News & Events

8/28/09: First X-Repair surgery performed
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.

5/11/09: Publication shows effectiveness of X-Repair
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]

4/15/09: New NIH SBIR Phase I Grant Awarded
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.

3/27/09: FDA grants 510(k) clearance for X-Repair
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.

2/28/09: Presentation made at the American Shoulder and Elbow Surgeons Specialty Day meeting
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

2/25/09: Presentations made at the American Academy of Orthopaedic Surgeons annual meeting
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

2/22/09: Presentations made at the Orthopaedic Research Society annual meeting
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

4/1/08: New NIH R01 Grant Awarded
Anthony Ratcliffe was awarded a 4 year R01 research grant "Tissue Engineering TMJ Articular Fibrocartilage". This grant is a continuation of a previously awarded R01 grant, developing tissue engineered cartilages for the temporomandibular joint.

3/02/08: Presentation at the Orthopaedic Research Society annual meeting
Dr McCarron of the Department of Orthopaedic Surgery at Cleveland Clinic, together with Dr Derwin and colleagues of the Department of Bioengineering at the Cleveland Clinic Foundation, presented a paper on the ability of a Synthasome device to enhance the mechanical properties of rotator cuff repairs.

9/04/07: New NIH SBIR Phase II Grant Awarded
Synthasome was awarded a new Phase II SBIR grant "A Novel Engineered Composite Construct for Articular Cartilage Repair". This grant continues the work of the Phase I grant, performing studies to demonstrate effectiveness and safety.

6/22/06: New NIH SBIR Phase I Grant Awarded
Synthasome was awarded a new Phase I SBIR grant "A Novel Engineered Composite Construct for Articular Cartilage Repair". This grant will fund work using two novel and complementary technologies that together have the potential to provide a mechanically functional and stable repair of articular cartilage.

9/6/05: New NIH SBIR Phase II Grant Awarded
Synthasome was awarded a new Phase II SBIR grant "Cartilage-Cartilage Adhesion by Photopolymerization". This grant follows from the successful completion of the Phase I grant, and is to further develop a technology that forms covalent attachment of cartilage to cartilage, with this application being to enhance repair of articular cartilage.

5/15/2005: New NIH SBIR Phase I Grant Awarded
Synthasome was awarded a new NIH SBIR Phase I grant "Human tissue engineered matrix constructs for repair". This grant will fund work using a functional tissue engineering approach to develop constructs for enhancing surgical repair of tendons.

01/01/2005: New Army SBIR Grant Awarded
Synthasome was awarded a new Army SBIR Phase I grant "Assay System for Cartilage and Bone Regeneration". This grant will fund work toward the development of a new assay system that can assess the performance of growth factors and other agents that can affect cartilage and bone development and regeneration.

07/12/2004: New SBIR Grant Awarded
Synthasome was awarded a new NIH SBIR Phase I grant Cartilage-Cartilage Adhesion by Photpolymerization. This grant, in collaboration with Dr. Jennifer Ellisseeff at Johns Hopkins University, will fund work toward the development of a tissue glue that will bind cartilage to cartilage. The glue, using a new technology called tissue-initiated photopolymerization, will bind cartilage implanted into an articular joint for repair of the articular surface, to the surrounding patient articular cartilage, thereby stabilizing the repair and increasing the likelihood of success in the repair procedure.