50 U.S. Hospitals approve Osteotech's Plexur M bone-polymer biocomposite

Dec 1 2009

Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic products for regenerative healing, announced today that Plexur M® (moldable), a bone-polymer biocomposite built upon the Company's proprietary Plexur® technology platform, has been approved for use by 50 U.S. hospitals to date. The Company expects to receive additional approvals as Plexur M continues to gain mindshare among surgeons.

"Since the advent of the controlled release in the U.S., Plexur M has been used in a range of surgical procedures and is building a reputation as a go-to biologic for orthopedic surgeries requiring tailored solutions," said Sam Owusu-Akyaw, Osteotech's President and Chief Executive Officer. "As we have continued to communicate the differentiating advantages that Plexur M offers, we have gained mindshare among orthopedic surgeons focused on orthopedic trauma, joint replacements, and oncology-related procedures. As a result, 50 hospitals have approved Plexur M for use in surgery to date, and we expect to exit the year with a total of 75 or more hospital approvals. These approvals are driven by surgeon use of Plexur M and as our proprietary product continues to gain traction within the surgical community, we believe procedural usage and hospital approvals should continue to increase."

Plexur M is a bone-polymer composite of bioresorbable polymer and cortical bone fibers used in a variety of orthopedic procedures. One of Osteotech's proprietary biologics, Plexur M is highly differentiated from competing products by being the only radiopaque, moldable, settable and machinable bone graft implant that completely remodels into new bone. Since its launch in a controlled release in the U.S. during the second quarter of 2009, Plexur M has continued to gain traction with leading surgeons and has been recognized for its unique properties.

"Plexur M is a moldable and settable bone graft substitute, has very good handling characteristics and when it hardens, it holds its shape very well," stated David Lewallen, M.D., chair of orthopedic surgery at the Mayo Clinic in Rochester, Minnesota. "Plexur M has been very helpful in procedures involving uncontained defects where restoration of bone and avoidance of soft tissue impingement against the underlying implant is wanted. Short-term radiographic appearance is gratifying and long-term follow-up is ongoing."

Orthopedic Trauma and Joint Replacement Procedures

Since its introduction, Plexur M has received positive feedback from leading surgeons focused on trauma and reconstruction surgical procedures. Based upon its exceptional handling characteristics and its rapid incorporation with the host bone, surgeons have found Plexur M to be an ideal bone graft substitute in a variety of surgical indications.

"Plexur M's moldable and settable graft provides incredible handling, and has become very helpful for my complex revision procedures requiring grafting," said Frank Liporace, M.D., Assistant Professor of Orthopedic Surgery at the University of Medicine and Dentistry of New Jersey (UMDNJ), a Level 1 Trauma Center in Newark, New Jersey. "Plexur M conforms to even the most irregular defects and fully remodels naturally into robust bone providing excellent clinical outcomes. I have been very pleased with Plexur M's versatility and efficacy."

"I have used Plexur M in trauma over the past several months as a bone substitute for periarticular fractures, acetabular fractures and significant bone loss," stated Thomas Moore, M.D., Associate Professor Emory School of Medicine and Chief of Orthopedic Trauma at the Level 1 Trauma Center Grady Hospital in Atlanta, Georgia. "I have found its handling properties to be excellent - initial moldability and subsequent hardening - making it ideal for fractures. Unlike other bone substitutes, Plexur M can be drilled into and screws can be placed through it, important characteristics for the most common procedures that I perform."

Oncology-Related Procedures

In addition to being the only bone graft that fully remodels into host bone and that is moldable, settable, machinable and radiopaque. In as few as six weeks, Plexur M has been shown to incorporate into host bone and subsequently be replaced evenly by new bone that has a similar density to surrounding bone. Other bone graft materials are often resorbed erratically and can be mistaken for tumor recurrence on radiographs and other images. With its rapid incorporation into host bone, Plexur M looks unique on radiographs and other images and can aid surgeons in the early detection of tumor recurrences.

"In the care and treatment of bone tumors, Plexur M has exhibited easy moldability, allowing for simple application into various cavities in bone, early incorporation, and fast remodeling," added Howard Rosenthal, M.D., board certified orthopedic oncology surgeon and head of the Sarcoma Institute at Menorah Medical Center in Overland Park, Kansas. "Plexur M sets up quickly with signs of firm bone formation at the site assisting in stability and structure of the excised area. I have found that Plexur M has superior compression, torque and tensile strength compared with any other bone graft."

"We are pleased with the feedback we have received from key surgeons who are leaders within their respective specialties that highlights Plexur M's unique qualities including its ability to remodel completely into new bone," continued Mr. Owusu-Akyaw. "The feedback has also underscored Plexur M's exceptional handling characteristics that allow it to be molded to fit irregularly shaped defects, hold comminuted fractures in place when plating, maintain articular surface height as an ideal adjunct to the standard hardware and ultimately, to restore normal anatomy. These ease-of-use and efficacy characteristics make it ideal for use in correcting defects that may be large in size or oddly shaped. Based upon this feedback and the increasing number of hospitals that are approving its usage, we believe that Plexur M is well positioned to continue to capture market share in many procedures where an easily customizable biologic is needed."

SOURCE Osteotech, Inc.