SBIR/STTR Award attributes
Abstract Osteopenia is a highly common skeletal condition with accelerated loss of bone mass that leads to osteoporosisCharacterized by below normal bone mineral densityBMDosteopenia affectsmillion AmericansIf BMD loss is not mitigatedpatients become osteoporotic and are at increased risk of bone fracturesparticularly of the hip and spineSuch fractures decrease independent livingshorten life and increase morbidityClinical guidelines for treating osteopenia include both dietary modifications and high impact exerciseWhile diet and exercise are highly effective in maintaining BMDcompliance is lowThe alternative is prescribed bisphosphonateswhich effectively inhibit bone resorptionHoweverserious adverse events with prolonged use limit their use to patients with osteoporotic levels of BMDwhen their antifracture benefits considerably outweigh their potential for harmOur scientific premise is that delivering mechanical stimulation to the hips and spine via a wearable vibration device can serve as a surrogate for exercise and thusan effective non drug intervention for osteopeniaWhole body vibrationwhich is administered by standing on a vibrating platformhas demonstrated significant improvement in BMD in some casesHoweverwith substantial attenuation of vibration as it passes through the bodya high and unsafe vibration magnitude is required to elicit an improvement in hip and spine BMD in older individualsTheraNova has developed Mimetixa novel wearable vibration device designed to provide controlledsafe and therapeutic mechanical stimulation localized to the hip and spine in order to mitigate bone mass loss and fracture riskIn our clinical Phase I studieswe successfully demonstrated that Mimetix providesDelivery of consistent mechanical stimulation localized to the hips and spineEffective mitigation of bone resorptionobserved via bone turnover markersBTMsusing safe magnitudes of vibration andEnhanced potential for patient compliance based on ease of use and comfortThe goal of this proposal is to validate the efficacy of Mimetix treatment on improving bone resistance to fracturebone strengthand BMDIn Specific Aimwe will conduct aweek study withpostmenopausal patients to verify that the Mimetix device can be tuned to apply a consistent acceleration dose to each patientDuring both in clinic and at home useaccelerations will be monitored via body worn accelerometers to validate personalized device calibration for delivery of consistent levels of vibrational acceleration that are both therapeutic and safeaacross different patientsbover an extended time periodandcduring at home daily activitiesIn Specific Aimwe will conduct anmonthprospectivesingle blindedat home study to validate the efficacy of mechanical stimulation via the Mimetix device compared to a sham device inpostmenopausalosteopenic patientsEfficacy will be evaluated based onahip bone strengthbhip and spine BMD andcBTMs indicative of both bone formation and resorptionOnce completedthe results from these studies support regulatory approval and commercializationallowing Mimetix to meet the largeunmet clinical need for a simplenon invasiveeffective treatment for osteopenia Narrative Osteopenia is a highly common skeletal condition with accelerated loss of bone masswhich affects aboutmillion AmericansIf bone mass loss is not mitigatedpatients become osteoporotic with serious clinical consequences due to fractured bonesThere is a need for an effective non drug intervention to prevent early progression of bone loss prior to patients reaching an osteoporotic stateWe propose a novel wearable vibration device that is designed to provide controlledsafe and consistent mechanical stimulation to the hip and spine to mitigate bone mass loss and fracture risk
