Osteopore (OSX)'s technology harnesses the body’s regenerative capacity to rebuild lost tissues, by leveraging on the natural healing process to guide the functional restoration of tissues at the defect site.
With In-Situ Tissue Engineering (ISTE), surgeons and dentists can reduce time to treatment as they are not required to extensively manipulate/culture cells and material outside of the body, unlike in-vitro tissue engineering.
Expanding Global Presence
Osteopore is approved for use across several regions and operate in over 20 countries and autonomous regions.
How do biodegradable implants work?
Osteopore's implant biodegrades (breaks down) completely over 18 to 24 months through simple hydrolysis. As tissue regeneration occurs through the natural healing process, our implant is replaced by the patient’s own tissue and bones.
Osteopore develops implants alongside leading surgeons and dentists to ensure that in-situ tissue growth is limited to the defect and occurs only in the required area and stops when the regenerative process completes.The technology meets the strict requirements of many regulatory bodies in various regions.
Osteopore is cleared by FDA (U.S.), CE Mark (European Union), TGA (Australia), HSA (Singapore), and more.
1 Predictable degradation profile
Osteopore (OSX) implant’s material provides a predictable profile throughout the entire regenerative phase.
The honeycomb microstructure allows infiltration of blood vessels and new bone formation deep within the material, not only on the surface.3 This ensures that the viable tissue is maintained throughout the scaffold volume during the regeneration phase.
Studies showed vascularization within our implants, allowing direct mineralized matrix formation in the scaffold interior.4
2 Structural properties similar to cancellous bone
The unique 3D printing technology—coupled with the choice of polycaprolactone—allows our implant to attain a structural stiffness similar to cancellous bone.5 This enables our implants to provide structural support during the regenerative phase.
3 Interconnected microstructure to facilitate regeneration
The pores in our implants are interconnected to support the regeneration process by facilitating tissue ingrowth and vascularization.6
4 Low post-operative complication rates & better outcomes
Osteopore's products have been implanted globally for more than 15 years, with no record of adverse events or serious adverse events.
Osteopore's post-marketing data have shown that post-op complication rates with our implants to be low. With no permanent foreign materials in the body, the chances for long-term complication and reoperations are reduced.7
Quality Systems
EN ISO 13485
US FDA QSR-21 CFR Part 820
SURGICAL SPECIALITY
1. Craniotomy
Osteoplug® in strip craniotomy format allows for the full restoration of patients’ skull contours in post-craniotomy procedures without cosmesis issues. The interconnected porosity of the material provides a vascular ingrowth interface to the adjacent bone.
The regenerative scaffold fully resorbs by hydrolysis in 18-24 months leaving only natural bone.
Placement is facilitated by flanges.
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.
2. Orbital Floor Reconstruction
The Osteomesh® biomimetic design structure delivers predictable bone regeneration whilst providing structural support. The resultant regenerated bone minimizes complications, such as orbit compartment syndrome of permanent implants as evidenced by a 10-year clinical series.
Osteomesh® is easy to use as it is mouldable in warm saline and shaped by surgical scissors.
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.
3. Socket Preservation
Osteoplug® is a bioresorbable implant designed with a patented interconnected porous architecture that promotes tissue and vascular ingrowth.
It is an integrating implant to preserve dental socket after tooth extraction. This device regenerate bone in the socket width and height to support the dental implant.
Design Features:
This product is available in more sizes. Please approach our local representatives for more information.
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.
4. Cranioplasty PSI
Patient Specific Implant
Our 3D printing technology enables us to build customized implants that fit patients' defects. Our implants facilitates bone growth with its microarchitecture which creates an ideal environment for natural tissue regeneration.
Bone marrow aspirate is recommended to be used together with the implant to supplement the necessary cells and growth factors. The procedure can be completed in situ within the operating room.
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.
5. Craniosynostosis
With a reliable degradation profile and compressive strength, Osteomesh® achieves excellent results in cranial remodeling.
The osteoconductive nature of Osteomesh® allows progenitors to regenerate tissues —leaving behind only bones in situ, without long-term complications.
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.
6. Guided Bone Regeneration
Osteomesh® is a semi-flexible bioresorbable mesh that provides dimensional retention and support of graft material, delivering a predictable shape and volume of regenerated bone tissue in guided bone regeneration.
The unique architecture allows for rapid saturation with marrow, blood, and nutrients, stimulating the patient's own cells with biochemical signals required for bone ingrowth and remodelling. Osteomesh® is made from polycaprolactone (PCL) which slowly resorbs into the body over 18-24 months, during which the Osteomesh® supports bone formation.
This product is available in more sizes. Please approach our local representatives for more information.
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.
7. Endoscopic Transsphenoidal Skull Base Surgery
Some types of cranial tumors may be removed via the nasal passage. Minimally invasive skull base surgery do not require access through the skull, and as a result, may result in fewer complications and faster recovery time.
The ideal implant to reconstruct cranial bone defect should easily fit through the nasal passage. Osteomesh® can easily be modified to your needs during surgery with scissors and scalpels.
The regenerative scaffold fully resorbs by hydrolysis in 18-24 months leaving only natural bone.
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.
8. Burr Hole Restoration with Shunt Drainage System
In the treatment of high intracranial pressure in hydrocephalus, shunt systems are frequently used by surgeons. Such systems often require that drains be reinserted and removed from the scalp.
To accommodate this, Osteoplug®-C has been especially developed while preventing skin depressions resulting from burr holes.
Osteoplug®-C is shown to be safe and effective in a series with up to 10 years of follow-up.
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.
9. Burr Hole Restoration after Subdural Hematoma Evacuation
Burr holes are created to drain fluid accumulated in the brain after trauma or weakened blood vessels due to ageing, some of which are covered with permanent implants. Some burr holes are not covered due to cost, extra time, and additional permanent objects in the body.
With a one-step plug, the Osteoplug® solution fits snugly into into burr holes—and does not require extra time. It is made of bioresorbable polymer that biodegrades between 18-24 months. It also facilitates natural bone healing to cover the hole permanently.
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.
10. Mandible Patient Specific Implant
Osteopore PSI for mandibular bone reconstruction is a custom-made 3D printed bone scaffold made from polycaprolactone (PCL). The implant is bioresorbable, biocompatible, and non-toxic. Osteopore 3D bone scaffold had the excellent track record in reconstruction of craniofacial & maxillofacial bone defects.
Osteopore PSI is designed alongside the patient's surgeon and modelled according to CT scans. The implant can be safely combined with biologic (synthetic, autologous) substance or material to safely regrow the patient's bones.
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.
11. Immediate Implant Loading
Advances in dental implant technology and surgical technique has resulted in high success rates for immediate implant placement procedures1. Patients can now have both teeth extraction and replacement with dental implants on the same visit2,3. However challenging indications such as buccal defects or alveolar resorption require bone grafting or regenerative techniques to deliver desired patient outcomes.4
Osteomesh® is a semi-flexible bioresorbable mesh with a bone-like microarchitecture5. It facilitates the immediate implant placement technique, even in compromised extraction sites, opening up possibilities for more complex implant surgery. Osteomesh® offers the following benefits:
This product is available in more sizes. Please approach our local representatives for more information.
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.
12. Septal Extension Grafting
The incorporation of Osteomesh strengthens the patient's septal extension graft. This scaffold is made of bioresorbable polymer that biodegrades between 18-24 months via hydrolysis.
Osteomesh provides good structural support to achieve long-term aesthetically pleasing nose reconstruction outcome.
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.
13. Critical-Sized Defect
aXOpore® Custom Made Device (CMD) is a 3D printed scaffold, made to fit bioresorbable implant used in the treatment of critical sized segmental defects.
aXOpore® is designed with a patented interconnected architecture that promotes tissue and vascular ingrowth. aXOpore®’s homogenous composite of Polycaprolactone-Tricalcium Phosphate (PCL-TCP), provides sufficient mechanical strength, is biodegradable, and provide osteoconductive properties.
This bioresorbable implant is designed alongside the patient's surgeon and modelled according to CT scans that is recommended for bone reconstruction of severely injured patients up to 20cm and compatible with fixation devices.
aXOpore® offers the following benefits:
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.
14. High Tibial Osteotomy (HTO) Wedge
PCL-TCP Regenerative Implant
aXOpore® OTO Wedge for High Tibial Osteotomy (HTO) is a 3D printed scaffold, made to fit bioresorbable implant used in conjunction with knee preservation surgeries.
aXOpore® OTO Wedge is designed with a patented interconnected architecture that promotes tissue and vascular ingrowth. aXOpore®’s homogenous composite of Polycaprolactone-Tricalcium Phosphate (PCL-TCP), provides sufficient mechanical strength, is biodegradable, osteoconductive, and supports early weight bearing.
This bioresorbable implant is recommended for Medial Opening Wedge High Tibial Osteotomy (MOWHTO). If required, aXOpore® OTO Wedge can be trimmed with a blade to ensure a proper fit and no soaking of arterial blood is required.
aXOpore® OTO Wedge offers the following benefits:
PLEASE NOTE: This product may not be approved yet in your country. Product indications may also vary from country to country. Please check with our local representatives for more information.