Medical Technologies

Researchers at the University of the Basque Country have developed a technique that allows them to 3D print pharmaceutical tablets using different types of starch. By modifying the types of starch used and the shape of the tablets, the team can fine-tune drug release to be either rapid or slow. This includes full release of the encapsulated drug in as little as ten minutes to as long as six hours, providing significant scope to address a wide variety of therapeutic situations. The technique could allow for more personalized medicine for patient cohorts who require specialized dosing regimens, such as young children and elderly people. Another benefit of the approach is the ability to deliver hydrophobic drugs, which typically are challenging to formulate because they won’t dissolve in water.

Oral dosing of drugs in the form of ingestible tablets is in some ways the simplest way to deliver a drug, requiring a patient to simply swallow a tablet. However, there is a lack of diversity in the doses available for certain patients. Such patients will often require different doses compared with standard adult doses, and may benefit from different release profiles. This is also true of patients with differing levels of disease severity, and genetics and gender can also play a role in the most appropriate dosing and release profile for a specific patient.

However, tablets are often available in a ‘one-size-fits-all’ formulation that does not account for these nuances. To address this, these researchers have developed a method to 3D print tablets and fine tune release to create a more personalized approach to oral medication.

To create their customs pills, the researchers turned to a natural material, starch. “We were able to prepare tablets based on three types of starch -two types of maize starch (normal and waxy) and one type of potato starch- with different geometries and loaded with a non-soluble drug,” said Kizkitza González, one of the creators of the new types of tablets.

By using different types of starch, the researchers were able to drastically alter the release profile of the included drug. “We observed the importance of the botanic origin of the starch in practically all the properties, such as porous microstructure, the formation of a stable network or the release of the drug,” said González. “In the case of normal maize starch, drug release is instantaneous and the drug is fully released within 10 minutes; in the case of waxy maize starch and potato starch, release is more continuous and can take up to 6 hours for full release. We were also able to demonstrate the importance of tablet geometry in drug release.”

Finally, by combining two different types of starch, the researchers were able to create bi-phasic release, allowing for more advanced applications. “Tablets combining different types of starch were also printed,” said González. “In this case, release takes place in two stages. For example, in the case of an infection, in an initial stage using normal maize starch, a medicine could be released immediately to alleviate pain, and in a subsequent stage, with either of the other two types of starch, an antibiotic could be released more continuously.”

Study in journal International Journal of Pharmaceutics: 3D printing of customized all-starch tablets with combined release kinetics

Via: University of the Basque Country

Researchers at Penn State have developed a granular hydrogel that contains both hydrogel microparticles and self-assembling nanoparticles, and which could be highly suited for bioprinting purposes. The concept involves the nanoparticles becoming adsorbed onto the hydrogel microparticles and reversibly adhering the microparticles together, providing a printed gel structure that is porous enough to permit cell viability, but which maintains a desired shape and mechanical properties. Unlike conventional hydrogels, which consist of long polymer strands that are interlinked and surrounded by water, and which require a substantial trade-off between their porosity and their ability to maintain shape, the new bioink finds a sweet spot, allowing both porosity and shape-fidelity.

Bioprinting offers great opportunities in addressing the transplant shortage. Simply printing a new organ to order could revolutionize how we deliver medicine. However, printing viable tissues or organs is no small task, and a significant amount of research is devoted to fine tuning the properties of such printed materials so that they are best suited for their purpose.

Many bioinks trialed to date consist of bulk hydrogels. These conventional materials typically consist of an interlinked network of long polymer strands that is infused with significant amounts of water. While the material can be tuned to maintain its shape after printing, typically this results in diminished porosity, which limits the influx of biological fluids carrying nutrients and oxygen for cells within the gel. This essentially means that there is a trade-off between the mechanical properties of conventional hydrogel bioinks and their ability to support living cells.    

“The main limitation of 3D bioprinting using conventional bulk hydrogel bioinks is the trade-off between shape fidelity and cell viability, which is regulated by hydrogel stiffness and porosity,” said Amir Sheikhi, a researcher involved in the study. “Increasing the hydrogel stiffness improves the construct shape fidelity, but it also reduces porosity, compromising cell viability.”

To address this, these researchers have turned to another type of hydrogel that consists of small granules that are packed together. Their hydrogel consists of gel microspheres that are mixed with self-assembling nanoparticles. The microspheres are sticky and will pack together when printed, and the self-assembling nanoparticles also help them to bind together into a cohesive shape. This mixture forms a porous gel, but still maintains its shape.

“Our work is based on the premise that nanoparticles can adsorb onto polymeric microgel surfaces and reversibly adhere the microgels to each other, while not filling the pores among the microgels,” said Sheikhi. “The reversible adhesion mechanism is based on heterogeneously charged nanoparticles that can impart dynamic bonding to loosely packed microgels. Such dynamic bonds may form or break upon release or exertion of shear force, enabling the 3D bioprintability of microgel suspensions without densely packing them.”

Study in journal Small: Nanoengineered Granular Hydrogel Bioinks with Preserved Interconnected Microporosity for Extrusion Bioprinting

Via: Penn State

Researchers at Rice University have developed a textile control system, free of any electronics, for pneumatic wearable technology that is designed to be helpful for people with limited mobility. Medgadget recently covered the pneumatic ‘gripper’ developed by Rice researchers. Now, they have created a textile control system for such wearables, that consists of tubes through which compressed air can pass and a series of logic gates, similar to those used in computer systems, that can control the passage and pressure of the compressed air. The system would allow someone to direct the energy in the system, in the form of pressurized air, to different components in the wearable system. As an example, the researchers have developed a device that would allow someone to raise the hood of a jacket at the touch of a button.

Wearables have great potential for people with mobility issues and disabilities. However, typically such systems require an integrated computer system and a consistent snag with this approach is the need for a power supply. Such devices must either be tethered to a power cable or require an on-board battery. In the case of a wearable designed to assist someone in lifting something heavy, the required on-board battery may have to be large and bulky to cope with the energy demands of the tasks the wearable performs.

In any case, this technology dispenses with the electronics, but is inspired by the logic gates used to control digital circuits. Logic gates are junctions in circuits that take multiple inputs and then produce a single output signal. In this case, the textile logic gates are receiving an input of compressed air, and then converting that signal to an output, which could mean accepting air at a high pressure and releasing it at a lower pressure, for example.

The concept here is to allow these textile logic gates to control a series of actuators that can perform useful tasks, such as raising the hood on a jacket or activating a gripper to lift objects. “The idea of using fluids to construct digital logic circuits is not new,” said Daniel Preston, a researcher involved in the study. “And in fact, in the last decade, people have been moving towards implementing fluidic logic in soft materials, things like elastomers. But so far, no one had taken the step to implement it in sheet-based materials, a feat which required redesigning the entire approach from first principles.”

So far, the researchers have tested the system in a jacket that can raise the hood at the touch of a button and they have also tested the resilience of the textile devices, subjecting them to thousands of rounds of activity and even riding over them with a pick-up truck to demonstrate how hard-wearing they are.

See a video about the technology below.

Study in journal Proceedings of the National Academy of Sciences: Logic-enabled textiles

Flashback: Pneumatic Assistive Device for People with Disabilities

Via: Rice

Researchers at the University of Bern in Switzerland have developed a motion tracking system that is intended to assist in detecting age-related disease in elderly people. The system could be installed in someone’s home or in assisted-living facilities, and consists of a series of motion sensors that can monitor for signs of unusual movement. The system can inform caregivers if an emergency arises, such as a fall, which can be detected when someone does not return to their bed at night or is stationary for a long period, for example. However, the researchers also envisage it as helping to provide early detection for a variety of health issues, including sleep problems, cardiac arrhythmias, a worsening COVID-19 infection, or cognitive impairment.    

As our population ages, we will need to develop new solutions to keep people as healthy as possible for as long as possible. It is not practical to provide round the clock care for every aging person, but technology may be poised to provide the next best thing – a lookout. This is the motivation behind this latest technology, a motion sensing system for use at home or in healthcare facilities.

Most previous attempts to provide monitoring for vulnerable aging patients have involved wearables. While these pieces of equipment can be very effective, they are only effective if they are used properly and consistently. At the risk of generalizing, older people can sometimes struggle with new technologies, particularly if they have cognitive issues or problems with dexterity. Consequently, the need to wear and perhaps interact with a wearable can pose a problem in terms of compliance and effective use.

To address this, this latest approach is completely non-invasive and does not require input from the monitored person. Instead, a series of motion detectors are installed in someone’s living quarters, along with door sensors, a sensor in their bed, and one on their refrigerator. “We used non-contact sensors at home to create an extensive collection of digital measures that capture broad parts of daily life, behavior and physiology, in order to identify health risks of older people at an early stage,” said Narayan Schütz, one of the developers of the technology.   

In tests so far, the researchers report that the system is surprisingly good at helping in identifying health issues at an early stage. “We were able to show that such a systems approach — in contrast to the common use of a few health metrics — allows to detect age-relevant health problems such as cognitive impairment, fall risk or frailty surprisingly well,” said Tobias Nef, another researcher involved in the study.

While the system may sound like something out of 1984, the researchers are keen to point out the data security and privacy aspects of their technology. The sensors do not record video or sound, and the data are protected to medical data security standards. Moreover, installation in someone’s room or house is conceived as completely voluntary.  

Study in journal npj Digital Medicine: A systems approach towards remote health-monitoring in older adults: Introducing a zero-interaction digital exhaust

Via: University of Bern

Researchers at MIT have developed an AI system that can diagnose Parkinson’s disease and track its progression, simply by monitoring someone’s breathing patterns as they sleep. The device looks like an internet router and can be mounted on the wall in a bedroom. It emits radio waves and then a neural network analyzes the reflected waves to assess breathing patterns. Crucially, the technology may be able to assist in diagnosing Parkinson’s disease much earlier than many conventional techniques and it is highly convenient and non-invasive compared with traditional diagnostics. It may also be particularly beneficial in testing new treatments for Parkinson’s as a non-invasive method to monitor disease progression.

Diagnosing Parkinson’s in a timely manner is difficult, since in most cases the diagnostic journey does not even start until motor symptoms, such as tremor and stiffness, have become apparent. However, in many cases, the disease may have begun years earlier, meaning that the chance for early intervention has been lost. Researchers have experimented with techniques such as neuroimaging or analyzing cerebrospinal fluid, but these approaches are invasive and inconvenient, particularly for repeated assessments to check disease progression.

Now, a new method has the potential to change all this. The approach is completely non-invasive, and involves simply placing a device in the bedroom a patient sleeps in. A neural network then analyzes the patient’s breathing patterns as they sleep, which are known to be dysregulated in Parkinson’s.

“A relationship between Parkinson’s and breathing was noted as early as 1817, in the work of Dr. James Parkinson,” said Dina Katabi, one of the developers of the new system. “This motivated us to consider the potential of detecting the disease from one’s breathing without looking at movements. Some medical studies have shown that respiratory symptoms manifest years before motor symptoms, meaning that breathing attributes could be promising for risk assessment prior to Parkinson’s diagnosis.”  

Aside from early diagnosis of Parkinson’s disease, the new technology is well-suited to allow clinicians to monitor disease progression without repeat visits to the clinic and expensive and invasive interventions. It may be very useful for clinical trials of Parkinson’s treatments, where disease progression or recovery will obviously be key outcomes.  

“In terms of drug development, the results can enable clinical trials with a significantly shorter duration and fewer participants, ultimately accelerating the development of new therapies,” said Katabi. “In terms of clinical care, the approach can help in the assessment of Parkinson’s patients in traditionally underserved communities, including those who live in rural areas and those with difficulty leaving home due to limited mobility or cognitive impairment.”

Flashbacks: MIT’s WiFi System Detects People’s Breathing, Heart Rate, Even Through Walls; MIT Researchers Detect REM in Sleeping Persons Using Wi-Fi Radio Signals

Study in journal Nature Medicine: Artificial intelligence-enabled detection and assessment of Parkinson’s disease using nocturnal breathing signals

Via: MIT

Researchers at Rice University have developed a pneumatic assistive device for people with disabilities. The technology includes an air pump that is mounted in the wearer’s shoe, providing pneumatic power with each step. This power is stored in a wearable belt that includes an “arm” that can reach out and grip items when activated. The device may be very practical for people with arm weakness who struggle to lift objects.

The research team also developed a shirt with a bellows mechanism in the armpit that lets a wearer pick up an object that weighs 10 pounds. The researchers are exploring the possibility of using the compressed air mechanism to power other assistive and medical technologies, from leg compression technologies for deep vein thrombosis to gloves that help people with gripping objects.

Wearable assistive technologies have the potential to completely change the lives of disabled people, allowing them to perform activities that would otherwise have been impossible, increasing their independence and their quality of life. There are a large number of people who would benefit from such devices.

“Census statistics say there are about 25 million adults in the United States who find it difficult to lift 10 pounds with their arms,” said Anoop Rajappan, a researcher involved in the study. “That’s something we commonly do in our daily lives, picking up household objects or even a baby.”

However, many such devices require an electricity supply, meaning either a wired tether or a battery that the wearer must carry around. This latest technology does not need electrical power, deriving its energy from compressed air that is produced using a foot pump.

The textile pump resides within the shoe of the wearer, which compresses air into a belt worn around the waist with every step. The belt acts as a reservoir for the compressed air, which can be used to inflate and actuate a “gripper” that extends from the belt and grabs objects. The inexpensive garments cost less than $20 per unit, and the researchers used conventional textile techniques that are employed in the garment industry.  

“The fabrication approach uses techniques that are already employed in the garment industry, things like cutting textile sheets and bonding them with heat and pressure,” said Daniel Preston, another of the study researchers. ‘We’re ready to think about translating our work towards products.”

The Rice team also have other plans for the basic pneumatic technology at the heart of the system. “We’re also thinking about devices like pneumatic actuators that apply therapeutic compression for things like deep vein thrombosis, blood clots in the legs,” said Rajappan. “Anything that requires air pressure can be powered by our system.”

See a video about the technology below.

Study in Science Advances: A wearable textile-based pneumatic energy harvesting system for assistive robotics

Via: Rice University

A team at the University of Michigan has developed a coating for frequently touched surfaces that can rapidly kill a wide array of pathogens, including MRSA and SARS-CoV-2. The technology incorporates polyurethane that contains crosslinked compounds from essential oils with wide-spectrum anti-microbial action. The researchers fine-tuned the crosslinking process so that the oils were available to kill microbes but not sufficiently free to evaporate rapidly. Unlike anti-microbial surface coatings that are based on metals, such as copper or zinc, the new coating can kill microbes quite fast, in as little as two minutes. However, the coatings remain effective for as long as six months, when they can be recharged by painting them with some fresh oils.

The ongoing pandemic has highlighted the power of tiny microbes to bring our society to a grinding halt. However, if there is a silver lining, it is that this crisis has inspired numerous new technologies, from impressive mRNA-based vaccines to inexpensive ventilators. One important area of new technological development lies in disinfecting public spaces, such as train stations and airports, along with healthcare facilities where the most vulnerable people are.   

This latest technology is a highly effective anti-microbial coating that can provide rapid antimicrobial action and long lasting efficacy. “We’ve never had a good way to keep constantly-touched surfaces like airport touch screens clean,” said Anish Tuteja, a researcher involved in the study. “Disinfectant cleaners can kill germs in only a minute or two but they dissipate quickly and leave surfaces vulnerable to reinfection. We do have long-lasting antibacterial surfaces based on metals like copper and zinc, but they take hours to kill bacteria. This coating offers the best of both worlds.”

These images show the bacterial load on a coated and uncoated computer keyboard, cell phone and cutting board with raw chicken. Images credit: Anish Tuteja

The coating is clear, and consists of polyurethane, a tough sealant that is often a component in varnishes. However, the material also includes antimicrobial compounds derived from essential oils, in this case cinnamon oil and tea tree oil. The nice thing about these components is that they were already classified as safe before use in the coating.

“The antimicrobials we tested are classified as ‘generally regarded as safe’ by the FDA, and some have even been approved as food additives,” said Tuteja. “Polyurethane is a safe and very commonly used coating. But we did do toxicity testing just to be sure, and we found that our particular combination of ingredients is even safer than many of today’s antimicrobials.”

The researchers conducted some disgusting experiments to show that their technology can kill bacteria in challenging situations, including smearing surfaces with raw chicken and then testing if any of the microbes left on the surface survived contact with the coating. Thankfully, the coating worked well, so they can put the raw chicken away for now.  

Study in journal Matter: Surfaces with instant and persistent antimicrobial efficacy against bacteria and SARS-CoV-2

Via: University of Michigan

Researchers at UCLA have developed a fingertip sensor that can rapidly provide data on the levels of lithium in the body. Used as a treatment for bipolar disorder and depression, lithium requires very accurate and sensitive dosing, with too little providing no therapeutic benefit but slightly too much potentially leading to unwanted side-effects. At present, the most common method to assess lithium levels involves a blood draw and subsequent lab testing, which is inconvenient and cumbersome. The new electrochemical sensor incorporates a hydrogel pad that facilitates the sensitive measurements, which require an aqueous environment. An ion-selective electrode detects the lithium ions present in the sweat on the fingertip, providing a result in as little as 30 seconds.

Lithium can be a very effective treatment for bipolar disorder, but it is tricky to get the dose just right to maximize its therapeutic properties while reducing the risk of potentially dangerous side-effects. Another issue with the drug is the potential for poor patient compliance. If a patient misses some doses and their medication does not appear to be working, a clinician typically must perform a blood draw and order a lab test to see if lithium levels are out of whack. This is time consuming, invasive, and expensive.

To address this, these researchers have created a tiny fingertip sensor that can measure the levels of lithium in sweat. “Although it may not be visible, the human body constantly produces sweat, often only in very small amounts,” said Shuyu Lin, one of the creators of the new sensor. “Small molecules derived from medication, including lithium, show up in that sweat. We recognized this as an opportunity to develop a new type of sensor that would detect these molecules.”   

The tiny sensor can detect lithium in sweat from a fingertip, although the small amount of sweat that is typically present in that location provided a challenge, as the electrodes in the sensor require an aqueous environment to function. To achieve this, the researchers incorporated a hydrogel on the sensor surface, which creates these conditions. The gel includes glycerol, which helps to prevent it from drying out.

An ion-selective electrode detects the lithium ions, using a paired reference electrode to calculate a difference in electrical potential that indicates the concentration of lithium in the sweat sample. The device can deliver results in as little as 30 seconds.   

“Through a single touch, our new device can obtain clinically useful molecular-level information about what is circulating in the body,” said Sam Emaminejad, another researcher involved in the study. “We already interact with a lot of touch-based electronics, such as smart phones and keyboards, so this sensor could integrate seamlessly into daily life.”

The researchers presented their technology at the 2022 fall meeting of the American Chemical Society (ACS).

Via: ACS

Researchers at the Ohio State University Wexner Medical Center have tested the PUP (Patient is Up) Smart Socks, developed by a medtech company called Palarum, in their ability to reduce falls among at-risk patients. The socks contain pressure sensors that alert caregivers when a patient is attempting to stand up. This can include situations such as a patient getting out of bed to go to the toilet. The socks can wirelessly communicate with the system, which then alerts the caregivers that are closest to the patient, so that they can arrive and provide assistance as soon as possible. The recent study showed that the system significantly reduced fall rates in patients at high risk of such incidents.

A fall can spell serious consequences for frail and vulnerable patients, and can often be the start of a downward health spiral. It is not typically possible to monitor high-risk patients every minute of the day, but wireless technologies are well-suited to fulfill an assistive role in this context.   

“Due to the rapidly aging population, the number of patients at higher risk of falling in hospitals is expected to increase substantially,” said Tina Bodine, a researcher involved in the study. “About 30% of in-hospital falls are thought to be preventable, so it’s imperative to determine better ways to keep our patients safe from falling while hospitalized.”

Falls often happen when a high-risk patient attempts to get out of bed to use the restroom, and this is the time that having a caregiver present to assist can dramatically reduce the risk of such incidents. Current approaches sometimes involve pressure sensors in beds or seating, but these frequently give false alarms, leading to alarm fatigue and reduced effectiveness of such systems.

This new system is present on the patients and staff themselves, in the form of wireless smart socks containing pressure sensors and alert badges that staff wear. The socks alert the three nearest caregivers when a patient attempts to get out of bed, and then the next nearest three if one the first three is not present in the room within the first 60 seconds, and the system progresses to an all-staff call within 90 seconds.

“Patients can fall while they are hospitalized, and this can sometimes lead to injury or death. We know that existing fall prevention measures do not work consistently,” said Tammy Moore, another researcher involved in the study. “During our study, we observed zero falls, which was a lower fall rate among the patients wearing these socks than the historical fall rate of 4 falls per 1,000 patient-days.”

“A major problem with bed and chair pressure sensors is that the high numbers of false alarms may cause ‘alarm fatigue’ that can contribute to delayed response,” said Bodine. “With this system, no falls were detected, and only 0.2% of the alarms were false alarms. We also analyzed nurse response times that ranged from 1 second to nearly 10 minutes and found that the median nurse response time was 24 seconds.”

See a video about the technology below.

Study in Journal of Nursing Care Quality: Prevention With the Smart Socks System Reduces Hospital Fall Rates

Link: Palarum homepage…

Via: Ohio State University Wexner Medical Center

Oncoustics, a medtech company based in Ontario, Canada, developed the OnX Liver Assessment Solution, an AI-powered ultrasound-based diagnostic system for liver disease. At present, detecting liver disease is a challenge, potentially involving high-end imaging systems, specialists, and invasive biopsies. These challenges, and the related expense, can limit patient access to such testing for those with strong indications of liver disease.

Consequently, in many cases, liver disease may not be detected until it is already quite advanced, limiting the potential for early detection and treatment. There is a clear need for a non-invasive, inexpensive, and relatively simple method to assess a patient’s liver for signs of disease. This latest technology aims to achieve this.

The OnX system is intended to offer a full liver screen from any clinician, with the test itself taking as little as five minutes. The test is based on an inexpensive point-of-care ultrasound system and the AI in the product uses both the ultrasound images and the raw data to infer the disease state of the imaged liver. The company describes the procedure as a virtual biopsy.

Medgadget had the opportunity to speak with Beth Rogozinski, CEO at Oncoustics, about the technology.

Conn Hastings, Medgadget: Please give us an overview of liver disease, its prevalence, and consequences for patients.

Beth Rogozinski, Oncoustics: The landscape of chronic liver disease (CLD) has evolved over the past decades. Despite advances in identifying and treating viral hepatitis, the rise of type 2 diabetes, metabolic syndrome and associated non-alcoholic fatty liver disease (NAFLD) have substantially increased the burden of chronic liver diseases worldwide. Today, it is estimated that 1.5 billion people globally have chronic liver disease and the numbers of at-risk patients are estimated to be significantly higher as NAFLD rates have increased due to the growing obesity epidemic. Structural and behavioral liver diseases like NAFLD that result in hepatic injury, starting with fatty liver infiltrates (steatosis) that can lead to inflammation and progressive fibrosis, are expected to drive most liver-related cancers, liver transplants and/or mortalities from end stage liver disease in the next decade. These diseases are most often asymptomatic until they reach very advanced stages when treatment options are limited. The COVID pandemic may also be contributing to the acceleration of liver diseases as a recent report by the American Psychological Association showed that, since the pandemic began, about 42 percent of U.S. adults have gained weight — 29 pounds, on average. Additionally, alcohol consumption has increased considerably in the context of COVID-19. There was a 54% surge in national alcohol sales during the first week of the pandemic and subsequent reports indicated persistent increases in rates of alcohol intake. Alcohol-associated liver disease (ALD) has increased in the population, with especially high increases in women. All of this is leading to an unprecedented increase in CLD and the manifold comorbid risks associated with this condition.

Medgadget: How is liver disease currently detected and assessed? How is this suboptimal?

Beth Rogozinski: Current preventative approaches to catch and diagnose liver disease early are complex and time consuming, with several appointments and specialists including hepatologists and radiologists. These exams can be expensive and minimally available and involve high end imaging such as MRIs, or they involve highly invasive biopsies. Due to these costs and lack of availability, many structural and morphological diseases go undiagnosed at early stages where there are far more options for patient interventions. 

Medgadget: Please give us an overview of the Oncoustics virtual biopsy approach to liver disease diagnosis. What liver diseases can it detect?

Beth Rogozinski: Oncoustics applies AI to raw ultrasound signals from readily-available handheld ultrasound devices to rapidly differentiate healthy versus diseased tissues. There’s a wealth of information in these raw signals and this approach reveals novel biomarkers that can be aligned with existing standards and categorization systems. By mining the sound in ultrasound, Oncoustics can provide a quantitative and comparative score. While still for investigational use only, the OnX Liver Assessment Solution can be used to aid in the detection of fatty liver (steatosis) and fibrosis/cirrhosis. Other liver indications that are in development include NASH (non-alcoholic steatohepatitis) liver inflammation and liver cancer.

Medgadget: How does the system compare with conventional approaches and what are its advantages?

Beth Rogozinski: The OnX has been validated against the existing clinical standard for liver fibrosis screening with an approach called “vibration controlled transient elastography.” These systems cost up to $320,000 to buy and $20,000 a year to maintain. They require a trained operator and tests can require up to 10 separate measures to get an accurate reading. Results require evaluation and interpretation by a trained clinician. By contrast, the OnX will be low-cost, pocket-sized and easy-to-use and read by any frontline clinician. We’re simultaneously improving this product by validating it against the gold standard in liver diagnostics – the liver biopsy. In some of the clinics in which we’re currently deployed and collecting data many patients undergo a biopsy. This important data not only helps improve the labels of our fibrosis product, but it fuels the development of our NASH (non-alcoholic steatohepatitis) diagnostic – which today can only be determined via MR PDFF (magnetic resonance proton density fat fraction) or biopsy.

Medgadget: Do you have any plans to expand the technology to assist in the assessment of other organs?

Beth Rogozinski: Our approach is highly scalable and works across any anatomical region of the body that ultrasound can image. Oncoustics has already developed a proof-of-concept solution for prostate cancer, and we have a roadmap that includes breast and ovarian cancer, thyroid disease and more.

Medgadget: What stage is the technology at in terms of testing and regulatory approval? If all goes well, when do you anticipate that the technology could be available?

Beth Rogozinski: Our initial product, the OnX Liver Assessment Solution, is currently for investigational use only and has not been deployed into public clinical practice. We have been deployed for studies and data collections in six public clinics and are rapidly expanding. We are currently working on our initial FDA submission and expect to have this product cleared and available by mid-2023.

Link: Oncoustics homepage…