CROSSCART, INC. RECEIVES FDA CLEARANCE FOR PIVOTAL TRIAL OF ITS Z-LIG™ DEVICE FOR ACL RECONSTRUCTION

SAN FRANCISCO, CA – February 23 – CrossCart, Inc., a private medical device company focused on the development, manufacture and commercialization of animal derived tissue products for humans, announced today it has received clearance from the Food and Drug Administration (FDA) to initiate a pivotal trial for its lead product, a porcine derived ligament known as the Z-Lig™. CrossCart’s Z-Lig device is designed to replace a torn anterior cruciate ligament (ACL) in the human knee, addressing a worldwide market that is expected to exceed $1.6 billion.

Currently, ligament replacement surgeries are performed using either the patient’s own tissue (autograft) or cadaver tissue (allograft). CrossCart’s Z-Lig device offers significant advantages over autograft and allograft tissue sources. In the case of autograft tissue, use of the Z-Lig avoids the necessity of a second surgical site for the harvest of donor tissue, which increases the time and cost of surgery and results in a slower and more difficult rehabilitation for the patient.  In the case of allograft tissue, use of the Z-Lig avoids the quality variations, potential for disease transmission from contaminated tissue and limited supply inherent in harvest from allograft tissue sources.

The major hurdle limiting successful direct transplantation of animal tissue into humans has been tissue rejection caused by the body’s natural response to cell and matrix surface antigens, which trigger an immune response. To overcome this obstacle, CrossCart developed a novel, proprietary tissue treatment technology called the "Z-Process™" that effectively strips the key antigens and sterilizes the target tissue. The Z-Process employs a three-step procedure of enzymatic elimination of Gal antigens, chemical neutralization of non Gal antigens, and electron beam sterilization. CrossCart’s core technology platform is applicable to other medical devices in the orthopedic, cardiovascular and general surgical fields. This process is covered by 19 patents and 11 patents pending.

"CrossCart’s pivotal trial gives us the opportunity to demonstrate that our Z-Process technology results in both safe and effective replacements for human tissue," said Dr. Kevin Stone of the Stone Clinic and Founding Scientist of CrossCart. "CrossCart’s porcine derived Z-Lig device is expected to remodel to human tissue within 12-18 months post-implantation. If the Z-Process works well for ACL reconstruction, it could open up a wide range of other products and/or licensing opportunities for CrossCart."

The objective of the pivotal trial is to evaluate the safety and effectiveness of the Z-Lig device in patients with an acute or chronic injury that requires reconstruction of a ruptured ACL. The study will be a non-inferiority trial, comparing the Z-Lig device to allograft in a prospective, randomized, blinded multicenter clinical trial at up to ten clinical sites. The trial is approved for the enrollment of 326 subjects, with half receiving the Z-Lig device and half receiving an allograft control.

The pivotal study will be conducted on a single-blind basis with an independent, blinded evaluator. While the surgeon investigator who performs the ACL repair will know whether a ZLig device or an allograft was used in the procedure, both the patient and the evaluator performing post-operative assessments will be blind to the patient’s treatment group. The primary outcomes to determine clinical success will be two standard measures of knee laxity and the assessment of knee effusion.

CrossCart, Inc., a private medical device company focused on the development, manufacture and commercialization of animal-based tissue implants designed for human use. CrossCart’s initial products are focused on musculoskeletal (orthopedic) applications. However the company’s core Z-Process technology is applicable to a variety of animal-based tissue implants currently used in the orthopedics, cardiovascular and general surgical markets. To date, the company achieved several critical milestones including the receipt of SBIR Phase I support in 1998, initial award of SBIR Phase II grant in 2002, FDA IDE approval the Z-Lig device and launch of a pilot feasibility and safety trial in 2003, and FDA approval for launch of a Z-Lig pivotal trial in 2005.

Roy Fiebiger
Chief Executive Officer
CrossCart, Inc.
Tel: 415-923-6444

Media:

Kathy Jones Nugent, PhD.
Senior Vice President
Burns McClellan, Inc. Tel: 212-213-0006

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