We design, develop, manufacture and market bioresorbable polymer implants for use in the reconstruction, repair and regeneration of hard tissue (bone) throughout the body. Additionally, we design, develop, and manufacture related instruments and accessories used in connection with our implants. Our bioresorbable implants are used in spine, orthopedic, neurosurgical, and other musculoskeletal reconstructive surgical applications.
Our bioresorbable implants are made from a polylactide copolymer composed of lactic acid similar to that, which occurs naturally in the human body. The polymer implant maintains its strength during the healing process, while slowly breaking down in the body through hydrolysis. The polymer fragments into single lactic acid molecules. The lactic acid molecules are then metabolized by the liver into carbon dioxide and water, and released from the body through the lungs.
We believe the benefits of using a bioresorbable material in bone healing and regenerating applications include:
A. no long-term growth restrictions such as those related to the use of metallic plates and screws in pediatric patients
B. no distortion of diagnostic and therapeutic imaging and no creation of imaging artifacts such as are commonly encountered with metal systems
C. no long-term patient palpation
D. no interference with x-rays
E. virtually eliminates thermal sensitivity from temperature changes
F. reduced risk of migration of plates and screws during the bone healing process
G. lowered risk of infection
H. strength appropriate for specific applications
I. predictable resorption rate
J. avoids risk of disease transmission associated with human or animal materials
K. may eliminate additional surgery to remove non-bioresorbable implants
L. encouragement of normal bone growth and increased strength of regenerated bone compared to non-bioresorbable products, particularly metal, that may shield the bone from the stress that facilitates bone growth and bone strength
In addition, because of the thermoplastic properties, bioresorbable products can be easily shaped, sized and applied to varying anatomical structures. We believe this ease-or-use along with the versatility capabilities allows the surgeon to save time in the operating room.
We have received regulatory clearance or approval to market and sell some of our bioresorbable implant products in the United States. We are in process entering into an exclusive worldwide Distribution agreement with a European medical device for the global marketing and distribution of number of our products for use in CMF, hand and foot applications.
We have developed and obtained clearance from FDA in the United States for plate, screw and tag system implants for craniomaxillofacial clinic application and bioresorbable pin for trauma clinical application.
Building on our initial biomaterials platform technology, we are in process of developing families of three patented bioresorbable surgical riveting system. These products are constructed from the same polylactide copolymer as our other implants. Our bioresorbable riveting system have present and potential clinical applications across multiple surgical specialties in which the primary intended market includes attaching bone plates or soft tissues to the bone. We have not yet obtained clearance for these indications in the United States. We have patent pending for two diffrent designs of bioresorbable cages and an artificial spinal disk with unique locking mechanism for spine surgery applications.