of the human neurological disorder, Creutzfeldt-Jakob disease. Termed variant Creutzfeldt-Jakob Disease (vCJD), its emergence triggered recent bans on exportation of beef from Europe. Variant CJD also can be transmitted in blood transfusions. "The use of the device will significantly decrease the risk of acquiring vCJD through blood transfusions," co-author Patrick V. Gurgel, Ph.D., reported at the 235th national meeting of the American Chemical Society. The device has been approved for use in Europe "and has no competitor at the moment," said Gurgel. About the size of a person's hand, the device contains a specially-designed material that recognizes and binds to prions. "This technology adds a needed layer of protection against the transmission of vCJD through blood transfusion," said Gurgel, senior research scientist at ProMetic Life Sciences in Mont-Royal, Quebec, Canada. "Our research shows that it works." The new filter can remove prions from red blood cell concentrate in less than an hour. Transfusions of red blood cells go to thousands of patients with chronic anemia resulting from kidney failure, cancer, gastrointestinal bleeding, and acute blood loss resulting from trauma. The researchers needed five years to develop the device and are now working on ways to remove prion proteins from other blood components, including plasma and plasma proteins, Gurgel said. In previous studies, the scientists showed that the device could successfully remove prions from the blood of infected hamsters and that the disinfected blood could be injected into healthy hamsters without causing disease. More recently, the researchers demonstrated that the device can also filter healthy human blood without damaging the red blood cells and other blood components, a finding that demonstrates that the technique is safe for use on human blood, they said. Human clinical studies using the device, called the P-Capt® Prion Capture Filter, are now underway in Europe, where it has received approval for commercialization, the scientists say. The first commercialization will be in Ireland and the United Kingdom (UK) and is expected in mid 2008, in an effort to help safeguard blood supplies, Gurgel suggested. Experts believe that vCJD is acquired from eating beef from prion-infected cattle. As in cows, the disease is characterized by a slow destruction of the brain tissue, which results in nerve damage, paralysis, and eventually death. So far, vCJD has killed at least 200 people in Europe alone. Health officials are increasingly concerned that the disease may spread elsewhere, including the United States, through blood transfusions from infected individuals. There is currently no reliable blood test for detecting the disease or a way of destroying the infectious prion proteins in blood. As a result, blood donation centers in the U.S. have imposed restrictions on blood donations from individuals who have lived in Europe for at least five years, particularly in the UK, where most vCJD cases have occurred.

Hemostasis LLC

Minneapolis based Hemostasis LLC has a technology very similar to Medafor Inc.'s Arista although it is unclear which applications or countries their products are approved for? The company website says the company............. "designs and manufactures advanced Natural Clotting Polymers (NCP™) and applicators for the treatment of severe externally bleeding lacerations for first aid kits, military, civilian and emergeny room trauma. Combined disciplines of R&D experience from our MTRC™ (Medical Technology Research Center) within the medical device industry, have developed an advanced, biocompatible, natural biopolymer which revolutionizes the way hemorrhaging is treated.
Hemostasis LLC's; BleedArrest™ CP (Clotting Powder) and BleedArrest™ CF (Clotting Foam) are two new hemorrhaging and bleeding control technologies that are changing the way medical professionals are stopping bleeding in seconds. "
Their website does not disclose a lot of information, I will update as further news becomes available.
Patent info is available HERE and HERE and the 510k from the FDA HERE

Haemacure Reveals Positive Results Of Preclinical Study Of Fibrin Sealant In Adhesion Prevention

Haemacure Corp. (HAE.TO) on Thursday revealed the results of a preclinical study it recently conducted on the use of its proprietary lead product candidate, the human fibrin sealant HemaseelHMN, in preventing the formation of post-surgical adhesions. In preclinical testing, Hameacure's fibrin sealant was found to be significantly superior to the control group in preventing the formation of post-surgical tissue adhesion. It was also found to be superior to historical data disclosed in published literature for GYNECARE INTERCEED Absorbable Adhesion Barrier, marketed by Ethicon, Inc. The company said the preclinical results are strategically significant as Haemacure's current fibrin sealant haemostasis formulation was used in this study. Initial analysis indicates that no change in the formulation or the manufacturing of Haemacure's fibrin sealant would be required to pursue an adhesion prevention indication. The company noted that the U.S. market for adhesion prevention products is estimated currently at $100 million and is expected to grow to US$150-200 milion in fibrin sales.

Canadian Government Drops Remaining Charges Against Former Red Cross Director

Nearly two years after the criminal trial first began on February 2006, prosecutors for the Canadian government have dropped all remaining charges against Roger Perrault, former director of the Canadian Red Cross (CRC). The charges stem from Canada’s contaminated blood scandals of the 1980s and early 1990s.
Approximately 1,000 Canadians were infected with HIV and an additional 20,000 with hepatitis C (HCV) when they inadvertently used contaminated blood and blood products. The majority of the HIV infections occurred in the 1980s, while the HCV infections occurred from the 1970s to the early 1990s. Complications related to HIV and HCV have resulted in the deaths of at least 3,000 Canadians.
In May 2005, CRC pled guilty to federal charges filed in 2002 under Canada’s Food and Drug Act for distributing products tainted with HIV and HCV from 1983 to 1990. It paid the maximum fine allowed under the offense. In addition, CRC agreed to contribute 1.5 million Canadian dollars ($1.4 million) to the University of Ottawa; with half the money going to a scholarship fund for victims and their families and the other half to a “national medical error project” to prevent such a crisis in the future.
In 1998, the Canadian government established a one billion Canadian dollars ($970 million) trust for HCV victims. The fund, initially open only to those infected with HCV from 1986-1990, was expanded in 2006 to include all Canadian citizens who contracted HCV from contaminated blood or blood-derived products.
While the compensation packages were welcome developments, the existing charges against Perrault represented for many a chance for accountability. Instead, Perrault’s “exoneration” is difficult for victims and their advocates to accept. They hold the former CRC blood transfusion service director largely responsible for allowing contaminated blood products to infect patients in the 1980s and early 1990s.
Also acquited in that decision were John Furesz, former director of the Bureau of Biologics at Health Canada; Wark Boucher, former chief of the blood products division of the Bureau of Biologics; Michael Rodell, former Armour Pharmaceutical vice president; and Armour Pharmaceutical, the New Jersey-based manufacturer of Factorate, the factor VIII product sold in Canada. In November 1987, Armour withdrew Factorate from the Canadian market in response to evidence that the heat-based, viral inactivation process being used did not adequately kill HIV.
The Canadian Hemophilia Society (CHS), which represents the country’s bleeding disorders population, reacted to the government’s latest move with indignation.
“A lot of money and time was spent and it all just ended today with a 10-minute speech from the Crown,” said John Plater of CHS. “There are a lot of people out there that are hurting as a result of what happened and they are going to walk away from this very confused, very upset, with a lot of questions. People can say that the system has failed them once again.”
Source: The Toronto Star (online), January 19, 2008, and Medical News Today, January 24, 2008

Japanese Victims of HCV Blood Scandal To Receive Compensation

New legislation in Japan will require the government and manufacturers of hepatitis C-contaminated blood products to compensate those infected with the virus years ago. The manufacturers of the contaminated products are expected to jointly administer a compensation fund with the government. The law, which was enacted by the Japanese Parliament on December 28, 2007, was followed by a statement from Yasuo Fukuda, Japanese Prime Minister.
“We must frankly admit the state’s responsibility for causing huge harm to the victims and for failing to prevent the harm from spreading,” said Fukuda. “I express my apologies from my heart.”
Momentum had been building in favor of the law as a group of approximately 200 HCV patients had brought multiple successful suits to several district courts during the past five years. The plaintiffs claim that the government’s failure to properly regulate blood products from the 1970s to early 1990s demonstrated clear negligence, resulting in as many as 10,000 HCV infections. Some Japanese media outlets report an even higher number--upwards of two million people infected. According to the Health Ministry, approximately 1,000 individuals are eligible to file a claim. They will receive $109,450-$365,000, depending on how severely they were affected.
“Our five-year battle was finally rewarded,” said Michiko Yamaguchi, leader of the plaintiffs nationwide. The case for government culpability was made stronger in light of events abroad. In 1977, a plasma-derived fibrinogen concentrate lost U.S. Food and Drug Administration approval after it became clear that the product could transmit HCV. Nonetheless, the Japanese government continued to approve the product long after the U.S. ban. Fibrinogen and other plasma products were commonly used in the 1970s by Japanese obstetricians, gynecologists and surgeons to treat hemophilia or simply stop hemorrhaging during childbirth or surgeries.
Several pharmaceutical companies also share a significant responsibility for failure to use viral-inactivation technologies that had become available by the late 1970s. Although these technologies, which included heat and solvent-detergent treatment, effectively eliminated HCV from plasma-derived products, pharmaceutical companies were reluctant to implement them, citing cost and efficacy concerns. Nihon Pharmaceutical Co. and Mitsubishi Tanabe Pharma (formerly Mitsubishi Pharma Corp.), along with Mitsubishi’s subsidiary, Benesis Corp., are all expected to contribute to Japan’s HCV compensation fund.
Sources: ABC news (online), December 28, 2007; BBC news (online), January 8, 2008; and International Herald Tribune, January 11, 2008