Transforming Tissue Transplantation

Orthopedic Ligament Reconstruction
Z-Lig^® is anticipated by the Company to transform the standard of care (autograft) and impact current options for tissue grafts. More broadly, Aperion believes it will become a leading tissue products company.

Highly Unmet Need

• Nearly all surgeons performing Anterior Cruciate Ligament (ACL) reconstruction procedures utilize only two graft types, autograft and allograft, each of which have shortcomings.
• Autograft shortcomings include: Extended operative time, complications, morbidity, additional rehabilitation time, and a decrease in function at the harvest site.
• Allograft shortcomings include: supply constraints, variable tissue quality,  and the risk of disease transmission.
• Z-Lig^® potentially represents a readily available, off the shelf, high quality tissue graft; an alternative that has been sought for years.
• In most of Europe and other markets outside the United States, where allografts are generally not available, the need for an alternative is even more significant.

Unique in the Industry

• Outside of autografts and allografts, Z-Lig^® is completely unique as an ACL medical device within the orthopaedic/sports medicine industry in its ability to successfully maintain a biological scaffold.
• No other company is known to have a tissue-based ACL graft in advanced human clinical development.
• The only non-human ACL products available are synthetic based which have limited ability to regenerate and are only available in select markets (Europe and Australia).

Clinical Progress

• Safety pilot study in 10 humans showed no infections, and no acute or long-term immune responses (Transplantation. January 2007;83:211-219.)
• A randomized, multicenter trial is currently being conducted in Europe and South Africa.

Leveragability of Platform

• Proprietary product platform has broad applicability to many other human tissue needs beyond ACL replacement.
• Earlier stage product designs are being developed by Aperion for general and reconstructive surgery, bone grafting, and other applications.
• Potential as a dynamic and functional scaffold, ideal for delivery of bioactive agents.

Expansive Issued Patent Estate

• Exclusive rights to the only patented method for humanizing non-primate animal grafts for human tissue replacement.
• Extensive coverage of immunochemical modification and sterilization techniques across multiple animal species for tissues and bone.
• 28 issued U.S. and international patents.