Promising results: P3D Bone ― A natural and bone-forming implant
Good preclinical proof from laboratory testing, cell culture, and five separate animal trials (three in mice and two in pigs) shows that the P3D Bone implants perform as well as predicted. Specifically, the results demonstrate that the P3D Bone implants:
- Are mechanically strong
- Are free from contaminants
- Support a rapid formation of new vascularized bone
- Integrate with neighboring bone in vivo
The two pig trials were conducted in order to test the implant material in an animal close to human size. The first trial involved six pigs, each of which received a mandibular resection in the body of the jaw beneath the teeth, and a P3D Bone was 3D printed for each pig.
Then, in the second pig trial, eight pigs received surgically created voids on each side of the angle of the mandible. Here, all eight pigs received a P3D Bone, and half received either a predicate competitor product or a negative control (unfilled void). Early observations indicate a positive result in line with previous data. Based on the CT scan, M.D. Torben Thygesen concludes:
“All P3D implants showed a nice integration especially medially and laterally, with minor gapping in the junction between implant and native bone. From the current data P3D implants performed equally or even better in some cases when compared to the control implants. Preliminary analysis suggests a higher porosity of the implant perimeter, which would probably aid in the further integration in the junctions between native bone and implant, when compared to a dense shallow in the current P3D implants. No implants were lost during the trial. Further histological analysis is needed to confirm the initial findings.”
The full results supported by histology data are scheduled for publication in 2021.
Drug releasing bone implants
Particle3D’s laboratory testing has also shown that pharmaceuticals — including antibiotics, chemotherapy or growth factors — can be released from implants to kill bacteria or cancer cells, or stimulate faster bone growth, respectively, in the vicinity of the implants.
Tests have shown that the resorption speed and release rate of the pharmaceutical can be controlled by varying the fatty acid tail length. This allows for a local, long-term and controlled release of one or more additives from the bone implant. The P3D Bone can maintain a desired concentration and thereby maintain a level in the middle of the therapeutic window for long periods of time without reaching a toxic level or dropping below the minimum effective level as shown in the figure below.
If you are interested in learning more about the potential of P3D Bone as controlled release drug depots, these results have been published in the peer-reviewed paper Composites of fatty acids and ceramic powders are versatile biomaterials for personalized implants and controlled release of pharmaceuticals.