2018 Medtech Startup Showdown: Round 1

These eight medtech startups are facing off to see which has what it takes to make it in the industry. Vote for your favorite!

  • The stage has been set for MD+DI's fourth Medtech Startup Showdown tournament, in which medical device and diagnostics startups compete head to head to determine which has what it takes to succeed in the industry. MD+DI narrowed the field of submissions to eight and organized the finalists into brackets. We'll give readers a week to vote, and the company in each bracket that gets the most votes will continue on to the next round. The ultimate winner will be profiled on our site (see complete rules here).

    In round one, here are the matchups:

    • Bigfoot Biomedical vs. Raydient Oximetry
    • Spry Health vs. Liberate Medical
    • PolyVascular vs. Vitls
    • Strados Labs vs. Group K Diagnostics

    Click through the slideshow to learn more about these companies and their devices and vote for your favorites at the bottom of each page. Voting for round 1 closes Wednesday, March 21, at 5 p.m. PT.

    Adchariya Sudwiset/Shutterstock.com
  • Company name

    Bigfoot Biomedical Inc.

    Raydiant Oximetry Inc.

     

     

    Describe your device and how it will benefit healthcare.

    Bigfoot Biomedical is developing technologies to significantly reduce the cognitive, emotional, and financial burden of insulin-requiring diabetes. With an intense focus on ease of use, Bigfoot intends to optimize the dosing and delivery of insulin through an integrated medical device ecosystem powered by machine learning and enhanced by secure, user-friendly consumer technologies. The company’s smartphone-enabled systems include both automated infusion pump and connected insulin pen options for consumers, and will be delivered via a first-of-its-kind monthly subscription service model.

     

    Raydiant  Oximetry  has  developed  a  safe and noninvasive  technology  that  directly monitors a baby’s oxygenation during childbirth. For obstetric providers who are dissatisfied with current fetal heart rate monitoring systems, this technology leads to better-informed decision-making and better patient care.  

     

    How does your product differ from the competition?

    Current diabetes management offerings perform poorly in terms of day-to-day usability, require extensive, specialized clinical support, correlate poorly with healthcare economic outcomes measured by payers, lack upgradeability and secure cloud connectivity due to inflexible technology platforms, and create significant burdens for people with diabetes, providers, and payers. In line with the vision to expand access and meet patients where they are, Bigfoot will be the first company to embrace a platform approach with flexibility in insulin delivery methods (infusion pumps and connected injection) to expand the market to reach less tech savvy, less engaged people with insulin-requiring diabetes. It will also be the first company to seamlessly and securely use a mobile application running on an off-the-shelf smartphone as the primary user interface for all disease management and to capture comprehensive data to the cloud, leveraging a powerful, pervasive platform already in the hands of patients.

     

    Unlike past sensors developed by competitors, our device is noninvasive and comfortable for mothers and clinicians. Our sensor determines the baby’s oxygen level using a disposable sticker placed on the mother’s abdomen. There is currently no other product on the market that can determine the baby’s oxygen level in utero.

     

    Do you have customers yet?

    No. Pending completion of a pivotal clinical trial and regulatory approval, we anticipate a commercial launch in 2020.

     

    We are pre-FDA approval and pre-commercialization.

     

     

    How much money have you raised?

    Between our Series A and initial Series B rounds, Bigfoot has raised $74 million.

     

     

    $1.5 million

     

     

    Who are your investors?

    Our largest investors include funds managed by Janus Henderson and entities advised by Quadrant Capital Advisors. Additional notable investors: Cormorant Asset Management, Senvest Capital Inc., Senvest Management LLC, Visionnaire Ventures, JDRF T1D Fund, and T1D Exchange.

     

    MD Angels, Chicago Arch Angels, and Fogarty Institute for Innovation

     

     

    What is the next milestone for your product?

    We’re preparing now for a pivotal trial in the United States, which we anticipate announcing late this year. After the completion of our pivotal trial in 2019, we’ll be in a position to submit our solutions to FDA for approval. Pending FDA review and approval, we will launch our automated system in 2020, with our connected pen solution launching along a similar timeframe.

     

    Improve reliability and accuracy to establish a technical design freeze

     

     

    CLICK HERE TO VOTE

    Bigfoot Biomedical, Raydiant Oximetry
  • Company name

    Spry Health

     

     

    Liberate Medical

     

     

    Describe your device and how it will benefit healthcare.

    Spry Health has developed the clinical-grade Loop wearable that collects continuous vital signs and physiologic biomarkers. Using machine learning, Loop Analytics contextualizes the data and identifies early signs of deterioration before symptoms are noticeable. Clinicians are provided with information to intervene and provide targeted care to patients, resulting in better health outcomes and avoiding costly hospitalizations. Additionally, continuous health data collection will create an unprecedented understanding of human health and disease progression. The insights into disease progression created by the Loop System will transform population health management strategies, saving billions of dollars in emergency interventions and costly treatments.

     

    VentFree is a noninvasive electrical muscle stimulator that automatically activates the respiratory muscles in synchrony with mechanical ventilation. In doing so, it is expected to prevent the considerable muscle atrophy that normally occurs and allow mechanically ventilated patients to be discharged from the ICU quicker than under the current standard of care.

     

     

    How does your product differ from the competition?

    The Loop is the first wrist-based wearable that measures a continuous breadth of vitals, including blood pressure, pulse oximetry, heart rate, and respiration rate. This device, providing ICU-level data in the convenience of a wristwatch, enables ambulatory vital sign monitoring previously only available in the hospital.

     

    VentFree is the only noninvasive therapeutic option that can be used to prevent breathing muscle atrophy in these patients.

     

     

    Do you have customers yet?

    Spry Health has conducted three clinical validation studies with over 500 patients demonstrating the equivalency in standard of care for blood pressure and pulse oximetry. Additionally, Spry has completed six evaluations with some of the largest healthcare organizations in the country and will be kicking off its first pilots in Q2 of this year. Full commercial rollout will take place after FDA approval, expected in early Q3.

     

    No, we are currently undergoing clinical testing of our product.

     

     

    How much money have you raised?

    $7.1 million

     

    $3 million

    Who are your investors?

    Grove Ventures, Stanford-StartX Fund, OVO Fund, and others

    Angel groups and individual angels. We are also supported by federal and state grant funding.

     

    What is the next milestone for your product?

    Spry is launching several pre-FDA commercial pilots in the spring of 2018 to demonstrate the value of the Loop System in helping healthcare organizations avoid hospital admissions (including readmissions) and reduce healthcare costs while improving outcomes. We expect FDA approval early in Q3 of this year.

     

    Completion of our clinical validation study

     

    CLICK HERE TO VOTE 

    Spry Health, Liberate Medical
  • Company name

    PolyVascular

     

     

    Vitls

     

     

    Describe your device and how it will benefit healthcare.

    Children with congenital heart defects (CHD) may require valve replacement early in life, usually with surgically implanted homografts (cadaveric valves from other children). These homografts induce significant immune sensitization in a young child and have poor durability, leading to a cycle of repeat open-heart valve replacement surgeries during childhood and adolescence. Transcatheter valve replacement (TVR) is a rapidly advancing field that greatly reduces the negative aspects of surgical replacement, but current TVR solutions are too bulky for use in infants and small children. Additionally, these TVRs are hand-sewn bovine tissue valves, with high production cost, low yield, and poor customizability. PolyVascular addresses this unmet need by developing pediatric-sized TVR pulmonary valves, manufactured from durable, calcification-resistant polymers. Our valves avoid immune sensitization and provide a feasible option to the current cycle of repeat open-heart surgeries.

     

     

    We collect multi-parameter vital sign data with an innovative device that monitors body temperature, heart rate, RR interval, respiration rate, blood oxygen saturation (SpO2), movement (including fall detection), and sleep cycles. With continuous monitoring, healthcare providers can detect deterioration earlier, which reduces length of stay, treatment costs, and readmissions. It also improves patient outcomes and patient satisfaction scores (now the nurse doesn't need to wake the patient up during rounds).

     

     

    How does your product differ from the competition?

    Our use of polymeric valve leaflets in these devices enables a scalable platform technology that reduces the variability and manufacturing costs of hand-sewn tissue valves, and offers a far less invasive option than surgical methods for valve replacement. Tissue-based valves are too bulky for use in small children, while our polymer-based valves can be scaled to sizes that match the needs of the youngest children. Our customized leaflet design also enables progressive expansion to accommodate a child’s later growth, while still retaining a competent valve.

     

     

    We monitor a full suite of vital signs that allows care providers to see a full picture of a patient's status. We do this with a single device that is unobtrusive, thin, flexible, and waterproof. Our platform is also the first continuous and remote vital signs monitoring platform for pediatric use.

     

     

     

    Do you have customers yet?

    No

     

    No

     

     

     

    How much money have you raised?

    ~$850,000

     

     

    $420,000

     

     

    Who are your investors?

    None yet; all of our work has been through philanthropic donations, competitive grants, and an NIH/NHLBI STTR Phase I grant.

     

     

    Founders and individual angel investors who are involved in bio-pharma

    What is the next milestone for your product?

    Full GLP animal studies and a manufacturing partnership. Our device exceeds ISO 5840 performance and durability requirements, but these data are for devices made by hand in the lab. Similarly, we have in vivo data in sheep out to 10 months with low pressure gradients and negligible leakage, but these are preliminary, non-GLP studies. Our next milestones will be to institute the design control process with a manufacturing partner and verify the device’s performance in a complete GLP study.

     

     

    We have a pilot with Texas Children's Hospital’s emergency department coming up. This will be their first medical device pilot and will provide us with clinically validated data to show the efficacy of our platform as well as the value of continuous monitoring. We're also in early-stage pilot discussions with the Texas Children's critical care department as well as several departments within MD Anderson. 

     

     

     CLICK HERE TO VOTE 

    PolyVascular, Vitls
  • Company name

    Strados Labs

     

     

     

    Group K Diagnostics

     

     

     

    Describe your device and how it will benefit healthcare.

    Strados Labs makes the first and only always-on health device and platform that combines heart and lung data, so doctors can make informed decisions for asthma and COPD patients. Strados pairs real-time respiratory data with a multitude of external features including activity level, heart rate, altitude, medications, pollen, and temperature. This enables physicians to create more personalized management plans for their patients, which may improve medication compliance, self-monitoring, and quality of life. Strados bridges the data gap for chronic respiratory patients who aim to better understand breathing patterns and enables positive behavioral change using the Strados platform.

     

     

    Our point-of-care diagnostic device delivers accurate results in 20 minutes for an affordable price. Laboratory testing is a vital step in the clinical decision-making process, as 60% of diagnoses are completed via lab testing. However, providers are struggling to effectively manage test results in a system wrought with lag time between patient appointments and results. Currently, patients have to go to an outside lab for blood work. The delayed results have led to complicated workflows and 77% of abnormal results never being communicated to patients, causing suboptimal patient care and significant expenses downstream. Our device leverages microfluidic technology to deliver liver function test results in 20 minutes, which will allow providers to take immediate therapeutic actions to improve patient outcomes and expenses. The device is accompanied by a software app for quality control (by reading test results and validating devices) and managing test results.

     

    How does your product differ from the competition?

    Competing solutions include AirSonea, Wing, and Propeller Health. AirSonea employs a handheld device designed for episodic identification of wheezes that is measured at the trachea. Wing assesses lung function via spirometry, which requires a non-wearable device to connect into a smartphone. Propellor Health assesses asthma control and medication compliance via a non-wearable device that records inhaler use for medication management. Strados is designed for continuous as well as passive monitoring, in stark contrast to the active user participation required in episodic data acquisition inherent in the competing solutions. Our product also monitors two of the three parameters for assessing asthma control (reliever use, signs, and symptoms), which together with manual entry of spirometry results, leads to a more accurate assessment of asthma control. Provisional patent applied.

     

     

    Our most direct competition is the Abbott iStat and the Abaxis Piccolo Xpress. These point-of-care solutions require high upfront hardware costs or extensive training to use, so providers often forego investing in any point-of-care solution. The affordability of our solution—priced between $8 and $12 per diagnostic panel, depending on the complexity—will eliminate the barriers of access to point-of-care benefits for all providers and patients. Additionally, unlike our competitors, our solution integrates directly with the providers' EHRs without having to plug it into a download station or go through a data management system.

     

     

     

     

    Do you have customers yet?

    We have signed letters of intent with two collaborators, including a large public health system and a chronic care management platform. In addition, we have signed a study with a major health system in New York to conduct clinical studies with over 500 patients with asthma/COPD.

     

    No, but we are conducting our clinical trials for our liver function panel with PennMedicine and are partnering with Mount Sinai (NYC) to develop a liver cancer diagnostic.

     

     

    How much money have you raised?

    $250,000

     

    $221,000

     

    Who are your investors?

    Ben Franklin Technology Partners, NextFab Ventures, Brinc Ventures, and private angels.

     

    Bioadvance, Lehigh Valley Angels, and private angel investors

     

     

    What is the next milestone for your product?

    Clinical study validation of our wheeze/cough algorithms to support our FDA submission. Device will be revised after first phase of clinical work to inform our pre-manufacturing readiness and FDA submission.

     

     

     

    Our next milestone will be completing the clinical trials for our MultiDiagnostic device and liver function test panel. We are beginning the trials at PennMedicine, and we project to complete them in May 2018, with FDA approval potentially following in December 2018.

     

     CLICK HERE TO VOTE 

    Strados Labs, Group K Diagnostics
Jamie Hartford, editor-in-chief, MD+DI

Jamie Hartford

Jamie Hartford is editor-in-chief of MD+DI and director of content for medtech brands in UBM's Advanced Manufacturing Group, where she oversees content creation for the MD&M and BIOMEDevice conferences. Reach her at [email protected].

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