The U.S. Food and Drug Administration (FDA) has approved a new clinical trial for testing a unique bone adhesive, designed to surgically join bones. The study will be performed by RevBio, a Boston-based biotech firm, and will utilise their patented product, Tetranite. The product aims to provide an alternative to the traditional metal plates and screws used in cranial surgeries to reconnect skull pieces following brain procedures. This innovative adhesive not only encourages new bone growth, but is also self-setting and injectable, potentially enhancing cranial surgery techniques. This advancement is in line with recent innovation in cranioplasty, where 3D printing is increasingly used for creating custom fitted implants and models for cranial reconstruction, optimizing surgery precision and outcomes.
The trial will be lead by neurosurgeons Timothy Smith and Madison Michael and will involve 20 patients to validate Tetranite’s safety and effectiveness in rejoining skull fragments post brain surgery. This significant step follows successful preliminary medical evaluations and extensive lab research by RevBio. Both Smith and Michael contribute extensive neurosurgery experience to the trial. Smith is a noted figure at Brigham and Women’s Hospital and Brigham and Women’s Faulkner Hospital in Massachusetts and also an Associate Professor of Neurosurgery at Harvard Medical School. Michael, an expert at Semmes-Murphey Clinic, serves as Professor and Program Director at University of Tennessee. His expertise includes skull base surgery, brain tumors, microvascular compression syndromes, and endoscopic surgery, further enriching the knowledge and experience driving this revolutionary study.
Surgical breakthrough
A craniotomy, an essential surgical procedure for treating brain tumors, aneurysms, and other inner-cranial conditions, necessitates the removal of a section of the skull known as the cranial flap. In traditional post-operation, this flap is attached again using metal hardware like plates and screws. But this approach has its limitations including, the potential for infections, particularly cerebrospinal fluid (CSF) leaks, which could result in severe complications like meningitis, subdural empyema, or cerebral abscesses.
RevBio discusses that existing complications are worsened by the conventional method’s inability to adequately seal the kerf line – a gap created by surgical instruments. The presence of this gap can invite infections and deter the natural merging of the cranial flap with the nearby bone. The usage of metallic hardware often requires additional surgeries to fix problems associated with pain and the protrusion of the hardware.
Tetranite envisions a desirable solution to these issues. It aims to substitute absent bone, safeguard the surgical site from infections, and stimulate osteogenesis – the creation of new bone. As time passes, Tetranite is absorbed and replaced by organic bone, as shown in RevBio’s pre-clinical trials. Its capacity to provide a biological bond between the edges of the bone flap and the skull, while also serving as a scaffold for bone regrowth, signifies a substantial improvement over existing methods.
Objectives in Clinical Trials
“Our intention is to assess the effectiveness of a product that could offer instant, solid fixation, which would be a preferable alternative to the current standard treatment — plates and screws,” Smith stated. “We are thrilled by the likelihood that this product could foster a biological connection between the edges of the bone flap and the skull, as well as a structure for osteogenesis over time. We eagerly await the outcomes of the clinical trials.”
Brian Hess, CEO and Founder of RevBio, expresses his hope for Tetranite to become the new standard in cranial flap fixation due to multiple advantages over traditional approaches.
RevBio has recently received a grant of $3.4 million from the National Institutes of Health (NIH) for further development of Tetranite in treating complex fractures. This grant is set to bolster the company’s research until the completion of clinical trials. Previous studies, including one involving sheep to evaluate the safety and efficiency of Tetranite in a wedge osteotomy fracture model in the distal femur, have displayed encouraging results. The investigations show that Tetranite not only provides immediate load sharing between bone and metallic hardware but also advances healing and minimizes the risk of hardware failure and delayed healing.
RevBio carried out a sheep study of Tetranite with the help of a wedge osteotomy fracture model in the distal femur. (Business Wire)
“Our pre-clinical studies have indicated that Tetranite can effectively redistribute most of the load from plates and screws, thus reducing the risk of hardware failure and delayed healing,” commented Brittany McDonough, RevBio’s R&D Program Manager who has led the development of the fracture fixation product. “Along with redistributing the load, the adhesive material offers a resorbable framework for bone regeneration which promotes faster recovery following a traumatic injury.”
Patient benefits
3D printing has become an ideal tool in cranioplasty, particularly at leading medical institutions where it’s used for creating patient-specific implants and surgical models. For example, the Mayo Clinic has employed 3D printing to manufacture custom cranial implants, enabling a more precise fit and better aesthetic outcomes. These implants are tailored to the exact dimensions of a patient’s skull defect.
Similarly, the University of Michigan‘s medical center reported a groundbreaking case where they employed 3D printing for a complex cranial reconstruction. The patient, suffering from a significant cranial defect, received a 3D printed implant that was designed based on their CT scans. This approach not only reduced the surgical time but also significantly improved the recovery process, setting a new standard for such procedures.
These real-world applications of 3D printing in cranioplasty not only highlight the technology’s transformative impact on neurosurgery but also pave the way for integrating innovative solutions like RevBio’s Tetranite. By combining the precision and customization offered by 3D printing with the advanced properties of Tetranite, the future of surgical healthcare looks super efficient and patient-centric. This synergy between cutting-edge 3D printing techniques and new biomaterials like Tetranite could set a new standard in cranial reconstruction, offering more effective, less invasive, and faster-healing surgical options. As the medical field continues to evolve, these advancements are poised to become the norm, dramatically enhancing patient outcomes and redefining the possibilities in neurosurgery.
As the clinical trial proceeds, RevBio stands at the forefront of a significant transition in medical technology, particularly in cranial and orthopedic surgery. Like with 3D printing, the success of Tetranite in this trial could not only improve patient outcomes but also potentially reduce healthcare costs associated with post-surgical complications. The broader implications for cranial surgery and beyond are substantial, as this innovative approach could redefine standards and practices in surgical procedures, enhancing patient safety and recovery.
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“Why did the 3D printer go to therapy? Because it had too many layers of unresolved issues!”
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