Revolutionizing Medical Device Innovation

Transcription

1 Revolutionizing Medical Device Innovation

2 Innovating to Win The Valley of Death for Medical Devices

3 Innovating to Win 1) To build meaningful and productive collaborations with clinicians and companies 2) Reduce risk so companies pull technology out of UTD 3) Leverage small seed grants from center into federal funding (~25X ROI) 4) Create a reputation that results in partnerships with donors and companies 5) Create talent that can enter the biomedical engineering workforce 6) Increase research publications to add value to technology and center 7) Recruit talent to increase bandwidth and skill sets 8) Develop corporate and individual support to sustain activities

4 Technology Pathway

5 TxBDC Research Center Success Productivity (Years ) $12 Million in External Funding DARPA, GlaxoSmithKlein, and NIH 40 Peer Reviewed Publications 4 Clinical Trials 8 Pre-clinical Trials 2 Commercial Devices Exiting this Year

6 Twentieth century medical innovation changed the world by focusing on infectious disease. Smallpox Measles Flu Whooping cough Tetanus Meningitis Hepatitis B Diphtheria Polio 400 million deaths 97 million deaths 76 million deaths 38 million deaths 37 million deaths 22 million deaths 13 million deaths 1 million deaths 0.1 million deaths World Health Organization

7 Twenty-first century innovation will change the world by focusing on brain disorders. Chronic Pain Anxiety Depression Drug Addiction Severe Tinnitus Traumatic Brain Injury Epilepsy Alzheimer's Disease Autism Stroke Parkinson s Disease 700 million 650 million 350 million 185 million 70 million 54 million 50 million 36 million 34 million 33 million 10 million World Health Organization

8 Diphtheria Tuberculosis Whooping Cough Yellow Fever Typhus Technology Tipping Point Timeline of Vaccine Development Influenza Polio Japanese Encephalitis Anthrax Adenovirus Oral Polio Vaccine Measles Mumps Rubella Chicken Pox Pneumonia Meningitis Hepatitis B Influenza Hepatitis A Lyme Disease Rotavirus Papillomavirus Present

9 Young brains can change Adult brains can change Brain stimulation changes the brain Plasticity rules discovered VNS-directed plasticity Tinnitus Therapy Developed First Human Clinical Trial Technology Tipping Point Timeline of Targeted Plasticity Therapy Miniaturized Wireless Implant By 2018 Outpatient Procedure Stroke Therapy Developed PTSD Therapy Developed First Human Stroke Trial TBI Therapy Developed US Clinical Trial for Tinnitus US Clinical Trail for Stroke SCI Therapy Developed Pain Therapy Developed US Clinical Trial MS and SCI Clinical Trial Chronic Pain US Clinical Trial PTSD Future

10 Minute Week Year Precision Therapeutic White Space Specific Circuit DBS Brain Region Whole Brain TMS Drugs ECT Duration

11 TPT Provides Specific and Long Lasting Changes in Function Precision Minute Week Year Specific Circuit DBS TARGETED PLASTICITY Brain Region Whole Brain TMS Drugs ECT Duration

12 Use The Bodies Natural Pathway To Enhance Learning

13 Stimulation of the Vagus Nerve Strengthens Active Circuits VNS Acetylcholine + Norepinephrine + Experience Neural Plasticity Locus Coeruleus Nucleus Basalis Vagus Nerve

14 VNS paired with Motor Rehab

15 VNS paired with Stroke Rehab Strengthens The Circuits Generating Those Movements

16 VNS paired with Stroke Rehab

17 These Brain Changes Lead to Motor Function Improvement

18 Targeted Plasticity Therapy Enhances Motor Recover Following Stroke in Animals Aged Stroke Chronic Stroke Unpublished Unpublished

19 Targeted Plasticity Therapy Enhances Motor Recover Following Stroke and TBI in Animals TBI: Handle Pull Task * * *

20 Targeted Plasticity Therapy Enhances Motor Recover Following Different Types of Strokes in Animals TBI: Handle Pull Task

21 Potential VNS-facilitated Therapies Tones + VNS - Tinnitus Speech therapy + VNS - Communication disorders Touch + VNS - Chronic Pain Skilled movement + VNS - Motor Impairments Cognitive therapy + VNS - Cognitive Impairments Desensitization therapy + VNS - PTSD / Anxiety Auditory Rehab Motor Rehab PTSD Rehab

22 Stroke Clinical Trials

23 Post VNS Therapy

24 Pre and 1 Month Post

25 Pre and 7 Months Post micro1

26 Innovations micro1

27 Innovations Reduce cost and size so it is minimally invasive and readily available. Provide from a non-profit Next Year

28 Center Innovations Productivity Flexible Electronics and Advanced Materials

29 Center Innovations Productivity Clinical Trial at UTSW Exiting the University This Year

30 PTSD with USC

31 VNS for Tinnitus Overview The therapy pairs each tone played via headphones with a burst of vagus nerve stimulation. Over time, this will alter the neurons in the auditory cortex and reduce the perception of tinnitus in the patient. page 31

32 Center Faculty Involved in Targeted Plasticity Initiative Rob Rennaker, Ph.D. Mike Kilgard, Ph.D. Jane Wigginton, MD Diana Easton, Ph.D. Elliot Frohman, MD Ph.D. Teresea Frohman, PA-C Hunt Batjer, MD Seth Hays, Ph.D. Sven Vanneste, Ph.D. Christa McIntyre, Ph.D. Ted Price, Ph.D. Walter Voit, Ph.D. Shalini Prasad, Ph.D. Mario Romero-Ortega, Ph.D. Stuart Cogan, Ph.D. Patrick Ganzer, Ph.D. Dane Grasse, Ph.D. Director Assoc. Director Chief Medical Officer Director of Regulatory Affairs MS MS Neurosurgeon Stroke and Parkinson s Disease Tinnitus Post-Traumatic Stress Disorder Chronic Pain Materials Science Sensory Technology Peripheral Nerve Injury Biomedical Devices Spinal Cord Injury Wireless Implant Technology