Currently 23 successful surgeries by 6 different surgeons have been performed using X-Repair as an assist device for three different applications (rotator cuff tendon, Achilles tendon, quadriceps tendon). Surgeons are reporting excellent clinical outcome in all cases. Rotator cuff surgeries were performed on large or massive tears, or re-torn tendons. Six of these repairs have been assessed by ultrasound which showed no gap formation.

The R01 research grant “Tissue Engineering TMJ Articular Fibrocartilage” was renewed for year 2010.

As reported previously, Dr. John Lane of San Diego performed the first clinical surgery using X-Repair on August 28th, 2009. This arthroscopic repair of a large rotator cuff tendon re-tear (see below paragraph for more details) has reached its 6-month time point. According to Dr. Lane the patient has excellent clinical outcome to date.

Dr John Lane of San Diego performed the first clinical surgery using X-Repair, used to augment the repair of a rotator cuff tendon. The injury was a re-tear that had been repaired twice previously, and the surgery was performed arthroscopically.

Dr Kathe Derwin, Dr Joe Iannotti and colleagues published an article in the Journal of Bone and Joint Surgery showing X-Repair when used in a pre-clinical study was able to “limit but not eliminate tendon repair retraction, the augmentation device provided a tendon-bone bridge and scaffold for host tissue deposition and ingrowth, resulting in improved biomechanical function of the repair at 12 weeks.” They concluded “the augmentation device, applied in a similar manner as described in the present study, might offer a functional benefit to patients undergoing rotator cuff repair”. [JBJS 91:1159-1191, 2009]

Synthasome was awarded a new Phase I SBIR grant “A Novel Cell-Hydrogel Technology for the Repair of Fibrillated Articular Cartilage”. This grant will fund work using hydrogel adhesion technology that has the potential to provide a biologic and mechanically stable repair of fibrillated articular cartilage.

X-Repair, Synthasome’s first product, was cleared for use in:

• Reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendon;

• General surgical procedures for reinforcement of soft tissues where weakness exists.

Dr Jesse McCarron presented his work on the use of X-Repair to augment surgical repair of rotator cuff surgery in a cadaveric study.

• McCarron JA, Milks R, Iannotti J, Derwin KA. Improved time-zero biomechanical properties using PLLA graft augmentation in a cadaveric rotator cuff repair model. American Shoulder and Elbow Surgeons 2009 Open Meeting, # 4, 2009

The work presented by Dr Derwin at the Orthopaedic Research Society meeting received the Best Poster award for Shoulder and Elbow, and was therefore presented at the AAOS meeting.

• Derwin KA, Codsi M, Milks R, Baker A, McCarron J, Iannotti J. Rotator cuff repair augmentation in a canine model using a woven PLLA device. Transactions of the 55th Annual meeting of the Orthopaedic Research Society, #ORS5, 2009

• Dr Kathe Derwin and colleagues of the Cleveland Clinic presented work demonstrating the ability of X-Repair to improve outcome of rotator cuff surgery in a pre-clinical study

• Derwin KA, Codsi M, Milks R, Baker A, McCarron J, Iannotti J. Rotator cuff repair augmentation in a canine model using a woven PLLA device. Transactions of the 55th Annual meeting of the Orthopaedic Research Society, #1268, 2009 (Best Shoulder and Elbow poster award)

• Dr Andreas Kern and colleagues of Synthasome, Inc presented work describing a tissue engineered tendon equivalent, using X-Repair as the scaffold material.

• Kern A, Saed-Nejad F, Soutoudeh M, Ratcliffe A. Functional tissue engineering of a rotator cuff tendon. Transactions of the 55th Annual meeting of the Orthopaedic Research Society, #1267, 2009

• Dr Steven Arnoczky and colleagues from Michigan State University presented work describing the use of growth factor-rich plasma to enhance tendon cell proliferation on X-Repair.

• The Use of Growth Factor-Rich Plasma to Enhance Tendon Cell Proliferation on a Synthetic Polymeric Scaffold -An In Vitro Study. Visser, LC; Austin, JA; Caballero, O; Gardner, KL; +Arnoczky, SP Transactions of the 55th Annual meeting of the Orthopaedic Research Society, #1274, 2009