VITA » Topics » VITOSS Bone Graft Substitute

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

VITOSS Bone Graft Substitute

 

VITOSS Blocks and Morsels   

FDA 510(k) cleared December 2000

Approved in European Union July 2000

VITOSS Micro and Macro Morsels   

FDA 510(k) cleared December 2000

Approved in European Union July 2003

VITOSS Standard and Micro Canisters   

FDA 510(k) cleared November 2003

Approved in European Union July 2003

VITOSS FOAM Product Platform, including:   

FDA 510(k) cleared December 2003

Approved in European Union May 2005

VITOSS FOAM Strips and Cylinders

VITOSS FOAM Flow

VITOSS FOAM Shapes

VITOSS FOAM Pack

  
VITOSS Bioactive FOAM Strips    FDA 510(k) cleared September 2007
VITOSS Bioactive FOAM Pack    FDA 510(k) cleared June 2008

VITOSS is an ultra-porous resorbable beta-tricalcium phosphate bone void filler used to help the body guide the three-dimensional regeneration of the patient’s own bone. We launched VITOSS in the U.S. and the EU in 2001 and have sold approximately 275,000 units through December 31, 2008. VITOSS’s ultra-porosity allows it to soak and hold its own volume in blood and bone marrow aspirate and has been shown to perform well in an array of applications in the spine, extremities and pelvis, such as spinal grafting and the treatment of bone defects due to trauma, degenerative disease and tumors, including posterolateral spine fusion procedures. VITOSS integrates well into existing bone and allows for bone in-growth and maturation. VITOSS, the VITOSS FOAM products and the VITOSS Bioactive FOAM products are covered by issued and pending U.S. and non-U.S. patents.

Since the initial U.S. regulatory clearance and subsequent product launch in mid-2001, we have developed and are developing a number of new VITOSS-based products and related delivery devices that are designed to expand the market for our VITOSS products by broadening the range of surgical indications and by addressing additional

 

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surgeon preferences and needs. In 2003, we entered into a development, manufacturing and supply agreement with Kensey, leading to the development and launch of the VITOSS FOAM product platform. The VITOSS FOAM products combine our base VITOSS technology with Kensey’s proprietary resorbable biomaterials to produce a wide array of pliant, flexible, flowable and compression resistant bone graft materials. The VITOSS FOAM products have the ability to soak and hold their own volume in blood and bone marrow aspirate while retaining these biological fluids in pliable and compression resistant forms. These forms can be designed into specific shapes and material characteristics to meet a surgeon’s need for handling and delivery in a variety of surgical approaches and applications. We launched our VITOSS Bioactive FOAM strip product as part of a controlled rollout in the first quarter of 2008, and fully launched the product during the second quarter of 2008. We launched our VITOSS Bioactive FOAM pack product during the end of the third quarter of 2008. In addition to our proprietary VITOSS beta-tricalcium phosphate bone graft substitute and Kensey’s proprietary resorbable biomaterials, VITOSS Bioactive FOAM products also contain our proprietary combeite bioactive glass.

Bone Defect Grafting. Injury or trauma to the bone, degenerative conditions, disease and aging all affect the health and viability of the human skeleton. These conditions often result in the need for the repair of bone defects through a bone grafting procedure. We estimate that approximately 1,000,000 bone grafting procedures on a worldwide basis are performed each year in the spine, extremities and pelvis. Bone grafting material is either (i) autograft material, which is often obtained or harvested from the iliac crest region of the patient’s own hip, (ii) allograft material, which is obtained from a cadaver, or (iii) synthetically derived materials that provide one or more components of either bone-like scaffold (such as VITOSS), cells or signals (such as bone morphogenic proteins). VITOSS has been used in bone grafting procedures as a bone graft substitute to provide a synthetic scaffold in a variety of applications, including those of the extremities, spine and pelvis. When used with the patient’s bone marrow, VITOSS provides all components of scaffold, cells and signals.

A harvest of autograft material involves an additional procedure that extends surgical time, adding to costs and increasing blood loss and patient risk of infection or adverse reaction from the additional time under anesthesia. In addition, harvesting bone for autograft sometimes causes protracted pain that may necessitate additional medical care after the surgical procedure. Using VITOSS instead of autograft material may avoid these potential complications.

Disadvantages of allograft bone include the possibility of disease transmission, antigenic response and quality variability from donor to donor. VITOSS is a synthetic beta-tricalcium phosphate material without these possible disadvantages.

Spinal Fusion and Grafting. Many patients affected by severe back pain due to degeneration of one or more discs are often treated with spinal surgical procedures. We estimate that each year approximately 500,000 spinal fusion procedures are performed in the United States. In cases where the patient has advanced disc degeneration or spinal instability, a fusion procedure can involve a surgical incision in the patient’s back or abdomen to access and remove the affected disc material. To provide initial stability and support of the surrounding vertebrae, the resulting defect is filled with a structural implant made of either titanium, shaped bone derived from a human cadaver, or a synthetic material known as polyetheretherketone (“PEEK”). Adjunctively, these procedures may require the use of bone grafting material repair defects and facilitate the fusion of two bony elements. We believe the use of VITOSS provides a clinically proven alternative to patient- or cadaver-derived tissues and may be preferable for both patients and their surgeons for its efficacy and safety.

Trauma. Physical trauma such as falls and accidents can result in bone fracture or damage. Fractures of broken bones are often realigned with hardware, such as plates, rods and screws. Once the hardware has been used to recreate the skeletal anatomy and to provide the stability of the bony structure, there are often defects or voids in the bone which remain. Those voids may require the use of bone graft material. The goal of bone grafting in trauma applications is to rapidly heal the damaged bone. Approximately 250,000 trauma related bone graft repairs are performed annually on a worldwide basis. Autograft, cadaver allograft, as well as synthetic scaffolds like VITOSS, are used for trauma related bone graft repairs. VITOSS has been used as a bone graft substitute in a variety of trauma applications, including those of the extremities, spine and pelvis.

 

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Dental, Periodontal, Oral and Cranio-Maxillofacial. In August 2002, we entered into a supply agreement with BioMimetic Therapeutics, Inc. for our proprietary VITOMATRIX™ particulate synthetic scaffold biomaterial, which we produce in the same process used to manufacture VITOSS. In January 2008, in connection with the sale of its dental business to Luitpold Pharmaceuticals, Inc., BioMimetic assigned its rights and obligations under the supply agreement to Luitpold. Under the agreement, we supply our proprietary beta tricalcium phosphate biomaterial to Luitpold for its clinical and commercial use in combination with rhPDGF. Luitpold markets the combined product in the dental, periodontal, oral and cranio-maxillofacial bone grafting markets through its Osteohealth Company division.

VITOSS Bone Graft Substitute

 



















































VITOSS Blocks and Morsels  

FDA 510(k) cleared December 2000

Approved in European
Union July 2000

VITOSS Micro and Macro Morsels  

FDA 510(k) cleared December 2000

Approved in European
Union July 2003

VITOSS Standard and Micro Canisters  

FDA 510(k) cleared November 2003

Approved in European
Union July 2003

VITOSS FOAM Product Platform, including:  

FDA 510(k) cleared December 2003

Approved in European
Union May 2005

VITOSS FOAM Strips and Cylinders

FACE="Times New Roman" SIZE="2">VITOSS FOAM Flow

VITOSS FOAM Shapes

STYLE="margin-top:0px;margin-bottom:1px; margin-left:2.00em">VITOSS FOAM Pack

  
VITOSS Bioactive FOAM Strips  FDA 510(k) cleared September 2007
VITOSS Bioactive FOAM Pack  FDA 510(k) cleared June 2008

VITOSS is an ultra-porous resorbable beta-tricalcium phosphate bone void filler used to help the
body guide the three-dimensional regeneration of the patient’s own bone. We launched VITOSS in the U.S. and the EU in 2001 and have sold approximately 275,000 units through December 31, 2008. VITOSS’s ultra-porosity allows it to soak
and hold its own volume in blood and bone marrow aspirate and has been shown to perform well in an array of applications in the spine, extremities and pelvis, such as spinal grafting and the treatment of bone defects due to trauma, degenerative
disease and tumors, including posterolateral spine fusion procedures. VITOSS integrates well into existing bone and allows for bone in-growth and maturation. VITOSS, the VITOSS FOAM products and the VITOSS Bioactive FOAM products are covered by
issued and pending U.S. and non-U.S. patents.

Since the initial U.S. regulatory clearance and subsequent product launch in mid-2001, we
have developed and are developing a number of new VITOSS-based products and related delivery devices that are designed to expand the market for our VITOSS products by broadening the range of surgical indications and by addressing additional

 


3







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surgeon preferences and needs. In 2003, we entered into a development, manufacturing and supply agreement with Kensey, leading to the development and launch
of the VITOSS FOAM product platform. The VITOSS FOAM products combine our base VITOSS technology with Kensey’s proprietary resorbable biomaterials to produce a wide array of pliant, flexible, flowable and compression resistant bone graft
materials. The VITOSS FOAM products have the ability to soak and hold their own volume in blood and bone marrow aspirate while retaining these biological fluids in pliable and compression resistant forms. These forms can be designed into specific
shapes and material characteristics to meet a surgeon’s need for handling and delivery in a variety of surgical approaches and applications. We launched our VITOSS Bioactive FOAM strip product as part of a controlled rollout in the first
quarter of 2008, and fully launched the product during the second quarter of 2008. We launched our VITOSS Bioactive FOAM pack product during the end of the third quarter of 2008. In addition to our proprietary VITOSS beta-tricalcium phosphate bone
graft substitute and Kensey’s proprietary resorbable biomaterials, VITOSS Bioactive FOAM products also contain our proprietary combeite bioactive glass.

FACE="Times New Roman" SIZE="2">Bone Defect Grafting. Injury or trauma to the bone, degenerative conditions, disease and aging all affect the health and viability of the human skeleton. These conditions often result in the need for the repair
of bone defects through a bone grafting procedure. We estimate that approximately 1,000,000 bone grafting procedures on a worldwide basis are performed each year in the spine, extremities and pelvis. Bone grafting material is either
(i) autograft material, which is often obtained or harvested from the iliac crest region of the patient’s own hip, (ii) allograft material, which is obtained from a cadaver, or (iii) synthetically derived materials that provide
one or more components of either bone-like scaffold (such as VITOSS), cells or signals (such as bone morphogenic proteins). VITOSS has been used in bone grafting procedures as a bone graft substitute to provide a synthetic scaffold in a variety of
applications, including those of the extremities, spine and pelvis. When used with the patient’s bone marrow, VITOSS provides all components of scaffold, cells and signals.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">A harvest of autograft material involves an additional procedure that extends surgical time, adding to costs and increasing blood loss and patient risk
of infection or adverse reaction from the additional time under anesthesia. In addition, harvesting bone for autograft sometimes causes protracted pain that may necessitate additional medical care after the surgical procedure. Using VITOSS instead
of autograft material may avoid these potential complications.

Disadvantages of allograft bone include the possibility of disease
transmission, antigenic response and quality variability from donor to donor. VITOSS is a synthetic beta-tricalcium phosphate material without these possible disadvantages.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">Spinal Fusion and Grafting. Many patients affected by severe back pain due to degeneration of one or more discs are often treated with spinal
surgical procedures. We estimate that each year approximately 500,000 spinal fusion procedures are performed in the United States. In cases where the patient has advanced disc degeneration or spinal instability, a fusion procedure can involve a
surgical incision in the patient’s back or abdomen to access and remove the affected disc material. To provide initial stability and support of the surrounding vertebrae, the resulting defect is filled with a structural implant made of either
titanium, shaped bone derived from a human cadaver, or a synthetic material known as polyetheretherketone (“PEEK”). Adjunctively, these procedures may require the use of bone grafting material repair defects and facilitate the fusion of
two bony elements. We believe the use of VITOSS provides a clinically proven alternative to patient- or cadaver-derived tissues and may be preferable for both patients and their surgeons for its efficacy and safety.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">Trauma. Physical trauma such as falls and accidents can result in bone fracture or damage. Fractures of broken bones are often realigned with
hardware, such as plates, rods and screws. Once the hardware has been used to recreate the skeletal anatomy and to provide the stability of the bony structure, there are often defects or voids in the bone which remain. Those voids may require the
use of bone graft material. The goal of bone grafting in trauma applications is to rapidly heal the damaged bone. Approximately 250,000 trauma related bone graft repairs are performed annually on a worldwide basis. Autograft, cadaver allograft, as
well as synthetic scaffolds like VITOSS, are used for trauma related bone graft repairs. VITOSS has been used as a bone graft substitute in a variety of trauma applications, including those of the extremities, spine and pelvis.

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


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Dental, Periodontal, Oral and Cranio-Maxillofacial. In August 2002, we entered into a supply
agreement with BioMimetic Therapeutics, Inc. for our proprietary VITOMATRIX™ particulate synthetic scaffold biomaterial, which we produce in the same process used to manufacture VITOSS. In January 2008, in connection with the sale of its dental
business to Luitpold Pharmaceuticals, Inc., BioMimetic assigned its rights and obligations under the supply agreement to Luitpold. Under the agreement, we supply our proprietary beta tricalcium phosphate biomaterial to Luitpold for its clinical and
commercial use in combination with rhPDGF. Luitpold markets the combined product in the dental, periodontal, oral and cranio-maxillofacial bone grafting markets through its Osteohealth Company division.

STYLE="margin-top:18px;margin-bottom:0px">Bone Marrow Aspiration System with IMBIBE Needles, Syringes and IMBIBE Disposable Delivery Instrumentation, used with VITOSS

STYLE="font-size:12px;margin-top:0px;margin-bottom:0px"> 

































Bone Marrow Aspiration Needle  FDA 510(k) cleared June 2005
Bone Marrow Aspiration Syringe  

FDA 510(k)s cleared September 2001 and March 2003

SIZE="2">Approved in European Union September 2004

Disposable Delivery Funnel  

Class I exempt device (see GOVERNMENT REGULATION below)

SIZE="2">Approved in European Union September 2004

Disposable Delivery Tube  

Class I exempt device (see GOVERNMENT REGULATION below)

SIZE="2">Approved in European Union January 2005

The disposable IMBIBE devices provide spine and orthopedic surgeons with a simple method for
harvesting a patient’s own bone marrow, mixing it with VITOSS, and delivering the mixture to the bone graft site. We believe IMBIBE, when used together with VITOSS, will provide greater flexibility and options for surgeons. IMBIBE is covered by
a U.S. issued patent.

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

VITOSS Bone Graft Substitute

 

VITOSS Blocks and Morsels  

FDA 510(k) cleared December 2000

Approved in European Union July 2000

VITOSS Micro and Macro Morsels  

FDA 510(k) cleared December 2000

Approved in European Union July 2003

VITOSS Standard and Micro Canisters  

FDA 510(k) cleared November 2003

Approved in European Union July 2003

VITOSS FOAM Product Platform, including:  

FDA 510(k) cleared December 2003

Approved in European Union May 2005

VITOSS FOAM Strips and Cylinders

VITOSS FOAM Flow

VITOSS FOAM Shapes

VITOSS FOAM Pack

 
Bioactive VITOSS FOAM   FDA 510(k) cleared September 2007

VITOSS is an ultra-porous resorbable beta-tricalcium phosphate bone void filler used to help the

 

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body guide the three-dimensional regeneration of the patient’s own bone. We launched VITOSS in the U.S. and the EU in 2001 and have sold approximately 200,000 units through December 31, 2007. VITOSS’s ultra-porosity allows it to soak and hold its own volume in blood and bone marrow aspirate and has been shown to perform well in an array of applications in the spine, extremities and pelvis, such as spinal grafting and the treatment of bone defects due to trauma, degenerative disease and tumors. VITOSS integrates well into existing bone and allows for bone in-growth and maturation. VITOSS, the VITOSS FOAM products and the Bioactive VITOSS FOAM products are covered by issued and pending U.S. and foreign patents.

Since the initial U.S. regulatory clearance and subsequent product launch in mid-2001, we have developed and are developing a number of new VITOSS-based products and related delivery devices that are designed to expand the market for our VITOSS products by broadening the range of surgical indications and by addressing additional surgeon preferences and needs. In 2003, we entered into a development, manufacturing and supply agreement with Kensey, which led to the development and launch of the VITOSS FOAM product platform. The VITOSS FOAM products combine our base VITOSS technology with Kensey’s proprietary resorbable biomaterials to produce a wide array of pliant, flexible, flowable and compression resistant bone graft materials. The VITOSS FOAM products have the ability to soak and hold their own volume in blood and bone marrow aspirate while retaining these biological fluids in pliable and compression resistant forms. These forms can be designed into specific shapes and material characteristics to meet a surgeon’s need for handling and delivery in a variety of surgical approaches and applications. We launched our Bioactive VITOSS FOAM product as part of a controlled rollout in the first quarter of 2008, and expect to fully launch the product during the second quarter of 2008. In addition to our proprietary VITOSS beta-tricalcium phosphate bone graft substitute and Kensey’s proprietary resorbable biomaterials, VITOSS Bioactive FOAM also contains ours proprietary combeite bioactive glass.

Bone Defect Grafting. Injury or trauma to the bone, degenerative conditions, disease and aging all affect the health and viability of the human skeleton. These conditions often result in the need for the repair of bone defects through a bone grafting procedure. We estimate that approximately 1,000,000 bone grafting procedures on a worldwide basis are performed each year in the spine, extremities and pelvis. Bone grafting material is either (i) autograft material, which is often obtained or harvested from the iliac crest region of the patient’s own hip, (ii) allograft material, which is obtained from a cadaver, or (iii) synthetically derived materials that provide one or more components of either bone-like scaffold (such as VITOSS), cells or signals (such as bone morphogenic proteins). VITOSS has been used in bone grafting procedures as a bone graft substitute to provide a synthetic scaffold in a variety of applications, including those of the extremities, spine and pelvis. When used with the patient’s bone marrow, VITOSS provides all components of scaffold, cells and signals.

A harvest of autograft material involves an additional procedure that extends surgical time, adding to costs and increasing blood loss and patient risk of infection or adverse reaction from the additional time under anesthesia. In addition, harvesting bone for autograft sometimes causes protracted pain that may necessitate additional medical care after the surgical procedure. Using VITOSS instead of autograft material may avoid these potential complications.

Disadvantages of allograft bone include the possibility of disease transmission, antigenic response and quality variability from donor to donor. VITOSS is a synthetic beta-tricalcium

 

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phosphate material without these possible disadvantages.

Spinal Grafting. Many patients affected by severe back pain due to degeneration of one or more discs are treated with a spinal surgical procedure. We estimate that each year approximately 500,000 spinal surgical procedures are done on a worldwide basis. In cases where the patient has advanced disc degeneration or spinal instability, a spinal surgical procedure may involve a surgical incision in the patient’s back or abdomen and frequently requires the removal of the affected disc material and the surgical attachment of a metal implant, spinal fusion cage, or machined bone derived from a cadaver to provide the initial support and intrinsic stability of the bony structure for the two surrounding vertebrae. Such spinal surgical procedures may require the use of a bone grafting material to help treat any surgically created bony defects. We believe the use of VITOSS as a bone void filler, rather than allograft or autograft materials, in spinal grafting procedures may be preferable for both the patient and the surgeon.

Trauma. Physical trauma such as falls and accidents can result in bone fracture or damage. Fractures of broken bones are often realigned with hardware, such as plates, rods and screws. Once the hardware has been used to recreate the skeletal anatomy and to provide the stability of the bony structure, there are often defects or voids in the bone which remain. Those voids may require the use of bone graft material. The goal of bone grafting in trauma applications is to rapidly heal the damaged bone. Approximately 100,000 trauma related bone graft repairs are performed annually on a worldwide basis. Autograft, cadaver allograft, as well as synthetic scaffolds like VITOSS, are used for trauma related bone graft repairs. VITOSS has been used as a bone graft substitute in a variety of trauma applications, including those of the extremities, spine and pelvis.

Dental, Periodontal, Oral and Cranio-Maxillofacial. In August 2002, we entered into a supply agreement with BioMimetic Therapeutics, Inc. for our proprietary VITOMATRIX particulate synthetic scaffold biomaterial, which we produce in the same process used to manufacture VITOSS. In January 2008, in connection with the sale of its dental business to Luitpold Pharmaceuticals, Inc., BioMimetic assigned its rights and obligations under the supply agreement to Luitpold. Under the agreement, we supply our proprietary beta tricalcium phosphate biomaterial to Luitpold for its clinical and commercial use in combination with rhPDGF. Luitpold markets the combined product in the dental, periodontal, oral and cranio-maxillofacial bone grafting markets through its Osteohealth Company division.

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

VITOSS Bone Graft Substitute

 

VITOSS Blocks and Morsels

   Approved in European Union in July 2000 FDA 510(k) cleared December 2000

VITOSS Micro and Macro Morsels

   FDA 510(k) cleared December 2000

VITOSS Standard and Micro Canisters

   FDA 510(k) cleared November 2003
VITOSS FOAM Product Platform, including:    FDA 510(k) cleared December 2003

VITOSS FOAM Strips and Cylinders

VITOSS FOAM Flow

VITOSS FOAM Shapes

VITOSS FOAM Pack

  

VITOSS is an ultra-porous resorbable beta-tricalcium phosphate bone void filler used to help the body guide the three-dimensional regeneration of the patient’s own bone. We launched VITOSS in the U.S. and the EU in 2001 and have sold over 180,000 units through December 31, 2006. VITOSS’s ultra-porosity allows it to soak and hold its own volume in blood and bone marrow aspirate and has been shown to perform well in an array of applications in the spine, extremities and pelvis, such as spinal grafting and the treatment of bone defects due to trauma, degenerative disease and tumors. VITOSS integrates well into existing bone and allows for bone in-growth and maturation. VITOSS and the VITOSS FOAM products are covered by issued and pending U.S. and foreign patents.

Since the initial U.S. regulatory clearance and subsequent product launch in mid-2001, we have developed and are developing a number of new VITOSS-based products and related delivery devices that are designed to expand the market for our VITOSS products by broadening the range of surgical indications and by addressing additional surgeon preferences and needs. In 2003, we entered into a development, manufacturing and supply agreement with Kensey, which led to the development and launch of the VITOSS FOAM product platform. The VITOSS FOAM products combine our base VITOSS technology with Kensey’s proprietary resorbable biomaterials to produce a wide array of pliant, flexible, flowable and compression resistant bone graft materials. The VITOSS FOAM products have the ability to soak and hold their own volume in blood and bone marrow aspirate while retaining these biological fluids in pliable and compression resistant forms. These forms can be designed into specific shapes and material characteristics to meet a surgeon’s need for handling and delivery in a variety of surgical approaches and applications. We also launched VITOSS Cancellous Chips during the first half of 2006.

Bone Defect Grafting. Injury or trauma to the bone, degenerative conditions, disease and aging all affect the health and viability of the human skeleton. These conditions often result in the need for the repair of bone defects through a bone grafting procedure. We estimate that approximately

 

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1,000,000 bone grafting procedures on a worldwide basis are performed each year in the spine, extremities and pelvis. Bone grafting material is either (i) autograft material, which is often obtained or harvested from the iliac crest region of the patient’s own hip, (ii) allograft material, which is obtained from a cadaver, or (iii) synthetically derived materials that provide one or more components of either bone-like scaffold (such as VITOSS), cells or signals (such as bone morphogenic proteins). VITOSS has been used in bone grafting procedures as a bone graft substitute to provide a synthetic scaffold in a variety of applications, including those of the extremities, spine and pelvis. When used with the patient’s bone marrow, VITOSS provides all components of scaffold, cells and signals.

A harvest of autograft material involves an additional procedure that extends surgical time, adding to costs and increasing blood loss and patient risk of infection or adverse reaction from the additional time under anesthesia. In addition, harvesting bone for autograft sometimes causes protracted pain that may necessitate additional medical care after the surgical procedure. Using VITOSS instead of autograft material may avoid these potential complications.

Disadvantages of allograft bone include the possibility of disease transmission, antigenic response and quality variability. VITOSS is a synthetic beta-tricalcium phosphate material without these possible disadvantages.

Spinal Grafting. Many patients affected by severe back pain due to degeneration of one or more discs are treated with a spinal surgical procedure. We estimate that each year approximately 500,000 spinal surgical procedures are done on a worldwide basis. In cases where the patient has advanced disc degeneration or spinal instability, a spinal surgical procedure may involve a surgical incision in the patient’s back or abdomen and frequently requires the removal of the affected disc material and the surgical attachment of a metal implant, spinal fusion cage, or machined bone derived from a cadaver to provide the initial support and intrinsic stability of the bony structure for the two surrounding vertebrae. Such spinal surgical procedures may require the use of a bone grafting material to help treat any surgically created bony defects. We believe the use of VITOSS as a bone void filler, rather than allograft or autograft materials, in spinal grafting procedures may be preferable for both the patient and the surgeon.

Trauma. Physical trauma such as falls and accidents can result in bone fracture or damage. Fractures of broken bones are often realigned with hardware, such as plates, rods and screws. Once the hardware has been used to recreate the skeletal anatomy and to provide the stability of the bony structure, there are often defects or voids in the bone which remain. Those voids may require the use of bone graft material. The goal of bone grafting in trauma applications is to rapidly heal the damaged bone. Approximately 100,000 trauma related bone graft repairs are performed annually on a worldwide basis. Autograft, cadaver allograft, as well as synthetic scaffolds like VITOSS, are used for trauma related bone graft repairs. VITOSS has been used as a bone graft substitute in a variety of trauma applications, including those of the extremities, spine and pelvis.

Dental, Periodontal, Oral and Cranio-Maxillofacial. In August 2002, we entered into a supply agreement with BioMimetic that allows BioMimetic to use its rhPDGF in combination with our

 

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proprietary VITOMATRIX particulate synthetic scaffold biomaterial, which we produce in the same process used to manufacture VITOSS. Under the agreement, we supply our proprietary beta tricalcium phosphate biomaterial to BioMimetic for its clinical and commercial use in conjunction with rhPDGF. BioMimetic markets the combined product in the dental, periodontal, oral and cranio-maxillofacial bone grafting markets.

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

VITOSS Bone Graft Substitute

 

VITOSS Blocks and Morsels

   Approved in European Union in July 2000
   FDA 510(k) cleared December 2000

VITOSS Micro and Macro Morsels

   FDA 510(k) cleared December 2000

VITOSS Standard and Micro Canisters

   FDA 510(k) cleared November 2003

VITOSS FOAM Product Platform, including:

   FDA 510(k) cleared December 2003

VITOSS FOAM Strips and Cylinders

  

VITOSS FOAM Flow

  

VITOSS FOAM Shapes

  

VITOSS FOAM Pack

  

VITOSS Bone Graft Substitute is an ultra-porous resorbable beta-tricalcium phosphate bone void filler used to help the body guide the three-dimensional regeneration of the patient’s own bone. We launched VITOSS Bone Graft Substitute in the U.S. and the EU in 2001 and have sold over 98,000 units through December 31, 2005. VITOSS Bone Graft Substitute’s ultra-porosity allows it to soak and hold 90% of its own volume in blood and bone marrow aspirate and has been shown to perform well in an array of applications in the spine, extremities and pelvis, such as spinal grafting and the treatment of bone defects due to trauma, degenerative disease and tumors. VITOSS Bone Graft Substitute integrates well into existing bone and promotes new bone in-growth and maturation. Since the initial U.S. regulatory clearance and subsequent product launch in mid-2001, we have developed and are developing a number of new VITOSS-based products and related delivery devices that are designed to expand the market for our VITOSS Bone Graft Substitute products by broadening the range of surgical indications and by addressing additional surgeon preferences and needs.

In 2003, we entered into a development, manufacturing and supply agreement with Kensey, which led to the development and launch of the VITOSS FOAM product platform. The VITOSS FOAM products combine our base VITOSS Bone Graft Substitute technology with Kensey’s proprietary resorbable biomaterials to produce a wide array of pliant, flexible, flowable and compression resistant bone graft materials. The VITOSS FOAM products have the ability to soak and hold 90% of its own volume in blood and bone marrow aspirate while retaining these biological fluids in pliable and compression resistant forms. These forms can be designed into specific shapes and material characteristics to meet a surgeon’s need for handling and delivery in a variety of surgical approaches and applications.

Bone Defect Grafting. Injury or trauma to the bone, as well as degenerative conditions, disease and aging, affect the health and viability of the human skeleton. These conditions often result in the need for the repair of bone defects through a bone grafting procedure. We estimate that approximately 700,000 bone grafting procedures on a worldwide basis are performed each year in the spine, extremities and pelvis. Bone grafting material is either (i) autograft material, which is often obtained or harvested from the iliac crest region of the patient’s own hip, or (ii) allograft material, which is obtained from a cadaver, or (iii) synthetically derived materials that provide one or more components of either bone-like scaffold (such as VITOSS Bone Graft Substitute), cells or signals (such as bone morphogenic proteins). VITOSS Bone Graft Substitute has been used in bone grafting procedures as a bone graft substitute to provide a synthetic scaffold in a variety of applications, including those of the long bone, extremity, spine and pelvic areas.

 

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Table of Contents

A harvest of autograft material involves an additional procedure that extends surgical time, adding to costs and increasing blood loss and patient risk of infection or adverse reaction from the additional time under anesthesia. In addition, harvesting bone for autograft sometimes causes protracted pain that may necessitate additional medical care after the surgical procedure. Using VITOSS Bone Graft Substitute instead of autograft material may avoid these potential complications.

Spinal Grafting. Many patients affected by severe back pain due to degeneration of one or more discs are treated with a spinal surgical procedure. We estimate that each year approximately 500,000 spinal surgical procedures are done on a worldwide basis. In cases where the patient has advanced disc degeneration or spinal instability, a spinal surgical procedure may involve a surgical incision in the patient’s back or abdomen and frequently requires the removal of the affected disc material and the surgical attachment of a metal implant, spinal fusion cage, or machined bone derived from a cadaver to provide the initial support and intrinsic stability of the bony structure for the two surrounding vertebrae. Such spinal surgical procedures may require the use of a bone grafting material to help treat any surgically created bony defects. We believe the use of VITOSS Bone Graft Substitute, rather than allograft or autograft materials, in spinal grafting procedures may be preferable for both the patient and the surgeon.

Iliac Crest Repair. The bone grafting material used to pack certain implants and cages used in spinal fusion procedure is often autograft material, obtained or “harvested” from the iliac crest region of the patient’s own hip through an operating procedure. This procedure leaves an open space in the iliac crest, which is often painful and slow healing. We estimate that each year, autograft material is used in approximately 200,000 spinal fusion procedures worldwide and that harvested material is used in another 100,000 non-spinal fusion related procedures worldwide. VITOSS Bone Graft Substitute can be used to repair the bone void left by the harvest procedure at the time of surgery and may reduce the incidence of post-operative bleeding and post-operative pain at the harvest site and speed healing time. In post-marketing studies of VITOSS Bone Graft Substitute for iliac crest repair, initial results suggested the use of VITOSS Bone Graft Substitute performs well in the formation of new bone.

Trauma. Physical trauma such as falls and accidents can result in bone fracture or damage. Fractures of broken bones are often realigned with hardware, such as plates, rods and screws. Once the hardware has been used to recreate the skeletal anatomy and to provide the stability of the bony structure, there are often defects or voids in the bone which remain. Those voids may require the use of bone graft material. The goal of bone grafting in trauma applications is to rapidly heal the damaged bone. Approximately 100,000 trauma related bone graft repairs are performed annually on a worldwide basis. Autograft, cadaver allograft, as well as synthetic scaffolds, like VITOSS Bone Graft Substitute, are used for trauma related bone graft repairs. VITOSS Bone Graft Substitute has been used as a bone graft substitute in a variety of trauma applications, including those of the long bone, extremity, and pelvis, as well as to fill bone void defects due to trauma in fractures of the wrist, ankle, tibia and femur.

Dental, Periodontal, Oral and Cranio-Maxillofacial. In August 2002, we entered into a supply agreement with BioMimetic that allows BioMimetic to use its rhPDGF in combination with our proprietary VITOMATRIX particulate synthetic scaffold biomaterial, which we produce in the same process used to manufacture VITOSS Bone Graft Substitute. Under the agreement, we will supply our proprietary beta tricalcium phosphate biomaterial to BioMimetic for its clinical and commercial use in conjunction with rhPDGF. The agreement provides that, upon obtaining the requisite regulatory approvals, which were received during 2005, BioMimetic will market and sell the combined product in the dental, periodontal, oral and cranio-maxillofacial bone grafting markets.

 

7


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

VITOSS Bone Graft Substitute

 

VITOSS Blocks and Morsels   

Approved in European Union in July 2000

 

FDA 510(k) cleared December 2000

VITOSS Micro and Macro Morsels    FDA 510(k) cleared December 2000
VITOSS Standard and Micro Canisters    FDA 510(k) cleared November 2003
VITOSS FOAM Product Platform, including:     

VITOSS FOAM Strips and Cylinders

   FDA 510(k) cleared December 2003

VITOSS FOAM Flow

   FDA 510(k) cleared December 2003

VITOSS FOAM Shapes

   FDA 510(k) cleared December 2003

 

VITOSS Bone Graft Substitute is an ultra-porous resorbable beta-tricalcium phosphate bone void filler used to help the body guide the three-dimensional regeneration of the patient’s own bone. We launched VITOSS Bone Graft Substitute in the U.S. and the European Union in 2001 and have sold over 70,000 units to date. VITOSS Bone Graft Substitute’s ultra-porosity allows it to soak and hold 90% of its own volume in blood and bone marrow aspirate and has been shown to perform well in an array of applications in the spine, extremities and pelvis, such as spinal grafting and the treatment of bone defects due to trauma, degenerative disease and tumors. VITOSS Bone Graft Substitute integrates well into existing bone and promotes new bone in-growth and maturation. Since the initial U.S. regulatory clearance and subsequent product launch in mid-2001, we have developed and are developing a number of new VITOSS-based products and related delivery devices that are designed to expand the market for our VITOSS Bone Graft Substitute products by broadening the range of surgical indications and by addressing additional surgeon preferences and needs.

 

In 2003, we entered into a development, manufacturing and supply agreement with Kensey, which has led to the development and initial launch of a new product platform branded under the name VITOSS FOAM. The VITOSS FOAM products combine our base VITOSS Bone Graft Substitute technology with Kensey’s proprietary resorbable biomaterials to produce a wide array of pliant, flexible, flowable and compression resistant bone graft materials. The VITOSS FOAM products have the ability to soak and hold 90% of its own volume in blood and bone marrow aspirate while retaining these biological fluids in pliable and compression resistant forms. These forms can be designed into specific shapes and material characteristics to meet surgeon needs for handling and delivery in a variety of surgical approaches and applications.

 

Bone Defect Grafting. Injury or trauma to the bone, as well as degenerative conditions, disease and aging, affect the health and viability of the human skeleton. These conditions often result in the need for the repair of bone defects through a bone grafting procedure. We estimate that approximately 700,000 bone grafting procedures on a worldwide basis are performed each year in the spine, extremities and pelvis. Bone grafting material is either (i) autograft material, which is often obtained or harvested from the iliac crest region of the patient’s own hip, or (ii) allograft material, which is obtained from a cadaver, or (iii) synthetically derived materials that provide one or more components of either bone-like scaffold (such as VITOSS Bone Graft Substitute), cells or signals (such as bone morphogenic proteins). VITOSS Bone Graft Substitute has been used in bone grafting procedures as a bone graft substitute to provide a synthetic scaffold in a variety of applications, including those of the long bone, extremity, spine and pelvic areas.

 

A harvest of autograft material involves an additional procedure that extends surgical time, adding to costs and increasing blood loss and patient risk of infection or adverse reaction from the additional time under anesthesia. In addition, harvesting bone for autograft sometimes causes protracted pain that may necessitate additional medical care after the surgical procedure. Using VITOSS Bone Graft Substitute instead of autograft material may avoid these potential complications .

 

Spinal Grafting. Many patients affected by severe back pain due to degeneration of one or more discs are treated with a spinal surgical procedure. We estimate that each year approximately 500,000 spinal surgical procedures are done on a worldwide basis. In cases where the patient has advanced disc degeneration or spinal instability, a spinal surgical procedure may involve a surgical incision in the patient’s back or abdomen and frequently requires the removal of the affected disc material and the surgical attachment of a metal implant, spinal fusion cage, or machined bone derived from a cadaver to provide the initial support and intrinsic stability of the bony structure for the two surrounding vertebrae. Such spinal surgical procedures may require the use of a bone grafting material to help treat any surgically created bony defects. We believe the use of VITOSS Bone Graft Substitute, rather than allograft or autograft materials, in spinal grafting procedures is preferable for both the patient and the surgeon.

 

Iliac Crest Repair. The bone grafting material used to pack certain implants and cages used in spinal fusion procedure is often autograft material, obtained or “harvested” from the iliac crest region of the patient’s own hip through an operating procedure. This procedure leaves an open space in the iliac crest, which is often painful and slow healing. We estimate that each year, autograft material is used in approximately 200,000 spinal fusion procedures worldwide and that harvested material is used in another 100,000 non-spinal fusion related procedures worldwide. VITOSS Bone Graft Substitute can be used to repair the bone void left by the harvest procedure at the time of surgery and may reduce the incidence of post-operative bleeding and post-operative pain at the harvest site and speed healing time. In post-marketing studies of VITOSS Bone Graft Substitute for iliac crest repair, initial results indicated the use of VITOSS Bone Graft Substitute performs well in the formation of new bone.

 

Trauma. Physical trauma such as falls and accidents can result in bone fracture or damage. Fractures of broken bones are often realigned with hardware, such as plates, rods and screws. Once the hardware has been used to recreate the skeletal anatomy and to provide the stability of the bony structure, there are often defects or voids in the bone which remain. Those voids may require the use of bone graft material. The goal of bone grafting in trauma applications is to rapidly heal the damaged bone. Approximately 100,000 trauma related bone graft repairs are performed annually on a worldwide basis. Autograft, cadaver allograft, as well as synthetic scaffolds, like VITOSS Bone Graft Substitute, are used for trauma related bone graft repairs. VITOSS Bone Graft Substitute has been used as a bone graft substitute in a variety of trauma applications, including those of the long bone, extremity, and pelvis, as well as to fill bone void defects due to trauma in fractures of the wrist, ankle, tibia and femur.

 

4


Table of Contents

Dental, Periodontal, Oral and Cranio-Maxillofacial. In August 2002, we entered into a supply agreement with BioMimetic that allows BioMimetic to use its rhPDGF in combination with our proprietary VITOMATRIX particulate synthetic scaffold biomaterial, which we produce in the same process used to manufacture VITOSS Bone Graft Substitute. Under the agreement, we will supply our proprietary calcium phosphate biomaterial to BioMimetic for its clinical and commercial use in conjunction with rhPDGF, which is currently distributed for investigational use. The agreement provides that, upon obtaining the requisite regulatory approvals, BioMimetic will market and sell the combined product in the dental, periodontal, oral and cranio-maxillofacial bone grafting markets.

 

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