Projects from 2020-21
MelioLabs
Melio is committed to transforming testing for infectious disease, beginning by focusing on the neonatal sepsis market. Neonatal sepsis kills 1 million newborns annually worldwide, and affects 1-2 cases per 1,000 live births in the US alone. This fosters broad-spectrum antibiotic use, leading to poor outcomes and unnecessary costs associated with hospital stay and antibiotic overuse. Rapid diagnosis would allow for quicker, more targeted sepsis treatment for this vulnerable patient population, and this is where Melio comes in. Melio has developed a low-cost, universal platform to detect common pathogens and antibiotic resistance signatures directly from a patient sample in under 3 hours by machine learning and digital melt analysis.
This year, our MTM team has performed competitive market analysis, regulatory planning, data processing pipeline architecture design, creation of marketing materials, patent and freedom-to-operate analysis, species characterization, and reimbursement strategy.
MTM Team Members: Hang Chang, Keerthana Elango, Reuben Sarwal, Zach Scott
Project Leader: Mridu Sinha (Co-Founder and CEO of MelioLabs)
SiMOx
In the United States alone, ~25,000 newborns are born extremely premature (EPT) with high mortality due to their severely undeveloped lungs. Although current NICU technology enables survival, there is a definitive need for life support that mitigates resulting severe chronic complications associated with this vulnerable population. SiMOx-AP is a novel artificial placenta oxygenator that provides respiratory support that mimics placental gas exchange to overcome key clinical obstacles in EPT care. In collaboration with UCSF’s Roy Lab, our team has significantly contributed to engineering a second-generation device and performing analyses on business strategy, regulatory approach, and intellectual property review to ultimately help change the paradigm of neonatal care and improve EPT patient outcomes.
MTM Team Members: Anjali Gehani, Monica Plascencia, Aarushi Sharma
Project Leaders: David Blauvelt, MD (Clinical Fellow, Pediatric Critical Care Medicine at UCSF)
Project Cool
Great Circle Technologies, Inc (GCT) has developed a novel, minimally invasive and simple technology for local cooling of the spinal cord. This procedure could be widely used in emergency situations to “buy time” prior to surgery for spinal cord injury (SCI) patients, help the patient to achieve better recovery after the SCI, and has a potential role in military battlefield SCI treatment in combat support hospitals. The device consists of a thermally conductive catheter, a cooling system and an interface that combines the two. This device can be utilized by physicians in a standard bedside procedure.
MTM Team Members: Yu-Jing Chen, Timothy King, Maggie Zhou
Project Leader: Sanjay Dhall, MD (Director of Spinal Neurotrauma at UCSF)
Hydrodissection
We are presenting a novel injectable hydrogel material to be utilized for separating tissues during percutaneous thermal ablation procedures. Thermal ablation is a procedure commonly used to heat or cool kidney and liver tumors to cytotoxic temperatures. However, there remains a significant unmet need in clinical strategies for mitigating damage to adjacent tissues and organs. This year our team interviewed stakeholders including UCSF proceduralists in various departments, helped secure additional UCSF Catalyst funding, and designed a regulatory/reimbursement strategy surrounding bringing our gel to market. Our hydrogel will improve user experience and save time compared to the current standard of care (hydrodissection) while reducing both complications and costs associated with thermal ablation.
MTM Team Members: Ramandeep Gill, Wendy Gulden, Neel Vahil
Project Leaders: Miles Conrad, MD (Clinical Professor of Radiology at UCSF) & Philip Messersmith, PhD (Professor of Materials Science and Engineering at UC Berkeley)
Kid Cath
Current pediatric hemodialysis catheters come with an array of complications that subject children to unnecessary discomfort, increased risk of arrhythmia, poor dialysis, and thrombosis. In collaboration with Stanford’s Maternal and Child Health Research Institute and Thakor Lab, Kid Cath aims to create a market analysis, regulatory strategy and expand clinical indications for a modular hemodialysis catheter, designed to meet the needs of hemodialysis pediatric patients.
MTM Team Members: Jessica Santhakumar, Neeki Tahmassebi, Mia von Knorring
Project Leaders: Grant Wells (Director of Innovation & Development at Stanford) & Avnesh Thakor (Inventional Radiologist and Assistant Professor at Stanford)
InCarda
Atrial Fibrillation (AF) is the most common cardiac arrhythmia affecting over 6 million people with an annual cost of $10.1B in the US alone, and approximately 30-40% of this population have Paroxysmal Atrial Fibrillation (PAF). InCarda therapeutics is developing a novel medication called InRhythm that is a nebulized formulation of an antiarrhythmic medication called flecainide acetate. This novel medication provides the symptomatic PAF patient the treatment option of self-administering the orally inhaled flecainide, and provides acute cardioversion to sinus rhythm via the lung delivery route. InRhythm can be self-administered by patients on an outpatient basis as needed compared to the costly current standard of care that involves emergency services, and a likely hospital admission. The MTM team is developing the infrastructure for InCarda’s treatment paradigm that includes a stakeholder analysis of the combination of wearable devices, telehealth platforms, reimbursement strategy, and a market analysis. The MTM team’s efforts will potentially improve InRhythm’s market entry and user adoption that includes increased prescriptions to patients, and revenues. Patients will be empowered to self-treat their PAF at home, with an optional form of clinical support via telemedicine that includes remote monitoring and wearable devices.
MTM Team Members: Cindy Arregoitia, Amber Hafterson, Jessica Zhang
Project Leaders: Carlos Schuler, PhD (Chief Operating & Technology Officer & Co-Founder of InCarda), Luiz Belardinelli, MD, (CMO and Co-Founder of InCarda), Jeff Ho (Vice President of Commercial Strategy at InCarda), and Debra S. Echt, MD (SVP of Medical Affairs)
Netic Health
The current system of physical therapy is fragmented, and prevalent chronic injuries frequently derail the careers of athletes. Netic Health aims to solve this problem through a digital care platform for physical health and physical therapy. We connect patients with personalized, athletic-focused physical therapists and treat them using telehealth, chat-based care and artificial intelligence in order to make the care 10x more affordable and 10x more accessible. After conducting interviews to understand the tight-knit running community, the MTM team has analyzed clinical indications to refine the business model, performed a market analysis, helped implement an advertising campaign, and helped manage two pilot studies with paying customers.
MTM Team Members: Mason Comerford, Tong Jin, Divek Toprani
Project Leader: Mathias Vissers, MD, MTM (Co-Founder of Netic Health)
Ear Buddy
Otitis Media with Effusion (OME) or ‘glue-ear’ is an extremely common disease in children, causing discomfort, hearing difficulties, and developmental delays. Currently, the American medical system spends $1.9B on OME management per year. EarBuddy is an affordable, novel, non-invasive device that can be used to deliver a positive pressure therapy to the middle ear to drain the effusion and resolve OME. This year, our team has completed stakeholder interviews with pediatricians and ENT specialists, identified our total addressable market size, developed a reimbursement strategy based on our health economics analysis, and designed clinical trials. We are also in the process of finalizing our 510(k) technical dossier for submission and setting up our quality management system and manufacturing.
MTM Team Members: Sydney Adams, Varun Govil, Artiom Kisselev, Daniel Madera
Project Leaders: Matthew Oldakowski, PhD (Director at Perth Biodesign), Peter Santa Maria, MD, PhD (Surgeon and Assistant Professor of Otolaryngology at Stanford) & Paul Yock, MD (Director, Stanford Byers Center for Biodesign)
Projects from 2019-20
Pinpoint Science
Pinpoint Science has developed a novel bioelectronic nanosensor-based platform for the detection of the SARS-CoV-2 virus from individuals with or without symptoms of infection. The purpose of this test is to aid in the rapid screening of individuals who may be suspected to have COVID-19. The intended use is point-of-care and point-of-need screening. Testing may be performed at any location, including point of care or need, clinical laboratories, hospitals, clinics, pharmacies, and triage sites.
Pinpoint Science believes that democratizing screening and improving access to accurate, affordable testing allows for early detection and enhances overall health management. The Pinpoint Science platform is simple to use. Using interchangeable cartridges and a reader device, the platform can detect the presence of viruses, bacteria, fungi, and other biomolecules in under one minute. In addition to COVID-19 virus tests, Pinpoint Science plans to develop COVID-19 antibody serology tests, and tests for influenza, IL6, and others. Our MTM team is assisting with funding applications, emergency use authorization, quality and project management, and creating device shell prototypes to further validate the technology, and helping expedite the process of getting the tests to market.
MTM Team Members: Bria Bailey, MS, Ames Ma, Brad Wait
Project Leaders: Lisa Diamond (CEO of Pinpoint Science)
Eysz
Diagnosing an epileptic seizure outside of the hospital is like detecting a fever without a thermometer. The gold standard for seizure detection is a video-EEG in the hospital, capturing only a fraction of the patient’s story. The lack of objective outpatient data on the frequency of seizures and pharmaceutical side effects at home often leads to the under- or overtreatment of epilepsy, causing a reduced quality of life, unnecessary hospitalizations, or even death. We are developing software algorithms that can detect and predict seizures using oculometric data (eye movement) by employing machine learning capabilities. We intend our product to easily interface and/or integrate with consumer grade eye-tracking systems (eg. smart glasses) and therapeutic devices (eg. neuromodulation) outside of a hospital setting. We are targeting the detection of absence seizures first, which are characterized by short lapses of consciousness. We aim to assist clinicians to remotely detect seizures and assess whether treatments reduce the frequency of seizures, thus decreasing risk of injury, and improving productivity and quality of life for people with epilepsy.
MTM Team Members: Julia Martinez Franks, Wei-Kai Lin, MD, Mathias Vissers, MD
Project Leaders: Rachel Kuperman (Founder, CEO of Eysz, Inc.)
Voyage Biomedical
In the United States alone, there are an estimated 795,000 strokes per year. Every forty seconds, one person in the US will have a stroke and every four minutes one person will die as a result of their stroke. Although current treatments focus on removing blockages to blood flow causing stroke, there is a definitive clinical need for a bedside device that can further protect the brain before, during, and after blockage-removal treatment. We are working to change the paradigm of stroke care to improve patient outcomes by developing a catheter-based technology to selectively cool the brain. Normally cooling the brain is an invasive technique performed during cardiac surgery to protect the brain when the heart is stopped. We are taking the same brain cooling techniques out of the cardiac surgery OR and to the bedside to prevent brain damage during stroke.
MTM Team Members: Nitika Chellappa, Annam Quraishi, Akhilesh Yeluru
Project Leaders: Robert Shultz, MD, MTM, Justin Olshavsky, MTM, Bridget Vaughan, MTM (Co-Founders of Voyage Biomedical)
Intravascular Bioartificial Pancreas (iBAP)
Currently ~10% of the US population (30.3 million Americans) have diabetes. Of this population, 5% of diabetic (1.25 million American) children and adults have type 1 diabetes. As the number of patients with T1D continues to increase, there is a need for a permanent treatment to prevent complications associated with diabetes such as uncontrolled hyperglycemic unawareness. Even with current solutions, Type 1 diabetics suffer from daily pin pricks, injections, or invasive surgeries that do not always achieve a long-term functional cure. The intravascular Bioartificial Pancreas (iBAP) is an intervention that will enable islet cells to achieve long-term control of blood glucose levels. The device utilizes a silicon nanopore membrane (SNM) allowing size selective admission of physiologically necessary molecules to sustain islet cells for insulin delivery while blocking the immune system from attacking the cells. This will provide patients enhanced and automated glucose control therefore achieving better outcomes while also reducing costs.
MTM Team Members: Nitasha Goyal, Nathan Ackermann, Brooke Stephanian
Project Leaders: Charles Blaha (Research Associate, UCSF)
Spinal Interbody Device
Spinal fusion is a surgery performed to connect two or more vertebrae in your spine and involves techniques to mimic the normal healing process of broken bones. One technique that surgeons use for spinal fusion is to place a biocompatible implant aimed to enhance bone fusion between the space of the spinal vertebrae. Approximately 40% of patients experience complications from spinal fusion surgery. These complications include either implant subsidence into the bone or failure to fuse, often leading to half of these patients requiring subsequent surgeries. Our team aims to reduce current device complications and decrease the rate of repeat surgeries in patients with a novel spinal implant design. We are utilizing computer assisted design and titanium 3D printing to develop a spinal interbody device specifically for lumbar fusion surgeries with a proprietary UCSF anisotropic lattice design based upon trabecular bone structure. The current design features will allow for long-term stability, high rate of bone fusion, decreased subsidence and reduced pain. The ultimate goal is to create a viable product that can be integrated into current surgical practices and enhance the spinal market.
MTM Team Members: Malavika Shankar, Melissa Keller, Lindsey Milisits, Rhett Larson
Project Leaders: Alexis Dang, MD, (Associate Professor, UCSF Division of Orthopaedic Surgery), Alan Dang, MD, (Assistant Professor, UCSF Division of Orthopaedic Surgery)
LookDeep Health
The typical hospitalized patient receives only several minutes of physician monitoring daily and status checks every several hours. Patient deterioration often occurs in the absence of clinical monitoring. With limited staff capacity, hospitals deploy non-clinical labor (i.e. patient sitters) at an excessive cost to increase monitoring of some patients without gaining any additional clinical insight. Our computer vision and machine learning technology provides continuous monitoring and real-time status updates to healthcare providers. The opportunity to increase monitoring for patients outside of an ICU without additional labor is dually beneficial for patients by reducing negative outcomes, and to health care settings by decreasing their financial burden.
MTM Team Members: Philip A. Alves, MD, Brandon Shih, Xinyu Li
Project Leaders: Narinder Singh, Michael Choma
Nephrosant
Kidney stone disease (nephrolithiasis) is a common problem worldwide. In the Western world, the reported lifetime prevalence is 10–12% in men and 5–6% in women. Nephrolithiasis is largely a recurrent disease with a relapse rate of 50% in 5–10 years and 75% in 20 years. Relapses cannot be predicted with contemporary and burdensome 24-hour urine supersaturation collections, and this incurs significant financial costs for patients and the health care system. With the clinical unmet needs in mind, Nephrosant seeks to develop an innovative urine-based point-of-care (POC) dipstick device that can be used in the clinical and at-home settings and allow for personalized patient monitoring of kidney stone risk. MTM students are involved in all aspects of the project ranging from clinical test, regulatory and commercialization plans, and external industry collaborations.
MTM Team Members: Deepika Sarode, Olivia Prior Palomares, Zoë Hurtado, Raymond Dong
Project Leaders: Minnie Sarwal, MD (Professor, UCSF Division of Surgery; Founder and CEO of Nephrosant), Joshua Yang, MTM
Vitruvian
Pressure ulcers, also more commonly known as bedsores, affect up to ~2.5M patients annually in the U.S., and can cost up to ~$ 26 B in annual healthcare spending. However, despite the significant threat it poses to public health and the economy, the way we assess and manage chronic wounds has not changed for decades. The current standard of care, the Braden Scale, relies heavily on caregivers’ sight and touch, and is a highly subjective method that is susceptible to human variance and error. Vitruvian hopes to modernize wound care and management with a noninvasive SMART bandage that can quantify skin tissue health via impedance spectroscopy to prevent pressure ulcers. We aim to provide a new standard for pressure ulcer care by providing personalized and objective measures of tissue damage that reduces economic and patient burdens.
MTM Team Members: Donghyeok “Danny” Kim, Yujia “Emily” Zeng, Michele Lin
Project Leaders: Vinod Mahendroo, MBA (CEO, Vitruvian Medical Devices), David Young, MD (Professor, UCSF Division of Plastic and Reconstructive Surgery), Hobart Harris, MD (Professor, UCSF Division of General Surgery)
Zordera
Glaucoma is the leading cause of irreversible blindness worldwide and affects more than 3 million patients in the United States. Eye drops, the current standard of care, are efficacious in controlled studies but are not as effective in practice. The patient burdens associated with intense medication regimens, side-effects and inconvenient procedures for proper drop instillation result in a non-compliance rate as high as 50%. Zordera, therefore, aims to ease the burden of daily administered eye drops for glaucoma by developing a continuous drug delivery implant that lasts up to a year without any patient involvement. To gain direct insights from future stakeholders, we have carried out a voice of customer study which includes designing questionnaires, applying for the IRB review and conducting multiple interviews. This has enabled further optimization of the current prototype, development of strategic regulatory and clinical pathways as well as clinical adoption and reimbursement plans.
MTM Team Members: Ao-Mei Lee, Janak Jobanputra, Okuoma Idah, William Xie
Project Leaders: Murty Vyakarnam Ph.D., Dan Bernards Ph.D., Robert Bhisitkul M.D. Ph.D., Tejal Desai Ph.D. (Professor and Chair, UCSF Department of Bioengineering and Therapeutic Sciences)
Projects from 2018-19
ArticUGrip
Advanced endoscopic resection of early stage upper gastrointestinal lesions is a rapidly advancing field. Currently available platforms are limited by their size, cost and concerns regarding the ability to adequately sterilize these instruments. Attempts at performing advanced endoscopic tumour resection using standard endoscopes are fraught with issues. This is due to the inability to maneuver tissue retractors independently of the endoscope, resulting in difficulty maintaining a stable field of view. Our team has designed a novel endoscopic retractor that is aimed at addressing this problem. The ArticUGrip helps endoscopists perform advanced endoscopic procedures more efficiently by allowing for articulation within the GI tract independent of the endoscope, ultimately enabling adequate triangulation within the lumen. The ability to insert the ArticUGrip through the working channel of a standard endoscope mitigates the costs associated with other platforms. In addition, its disposable nature and inexpensive design allows for infection risk reduction, controlled tissue manipulation and easy adoption.
MTM Team Members: Ikennah Browne, MD, Allyson Coble, Truc Dinh
Project Leaders: Matthew Lin, MD (Assistant Professor, UCSF Division of Surgery), Alex Balus, MTM
CleftAid
Cleft palate with or without cleft lip (CLP) is a birth defect that over 200,000 babies worldwide are born with each year. Babies with CLP have difficulty breastfeeding because they can not create sufficient intra-oral negative pressure due to the air leak through the nose. Currently, mothers use a variety of methods including breast pumps and specialized bottles, formulas, cups, and spoons to feed their babies. None of these methods provide the nutritional and emotional benefits proven to be gained from breastfeeding. We are developing a Breastfeeding Device to enable infants with CLP to directly feed from their mother’s breast. Our device is made of a single piece of FDA approved silicone. One side of the device is placed over the mother’s nipple and areola, while the baby places his or her mouth on the other side of the device. As the baby’s mouth goes through normal feeding compression cycles, a negative pressure is created within the device allowing milk to flow from the mother’s breast into the baby’s mouth through a one-way valve on the tip of the appliance. We are designing the appliance with the intent of reaching mothers in high, middle, and low resource countries through multiple distribution networks and partnerships.
MTM Team Members: Madeline Krenek, Elisabeth Rebholz, Kendra Sellers
Project Leaders: Anne Boekelheide, RN, Randy Bertuccelli
3D Printing
Cast removal methods have remained relatively unchanged in the past few decades. They utilize a small-toothed blade that rapidly oscillates back and forth over a very small arc to cut material. Since the skin tends to be mobile enough to oscillate with the blade, the risk of cutting a patient is negligible. However, the risk of burning the patient from overheated cast saw blades still exists. The blade can reach temperatures of 65˚C from oscillating at high speed, which can burn patients if skin contact is maintained for as little as one second. Our team has a two-step plan for exploring design solutions to reduce the risk of burns in patients. These approaches include options to manage heat and prevent skin contact. We are primarily utilizing computer assisted design and 3D printing to rapidly realize and prototype our ideas. Our goal is to create a viable product that can be integrated into current practices with minimal behavioral changes.
MTM Team Members: Cole Cuthbert, Jiali Lei, Sunaina Santhiveeran, Matt Sprinkel
Project Leaders: Alexis Dang, MD, (Associate Professor, UCSF Division of Orthopaedic Surgery), Alan Dang, MD, (Assistant Professor, UCSF Division of Orthopaedic Surgery), Musa Zaid, MD.
Nima
The Nima Sensor is the world’s first portable device that tests food for gluten or peanuts in minutes — anytime, anywhere. Nima empowers you to dine out more often, say yes to catered events, double-check a packaged food, and travel far and wide. Using the Nima sensor is fast and simple. Put a bit of food into a test capsule, put the capsule in the sensor, and push start. Nima’s award-winning technology and antibody-based chemistry identify any gluten or peanut in your food. The sensor displays your result in less than 5 minutes. Enjoy your meal, knowing if your food is really gluten or peanut-free! With the free Nima app, share your test result to help others in the gluten or peanut-free community and discover Nima-tested packaged foods and restaurants nearby.
MTM Team Members: Maria D’Azevedo, Jack Jung, Jack Wang
Project Leaders: Paul Pemberton, MTM, Francisco Dias Lourenco
Perikinetics
Perikinetics is developing an all-in-one glucose monitor and insulin pump that serves as an autonomous or “set it and forget it” artificial pancreas solution for type 1 diabetes (T1D), a chronic disease that requires frequent and burdensome glucose monitoring and insulin delivery. The technology utilizes the intraperitoneal space allowing for faster kinetics (insulin delivery and glucose sensing) to allow patients to maintain a more stable glycemic level and decrease adverse events such as hospitalization. This is unique because traditional insulin delivery and glucose sensing technologies use the subcutaneous space that has greater lag times of absorption and sensing detection.
MTM Team Members: Megan Cable, Mark Gutin, Yihan Hu, Tatiana Jansen
Project Leaders: Michael Hemati (Co-founder) , Chris Hanson (CEO), Daniel Burnett, MD, MBA (CEO TheraNova)
RadHA
Inadequate preoperative planning can lead to surgical errors and complications that may harm patients and may impose substantial costs. Current imaging techniques compromise patient wellbeing by requiring surgeons to spend more time during surgery fitting hardware. HoloSurg3D’s Augmented Reality software app “RadHA”(Radiology with Holographic Augmentation), allows surgeons to view their patient’s anatomy in 3D on a real-world background before the operation even starts. This makes surgery faster, safer, and more efficient by helping surgeons to better educate patients about their surgeries, understand complicated anatomy before surgery, and “roadmap” important structures and hardware prior to surgery. Through market research interviews, we have identified the orthopedic specialty to be our beachhead market and plan to complete a regulatory submission and a pilot study clinical trial in order to validate our claims and solidify our business model.
MTM Team Members: David Dallar-Orr, Dancho Penev, Robert Schultz, MD
Project Leader: Jesse Courtier, MD (Assistant Professor, UCSF Department of Radiology)
Silicon Kidney
End-Stage Renal Disease (ESRD) is the final stage of chronic kidney disease in which renal function drops to less than 15%, necessitating dialysis treatments. Currently, ESRD patients are most commonly treated with in-center thrice-weekly hemodialysis, which is costly, carries impacts of inconvenience and transportation on quality of life, and results in 5-year survival rates of only 42%. Silicon Kidney, a company formed out of the Roy Lab at UCSF aims to revolutionize dialysis treatment for ESRD patients by developing a novel implantable hemodialyzer, the iHemo. The iHemo incorporates silicon nanopore technology for filtration and allows for an internal blood circuit, limiting existing risks for exsanguination. By making more frequent, lower risk treatment possible, outcomes and quality of life will be improved, all from the comfort of the patient’s home.
MTM Team Members: Aurko Shaw, Bridget Vaughan, Alice Vergani, Mingxi Yin
Project Leaders: Charlie Blaha, MS, Lynda Frassetto, MD, Jimmy Ly, PhD, Nina Hojs, MD, PhD, Nathan Wright, MS, Peggy Lees, MTM, Avinash Patil, PhD , Tom Horn, BS
Tabla
Tabla is a device designed by researchers at UCSF that makes use of sound waves to sense fluid in the lungs and then uses a machine learning algorithm to determine if the fluid is characteristic of pneumonia. The device relies on the differences in sound-wave speed travelling through air compared to sound-wave speed travelling through liquid to assess if there is fluid in a patient’s lung. These diagnostic results provide patients with more information regarding their lung health. This device is designed to be used in low resource settings, and will combat the enormous public health crisis of childhood pneumonia in India and Sub-Saharan Africa. Team Tabla aims to provide health workers in these areas with an accurate and precise alternative to chest X-Rays for diagnosing pneumonia.
MTM Team Members: Liya Abraha, MD, Audrey Denman, Justin Olshavsky, Grant Pemberton
Project Leaders: Adam Rao (Medical Student, UCSF),
Vitruvian
Vitruvian Medical’s Sentinel Bandage modernizes wound care management by providing healthcare professionals with a noninvasive, easy to use “smart bandage” that utilizes impedance spectroscopy across a flexible electrode array to assess skin health and integrity for early detection and prevention of pressure ulcers. We aim to reduce the economic and patient burden associated with these “never events” by providing an individualized, objective monitor of tissue damage to optimize the standard of care for PU prevention.
MTM Team Members: Lindsay Axelrod, Roxanne De Leon, Raquel Izquierdo Albero, Samson Peter
Project Leaders: Vinod Mahendroo, MBA (CEO, Vitruvian Medical Devices), David Young, MD (Professor, UCSF Division of Plastic and Reconstructive Surgery), Hobart Harris, MD (Professor, UCSF Division of General Surgery)
Zetagen
Zetagen Therapeutics, Inc is an early stage regenerative medicine company that is commercializing a small molecule-based osteoinductive platform technology to promote bone growth by activating a novel molecular pathway. Our first product, ZetaFuse™, is a small molecule drug with an established safety profile housed in a putty carrier. ZetaFuse™ will be used as local implants to promote local bone growth through activation of molecular pathways in mesenchymal stem cells (MSC) to differentiate into osteoblasts while inhibiting tumor cell growth at the delivered site. As opposed to existing bone growth products that contain biologic growth factors (e.g. Infuse™ Bone Graft by Medtronics), which have declined in use precipitously due to increased risk of tumor lesions and other side effects, Zetagen Therapeutics aims to enhance bone growth while preventing local tumor recurrence among orthopedic surgery patients at a significantly higher efficacy, and lower cost and side effects. Focusing on lumbar spinal fusion as a potential initial indication for ZetaFuse™, the MTM team is currently working on finalizing use case identification, gathering product requirements, and preparing for the FDA submission meeting.
MTM Team Members: Yi-Yun “Peggy” Ho, Suphada “Dream” Lertphinyowong, Pin-hsiang “Sean” Huang
Project Leader: Darren Sun (Zetagen Inc)
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Projects from 2017-18
Augmented Surgical Vision
Surgical headlamps are an essential tool for effective illumination of tissues during many surgical procedures. However, current headlamp designs vary considerably in performance and ergonomics. Commercially available headlamps emphasize brightness that is measured at artificially close working distances in contrast to a true surgical working distance and do not consider light quality or color performance. Many headlamps are expensive, bulky, and powered with proprietary batteries. We propose to overcome these deficiencies with a novel headlamp design with three main features: a modular design to allow for procedure-specific lighting and feature upgrades; support for conventional, off-the-shelf battery compatibility; and a lightweight, ergonomic design. We believe that such a design will confer tremendous advantages over existing products on the market.
– Project Leader: Alexis Dang, MD (Assistant Professor, Orthopaedic Sports Medicine Surgery, UCSF)
– Key Personnel: Alan Dang, MD (Assistant Professor, Spine Surgery, UCSF and SF VAHC)
Ethanova
Cervical Cancer is the fourth most common cancer among women, seventh most common cancer including men. 84% of these cases are in low income countries. We help women affected by precancerous cervical lesions in developing countries lower their chances of getting cervical cancer by providing them with a device that can sustainably be used in their environment. Our device is targeted to serve low income countries where they do not have the resources available to provide the cervical lesion removal. These resources include electricity, trained specialized medical staff, and money to purchase additional assets. Our device design is centered around usability, low cost and not resource intensive.
– Project Leader: Michael Baycura (Director of Engineering and Operations, Theranova) | Daniel Burnett, MD, MBA (CEO TheraNova)
– Key Personnel: Michael Jaasma (Director of Product Development, Theranova)
Fusologics
Orthopedic, trauma, and cranial-maxillofacial procedures account for over 22 million cases per year globally and over 6 million cases per year in the US. The success of many of these procedures relies heavily on successful arthrodesis in fracture/fusion sites. Fusologics is a preclinical regenerative medicine company commercializing products that activate a novel and proprietary molecular pathway for growing bone. Discovered serendipitously, Fusologics is leveraging the first-ever, small molecule-based osteoinductive technology to develop a drug-device combination product that addresses a large unmet need for several high volume medical applications for which bone growth leads to optimal outcomes. As opposed to other products on the market that contain biologic growth factors (e.g., bone morphogenic proteins), which have seen a precipitous decline in use due to high cancer risk and significant side effects, recent data have demonstrated that Fusologics’ solution has a unique safety profile, is significantly less costly to manufacture and is more effective at growing bone. The MTM team is currently working on 4 sub-projects: indication selection strategy, product requirements gathering, product prototyping and testing, and go-to-market strategy.
– Project Leader: David Tischler, MBA (CEO, Fusologics, Inc.)
– Key Personnel: Nikhil Thakur, MD (President, Fusologics, Inc.; Director, Orthopaedics Northeast) | Bryan Margulies, PhD (CSO, Fusologics, Inc.; Former Assistant Professor, SUNY – Upstate)
Cystic Fibrosis Viral Gene Therapy
Cystic fibrosis is a rare, life-threatening genetic disease caused by mutations in the CFTR gene. Our approach to addressing this condition is to utilize an adeno-associated virus (AAV) vector to deliver functional CFTR genes to affected tissues. Previous AAV vectors have shown poor clinical utility, but 4D believes that the failures of these past trials are because of the lack of specificity of the AAV viruses. Using a proprietary Therapeutic Vector Evolution technique, 4D has developed a vector most optimized to address the need in cystic fibrosis. Our team’s goals for this year relate to business (marketing assessments), clinical (target product profile), CMC (optimization of the purification process), and R&D (organotypic lung model development).
– Project Leader: David H. Kirn, MD (Adjunct Professor of Bioengineering, UC Berkeley; Co-Founder & CEO, 4D Molecular Therapeutics)
– Key Personnel: Tandis Vazin, PhD (Senior Director of Translational Medicine, Stem Cell & Disease Modeling Group, 4D Molecular Therapeutics) | Melissa Kotterman, PhD (Senior Director of Translational Medicine, Vector Discovery & Product Engineering Group, 4D Molecular Therapeutics) | Kevin Whittlesey, PhD (Senior Director of Program and Alliance Management, Cystic Fibrosis and Lung Therapeutic Area Program, 4D Molecular Therapeutics)
Do or Die-alysis
There are over 2 million patients receiving hemodialysis worldwide, each requiring vascular access. Patients that are dialyzed through an arteriovenous fistula (AVF) have a 37% lower mortality than those that receive dialysis from a tunneled catheter. However, fewer than 20% of hemodialysis patients in the US receive an AVF prior to initiating dialysis, which has been attributed to several causes including specialist scheduling obstacles and fear or anxiety of a surgical procedure. A percutaneous AVF designed to be delivered by a single operator under ultrasound guidance, would increase the number of patients receiving dialysis with an AVF, which would translate into less mortality for patients and cost savings for the health care system. Our device will be designed for a single operator to create the AVF under ultrasound guidance. There will be two components to our approach: a delivery device, and a connector device. The MTM team will be helping out with general engineering support, user needs and market assessment, IP and regulatory strategy, reimbursement planning and business model development.
– Project Leader: Shant Vartanian, MD (Assistant Professor of Surgery, Division of Vascular & Endovascular Surgery, UCSF; Interim Chief, Department of Surgery at Zuckerberg San Francisco General)
– Key Personnel: Dillon Kwiat (Research and Development Engineer, Surgical Innovations Team, Departments of Surgery, Bioengineering and Therapeutic Sciences, UCSF)
ChameLeo
Episodic and chronic migraines are prevalent disorders affecting 15-18% of the population, with an estimated yearly economic burden of $19.6bn in the US and €27bn in the EU. The most common method of treatment is medication, which may cause addiction or undesired side effects and is generally overused. Neurostimulation devices have arisen as a promising alternative, but existing technologies show poor usability and compliance. Leo Labs is developing a hand wearable neuromodulation device for the acute treatment of migraines, significantly improving usability versus existing solutions. Our goal is to refine current prototypes into a commercial product with a suitable business, regulatory and reimbursement plan, whilst characterizing its performances and the neural pathways through which it treats migraines.
– Project Leaders: Michael Hemati, M.T.M. (CEO, Leo Labs; R&D Engineer Theranova) | Daniel Burnett, MD, MB.A (CEO, Theranova)
– Key Personnel: Blake Gurfein, PhD (CMO, Leo Labs; Assistant Professor, UCSF) | George Chen, MTM (Electrical & Software Engineer, Theranova)
Perceus
Percutaneous nephrolithotomy (PNL) is a minimally invasive procedure for kidney stone removal that is performed ~20,000 times per year in the United States. Gaining percutaneous access is a complicated process that requires high levels of technical skill of least two surgeons to perform multiple, time-intensive steps.
We propose a reliable, fast, adjustable sheath that combines the first three steps of percutaneous access into a single-step solution. The sheath can be dilated to different diameters and a surface marker provides consistent visualization of the moving needle tip under ultrasound. These characteristics offer competitive advantage over current multi-step dilation techniques that take valuable OR time (~$35/minute) and are only available in single-diameter units. The dilator is indicated for PNL and is designed to operate with one hand.
– Project Leader: Thomas Chi, MD (Associate Professor, UCSF Department of Urology)
– Key Personnel: Eben Alsberg, PhD (Professor, Case Western Department of Orthopaedic Surgery & Bioengineering) | Sarah Knox, PhD (Assistant Professor, UCSF Department of Cell and Tissue Biology) | Ted Miclau, MD (Professor, UCSF Department of Orthopaedic Surgery)
Hydronova
Xerostomia, or dry mouth, is a medical condition commonly resulting from radiation therapy for head and neck cancer, autoimmune or Alzheimer’s disease, and aging. Xerostomia often leads to tooth decay, oral mucosa damage, difficulty swallowing, and a significantly-compromised quality of life. Current treatments for xerostomia merely alleviate the condition’s symptoms and fail to address the underlying causes of dry mouth, such as damaged or non-functioning salivary tissue. The MTM team aims to develop a low-cost, long-term therapeutic treatment to promote salivary gland regeneration. Our injectable hydrogel will deliver drugs that locally stimulate stem cell regeneration within the salivary tissue. The MTM team will be optimizing both gel composition and release kinetics based on user needs assessments, evaluating the competitive landscape and market potential, and identifying an appropriate FDA approval pathway.
– Project Leader: Chelsea S. Bahney, PhD (Assistant Professor, UCSF Department of Orthopaedic Surgery) | Sarah Knox, PhD (Assistant Professor, UCSF Department of Cell & Tissue Biology)
– Key Personnel: Eben Alsberg, PhD (Professor, Case Western Department of Orthopaedic Surgery & Bioengineering) | Ted Miclau, MD (Professor, UCSF Department of Orthopaedic Surgery) | Jiun Chang, PhD (Postdoctoral Researcher, UCSF)
Ashpyxi-Alert
A tracheostomy is a surgical procedure that creates an opening in the trachea through the neck of a patient, followed by intubation to provide a safe accessory airway. Accidental decannulation (tube dislodgement) and tube occlusion (clogging due to mucus) are two complications of a tracheostomy that pose major risks to the patient. The inability to recognize and address these conditions in a timely matter will leave the patient unable to breathe or result in hospitalization. If unnoticed, the lack of oxygen can have severe consequences for the patient, including death or anoxic brain injury. In order to address this concern, our team, comprised of three MTM students, one MTM alum, and a UCSF physician, propose to construct a device that can be placed on a standard tracheostomy tube. The wireless device will monitor the patient’s breathing patterns and transmit data to the cloud continuously via an app on a mobile device or nursing station monitor. In the case of accidental decannulation or occlusion, the device and the mobile app will audibly alert caretakers.
– Project Leader: David Conrad, MD (FAAP Assistant Professor, UCSF Department of Otolaryngology – Head and Neck Surgery)
– Key Personnel: Romain Roux (UCSF)
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Projects from 2016-17
The Open Multiple Sclerosis BioScreen: Providing Personalized Outlooks for MS Patients
Multiple Sclerosis (MS) is a neurological disease characterized by manifestations across a wide range of symptoms and resulting in a highly variable course. To address this variability,
proper contextualization is crucial for effective disease management. The Open MS BioScreen (MSB-Open) aims to be an open-access, web-based platform that contextualizes an individual’s MS progression against that of patients with similar medical histories. It does so by applying machine learning towards existing clinical data, and is targeted for use as a disease monitoring tool for both providers and patients. Within the UCSF-sponsored project, the MTM team will be developing an agile user interface for the platform, as well as refining and organizing the back-end algorithms and front-end features to better suit clinician and patient needs.
– Project Leader: Riley Bove, MD (Assistant Professor, UCSF Department of Neurology)
– Key Personnel: Stephen L. Hauser, MD (Chair, Department of Neurology, UCSF) | Arno Klein, Ph.D. (Technology Lead, Open Multiple Sclerosis BioScreen project)
Uprite
Falls are the leading cause of unintentional injuries and death in adults over 75 years of age. The cost of treating falls and subsequent care in 2013 was $34 billion and is estimated to be $67 billion by 2020. Theranova is creating a “Fitbit for the elderly” by developing a novel wearable for the shoe and algorithms to assess distinctive gait patterns and metrics. The hope is that this algorithm can be developed for predicting fall risk and, eventually, fall prevention. The project objectives can be divided into four goals which we will all be responsible for: user needs assessment, technology development, clinical trial research, and business development. While the current focus of the project is to prevent falls, other applications of the wearable technology, such as athletic improvement and rehabilitation are being explored as well.
– Project Leaders: Dan Burnett (Founder and CEO, Theranova LLC) | Michael Hemati, MTM (CEO and Co-Founder of SmartDerm Inc.; Associate Specialist, UCSF) | George Chen, MTM (Software & Electrical Engineer, Theranova)
– Key Personnel: Brian Feeley, MD (Associate Professor, UCSF Dept. of Orthopaedic Surgery) | Kate Hamel, PhD (Associate Professor, San Francisco State University Dept. of Kinesiology)
Pressure
The goal of this capstone project is to non-invasively and remotely map pressure trends. This will facilitate clinical decision making – therapeutic intervention and alert to potentially harmful symptoms before they arise. To do this, we have engineered a small, wireless pressure sensing device. We are currently optimizing device designs based on extensive interviews with providers who specialize in cardiovascular, neurological, and abdominal disease processes. Additionally, we are devising a regulatory pathway, studying the IP landscape, developing commercialization strategies, and arranging plans for animal testing.
– Project Leader: Mohammad Mofrad, PhD (Professor of Bioengineering and Mechanical Engineering, UC Berkeley)
– Key Personnel: Ali Madani PhD (Researcher, UCSF)
Dascena
The Dascena project is part of a healthcare analytics startup developing first-in-class cloud-based autonomous clinical decision support platforms for transfer/discharge management and predictive diagnostics. The goal of this project is to engage in several aspects of the management, regulatory, and product development processes for our flagship product — a software tool that uses information routinely entered into electronic medical records to autonomously calculate risk trajectories to reduce patient mortality in inpatient and emergency settings. Specifically, the team has been working in roles developing regulatory strategy, IP approach, and strategizing for how to best position a product in the healthcare IT space and overcome the related challenges.
– Project Leader: Jeff Meitler (Director of Sales and Marketing, Descena)
– Key Personnel: Melissa Jay (Technical Writing Lead, Dascena)
SmartPessary: A novel device for detecting physiological changes associated with preterm labor
The SmartPessary project is working on developing an intra-vaginal device that can detect microscopic changes in the cervix. By detecting these changes, we hope to catch the early signs of preterm labor, and provide this information to patients and their doctors for follow-up treatment. Ultimately, our goal is to decrease the global burden of preterm birth by providing this SmartPessary, which can give both the mother and the doctor more time to manage early signs of preterm labor and delivery. The SmartPessary team is currently working on optimizing the device design for minimal power consumption, maintaining high accuracy in detection, while simultaneously designing clinical trials for eventual validation in our targeted global markets.
– Project Leader: Larry Rand, MD (Associate Professor, UCSF Department of Ob/Gyn, Reproductive Sciences)
– Key Personnel: Shuvo Roy, PhD (Professor, UCSF Department of Bioengineering) | Sara Newmann, MD (Associate Professor, UCSF Department of Ob/Gyn, Reproductive Sciences) | Kamran Haikal, (Project Coordinator, UCSF Department of Family and Community Medicine) | Susana Berrios, (Clinical Research Coordinator, UCSF)
SuperAlarm
In an ICU setting, monitoring alarms indicating potential medical issues occur ~200 time per day per patient. False alarms represent 80+% of this total leaving nurses and providers with alarm fatigue, desensitized to actual patient emergencies. Super Alarm uses a machine-learning approach to analyze physiologic monitoring, alarm data, lab results, EHR information, and electrocardiogram waveform data using sophisticated software algorithms to 1) Provide more meaningful views of real time patient condition, and 2) Generate higher level insights that can predict patients who will suffer cardiopulmonary events hours in advance.
Super Alarm has used structured clinician input to identify how to use alarm patterns and incorporate them into workflow in order to prevent code blue occurrences. Our team believes that SuperAlarm technology can be used to improve hospital alarm fatigue by managing nuisance and false alarms and will provide caregivers with clinical patterns that can identify patients at-risk for cardiac arrest.
– Project Leaders: Xiao Hu, PhD (Associate Professor, UCSF Department of Physiological Nursing) | Richard Fidler, Ph.D., CRNA (Assistant Professor, UCSF Department of Physiological Nursing)
– Key Personnel: Andrea Villaroman, MTM | Michele Pelter, PhD, RN (Assistant Professor, UCSF Department of Physiological Nursing) | Jacob Abba (Software Developer) | Del Bold, M.S. (Programmer | Kavya Katipalli, M.S. (Software Engineer) | Robin Ma (Programmer) | Yong Bai, PhD (Algorithm Programming Developer | Suba Sukardi, RN, MSN (Research Assistant, UCSF School of Nursing) | Matt Aldrich, MD (Chief of Critical Care Medicine, UCSF Medical Center) | David Kim, M.D., MBA (Clinical and Business Strategy Advisor) | Paul Work, JD, MBA (Legal and Business Strategy Advisor)
Lamprey
Lamprey helps surgeons perform minimally invasive surgery by facilitating soft tissue manipulation with minimal injury. Tools included in the current standard of care – mostly plier-like graspers – have the potential to cause damage to tissue through forces applied inadvertently by the surgeon. Lamprey uses vacuum force to atraumatically grip and manipulate tissues. We are working on optimizing the design to safely and firmly grip a variety of tissues while ensuring that the ergonomics of the device are comfortable, familiar to surgeons, and intuitive. As part of our goals for this year, we are assisting with the patent application process, designing pre-clinical testing, and developing commercialization strategies.
– Project Leader: Insoo Suh, MD (Assistant Professor, UCSF Department of Surgery)
– Key Personnel: Orlo Clark (Professor Emeritus, (UCSF) | Isabelle Chumfong (Surgical Innovations Fellow) | Sachin Rangarajan (Engineer, UCSF Department of Surgery) | Romain Roux, Lamprey, MTM | Sam Seymour, MTM
MayaLife
In recent years, medical innovations have increased the likelihood of early breast cancer risk detection. However, current methods for acting on this newly accessible knowledge – preventing and managing breast cancer – are limited to bilateral mastectomies (removal of both breasts), hormone treatment, and regular physical examinations. These methods are, respectively, highly morbid, fraught with side effects, and highly tedious necessitating a better solution.
The MayaLife team is working on an implantable medical device for breast cancer which will deliver anti-hormone drug directly and locally to breast tissue. The device is designed to include tubing filled with an FDA approved anti-hormone drug, a backing which limits drug release solely to breast tissue and a biocompatible encasing. As a result, drug delivery will be more efficient, patient compliance would increase compared to traditional hormone therapy, and the side effects from systemic exposure to their medication would be minimized. The team is working towards implementing the device into a large animal study, evaluating the market potential for the product and navigating through the intellectual property and regulatory landscape.
– Project Leader: Pamela Munster, MD (Professor in Residence, UCSF)
– Key Personnel: Scott Thomas, PhD (Manager, Munster Laboratory) | Hani Sbitany, MD (Assistant Director of Clinical Surgery, UCSF Department of Surgery), Jim Kiriakis (Director of Innovation, Technology and Alliances at UCSF) | Don Pearline (FDA Consultant and Regulatory Advisor)
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Projects from 2015-16
SmartDerm
SmartDerm is an intelligent wound dressing that detects pressure. This can be used to map out pressure over time of different areas on a patient and ultimately prevent pressure ulcers through interventions informed by pressure data. We have a working prototype for the pressure sensor and are currently refining a static algorithm which can stratify patients for ulcer risk based on their existing health conditions. In addition, we are developing a web-based software platform so that nurses can have easier access to the information.
– Project Leaders: Hanmin Lee, MD (Director of the Fetal Treatment Center; Professor & Surgeon in Chief, Vice-Chair, Department of Surgery, UCSF) | Michael Hemati, MTM (CEO and Co-Founder of SmartDerm Inc.; Associate Specialist, UCSF)
– Academic Collaborator: Shuvo Roy, PhD (Professor of Bioengineering and Therapeutic Science, UCSF)
– Project Collaborators: Sachin Rangarajan, MTM (CTO and Co-Founder SmartDerm Inc.; Assistant Specialist, UCSF)
The Lamprey: A novel surgical device for atraumatic grasping and manipulation of soft tissues
The goal of the Lamprey capstone project is to develop an improved instrument for soft tissue manipulation in laparoscopic surgery. Current tools – mostly plier-like graspers – have the potential to cause damage to tissue through forces applied inadvertently by the surgeon-user. The Lamprey uses a novel tissue contact mechanism to more effectively grip and manipulate tissues without injury. Inherent to our device is the ability to be deployed through the very small incisions required of laparoscopic surgery. We are working on strategies for collapsing the head of the device into a small chamber so that it may be deployed once it has passed through the incision. We are also optimizing the design of the handle used for adjusting the gripping force so that the ergonomics are comfortable, familiar to surgeons, and intuitive. Additionally, management of IP, identification of regulatory pathways, and commercialization strategies are all important parts of the Lamprey project.
– Project Leader: Insoo Suh, MD (Assistant Professor of Surgery, UCSF)
– Project Collaborators: Orlo Clark, MD (Professor Emeritus of Surgery, UCSF) | Sachin Rangarajan, MTM (Assistant Specialist, UCSF) | Isabelle Chumfong, MD (Design and testing co-lead)
Device for local anti-estrogen drug delivery in high risk individuals
In recent years, medical innovations have increased the likelihood of early breast cancer risk detection. However, current methods for acting on this newly accessible knowledge – preventing and managing breast cancer – are limited to bilateral mastectomies (removal of both breasts), hormone treatment, and regular physical examinations. These methods are, respectively, highly morbid, fraught with side effects, and highly tedious. Our project aims mitigate all three of these disadvantages through the development a flat implantable device that will deliver anti-estrogen drugs directly and locally to breast tissue over an extended period of time. Ideally, the device will be used not only for low-burden therapeutic methods, but also for sustained prevention of this deadly disease.
– Project leader: Pamela Munster, MD (Professor, Program Leader for Developmental Therapeutics, Helen Diller Family Comprehensive Cancer Center, UCSF)
– Business collaborator: Jim Kiriakis (Director of Innovation, Technology and Alliances, UCSF)
– Prototype design collaborator: Hani Sbitany, MD (Assistant Professor of Clinical Surgery, UCSF)
– Chief operational scientist: Scott Thomas, PhD (Assistant Researcher, UCSF)
– FDA consultant: Don Pearline
UCRIT: Monitoring kidney transplant injury with a mobile phone
Kidney transplantation is the treatment of choice for patients with end-stage kidney failure. However, the life of the donor kidney is limited, commonly due to unrecognized immune injury that can progress to acute rejection (AR). Once a patient is determined to have AR, they can either be put back on the waiting list for another donor kidney, or more likely, are put on dialysis. Current methods for detecting AR are costly, invasive, and limited in predicting rejection. Therefore, there is a need to develop a cost-effective, noninvasive method of detection that can help physicians increase the efficacy of kidney transplantation by adjusting treatment plans as necessary. Our project’s goal is to create a non-invasive kidney transplant monitoring device to accurately assess renal injury either in the clinical or at-home setting. This device will work to detect biomarkers in urine that have a positive correlation to kidney AR. The development of a cost-effective device has implications both in the United States and developing countries that will significantly lower the burden on the health care system by extending the lifespan of transplant kidneys.
– Project leaders: Tara Sigdel, PhD (Assistant Professor, Department of Surgery, UCSF) | Minnie Sarwal, MD, PhD (Professor of Surgery, UCSF)
– Academic Collaborator: Shuvo Roy, PhD (Professor of Bioengineering and Therapeutic Science, UCSF)
SuperAlarm: System to predict patient deterioration and address monitor alarm fatigue
SuperAlarm is an advanced analytics platform for precise patient monitoring. The goals of this technology is three-fold. First, SuperAlarm prioritizes the most critical alarms, safely silencing others, thus reducing alarm fatigue in staff. Second, our pattern-recognizing analytics will allow reliable prediction of declining patient conditions. Third, the platform seamlessly integrates vital signs, waveforms, lab results, and alarms into one easy to understand system.
– Project leaders: Xiao Hu, PhD (Associate Professor, Department of Physiological Nursing, UCSF) | Matt Aldrich, MD (Associate Professor of Anesthesia & Perioperative Care, UCSF) | Mitchell Cohen, MD (Professor of Surgery, UCSF) | Michele Pelter, RN, PhD (Assistant Professor, Department of Physiological Nursing, UCSF) | Richard Fidler, RN, PhD (Adjunct Professor, Department of Physiological Nursing, UCSF)
– Project collaborators: Yong Bai (PhD Candidate, UCLA) | Andrea Villaroman, MTM
Next Generation Contrast for CT (Nextrast)
We are working on developing a novel enteric CT contrast material that will improve the diagnosis of various abdominal injuries, tumors, and other conditions. The imaging properties of the contrast agent will increase the diagnostic yield while reducing the CT radiation dose by curbing the need for repeat scans. Hurdles remain in defining the highest impact clinical niche, analytical tests, and optimal formulation. As MTM students working with UCSF investigators, our focus is to help in toxicity testing, clinical trial design, image processing, and literature reviews. We are aiding in pushing this technology to the next step: FDA approval for clinical trials.
– Project Leader: Benjamin Yeh, M.D. (Professor of Radiology, UCSF)
– Academic Collaborators: Jack Lambert, PhD (CT Physicist, UCSF) | Yan Jun Fu PhD (Associate Research Scientist, UCSF)
– Clinical Collaborators: Zhen Jane Wang MD (Associate Professor of Radiology, UCSF)
Wearable Cognitive Assist Device for the Elderly
Otto is an integrated smartwatch solution to the progressive needs of elderly patients. It permits family caregivers or clinicians to (i) facilitate telecommunication between the patient and a limited number of key contacts; (ii) push calendar reminders to the patient for medications, appointments and other important events; (iii) passively monitor patient activity; and (iv) maintain an ongoing cognition assessment through a series of basic Longitudinal Cognitive Measurement (LCM) tests displayed on the device. We expect this device will support patients living in the home safely longer, and thus delay long-term care placement and reduce caregiver stress. Caregivers who do not live with the patient or who have obligations outside the home can monitor and communicate with the patient more easily and ensure their loved one’s safety. With our memory-supporting device, the patient can function at a higher level, thus reducing caregiving demands and improving his or her own self-efficacy
– Project Leader: Pierre Theodore, MD (Associate Professor of Cardiothoracic Surgery, UCSF)
– Collaborators: Helena Mentis, PhD (Assistant Professor of Information Systems, University of Maryland, Baltimore County) | Galina Madjaroff, MA (Clinical Assistant Professor, Management of Aging Services, University of Maryland, Baltimore County)
MARC: Magnetically assisted remote controlled catheter for endovascular interventional MRI
Magnetically-assisted remote control (MARC) steering of endovascular catheters: The goal of this project is to develop a novel MR-compatible surgical device for stroke intervention to increase the efficacy of endovascular surgery. The MARC Catheter is a remotely steerable microcatheter that exploits the magnetic field generated by a MR scanner. The microcatheter tip utilizes microcoils which allow the tip of the catheter to be deflected in two dimensions by applying a small current while under a strong magnetic field. The MARC Catheter also includes a wireless resonant coil for increased visualization of the catheter location during procedures.
– Project Leader: Steven Hetts, MD (Associate Professor of Radiology, UCSF)
– Collaborators: Caroline Jordan, PhD (Postdoctoral Fellow in Radiology, UCSF) | Mark Wilson, MD (Professor of Radiology, UCSF) | Alastair Martin, PhD (Professor of Radiology, UCSF) | Maythem Saeed, DVM, PhD (Professor of Radiology, UCSF)
HEAL: High-efficiency External Ambulatory Lung
The HEAL project involves working on development of a new device as an alternative to the existing treatment for severe respiratory failure due to cardiac shock, organ failure and other lung diseases such as COPD and ARDS. The current device which is an extracorporeal membrane oxygenator (ECMO) consists of a hollow fiber membrane for gas exchange, connected to a pump and catheters that takes deoxygenated blood from either a vein or artery in the body and return oxygenated blood back into the body. This procedure has many barriers to efficient gas exchange, which include large foreign surface area exposure due to tubing, problems with achieving sufficient blood flow and inefficient gas diffusion due to membrane material. These cause risks of clotting or excess bleeding when anticoagulants are used. The bulky ECMO system also decreases opportunity for mobilization and increases sedation. ECMO is also limited due to its complexity, requiring specialized surgical and care teams that are only available at a few quaternary care centers.
HEAL aims to address these issues using the unique PDMS membrane which is assembled in a parallel plate and is much more compressed and smaller than most current ECMO membrane oxygenators. Our team is facilitating commercialization of this product through prototype testing and market analysis as well as acquiring further funding for the project. We will also be involved in animal testing and further clinical studies for the device.
– Project Leader: Benjamin Padilla, MD (Assistant Professor of Pediatric Surgery, UCSF)
– Collaborators: Shuvo Roy, PhD (Professor of Bioengineering and Therapeutic Science, UCSF) | Emily Abada, (Graduate student in Bioengineering, UCSF) | Ajay Dharia, MD (Fellow in Pulmonology and Critical Care Medicine, UCSF) | Willieford Moses, M.D. (Resident and Fellow, Department of Surgery, UCSF) | Nathan Wright (Staff engineer, UCSF)
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Projects from 2014-15
Aligned Microfibrous Dural Graft for Enhanced Dura Mater Regeneration
– Project Leader: Shyam Patel, PhD (CSO, NanoNerve, Inc.)
– Academic Collaborator: Song Li, PhD (UCB)
– Clinical Collaborators: Michael McDermott, MD (UCSF) | Edward Diao, MD (UCSF)
– Regulatory Collaborator: Alan Curtis (Medical Device Industry)
Device for local anti-estrogen drug delivery in high risk individuals
– Project leader: Pamela Munster, MD (Professor, Program Leader for Developmental Therapeutics, Helen Diller Family Comprehensive Cancer Center, UCSF)
– Business collaborator: Jim Kiriakis (Director of Innovation, Technology and Alliances, UCSF)
– Prototype design collaborator: Hani Sbitany, MD (Assistant Professor of Clinical Surgery, UCSF)
– Preclinical studies collaborator: Scott Thomas, PhD (Assistant Researcher, UCSF)
Endochondral Tissue Therapy for Bone Regeneration
– Project Leader: Chelsea S. Bahney, PhD (Assistant Adjunct Professor – UCSF Department of Orthopaedic Surgery, Visiting Scientist – UC Berkeley Bioengineering & Material Science)
– Academic Collaborators: Ralph Marcucio, PhD (Director of the Laboratory of Skeletal Regeneration, UCSF) | Kevin Healy, PhD (Chair of the Department of Bioengineering and Material Science, UC Berkeley) | Wes Jackson, PhD (Senior Scientist UC Berkeley and Chief Science Officer, Valitor Inc.) | Amit Jha, PhD (Post-Doctoral Fellow, UC Berkeley)
– Clinical Collaborator: Theodore Miclau, M.D. (Chair of the Orthopaedic Trauma Institute, UCSF)
Gauss Surgical
– Project Leaders: Siddarth Satish (Founder and CTO, Gauss Surgical, Inc) | Drew Hosford (Director of Engineering, Gauss Surgical, Inc.) | Charlie Carroll (Operations Lead, Gauss, Inc.
– Project Collaborator: David M. Rempel, MD, MPH (Professor of Medicine, UCSF; Professor in Bioengineering, UC Berkeley)
MYOSEAL: A Novel Product for Hernia Prevention
– Project Leader: Hobart Harris, MD, MPH (UCSF Professor of Surgery and Chief of the Division of General Surgery, J. Engelbert Dunphy Endowed Chair in Surgery)
– Clinical Collaborator: David Young, MD (UCSF Professor of Surgery, Division of Plastic and Reconstructive Surgery)
Next Generation Contrast for CT (Nextrast)
– Project Leader: Benjamin Yeh, MD (Radiologist, UCSF)
– Academic Collaborators: Jack Lambert, PhD (CT Physicist, UCSF) | Yan Jun Fu, PhD (Chemist, UCSF)
– Clinical Collaborators: Zhen Jane Wang MD (Radiologist, UCSF) | Margaret Wong (Medical Student, UCSF)
– Business Collaborator: Tony Yeh (Business Consultant)
SmartDerm
– Project Leaders: Hanmin Lee, MD (Director of the Fetal Treatment Center; Professor & Surgeon in Chief, Vice-Chair, Department of Surgery, UCSF) | Michael Hemati, MTM (CEO and Co-Founder of SmartDerm Inc.; Associate Specialist, UCSF)
– Academic Collaborator: Shuvo Roy, PhD (Professor of Bioengineering and Therapeutic Science, UCSF)
– Project Collaborators: Sachin Rangarajan, MTM (CTO and Co-Founder SmartDerm Inc.; Assistant Specialist, UCSF) | Elizabeth Gress (Innovation Program Coordinator, Pediatric Device Consortium, Department of Surgery, UCSF)
Smart Diaphragm
– Project Leader: Larry Rand, MD (Director of Perinatal Services at the UCSF Fetal Treatment Center, UCSF OB/GYN)
– Technical Collaborators: Shuvo Roy, PhD (UCSF Bioengineering & Therap. Sci. Professor – Director of UCSF Biodesign Laboratory & Co-PI of Smart Diaphragm Project) | Mozziyar Etemadi, MS, PhD, 3rd Year Medical Student (Electrical Engineer & Co-PI of Smart Diaphragm Project) | Philip Chung, MS, 1st Year Medical Student (Bioengineer & Smart Diaphragm Project Director) | J. Alex Heller, MS (Staff Mechanical Engineer – Hardware Manager in UCSF Biodesign Laboratory) | Kamran Haikal, BA (Staff Analyst – Smart Diaphragm Project Coordinator)
– Clinical Collaborators: Juan Gonzalez, MD, MS, FACOG (UCSF Perinatologist & Asst. Professor) | Megan Huchko, MD, MPH (UCSF OB/GYN & Asst. Professor) | Sara Newmann, MD, MPH (UCSF OB/GYN & Asst. Professor) | Lily Black, BA (OB/GYN Researcher – Clinical Research Coordinator) | Samantha Torres, MS (OB/GYN Researcher – Clinical Research Coordinator)
Valitor, Inc.
– Project Leader: Wesley M. Jackson, PhD (Chief Science Officer)
– Project Collaborators: Kevin E. Healy, PhD (Director), David V. Schaffer, Ph.D. (Director)
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Projects from 2013-14
Aligned Nanofibrous Dural Substitute for Enhanced Dura Mater Regeneration
– Project Leader: Shyam Patel, Ph.D. (CSO, NanoNerve, Inc.)
– Academic Collaborator: Song Li, PhD (UCB)
– Clinical Collaborators: Michael McDermott, M.D. (UCSF) | Edward Diao, MD (UCSF)
– Regulatory Collaborator: Alan Curtis (Medical Device Industry)
Amnioseal
– Project Leader: Michael R. Harrison, MD (Director, Division of Pediatric Device Consortium, UCSF)
– Project Collaborators: Robert Grubbs, PhD (Associate Professor of Chemistry, Caltech) | Shuvo Roy, PhD (Co-Director, Pediatric Device Consortium) | Richard Fechter, (Clinical Engineer, Pediatric Device Consortium) | Elisabeth Leeflang, MD (Postdoctoral Research Fellow, Pediatric Device Consortium) | Dillon Kwiat, (Mechanical Engineer, Pediatric Device Consortium) | Elizabeth Gress (Program Coordinator, Pediatric Device Consortium)
DiAssess
– Project leaders: John Waldeisen, PhD (CEO and Co-Founder of DiAssess, Inc) | Deborah Dean, PhD, MPH (Executive Director of CGHI)
– Project collaborators: Debkishore Mitra, PhD (Co-Founder of DiAssess, Inc) | Ivan Dimov, PhD (Research Scientist at UC Berkeley BioPOETS Lab)
Ocular CellScope
– Project Leader: Dan Fletcher, Ph.D. (Purnendu Chatterjee Chair in Engineering Biological Systems, Department of Bioengineering, UCB)
– Clinical Collaborator: Todd P. Margolis, M.D., Ph.D. (Professor of Ophthalmology, Director of Francis I. Proctor Foundation for Research in Ophthalmology, UCSF)
– Project Collaborators: Frankie Myers, Ph.D. (Assistant Research Engineer, Department of Bioengineering, UCB) | Robi Maamari (M.D. Student, UC Irvine School of Medicine) | Tyson Kim, M.D. (Ph.D. Candidate, UCSF) | Jeremy Keenan, M.D., MPH (Associate Professor in Residence at Francis I. Proctor Foundation for Research in Ophthalmology, UCSF) | Clay Reber, MTM (Research Assistant, Department of Bioengineering, UCB)
SmartDerm
– Project Leader: Hanmin Lee, MD (Director of the Fetal Treatment Center and Professor & Surgeon in Chief, UCSF)
– Academic Collaborator: Shuvo Roy, PhD (Associate Professor of Bioengineering and Therapeutic Science, UCSF)
– Clinical Collaborator: Shinjiro Hirose, MD (Assistant Professor of Surgery, Division of Pediatric Surgery and Fetal Treatment Center, UCSF)
– Project Collaborators: Mozziyar Etemadi, M.S. (MD/PhD Student, UCSF/UC Berkeley) | Derek Ulvila, MD (Surgical Research Fellow, UCSF) | Philip Chung, MS (Engineer, Pediatric Device Consortium) | Elizabeth Gress ( Program Coordinator, Pediatric Device Consortium)
Valitor
– Project Leaders: Wesley M. Jackson, PhD (Chief Science Officer, Valitor) | Kevin E. Healy, PhD.(Founder, Valitor) | David V. Schaffer (Founder, Valitor)
– Project Collaborators: Nancy Boudreau, PhD.(General advisor, Valitor) | David Young, MD (General advisor, Valitor) | Taylor Holstlaw (Lab staff, Valitor)
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Projects from 2012-13
Aligned Nanofibrous Dural Substitute for Enhanced Dura Mater Regeneration
– Project Leader: Shyam Patel, Ph.D. (CSO, NanoNerve, Inc.)
– Academic Collaborator: Song Li, PhD (UCB)
– Clinical Collaborators: Michael McDermott, MD (UCSF) | Edward Diao, MD (UCSF)
HDL Nexus Assay
– Project Leader: Michael Oda, PhD (Childrens Hospital Oakland Research Institute)
– Academic Collaborator: Mark Borja, PhD (Childrens Hospital Oakland Research Institute)
HeartPulse: A Cloud-Enabled Device for Monitoring Heart Failure at Home
– Project Leader: Shuvo Roy, PhD (Associate Professor of Bioengineering and Therapeutic Science, UCSF)
– Project Collaborators: Mozziyar Etemadi, MS (MD/PhD Student, UCSF/UC Berkeley) | Kendra Johnson, (Medical Student, UCSF) | David Tseng, (Medical Student, UCSF)
– Clinical Collaborators: Teresa DeMarco, MD (Director of Heart Failure and Pulmonary Hypertension Program & Professor of Medicine, Division of Cardiology, UCSF) | Liviu Klein, MD, MS (Assistant Professor of Medicine, Division of Cardiology, UCSF) | Munir Janmohamed, MD (Assistant Professor of Medicine, Division of Cardiology, UCSF) | Thomas Bodenheimer, MD, MPH (Co-Director of Center for Excellence in Primary Care & Professor of Family and Community Medicine, UCSF) | Margaret Wheeler, MD (Professor of Medicine, UCSF)
Magnagrasp
– Project Leader: Michael R Harrison, MD (Professor Emeritus of Surgery, Pediatrics and OB/GYN; Director, Pediatric Device Consortium)
– Academic Collaborators: Shuvo Roy, PhD (Associate Professor of Bioengineering and Therapeutic Sciences at UCSF; Director, Biomedical Microdevices Laboratory at Mission Bay | Co-director, Pediatric Device Consortium) | Dillon Kwiat, B.S. (Mechanical engineer, Pediatric Device Consortium)
Phantom To Improve Deformable Image Registration
– Project Leader: Jean Pouliot, PhD (Professor and Vice Chair, Director of Physics Division, UCSF Department of Radiation Oncology)
– Academic Collaborators: Neil Kirby, PhD (Postdoctoral Fellow, UCSF Department of Radiation Oncology) | Kamal Singrao (Research Assistant, UCSF Department of Radiation Oncology)
Using True3D to Increase Intuition in Medical Visualization
– Project Leader: Elizabeth Lytle, MPH, RN (Director of Business Development, EchoPixel, Inc.)
– Project Collaborators: Ron Schilling, PhD (CEO, EchoPixel, Inc.) | Sergio Aguirre, M.S.E.E. (CTO/Founder, EchoPixel, Inc.)
– Clinical Collaborator: Judy Yee, MD (UCSF and SF VA Medical Center)
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Projects from 2011-12
Aligned Nanofibrous Dural Substitute for Enhanced Dura Mater Regeneration
– Project Leader: Shyam Patel, PhD (CSO, NanoNerve, Inc.)
– Academic Collaborator: Song Li, PhD (UCB)
– Clinical Collaborators: Michael McDermott, MD (UCSF) | Edward Diao, MD (UCSF)
Bringing Virtual Health to the West
– Project Leader: Alex Go (CEO, Virtual Health Corp.)
– Clinical Collaborator: Albert Levy, MD (Chief Medical Officer, Virtual Health Corp.)
– Technical Collaborator: Amit Gupta (CTO, Virtual Health Corp.)
Endovascular Magnetic Catheter for Interventional MRI
– Project Leader: Steven Hetts, MD (UCSF)
– Academic Collaborators: Maythem Saeed, PhD (Adjunct Professor of Radiology and Biomedical Imaging, UCSF) | Alastair Martin, PhD (Associate Adjunct Professor of Radiology, UCSF) | Shuvo Roy, PhD (Associate Professor of Biopharmaceutical Sciences, UCSF) | Anthony Bernhardt, PhD (Independent Consultant, UCSF) | Leland Evans (Electronics Technologist, Lawrence Livermore National Laboratory) | Vincent Malba, PhD (Assistant Adjunct Professor of Radiology, UCSF) | Timothy Roberts, Ph.D. (Professor of Radiology, UPenn)
– Clinical Collaborators: Mark Wilson, MD (Professor of Radiology, UCSF) | Joey English, MD (Assistant Professor of Clinical Radiology, UCSF) | Fabio Settecase, MD (Resident Physician, UCSF) | Ronald Arenson, MD (Professor and Chair of Radiology and Biomedical Imaging, UCSF)
MAGIC Magnetic Grasper
– Project Leader: Michael Harrison, MD (UCSF)
– Engineering Collaborator: Dillon Kwiat (Jr. Development Engineer, UCSF)
Point-of-Care for Global Health Diagnostics
– Project Leader: Amy Herr, PhD (UCB)
– Academic Collaborators: Kelly Karns (Graduate student researcher, UCB) | Todd Duncombe (Graduate student researcher, UCB)
– Clinical Collaborator: Deborah Dean, MD, MPH (CHORI)
Portable Artificial Kidney
– Project Leader: Shuvo Roy, PhD (UCSF)
– Academic Collaborator: Rishi Kant, PhD (Postdoctoral Researcher, UCSF)
– Clinical Collaborator: Paul Brakeman, MD, PhD (Associate Professor, Department of Pediatric Nephrology, UCSF)
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Projects from 2010-11
Amnioseal: Presealing the Amniotic Membrane Prior to Fetoscopic Surgery
– Project Leader: Michael Harrison, MD, Pediatric Surgery (UCSF)
– Academic Collaborators: Shuvo Roy, PhD, Biomedical Microdevices Laboratory (UCSF) | Jenni Buckley, PhD, Orthopaedic Trauma Institute (UCSF)
Biomimetic Matrices Improve Post-Infarct Cardiac Function
– Project Leader: Kevin E. Healy, PhD (UCB)
– Clinical Collaborators: Michael J. Mann, MD (UCSF) | Yerem Yeghiazarians, MD (UCSF)
Bringing Direct-Brain Drug Delivery for the Treatment of Neurological Diseases to Patients
– Project Leader: Krystof Bankiewicz, MD, PhD (UCSF)
DiAssess: Self-powered Integrated Microfluidic Blood Analysis System
– Project Leader: Dr. Luke Lee, PhD (UCB)
– Clinical Collaborators: Professor Paul Van Helden (Director, Centre for Cellular and Molecular Biology and the Desmond Tutu Tuberculosis Centre for Excellence, University of Stellenbosch) | Gert Van Zyl, MD (Medical Virology, University of Stellenbosch) | Susan Lynch (Assistant Professor, Director, Colitis and Crohn’s Disease Microbiome Research Core, Department of Medicine, UCSF)
Intelligent Obstetrics: Minimally Invasive Probe for Detection of Pre-Term Labor
– Project Leader: Shuvo Roy, PhD (UCSF)
– Clinical Collaborator: Larry Rand, MD, Obstetrics and Gynecology (UCSF)
The Interface Design for Robotic Surgery: Impact on Quality and Productivity
– Project Leader: Dr. David Rempel, MD, MPH (UCSF/UCB)
