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Patient Highlight:
Pilot Study Patient 4

Ski Racing in 2003, RL ruptured his right knee ACL. In the previous decade, he had torn his left ACL and had it surgically reconstructed with this own tissue or autograft. RL was enrolled in the pilot FDA clinical trial of the Z-Lig^® BTB device (an investigational ACL reconstruction device) developed by Aperion Biologics, Inc. The Z-Lig^® BTB consists of specially treated and sterilized pig tissue designed to serve a cell-friendly, functional scaffold once implanted without concern of rejection.

Five years post ACL reconstruction, this device continues to perform successfully. RL continues as a professional ski instructor and racer and has averaged over 100 ski days a year. In addition, RL has won the Canadian Masters Ski Championship three of the last four years with the Z-Lig^® device.

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Ligament Reconstruction

Ligament Reconstruction
According to a recent report by Millennium Research Group (MRG) (November 2007), over 400,000 knee ligament reconstruction procedures were performed in the U.S. in 2007. Over half of these used bone-tendon-bone grafts. Approximately 20% of these procedures were performed using allograft. Aperion believes that the supply of high quality allografts does not sufficiently meet the demand for knee ligament procedures. Furthermore, the demand is expected to be driven higher by the expanding aging and active population suffering from degenerative joint ailments.

Today, nearly all surgeons performing ACL reconstruction procedures use only two graft types, autograft and allograft, and each have shortcomings.

Autograft - During an autograft procedure, a second surgical site is chosen on the patient’s body and tendon (patellar tendon or hamstring) is harvested. Consequently, the patient suffers from additional pain, morbidity and scarring at the harvest site. The requirement for a second surgical site prolongs operating time, is potentially subject to infection and causes a more complex and extended recovery period.

Allograft - Allografts are produced in tissue banks which are regulated differently than medical devices. Product from tissue banks is not subject to the medical device regulatory review and approval and is therefore not subject to the same controls and regulations as is a commercial device. Despite a range of improvements in industry monitoring and oversight beginning predominantly in 2005, patients with soft tissue allograft infections continue to be reported and have resulted in recalls from several tissue banks. (“Musculoskeletal Allograft Tissue Safety”, American Academy of Orthopaedic Surgeons. March 2008). While allografts are generally safe, the risk of human disease transmission continues to exist. The demand for high quality tissue significantly surpasses the supply. Only half of the 25,000 cadavers available in the U.S. annually provide transplantable tissue meeting the specific requirements of orthopaedic tissue donation and, of those that meet the requirements, the yield is limited per cadaver of grafts suitable for ACL replacement (Industry Sources).

Xenografts or Synthetics. Historical attempts by competitors to use xenografts for human transplantation have ended with failure. Numerous attempts were made to develop artificial ligament devices. Almost all of these have had problems with biocompatibility, mechanical stability or durability issues.

Z-Lig^® Family
Aperion has developed the Z-Lig^® device as an immunocompatible, porcine-derived ACL reconstruction alternative which potentially provides a readily available, off-the-shelf solution and is strong, sterile, and reproducible. The Company believes that the Z-Lig^® remodels at a similar rate as human allografts, with substantial ligamentization occurring within expected timeframes.

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Patient Highlight: Pilot Study Patient 4 Ski Racing in 2003, RL ruptured his right knee ACL. In the previous decade, he had torn his left ACL and had it surgically reconstructed with this own tissue or autograft. RL was enrolled in the pilot FDA clinical trial of the Z-Lig^® BTB device (an investigational ACL reconstruction device) developed by Aperion Biologics, Inc. The Z-Lig^® BTB consists of specially treated and sterilized pig tissue designed to serve a cell-friendly, functional scaffold once implanted without concern of rejection. Five years post ACL reconstruction, this device continues to perform successfully. RL continues as a professional ski instructor and racer and has averaged over 100 ski days a year. In addition, RL has won the Canadian Masters Ski Championship three of the last four years with the Z-Lig^® device. *The Z-Lig^® device has not been approved for sale in the United States, European Union or other markets.*	Ligament Reconstruction Ligament Reconstruction According to a recent report by Millennium Research Group (MRG) (November 2007), over 400,000 knee ligament reconstruction procedures were performed in the U.S. in 2007. Over half of these used bone-tendon-bone grafts. Approximately 20% of these procedures were performed using allograft. Aperion believes that the supply of high quality allografts does not sufficiently meet the demand for knee ligament procedures. Furthermore, the demand is expected to be driven higher by the expanding aging and active population suffering from degenerative joint ailments. Today, nearly all surgeons performing ACL reconstruction procedures use only two graft types, autograft and allograft, and each have shortcomings. Autograft - During an autograft procedure, a second surgical site is chosen on the patient’s body and tendon (patellar tendon or hamstring) is harvested. Consequently, the patient suffers from additional pain, morbidity and scarring at the harvest site. The requirement for a second surgical site prolongs operating time, is potentially subject to infection and causes a more complex and extended recovery period. Allograft - Allografts are produced in tissue banks which are regulated differently than medical devices. Product from tissue banks is not subject to the medical device regulatory review and approval and is therefore not subject to the same controls and regulations as is a commercial device. Despite a range of improvements in industry monitoring and oversight beginning predominantly in 2005, patients with soft tissue allograft infections continue to be reported and have resulted in recalls from several tissue banks. (“Musculoskeletal Allograft Tissue Safety”, American Academy of Orthopaedic Surgeons. March 2008). While allografts are generally safe, the risk of human disease transmission continues to exist. The demand for high quality tissue significantly surpasses the supply. Only half of the 25,000 cadavers available in the U.S. annually provide transplantable tissue meeting the specific requirements of orthopaedic tissue donation and, of those that meet the requirements, the yield is limited per cadaver of grafts suitable for ACL replacement (Industry Sources). Xenografts or Synthetics. Historical attempts by competitors to use xenografts for human transplantation have ended with failure. Numerous attempts were made to develop artificial ligament devices. Almost all of these have had problems with biocompatibility, mechanical stability or durability issues. Z-Lig^® Family Aperion has developed the Z-Lig^® device as an immunocompatible, porcine-derived ACL reconstruction alternative which potentially provides a readily available, off-the-shelf solution and is strong, sterile, and reproducible. The Company believes that the Z-Lig^® remodels at a similar rate as human allografts, with substantial ligamentization occurring within expected timeframes.
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