Recombinant human collagens and gelatins
Based on expertise in collagen and the role of prolyl hydroxylase enzymes in the formation of collagen, FibroGen has developed the first known recombinant methodology for making fully synthetic collagens that are essentially identical to those found in nature. By making and testing different types of collagen that exist in nature, FibroGen scientists have demonstrated that recombinant type III collagen persists longer in tissue than any form of human or animal type I collagen. This unique characteristic of type III collagen serves as the basis for FibroGen's dermal filler product candidate for cosmetic applications.
Focused efforts over several years have also led to the development of a highly efficient production system employed by FibroGen to supply recombinant human collagens and gelatins (collagen fragments) as biomaterials for use in a variety of pharmaceutical and medical device applications. FibroGen produces recombinant human type III collagen (never before available in commercial quantities), recombinant human type I collagen, and distinct recombinant gelatin molecules optimized for specific applications. FibroGen's biomaterials address the needs of a wide range of customers in the pharmaceutical and medical device industries for safer, highly pure, and fully characterized alternatives to animal-sourced collagen and gelatin.
Friday, March 28, 2008
FDA moves to prevent Mad Cow Disease infecting Hemostat's and other Devices
The FDA is moving (some would say with glacier-like speed) to barr deadly prions from contaminating humans and animals via prohibiting the use of "high risk" animal products being used in drugs, biologics and medical devices (e.g. hemostat's) intended for humans as well as drugs intended for use in ruminant animals like cattle and sheep. Cattle can get mad cow disease, while sheep can get a similar disease known as scrapie.
The cattle materials prohibited in the proposed rule are those that pose the highest risk of containing infectious material and include:
the brain, skull, eyes and spinal cords from cattle 30 months and older;
the tonsils and a portion of the small intestines from all cattle regardless of their age or health;
any material from "downer" cattle--those that cannot walk;
any material from cattle not inspected and passed for human consumption;
fetal calf serum if appropriate procedures have not been followed to prevent its contamination with materials prohibited by this proposed rule;
tallow that contains more than 0.15 percent insoluble impurities if the tallow is derived from materials prohibited by this proposed rule and;
mechanically separated beef.
FULL TRANSCRIPT HERE
Collagen from Plants
CollPlant Ltd. is a biotechnology company specializing in the development and commercialization of safe, plant-derived collagen and protein-based biomaterials for the healthcare industry.
Collagen is one of the primary materials found in a variety of medical products including bone growth matrices, facial aesthetics, wound dressings, hemostats and sealants. During the last few years public awareness of the potential hazards of animal-derived collagen has begun to drive the healthcare industry to seek alternative sources for collagen.
CollPlant has developed a proprietary transgenic plant-based expression and production system for safe, high-quality, Type I recombinant human collagen. The Company's plant-derived collagen has an enhanced safety profile, as it is free of potential viral and other animal-derived hazards such as prions associated with Mad Cow Disease. In addition, CollPlant's transgenic plants are grown and cultivated within a completely sealed, environmentally-safe greenhouse.
In addition to its Type I collagen product, CollPlant is developing an extensive pipeline of additional high value, plant-derived protein polymers and composites with a variety of specialized characteristics tailored to specific markets such as orthopedics, aesthetic medicine, urinary incontinence, and wound healing.
CollPlant was founded in 2004 by a group of leading scientists, and is spearheaded today by experienced market-oriented executives from the global biotechnology arena.
Collagen is one of the primary materials found in a variety of medical products including bone growth matrices, facial aesthetics, wound dressings, hemostats and sealants. During the last few years public awareness of the potential hazards of animal-derived collagen has begun to drive the healthcare industry to seek alternative sources for collagen.
CollPlant has developed a proprietary transgenic plant-based expression and production system for safe, high-quality, Type I recombinant human collagen. The Company's plant-derived collagen has an enhanced safety profile, as it is free of potential viral and other animal-derived hazards such as prions associated with Mad Cow Disease. In addition, CollPlant's transgenic plants are grown and cultivated within a completely sealed, environmentally-safe greenhouse.
In addition to its Type I collagen product, CollPlant is developing an extensive pipeline of additional high value, plant-derived protein polymers and composites with a variety of specialized characteristics tailored to specific markets such as orthopedics, aesthetic medicine, urinary incontinence, and wound healing.
CollPlant was founded in 2004 by a group of leading scientists, and is spearheaded today by experienced market-oriented executives from the global biotechnology arena.
Thursday, March 27, 2008
Baxters Heparin worries cause concern for many Animal derived products
The US Food and Drug Administration (FDA) has received hundreds of reports of serious injuries and/or deaths in patients who have been administered heparin made by Baxter containing this contaminant - Baxter had sourced its API from SPL, who had sourced it from China. The lots in question were recalled in February.
SPL said it voluntarily initiated the nationwide withdrawal of the API as a precaution following the recent health scare involving Baxter's heparin, although as yet, no new adverse events related to this latest issue have been reported.
The voluntary recall also affects 23 finished product lots of heparin sodium in 5% dextrose and 0.9% sodium chloride injection solution manufactured and distributed by B. Braun Medical within the US and Canada. The company pulled these products from the market after it was notified by SPL of the API contaminant.
After weeks of investigations, the FDA has now identified the contaminant found in samples of Baxter's recalled heparin and confirmed that it is indeed linked to a Chinese manufacturing plant.
It has been revealed as oversulfated chondroitin sulphate, which is made from animal cartilage and is a cheaper alternative to raw heparin, which is normally derived from pig's intestines. It is not approved use in medicine, said Dr Janet Woodcock, director of the FDA Center for Drug Evaluation and Research.
"It doesn't appear to be a natural contaminant that got in there," said the agency, but a man-made compound that had been chemically modified to mimic raw heparin, the API used in a finished heparin product.
SPL supplies a refined form of the heparin API to Baxter and other firms from a plant it partly owns in China, called Changzhou SPL, along with a facility it owns in Wisconsin, US.
The contamination was present in the powdered form of raw heparin that was purchased by SPL's suppliers in China, according to Robert Rhoades, a pharmaceutical consultant for Becker & Associates, speaking on behalf of SPL.
SPL said it voluntarily initiated the nationwide withdrawal of the API as a precaution following the recent health scare involving Baxter's heparin, although as yet, no new adverse events related to this latest issue have been reported.
The voluntary recall also affects 23 finished product lots of heparin sodium in 5% dextrose and 0.9% sodium chloride injection solution manufactured and distributed by B. Braun Medical within the US and Canada. The company pulled these products from the market after it was notified by SPL of the API contaminant.
After weeks of investigations, the FDA has now identified the contaminant found in samples of Baxter's recalled heparin and confirmed that it is indeed linked to a Chinese manufacturing plant.
It has been revealed as oversulfated chondroitin sulphate, which is made from animal cartilage and is a cheaper alternative to raw heparin, which is normally derived from pig's intestines. It is not approved use in medicine, said Dr Janet Woodcock, director of the FDA Center for Drug Evaluation and Research.
"It doesn't appear to be a natural contaminant that got in there," said the agency, but a man-made compound that had been chemically modified to mimic raw heparin, the API used in a finished heparin product.
SPL supplies a refined form of the heparin API to Baxter and other firms from a plant it partly owns in China, called Changzhou SPL, along with a facility it owns in Wisconsin, US.
The contamination was present in the powdered form of raw heparin that was purchased by SPL's suppliers in China, according to Robert Rhoades, a pharmaceutical consultant for Becker & Associates, speaking on behalf of SPL.
PolyHeme
PolyHeme® is a human hemoglobin-based temporary oxygen-carrying red blood cell substitute in development for the treatment of life-threatening blood loss when an oxygen-carrying fluid is required and red blood cells are not available.
PolyHeme® is a solution of chemically modified human hemoglobin which simultaneously restores lost blood volume and hemoglobin levels and is designed for rapid, massive infusion.
PolyHeme’s characteristics include:
Simultaneously restores lost blood volume and hemoglobin levels
Universally compatible (does not require typing or cross-matching before infusion)
Immediately available
Has extended shelf life in excess of 12 months
Is manufactured from human red blood cells using steps to reduce the risk of viral transmission.
PolyHeme® is a solution of chemically modified human hemoglobin which simultaneously restores lost blood volume and hemoglobin levels and is designed for rapid, massive infusion.
PolyHeme’s characteristics include:
Simultaneously restores lost blood volume and hemoglobin levels
Universally compatible (does not require typing or cross-matching before infusion)
Immediately available
Has extended shelf life in excess of 12 months
Is manufactured from human red blood cells using steps to reduce the risk of viral transmission.
Tuesday, March 25, 2008
Insights, perspectives and inside data from the founder of MMD
Link for hemostasis marketresearch MedMarket Diligence
Friday, March 21, 2008
Thursday, March 20, 2008
Two-week-old blood no good for transfusions
Source: New Scientist
The common practice of storing blood for more than two weeks could be proving fatal for thousands of heart surgery patients, according to a major study.
Doctors at the Cleveland Clinic in Ohio have found that patients who receive blood that is more than 14 days old are nearly two-thirds more likely to die than those who get newer blood.
The survey of more than 9000 heart surgery patients also suggests that recipients of older blood are more at risk from blood poisoning and organ failure. The conclusion? "Blood should be classified as outdated earlier than current recommendations," says lead researcher Colleen Koch. Koch's team note that in the US the average age of transfused blood is more than two weeks - and that around half of all heart surgery patients receive blood transfusions.
New measures are urgently needed, say the researchers, to prevent unnecessary deaths among this large and vulnerable group of patients. Previous studies have suggested that transfusions increase the risk of death and serious complications. This latest study suggests the age of the blood used is a major factor.
Broken blood
On the basis of earlier laboratory studies, Koch speculates that, at the two-week stage, stored red blood cells begin to break down. This, she says, may make them more likely to block blood vessels while reducing their capacity to carry oxygen. Her team studied the medical records of patients who received major heart surgery at the Cleveland Clinic between June 1998 and January 2006.
A total of 2,872 patients received blood that had been stored for 14 days or less, and 3,130 patients received blood that was more than 14 days old. The mean storage age was 11 days for the newer blood and 20 days for the older blood. In-hospital mortality was significantly higher among those who received older blood: 2.8% compared to 1.7%.
The researchers also found that death rates a year on were nearly half as high again in the patients who had received older blood, compared to those who received newer blood. 11% of the patients who had received older blood had died a year later, compared to 7.4% of those who received newer blood. Both sets of patients received the same volume of blood.
"This research suggests that the longer transfused blood has been stored, the greater the risk of complications following cardiac surgery," says Peter Weissberg of the UK charity, the British Heart Foundation. He says that research last year indicated that, in many heart surgery patients, transfusions did more harm than good.
"Together, these studies suggest that only those heart patients whose lives are at serious risk without a transfusion should receive blood," Weissberg says.
"Further research is urgently needed to clarify the indications for transfusion and the effects of blood storage on outcome."
There are around 30,000 heart operations every year in the UK, and over 100,000 in the US.
Journal refs: New England Journal of Medicine, vol 358, p1229
Circulation, vol 116, p2544
The common practice of storing blood for more than two weeks could be proving fatal for thousands of heart surgery patients, according to a major study.
Doctors at the Cleveland Clinic in Ohio have found that patients who receive blood that is more than 14 days old are nearly two-thirds more likely to die than those who get newer blood.
The survey of more than 9000 heart surgery patients also suggests that recipients of older blood are more at risk from blood poisoning and organ failure. The conclusion? "Blood should be classified as outdated earlier than current recommendations," says lead researcher Colleen Koch. Koch's team note that in the US the average age of transfused blood is more than two weeks - and that around half of all heart surgery patients receive blood transfusions.
New measures are urgently needed, say the researchers, to prevent unnecessary deaths among this large and vulnerable group of patients. Previous studies have suggested that transfusions increase the risk of death and serious complications. This latest study suggests the age of the blood used is a major factor.
Broken blood
On the basis of earlier laboratory studies, Koch speculates that, at the two-week stage, stored red blood cells begin to break down. This, she says, may make them more likely to block blood vessels while reducing their capacity to carry oxygen. Her team studied the medical records of patients who received major heart surgery at the Cleveland Clinic between June 1998 and January 2006.
A total of 2,872 patients received blood that had been stored for 14 days or less, and 3,130 patients received blood that was more than 14 days old. The mean storage age was 11 days for the newer blood and 20 days for the older blood. In-hospital mortality was significantly higher among those who received older blood: 2.8% compared to 1.7%.
The researchers also found that death rates a year on were nearly half as high again in the patients who had received older blood, compared to those who received newer blood. 11% of the patients who had received older blood had died a year later, compared to 7.4% of those who received newer blood. Both sets of patients received the same volume of blood.
"This research suggests that the longer transfused blood has been stored, the greater the risk of complications following cardiac surgery," says Peter Weissberg of the UK charity, the British Heart Foundation. He says that research last year indicated that, in many heart surgery patients, transfusions did more harm than good.
"Together, these studies suggest that only those heart patients whose lives are at serious risk without a transfusion should receive blood," Weissberg says.
"Further research is urgently needed to clarify the indications for transfusion and the effects of blood storage on outcome."
There are around 30,000 heart operations every year in the UK, and over 100,000 in the US.
Journal refs: New England Journal of Medicine, vol 358, p1229
Circulation, vol 116, p2544
Tuesday, March 18, 2008
King Pharmaceuticals Acquires License from Gelita Medical to Hemostatic Products
King Pharmaceuticals, Inc. (NYSE:KG) and Gelita Medical BV announced today that the companies have entered into an exclusive license agreement relating to Gelita’s absorbable gelatin hemostatic products.
Pursuant to the agreement, King received an exclusive license to market, distribute and sell Gelita’s absorbable gelatin sponge in the U.S. Gelita will manufacture and supply the hemostatic product to King under the agreement. King’s THROMBIN-JMI® (thrombin, topical, bovine, USP), a topical active hemostatic agent, is often used by surgeons together with a variety of passive hemostatic agents, including absorbable gelatin sponges.
Brian A. Markison, President and Chief Executive Officer of King, stated, “The addition of Gelita’s absorbable gelatin hemostatic agents to our product line will further strengthen our expanding portfolio of hospital products. Importantly, this transaction further enhances the wide array of hemostatic options that our hospital sales team of over 110 professionals can offer physicians for the purpose of controlling bleeding during surgery.” Dr. Harrie van Baars, CEO of Gelita Medical, stated, “With King we have attracted an excellent and well focused marketing partner for our products in the U.S. market.”
King plans to begin marketing Gelita’s absorbable gelatin sponge in the U.S. after the product receives approval from the U.S. Food and Drug Administration for use during surgery. The license also provides King an exclusive option to acquire U.S. commercialization rights to any new hemostatic products developed by Gelita. The companies did not provide financial details relating to the transaction.
Dr. Harrie Van Baars of the Netherlands, CEO Gelita Medical, was previously CEO of Curamedical he also is also linked to company CircumventBV and the circumcision device the Smartklamp
Click Here for action Gelita is taking against Equicel
Link to FDA letter for Gelita approval Here
Pursuant to the agreement, King received an exclusive license to market, distribute and sell Gelita’s absorbable gelatin sponge in the U.S. Gelita will manufacture and supply the hemostatic product to King under the agreement. King’s THROMBIN-JMI® (thrombin, topical, bovine, USP), a topical active hemostatic agent, is often used by surgeons together with a variety of passive hemostatic agents, including absorbable gelatin sponges.
Brian A. Markison, President and Chief Executive Officer of King, stated, “The addition of Gelita’s absorbable gelatin hemostatic agents to our product line will further strengthen our expanding portfolio of hospital products. Importantly, this transaction further enhances the wide array of hemostatic options that our hospital sales team of over 110 professionals can offer physicians for the purpose of controlling bleeding during surgery.” Dr. Harrie van Baars, CEO of Gelita Medical, stated, “With King we have attracted an excellent and well focused marketing partner for our products in the U.S. market.”
King plans to begin marketing Gelita’s absorbable gelatin sponge in the U.S. after the product receives approval from the U.S. Food and Drug Administration for use during surgery. The license also provides King an exclusive option to acquire U.S. commercialization rights to any new hemostatic products developed by Gelita. The companies did not provide financial details relating to the transaction.
Dr. Harrie Van Baars of the Netherlands, CEO Gelita Medical, was previously CEO of Curamedical he also is also linked to company CircumventBV and the circumcision device the Smartklamp
Click Here for action Gelita is taking against Equicel
Link to FDA letter for Gelita approval Here
Novoseven
Novo Nordisk has the following interesting details plus another video.
Blood use
- Some statistics
Approximately 10,000 units of blood are required per day to meet the demands of hospitals in England and North Wales. Thirty-two thousand units of red blood cells are used per day in the USA and 26.5 million units of blood are transfused per year. Similar requirements exist throughout Europe.
To meet these demands, 2.5 million blood donations are made in the UK every year, and almost 14 million in the USA. At each donation, approximately 475 ml (1 unit) of blood are collected. 1.9 million volunteer donors in the UK and 8 million in the USA (approximately 5% of the population of each country) donate this blood. With 10% of the adult population (260,000) donating blood Denmark has the highest participation rate as well as the highest consumption of blood products per capita in Europe and is primarily due to the high acceptance of blood donation in Denmark.
Donation by apheresis is also becoming increasingly common and essential for the supply of specific components. Apheresis describes any procedure in which blood is drawn from a donor and a component (platelets, plasma or white blood cells) is separated out, with the remaining blood being returned to the body. Apheresis allows the donor's blood volume to replenish itself much more quickly than whole blood donation. One type of apheresis, plasmapheresis, is commonly used in commercial blood banks. In plasmapheresis the plasma is separated from donated blood, the red blood cells being returned to the donor.
How many components can be made from one unit of blood?
Once blood has been tested for infectious agents and blood groups have been determined, it is separated into its useful components, allowing several patients to benefit from one unit of whole blood.
Red cells are used for the treatment of certain types of anaemia, such as bone marrow failure, sickle cell disease and anaemia associated with chronic renal failure. Transfusion is also used to replace lost red cells after accidents, surgery and childbirth. Red cells have a shelf life of up to 42 days, but if fresh-frozen can be stored for up to 10 years.
Platelets are mainly used in the treatment of patients with bone marrow failure or those undergoing chemotherapy. The shelf life of platelets is up to five days.
Fresh frozen plasma (FFP) is normally used after substantial blood loss, for example following childbirth or during cardiac surgery. FFP is also used for the reversal of anticoagulant treatments, burn/shock cases and to replace clotting factors after blood transfusion. Its shelf life is one year.
Processed plasma is also fractionated for the production of factor VIII and factor IX, immunoglobulins and antibodies. Very large 'pools' of donated units of plasma are used in the production of such products.
The main uses of whole blood are: general surgery (23%), general medicine (15%), cardiothoracic surgery (13%), orthopaedics (11%), haematology (9%), accident and emergency (8%).
Expense associated with blood collection
Collecting blood is expensive. The main costs are for staff salaries, transport, storage, and for the screening tests required by individual nations in addition to blood aquisition cost. In Europe, blood is usually screened for:
Type (ABO/Rh)
Antibodies to red cell antigens
Antibodies to HIV-1/2 and HIV antigen
Antibody to HTLV I/II
Hepatitis B surface antigen and antibody to the core antigen
Antibody to hepatitis C
Syphilis
Liver function (alanine aminotransferase)
Blood transfusion
The majority of blood transfusions are heterologous (also referred to as allogenic), which means that the patient receives donated blood from another person (usually an unnamed volunteer donor via a blood bank or transfusion service such as 'The National Blood Service' in the UK or the 'American Association of Blood Banks' (AABB).
Alternatively patients can donate and later, that is during elective surgery, receive back their own blood (autologous transfusion). Autologous blood donors can give blood twice weekly for up to five weeks prior to elective surgery. After donating, the patient is immediately given IV fluids to compensate for the decrease in blood volume. The advantage of this type of donation is that disease transmission and allergic reactions are eliminated - the patient's own blood is the safest blood for their transfusion needs. Autologous transfusion is also useful for patients with rare blood types who might have difficulty in finding a compatible donor. In addition, autologously collected blood can be frozen and stored for up to 10 years. Disadvantages of autologous transfusions include the fact that the donation must be planned in advance, that it may delay surgery, and that certain medical conditions (eg cardiac conditions under which patients cannot tolerate sudden blood loss) disqualify individuals from this type of donation. Units infected with HBV or HIV from autologous donations, are not stored in the blood bank because of the potential risk of clerical error.
Blood that would otherwise be lost during surgery can also be collected and returned to the patient. This is a different kind of autologous donation called perioperative autologous transfusion or PAT and reduces the need for allogenic blood transfusion. Anticoagulant is added to this salvaged blood prior to centrifugation and washing of the resulting packed red cells. These are pumped into a transfusion bag and re-infused into the patient during or after some types of surgery, such as cardiac, gynaecologic and orthopaedic procedures.
Autologous transfusions are generally more costly than traditional heterologous transfusions and are only appropriate in certain types of treatment. Patients must be stable enough to donate their own blood and to cope with the potential anaemia that may be suffered after surgery.
Blood use
- Some statistics
Approximately 10,000 units of blood are required per day to meet the demands of hospitals in England and North Wales. Thirty-two thousand units of red blood cells are used per day in the USA and 26.5 million units of blood are transfused per year. Similar requirements exist throughout Europe.
To meet these demands, 2.5 million blood donations are made in the UK every year, and almost 14 million in the USA. At each donation, approximately 475 ml (1 unit) of blood are collected. 1.9 million volunteer donors in the UK and 8 million in the USA (approximately 5% of the population of each country) donate this blood. With 10% of the adult population (260,000) donating blood Denmark has the highest participation rate as well as the highest consumption of blood products per capita in Europe and is primarily due to the high acceptance of blood donation in Denmark.
Donation by apheresis is also becoming increasingly common and essential for the supply of specific components. Apheresis describes any procedure in which blood is drawn from a donor and a component (platelets, plasma or white blood cells) is separated out, with the remaining blood being returned to the body. Apheresis allows the donor's blood volume to replenish itself much more quickly than whole blood donation. One type of apheresis, plasmapheresis, is commonly used in commercial blood banks. In plasmapheresis the plasma is separated from donated blood, the red blood cells being returned to the donor.
How many components can be made from one unit of blood?
Once blood has been tested for infectious agents and blood groups have been determined, it is separated into its useful components, allowing several patients to benefit from one unit of whole blood.
Red cells are used for the treatment of certain types of anaemia, such as bone marrow failure, sickle cell disease and anaemia associated with chronic renal failure. Transfusion is also used to replace lost red cells after accidents, surgery and childbirth. Red cells have a shelf life of up to 42 days, but if fresh-frozen can be stored for up to 10 years.
Platelets are mainly used in the treatment of patients with bone marrow failure or those undergoing chemotherapy. The shelf life of platelets is up to five days.
Fresh frozen plasma (FFP) is normally used after substantial blood loss, for example following childbirth or during cardiac surgery. FFP is also used for the reversal of anticoagulant treatments, burn/shock cases and to replace clotting factors after blood transfusion. Its shelf life is one year.
Processed plasma is also fractionated for the production of factor VIII and factor IX, immunoglobulins and antibodies. Very large 'pools' of donated units of plasma are used in the production of such products.The main uses of whole blood are: general surgery (23%), general medicine (15%), cardiothoracic surgery (13%), orthopaedics (11%), haematology (9%), accident and emergency (8%).
Expense associated with blood collection
Collecting blood is expensive. The main costs are for staff salaries, transport, storage, and for the screening tests required by individual nations in addition to blood aquisition cost. In Europe, blood is usually screened for:
Type (ABO/Rh)
Antibodies to red cell antigens
Antibodies to HIV-1/2 and HIV antigen
Antibody to HTLV I/II
Hepatitis B surface antigen and antibody to the core antigen
Antibody to hepatitis C
Syphilis
Liver function (alanine aminotransferase)
Blood transfusion
The majority of blood transfusions are heterologous (also referred to as allogenic), which means that the patient receives donated blood from another person (usually an unnamed volunteer donor via a blood bank or transfusion service such as 'The National Blood Service' in the UK or the 'American Association of Blood Banks' (AABB).
Alternatively patients can donate and later, that is during elective surgery, receive back their own blood (autologous transfusion). Autologous blood donors can give blood twice weekly for up to five weeks prior to elective surgery. After donating, the patient is immediately given IV fluids to compensate for the decrease in blood volume. The advantage of this type of donation is that disease transmission and allergic reactions are eliminated - the patient's own blood is the safest blood for their transfusion needs. Autologous transfusion is also useful for patients with rare blood types who might have difficulty in finding a compatible donor. In addition, autologously collected blood can be frozen and stored for up to 10 years. Disadvantages of autologous transfusions include the fact that the donation must be planned in advance, that it may delay surgery, and that certain medical conditions (eg cardiac conditions under which patients cannot tolerate sudden blood loss) disqualify individuals from this type of donation. Units infected with HBV or HIV from autologous donations, are not stored in the blood bank because of the potential risk of clerical error.
Blood that would otherwise be lost during surgery can also be collected and returned to the patient. This is a different kind of autologous donation called perioperative autologous transfusion or PAT and reduces the need for allogenic blood transfusion. Anticoagulant is added to this salvaged blood prior to centrifugation and washing of the resulting packed red cells. These are pumped into a transfusion bag and re-infused into the patient during or after some types of surgery, such as cardiac, gynaecologic and orthopaedic procedures.Autologous transfusions are generally more costly than traditional heterologous transfusions and are only appropriate in certain types of treatment. Patients must be stable enough to donate their own blood and to cope with the potential anaemia that may be suffered after surgery.
Sunday, March 16, 2008
Hemcon acquire Alltracel
In a move that would more than double its annual revenue to $100 million, wound care product company HemCon Medical Technologies Inc. has announced plans to acquire the publicly-traded Irish firm Alltracel Pharmaceuticals.
The acquisition will give HemCon, one of Portland's fastest-growing businesses, a strong and immediate presence in Europe, and will also offer Alltracel inroads into the U.S. market. The deal will also boost HemCon's manufacturing capabilities through access to Alltracel factories, and offer access to a proprietary nanotechnology manufacturing process called Nanospider.
The purchase is a cash-for-stock arrangement worth about $40.8 million in U.S. dollars, or $20.8 million pounds sterling, according to Thomson Financial News. The deal is subject to approval by Alltracel's shareholders and the Irish High Court, but HemCon leaders hope to close the sale in the second quarter. HemCon would take publicly-traded Alltracel private as part of the transaction.
Based in Dublin, Ireland, Alltracel manages commercial offices in London and Cologne, Germany. It also operates a research and development subsidiary in the Czech Republic and manufacturing facilities in Shenzhen, China. Alltracel focuses on taking proprietary technology from research stage to commercialization, including private-label oral care products licensed in Europe through the Butler and GUM brands.
To execute and broker the deal, HemCon formed a wholly owned subsidiary called Castlerise Investments Limited. The structure offered tax advantages for HemCon, company officials said. Alltracel will be a wholly owned subsidiary of HemCon following the acquisition, maintaining its headquarters in Dublin.
The two companies started doing business together about one year ago. Acquisition talks started soon after.
Founded in 2001, HemCon created a new type of bandage -- made from material extracted from shrimp shells called chitosan -- that bonds to even the most severe wounds within minutes of being applied. The company has reaped millions in military contracts, but is making a strong push into the civilian medical market in the U.S. and abroad. The company recently released an over-the-counter version of its bandages that it has distributed to more than 1,000 retail locations, including grocery stores and pharmacies.
HemCon has 110 workers and reported $24 million in revenue in 2006, up 100 percent from 2005. It reported just shy of $40 million in 2007.
HemCon President John Morgan said the recent tightening of credit markets made it somewhat challenging to obtain financing for the deal.
"It's a conservative credit environment, and we had to deal with that," Morgan said.
Bank of America N.A. is the lead financier for transaction.
The purchase is a cash-for-stock arrangement worth about $40.8 million in U.S. dollars, or $20.8 million pounds sterling, according to Thomson Financial News. The deal is subject to approval by Alltracel's shareholders and the Irish High Court, but HemCon leaders hope to close the sale in the second quarter. HemCon would take publicly-traded Alltracel private as part of the transaction.
Based in Dublin, Ireland, Alltracel manages commercial offices in London and Cologne, Germany. It also operates a research and development subsidiary in the Czech Republic and manufacturing facilities in Shenzhen, China. Alltracel focuses on taking proprietary technology from research stage to commercialization, including private-label oral care products licensed in Europe through the Butler and GUM brands.
To execute and broker the deal, HemCon formed a wholly owned subsidiary called Castlerise Investments Limited. The structure offered tax advantages for HemCon, company officials said. Alltracel will be a wholly owned subsidiary of HemCon following the acquisition, maintaining its headquarters in Dublin.
The two companies started doing business together about one year ago. Acquisition talks started soon after.Founded in 2001, HemCon created a new type of bandage -- made from material extracted from shrimp shells called chitosan -- that bonds to even the most severe wounds within minutes of being applied. The company has reaped millions in military contracts, but is making a strong push into the civilian medical market in the U.S. and abroad. The company recently released an over-the-counter version of its bandages that it has distributed to more than 1,000 retail locations, including grocery stores and pharmacies.
HemCon has 110 workers and reported $24 million in revenue in 2006, up 100 percent from 2005. It reported just shy of $40 million in 2007.
HemCon President John Morgan said the recent tightening of credit markets made it somewhat challenging to obtain financing for the deal."It's a conservative credit environment, and we had to deal with that," Morgan said.
Bank of America N.A. is the lead financier for transaction.
Thursday, March 13, 2008
Arista - indicated in surgical procedures EXCEPT neurological, ophthalmic, and urological
The FDA has announced the approval to market Arista™ AH Absorbable Hemostat, a device from Minneapolis, MN based Medafor, Inc. Have you ever heard of absorbable hemostat? Turns out the device is not a surgical instrument, but rather a polysaccharide material, manufactured from potato starch, that promotes local clot formation.
Here's how the company explains its technology that might be useful for multiple specialities, from trauma to ophthalmic, and urological procedures.
MPH® (Microporous Polysaccharide Hemospheres) represents a new process for effecting almost instantaneous hemostasis at wound sites, even in the presence of profuse bleeding. The technology consists of an engineered biopolymeric, microporous particle, with a controlled pore size, which is designed to act as a s
ieve to dehydrate the blood and thus serve to accelerate the natural clotting process.
Using this technology, clotting has been demonstrated to initiate within as little as 30 seconds to one minute, compared to as much as 30 minutes required by traditional hemostats. Applied topically, MPH gels rapidly with no tissue irritation, creating a protected environment for hemostasis and healing.
The particles, or beads, are derived from plant-based biomaterials with an extensive history of use in humans. The final packaged material is stable, bio-compatible and sterile.
Here's how the company explains its technology that might be useful for multiple specialities, from trauma to ophthalmic, and urological procedures.
MPH® (Microporous Polysaccharide Hemospheres) represents a new process for effecting almost instantaneous hemostasis at wound sites, even in the presence of profuse bleeding. The technology consists of an engineered biopolymeric, microporous particle, with a controlled pore size, which is designed to act as a s
ieve to dehydrate the blood and thus serve to accelerate the natural clotting process.Using this technology, clotting has been demonstrated to initiate within as little as 30 seconds to one minute, compared to as much as 30 minutes required by traditional hemostats. Applied topically, MPH gels rapidly with no tissue irritation, creating a protected environment for hemostasis and healing.
The particles, or beads, are derived from plant-based biomaterials with an extensive history of use in humans. The final packaged material is stable, bio-compatible and sterile.
Sunday, March 9, 2008
Thursday, March 6, 2008
Use of Arista in Open Heart Surgery
This video shows the use of Medafors "Arista" in an acute dissection of the ascending Aorta.
Arista™AH is indicated in surgical procedures as an adjunctive hemostatic device in the control of capillary, venous and arteriolar bleeding.
Arista™AH is a sterile, absorbable hemostatic powder consisting of Microporous Polysaccharide Hemospheres (MPH®), Medafor's patented clotting technology derived from purified plant starch.
When applied directly to the source of bleeding, Arista™AH begins clotting on contact, achieving complete hemostasis, in most cases, within minutes.
Arista™AH is indicated in surgical procedures as an adjunctive hemostatic device in the control of capillary, venous and arteriolar bleeding.
Arista™AH is a sterile, absorbable hemostatic powder consisting of Microporous Polysaccharide Hemospheres (MPH®), Medafor's patented clotting technology derived from purified plant starch.
When applied directly to the source of bleeding, Arista™AH begins clotting on contact, achieving complete hemostasis, in most cases, within minutes.
Sunday, March 2, 2008
Woundstat
WoundStat was developed in VCU Medical Center's Reanimation Engineering Shock Center, which does research on treating critical illness and injury. Part of the center, Operation Purple Heart, focuses on treating combat casualties.
"We took a step back and examined what the strengths and weaknesses were with the current (blood-stopping) products that were out there to see if there was something we could improve upon," said Dr. Kevin Ward, an emergency physician and the shock center's associate director.
Ward and two colleagues - biochemist Robert Diegelmann and biomedical engineer Gary Bowlin - developed a tan-colored concoction of minerals that looks like a cross between flour, sand and cat litter. After its use, WoundStat can be peeled off the wound.
The researchers were introduced to Jack McDonnell, who licensed the technology and established a company called TraumaCure in May 2006.
McDonnell expects the Food and Drug Administration to approve WoundStat by October, after which TraumaCure will market its product to the military, firefighters and police departments.
Blanck, the retired surgeon general and an outside director of TraumaCure, said current hemorrhage-stopping products - specifically, HemCon and QuikClot - have been a step in the right direction but that there is room for improvement.
"I'm not critical of them because I think they've been responsible for saving lives. Our goal is to save even more," he said.
A spokeswoman for HemCon said its standard-issue bandages work best on large, high-blood flow wounds but are limited on smaller but serious injuries such as a gunshot. QuikClot clots blood but produces a reaction when used that creates excessive heat, and studies have found that it may damage organs and tissues.
An independent study by the Army's Institute of Surgical Research found WoundStat to be a highly effective wound dressing that doesn't produce a heat reaction. The report said the product's primary limitation is that it will stop blood flow on damaged vessels, acting as a granular tourniquet in areas where an actual tourniquet cannot be tied, such as the groin.
Please find the FDA 510K approved 2007 HERE
"We took a step back and examined what the strengths and weaknesses were with the current (blood-stopping) products that were out there to see if there was something we could improve upon," said Dr. Kevin Ward, an emergency physician and the shock center's associate director.
Ward and two colleagues - biochemist Robert Diegelmann and biomedical engineer Gary Bowlin - developed a tan-colored concoction of minerals that looks like a cross between flour, sand and cat litter. After its use, WoundStat can be peeled off the wound.
The researchers were introduced to Jack McDonnell, who licensed the technology and established a company called TraumaCure in May 2006.
McDonnell expects the Food and Drug Administration to approve WoundStat by October, after which TraumaCure will market its product to the military, firefighters and police departments.
Blanck, the retired surgeon general and an outside director of TraumaCure, said current hemorrhage-stopping products - specifically, HemCon and QuikClot - have been a step in the right direction but that there is room for improvement.
"I'm not critical of them because I think they've been responsible for saving lives. Our goal is to save even more," he said.
A spokeswoman for HemCon said its standard-issue bandages work best on large, high-blood flow wounds but are limited on smaller but serious injuries such as a gunshot. QuikClot clots blood but produces a reaction when used that creates excessive heat, and studies have found that it may damage organs and tissues.
An independent study by the Army's Institute of Surgical Research found WoundStat to be a highly effective wound dressing that doesn't produce a heat reaction. The report said the product's primary limitation is that it will stop blood flow on damaged vessels, acting as a granular tourniquet in areas where an actual tourniquet cannot be tied, such as the groin.
Please find the FDA 510K approved 2007 HERE
Marketing of Trasylol Suspended
Bayer AG suspended worldwide sales of Trasylol, a clotting drug using during heart surgery to prevent bleeding, on Monday following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons.
"The" 5 Ideal Hemostat Characteristics
1. First, the ideal hemostatic agent would of course be such that the agent itself is as well as any of its metabolic breakdown products would be safe to use within the body.
2. Second, you want it to work and you want it to be efficacious.The definition of efficacy can vary between the different uses, for example a vascular surgeon may want something that polymerizes very quickly in order to stop bleeding, but does not cause clot of the vessel that they spent all this time anastomosing, where as a reconstructive surgeon for example may want something that polymerizes very slowly to give them time to reposition their flaps or grafts.
3. Third is usability; you want something that is easy to use and that you can use in a variety of different circumstances.
4. Fourth is affordability. This may be more relevant to a hospital administrator or pharmacist who actually does the purchasing, but it impacts the surgeon because that determines what you have available to you in the operating room.
5. And finally, fifth, approvability. Any of these agents need to be approved by the FDA in order to be used in the US.
2. Second, you want it to work and you want it to be efficacious.The definition of efficacy can vary between the different uses, for example a vascular surgeon may want something that polymerizes very quickly in order to stop bleeding, but does not cause clot of the vessel that they spent all this time anastomosing, where as a reconstructive surgeon for example may want something that polymerizes very slowly to give them time to reposition their flaps or grafts.
3. Third is usability; you want something that is easy to use and that you can use in a variety of different circumstances.
4. Fourth is affordability. This may be more relevant to a hospital administrator or pharmacist who actually does the purchasing, but it impacts the surgeon because that determines what you have available to you in the operating room.
5. And finally, fifth, approvability. Any of these agents need to be approved by the FDA in order to be used in the US.
Saturday, March 1, 2008
Risks of infected animal and human derived Devices
The FDA has recently changed its position with regard to the use of gelatin. A guidance document has been issued regarding the use of gelatin in FDA-regulated products for human use (Attachment 4). The guidance pertinent to medical devices reads:
"Gelatin produced from bones and hides obtained from cattle residing in, or originating from, countries reporting BSE or from countries that do not meet the latest BSE-related standards of the Office International des Epizooties (OIE) should not be used either in injectable, ophthalmic, or implanted FDA regulated products, or in their manufacture."
The guidance also states:
"At this time there does not appear to be a basis for objection to the use of gelatin produced from bovine hides and bones in FDA products for human use if the gelatin is produced in the United States from US-derived raw materials or from cattle born, raised and slaughtered in other countries that have no reported BSE cases and that meet OIE BSE standards."
Bovine Spongiform Encephalopathy (BSE) is a degenerative disease which affects the central nervous system of cattle. It is similar to other transmissible spongiform encephalopathies (TSEs) such as scrapie in sheep and Creutzfeldt-Jakob Disease (CJD) in humans. At this point in time the incubation period of BSE appears to be from 2 to 8 years. There is currently no treatment, nor is there a validated test to detect the disease in a live animal. Diagnosis is determined by microscopic examination of brain tissue. The nature of the BSE agent is widely theorized to be a prion, an abnormally folded version of a normal cellular protein. The abnormal protein then recruits additional molecules of normal protein and facilitates their conversion to the abnormal form. The agent is extremely resistant to traditional forms of disinfection and sterilization. As new information on the diagnosis, treatment and nature of the agent becomes available, this guidance will be modified as appropriate.
Epidemiologic data suggest that the BSE epidemic in Great Britain which began in 1986 occurred through feeding cattle contaminated meat and bone meal as a protein source. The BSE agent may have been present for a long time, but changes in rendering procedures in the late 70's and early 80's may have enabled the active agent to survive in the animal feeds. The agent is thought to be from scrapie-infected sheep, but cattle with a previously unidentified TSE have not been ruled out. An association between cases of variant CJD in Great Britain and BSE seems likely, although causality has not been proved. To date, there have been no cases of BSE in the United States.
The possibility of introducing the BSE agent through a medical device requires special attention on the part of manufacturers with regard to the sourcing and processing of bovine-derived material. At present this can most easily be accomplished by assuring that the source cattle are free of BSE. In 1993 and more recently, on May 9, 1996, the Food and Drug Administration (FDA) issued letters to manufacturers to request that bovine-derived materials from cattle which have resided in or originated from countries where BSE has been diagnosed not be used in the manufacture of FDA-regulated products. (Attachments 1, 2 and 3)
Since 1989, the USDA has restricted the importation of live ruminants from Great Britain. Currently the USDA restricts the importation of live ruminants from countries where BSE is known to exist, and from those countries that present a significant risk of introducing BSE into the United States. Also restricted (by USDA) from import from these countries are other ruminant-derived products such as bone meal, meat and bone meal, blood meal, offal, glands, and gelatin for animal consumption. FDA recently prohibited protein derived from mammalian tissues to be used in ruminant feed for animals in the US (Federal Register June 5, 1997; 21 CFR Part 589 "Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed").
To track medical devices which either contain or are exposed to animal-derived materials during manufacturing (e.g., human cells grown in media containing fetal calf serum), CDRH has developed the CDRH Biomaterials Database which contains an inventory of these devices, including type of material, animal species and country of origin, and target organ or tisssue for each device. Originally proposed in response to the BSE issue, the Database was expanded to include all animal-derived products (including human) in order to respond to other animal material-based sourcing concerns that may arise in the future.
"Gelatin produced from bones and hides obtained from cattle residing in, or originating from, countries reporting BSE or from countries that do not meet the latest BSE-related standards of the Office International des Epizooties (OIE) should not be used either in injectable, ophthalmic, or implanted FDA regulated products, or in their manufacture."
The guidance also states:
"At this time there does not appear to be a basis for objection to the use of gelatin produced from bovine hides and bones in FDA products for human use if the gelatin is produced in the United States from US-derived raw materials or from cattle born, raised and slaughtered in other countries that have no reported BSE cases and that meet OIE BSE standards."
Bovine Spongiform Encephalopathy (BSE) is a degenerative disease which affects the central nervous system of cattle. It is similar to other transmissible spongiform encephalopathies (TSEs) such as scrapie in sheep and Creutzfeldt-Jakob Disease (CJD) in humans. At this point in time the incubation period of BSE appears to be from 2 to 8 years. There is currently no treatment, nor is there a validated test to detect the disease in a live animal. Diagnosis is determined by microscopic examination of brain tissue. The nature of the BSE agent is widely theorized to be a prion, an abnormally folded version of a normal cellular protein. The abnormal protein then recruits additional molecules of normal protein and facilitates their conversion to the abnormal form. The agent is extremely resistant to traditional forms of disinfection and sterilization. As new information on the diagnosis, treatment and nature of the agent becomes available, this guidance will be modified as appropriate.
Epidemiologic data suggest that the BSE epidemic in Great Britain which began in 1986 occurred through feeding cattle contaminated meat and bone meal as a protein source. The BSE agent may have been present for a long time, but changes in rendering procedures in the late 70's and early 80's may have enabled the active agent to survive in the animal feeds. The agent is thought to be from scrapie-infected sheep, but cattle with a previously unidentified TSE have not been ruled out. An association between cases of variant CJD in Great Britain and BSE seems likely, although causality has not been proved. To date, there have been no cases of BSE in the United States.
The possibility of introducing the BSE agent through a medical device requires special attention on the part of manufacturers with regard to the sourcing and processing of bovine-derived material. At present this can most easily be accomplished by assuring that the source cattle are free of BSE. In 1993 and more recently, on May 9, 1996, the Food and Drug Administration (FDA) issued letters to manufacturers to request that bovine-derived materials from cattle which have resided in or originated from countries where BSE has been diagnosed not be used in the manufacture of FDA-regulated products. (Attachments 1, 2 and 3)
Since 1989, the USDA has restricted the importation of live ruminants from Great Britain. Currently the USDA restricts the importation of live ruminants from countries where BSE is known to exist, and from those countries that present a significant risk of introducing BSE into the United States. Also restricted (by USDA) from import from these countries are other ruminant-derived products such as bone meal, meat and bone meal, blood meal, offal, glands, and gelatin for animal consumption. FDA recently prohibited protein derived from mammalian tissues to be used in ruminant feed for animals in the US (Federal Register June 5, 1997; 21 CFR Part 589 "Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed").
To track medical devices which either contain or are exposed to animal-derived materials during manufacturing (e.g., human cells grown in media containing fetal calf serum), CDRH has developed the CDRH Biomaterials Database which contains an inventory of these devices, including type of material, animal species and country of origin, and target organ or tisssue for each device. Originally proposed in response to the BSE issue, the Database was expanded to include all animal-derived products (including human) in order to respond to other animal material-based sourcing concerns that may arise in the future.
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