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