Osteocrete Technology
The magnesium based Bone Solutions Technology, with OsteoCrete™ as its first planned product, has been commercially proven in two other industries. Bindan Corp, co-owned by President Tom Lally, has successfully deployed a related magnesium oriented technology to the fiberboard and transportation road repair industry where its binder has been found to be a superior fire-proof resistant element and a binder for road repair than any product in that industry.
The core patent for the BSI technology which describes its multiple claims is being planned for multiple medical applications on approval by the FDA.
OsteoCrete™ Bone Void Filler
OsteoCrete is a biologic, biocompatible magnesium based bone void filler which is both injectable and moldable. Key components of the OsteoCrete powder include Magnesium Oxide, Monopotassium Phosphate, Monosodium Phosphate, small amounts of Tricalcuim phosphate, and other ingredients. When mixed with a modified saline solution it forms a Magnesium Potassium Phosphate.
The above pictured kit will be available on FDA approval in a 5 cc pack, 10 cc pack, and a 15 cc pack. This package, on FDA approval, of OsteoCrete powder will be part of a sterile kit in a sealed preformed tray. The kit will include the following sterilized items: 1 heat sealed foil pouch of OsteoCrete™ powder-(varies depending on size of pouch ordered); 1 vial modified saline solution provided by Baxter and is USP certified (vial contents volume dependent on kit ordered); 1 plastic mixing bowl and mixing spatula, medical grade; 1 12 gauge dispensing needle, stainless steel, BD; 1 20 ml dispensing syringe, medical grade; 1 flexible dispensing PVC tube for 20 ml syringe, medical grade (2 inches in length); 1 Product insert; 1 copy mixing instructions.
OsteoCrete™ does not require any special mixing equipment and it is simple to use. Mixing should be done at room temperature. First, the vial of saline solution is opened and all contents poured into the mixing bowl. Then the full contents of the OsteoCrete™ pouch are poured into the mixing bowl. Stirring vigorously for two minutes triggers the activation of the compound in its slurry mode and the OsteoCrete™ is now ready for use. The plan is that if the physician seeks to dispense by injection, the applicant can draw the slurry into the syringe without the needle attached.
The mixture has a set time is basically 10-15 minutes. To dispense as a moldable product, OsteoCrete™ can remain in the mixing bowl, be stirred as desired and applied directly to a surface with the spatula or other surgical instrument.
OsteoCrete™ will progress through phases of increased consistency, until hardening at approximately 10 minutes. Conditions of greater ambient temperature, stirring, molding, or mass will have a shorter set time.
The Solution is bio-absorbable, non-toxic, and given its slight expansion on injection which help in its compressive strength levels, could also be used to potentially augment, on separate FDA approval, the screws and other fasteners often used in knee, leg and shoulder surgery, and polymethylmethacrylate cements. Often these fasteners are not biodegradable.
Since the Solution is also Ph neutral, it may also be a candidate on FDA separate approval to act as a delivery system for stem cells, growth hormones, protein and other biologics. The key initial focus of Bone Solutions is to commercialize the bone technology application as a bone void filler following FDA approval, currently under review.