CPTS » Topics » COMPETITION

These excerpts taken from the CPTS 10-K filed Mar 13, 2009.

Competition

        The medical device industry is highly competitive and is characterized by rapid and significant technological change. To compete successfully, we will need to continue to demonstrate the advantages of our Essure products and technologies over well-established alternative procedures, products and technologies, and convince physicians and other healthcare decision makers of the advantages of our products and technologies. As we commercialize and market the Essure system, we expect to compete with:

    other methods of permanent contraception, in particular tubal ligation;

    other methods of non-permanent contraception, including devices such as intrauterine devices, or IUDs, vaginal rings, condoms and prescription drugs such as the birth control pill, injectable and implantable contraceptives and patches; and

    other companies that may are developing permanent contraception devices that are similar to or otherwise compete with the Essure system.

        We compete against other surgical procedures for permanent birth control, mechanical devices and other contraceptive methods, including existing methods of reversible birth control for both women and men.

        As of December 31, 2008, we were aware of two companies, Hologic, Inc. and American Medical Systems, Inc. which were attempting to bring transcervical sterilization devices to the market. In January 2009, Hologic received CE marking approval for its permanent contraception system, allowing it to market its product in the 27 countries of the European Union (EU) and three of the four member states of the European Free Trade Associations (EFTA). In the United States, the PMA application for this company is currently under Food and Drug Administration (FDA) review. This company is in the process of registering its product in Canada and Australia. In February 2009, American Medical Systems announced it has decided to suspend their development efforts in the women's permanent contraception product market.

        Many of our competitors possess a larger women's health focused sales force and have access to the greater resources required to develop and market a competitive product than we do. In addition, new competition and products may arise due to consolidation within the industry and other companies may develop products that could compete with the Essure system. Our competitive position also depends on:

    widespread awareness, acceptance and adoption of our Essure product;

    our ability to respond promptly to medical and technological changes through the development and commercialization of new products;

    availability of coverage and reimbursement from third-party payors, insurance companies and others for the Essure procedure;

    the manufacture and delivery of our products in sufficient volumes on time, and accurately predicting and controlling costs associated with manufacturing, installation, warranty and maintenance of the products;

    our ability to attract and retain qualified personnel;

    the extent of our patent protection or our ability to otherwise develop proprietary products and processes; and

    securing sufficient capital resources to expand our sales and marketing efforts.

15


Table of Contents

        These and other competitive factors may render the Essure system obsolete or noncompetitive or reduce demand for the Essure system.

Competition

        The medical device industry is highly competitive and is characterized by rapid and significant technological change. To compete successfully, we will need to continue to demonstrate the advantages of our Essure products and technologies over well-established alternative procedures, products and technologies, and convince physicians and other healthcare decision makers of the advantages of our products and technologies. As we commercialize and market the Essure system, we expect to compete with:

    other methods of permanent contraception, in particular tubal ligation;

    other methods of non-permanent contraception, including devices such as intrauterine devices, or IUDs, vaginal rings, condoms and prescription drugs such as the birth control pill, injectable and implantable contraceptives and patches; and

    other companies that may are developing permanent contraception devices that are similar to or otherwise compete with the Essure system.

        We compete against other surgical procedures for permanent birth control, mechanical devices and other contraceptive methods, including existing methods of reversible birth control for both women and men.

        As of December 31, 2008, we were aware of two companies, Hologic, Inc. and American Medical Systems, Inc. which were attempting to bring transcervical sterilization devices to the market. In January 2009, Hologic received CE marking approval for its permanent contraception system, allowing it to market its product in the 27 countries of the European Union (EU) and three of the four member states of the European Free Trade Associations (EFTA). In the United States, the PMA application for this company is currently under Food and Drug Administration (FDA) review. This company is in the process of registering its product in Canada and Australia. In February 2009, American Medical Systems announced it has decided to suspend their development efforts in the women's permanent contraception product market.

        Many of our competitors possess a larger women's health focused sales force and have access to the greater resources required to develop and market a competitive product than we do. In addition, new competition and products may arise due to consolidation within the industry and other companies may develop products that could compete with the Essure system. Our competitive position also depends on:

    widespread awareness, acceptance and adoption of our Essure product;

    our ability to respond promptly to medical and technological changes through the development and commercialization of new products;

    availability of coverage and reimbursement from third-party payors, insurance companies and others for the Essure procedure;

    the manufacture and delivery of our products in sufficient volumes on time, and accurately predicting and controlling costs associated with manufacturing, installation, warranty and maintenance of the products;

    our ability to attract and retain qualified personnel;

    the extent of our patent protection or our ability to otherwise develop proprietary products and processes; and

    securing sufficient capital resources to expand our sales and marketing efforts.

15


Table of Contents

        These and other competitive factors may render the Essure system obsolete or noncompetitive or reduce demand for the Essure system.

Competition



        The medical device industry is highly competitive and is characterized by rapid and significant technological change. To compete
successfully, we will need to continue to demonstrate the advantages of our
Essure products and technologies over well-established
alternative procedures, products and technologies, and convince physicians and other healthcare decision makers of the advantages of our products and technologies. As we commercialize and market the
EssureSIZE=2> system, we expect to compete with:





    other methods of permanent contraception, in particular tubal ligation;


    other methods of non-permanent contraception, including devices such as intrauterine devices, or IUDs, vaginal
    rings, condoms and prescription drugs such as the birth control pill, injectable and implantable contraceptives and patches; and



    other companies that may are developing permanent contraception devices that are similar to or otherwise compete with the Essure
    system.



        We
compete against other surgical procedures for permanent birth control, mechanical devices and other contraceptive methods, including existing methods of reversible birth control for
both women and men.



        As
of December 31, 2008, we were aware of two companies, Hologic, Inc. and American Medical Systems, Inc. which were attempting to bring transcervical sterilization
devices to the market. In January 2009, Hologic received CE marking approval for its permanent contraception system, allowing it to market its product in the 27 countries of the European Union (EU)
and three of the four member states of the European Free Trade Associations (EFTA). In the United States, the PMA application for this company is currently under Food and Drug Administration (FDA)
review. This company is in the process of registering its product in Canada and Australia. In February 2009, American Medical Systems announced it has decided to suspend their development efforts in
the women's permanent contraception product market.



        Many
of our competitors possess a larger women's health focused sales force and have access to the greater resources required to develop and market a competitive product than we do. In
addition, new competition and products may arise due to consolidation within the industry and other companies may develop products that could compete with the
Essure system. Our competitive position
also depends on:





    widespread awareness, acceptance and adoption of our Essure product;


    our ability to respond promptly to medical and technological changes through the development and commercialization of new
    products;



    availability of coverage and reimbursement from third-party payors, insurance companies and others for the Essure
    procedure;



    the manufacture and delivery of our products in sufficient volumes on time, and accurately predicting and controlling
    costs associated with manufacturing, installation, warranty and maintenance of the products;



    our ability to attract and retain qualified personnel;


    the extent of our patent protection or our ability to otherwise develop proprietary products and processes; and


    securing sufficient capital resources to expand our sales and marketing efforts.


15










HREF="#bg10801a_main_toc">Table of Contents








        These
and other competitive factors may render the
Essure system obsolete or noncompetitive or reduce demand for the Essure system.



Competition



        The medical device industry is highly competitive and is characterized by rapid and significant technological change. To compete
successfully, we will need to continue to demonstrate the advantages of our
Essure products and technologies over well-established
alternative procedures, products and technologies, and convince physicians and other healthcare decision makers of the advantages of our products and technologies. As we commercialize and market the
EssureSIZE=2> system, we expect to compete with:





    other methods of permanent contraception, in particular tubal ligation;


    other methods of non-permanent contraception, including devices such as intrauterine devices, or IUDs, vaginal
    rings, condoms and prescription drugs such as the birth control pill, injectable and implantable contraceptives and patches; and



    other companies that may are developing permanent contraception devices that are similar to or otherwise compete with the Essure
    system.



        We
compete against other surgical procedures for permanent birth control, mechanical devices and other contraceptive methods, including existing methods of reversible birth control for
both women and men.



        As
of December 31, 2008, we were aware of two companies, Hologic, Inc. and American Medical Systems, Inc. which were attempting to bring transcervical sterilization
devices to the market. In January 2009, Hologic received CE marking approval for its permanent contraception system, allowing it to market its product in the 27 countries of the European Union (EU)
and three of the four member states of the European Free Trade Associations (EFTA). In the United States, the PMA application for this company is currently under Food and Drug Administration (FDA)
review. This company is in the process of registering its product in Canada and Australia. In February 2009, American Medical Systems announced it has decided to suspend their development efforts in
the women's permanent contraception product market.



        Many
of our competitors possess a larger women's health focused sales force and have access to the greater resources required to develop and market a competitive product than we do. In
addition, new competition and products may arise due to consolidation within the industry and other companies may develop products that could compete with the
Essure system. Our competitive position
also depends on:





    widespread awareness, acceptance and adoption of our Essure product;


    our ability to respond promptly to medical and technological changes through the development and commercialization of new
    products;



    availability of coverage and reimbursement from third-party payors, insurance companies and others for the Essure
    procedure;



    the manufacture and delivery of our products in sufficient volumes on time, and accurately predicting and controlling
    costs associated with manufacturing, installation, warranty and maintenance of the products;



    our ability to attract and retain qualified personnel;


    the extent of our patent protection or our ability to otherwise develop proprietary products and processes; and


    securing sufficient capital resources to expand our sales and marketing efforts.


15










HREF="#bg10801a_main_toc">Table of Contents








        These
and other competitive factors may render the
Essure system obsolete or noncompetitive or reduce demand for the Essure system.



These excerpts taken from the CPTS 10-K filed Mar 14, 2008.

COMPETITION

        We compete against other surgical procedures for permanent birth control, mechanical devices and other contraceptive methods, including existing methods of reversible birth control for both women and men.

        We are aware of two companies that are attempting to bring transcervical sterilization devices to the market. In December 2007, one company submitted a PMA to the FDA and received a recommendation for approval with conditions from an FDA panel. The FDA has requested additional data from this company prior to an approval decision. The other company is in the clinical stages of development, although they halted their clinical study in 2007. Both companies possess superior resources to us, including sales force and access to capital and are significantly larger in net sales and profits. In addition, new competition and products may arise due to mergers or acquisitions performed by external parties and other companies may develop products that could compete with the Essure system. Moreover, the medical device industry is characterized by rapid and significant technological change. The length of time required for product development and regulatory approval impacts remarkably a company's competitive position. As a result, our success will depend in part on our ability to respond promptly to medical and technological changes through the development and commercialization of new products. Competitive factors may render the Essure system obsolete or noncompetitive or reduce demand for the Essure system.

COMPETITION



        We compete against other surgical procedures for permanent birth control, mechanical devices and other contraceptive methods, including existing methods of
reversible birth control for both women and men.



        We
are aware of two companies that are attempting to bring transcervical sterilization devices to the market. In December 2007, one company submitted a PMA to the FDA and received a
recommendation for approval with conditions from an FDA panel. The FDA has requested additional data from this company prior to an approval decision. The other company is in the clinical stages of
development, although they halted their clinical study in 2007. Both companies possess superior resources to us, including sales force and access to capital and are significantly larger in net sales
and profits. In addition, new competition and products may arise due to mergers or acquisitions performed by external parties and other companies may develop products that could compete with the
Essure
system. Moreover, the medical device industry is characterized by rapid and significant technological change. The length of time required for
product development and regulatory approval impacts remarkably a company's competitive position. As a result, our success will depend in part on our ability to respond promptly to medical and
technological changes through the development and commercialization of new products. Competitive factors may render the
Essure system obsolete or
noncompetitive or reduce demand for the
Essure system.



This excerpt taken from the CPTS 10-K filed Mar 15, 2007.

COMPETITION

We compete against other surgical procedures for permanent birth control, mechanical devices and other contraceptive methods, including existing methods of reversible birth control for both women and men.

We are aware of a company that is in the clinical stages of development for non-incisional permanent contraception devices. In addition, new competition and products may arise due to mergers or acquisitions performed by external parties and other companies may develop products that could compete with the Essure system. Moreover, the medical device industry is characterized by rapid and significant technological change. The length of time required for product development and regulatory approval impacts remarkably a company’s competitive position. As a result, our success will depend in part on our ability to respond promptly to medical and technological changes through the development and commercialization of new products. Competitive factors may render the Essure system obsolete or noncompetitive or reduce demand for the Essure system.

This excerpt taken from the CPTS 10-K filed Mar 16, 2006.

COMPETITION

        We compete against other surgical procedures for permanent birth control, mechanical devices and other contraceptive methods, including existing methods of reversible birth control for both women and men.

        We are aware of a company that is in the clinical stages of development for non-incisional permanent contraception devices. In addition, high competition may arise due to mergers or acquisitions performed by external parties and other companies may develop products that could compete with the Essure system. Moreover, the medical device industry is characterized by rapid and significant technological change. The length of time required for product development and regulatory approval impacts remarkably a company's competitive position. As a result, our success will depend in part on our ability to respond promptly to medical and technological changes through the development and commercialization of new products. Competitive factors may render the Essure system obsolete or noncompetitive or reduce demand for the Essure system.

This excerpt taken from the CPTS 10-K filed Mar 31, 2005.

COMPETITION

        We compete against other surgical procedures for permanent birth control, mechanical devices and other contraceptive methods, including existing methods of reversible birth control for both women and men.

        We are aware of one company that is in the early stage of developing a non-incisional permanent birth control device, and other companies may develop products that could compete with Essure in the future.

        The medical device industry is characterized by rapid and significant technological change. The length of time required for product development and regulatory approval plays an important role in a company's competitive position. As a result, our success will depend in part on our ability to respond quickly to medical and technological changes through the development and commercialization of new products. Competitive factors may render Essure obsolete or noncompetitive or reduce demand for Essure.

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