A New mHealth Device to Tackle Global Health

A New mHealth Device to Tackle Global Health

A U.S-educated academic returns to India to create a mobile diagnostic device powered my digital health tools to assist rural healthcare workers.

Arundhati Parmar

That global health is a puzzle that mobile health technologies can help to solve is not new.

But it's always amazing to see entrepreneurs dream up new applications nonetheless.

This latest story comes from India and a device called Swasthya (Health) Slate that was designed to help rural healthcare workers run diagnostic tests and get results quickly. For the past few years, the device has been used It is a mobile platform that comprises of a hardware device that connects to a digital thermometer, a blood pressure monitor, heart rate sensor, a 3-lead ECG system, a blood sugar monitor and a water quality meter.

When connected that interface unit uses Bluetooth to communicate with a Swasthya Slate app on Android phone or tablet can help to run 33 diagnostic tests. The tests run everything from the body temperature, blood pressure, ECG, rapid pregnancy to others tests like protein in urine, rapid typhoid test and HIV 1 and HIV 2 testing.

The goal is to record and store data in the cloud very easily and quickly, says Kanov Kahol, team leader of Affordable Health Technologies Division, Public Health Foundation of India, who is credited with conceiving the device. Kahol was an assistant professor in the School of Biological and Health Systems Engineering,Arizona State University, and an assistant professor adjunct in Mayo Clinic.

In YouTube videos explaining how the device works, Kahol talks about how Swasthya Slate can hold great value for health researchers for epidemiological purposes. That goes beyond the more immediate value it holds just for patients and frontline healthcare workers struggling to manage their patients.

The system takes into account that users - healthcare workers - may not be fluent in English. As such the device supports Hindi, Urdu and Telegu. And perhaps most importantly data can be stored on the Android phone or tablet in areas without Internet connection. Once, connection is available a batch upload or single upload is possible. The device can even use SMS to upload data, according to its website.

An article on TechCrunch notes how cheap the device is - $600 - compared with diagnostic systems in the U.S. and each test takes just minutes to report results. Usability testing results reported on the Swasthya Slate website shows that "average learning time to first correct execution of the software was 10 minutes, and by 45 minutes users were able to use the apps with less than 1% "slip" errors (e.g., accidental pressing of buttons and other errors). 

The device is not just being used in India, but parts of South America, Africa and Europe as well, according to Swasthya Slate's website

The video below demonstrates the challenges that average Indians face in getting diagnostic test results and a demo of the device in the field. 

More Questions about Accuracy of Theranos Tests

Theranos, already under fire from regulatory authorities at CMS and FDA, is facing renewed allegations that its blood-testing technology is inaccurate.

Qmed Staff


Elizabeth Holmes
Elizabeth Holmes is the CEO of Theranos

A recent study published in the Journal of Clinical Investigation (JCI) found that the company's fingertip-blood-testing technology could not match the accuracy of more conventional tests from LabCorp or Quest. "Theranos flagged tests outside their normal range 1.6× more often than other testing services (P < 0.0001)," the study concluded. "Of the 22 lab measurements evaluated, 15 (68%) showed significant interservice variability (P < 0.002). We found nonequivalent lipid panel test results between Theranos and other clinical services. Variability in testing services, sample collection times, and subjects markedly influenced lab results."

The tests were performed without the companies' knowledge.

The cholesterol tests carried out using Theranos technology differed sufficiently from the other labs' tests that they could affect physicians' ability to make medical decisions. The researchers concluded that the tests could lead physicians to "either inappropriately initiate or fail to appropriately initiate statin therapy" for some patients.

Also, Theranos technology did not provide results at all for 2.2% of the tests. The rate of non-results from the other two companies' technology was practically zero.  

Still, the results of the study were mixed and the Theranos results mostly agreed with more the results of traditional lab tests. But JCI concluded that "the disparities between testing services we observed could potentially alter clinical interpretation and health care utilization."

The company, which had received considerable accolades for the promise of its fingertip blood testing technology, has been the subject of mostly negative press attention after the Wall Street Journal published a series of scathing articles question its accuracy.

According to the New York Times, Theranos had sent a letter to the Journal last week attempting to block the publication of the study, arguing that the study was "flawed and inaccurate."

Theranos released a letter faulting the study for its reportedly "false and misleading statements."

Theranos states that "the authors informed the media that they reached out to Theranos regarding this study by email and that the authors received no response from Theranos." The letter goes on to say that none of its senior executives were contacted regarding the study.

Furthermore, the Theranos letter states that one of the authors of the study (EE Schadt) had a conflict of interest in that he works on the scientific advisory board of a firm known as NuMedii. Another author, Joel Dudley, has a more than 5% ownership stake in NuMedii according to Theranos. Furthermore, the Theranos letter goes on to criticize the study design and argue that the authors "fail to report how many finger pricks were performed at the first and second collection sites and whether or not they were on the same finger."

The recent study published in JCI was performed at the Icahn School of Medicine at Mount Sinai. The study was conducted in July 2015.

In all, 60 healthy adults participated in the study, which was carried out at two walk-in Theranos facilities in Arizona. 22 different variables were gauged in the study.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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How Frog Foam Can Deliver Antibiotics

Scientists discover a foamy substance made by Trinidadian frogs that could provide a non-toxic antibiotic delivery system, which could help treat and prevent the spread of infections.

Kristopher Sturgis

FrogThe discovery was presented at the Microbiology Society's annual conference in Liverpool last week, detailing a substance that Tungara frogs (Engystomops pustulosus) produce while mating that contains protein that they beat into a foamy substance with their back legs. The frogs then use this foam to nest their eggs in to protect them from harmful bacteria, diseases, and environmental stresses.

A research team at the University of Strathclyde in Glasgow began analyzing the foam and found that it is highly stable and can be used as a drug delivery system that can release drugs at a steady rate. Paul Hoskisson (pictured), senior lecturer at the university and team leader on the research, says that the foam makes an ideal substance for drug-delivery given its stability in nature.

"We became interested in potential applications of frog foam from the nests of these frogs given their stability in the natural environment," he said. "We collaborated with some researchers from the University of Glasgow who have worked on these proteins for a while, and we began looking at the biophysical and antimicrobial properties of the foam from a few species who make these nests. We noticed that they resemble some materials that have been used for drug delivery, so we tried loading the frog produced foams with drug mimics (hydrophobic and hydrophilic dyes) to look at the release. We then moved to looking at antibiotic release, and we are currently close to making synthetic frog foams in the lab."

Hoskisson says that stable foams are rare in biology, as most foams are usually reduced to denatured proteins. However, this naturally produced foam from the Tungara frog is comprised of 7-8 different proteins that combine to form a stable foam in the environment, making the foam an ideal vessel for drug delivery.

"The bubbles in the foam are largely comprised of water, so it can be loaded with drugs fairly easily and then diffuse out over a period of time," Hoskisson says. "We have worked mainly with vancomycin, and this is released over a 24-48 hour period. We are still elucidating the exact mechanism, but it appears to be a simple diffusion mechanism."

Due to the increased usage of antibiotics, new technologies have been springing up in recent months as researchers continue to address the growing need for alternative treatments for infection. Earlier this year researchers from Bath University in the UK developed a new 'smart' bandage that could detect potential wound infections before the need for antibiotic treatment. In a similar vein, Hoskisson says that this new foam treatment isn't designed to circumvent the need for antibiotics, but rather provide an antibiotic drug delivery system that can be more efficient.

"The foam will not replace antibiotics," he says. "But it can help deliver them to infections that are often difficult to treat, such as burns. The foams appear to be very versatile and can be loaded with a range of drugs, so these may find applications in a range of pharmaceuticals, but there is still a large amount of basic work to be done."

Hoskisson says that he and his team are still in the process of expressing all of the proteins in E. coli which can enable them to make an entirely synthetic version of the foam, which could expand the wound healing models using cell lines. Despite it being very early in the process, he says the potential for the foam remains very promising.

"The work is still in a very early stage," he says. "There is still a need to biochemically characterize all of these proteins with our collaborators from the University of Glasgow, but these naturally occurring proteins appear to have great potential."

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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Wearable Defib Vest Shows Promise, Says AHA

 
The wearable cardiac defibrillator vest may be a good option for patients who cannot tolerate an implant.
 
Nancy Crotti
 
Zoll LifeVest
The American Heart Association, based on more than 100 studies of patients using the LifeVest Wearable Cardioverter Defibrillator. The group published an advisory in its journal, Circulation, its first on the devices.
 
Zoll Manufacturing of Pittsburgh, PA, makes the only defib vests on the market, for use by adults and children, but there are other devices in development, according to an AHA spokesperson. 
 
Zoll won FDA approval for its first vest in 2001 and began marketing it in 2002. The company declined to comment for this story.
 
The advisory described patients who are not good candidates for implants as those who recently had blood flow improved through surgery or angioplasty and those who have an active infection or unknown prognosis. Heart rhythm abnormalities are common in those patients as well as in those with cardiomyopathies. Sudden cardiac death accounts for more than 300,000 patient deaths in the United States annually, the AHA noted.
 
"For many of these patients, the risk for life-threatening rhythm abnormalities may be temporary, so the wearable cardiac defibrillator could be a short-term alternative to an ICD, which is permanently implanted in patient's chest," said Jonathan Paul Piccini, MD, lead author of the advisory and a cardiac electrophysiologist at Duke University Medical Center in Durham, NC, in an AHA statement. 
 
Heart failure patients waiting for a transplant may also be good candidates for the vest, the advisory says. However, patient compliance has been known to stumble due to the vest itself, fashioned like a fishing vest in the back with a broad strap across the chest. 
It's uncomfortable, Piccini said, adding that may change as the technology improves.
 
The advisory fell short of recommending systematic use of wearable defibrillators and said that randomized clinical trials would be needed to determine if they lead to improved outcomes.
 
"Although a growing number of patients are being prescribed wearable cardiac defibrillators by their doctors, there have been very few well-designed and completed studies of these devices. Wide spread use of the wearable defibrillator is not advisable because there isn't enough clinical evidence to support its use, except in a small number of patients with known life-threatening arrhythmias but for whom surgery to implant an ICD is not advised in the short-term," Piccini said.
 
Zoll did not respond to a request for comment on the advisory. 
 
"As with most new medical technologies, biomedical engineers are working to make them smaller, more lightweight and less burdensome. One company is already developing a self-contained system in a large, self-adhesive plastic bandage that a wearer just sticks on their chest," Piccini said.
 
The AHA declined to name manufacturers, as it does not make implied endorsements of individual products, a spokesperson said. Piccini could not be reached for comment.
 

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Lawsuit Claims Medical Device Caused Brain Damage

A Washington man is filing a suit against a California company for making an implant that he said malfunctioned.

Qmed Staff

The software developer is suing Penumbra Inc. because he says that the company's Penumbra Coil 400 device caused brain damage. After suffering an aneurysm in 2013, Dennis Montgomery was treated with the device. When the device was placed into the aneurysm, 10% remained stuck in the intracranial artery. 

According to Montgomery's attorney, Peter Mullenix, the device detached prematurely, leaving fragments from the device lodged in his brain, which later caused him to have a stroke. Mullenix said if the device were designed properly, a surgeon should have been able to extract the device intact and replace it in the brain. 

"When a coil system malfunctions and leaves the coil in the middle of the artery instead of safely inside the aneurysm, the coil starts throwing clots, which can turn into strokes," Mullenix told the AP. "That's what happened to Dennis."

The suit specifically cites the maker of the device, Penumbra, as well as two of its sales reps who were present during the surgery on Montgomery. Also, the suit also lists Overlake Hospital Medical Center in King County Superior Court.

Montgomery is seeking reimbursement for medical and economic costs as well as damages against the parties involved in the case.

Penumbra filed a motion to have the case dismissed.

In 2011, a recall of the Penumbra Coil 400 was given Class I status. According to the FDA description: "The Penumbra Coil 400 system includes a tool used to implant the coils inside a patient. The pull wire on the delivery tool can slip out of place and allow premature detachment of the coil. Premature detachment of the coil may cause the coil to migrate unintentionally. This detachment problem can lead to serious injury including blood clots and stroke." The FDA recall notice was posted in April of 2011.

According to the lawsuit, the device that was implanted in Montgomery was made on August 11, 2011 and had an expiration date of August 31, 2013, the suit said.

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Nanowire Discovery Could Lead to Enhanced Nanoelectronics

A new microbial protein fiber discovered by researchers at Michigan State University contains unique properties that can transport charges at speeds of 1 billion electrons per second.

Kristopher Sturgis

Reguera

The discovery came from a group study of a specific bacteria called Geobacter, a name of Latin origin that translates to "battery from earth." These bacteria contain a remarkable ability to respire minerals, meaning they breathe rust. Gemma Reguera, associate professor of microbiology and molecular genetics at the university and lead author of the research, says that studying this bacteria is what led to their rather unique discovery.

"We identified hair-like filaments produced by this bacterium that was needed to access and respire the minerals," Reguera said. "Later, we demonstrated that the filaments were binding and mineralizing uranium as well. The study published in Scientific Reports purified the filaments and demonstrated that they are made of protein and conduct electrons at high speeds of 1 billion electrons per second."

The fibers themselves are actually hair-like protein filaments known as "pili" and are only two nanometers in diameter, which Reguera says makes them ideal for integrating them into nanoelectronic devices. Her group also found that they are made of a single peptide subunit, which is assembled to form a conductive nanotube.

"The simple design, with just the same peptide component, facilitates that application of well-established genetic engineering approaches for mass-production at a reduced cost and functionalization to develop nanowires with custom-made properties," she says. For example, we can capitalize on the natural ability of the nanowires to bind uranium and develop nanowire-based sensors for this radionuclide. We can modify the metal-binding pockets that naturally bind uranium to enable the detection of other metals, and many more applications are possible."

The concept of how the nanowires function is quite simple. Bacterial cells, like all living cells, have to breathe -- and that respiration process involves the movement of electrons out of the cell. Geobacter bacteria use protein nanowires to bind respired minerals that contain metal like iron oxides, and toxic metals like uranium. The toxins are mineralized on the surface of the nanowires, which prevent the metals from permeating the cell.

"I found it remarkable that nature has created a protein fiber that can conduct electrons so fast without the need of metals and other molecules that are typically involved in the transfer of electrons in biological systems," Reguera said. "It's been known for years that some amino acids in proteins can transport charges, but at very short distances in the nanometer range. These organic nanowires that we discovered master charge transport at micrometer distances. Thus, they are a new paradigm in protein electron transfer. Understanding this mechanism will help us manipulate the conductive properties of the nanowires to suit specific applications."

Reguera says that the team has already developed some platforms that integrate the nanowires, showing their ability to interface electrodes with various molecules. She says that will be the foundation of devices that they will be optimizing for specific applications.

"Nature is pretty creative," she says. "We are still interested in understanding how these microbes use these nanowires in nature, and whether other microbes can make the same or comparable conductive appendages. We are pretty confident we will find a diversity of nanowires out there. We will continue to explore how we can manipulate the native nanowires to integrate them in nanoelectronic devices and develop biosensors of various classes. We are also exploring the possibility of interfacing them with living tissues, and the many applications that biocompatible nanowires such as these could have in medicine."

How Do Phyisicians View Boston Scientific's Watchman Device?

How Do Phyisicians View Boston Scientific&#039;s Watchman Device?

Boston Scientific thinks Watchman represents a $500 million market opportunity, but how are physicians viewing the device now that reimbursement is available?

Arundhati Parmar

Boston Scientific's left atrial appendage closure device — Watchman — has had a tortuous path through FDA to win approval and more recently had to navigate difficulty at CMS with respect to reimbursement.

FDA deemed that the device was appropriate for patients who are on anticoagulants like warfarin, and while CMS initially disagreed and recommended coverage for only those who couldn't take anticoagulants, its final decision was less stringent. The agency said instead that the device would be reimbursed for patients who took warfarin or other anticoagulants for the short term but who wouldn't be able to do so over a longer period of time. Watchman is aimed at high-risk atrial fibrillation patients who want to reduce the chance for stroke.

Given the broad FDA label and a somewhat narrower reimbursement decision from CMS, how are physicians viewing the device?

Get ready for Massachusetts Medtech Week and register for BIOMEDevice Boston, April 13-14 to stay on top of industry trends.

A small survey shows that physicians are largely hewing to CMS's stance. BMO Capital Markets surveyed 26 physicians in March and compared their responses to the same question in November and March. This is how they responded:

A majority of physicians — 62% — responded that they will implant Watchman only in patients that are either contraindicated for anticoagulant therapy long term or those who have side effects with their use over time. That response has taken hold as only 44% and 50% said they would use that criteria for implantation in April and November, 2015.

"... Clearly CMS’ message around distinguishing its reimbursement decision versus the FDA label has been noticed by physicians, as 62% of the physicians plan to limit usage of the device to fit within the parameters of the final [National Coverage Decision] and 0% plan to maximize the open-ended FDA label," wrote Joanne Wuensch in a research note highlighting results of the survey.

Still, there is positive news for Boston Scientific. Physicians don't seem to be hampered by reimbursement challenges with 0% saying that they like the technology but are limited by reimbursement. Compare that to 12% who reported feeling so in November.

And yet, while physicians said that they would be increasing use of Watchman for a certain percentage of their patients, 0% of the physicians checked the box for using the device in 30-40% of procedures (versus 8% in November and 2% in April) and 0% in greater than 50% of their patients (versus 0% in November and 2% in April), according to the survey.

That could suggest a natural, and not altogether unsurprising, waning of enthusiasm for Watchman.

"With every new technology, the pendulum tends to swing to an extreme point early on (as pent-up excitement elicits an expectation for high-levels of product adoption) and later returns to the middle as physicians identify the appropriate patients," Wuensch wrote. "The same might be true with Watchman, as there has been a shift over the past several surveys demonstrating a higher percentage of the cohort expecting their penetration to be less than initially thought." 

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com  and on Twitter @aparmarbb

Medtech Startup Showdown 2016: Round 1—Respirix vs PhotoniCare

 

Respirix

vs.

PhotoniCare

  

Describe your device and how it will benefit healthcare.

Cardiospire is a portable, handheld device for noninvasive monitoring of congestive heart failure (HF) patients. The device extracts hemodynamic parameters from naturally expired airflow. Our patented innovations allow us to obtain reproducible measurements independent of interpatient variability with little to no subject training required. Cardiospire indicates when it has successfully taken measurements and electronically transmits the processed data to the patient's physician's office. The data may then be used to tailor heart failure drug dosing to correct fluid balance and optimize cardiac function in order to prevent hospitalizations. The potential impact is significant, as HF is the leading cause of hospitalization in patients over 65 and 25% of patients are readmitted within 30 days.

 

Nearly every person on the planet has experienced an ear infection. They are painful and the bane of parents across the globe. They are the leading cause of hearing loss and surgery in children, and responsible for estimated annual costs of more than $10 billion and 30 million office visits in the United States. alone. Currently, the average physician misdiagnoses these infections up to 50% of the time, but that information is still used to determine antibiotic treatment and surgical intervention. We have developed the ClearView, a handheld imaging device that will help physicians quickly, easily, and accurately diagnose ear infections. We want to get children the appropriate treatment as soon as possible, avoiding months of repeat office visits, ineffective antibiotics, and poor quality of life.

How does your product differ from the competition?

The standard method of monitoring daily weights has been shown to be inadequate for keeping HF patients out of the hospital. Recently, CardioMEMS from St. Jude Medical has entered the market, but it requires surgery to implant the $17,000 device. Also, its price has been scrutinized by payers and independent third parties such as the Institute for Clinical and Economic Review. Similar to CardioMEMS, Cardiospire has been designed for at-home monitoring of cardiac function to detect early symptoms of acute decompensation. Our patented technology allows extraction of the same biometric signals plus additional parameters from the hands and respiration. While previous studies have shown that remote monitoring of cardiac function with physician feedback can reduce hospitalizations and improve quality of life, ours is the first device that can perform this function economically and non-invasively. This will substantially improve the cost-effectiveness of remote heart failure monitoring and eliminate many of the hurdles facing CardioMEMS, such as resistance from patients to have an implant and from payers to reimburse for the device.

 

Ear infections are currently diagnosed by looking at the surface of the eardrum with a magnifying glass (i.e., the otoscope). However, the infection is in the middle ear, which cannot be visualized with current technology. PhotoniCare's ClearView solves this limitation by simply looking through the eardrum and into the middle ear. The ClearView works like ultrasound imaging, except we use near-infrared light instead of sound to produce cell-level resolution, 3-D images of what's going on behind the eardrum and the infection hiding there. For the first time, we can visualize and characterize key features in the middle ear, like effusions (fluid) and biofilms (linked to tube surgery). Physicians can use this information to get children the care they need immediately. There are other established technologies that aim to improve diagnosis of ear infections, such as tympanometry and acoustic reflectometry, but these techniques are difficult to use and/or have poor diagnostic abilities. ClearView is the only technology that can see into the middle ear.

Do you have customers yet?

Respirix has completed a pilot study of its Cardiospire device and is currently entering a pivotal clinical trial in the United States.

 Over the past couple of years, we've piloted our technology on more than 200 patients. Our product is currently in use in an ongoing pilot clinical study in Children's National Health System, a top pediatric hospital in Washington, DC. We are currently looking to expand our clinical trial sites to other parts of the country, or perhaps international clinical sites.
 

How much money have you raised?

Approximately $1 million Series A

 

This technology was prototyped and validated in the academic lab of PhotoniCare's founders, where more than $5 million was leveraged to advance it to the clinical stage. In PhotoniCare, we have raised nearly $2.5 million from a mix of private capital and federal grants.

Who are your investors?

High net-worth individuals and institutional investors

 

Our investor team includes a mix of institutional and angel money. In addition to capital, they also bring extensive expertise in medical device development, regulatory strategy, reimbursement strategy, and several successful exits.

What is the next milestone for your device?

Clinical trials in HF patients

 Our next big milestones are prototype finalization and design freeze, FDA 510(k) approval, and a Series A raise planned in 2016 to launch our first product in 2017.

        

Continue to "10 Digital Health and Medtech Startups that Shone at SXSW"

Medtech Startup Showdown 2016: Round 1—Procyrion vs BioAnalytics

 

Procyrion

vs.

BioAnalytics

  

Describe your device and how it will benefit healthcare.

Procyrion Inc. is working to give chronic heart failure patients a solution by developing the world’s first catheter-deployed circulatory assist device intended for ambulatory use. The Aortix system, built around a powerful micromotor mounted on a set of expandable struts, is designed to rest the heart by reducing afterload and improve blood flow to vital organs. Unlike other circulatory assist devices, including ventricular assist devices (VADs), that involve invasive, high risk surgical procedures, Aortix is small enough—6 mm wide and less than 6.5 cm long—to allow for deployment without surgery and with minimal procedure risk.

In a simple 20-minute procedure, a cardiologist could deliver Aortix through a catheter in the femoral artery to the descending thoracic aorta, a strategic location downstream of the heart that allows for combined benefit to the heart, kidneys, and other vital organs. Once the catheter sheath is in place, it is retracted to deploy the self-expanding nickel-titanium struts that anchor the pump to the aortic wall.

 

The Medical Acute Immune Diagnostic (MedAID) system is a broadly applicable technology which reduces immunoassay complexity and cross reactivity to provide tests with faster turnaround times, fewer steps, decreased technician time requirement, easier to automate point-of-care devices, less variability, higher sensitivity, and increased capacity for multiplexing. This is achieved through the use of a proprietary immune complex, which allows for multiple steps to occur in tandem. To our knowledge, this system is the world’s first universally applicable, label based, single-step, sandwich immunoassay.

How does your product differ from the competition?

This reversible anchoring is essential to what makes Aortix the first catheter-based pump suitable for ambulatory use in a walking, active patient. Additionally, the pump’s location minimizes the common VAD surgical risks and potential for thrombotic stroke. In contrast to traditional VADs, where failure is often fatal, Aortix does not obstruct native blood flow and device failure is not life threatening. Aortix is designed to augment the natural function of the heart by accelerating a portion of the body’s native blood flow within the micropump and directing it downstream in a series of “jets” that entrain and accelerate the native flow. In pre-clinical animal studies, Aortix increased the amount of blood the heart pumps by 10-15% while simultaneously lowering its energy needs by almost 40%. The end result is a nearly 60% increase in efficiency, and a heart that is working at a sustainable level while providing healthy blood flow and pressure to end organs. This groundbreaking interventional cardiology tool, conceived by cardiologist Dr. Reynolds M. Delgado, III, medical director of Mechanical Support Devices in Heart Failure at the Texas Heart Institute, has the potential to replace high-risk surgical devices and lengthy hospital stays with a lower-risk outpatient cardiology procedure. This type of paradigm shift could not only improve the quality of life for millions of chronic heart failure patients, but also benefit hospitals and payers by potentially cutting treatment costs and readmission rates.

 

The MedAID system was developed using an alternative design of the molecular components already used in sandwich immunoassays. BioAnalytics technology is applicable to nearly all existing platforms within the immunoassay industry, allowing existing tests to be modified to achieve the same benefits as BioAnalytics developed tests. This manifests in tests that are able to provide half the number of steps, two times faster turnaround times, 100 times higher sensitivity, 37 times improved specificity, and 390 times reduced cross-reactivity in multiplexing.

Do you have customers yet?

Procyrion is a development-stage company, and the Aortix micro-pump is currently in preclinical testing to support a first-in-human trial scheduled for later this year (2016). Aortix is not approved for sale or use.

 BioAnalytics is currently prerevenue. To date BioAnalytics initiated an alpha prototype sale to a research group for early evaluation and validation. Through the National Science Foundation I-CORPs program, BioAnalytics has discussed the MedAID technology with more than 100 interested industry and academic professionals including researchers, purchasing agents, and clinicians from academic/federal research and hospital laboratories as well as drug-discovery and pharmaceutical companies. BioAnalytics will begin initial sales in the later stages of 2017.
 

How much money have you raised?

$13.5 million

 

Approximately $250,000 through both dilutive and nondilutive means

Who are your investors?

Fannin Innovation Studio, Scientific Health Development, undisclosed strategic and angel investors

 

Primarily founders and friends/family. BioAnalytics was awarded a $150,000 Phase I NSF SBIR in January 2015 and recently applied for a Phase II application (pending as of March 2016).

What is the next milestone for your device?

First-in-Human clinical trial scheduled for later in 2016.

 BioAnalytics next major milestone will be the introduction of it’s first product portfolio of 10 cytokine ELISA kits. To achieve this, the team will optimize protocols for manufacturing with currently selected OEMs as well as validate the manufacturing processes to be employed for large scale sales. Additionally, BioAnalytics will be optimizing the sensitivity component of it’s immunoassay technology in order to lower the limit of detection, or sensitivity benefits, to fg/ml instead of the currently accepted pg/ml limits. The last milestone set for the year will be to strengthen the patent portfolio through the use of a Continuation-in-Part application as well as three divisional applications.

        

Medtech Startup Showdown 2016: Round 1—Airware vs NERv Technology

 

Airware

vs.

NERv Technology

  

Describe your device and how it will benefit healthcare.

Continuous glucose monitoring with noninvasive optical technology for pass through and ultimately reflective methods based on new patent pending NIR optical configuration technology

 

NERv is developing an implantable biochip to monitor a patient's health after surgery. The biochip is capable of detecting post-operative complications in real-time. The biochip is designed to target surgeries in the abdominal region, such as operations in the urinary and digestive systems. The biochip is very small, provides instantaneous feedback, and is made entirely out of biocompatible materials, making it completely harmless to the body. The biochip's biosensors continuously gather data about the body and analyze them. If an unexpected change happens, the sensor analyzes the change and sends feedback to the physician. The data is sent to a receiver wirelessly. The receiver is located in the trans-dermal patch placed on the wound after surgery. The receiver then transmits the data to the physician in order to determine if a complication is about to happen. Concurrently, the receiver alerts the patient if a complication is detected in order to seek medical attention immediately.

How does your product differ from the competition?

Our methodology is the first to minimize scattering noise allowing detection to focus on just the weak glucose absorption in our particular NIR band achieving greater signal to noise specific to glucose over any prior techniques with hardware scaling to wearable dimensions.

 

Our technology is a disruptive one and thus there are no real competitors in our field. The nearest form of technology that provides value similar to ours is the medical imaging technology currently on the market, such as CT scans, MRIs, and radiography. These imaging techniques require the patient to show signs of sickness, before they can be used to identify the type and location of complications. However, they still fail 30% of the time (according to the Canadian Association of Radiologists). Our technology is predictive, real-time, and more efficient than the current alternatives on the market, promising to decrease the cost of inpatient healthcare.

Do you have customers yet?

Development stage with coming refinements to the light sources, optics, ADC electronics, and data analysis algorithms

 Our product will be tested in animals within the next six months. NERv has created a unique business model, where it will be targeting the veterinary market in order to prove clinical and commercial value for its product, before beginning clinical testing in humans.
 

How much money have you raised?

$445,000

 

NERv has raised more than $100,000 in nondilutive capital. NERv has also raised approximately $125,000 in in-kind services from institutions in Ontario and throughout Canada.

Who are your investors?

Internally funded to date.

 

--

What is the next milestone for your device?

Refinement of the optical bench for our "development state" to determine the ultimate system accuracy working with phantom tissue samples to achieve goals of detecting down to 10mg/dL of glucose in interstitial fluid of human skin.

 

The next milestone will be to begin testing the biochip in animals to prove clinical and commercial value.