Bioabsorbable Medical Device Design
4D’s bioabsorbable medical device designs use 4Degra© polymeric biomaterials as the basis for a new generation of implantable medical devices.
A New Approach to Bioabsorbable Medical Device Design
4D’s biomaterial science expertise and device design capabilities are powering strategic collaborations with medical device industry partners across three broad categories of bioabsorbable polymer device usage.
Utilising the unique properties of our patented 4Degra® bioabsorbable polymer, we are currently exploring new designs and manufacturing approaches for a range of medical devices.
Development Product | Bioabsorbable peripheral nerve protector for soft tissue
Introducing 4Degra® using polycarbonate-urethane chemistry
At 4D Medicine, we have perfected the transformation of our proprietary bioabsorbable material, 4Degra®, into high-performance medical-grade films and membranes. This breakthrough enables a new generation of medical devices that combine precision, versatility, and tunable degradation to meet the evolving needs of modern healthcare.
Our platform technology represents a significant step forward in biomaterials science. By engineering 4Degra® into thin, flexible formats, we unlock its potential across a wide range of clinical applications, from soft tissue support to advanced surgical interfaces. These materials are designed to integrate seamlessly with the body, providing temporary support before undergoing controlled and timely resorption.
First Product: Peripheral Nerve Protector
Our first medical device advancing toward FDA 510(k) clearance is a next-generation peripheral nerve protector. This device has been carefully engineered to address the delicate requirements of nerve repair and protection.
Key features include:
- Transparency – Allows surgeons to visually monitor the underlying nerve during and after device placement.
- Conformability – Designed to gently envelop and adapt to complex, delicate anatomical structures without causing compression or irritation.
- Tunable Resorption – Formulated to deliver effective protection during healing and to disappear when no longer needed.
Regulatory pathway for a bioabsorbable peripheral nerve protector for soft tissue
In close consultation with a leading international regulatory consultancy, we are currently taking our first product, a bioabsorbable peripheral nerve protector for soft tissue for musculoskeletal soft tissue fixation, through the U.S. FDA 510(k) regulatory pathway.
This application will facilitate a formal regulatory review of key information about the safety, biocompatibility and manufacturability of an implantable device composed of 4Degra®, creating a reference for future device regulatory applications.
This lead product is anticipated to receive FDA 510(k) clearance in early 2027 and will provide a technological, regulatory and commercial bridgehead into the musculoskeletal market.
We are excited to bring this versatile platform into the medical devices space, where its unique properties, biocompatibility, tunable resorption profiles, and mechanical adaptability, offer clear advantages over traditional materials.
This is just the beginning. Our film and membrane technology opens the door to a broad pipeline of medical devices across multiple specialties. As we continue to develop and refine our platform, we remain focused on delivering solutions that improve patient outcomes, simplify procedures, and redefine what is possible with bioabsorbable materials.
4D Medicine is committed to shaping the future of medical devices – one innovation at a time.
Design Concept | Bioabsorbable Microparticles
4Degra® unlocks the potential in medical device design and manufacture
4Degra® bioabsorbable polymer is suited to a wide range of implantable medical device applications. It is a photocurable resin that can be processed into the finished device form by 3D printing, casting or conversion into thin films, meshes or microspheres.
Softer grades of 4Degra® exhibit excellent shape memory response, making them ideally suited for the manufacture of minimally invasive surgical devices such as meshes, stents, films and soft tissue scaffolds. Harder formulations are suited to more mechanically demanding uses that include trauma fixation plates, pins, screws and load-bearing bone regeneration scaffolds.
4Degra® also has potential as a drug delivery device for a range of active pharmaceutical ingredients.
REGULATORY DISCLAIMER
The medical devices and product concepts featured on this website and in other corporate communication materials are for informational purposes only and are not currently cleared, approved, or authorized for marketing or sale in any geography or jurisdiction. Any references to potential applications or benefits are based on ongoing research and development efforts. Regulatory review and clearance or approval are required before these products can be made available for clinical use. Nothing on this site should be construed as a guarantee of future availability or regulatory clearance or approval.
Future product pipeline
In collaboration with our industry partners, 4D is exploring medical device applications for novel surgical solutions to challenging problems in high-value, high-growth segments across musculoskeletal, soft tissue and drug delivery categories.
Strategic partnerships
Alongside internal product development efforts, 4D is engaging with proven sales channel partners to explore synergistic opportunities to launch device innovations into key market segments and geographies.
If you would like to discuss future product innovations or explore new strategic partnerships, please do get in touch.