For surgeons What is Z-Lig?

Aperion is pioneering biologic tissue alternatives. Our first product Z-Lig is CE Marked and indicated for use for in revision and multiligament ACL reconstruction surgeries.

Z-Lig is strong, sterile, ready when you need it. 
The future is biologic.

Advantages

Z-Lig is designed to be better for patients, and better for doctors.

Clinical:

  • Maintains Integrity of the Body: Unlike Autograft, no harvesting from other parts of the body
  • Consistent Quality: Reliable strength, durability
  • Safety: Chemical processes controls immune response and “humanizes” animal tissue
  • Regenerative: Tissue remodels over time, becomes the patients’ own ligament
  • Performance: Stabilizes the knee, as good as or better than the standard of care
  • Easier on patient: No donor site pain, faster recovery

Procedural:

  • Consistently Available: Unlike Allograft, readily available supply
  • No surgical training: No changes to surgical technique, instruments and fixation devices
  • Cost effective: Competitive to other graft options
  • Z-Lig is a device and is safer than allografts
  • CE Mark Approved: Piloted in select countries

Z-Lig Comparison Chart

Product Information

The Z-Lig family of devices are tissue based ACL reconstruction devices. The tissue source is porcine. 

The device comes in a BTB (bone-tendon-bone) or a BT+ (bone-tendon-bone extension) configuration.

BTB: Part Number 7100
BT+: Part Number 7300

The Science behind Z-Lig

ACL injuries are common. There are an estimated 2,6M ACL injuries annually globally, and about a third of them require reconstruction. Z-Lig is designed to make ACL reconstruction procedures easier for patients and surgeons

  • 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 Z-Lig has been granted CE Mark approval for revision and multi-ligament ACL reconstruction procedures
  • It is the first and only solution of it’s kind, with 14 patents worldwide.

Aperion Biologics, Inc. developed and patented a technique to make animal-tissues usable for human applications without causing rejection.

The core platform technology is an enzymatic stripping of the key carbohydrate antigens followed by a unique conversion process that both “humanizes” and sterilizes the tissues without affecting their biomechanical or biological properties. This tissue scaffold provides mechanical stability and function while being biologically integrated and remodeled.

Rejection is the major obstacle preventing the use of animal derived tissue in human transplantation. Historically, tissue rejection was addressed by complete tissue crosslinking incorporating associated antigens into a non-remodelable prosthesis, much like leather. The complete crosslinking process renders a “permanent” tissue implant that inhibits human host cells of being incorporated and remodeled into natural biological tissue. Previous attempts at developing an animal derived tissue device have failed due to inflammation or adverse biological reactions.

To solve the xenotransplant rejection problems mentioned above, Aperion developed the Z-Process™. The Z-Process™ is a proprietary process that immunochemically modifies animal tissue to be compatible with the human immune system. Aperion uses α-galactosidase enzyme to cleave the terminal α-gal antigen so that the carbohydrate chain remaining on the animal tissue is the same in its structure as the carbohydrate chains present in humans. The Z-Process™ deactivates both αalpha-gal and non-gal antigens on the xenograft tissue to prevent rejection.

Aperion’s proprietary method addresses both the xenograft rejection as well as the ability to encourage a biological response to an implant.

The Z-Lig device as an immunocompatible, porcine-derived ACL reconstruction alternative which provides a readily available, off-the-shelf solution and is strong, sterile, and reproducible. The manufacturing process and subsequent product are protected by over 14 issued patents.

Aperion’s Z-Process™ of humanizing and sterilizing tissue can be applicable to a variety of tissues from orthopedic ligaments, bone, and meniscus to valves and vessels to soft tissue grafts for augmentation and repair.
 

Read about the Z-Lig Clinical Trial

Patents & Intellectual Property

An extensive intellectual property portfolio protects Aperion product candidates and Z-Process™ technology. Currently, 14 U.S. and international patents have been issued and a number are pending. Aperion’s patent portfolio includes claims relating to treatment and application of specific tissues for a variety of medical and surgical uses. The intellectual property portfolio includes combined patents of process and material composition that support deantigenation, sterilization and viral inactivation of a wide range of biological tissues. Aperion has exclusive rights to the only known method for humanizing non-primate animal grafts for replacement of ligaments, bone, etc. in humans without making the graft inert.

Patents regarding Z-Process™ include coverage of key immunochemical modification and sterilization techniques as applied to a variety of animal-derived tissues, including connective tissue grafts (tendon, ligament, articular cartilage and fibrocartilage); cardiovascular tissues (heart valve and pericardium); and calcified and de-calcified bone (granular bone matrix, cortical and cancellous structural bone for struts, cages and machined implants). The patent portfolio also includes immunochemical modifications of solubilized and homogenized dermal- and tendon-derived injectable collagen formulations.

Patent number
Title
EPO1065997
Bone xenografts
EPO1511445
Sterilized xenograft tissue
JP4535324
Sterilized xenograft tissue
JP5015376
Proteoglycan-reduced soft tissue xenografts
JP5015377
Aldehyde and glycosidase-treated soft and bone tissue xenografts

Papers & Publications

Presentations

  • "ACL Reconstruction Without Damage to the Patient - An alternative graft for ACL reconstruction, background and rationale." Zaffagnini, S. Workshop at the 8th European Federation of National Associations of Orthopaedic Sports Traumatology (EFOST) Congress 2015, Torino, Italy, November 28, 2015.
  • "Xenografts in Orthopaedics: the Future of Ligament Replacement." Stone, KR. 10th Biennial International Society of Arthroscopy, Knee Surgery, and Orthopaedic Sports Medicine (ISAKOS) Congress, Lyon, France, June 9, 2015.
  • "Z-Lig BT+ for ACL Reconstruction." Van der Merwe, WM. 1st European Symposium of Biomaterials in Orthopedics and Spine (ESBOS), Poznan, Poland, April 16, 2015.
  • "Xenografts in Orthopaedics: the Future of Ligament Replacement." Stone, KR. 16th European Society of Sports Traumatology, Knee Surgery & Arthroscopy (ESSKA) Congress, Amsterdam, Netherlands, May 15, 2014.
  • "New Emerging Technique: Z-Lig: Back to the Future: The Way to Treat an ACL Injury." Van der Merwe, WM. 3rd Annual Emerging Techniques in Orthopaedics, Las Vegas, NV, December 5, 2013.
  • "Graft Choices in ACL Reconstruction – Introducing the Z-Lig." Van der Merwe, WM and Zaffagnini, S. Lunch Symposium at the 9th Biennial International Society of Arthroscopy, Knee Surgery, and Orthopaedic Sports Medicine (ISAKOS) Congress, Toronto, Canada, May 15, 2013.
  • "Graft Choices in ACL Reconstruction – Introducing the Z-Lig." Zaffagnini, S and Van der Merwe, WM. Lunch Symposium at the 15th European Society of Sports Traumatology, Knee Surgery & Arthroscopy (ESSKA) Congress, Geneva, Switzerland, May 2, 2012
  • "Cartilage and Xenografts." Stone KR, Turek, TJ. 8th World Congress of the International Cartilage Repair Society, Miami FL, May 24, 2009.
  • "Treatment of ACL Ruptures with Xenografts. Where Are We Today?" Stone KR, Walgenbach AW, Turek TJ. Congress of the Portuguese Association of Arthroscopy and Sports Traumatology, Oeiras, Portugal, September 27, 2007.
  • "Immunological Considerations in Orthopaedic Xenografting." Stone KR, Walgenbach AW, Turek TJ, Galili U. ISAKOS 6th Biennial Congress, Florence Italy, May 27, 2007.
  • "Xenograft Ligament Transplantation: Development of a Porcine Xenograft for ACL Reconstruction." Stone KR, Turek TJ. XXIV Congreso de la Asociacion Espanola de Artroscopia, Leon, Spain, May 12, 2006.
  • "ACL Reconstruction with a Porcine Xenograft." Stone KR, Walgenbach AW, Turek TJ, Galili U. ACL Study Group Meeting, Kona, Hawaii, March 28, 2006.
  • "Xenograft Ligament Transplantation." Stone KR, Walgenbach AW, Turek TJ, Galili U. American Association of Tissue Banks Spring Meeting, Tucson, Arizona, March 26, 2006.
  • "A Six-Month Biomechanical and Histological Evaluation of Porcine Xenografts for Anterior Cruciate Ligament Reconstruction." Stone KR ,Turek TJ, , Somers D, Wicomb W, Galili U. International Orthopaedic Research Society Meeting, Banff Canada, February 2005
  • "A Six-Month Biomechanical and Histological Evaluation of Porcine Xenografts for Anterior Cruciate Ligament Reconstruction." Stone KR , Turek TJ, Hansen T, Gealer R, Walgenbach AW, Somers D, Wicomb W, Galili U. American Orthopaedic Society for Sports Medicine, San Diego, California, July 22, 2003.
  • "A Six-Month Biomechanical and Histological Evaluation of Porcine Xenografts for Anterior Cruciate Ligament Reconstruction." Stone KR, ACL Study Group Meeting, Big Sky, Montana, March 4, 2002.
  • "Xenograft ACL Device Development." Stone KR, Walgenbach AW, Turek TJ, Wicomb W, Galili U. Australian Knee Society Annual Scientific Meeting, Hobart, Australia, October 8 - 13, 2000.
  • "Xenograft Ligament Reconstruction." Stone KR, Walgenbach AW. ACL Study Group, Rhodes, Greece, May 20 - 26, 2000.

Poster Sessions

  • “Mechanism of Rejection in Orthopaedic Xenografts". Turek TJ, Stone KR, Walgenbach Aw, Lee DR, Galili U, Society for Biomaterials, San Antonio TX, April 23, 2009
  • "Long-Term follow-up of Anterior Criciate Ligament Reconstruction Using an Immunochemically Modified Porcine Patellat Tendon ." Stone KR, Turek TJ, Walgenbach AW, Smith S, Galili U. International Symposium on Tendon and Ligaments – VIII, Las Vegas, Nevada, February 22, 2009.
  • "Porcine Xenografts as Functional Scaffolds for ACL Reconstruction." Stone KR, Walgenbach AW, Turek TJ, Galili U. International Symposium on Tendon and Ligaments – VI, Chicago, Illinois, March 18, 2006.
  • "Immunological Considerations in Orthopaedic Xenografting." Stone KR, Walgenbach AW, Turek TJ. Orthopaedic Research Society, Chicago, Illinois, March 2006.
  • "Porcine Patellar Tendon Grafts for Anterior Cruciate Ligament Reconstruction." Stone KR, Walgenbach AW, Turek TJ, Somers D, Wicomb W, Galili U. The International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine, Montreaux, Switzerland, May 2001.
  • "Xenograft Implantation of Porcine Patellar Tendon: A Histological, Serological, and Bio-Mechanical Study." Stone KR, Walgenbach AW, Turek TJ, Hansen T, Galili. U Orthopaedic Research Society, February 2001.