USC Coulter Translational Research Partnership Program

Medical Devices

BaroFlex, Inc.- Non-invasive Control of Hypertension
(J. Yen, PhD & M. Nadim, PhD)

Clinical Need: Non-invasive treatment of drug refractory hypertension
Current Standard of Care: Implantable & ablative devices target vascular control elements (renal artery nerves or baroreceptors)
Technology Solution: Wearable, ultrasound-based device that modulates the baroreceptor complex & controls blood pressure
Project Status: Early prototypes built focus ultrasound energy on 1cm3
Completed pre-clinical pilot and successfully demonstrated ability of ultrasound energy to lower blood pressure

Fluid Synchrony – Wireless-controlled micropumps for chronotherapies, including CNS chemo
(E. Meng, PhD & H. Tran, MD)

Clinical Need: Maintaining effective drug concentration in the CNS over meaningful time periods to treat leptomenigeal metastases (LM)
Current Standard of Care: Systemic and/or IT bolus administration of drugs
Technology Solution: Implantable pump for metronomic drug infusion to CNS
Project Status:

  • Testing prototype in pre-clinical models
  • Developing clinical prototypes

Company Website: Fluid Synchrony

 Micropacemaker for Complete Heart Block & Adult Micropacemaker
(R. Chmait, MD; Y. Bar-Cohen; & G.Loeb, MD)

Clinical Need: Complete electrical heart block in fetuses
Current Standard of Care: No interventions currently available; often fatal
Technology Solution: In utero implantation of novel micropacemaker device to pace fetal heart long enough to allow delivery
Project Status: Developed prototype and currently testing in pre-clinical models
Exploring Applications for adult micropacemaker platform of percutaneous implantation

Platinum Group Coatings – Highly Efficient Biological Electrodes for Deep Brain Stimulation
(J. Weiland, PhD & M. Liker, MD)

Clinical Need: Deep brain stimulators (DBS) are large, costly, inefficient and limited lifetime
Current Standard of Care: DBS implants for chronic management of neurological diseases
Technology Solution: Novel electrode coating reduces size and costs while improving power efficiency and efficacy. Broad applications for any implantable electrode
Project Status: Prototype electrodes bench-top testing
Pursuing in vivo studies of efficacy and biocompatibility with industry partners
Company Website: Platinum Group Coatings

Antimicrobial Coating Technology QAtheter: QAC-Integrated Urinary Catheter
(P. Holtom, PhD & M. Humayun, MD, PhD)

Clinical Need: Catheter-associated urinary tract infections (UTIs) account for ~30% of hospital-acquired infections (HAIs)
Current Standard of Care: Few prophylactic measures are taken to prevent UTIs caused by urological catheters
Technology Solution: Novel, antibacterial surface coating technology with broad-spectrum bactericidal activity, long activity lifetime, at low cost
Project Status:

  • Demonstrated ability to reproducibly prepare QAC coatings on catheter material(s)
  • Demonstrated benchtop bactericidal activity
  • Pursing in vivo biocompatibility testing

Self-Aware Hydrocephalus Shunts: Senseer, LLC
(E. Meng, PhD, G. McComb, MD & M. Krieger, MD)

Clinical Need: Rapid, accurate detection of CSF shunt failure to initiate timely intervention and avoid prolonged suffering in hydrocephalus patients
Current Standard of Care: Invasive lumbar puncture and costly medical imaging to verify CSF shunt failure
Technology Solution: Wireless-operated multi-sensor module to remotely monitor physiological parameters real-time
Project Status: Prototype sensors with bench-top testing demonstrating shunt obstruction monitoring
Initiating clinical study with sensor module integrated into external CSF drainage shunt

CleftCorrect: SWIFT Health Systems, Inc InBrace
(B. Khoshnevis, PhD & S. Yen, MD)


Clinical Need: Effective, hygienic, aesthetic, and easier to use device for cleft palate corrections that is widely accessible for doctors
Current Standard of Care: Standard orthodontic and orthopedic movements requiring highly specialized training to perform.
Technology Solution: Novel “behind the teeth” comfort braces integrated with expander bars based on shape memory wire technology, computer programming and advanced robotics to achieve desired movements, and to reduce doctor interventions and training.
Project Status:

  • Human proof-of-concept trials completed (2015)
  • Beta trials with Schulman Study Group (top orthodontic practices in the US)

Company Website: InBrace

RESPivice– Technology Enabling Objective Management of CCU Patients on Mechanical Ventilation<
(Yan Liu, PhD, Robinder Khemani, MD)


Clinical Need: A non-invasive device that monitors breathing can significantly reduce cost of problems due to prolonged intubation and extubation failure (~$3B).
Current Standard of Care: Need for extubation and therapies post-extubation are decided by clinicians.
Technology Solution: RESPivice non-invasively provides objective, accurate, & reproducible measures to determine when patients are ready to have the ventilator turned down, be extubated, or when they’ve developed a serious complication that requires an intervention.

  • Project Status: Prototype and algorithms for objective measure of breathing being clinically validated. ~400 children enrolled in clinical study at CHLA. Conducting diligence with ventilator companies

Company Website: TBD

Therapeutics

Auxomel: Chitosan Amelogenin-based Hydrogel for Regrowth of Tooth Enamel
(J. Oldak, PhD & J.H. Phark, DDS)


Clinical Need: Effective repair of white spot and erosive lesions in teeth to preserve healthy tooth structure
Current Standard of Care: Re-mineralization approaches such as fluoride can promote re-mineralization but do not rebuild enamel with robust attachment and with effective anti-microbial properties
Technology Solution: Biomimetic enamel reconstruction formulation that effectively rebuilds enamel that robustly mimics the natural structure of tooth enamel
Project Status:

  • Ex vivo demonstration of the ability of the formulation to effectively rebuild enamel under simulated oral conditions
  • Clinical study in planning stages

CaliVive, Inc. – NutraceptTM for Improved Weight Management and Glucose Control
(E. Beale, MD & T. Williams, PhD)

Clinical Need: Non-invasive treatment for diabetes and obesity that mimics the beneficial hormonal effects of bariatric surgery
Current Standard of Care: Invasive, permanent bariatric surgery for which patient eligibility is very limited
Technology Solution: Oral delivery of GRAS stimulus that bypasses the foregut and induces hormonal spike (GLP-1 and PYY)
Project Status:

  • Clinical study demonstrated beneficial hormonal effects similar to bariatric surgery acutely
  • Clinical study demonstrated hormonal effect translates into improved glucose control/weight management over time
  • Pilot oral formulation currently being tested

Company Website: CaliVive, Inc.

TESI Kit to Support Intestinal Tissue Regeneration
(T. Grikscheit, MD)

Clinical Need: Necrotizing enterocolitis (NEC) in premature infants; small intestine replacement
Current Standard of Care: Surgical removal of necrotized tissue with lifelong management of nutritional insufficiencies (transplant and/or arterial line feeding)
Technology Solution: Device-based kit for processing salvaged small intestinal tissue during surgery to create bowel segments for implantation
Project Status: Proof-of-concept obtained in non-clinical models
Pursuing pediatric scalability in non-clinical studies

Implantable Smooth Muscle Pacemaker
(S. Yamashiro, PhD & E. Soffer, MD)(T. Grikscheit, MD)


Clinical Need: Effective and long-lasting Implantable electrical nerve stimulators improve sphincter closure for GERD.
Current Standard of Care: Adaptation to nerve stimulation reduces efficacy over time. Efficacy can only be improved by increasing stimulation strength which leads to pain.
Technology Solution: Novel stimulation parameters targeting the smooth muscle of the esophageal sphincter have been developed that are highly efficacious and lack the adaptation seen with nerve stimulation, similar to what occurs with the long term effectiveness of cardiac pacemakers.
Project Status: Parameters have been developed and tested ex vivo and in vivo studies have been designed to test in standard models of acid reflux.

Medical Imaging

Viderics, Inc.- Ultrasound-based Cardiac Monitor
(J. Yen, PhD & P. Lumb, MD)

Clinical Need: Real-time monitoring and detection of cardiac dysfunction in critical care patients.
Current Standard of Care: Intermittent assessments using standard ultrasound-based sonography.
Technology Solution: Continuous cardiac visualization in Critical/Intensive Care Units and Emergency Departments and in telemedicine applications.
Project Status:

  • Developed early prototype and currently bench testing with phantoms
  • IRB submission under review

Myocardial Perfusion Imaging Without Contrast Agents
(K. Nayak, PhD & R. Pai, PhD)

Clinical Need: Safe and effective heart health monitoring for the patients with kidney failure (~340,000 in U.S.). These patients require frequent testing and cannot tolerate contrast agents.
Current Standard of Care: Minimally effective stress echocardiography, and contrast-based nuclear medicine and X-ray techniques that cannot be performed frequently.
Technology Solution: Novel, MRI-based technique that does not rely on contrast agents.
Project Status:

  • Clinical study demonstrated effectiveness.
  • Developing technology for broader use and for complete heart coverage.

OCT/Ultrasound-directed Biology for Cholangiocarcinoma (CCA) Diagnosis
(J. Van Dam, MD & Q. Zhou, PhD)

Clinical Need: Current brush cytology-based diagnostics for CCA have 50% sensitivity resulting in serial biopsies and late diagnoses leading to poor prognosis
Current Standard of Care: Repeat biopsy procedure until positive diagnosis is made so that treatment can be pursued
Technology Solution: Dual probe for high resolution imaging of surface features (OCT) and deep ductal layers (US) to direct surgeon to appropriate biopsy site
Project Status:

  • Prototype completed
  • Pre-clinical feasibility and ex vivo studies with human tissue planned.

Magnetic Resonance Urography Cluster Software
(R. Moats, PhD & R. Lestz, MD)


Clinical Need: Early diagnosis and intervention is needed for congenital anomalies of the kidney and urinary tract
Current Standard of Care: Measurement of glomerular filtration rate, which is often inaccurate and cumbersome
Technology Solution: Automated method for medical imaging analysis of quantitative assessment of renal function and morphology from a time series of MRIs
Project Status: Software developed and ready for clinical validation

Clinical Care & Rehabilitation

Moving Analytics, Inc.-
Movn Telehealth Platform for Cardiac Rehabilitation 
(G. Sukhatme, PhD & M. Fong, MD)



Clinical Need: Compliance with prescribed cardiac rehabilitation programs after cardiac events is low, mainly due to limited accessibility
Current Standard of Care: 12 week long, 3x per week cardiac rehabilitation programs are offered on site, within regional centers
Technology Solution:  A web-based case management system for nurses and a smartphone application that guides patients through a home-based program. Nurses can track patient compliance in real time, and manage 5 times more patients.
Project Status: Clinical feasibility study underway to inform design of larger pilot study
Company Website: Moving Analytics

MotionScientific, Inc. – ARMMOV for Upper Limb Rehabilitation in Stroke Patients
(N. Schweighofer, PhD, D. Proulx, PhD, & Y. Matharu, DPT, OCS)


Clinical Need:  In the U.S. alone, at least three million individuals who have had a stroke suffer functional limitations and a decrease in use of their upper extremities.
Current Standard of Care: One-on-one time with physical therapists is limited and unsupervised training often leads to poor recovery outcomes, due to low compliance and development of abnormal compensatory movements.
Technology Solution: The Automated and Adaptive Arm Training (A3RT) system implements research-based principles to improve arm use and function in chronic stroke patients. A3RT can provide automated, personalized, and adaptive training feedback to minimize compensatory movements and increase motivation in arm use.
Project Status:

  • A3RT Software being developed with SBIR phase I funds
  • Raising money for patient testing

Company Website: http://motionscientific.com/

WhiteCoat– A web-based service providing accessible in-home medical care
(Mike Kwon, B. Liu, PhD & S. Yacoob, MD)


Clinical Need: There is a significant need for an affordable and accessible service that provides same day appointments and after- hours medical care to patients.
Current Standard of Care: Urgent Care and Emergency Rooms are the current Standard of Care.
Technology Solution:Smartphone-based application for requesting access to a wide range of in home health care services provided by nurse practitioners.
Project Status: Launched a mobile web platform for patients and a nurse practitioner iOS application to receive patient requests. Secured two BD deals with Otis College of Design and Boost Hydration, an IV Therapy clinic.
Company Website: http://getwhitecoat.com/

ReoLab– A rapid screening platform to combat the antibiotics crisis
(Krisna Bhargava, PhD, Noah Malmstadt, PhD, Robert Molinari, MBA/PhD, Ajit Medhekar)


Clinical Need: A system that can rapidly screen cough and cold symptoms as due to bacterial infection is needed to reduce overtreatment of acute respiratory infections and stem the rise of multi-drug resistant pathogens (e.g. MRSA).
Current Standard of Care: Physicians prescribe antibiotics or admit patients to the ER based on observation of patient symptoms and intuition. Objective diagnostic tests are currently confined to specialized hospital and central labs.
Technology Solution:An automated, portable testing system and machine-learning engine to assess the risk of respiratory bacterial infection that will fit into the clinical workflow at all levels (e.g. primary care, hospital, central lab).
Project Status: An analytical prototype has been completed and utilized in a external research customer setting. Currently raising funds to execute a first clinical study.
Company Website: https://www.reolab.io/