BSMD » Topics » Research and Development

These excerpts taken from the BSMD 10-Q filed May 11, 2009.

Research and Development

 

Research and development costs include payroll, facility costs, administrative expenses and third-party costs related to developing new products, making technological improvements to existing products and production methods. Research and development costs are expensed in the period incurred. Preclinical testing of product candidates and clinical trials and product

 

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validation costs associated with recently launched products are also included in research and development expenses.

 

In June 2007, the FASB ratified Emerging Issue Task Force (“EITF”) No. 07-3, “Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities” (“EITF 07-3”). EITF 07-3 concluded that nonrefundable advance payments for goods or services to be received in the future for use in research and development activities should be deferred and capitalized. The capitalized amounts should be expensed as the related goods are delivered or the services are performed. If an entity’s expectations change such that it does not expect it will need the goods to be delivered or the services to be rendered, capitalized nonrefundable advance payments should be charged to expense in the period such determination is made.  The Company did not have any nonrefundable advance payments capitalized at March 31, 2009. The Company adopted EITF 07-3 on January 1, 2008. The adoption of EITF 07-3 did not have a material impact on the Company’s results of operations, financial position or cash flows.

 

Research and Development

 

Research and development expense as a percentage of total revenue for the three months ended March 31, 2009 and 2008 was 14% and 9%, respectively. Research and development expense in these periods relate primarily to:

 

·                  seeking to develop improved manufacturing processes for our currently marketed products.

 

·                  research to identify and evaluate new and innovative embolotherapy products based on our platform microsphere technology, including a smaller-sized microsphere for our HepaSphere Microsphere and QuadraSphere Microsphere product offerings, as well as our MR Microspheres and Resorbable Microspheres, all of which are in preclinical development;

 

·                  seeking to develop a new generation of steerable guidewire to augment and/or replace our current guidewire product offerings; and

 

·                  further preclinical testing and nonclinical trials to support initial and/or additional clinical indications and/or premarketing approvals for our Embosphere Microspheres, HepaSphere Microspheres, QuadraSphere Microspheres, Sequitor Steerable Guidewire and EmboCath Plus Infusion Microcatheter, all of which are currently approved and marketed for specified indications and in specified geographic locations.

 

In the first quarter of 2009, a third-party developer delivered a working prototype relating to a new process for the manufacture of Embosphere Microspheres.

 

Our research and development functions typically work on a number of projects concurrently. In addition, except for clinical expenses, a substantial amount of fixed research and development costs such as salary and salary-related benefits, facility costs, equipment depreciation and maintenance are shared among various programs. Accordingly, we have not historically tracked specific costs for each of our research and development projects.

 

We cannot reasonably estimate or know the nature, timing and estimated costs of the efforts necessary to complete the development of any of our product candidates that are currently in development, or the period in which material net cash inflows are expected to commence from any of our product candidates that are currently in development or from any of our currently marketed products for which we are seeking expanded marketing approvals in selected indications or geographic regions, due to the numerous risks and uncertainties associated with developing and commercializing medical devices, including uncertainties relating to:

 

·                  the technical risks in new product research and development;

 

·                  the scope, rate of progress and cost of clinical trials and other research and development activities undertaken by us;

 

·                  future clinical trial results;

 

·                  publicity with respect to our products or their indications;

 

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·                  the cost, timing and success of regulatory approvals;

 

·                  the cost, timing and success of establishing sales, marketing and distribution capabilities;

 

·                  the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop;

 

·                  market acceptance of our approved products;

 

·                  the effect of competing technological and market developments; and

 

·                  the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.

 

Any failure to complete the development of our product candidates in a timely manner, or at all, could have a material adverse effect on our operations, financial position and liquidity. A discussion of the risks and uncertainties associated with completing our projects on schedule, or at all, and some consequences of failing to do so, are set forth in “Part II, Item 1A—Risk Factors” below.

 

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

RESEARCH AND DEVELOPMENT

        Research and development expenses for the years ended December 31, 2008, 2007 and 2006 were $3.31 million, $2.34 million and $2.29 million, respectively, or 11%, 9% and 10%, respectively, of total revenue. Research and development expenses in these periods relate primarily to:

    research to identify and evaluate new and innovative embolotherapy products based on our platform microsphere technology, including a smaller-sized microsphere for our HepaSphere Microsphere and QuadraSphere Microsphere product offerings, as well as our MR Microspheres and our Resorbable Microspheres, all of which are in preclinical development;

    seeking to develop a new generation of steerable guidewire to augment and/or replace our current guidewire product offerings;

    further preclinical testing and nonclinical trials to support initial and/or additional clinical indications and/or premarketing clearances for our Embosphere Microspheres, HepaSphere Microspheres, QuadraSphere Microspheres, Sequitor Steerable Guidewire and EmboCath Plus Infusion Microcatheter, all of which are currently cleared and marketed for specified indications and in specified geographic locations; and

    seeking to develop improved manufacturing processes for our currently marketed products.

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RESEARCH AND DEVELOPMENT



        Research and development expenses for the years ended December 31, 2008, 2007 and 2006 were $3.31 million,
$2.34 million and $2.29 million, respectively, or 11%, 9% and 10%, respectively, of total revenue. Research and development expenses in these periods relate primarily
to:





    research to identify and evaluate new and innovative embolotherapy products based on our platform microsphere technology,
    including a smaller-sized microsphere for our HepaSphere Microsphere and QuadraSphere Microsphere product offerings, as well as our MR Microspheres and our Resorbable Microspheres, all of which are in
    preclinical development;



    seeking to develop a new generation of steerable guidewire to augment and/or replace our current guidewire product
    offerings;



    further preclinical testing and nonclinical trials to support initial and/or additional clinical indications and/or
    premarketing clearances for our Embosphere Microspheres, HepaSphere Microspheres, QuadraSphere Microspheres, Sequitor Steerable Guidewire and EmboCath Plus Infusion Microcatheter, all of which are
    currently cleared and marketed for specified indications and in specified geographic locations; and



    seeking to develop improved manufacturing processes for our currently marketed products.


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Research and Development

        Research and development expense as a percentage of total revenue for the fiscal years ended December 31, 2008, 2007 and 2006 was 11%, 9% and 10%, respectively. Research and development expense in these periods relate primarily to:

    research to identify and evaluate new and innovative embolotherapy products based on our platform microsphere technology, including a smaller-sized microsphere for our HepaSphere Microsphere and QuadraSphere Microsphere product offerings; as well as our MR Microspheres and Resorbable Microspheres, all of which are in preclinical development;

    seeking to develop a new generation of steerable guidewire to augment and/or replace our current guidewire product offerings;

    further preclinical testing and nonclinical trials to support initial and/or additional clinical indications and/or premarketing approvals for our Embosphere Microspheres, HepaSphere

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      Microspheres, QuadraSphere Microspheres, Sequitor Steerable Guidewire and EmboCath Plus Infusion Microcatheter, all of which are currently approved and marketed in specified indications and in specified geographic locations; and

    seeking to develop improved manufacturing processes for our currently marketed products.

        Our research and development functions typically work on a number of projects concurrently. In addition, except for clinical expenses, a substantial amount of fixed research and development costs such as salary and salary-related benefits, facility costs, equipment depreciation and maintenance are shared among various programs. Accordingly, we have not historically tracked specific costs for each of our research and development projects.

        We cannot reasonably estimate or know the nature, timing and estimated costs of the efforts necessary to complete the development of, or the period in which material net cash inflows are expected to commence from, any of our product candidates that are currently in development or from any of our currently marketed products for which we are seeking expanded marketing approvals in selected indications or geographic regions, due to the numerous risks and uncertainties associated with developing and commercializing medical devices, including uncertainties relating to:

    the technical risks in new product research and development;

    the scope, rate of progress and cost of clinical trials and other research and development activities undertaken by us;

    future clinical trial results;

    publicity with respect to our products or their indications;

    the cost, timing and success of regulatory approvals;

    the cost, timing and success of establishing sales, marketing and distribution capabilities;

    the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop;

    market acceptance of our approved products;

    the effect of competing technological and market developments; and

    the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.

        Any failure to complete the development of our product candidates in a timely manner, or at all, could have a material adverse effect on our operations, financial position and liquidity. A discussion of the risks and uncertainties associated with completing our projects on schedule, or at all, and some consequences of failing to do so, are set forth in "Part I, Item 1A—Risk Factors."

Research and Development



        Research and development expense as a percentage of total revenue for the fiscal years ended December 31, 2008, 2007 and 2006
was 11%, 9% and 10%, respectively. Research and development expense in these periods relate primarily to:





    research to identify and evaluate new and innovative embolotherapy products based on our platform microsphere technology,
    including a smaller-sized microsphere for our HepaSphere Microsphere and QuadraSphere Microsphere product offerings; as well as our MR Microspheres and Resorbable Microspheres, all of which are in
    preclinical development;



    seeking to develop a new generation of steerable guidewire to augment and/or replace our current guidewire product
    offerings;



    further preclinical testing and nonclinical trials to support initial and/or additional clinical indications and/or
    premarketing approvals for our Embosphere Microspheres, HepaSphere


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      Microspheres,
      QuadraSphere Microspheres, Sequitor Steerable Guidewire and EmboCath Plus Infusion Microcatheter, all of which are currently approved and marketed in specified indications and in
      specified geographic locations; and





    seeking to develop improved manufacturing processes for our currently marketed products.



        Our
research and development functions typically work on a number of projects concurrently. In addition, except for clinical expenses, a substantial amount of fixed research and
development costs such as salary and salary-related benefits, facility costs, equipment depreciation and maintenance are shared among various programs. Accordingly, we have not historically tracked
specific costs for each of our research and development projects.



        We
cannot reasonably estimate or know the nature, timing and estimated costs of the efforts necessary to complete the development of, or the period in which material net cash inflows are
expected to commence from, any of our product candidates that are currently in development or from any of our currently marketed products for which we are seeking expanded marketing approvals in
selected indications or geographic regions, due to the numerous risks and uncertainties associated with developing and commercializing medical devices, including uncertainties relating
to:





    the technical risks in new product research and development;


    the scope, rate of progress and cost of clinical trials and other research and development activities undertaken by us;


    future clinical trial results;


    publicity with respect to our products or their indications;


    the cost, timing and success of regulatory approvals;


    the cost, timing and success of establishing sales, marketing and distribution capabilities;


    the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop;


    market acceptance of our approved products;


    the effect of competing technological and market developments; and


    the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.



        Any
failure to complete the development of our product candidates in a timely manner, or at all, could have a material adverse effect on our operations, financial position and liquidity.
A discussion of the risks and uncertainties associated with completing our projects on schedule, or at all, and some consequences of failing to do so, are set forth in "Part I,
Item 1A—Risk Factors."



Research and Development

        Research and development costs include payroll, facility costs, administrative expenses, and third-party costs related to developing new products, making technological improvements to existing products and production methods. Research and development costs are expensed in the period incurred. Preclinical testing of product candidates and clinical trials and product validation costs associated with recently launched products are also included in research and development expenses.

        In June 2007, the FASB ratified Emerging Issue Task Force ("EITF") No. 07-3, "Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities" ("EITF 07-3"). The EITF concluded that nonrefundable advance payments for goods or services to be received in the future for use in research and development activities should be deferred and capitalized. The capitalized amounts should be expensed as the related goods are delivered or the services are performed. If an entity's expectations change such that it does not expect it will need the goods to be delivered or the services to be rendered, capitalized nonrefundable advance payments should be charged to expense in the period such determination is made. The Company did not have any nonrefundable advance payments capitalized at December 31, 2008. The Company adopted EITF 07-3 on January 1, 2008. The adoption of EITF 07-3 did not have a material impact on the Company's results of operations, financial position or cash flows.

Research and Development





        Research and development costs include payroll, facility costs, administrative expenses, and third-party costs related to developing
new products, making technological improvements to existing products and production methods. Research and development costs are expensed in the period incurred. Preclinical testing of product
candidates and clinical trials and product validation costs associated with recently launched products are also included in research and development expenses.



        In
June 2007, the FASB ratified Emerging Issue Task Force ("EITF") No. 07-3, "
Accounting for Nonrefundable Advance Payments for Goods or
Services to Be Used in Future Research and Development Activities"
("EITF 07-3"). The EITF concluded that nonrefundable advance payments for goods or
services to be received in the future for use in research and development activities should be deferred and capitalized. The capitalized amounts should be expensed as the related goods are delivered
or the services are performed. If an entity's expectations change such that it does not expect it will need the goods to be delivered or the services to be rendered, capitalized nonrefundable advance
payments should be charged to expense in the period such determination is made. The Company did not have any nonrefundable advance payments capitalized at December 31,
2008. The Company adopted EITF 07-3 on January 1, 2008. The adoption of EITF 07-3 did not have a material impact on the Company's results of operations,
financial position or cash flows.





This excerpt taken from the BSMD 10-Q filed Nov 7, 2008.

Research and Development

 

Research and development expenses as a percentage of total revenue for the nine months ended September 30, 2008 and 2007 were 10% and 9%, respectively. Research and development expenses in each of these periods relate primarily to:

 

·                                         research to identify and evaluate new and innovative embolotherapy products based on our platform microsphere technology, including a smaller-sized microsphere for our HepaSphere Microsphere and QuadraSphere Microsphere product offerings; as well as our MR Microspheres and our Resorbable Microspheres, all of which are in preclinical development;

 

·                                         developing a new generation of steerable guidewire to augment and/or replace our current guidewire product offerings;

 

·                                         further preclinical testing and non-clinical trials to support initial and/or additional clinical indications and/or premarketing approvals for our Embosphere Microspheres, HepaSphere Microspheres, QuadraSphere Microspheres, Sequitor Steerable Guidewire and EmboCath Plus Infusion Microcatheter, all of which products are currently approved and marketed for specified indications and in specified geographic locations; and

 

·                                         seeking to develop new manufacturing processes for our currently marketed products.

 

Our research and development personnel typically work on a number of projects concurrently. In addition, except for clinical expenses, a substantial amount of fixed research and development costs such as salary and salary-related benefits, facility costs, equipment depreciation and maintenance are shared among various programs. Accordingly, we have not historically tracked specific costs for each of our research and development projects.

 

We cannot reasonably estimate or know the nature, timing and estimated costs of the efforts necessary to complete the development of, or the period in which material net cash inflows are expected to commence from, any of our product candidates that are currently in development or from any of our approved products for which we are seeking expanded marketing approvals in selected indications or geographic regions, due to the numerous risks and uncertainties associated with developing and commercializing medical devices, including uncertainties relating to:

 

·                                         the technical risks in new product research and development;

 

·                                          the scope, rate of progress and cost of clinical trials and other research and development activities

 

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undertaken by us;

 

·                                         future clinical trial results;

 

·                                         publicity with respect to our products or their indications;

 

·                                         the cost, timing and success of regulatory approvals;

 

·                                         the cost, timing and success of establishing sales, marketing and distribution capabilities;

 

·                                         the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop;

 

·                                         market acceptance of our approved products;

 

·                                         the effect of competing technological and market developments; and

 

·                                         the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.

 

Any failure to complete the development of our product candidates in a timely manner, or at all, could have a material adverse effect on our operations, financial position and liquidity. A discussion of the risks and uncertainties associated with completing our projects on schedule, or at all, and some consequences of failing to do so, are set forth in “Part II, Item 1A—Risk Factors” below.

 

This excerpt taken from the BSMD 10-Q filed Aug 11, 2008.

Research and Development

 

Research and development expenses as a percentage of total revenue for the six months ended June 30, 2008 and 2007 were 10% and 9%, respectively. Research and development expenses in each of these periods relate primarily to:

 

·                                          research to identify and evaluate new and innovative embolotherapy products based on our platform microsphere technology, including a 30-60 micron-sized microsphere for our HepaSphere Microsphere and QuadraSphere Microsphere product offerings; as well as our MR Microspheres and our Resorbable Microspheres, all of which are in preclinical development;

 

·                                          further preclinical testing and clinical trials to support initial and/or additional clinical indications and/or premarketing approvals for our Embosphere Microspheres, HepaSphere Microspheres, QuadraSphere Microspheres, Sequitor Steerable Guidewire and EmboCath Plus Infusion Microcatheter, all of which products are currently approved and marketed for specified indications and in specified geographic locations; and

 

·                                          seeking to develop new manufacturing processes for our currently marketed products.

 

Our research and development personnel typically work on a number of projects concurrently. In addition, except for clinical expenses, a substantial amount of fixed research and development costs such as salary and salary-related benefits, facility costs, equipment depreciation and maintenance are shared among various programs. Accordingly, we have not historically tracked specific costs for each of our research and development projects.

 

We cannot reasonably estimate or know the nature, timing and estimated costs of the efforts necessary to complete the development of, or the period in which material net cash inflows are expected to commence from, any of our product candidates that are currently in development or from any of our approved products for which we are seeking expanded marketing approvals in selected indications or geographic regions, due to the numerous risks and uncertainties associated with developing and commercializing medical devices, including uncertainties relating to:

 

·              the technical risks in new product research and development;

 

·              the scope, rate of progress and cost of clinical trials and other research and development activities undertaken by us;

 

·              future clinical trial results;

 

·              publicity with respect to our products or their indications;

 

·              the cost, timing and success of regulatory approvals;

 

·              the cost, timing and success of establishing sales, marketing and distribution capabilities;

 

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·                                          the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop;

 

·                                          market acceptance of our approved products;

 

·                                          the effect of competing technological and market developments; and

 

·                                          the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.

 

Any failure to complete the development of our product candidates in a timely manner, or at all, could have a material adverse effect on our operations, financial position and liquidity. A discussion of the risks and uncertainties associated with completing our projects on schedule, or at all, and some consequences of failing to do so, are set forth in “Part II, Item 1A—Risk Factors” below.

 

This excerpt taken from the BSMD 10-Q filed May 9, 2008.

Research and Development

 

Research and development expenses as a percentage of total revenue for the three months ended March 31, 2008 and 2007 were 9% and 10%, respectively. Research and development expenses in each of these periods relate primarily to:

 

·                                          research to identify and evaluate new and innovative embolotherapy products based on our platform microsphere technology, including our Resorbable Microspheres and our MR Microspheres, both of which are in preclinical development;

 

·                                          further preclinical testing and clinical trials to support initial and/or additional clinical indications and/or pre-marketing approvals for our Embosphere Microspheres, HepaSphere Microspheres, QuadraSphere Microspheres, Sequitor Steerable Guidewire and EmboCath Plus Infusion Microcatheter, all of which products are currently approved and marketed for specified indications and in specified geographic locations; and

 

·                                          improving our manufacturing processes for our currently marketed products.

 

Our research and development personnel typically work on a number of projects concurrently. In addition, except for clinical expenses, a substantial amount of fixed research and development costs such as salary and salary-related benefits, facility costs, equipment depreciation and maintenance are shared among various programs. Accordingly, we have not historically tracked specific costs for each of our research and development projects.

 

We cannot reasonably estimate or know the nature, timing and estimated costs of the efforts necessary to complete the development of, or the period in which material net cash inflows are expected to commence from, any of our product candidates that are currently in development or from any of our approved products for which we are seeking expanded marketing approvals in selected indications or geographic regions, due to the numerous risks and uncertainties associated with developing and commercializing medical devices, including uncertainties relating to:

 

·              the technical risks in new product research and development;

 

·              the scope, rate of progress and cost of clinical trials and other research and development activities undertaken by us;

 

·              future clinical trial results;

 

·              publicity with respect to our products or their indications;

 

·              the cost, timing and success of regulatory approvals;

 

·              the cost, timing and success of establishing sales, marketing and distribution capabilities;

 

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·                                          the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop;

 

·              market acceptance of our approved products;

 

·              the effect of competing technological and market developments; and

 

·              the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.

 

Any failure to complete the development of our product candidates in a timely manner, or at all, could have a material adverse effect on our operations, financial position and liquidity. A discussion of the risks and uncertainties associated with completing our projects on schedule, or at all, and some consequences of failing to do so, are set forth in “Part II, Item 1A—Risk Factors” below.

 

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

Research and Development

        Research and development costs include payroll, facility costs, administrative expenses, and third-party costs related to: developing new products, making technological improvements to existing products and production methods. Research and development costs are expensed in the period incurred. Preclinical testing of product candidates and clinical trials and product validation costs associated with recently released products are also included in research and development expenses.

Research and Development





        Research and development costs include payroll, facility costs, administrative expenses, and third-party costs related to: developing new products, making
technological improvements to existing products and production methods. Research and development costs are expensed in the period incurred. Preclinical testing of product candidates and clinical
trials and product validation costs associated with recently released products are also included in research and development expenses.





This excerpt taken from the BSMD 10-Q filed Nov 13, 2007.

Research and Development

        Research and development expenses as a percentage of total costs and expenses for the nine months ended September 30, 2007 and 2006 were 8% and 9%, respectively. Research and development expenses in these periods relate primarily to:

    research to identify and evaluate new and innovative embolotherapy products based on our platform microsphere technology, including our Resorbable Microspheres and our MR Microspheres, both of which are in preclinical development;

    further preclinical testing and clinical trials to support initial and/or additional marketing approvals for our Embosphere Microspheres, HepaSphere Microspheres, QuadraSphere Microspheres, Sequitor Steerable Guidewire and EmboCath Plus Infusion Microcatheter, all of which products are currently approved and marketed in specified indications and in specified geographic locations; and

    improving our manufacturing processes.

        Our research and development functions typically work on a number of projects concurrently. In addition, except for clinical trial expenses, a substantial amount of fixed research and development costs such as salary and salary-related benefits, rent, equipment depreciation, utilities, insurance and maintenance are shared among various programs. Accordingly, we have not historically tracked specific costs for each of our research and development projects.

        We cannot reasonably estimate or know the nature, timing and estimated costs of the efforts necessary to complete the development of, or the period in which material net cash inflows are expected to commence from, any of our product candidates that are currently in development or from any of our approved products for which we are seeking expanded marketing approvals in selected indications or geographic regions, due to the numerous risks and uncertainties associated with developing medical devices, including the uncertainty of:

    the scope, rate of progress and cost of clinical trials and other research and development activities undertaken by us;

    future clinical trial results;

    the cost, timing and success of regulatory approvals;

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    the cost, timing and success of establishing sales, marketing and distribution capabilities;

    the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop;

    market acceptance of our approved products;

    the effect of competing technological and market developments; and

    the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.

        Any failure to complete the development of our product candidates in a timely manner, or at all, could have a material adverse effect on our operations, financial position and liquidity. A discussion of the risks and uncertainties associated with completing our projects on schedule, or at all, and some consequences of failing to do so, are set forth in "Part II, Item 1A—Risk Factors" below.

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

Research and Development

Research and development costs include payroll, building costs, administrative expenses, and third party costs related to developing new products, making technological improvements to existing products and production methods are expensed in the period incurred. Preclinical testing of product candidates and clinical trials and product validation costs associated with recently released products are also included in research and development expenses.

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

Research and Development

Research and development costs, including product validation costs under FDA Good Manufacturing Practices, are expensed in the period incurred.

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This excerpt taken from the BSMD 10-Q filed Nov 14, 2005.

Research and Development

 

The following table identifies each of the programs for which we have incurred research and development expenses in the nine months ended September 30, 2005 and in the years ended December 31, 2004 and 2003 and the current development phase of each.

 

Product / Product Candidate

 

Development Status

Embosphere® Microspheres

 

Approved for uterine fibroid embolization, hypervascularized tumors and arteriovenous malformations in the United States, Canada, European Union, Argentina, Brazil, Columbia, Costa Rica, Peru, Panama, Uruguay, Hong Kong, Taiwan and Australia; clinical evaluation for liver cancer in China

 

 

 

EmboGold® Microspheres

 

Approved for hypervascularized tumors (other than uterine fibroids) and arteriovenous malformations in the United States, Canada, European Union, Argentina, Brazil, Columbia, Costa Rica, Peru, Panama, Uruguay, Hong Kong, Taiwan and Australia

 

 

 

EmboCath® Infusion Catheter

 

Approved for peripheral embolization procedures including UFE and liver embolization in the United States, Canada, European Union, Argentina, Brazil, Costa Rica, Panama, and Hong Kong

 

 

 

Segway® Guidewire

 

Approved for peripheral embolization procedures including UFE and liver embolization in the United States, Canada, European Union, Argentina, Brazil, Costa Rica, Panama, and Hong Kong

 

 

 

HepaSphere™ Microspheres

 

CE Mark obtained in the European Union; clinical evaluation in Japan

 

 

 

MR - Embosphere Microspheres

 

Preclinical research—animal studies

 

 

 

Embosphere Microspheres for Gastric Reflux Disease (GERD)

 

Preclinical research—animal studies

 

 

 

Radiosphere™ Microspheres

 

Feasibility

 

Research and development expenses relate primarily to:

 

This excerpt taken from the BSMD 10-Q filed May 13, 2005.

Research and Development

The following table identifies each of the programs for which we have incurred research and development expenses in the three months ended March 31, 2005 and in the years ended December 31, 2004 and 2003 and the current development phase of each.

Product / Product Candidate

 

 

 

Development Status

Embosphere® Microspheres

 

Approved for uterine fibroids, hypervascularized tumors and arteriovenous malformations in the United States, Canada, European Union, Argentina, Brazil, Costa Rica, Hong Kong, Korea, Taiwan and Australia

EmboGold® Microspheres

 

Approved for hypervascularized tumors and arteriovenous malformations in the United States, Canada, European Union, Argentina, Brazil, Costa Rica, Hong Kong, Korea, Taiwan and Australia

EmboCath® Infusion Catheter

 

Approved for peripheral embolization procedures in the United States, Canada, European Union, Argentina, Brazil, Costa Rica and Hong Kong

Segway® Guidewire

 

Approved for peripheral embolization procedures in the United States, Canada, European Union, Argentina, Brazil, Costa Rica and Hong Kong

Hepasphere SAP™ Microspheres

 

CE Mark obtained in the European Union; Clinical evaluation in Japan

TempRx™ Microspheres

 

Preclinical research—Animal Studies

Radiosphere™ Microspheres

 

Feasibility

 

Research and development expenses relate primarily to:

·                    research to identify and evaluate new and innovative embolotherapy products based on our platform microsphere technology;

·                    pre-clinical testing and clinical trials of product candidates;

·                    development related to improving manufacturing processes; and

·                    product and production facilities validation processes under FDA Good Manufacturing Practices.

Total research and development expenses were $802,000 or 15% of total costs and expenses, and $589,000 or 13% of total costs and expenses for the three months ended March 31, 2005 and 2004, respectively. Our research and development functions typically work on a number of projects concurrently. In addition, except for clinical expenses, a substantial amount of fixed research and development costs such as salary and salary-related benefits, rent, equipment depreciation, utilities, insurance and maintenance are shared among various programs. Accordingly, we have not historically tracked specific costs for each of our research and development projects.

There is a risk that any medical device development program may not produce revenue. Moreover, because of uncertainties inherent in medical device development, including those factors described below under “Factors That May Affect Future Results,” we may not be able to successfully develop and commercialize the product candidates included in the table above.

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As described in the table above, we recently have obtained CE mark approval for our Hepasphere SAP Microspheres, which are also in clinical evaluation in Japan. We have exclusive worldwide rights to the Hepasphere SAP Microspheres technology under a license from Dr. Shinichi Hori, subject only to Dr. Hori’s right to conduct clinical trials on our behalf in Japan, treat patients at Rinku Medical Center and Osaka Medical Center in Japan and engage in research at Osaka University. Our TempRxTM Microspheres and RadiosphereTM Microspheres product development initiatives are in preclinical and feasibility evaluation. The successful development of these early-stage product candidates is highly uncertain. We cannot reasonably estimate or know the nature, timing and estimated costs of the efforts necessary to complete the development of, or the period in which material net cash inflows are expected to commence from, any of our product candidates due to the numerous risks and uncertainties associated with developing medical devices, including the uncertainty of:

·                    the scope, rate of progress and cost of clinical trials and other research and development activities undertaken by us;

·                    future clinical trials results;

·                    the cost and timing of regulatory approvals;

·                    the cost and timing of establishing sales, marketing and distribution capabilities;

·                    the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop;

·                    the effect of competing technological and market developments; and

·                    the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.

Any failure to complete the development of our product candidates in a timely manner could have a material adverse effect on our operations, financial position and liquidity. A discussion of the risks and uncertainties associated with completing our projects on schedule, or at all, and some consequences of failing to do so, are set forth in “Factors That May Affect Future Results.”

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