AlloWide Buffer
Advanced Bone Graft Hydration Solution (Pending Regulatory Approval)
Overvie
AlloWide Buffer
is a novel chemical buffer solution designed to rehydrate and enhance bone allografts (donated bone grafts) prior to transplantation. This product replaces the traditional saline soak in the operating room with a scientifically formulated buffer that supercharges the graft with regenerative potential. AlloWide Buffer is the result of years of R&D and addresses a critical gap in graft preparation: it not only hydrates the tissue but also actively enhances its healing properties.
The Problem with Traditional Methods
Currently, bone allografts are cleaned and processed using harsh chemicals to ensure safety. Unfortunately, this process, while necessary, strips away natural proteins, weakens the graft’s microstructure, and can leave behind chemical residues. Before use, grafts are typically rehydrated in sterile saline or blood, which does nothing to restore what was lost. The outcome is a “clean but passive” graft that may be slow to integrate, leading to prolonged healing times for patients. In complex surgeries – for example, a child needing a bone graft after an accident – waiting months for the graft to heal can mean pain, immobility, and uncertainty. We have long accepted these limitations as the norm, but AlloWide Health knew it could be better.
How AlloWide Buffer Works
We developed AlloWide Buffer to work at the final step of graft preparation. Just before implantation, the donor bone graft is soaked in our buffer (the same way saline would be used). In that single simple step, AlloWide Buffer:
-
Neutralizes Residual Chemicals:
-
It immediately buffers and neutralizes any leftover processing agents (like peroxides or solvents) on the graft. By doing so, it removes barriers to healing and creates a friendlier surface for the patient’s cells.
-
Restores Microstructure:
-
The buffer’s proprietary formulation helps re-expand and preserve the natural collagen matrix of the bone. This gives the graft a surface that is closer to natural bone, with microporosity and proteins that cells can recognize. Instead of a smooth, improper surface, the treated graft has a proper surface.
-
Enhances Cell Attachment:
-
With the improved surface, the patient’s bone cells can more easily attach and migrate into the graft. In vitro tests show that cells readily adhere and spread on a buffer-treated graft, whereas untreated grafts see minimal cell attachment. This cell-friendly environment is key to kicking off the healing process.
-
Promotes Early Bone Formation:
-
AlloWide Buffer contains ions and factors that stimulate early bone mineralization. Lab studies demonstrated the presence of calcium deposits (Alizarin Red staining) on buffer-treated grafts – a sign of early bone formation – while grafts hydrated in saline showed little to no such activity. By jump-starting the bone regeneration process, our buffer helps the graft become fully incorporated into the patient’s skeleton faster.
-
Maintains Graft Integrity:
-
Importantly, AlloWide Buffer achieves all this without compromising the graft’s mechanical strength or safety. The buffer is gently formulated to protect the tissue’s integrity while maximizing its biological potential.
Benefits for Surgeons and Patients
-
Faster Healing:
-
An allograft prepared with AlloWide Buffer is primed to heal. Patients may experience significantly reduced healing times, allowing them to bear weight, rehabilitate, or return to daily activities sooner than with a standard graft.
-
Greater Success in Complex Cases:
-
For challenging reconstructions (multi-level spinal fusions, large bone defects, etc.), using AlloWide Buffer can mean the difference between a graft that slowly “takes” and one that robustly integrates. Early bone growth and stability reduce the chances of non-union or graft failure.
-
Reduced Pain and Inflammation:
-
By removing irritant residues and expediting integration, our buffer can help lessen the inflammatory response after surgery. Patients often have less post-operative pain and swelling when the graft cooperates with the body’s healing processes.
-
Cost Savings:
-
Faster recoveries and fewer complications translate to cost savings for the healthcare system. Shorter hospital stays, reduced need for revision surgeries, and quicker return to work for patients are economic benefits that add up, especially at scale.
-
No Change in Technique:
-
From a surgical workflow perspective, adopting AlloWide Buffer is easy. It does not require new instruments or complicated procedures – simply use our buffer instead of saline during graft rehydration. We provide clear instructions, and our team offers full support to ensure a smooth integration into operating room protocols.
Safety and Regulatory Status
AlloWide Buffer is composed of biocompatible ingredients that have a proven track record in medicine. Each component is selected from substances approved by regulatory authorities (e.g. FDA) for clinical use in other contexts, ensuring a high safety profile. Our buffer is sterile, endotoxin-tested, and produced under strict quality control standards (compliant with ISO 13485 for medical devices). We are currently working with Health Canada and the U.S. FDA to obtain the necessary clearances for AlloWide Buffer. Regulatory submissions are underway in 2025, and we anticipate making AlloWide Buffer available to tissue banks, hospitals, and surgical centers in Canada and the U.S. by early 2026 (pending approvals). We are committed to meeting or exceeding all regulatory requirements so that clinicians can have full confidence in our product upon its release.
Usages:
Upon approvals, AlloWide Buffer is intended for use with a wide range of orthopedic and dental allograft types. Whether it’s a cortical bone segment for a trauma repair, cancellous bone chips for a spinal fusion, or a demineralized bone matrix used in a dental implant procedure, our buffer can enhance the graft’s performance. It is suitable for:
-
Orthopedic Surgery:
-
e.g. long bone grafts in fracture repair, joint fusion procedures, bone void fillers.
-
Spinal Surgery:
-
e.g. intervertebral body fusions, where better graft integration can improve fusion rates.
-
Dental and Craniofacial Surgery:
-
e.g. socket preservation grafts, sinus lifts, mandibular reconstructions – areas where quicker bone fill means faster implant placement and recovery.
-
Sports Medicine:
-
e.g. ligament reconstruction with bone plugs, meniscal grafts – a bioactivated graft can integrate and heal more reliably in high-demand patients.
-
Biotech and Tissue Banks:
-
AlloWide Buffer can be used by tissue banks as part of their allograft processing workflow, adding value to their graft products. By pre-treating grafts with our buffer (or providing it to end-users), banks can differentiate their offerings with a graft that promotes better outcomes.