Phase II Amount
$1,500,000
Peripheral arterial disease (PAD) is a highly prevalent condition that is growing rapidly due to shiftingdemographics, affecting 202M people worldwide and 18M in the USA, with an annual growth rate of 6.8%.Approximately one-third of PAD patients experience lower extremity pain that limits activity, and one-third ofthese patients suffer from critical limb ischemia (CLI), which lacks any effective treatment option and isassociated with devastating complications including resting pain, skin ulcers, and gangrene, with 30% ofpatients requiring amputation and a mortality rate of 25% within 1 year post diagnosis. Invasive surgical orcatheter-based treatments are ineffective in CLI and associated with complications and up to 40% rate of long-term restenosis. Acoustic energy modalities have been shown to promote collateral vessel growth, angiogenesis, and toimprove perfusion in animal models of coronary artery disease (CAD) and PAD, with promising early humandata in both disease processes. Vibrato Medical has developed a groundbreaking new treatment with the firstwearable therapeutic ultrasound (TUS) device for the non-invasive, outpatient treatment of PAD that promotescollateral vessel growth and angiogenesis, and restores perfusion. The VibratoSleeve is a disruptive,paradigm-shifting device that will fundamentally alter the PAD/CLI landscape with a non-invasive,wearable, outpatient treatment (1-8 hours during rest or sleep) that will prevent amputations,hospitalizations and other complications of advanced PAD. We have already demonstratedVibratoSleeve's efficacy in markedly improving lower extremity perfusion in healthy volunteers using multipleperfusion measures. The goal of this NIH Phase II SBIR proposal is to perform a pilot randomized, sham-controlled clinicaltrial of the VibratoSleeve in 24 PAD patients with CLI, then build a 2nd generation device with which to obtain510(k) clearance. In Aim 1, Vibrato will build a 16-channel generator with integrated patient interface unit thatwill power the wearable VibratoSleeve array that was designed and built in Phase 1. Six total systems will bebuilt, and undergo verification and validation for clinical trial readiness. In Aim 2, Vibrato will conduct a double-blinded, randomized, sham-controlled clinical trial of 24 patients (Rutherford Class 3-5 with infra-popliteal PADand no revascularization options) with Dr. Mahmood Razavi at Vascular and Interventional Specialists ofOrange County. In Aim 3, Based on the efficacy, safety and patient feedback data from Aim 2, Vibrato will thendevelop its 2nd generation commercial VibratoSleeve and its entirely portable generator, such that the entiredevice will be wearable. With all our testing and clinical study done, Vibrato will apply for US FDA 510(k) clearance of theproduct as well as CE approval for European distribution.
Public Health Relevance Statement: Project Narrative Peripheral arterial disease (PAD) affects 202M people worldwide and 18M in the US, and is growing rapidly at a rate of 6.8%. Current PAD therapies have limited efficacy, and 250K patients per year in the US progress to critical limb ischemia (CLI), with resting pain, skin ulcers, gangrene, often requiring amputation or resulting in death. Based upon recent studies demonstrating that therapeutic ultrasound (TUS) is effective in promoting collateral vessel growth and angiogenesis and improving perfusion, Vibrato Medical has developed a disruptive, paradigm-shifting PAD treatment with the first wearable device for non- invasive, outpatient use (for 1-8 hours during rest or sleep) in order to improve symptoms and reduce amputations in PAD patients without other treatment options.
Project Terms: Accreditation ; Acoustics ; Acoustic ; Adoption ; Affect ; Ambulatory Care ; Outpatient Care ; outpatient treatment ; Amputation ; Ankle ; Regio tarsalis ; Tarsal Bone ; Tarsus ; Blood Vessels ; vascular ; Clinical Research ; Clinical Study ; Clinical Trials ; Controlled Clinical Trials ; Coronary Arteriosclerosis ; Coronary Artery Disease ; Coronary Artery Disorder ; Coronary Atherosclerosis ; atherosclerotic coronary disease ; coronary arterial disease ; Cessation of life ; Death ; Diagnosis ; Disease ; Disorder ; Double-Blind Method ; Double-Blind Study ; Double-Blinded ; Double-Masked Method ; Double-Masked Study ; Electromagnetics ; Engineering ; Feedback ; Gangrene ; Goals ; Growth ; Generalized Growth ; Tissue Growth ; ontogeny ; Hand ; Health Personnel ; Health Care Providers ; Healthcare Providers ; Healthcare worker ; health care personnel ; health care worker ; health provider ; health workforce ; healthcare personnel ; medical personnel ; treatment provider ; Hospitalization ; Hospital Admission ; Human ; Modern Man ; indexing ; Laboratories ; Lower Extremity ; Lower Limb ; Membrum inferius ; Methods ; mortality ; United States National Institutes of Health ; NIH ; National Institutes of Health ; Optics ; optical ; Outpatients ; Out-patients ; Pain ; Painful ; Patients ; Perfusion ; Pilot Projects ; pilot study ; Rest ; Safety ; skin ulcer ; ulcerative wounds ; Sleep ; Testing ; Toes ; Transducers ; Ultrasonography ; Echography ; Echotomography ; Medical Ultrasound ; Ultrasonic Imaging ; Ultrasonogram ; Ultrasound Diagnosis ; Ultrasound Medical Imaging ; Ultrasound Test ; diagnostic ultrasound ; sonogram ; sonography ; sound measurement ; ultrasound ; ultrasound imaging ; ultrasound scanning ; Vasodilation ; Vasodilatation ; Vasorelaxation ; County ; Generations ; Measures ; Catheters ; Specialist ; base ; improved ; Clinical ; Phase ; Medical ; Training ; European ; Therapeutic ; angiogenesis ; restenosis ; Hour ; Protocol ; Protocols documentation ; therapy duration ; System ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; experience ; human data ; Performance ; Animal Models and Related Studies ; model of animal ; model organism ; Animal Model ; Modality ; Devices ; Reporting ; performance tests ; portability ; Adverse Experience ; Adverse event ; Intervention Strategies ; interventional strategy ; Intervention ; patient safety ; Oranges ; preventing ; prevent ; Address ; Data ; randomisation ; randomization ; randomly assigned ; Randomized ; Enrollment ; enroll ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Validation ; Monitor ; Process ; Peripheral arterial disease ; peripheral artery disease ; Output ; design ; designing ; clinical efficacy ; clinical research site ; clinical site ; clinical effect ; novel therapeutics ; new drug treatments ; new drugs ; new therapeutics ; new therapy ; next generation therapeutics ; novel drug treatments ; novel drugs ; novel therapy ; healthy volunteer ; demographics ; commercialization ; symptomatic improvement ; improve symptom ; symptom improvement ; effective therapy ; effective treatment ; verification and validation ; ineffective therapies ; ineffective treatment ; wearable device ; wearable electronics ; wearable technology ; placebo group ; sham group ; primary endpoint ; primary end point ; critical limb Ischemia ; clinical trial readiness ; Home ;
