BSMD » Topics » COMPETITION

These excerpts taken from the BSMD 10-K filed Mar 20, 2009.

COMPETITION

        We encounter, and expect to continue to encounter, competition in the sale of our current and future embolotherapy and delivery system products. The primary competitive embolotherapy product has been polyvinyl alcohol, or PVA, particles, a product introduced into the market more than 20 years ago. Our principal competitors in both the fields of embolotherapy and the delivery systems used in the UFE procedure are AngioDynamics Incorporated, Biocompatibles, Limited., Boston Scientific Corporation, Cook Incorporated, Cordis Corporation, a Johnson & Johnson company, Pfizer Inc, and Terumo Corporation, as well as companies selling or developing non-embolotherapy solutions for UFE and liver cancer. Currently, the primary products with which our microspheres compete are spherical PVA, sold by Boston Scientific, Biocompatibles and Terumo; gel foam, sold by Pfizer; and nonspherical PVA, sold by Boston Scientific, AngioDynamics and Cook. CeloNova Biosciences, Inc. currently has market clearance for hypervascularized tumors, arteriovenous malformations, or AVMs, including uterine fibroids and hepatocellular carcinoma in Europe and for AVMs and hypervascularized tumors in the U.S. Many of our current competitors have, and our future competitors are likely to have, greater financial, operational, sales and marketing resources and more experience in research and development than we have.

        We compete primarily on the basis of product performance, ease of use, degree of targeted embolization control, and quality of patient outcome. Within the field of uterine artery embolization, we believe we are the market share leader and one of only three companies in the United States to have embolic products specifically indicated for use in UFE. Boston Scientific, which markets both a non-spherical PVA product and a spherical PVA product, is our principal competitor in this market. Based on both research and clinical studies conducted on our product for UFE, we believe we offer physicians a high degree of consistent and predictable product performance, ease of use, targeted delivery, and durable vessel occlusion, and therefore satisfactory short- and long-term clinical outcomes, when compared to our competitors.

        UFE competes with other treatments that are used to address symptoms related to fibroids. Endometrial ablation is a technique for addressing excessive uterine bleeding, or menorrhagia, in women. Most endometrial ablation systems are not indicated for use in treatment of fibroids; however, obstetricians and gynecologists may use this procedure to resolve symptoms secondary to fibroids. Robotic surgery is an additional option that offers a less invasive alternative to a full surgical hysterectomy or myomectomy. These procedures require purchase of an expensive piece of equipment and disposables required for the procedure. Although robotic surgery generally requires a smaller incision and therefore reduced time for healing, these procedures are still a surgical procedure requiring the surgical removal of either the tumor or entire uterus. Robotic surgery also requires extensive training and a specialized skill set.

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Table of Contents

        In the United States, our QuadraSphere Microsphere product competes with Biocompatibles' LC bead. Biocompatibles' LC bead is distributed by AngioDynamics. Market clearance for both our QuadraSphere Microspheres and Biocompatibles' LC bead in the United States is for the treatment of hypervascularized tumors and arteriovenous malformations.

        In drug-delivery microspheres our primary competition in Europe is Biocompatibles' DC bead. In Europe, we have CE Mark approval for HepaSphere Microspheres for drug delivery for hepatocellular carcinoma. Biocompatibles has CE Mark approval for its DC bead.

COMPETITION



        We encounter, and expect to continue to encounter, competition in the sale of our current and future embolotherapy and delivery system
products. The primary competitive embolotherapy product has been polyvinyl alcohol, or PVA, particles, a product introduced into the market more than 20 years ago. Our principal competitors in
both the fields of embolotherapy and the delivery systems used in the UFE procedure are AngioDynamics Incorporated, Biocompatibles, Limited., Boston Scientific Corporation, Cook Incorporated, Cordis
Corporation, a Johnson & Johnson company, Pfizer Inc, and Terumo Corporation, as well as companies selling or developing non-embolotherapy solutions for UFE and liver cancer.
Currently, the primary products with which our microspheres compete are spherical PVA, sold by Boston Scientific, Biocompatibles and Terumo; gel foam, sold by Pfizer; and nonspherical PVA, sold by
Boston Scientific, AngioDynamics and Cook. CeloNova Biosciences, Inc. currently has market clearance for hypervascularized tumors,
arteriovenous malformations, or AVMs, including uterine fibroids and hepatocellular carcinoma in Europe and for AVMs and hypervascularized tumors in the U.S. Many of our current competitors have, and
our future competitors are likely to have, greater financial, operational, sales and marketing resources and more experience in research and development than we have.



        We
compete primarily on the basis of product performance, ease of use, degree of targeted embolization control, and quality of patient outcome. Within the field of uterine artery
embolization, we believe we are the market share leader and one of only three companies in the United States to have embolic products specifically indicated for use in UFE. Boston Scientific, which
markets both a non-spherical PVA product and a spherical PVA product, is our principal competitor in this market. Based on both research and clinical studies conducted on our product for
UFE, we believe we offer physicians a high degree of consistent and predictable product performance, ease of use, targeted delivery, and durable vessel occlusion, and therefore satisfactory short- and
long-term clinical outcomes, when compared to our competitors.



        UFE
competes with other treatments that are used to address symptoms related to fibroids. Endometrial ablation is a technique for addressing excessive uterine bleeding, or menorrhagia,
in women. Most endometrial ablation systems are not indicated for use in treatment of fibroids; however, obstetricians and gynecologists may use this procedure to resolve symptoms secondary to
fibroids. Robotic surgery is an additional option that offers a less invasive alternative to a full surgical hysterectomy or myomectomy. These procedures require purchase of an expensive piece of
equipment and disposables required for the procedure. Although robotic surgery generally requires a smaller incision and therefore reduced time for healing, these procedures are still a surgical
procedure requiring the surgical removal of either the tumor or entire uterus. Robotic surgery also requires extensive training and a specialized skill set.



12









HREF="#bg40101a_main_toc">Table of Contents



        In
the United States, our QuadraSphere Microsphere product competes with Biocompatibles' LC bead. Biocompatibles' LC bead is distributed by AngioDynamics. Market clearance for both our
QuadraSphere Microspheres and Biocompatibles' LC bead in the United States is for the treatment of hypervascularized tumors and arteriovenous malformations.



        In
drug-delivery microspheres our primary competition in Europe is Biocompatibles' DC bead. In Europe, we have CE Mark approval for HepaSphere Microspheres for drug delivery
for hepatocellular carcinoma. Biocompatibles has CE Mark approval for its DC bead.



These excerpts taken from the BSMD 10-K filed Mar 26, 2008.

COMPETITION

        We encounter, and expect to continue to encounter, competition in the sale of our current and future embolotherapy and delivery system products. The primary competitive embolotherapy product

12



has been polyvinyl alcohol, or PVA particles, a product introduced into the market more than 20 years ago. Our principal competitors in both the fields of embolotherapy and the delivery systems used in the UFE procedure are AngioDynamics Incorporated, Biocompatibles, Ltd., Boston Scientific Corporation, Cook Incorporated, Cordis Corporation, a Johnson and Johnson Company, Pfizer, Inc. and Terumo Corporation, as well as companies selling or developing non-embolotherapy solutions for the disease states targeted by us. Currently, the primary products with which our microspheres compete for some of our applications are spherical PVA, sold by Boston Scientific Corporation, Biocompatibles and Terumo; gel foam, sold by Pfizer; and non-spherical PVA, sold by Boston Scientific, AngioDynamics and Cook. We are aware of other companies with active development programs for embolics targeted to uterine fibroid applications. CeloNova, a U.S. company, currently markets an embolic product in Europe that is being used for UFE procedures. CeloNova's embolic is not yet approved for use in any application in the U.S. Many of our current competitors have, and our future competitors are likely to have, greater financial, operational, sales and marketing resources and more experience in research and development than we have.

        We compete primarily on the basis of product performance, ease of use, degree of targeted embolization control, and quality of patient outcome. Within the field of uterine artery embolization, we believe we are the market share leader and one of only two companies in the United States to have embolic products specifically indicated for use in UFE. Boston Scientific, which markets both a non-spherical PVA product and a spherical PVA product, is our principal competitor in this area of the market. Based on both research and clinical studies conducted on our product for UFE, we believe we offer physicians a high degree of ease of use, targeted delivery, durable vessel occlusion, and therefore satisfactory short- and long-term clinical outcomes, when compared to our competitors.

        UFE competes with other treatments that are used to address symptoms related to fibroids. Endometrial ablation is a technique for addressing excessive uterine bleeding (menorrhagia) in women. Endometrial ablation is not indicated for use in treatment of fibroids; however, obstetricians and gynecologists may use this procedure to resolve symptoms secondary to fibroids. Robotic surgery is an option that offers a less invasive alternative to a full surgical hysterectomy. These procedures require purchase of an expensive piece of equipment and disposables required for the procedure,. Although robotic surgery generally requires a smaller incision and therefore reduced time for healing, these procedures are still a surgical procedure requiring the removal of either the tumor or entire uterus.

        In the United States our QuadraSphere Microspheres product competes with Biocompatible's LC bead. Biocompatible's LC bead is distributed by AngioDynamics. Market clearance for both our QuadraSphere Microspheres and Biocompatible's LC bead in the United States is for the treatment of hypervascularized tumors and arteriovenous malformations.

        In drug delivery microspheres our primary competition in Europe is Biocompatibles. In Europe we have CE Mark approval for HepaSphere Microspheres for drug delivery for hepatocellular carcinoma. Biocompatibles in Europe has CE Mark approval for DC bead.

COMPETITION



        We encounter, and expect to continue to encounter, competition in the sale of our current and future embolotherapy and delivery system products. The primary
competitive embolotherapy product



12











has
been polyvinyl alcohol, or PVA particles, a product introduced into the market more than 20 years ago. Our principal competitors in both the fields of embolotherapy and the delivery systems
used in the UFE procedure are AngioDynamics Incorporated, Biocompatibles, Ltd., Boston Scientific Corporation, Cook Incorporated, Cordis Corporation, a Johnson and Johnson Company,
Pfizer, Inc. and Terumo Corporation, as well as companies selling or developing non-embolotherapy solutions for the disease states targeted by us. Currently, the primary products
with which our microspheres compete for some of our applications are spherical PVA, sold by Boston Scientific Corporation, Biocompatibles and Terumo; gel foam, sold by Pfizer; and
non-spherical PVA, sold by Boston Scientific, AngioDynamics and Cook. We are aware of other companies with active development programs for embolics targeted to uterine fibroid
applications. CeloNova, a U.S. company, currently markets an embolic product in Europe that is being used for UFE procedures. CeloNova's embolic is not yet approved for use in any application in the
U.S. Many of our current competitors have, and our future competitors are likely to have, greater financial, operational, sales and marketing resources and more experience in research and development
than we have.



        We
compete primarily on the basis of product performance, ease of use, degree of targeted embolization control, and quality of patient outcome. Within the field of uterine artery
embolization, we believe we are the market share leader and one of only two companies in the United States to have embolic products specifically indicated for use in UFE. Boston Scientific, which
markets both a non-spherical PVA product and a spherical PVA product, is our principal competitor in this area of the market. Based on both research and clinical studies conducted on our
product for UFE, we believe we offer physicians a high degree of ease of use, targeted delivery, durable vessel occlusion, and therefore satisfactory short- and long-term clinical
outcomes, when compared to our competitors.



        UFE
competes with other treatments that are used to address symptoms related to fibroids. Endometrial ablation is a technique for addressing excessive uterine bleeding (menorrhagia) in
women. Endometrial ablation is not indicated for use in treatment of fibroids; however, obstetricians and gynecologists may use this procedure to resolve symptoms secondary to fibroids. Robotic
surgery is an option that offers a less invasive alternative to a full surgical hysterectomy. These procedures require purchase of an expensive piece of equipment and disposables required for the
procedure,. Although robotic surgery generally requires a smaller incision and therefore reduced time for healing, these procedures are still a surgical procedure requiring the removal of either the
tumor or entire uterus.



        In
the United States our QuadraSphere Microspheres product competes with Biocompatible's LC bead. Biocompatible's LC bead is distributed by AngioDynamics. Market clearance for both our
QuadraSphere Microspheres and Biocompatible's LC bead in the United States is for the treatment of hypervascularized tumors and arteriovenous malformations.



        In
drug delivery microspheres our primary competition in Europe is Biocompatibles. In Europe we have CE Mark approval for HepaSphere Microspheres for drug delivery for hepatocellular
carcinoma. Biocompatibles in Europe has CE Mark approval for DC bead.



This excerpt taken from the BSMD 10-K filed Mar 27, 2007.

COMPETITION

We encounter, and expect to continue to encounter, competition in the sale of our current and future embolotherapy and delivery system products. The primary competitive embolotherapy product has been polyvinyl alcohol, or PVA particles, a product introduced into the market more than 20 years ago. Our principal competitors in both the fields of embolotherapy and the delivery systems used in the UFE procedure are Angiodynamics Incorporated, Biocompatibles, Ltd., Boston Scientific Corporation, Cook Incorporated, Cordis Corporation, a Johnson and Johnson Company, Pfizer, Inc. and Terumo Corporation, as well as companies selling or developing non-embolotherapy solutions for the disease states targeted by us. Currently, the primary products with which our microspheres compete for some of our applications are spherical PVA, sold by Boston Scientific Corporation, Biocompatibles and Terumo, gel foam, sold by Pfizer, and non-spherical PVA, sold by Boston Scientific, Angiodynamics and Cook. Many of our current competitors have, and our future competitors are likely to have, greater financial, operational, sales and marketing resources and more experience in research and development than we have. We compete primarily on the basis of product performance, ease of use, degree of targeted embolization control, and quality of patient outcome. Within the field of uterine artery embolization, we believe we are the market share leader and one of only two companies in the United States to have embolic products specifically indicated for use in UFE. Boston Scientific, which markets both a non-spherical PVA product and a spherical PVA product, is our principal competitor in this area of the market. Based on both research and clinical studies conducted on our product for UFE, we believe we offer physicians a

13




high degree of ease of use, targeted delivery, durable vessel occlusion, and therefore satisfactory short and long-term clinical outcomes, when compared to our competitors.

This excerpt taken from the BSMD 10-K filed Mar 21, 2006.
COMPETITION

We encounter, and expect to continue to encounter, competition in the sale of our current and future embolotherapy and delivery system products. The primary competitive embolotherapy product has been polyvinyl alchol, or PVA particles, a product introduced into the market more than 20 years ago. Our principal competitors in both the fields of embolotherapy and the delivery systems used in the UFE procedure are Angiodynamics Incorporated, Biocompatibles, Ltd., Boston Scientific Corporation, Cook Incorporated, Cordis Corporation, a Johnson and Johnson Company, Pfizer, Inc. and Terumo Corporation, as well as companies selling or developing non-embolotherapy solutions for the disease states

10




targeted by us. Currently, the primary products with which our microspheres compete for some of our applications are spherical PVA, sold by Boston Scientific Corporation, Biocompatibles and Terumo, gel foam, sold by Pfizer, and non-spherical PVA, sold by Boston Scientific, Angiodynamics and Cook. Many of our current competitors have, and our future competitors are likely to have, greater financial, operational, sales and marketing resources and more experience in research and development than we have. We compete primarily on the basis of product performance, ease of use, degree of targeted embolization control, and quality of patient outcome. Within the field of uterine artery embolization, we believe we are the market share leader and one of only two companies in the United States to have embolic products specifically indicated for use in UFE. Boston Scientific, which markets both a PVA product and a next-generation spherical PVA product, is our principal competitor in this area of the market. Based on both research and clinical studies conducted on our product for UFE, we believe we offer physicians a high degree of ease of use, targeted delivery, durable vessel occlusion, and therefore satisfactory short and long-term clinical outcomes, when compared to our competitors.

This excerpt taken from the BSMD 10-K filed Mar 29, 2005.
COMPETITION

We encounter, and expect to continue to encounter, competition in the sale of our current and future embolotherapy and delivery system products. The primary competitive embolotherapy product has been polyvinyl alcohol, or PVA, a product introduced into the market more than 20 years ago. Our principal competitors in both the fields of embolotherapy and the delivery systems used in the UFE procedure are Angiodynamics Incorporated, Biocompatibles, Ltd., Boston Scientific Corporation, Cook Incorporated, Cordis Corporation, a Johnson and Johnson Company, Pfizer, Inc. and Terumo Corporation, as well as companies selling or developing non-embolotherapy solutions for the disease states targeted by us. Currently, the primary products with which our microspheres compete for some of our applications are spherical polyvinyl alcohol, sold by Boston Scientific Corporation, Biocompatibles and Terumo, gel foam, sold by Pfizer, and non-spherical polyvinyl alcohol, sold by Angiodynamics and Cook. Many of our current competitors have, and our future competitors are likely to have, greater financial, operational, sales and marketing resources and more experience in research and development than we have. We compete primarily on the basis of product performance, ease of use, degree of targeted embolization control, and quality of patient outcome. Within the field of uterine artery embolization, we believe we are the market share leader and one of only two companies in the United States to have embolic products specifically indicated for use in UFE. Boston Scientific, which markets both a PVA product and a next-generation spherical PVA product, is our principal competitor in this area of the market. Based on both research and clinical studies conducted on our product for UFE, we believe we offer physicians a high degree of ease of use, targeted delivery, durable vessel occlusion, and therefore satisfactory short and long-term clinical outcomes, when compared to our competitors.

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