2024 Create the Future Design Contest: Honorable Mentions

Vivally

Jill Schiaparelli
Avation Medical, St. Paul, MN

Overactive bladder (OAB) and urinary incontinence are chronic conditions that impact more than 500 million people globally, significantly reducing their quality of life and, in many cases, substantially reducing their work productivity. Traditional treatments for these conditions range from medications to neurotoxin injections to surgical implantation of stimulators to provide neuromodulation therapy. These treatment options come with such significant drawbacks that more than 90 percent of patients drop out of the treatment pathway — choosing to wear diapers rather than have therapy.

The Vivally System is the only FDA-cleared, closed-loop, athome, noninvasive neuromodulation device system. Combined with a companion mobile application, Vivally offers a comprehensive therapy and support system for patients suffering from urge urinary incontinence and urinary urgency caused by OAB. Vivally is prescribed by a clinician following a brief clinical evaluation which includes personalized calibration. Personalization establishes an EMG target and range of neuromodulation energy associated with the detection of an EMG signal to indicate nerve activation. Vivally delivers clinically effective therapy in just 30 minutes, as little as once per week.

Vivally employs an innovative, physiologic closed-loop design, a feature that sets it apart from conventional neuromodulation devices. The device dynamically adjusts therapy delivery in response to real-time physiological feedback from the patient’s EMG signal, ensuring that the nerve target — the tibial nerve — remains activated during therapy. Continuous monitoring of the EMG signal allows Vivally to automatically adjust therapeutic output based on the patient’s electrical demand during therapy.

Vivally’s electrical signal is personalized for each patient during an office visit where a physician calibrates Vivally and sets a therapeutic output range. During at-home therapy sessions, electrical output automatically adjusts within the range established by the care provider.

Beyond clinical efficacy, Vivally extends its impact through its companion mobile application, which serves as a comprehensive therapy and support platform for patients. With personalized therapy reminders and progress tracking, a bladder and fluid intake diary, and remote clinician connectivity, the mobile application empowers patients with tools and resources necessary to navigate their treatment journey with confidence.

The transformative potential of the Vivally System impacts patients, providers, and payers alike. By offering a costeffective, noninvasive alternative to traditional treatment modalities, Vivally reduces healthcare expenditures associated with OAB management while simultaneously improving patient outcomes and quality of life. Furthermore, its remote monitoring capabilities enable clinicians to remotely assess patient progress, adjust therapy parameters, and intervene proactively as needed, thereby streamlining care delivery.

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Wearable, Noninvasive, Continuous Blood Pressure Monitors for Maternal Health

Xina Quan
PyrAmes, Cupertino, CA

PyrAmes is a digital health company focused on fundamentally transforming healthcare delivery through continuous blood pressure (BP) monitoring that is accurate, wireless, and noninvasive. The wearable devices’ comfort and ease-of-use will enable better BP management for patients from newborns to seniors.

Blood pressure is a critical biomarker for many medical conditions affecting the lives of hundreds of millions of people. Tighter BP control can lead to better outcomes for the 116 million American adults suffering from hypertension. Frequent BP measurements are needed for critical or emergency care, home medical management for stroke or cardiac patients, and monitoring of women at risk of hypertension disorders of pregnancy such as preeclampsia.

Current BP monitoring includes inserting an invasive arterial line (high risk; requires highly trained clinicians; appropriate only for in-hospital settings) and intermittent measurements using inflatable BP cuffs (cumbersome; sparse data; fraught with patient compliance issues). Automated cuff devices (ABPMs) are inconvenient and uncomfortable (and painful for some) and carry risk of tissue damage.

The PyrAmes technology has been used successfully on patients ranging from newborns to adults 89+ years old. The device provides timely data to treat patients at risk of rapid changes in BP that can lead to stroke or multiple organ failure, while removing the pain and risk of the current standards of care at lower cost and increased patient compliance. It also offers the possibility of remote monitoring for caregivers.

FDA recently granted 510(k) market clearance as a Class II medical device for the company’s lead product Boppli^® (K223873), for neonates undergoing critical care. The Bosimi ^® and Bosimi@ Home^® platforms extend the technology to the adult population, currently focusing on maternal health for mothers during the important prenatal and critical 6–8-week postpartum periods, funded in part by the NIH RADx Tech for Maternal Health Challenge.

The wearable device uses paper-thin capacitive sensors to capture pulse waveforms processed with neural networks to produce BP values that meet the FDA’s accuracy guidelines. Its passive measurements with a comfortable band and an easy-to-use app will improve compliance to provide more effective care. In volume, the devices can be manufactured using roll-to-roll processes and could be integrated into smartwatch bands.

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Minimally Invasive Tissue Sealing (MITS) Patch

Sarah Wu
MIT, Cambridge, MA

Recent advancements in surgical technologies have enabled a shift toward less-invasive procedures, improving patient outcomes by reducing pain, operation and recovery times, and healthcare costs. However, minimally invasive surgery (MIS) still faces challenges, including loss of visualization, haptic feedback, and range of motion. One critical challenge in MIS is tissue repair and reconnection. Currently, the traditional strategies of applying mechanical fasteners (i.e., sutures and staples) are the gold standard. However, suturing is technically challenging and time-consuming, and both sutures and staples can cause tissue damage and leakage. Related postoperative complications, such as anastomotic leaks, can lead to serious consequences and potential need for additional surgeries.

Bioadhesives offer a potential solution but are limited by delivery methods, adhesion performance, and tissue interactions. Most are liquids or glues that can be easily displaced and diluted in physiological environments or are ineffective when contaminated by blood or mucus. Many also suffer from insufficient adhesion strength and poor biocompatibility.

Leveraging advances in material design, the team has proposed a novel multifunctional patch designed for robust, minimally invasive tissue adhesion in diverse physiological environments. The patent-pending minimally invasive tissue sealing (MITS) patch features a hydrophobic liquid interface that repels blood and contaminants, enabling delivery within the body. Upon pressure application, the adhesive layer contacts the tissue and adheres within seconds through a unique dry-cross-linking adhesion mechanism. An antifouling zwitterionic backing minimizes ostoperative infection and inflammation. The patch can be folded into compact shapes and coupled with existing MIS tools, such as balloon catheters and staplers, enabling user-friendly application in confined spaces.

The MITS patch prototype has demonstrated superior adhesion in benchtop tests and reduced inflammatory responses in in vivo subcutaneous implantations in mice. Ex vivo experiments with porcine organs have demonstrated effective sealing of tracheal, esophageal, aortic, and intestinal defects using minimally invasive delivery methods, even in the presence of blood and other biofluids.

The global surgical sealants and adhesives market, valued at USD 2.5 billion in 2023, is projected to reach $5.4 billion by 2030. The MITS patch’s advantages in fluid resistance, fast adhesion, and reduced inflammation position it for significant market capture. A forecasted 5 percent market share by 2030 translates to $27 million. Additionally, the MITS patch targets the MI surgical instruments market, valued at $31.7 billion in 2024. Partnering with leading medical device companies could be synergistic for optimizing and distributing the MITS patch, enhancing its market penetration and impact.

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Polymeric Nanoparticles (PNPs) and the HIT SCAN™ Platform

Krista Smith, Andrea McCue, Tony Duong, Allison Secard, Katie Lianez, Gabe Meister, Emma Coughlin, Russell Kittel
Battelle, Columbus, OH

Gene therapy holds the potential to cure genetic disorders by directly correcting underlying genetic defects. However, the delivery of genetic therapeutics to target specific cell types remains a challenge. Traditional adeno-associated viruses (AAVs) and lipid nanoparticles (LNPs) have been the primary carriers for gene therapies.

Battelle has developed a platform for the discovery of novel polymeric nanoparticles (PNPs) delivery vehicles. Battelle uses polymer chemistry to design PNPs with tailored properties that offer advantages over traditional gene carriers: they can encapsulate larger and multiple types of genetic material, are less immunogenic and toxic, and can be tailored to target specific cells, reducing both off-target effects and the required dose for efficacy. Additionally, PNPs can be manufactured cost-effectively at scale due to the simplicity of their synthetic processes.

At the heart of this advancement is Battelle’s HIT SCAN™ platform, which applies the design-build-test-learn approach to nanoparticle development. The platform begins with automated polymer synthesis, allowing for the creation of a diverse library of PNPs. These nanoparticles are then subjected to high-throughput in vitro and in vivo screening, assessing characteristics like cargo compatibility, delivery efficiency, biodistribution, and cytotoxicity. The data collected is used to refine the nanoparticles through machine learning algorithms, enhancing their design based on performance metrics.

Battelle applied this technology in a collaborative effort with UC Davis and the Pennington Biomedical Research Center at the University of Alabama, Birmingham. These institutions utilized PNPs developed via the HIT SCAN™ platform to target Schwann cells for the treatment of neurofibromatosis (NF1), a genetic condition characterized by tumor growth along nerves. Early results indicate successful targeting and delivery of a large genetic payload, showcasing the platform’s ability to rapidly iterate and improve nanoparticle designs based on biological feedback.

The HIT SCAN™ platform represents a significant advancement over current technologies. It not only addresses key limitations of AAVs and LNPs but also demonstrates feasibility through its streamlined synthesis process. Its ability to rapidly produce a wide array of targeted, effective, and safe nanoparticles at a reduced cost is a game-changer for the field of gene therapy.

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