VITA » Topics » COMPETITION

These excerpts taken from the VITA 10-K filed Mar 16, 2009.

COMPETITION

Extensive research efforts and rapid technological change characterize the market for products in the orthopedic, orthobiologics and biosurgery markets. We face intense competition from medical device and biomedical technology companies. Our products could be rendered noncompetitive or obsolete by competitors’ technological advances. We may be unable to respond to technological advances through the development and introduction of new products. Moreover, many of our existing and potential competitors have substantially greater financial, marketing, sales, distribution, manufacturing and technological resources than us. These competitors may also be in the process of seeking FDA or other regulatory approvals, or patent protection, for new products. Our competitors could, therefore, commercialize new competing products in advance of our products. There can be no assurance that we will be able to compete successfully against current or future competitors or that competition will not have a material adverse effect on our business, financial condition and results of operations.

 

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We believe VITOSS faces competition from numerous synthetic products, bone morphogenic proteins (BMPs), stem cell-based products and cadaver-based products, such as demineralized bone matrix (DBM) products, currently on the market that may be used for the same indications as our products as well as other products and technologies that may enter the market in the future. In 2004, lumbar total disc replacement (TDR) devices were introduced in the spinal market as a treatment alternative for degenerative disc disease designed to preserve the motion of the vertebrae of the spine. However, we believe that several factors may mitigate against the broad use of lumbar TDR devices, including the need for surgeon training, the high level of surgeon technical skills required, surgeon concern regarding the challenges of TDR revision surgery should that become necessary due to loosening or subsidence of the device over time, and procedure reimbursement. In 2007, cervical TDR devices were introduced in the spine market. As they may require a lower level of surgical technical skill than lumbar TDR devices, cervical TDR devices could become more widely adopted than lumbar TDR devices. TDR devices, particularly cervical TDR devices, could negatively impact the spinal fusion market which could in turn adversely impact the use of VITOSS in spine grafting procedures. It is too early to estimate the rate at which the market will ultimately adopt this or comparable technology as a treatment alternative or its resulting impact on our products.

VITAGEL is approved by the FDA as a surgical hemostat where bleeding may be a significant complication for many routine surgeries. As such, VITAGEL can be marketed broadly to general surgeons and is applicable in the spine, hip and knee replacement surgery markets. VITAGEL faces competition from several more established surgical hemostat products marketed by other companies with substantially greater resources than us. However, we believe VITAGEL offers unique advantages in comparison to these other products in terms of VITAGEL’s quick and easy preparation for use, as well as its use of the patient’s autologous plasma instead of pooled donated human plasma as is the case with the leading products in the market. In 2008, recombinant human thrombin was approved for sale in the U.S. We believe that recombinant human thrombin will be positioned as an improvement to bovine-derived thrombin, a raw material in our VITAGEL product, which could adversely affect our sales of VITAGEL. It is too early to estimate the effect of this new technology on our VITAGEL product. If management believes this effect to be material and adverse to our VITAGEL sales, it will consider alternative formulations of VITAGEL and the regulatory approvals that may be required for any such alternative formulations.

VITASURE competes with several thrombin products and surgical hemostats on the basis of its safety profile and pricing.

CORTOSS is under clinical development in the U.S. for use in the vertebral augmentation of VCFs and has received CE Certification for use in vertebral augmentation of VCFs and in screw augmentation. If CORTOSS is cleared by the FDA for use in vertebral augmentation of VCFs, it will face competition from the several PMMA bone cement products that have been 510(k) cleared by the FDA since 2004 for this indication. Outside the U.S., CORTOSS is facing competition from several other PMMA bone cement products that have received CE Certification since 2004 for this indication. We do not know of any products that have received FDA approval or a CE Certification for use in screw augmentation or for which such approval is being sought.

COMPETITION


Extensive research efforts and rapid technological change characterize the market for products in the orthopedic, orthobiologics and biosurgery
markets. We face intense competition from medical device and biomedical technology companies. Our products could be rendered noncompetitive or obsolete by competitors’ technological advances. We may be unable to respond to technological
advances through the development and introduction of new products. Moreover, many of our existing and potential competitors have substantially greater financial, marketing, sales, distribution, manufacturing and technological resources than us.
These competitors may also be in the process of seeking FDA or other regulatory approvals, or patent protection, for new products. Our competitors could, therefore, commercialize new competing products in advance of our products. There can be no
assurance that we will be able to compete successfully against current or future competitors or that competition will not have a material adverse effect on our business, financial condition and results of operations.

STYLE="margin-top:0px;margin-bottom:0px"> 


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We believe VITOSS faces competition from numerous synthetic products, bone morphogenic proteins (BMPs),
stem cell-based products and cadaver-based products, such as demineralized bone matrix (DBM) products, currently on the market that may be used for the same indications as our products as well as other products and technologies that may enter the
market in the future. In 2004, lumbar total disc replacement (TDR) devices were introduced in the spinal market as a treatment alternative for degenerative disc disease designed to preserve the motion of the vertebrae of the spine. However, we
believe that several factors may mitigate against the broad use of lumbar TDR devices, including the need for surgeon training, the high level of surgeon technical skills required, surgeon concern regarding the challenges of TDR revision surgery
should that become necessary due to loosening or subsidence of the device over time, and procedure reimbursement. In 2007, cervical TDR devices were introduced in the spine market. As they may require a lower level of surgical technical skill than
lumbar TDR devices, cervical TDR devices could become more widely adopted than lumbar TDR devices. TDR devices, particularly cervical TDR devices, could negatively impact the spinal fusion market which could in turn adversely impact the use of
VITOSS in spine grafting procedures. It is too early to estimate the rate at which the market will ultimately adopt this or comparable technology as a treatment alternative or its resulting impact on our products.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">VITAGEL is approved by the FDA as a surgical hemostat where bleeding may be a significant complication for many routine surgeries. As such, VITAGEL can
be marketed broadly to general surgeons and is applicable in the spine, hip and knee replacement surgery markets. VITAGEL faces competition from several more established surgical hemostat products marketed by other companies with substantially
greater resources than us. However, we believe VITAGEL offers unique advantages in comparison to these other products in terms of VITAGEL’s quick and easy preparation for use, as well as its use of the patient’s autologous plasma instead
of pooled donated human plasma as is the case with the leading products in the market. In 2008, recombinant human thrombin was approved for sale in the U.S. We believe that recombinant human thrombin will be positioned as an improvement to
bovine-derived thrombin, a raw material in our VITAGEL product, which could adversely affect our sales of VITAGEL. It is too early to estimate the effect of this new technology on our VITAGEL product. If management believes this effect to be
material and adverse to our VITAGEL sales, it will consider alternative formulations of VITAGEL and the regulatory approvals that may be required for any such alternative formulations.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">VITASURE competes with several thrombin products and surgical hemostats on the basis of its safety profile and pricing.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">CORTOSS is under clinical development in the U.S. for use in the vertebral augmentation of VCFs and has received CE Certification for use in vertebral
augmentation of VCFs and in screw augmentation. If CORTOSS is cleared by the FDA for use in vertebral augmentation of VCFs, it will face competition from the several PMMA bone cement products that have been 510(k) cleared by the FDA since 2004 for
this indication. Outside the U.S., CORTOSS is facing competition from several other PMMA bone cement products that have received CE Certification since 2004 for this indication. We do not know of any products that have received FDA approval or a CE
Certification for use in screw augmentation or for which such approval is being sought.

This excerpt taken from the VITA 10-K filed Mar 17, 2008.

COMPETITION

Extensive research efforts and rapid technological change characterize the market for products in the orthopedic market. We face intense competition from medical device, biomedical technology, and medical products companies. Our products could be rendered noncompetitive or obsolete by competitors’ technological advances. We may be unable to respond to technological advances through the development and introduction of new products. Moreover, many of our existing and potential competitors have substantially greater financial, marketing, sales, distribution, manufacturing and technological resources than us. These competitors may also be in the process of seeking FDA or other regulatory approvals, or patent protection, for new products. Our competitors could, therefore, commercialize new competing products in advance of our products. There can be no assurance that we will be able to compete successfully against current or future competitors or that competition will not have a material adverse effect on our business, financial condition and results of operations.

We believe VITOSS faces competition from numerous synthetic, bone morphogenic proteins (BMPs) and cadaver-based products, such as demineralized bone matrix (DBM) products, currently on the market that may be used for the same indications as our products as well as other products and technologies that may enter the market in the future. In 2004, lumbar total disc replacement (TDR) devices were introduced in the spinal market as a treatment alternative for degenerative disc disease designed to preserve the motion of the vertebrae of the spine. However, we believe that several factors may mitigate against the broad use of lumbar TDR devices, including the need for surgeon training, the high level of surgeon technical skills required, surgeon concern regarding the challenges of TDR revision surgery should that become necessary due to loosening or subsidence of the device over time, and procedure reimbursement. In 2007, cervical TDR devices were introduced in the spine market. As they may require a lower level of surgical technical skill than lumbar TDR devices, cervical TDR devices could become more widely adopted than lumbar TDR devices. TDR devices, particularly cervical TDR devices,

 

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could negatively impact the spinal fusion market which could in turn adversely impact the use of VITOSS in spine grafting procedures. It is too early to estimate the rate at which the market will ultimately adopt this or comparable technology as a treatment alternative or its resulting impact on our products.

VITAGEL is approved by the FDA as a surgical hemostat where bleeding may be a significant complication for many routine surgeries. As such, VITAGEL can be marketed broadly to general surgeons and is applicable in the spine, hip and knee replacement surgery markets. VITAGEL faces competition from several more established surgical hemostat products marketed by other companies with substantially greater resources than us. However, we believe VITAGEL offers unique advantages in comparison to these other products in terms of VITAGEL’s quick and easy preparation for use, as well as its use of the patient’s autologous plasma instead of pooled donated human plasma as is the case with the leading products in the market. In 2008, recombinant human thrombin was approved for sale in the U.S. We believe that recombinant human thrombin will be positioned as an improvement to bovine-derived thrombin, a raw material in our VITAGEL product, which could adversely affect our sales of VITAGEL. It is too early to estimate the effect of this new technology on our VITAGEL product. If management believes this effect to be material and adverse to our VITAGEL sales, it will consider alternative formulations of VITAGEL and the regulatory approvals that may be required for any such alternative formulations.

CORTOSS is under clinical development in the U.S. for use in the vertebral augmentation of VCFs and has received CE Certification for use in vertebral augmentation of VCFs and in screw augmentation. If CORTOSS is cleared by the FDA for use in vertebral augmentation of VCFs, it will face competition from the several PMMA bone cement products that have been 510(k) cleared by the FDA since 2004 for this indication. Outside the U.S., CORTOSS is facing competition from several other PMMA bone cement products that have received CE Certification since 2004 for this indication. We do not know of any products that have received FDA approval or a CE Certification for use in screw augmentation or for which such approval is being sought.

This excerpt taken from the VITA 10-K filed Mar 16, 2007.

COMPETITION

Extensive research efforts and rapid technological change characterize the market for products in the orthopedic market. We face intense competition from medical device, biomedical technology, and medical products companies. Our products could be rendered noncompetitive or obsolete by competitors’ technological advances. We may be unable to respond to technological advances through the development and introduction of new products. Moreover, many of our existing and potential competitors have substantially greater financial, marketing, sales, distribution, manufacturing and technological resources than us. These competitors may also be in the process of seeking FDA or other regulatory approvals, or patent protection, for new products. Our competitors could, therefore, commercialize new competing products in advance of our products. There can be no assurance that we will be able to compete successfully against current or future competitors or that competition will not have a material adverse effect on our business, financial condition and results of operations.

We believe VITOSS faces competition from numerous synthetic, bone morphogenic proteins (BMPs) and cadaver-based products, such as demineralized bone matrix (DBM) products, currently on the market that may be used for the same indications as our products as well as other products and technologies that may enter the market in the future. In 2004, total disc replacement devices (TDRs) were introduced in the spinal market as a treatment alternative for degenerative disc disease designed to preserve the motion of the vertebrae of the spine. These TDRs could negatively impact the spinal fusion market which could in turn adversely impact the use of VITOSS in spine grafting procedures. However, we believe that several factors mitigate against the broad use of TDRs, including the need for surgeon training, the high level of surgeon technical skills required, surgeon concern regarding the challenges of TDR revision surgery should that become necessary due to loosening or subsidence of the device over time, and procedure reimbursement. It is too early to estimate the rate at which the market will ultimately adopt this or comparable technology as a treatment alternative or its resulting impact on our products.

VITAGEL is approved by the FDA as a surgical hemostat where bleeding may be a significant complication for many routine surgeries. As such, VITAGEL can be marketed broadly to general surgeons and is applicable in the spine, hip and knee replacement surgery markets. VITAGEL

 

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faces competition from several more established surgical hemostat products marketed by other companies with substantially greater resources than us. However, we believe VITAGEL offers unique advantages in comparison to these other products in terms of VITAGEL’s quick and easy preparation for use, as well as its use of the patient’s autologous plasma instead of pooled donated human plasma as is the case with the leading products in the market.

CORTOSS is under clinical development in the U.S. for use in the vertebral augmentation of VCFs and has received CE Certification for use in vertebral augmentation of VCFs and in screw augmentation. If CORTOSS is cleared by the FDA for use in vertebral augmentation of VCFs, it will face competition from the several PMMA bone cement products that have been 510(k) cleared by the FDA since 2004 for this indication. Outside the U.S., CORTOSS is facing competition from several other PMMA bone cement products that have received CE Certification since 2004 for this indication. We do not know of any products that have received FDA approval or a CE Certification for use in screw augmentation or for which such approval is being sought.

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

COMPETITION

Extensive research efforts and rapid technological change characterize the market for products in the orthopedic market. We face intense competition from medical device, biomedical technology, and medical products companies. Our products could be rendered noncompetitive or obsolete by competitors’ technological advances. We may be unable to respond to technological advances through the development and introduction of new products. Moreover, many of our existing and potential competitors have substantially greater financial, marketing, sales, distribution, manufacturing and technological resources than us. These competitors may also be in the process of seeking FDA or other regulatory approvals, or patent protection, for new products. Our competitors could, therefore, commercialize new competing products in advance of our products. There can be no assurance that we will be able to compete successfully against current or future competitors or that competition will not have a material adverse effect on our business, financial condition and results of operations. We believe VITOSS Bone Graft Substitute faces competition from numerous synthetic and cadaver-based products currently on the market as well as other products and technologies that may enter the market in the future.

In 2004, total disk replacement devices (TDR’s) were introduced in the spinal market as a treatment alternative for degenerative disk disease designed to preserve the motion of the vertebrae of the spine. We believe that several factors mitigate against the broad use of TDR’s, including the need for surgeon training, the high level of surgeon technical skills required, surgeon concern regarding the challenges of TDR revision surgery should that become necessary due to loosening or subsidence of the device over time, and procedure reimbursement. It is too early to estimate the rate at which the market will ultimately adopt this or comparable technology as a treatment alternative or its resulting impact on our products.

VITAGEL is approved by the FDA as a surgical hemostat where bleeding may be a significant complication for many routine surgeries. As such, VITAGEL can be marketed broadly to general surgeons and is applicable in the spine, hip and knee replacement surgery markets. VITAGEL faces competition from several more established surgical hemostat products marketed by other companies with substantially greater resources than us. However, we believe VITAGEL offers unique advantages in comparison to these other products in terms of VITAGEL’s quick and easy preparation for use, as well as its use of the patient’s autologous plasma, instead of pooled donated human plasma as is the case with the leading products in the market.

CORTOSS is under clinical development in the U.S. for use in the vertebral augmentation of VCFs and has received a CE Certification for use in the vertebral augmentation of VCFs and in screw augmentation. If CORTOSS is approved by the FDA for use in the vertebral augmentation of VCFs, it will face competition from the several PMMA bone cement products that have been 510(k) cleared by the FDA since 2004 for this indication. Outside the U.S., CORTOSS is facing competition from several other PMMA bone cement products that have received CE Certification since 2004 for this indication. We do not know of any products that have received FDA approval or a CE Certification for use in screw augmentation or for which such approval is being sought.

 

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This excerpt taken from the VITA 10-K filed Mar 16, 2005.

COMPETITION

 

Extensive research efforts and rapid technological change characterize the market for products in the orthopedic market. We face intense competition from medical device, biomedical technology, and medical products companies. Our products could be rendered noncompetitive or obsolete by competitors’ technological advances. We may be unable to respond to technological advances through the development and introduction of new products. Moreover, many of our existing and potential competitors have substantially greater financial, marketing, sales, distribution, manufacturing and technological resources than us. These competitors may also be in the process of seeking FDA or other regulatory approvals, or patent protection, for new products. Our competitors could, therefore, commercialize new competing products in advance of our products. There can be no assurance that we will be able to compete successfully against current or future competitors or that competition will not have a material adverse effect on our business, financial condition and results of operations. We believe VITOSS Bone Graft Substitute faces competition from numerous synthetic and cadaver-based products currently on the market as well as other products and technologies that may enter the market in the future.

 

During 2002, synthetic recombinant signaling growth factors, also known as bone morphogenic proteins (“BMPs”), were introduced into the synthetic bone graft marketplace. BMPs are growth factors that are believed to significantly accelerate the healing mechanism of bone. We believe the healing mechanism of bone is dependent upon the presence of all three of the following components: (i) signaling molecules, either provided by the patient or commercially provided such as with BMPs, (ii) the patient’s own stem cells or osteoprogenitor cells, and (iii) scaffold or bone graft material, either provided by the patient or commercially provided, such as by VITOSS Bone Graft Substitute. We expect the introduction of BMPs to expand the overall bone graft market and in particular the synthetic segment of the bone graft market. We believe that several factors mitigate against the broad use of BMPs, including (i) concern over BMPs causing excess bone growth in unwanted areas, and (ii) the current high cost of BMPs in comparison to commercial bone graft materials and to VITOSS Bone Graft Substitute in particular. Moreover, due to the high cost of BMPs and the potential to cause excessive bone growth, surgeons may prefer using only a small volume of BMPs in relation to the anatomic site where new bone growth is sought. Additionally, now that BMPs have been on the market for almost two years, it is generally believed that better carriers or scaffolds must be developed to expand clinical usage and utility of BMPs.

 

In 2004, total disk replacement devices (TDR’s) were introduced in the spinal bone grafting market as a treatment alternative for degenerative disk disease designed to preserve the motion of the vertebrae of the spine. We believe that several factors mitigate against the broad use of TDR’s, including the need for surgeon training, the high level of surgeon technical skills required, surgeon concern regarding the challenges of TDR revision surgery should that become necessary due to loosening or subsidence of the device over time, and procedure reimbursement. It is too early to estimate the rate at which the market will adopt this technology as a treatment alternative or its resulting impact on our products .

 

VITAGEL is approved by the FDA as a surgical hemostat where bleeding may be a significant complication for many routine surgeries. As such, VITAGEL can be

 

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marketed broadly to general surgeons and is applicable in the spine, hip and knee replacement surgery markets. VITAGEL will face competition from several more established surgical hemostat products marketed by other companies with substantially greater resources than us. However, we believe VITAGEL offers unique advantages in comparison to these other products in terms of VITAGEL’s quick and easy preparation for use, as well as its use of the patient’s autologous plasma, instead of pooled donated human plasma as is the case with the leading products in the market.

 

CORTOSS is under clinical development in the U.S. for use in the vertebral augmentation of VCFs and has received a CE certification for use in the vertebral augmentation of VCFs and in screw augmentation. If CORTOSS is approved by the FDA for use in the vertebral augmentation of VCFs, it will face competition from the several PMMA bone cement products that have been 510(k) cleared by the FDA for this indication. Outside the U.S., CORTOSS is facing competition from several other PMMA bone cement products that have received CE Certification in 2004 for this indication. We do not know of any products that have received FDA approval or a CE Certification for use in screw augmentation or for which such approval is being sought.

 

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