Formation and Structural Property Relationships of a Tetracalcium Phosphate Bone Adhesive Biomaterial

Project Abstract Approximatelyof all fractures occur in the small bones of the wristshands and feetamounting to more thanmillion annuallyConsidering functional losses associated with the locations of these injuriesproper reduction and fixation is critical to ensure optimal rehabilitation and recoveryComplex injuries that include irreducible fractures or segmental bone loss require operative fixationIf improperly treatedthese can lead to deformitiessoft tissue damagechronic painand functional lossLaunchPad Medical is an early stage medical device company that was established to commercialize a novel bone adhesivecalled Tetranitethat is based on a synthetictetracalcium phosphate based biomaterialThe material is injectableself settingand adhesive both to bone and metal surfaces with load bearing strengthOver timethe material is bioresorbale and gradually replaced with new bone without losing structural strength or volumeCurrent orthopedic bone cements lack the combination of such properties andfor that reasonsurgeons today rely on implantable fixation devices typically composed of metal in the form of platesscrewswiresand intramedullary nailsDespite specific design efforts to reduce the size of these devices for use in small bonesmany still cause adjacent tissue damagei etendon and nerveand can sometimes result in adhesions and scarringrequiring revision surgeriesFurthermorea single fracture often requires several of these devices to meet the needs of the fracture geometry without limiting mobility and functionleading to high procedural costsIn addition to direct coststhe nature of these injuries can result in indirect costs from temporary or permanent disability and loss of productivityThe economic burden of hand and foot fractures in the US is estimated to be $ B and $M annuallyrespectivelyThough physicians have explored alternative options including various forms of bone cements for fracture fixationcurrent materials fall short of the necessary mechanical strength to stabilize bone and lack sufficient adhesion at the bone implant interface to serve as reliable fixation devicesConsequentlythere remains a need and commercial opportunity for a minimally invasiveload bearingbioresorbaleand versatile adhesive solution that can meet the anatomicalmechanicaland regenerative requirements for small bone fracture reduction and internal fixationThe aim of the Phase I STTR project is to characterize the formation and structural property relationship of this self setting bone adhesive biomaterialThe funds gained from this STTR grant will be used tooptimize the adhesive properties of Tetranite to meet the clinically relevant mechanical requirements for small bone fixationverify the mechanical properties and test the phase evolution of Tetranite compositions after incubation in a simulated physiological environmentThe learnings from this grant will help the company move the optimal formulation into translational animal studies for small fragment fracture fixation Project Narrative Despite the discovery and early development of a novel bone adhesive that can adhere fractured bone togetherthere remain many questions about the formation and structural property relationship of this self setting materialA better understanding of the material is key to optimizing the formulation for clinical applicationssuch as small fragment fracture fixationIn today s worldsurgical interventions to treat opencomminuted fractures utilize fixation implantstypically in the form of metal platesscrewsrodsand nailsThese devices require invasive procedures to reduce and stabilize the fracturesOftenthe placement of such devices can lead to insufficent stabilization and surrounding damage to tendons and nervesrendering the patient with pain and a functional deficitoften necitating revision surgeryThe impact to society is burdensome as patients suffer a drop in their quality of life and often lost wagesThe development of a injectable adhesive that could be adminstrered through less invasive approaches to augment or replace conventional metal fixation devices could prove to be a major step forward in the treatment of bone fractures