7 Start-Ups At HLTH 2024: Shaking Up Medtech’s Business Model, ‘AI’ For Cancer Detection, MCI Assessment, Validation, Monitoring

This year’s HTLH extravaganza drew over 12,000 attendees to Las Vegas this week, including hundreds of start-ups looking to showcase their innovations and opportunities to meet with potential investors and partners. Here are some of the highlights from Medtech Insight’s conversations with entrepreneurs .

OpenWater

OpenWater’s CEO Mary Lou Jepsen, a former Google and Meta executive, wants to turn the traditional business model for medical device development on its head by revolutionizing open access health care innovation.

The medical technology company announced in August that it has secured $100m in total funding from new and existing investors including Khosla Ventures, BOLD Capital Partners, Plum Alley Ventures, musician Peter Gabriel and others. The money will allow the company to further develop its hospital-grade technology platform that integrates semiconductor physics, light and sound to diagnose and treat a wide range of diseases at the cellular level. By employing the open-source approach, OpenWater seeks to advance medical innovation and reduce the cost and time it takes to bring a medical device to market.

“We decided to do open source for everybody to lower the cost of clinical trials, because 85% of the cost in the device development, or almost $700m in cost, [is what it takes now] to do a trial for a novel therapeutic device,” Jepsen told Medtech Insight. By leveraging consumer electronics manufacturing processes, OpenWater believes it can cut devices’ time to market from 13 years to under three years and the cost from $658m to around $10m.

The company is already taking orders for their Early Access Systems – the Open-LIFU 2.0 therapeutic ultrasound unit model and the Open-Motion 3.0 blood flow unit model.

Both the Open-LIFU 2.0 and Open Motion 3.0 are multi-user, multi-application products that can be configured by users for their specific applications to help develop medical devices that are efficient, low-cost and portable, the company said. The Open Motion 3.0 uses low-intensity, near-infrared light and employs short pulses of laser light and a holographic detection system to measure blood flow, blood volume, micro-motions and oxygenation deep under the tissue surface. The Open-LIFU 2.0 System uses low-intensity focused ultrasound (LIFU) therapy and can be configured to support clinical research across users and applications.

The company has already conducted preclinical and clinical studies that have shown promising results, including shrinking glioblastoma tumors in mice and treating severe depression in humans. It has collaborated with institutions including UCLA, the University of Arizona, the University of Pennsylvania and Brown University.

Paige AI

Paige AI, which aims to transform how pathologists work by leveraging AI to help them detect breast and prostate cancer, showcased its latest AI innovation, a co-pilot called Alba which seamlessly integrates computational pathology large vision models with conversational large language models to help pathologists become more efficient.

Alba integrates real-time insights and helps pathologists review cases by offering assistance such as summarizing all patient history relevant for the diagnosis including prior pathology and radiology findings, summarizing slide-level findings and relevant images, and pre-populating a report based on those findings.

When asked about how Paige AI is ensuring that the LLM generates reliable and correct answers, Paige AI’s CEO Razik Yousfi told Medtech Insight that the company has spent a lot of time “making sure that the questions you’re asking get grounded in the clinical context of information we’re parsing.” As such, Alba allows pathologists to verify the responses through sourcing, such as looking at a patient’s history or lab results.

Alba can also screen for multiple molecular biomarkers by looking at microscopic images of biological tissue. Alba’s database includes information from some 1,200 distinct genetic mutation pathways.

Paige AI is already being used by customers in the US, the UK and other European countries as well as Brazil, Razik Yousfi, who was appointed CEO in August, told Medtech Insight. Yousfi said the company plans to make additional announcements before year-end around new product capabilities and likely other AI models.

Ferrum Health

Ferrum Health’s CEO Pelu Tran is passionate about bringing AI solutions into hospitals to allow clinicians to validate and deploy AI algorithms within their existing workflow while keeping protected health information secure within the health system’s firewalls.

As of 2024, more than 2.5 million unique patient records have been analyzed via the Ferrum Enterprise AI Platform, the company said.

“All this is driven by my uncle, who passed away from a late-stage lung cancer that his doctors missed,” Tran told Medtech Insight. “They missed it three times over five years. He was getting screenings, but his doctors weren’t using AI, and if they had been using AI, I guarantee you, his cancer would have not been missed.”

He asked himself why health care was so hesitant to use AI and came to realize that a lot of it had to do with fears around securing patient data and sending millions of patient records to AI companies elsewhere in the world.

“Hospital systems are under massive cybersecurity pressures. They are constantly getting hacked – seven out of 10 of their hacks come from their vendors,” he said.

Ferrum’s solutions are being used at over 250 sites, including Sutter Health, Asheville Radiology Associates, Radiology Associates of Alburquerque, Mercy Radiology and Carle Premier, which has led to an 86% increase in revenue over the past six months, the company said.

The solution has also shown to be valuable for radiologists. An early partner saw a 77% higher rate of early lung cancer detection and an improvement in five-year cancer survival rates. The solution has helped health systems achieve a 75% reduction in internal IT staffing and computer costs and a 98% cut in AI implementation timelines, from an average of six weeks to less than a day, Ferrum claims.

Ferrum provides a secure platform that allows health systems to deploy AI without compromising data privacy or innovation, Tran said.

The health tech company raised $16m in series A funding led by Foundry with participation from Catalyst by Wellstar, Headwaters Ventures, UnitedHealthcare Accelerator, existing investors and others, bringing its total funding raised to $31m.

Tran predicted that more health systems will be looking for reliable AI tools to protect patients due to new requirements under Section 1557 of the Affordable Care Act, which prohibits discrimination in health care settings.

Peerbridge

Peerbridge CEO Chris Darland hopes to launch an AI-enabled wireless ECG patch for continuous heart monitoring of patients at home, especially for patients living in rural areas that don’t have easy access to hospitals. The device allows physicians to assess sleep and heart health remotely.

The company started enrollment for its Ejection Fraction AI-enabled Clinical Trial (EF-ACT) pivotal trial to evaluate Left Ventricular Ejection Fraction (LVEF) severity directly from its Peerbridge Cor wearable device. This will enable on-demand assessments of EF Severity on the American Society of Echocardiography scale and will be available in the clinic and at home, the company said.

The trial will involve about 1,000 patients across multiple trial centers, including Northwell Health, Hackensack Meridian Health, Mount Sinai Health System, LeBauer-Brodie Center for Cardiovascular Research at Cone Health and Orange County Heart Institute in California, Darland said. Darland expects the trial to complete in about five months. The trial follows a successful feasibility study in 2023.

“This is the first pivotal trial to study direct-from-ECG-ejection fraction severity at this level of fidelity,” said Darland. The device already received 510(k) US Food and Drug Administration clearance for detecting arrythmias including atrial fibrillation back in 2018, but Darland noted that there is lots of competition in the Afib remote monitoring space.

Last year, another company, Anumana, received 510(k) clearance from the FDA for its ECG-AI LEF algorithm for analyzing a 12-lead ECG scan to spot signs of low ejection fraction in patients with heightened risk of heart failure. Ejection fraction is a measure of how much blood the left ventricle pumps out with each contraction, and usually requires imaging techniques such as an ultrasound to determine accurately.

Darland said it requested the FDA to use Anumana as a predicate device. He noted that there are reimbursement codes in place to use ECGs for remote monitoring. The company’s goal is to make the device available to cardiologists and primary care doctors for rapid, five-minute assessments at $20 or less.

There are nearly 6.5 million adults with heart failure in the US, according to the Heart Failure Society of America. Many people don’t know they have heart problems, because the symptoms are often mistaken for signs of getting older. Heart failure is a progressive disease that starts slowly and gets worse over time, the Society said.

Darland said that heart failure is personal for him.

“My dad is the patient that’s always on my mind, because he’ll never go to the doctor. He lives at the end of a mile-long gravel driveway in the middle of Kentucky. He lives by himself, doesn’t eat well.” He noted that it would take at least 20 minutes to get an ambulance to his father’s house and another two hours to get him to a hospital for proper care. By bringing technology to monitor heart failure to the home, Darland hopes to help his father and millions of other Americans.

Linus Health

David Bates, CEO and co-founder of Linus Health, which focuses on early detection of mild cognitive impairment, Alzheimer’s and other dementias, showcased its digital platform which combines digital cognitive assessments (based on over 30 existing pen-and-paper-based cognitive assessments), actionable clinical decision support and patient plans to help providers find and act on cognitive issues early. The assessment takes only 3-5 minutes and evaluates speed of completion and accuracy of responses for each section, revealing any cognitive health concerns. The results are delivered to a secure platform for further analysis and interpretation and can be reviewed remotely by a specialist.

The company’s flagship assessment, DCTclock, is a digital upgrade from the long-established pen-and-paper Clock Drawing Test which unveils subtle signs of cognitive impairment that could otherwise go undetected for years, the company said. The next-generation digital cognitive assessment, Digital Clock and Recall (DCR), incorporates word recall elements to assess verbal memory, a key indicator of a person’s cognitive trajectory. This comes after the company acquired clinical-grade speech analytics company Aural Analytics earlier this year.

The DTCclock is an FDA-cleared Class II medical device and Bates noted that the company will soon receive a Class IIa designation and the CE mark for use in Europe, which will allow it to do clinical decision support. Linus Health partnered with Emory Healthcare to help primary care providers detect Alzheimer’s and dementia, and has also partnered with the University of Southern California, Rowan University and Indiana University Health System. It is also available in about 140 private clinics and is used by pharmaceutical companies.

Bates noted that the tests can be administered by medical assistants, which means doctors can dedicate their time elsewhere, cutting costs for the clinics. The business model is an enterprise software license, which involves a subscription and usage. The average subscription is $35 per assessment, he said.

Epitel

Epitel announced on 21 October it received FDA clearance for REMI Vigilenz AI for Bedside Notifications, a wearable electroencephalogram (EEG ) system that analyzes EEG data in real time to rapidly identify seizures.

“With Remi Vigilenz AI for Bedside Notifications, clinicians will be notified of the occurrence of potential seizures, which can reduce time to treatment and improve outcomes for patients in the smallest of clinics to the largest of hospitals,” said Mark Lehmkuhle, founder and CEO of Epitel, in a written statement.

The company’s first product, the REMI system consists of a wearable, wireless EEG sensor patch – two sensors applied to the forehead and one behind each ear – and software to monitor for seizures. The platform received 510(k) FDA clearance for in-hospital use in March 2021, but Epitel also wants to bring the device into the home.

“One in 10 people will have a seizure in their lifetime, but that doesn’t mean you have epilepsy,” Lemkuhle told Medtech Insight. “There are many things that can cause seizures. In the hospital, we are looking for provoked seizures … outside the hospital we are looking for seizures and epilepsy where there is no known cause.”

The product just arrived on the market six weeks ago, Lemkuhle said. After having raised $22.5m in series funding in 2022, he was meeting with investors at HLTH to fundraise and hire a sales team to bring the device to market.

Artisight

Artisight is a smart hospital platform that integrates computer vision and a multi-sensor network, voice-activation, video conferencing system. It can be connected to electronic health records and other third-party systems.

Stephanie Lahr, president of Artisight, describes the platform as leveraging a combination of Internet of Things (IoT) sensors to bring automation to the bedside, with the goal of improving the patient experience and quality of care.

“We have cameras, speakers, microphones and other IoT kinds of sensors so we can essentially mimic the senses of a human,” Lahr told Medtech Insight. “We can see, hear, speak, know where things are in space like a human and leverage that information then to either capture information and send it where it needs to go or identify that something is happening and communicate that downstream.”

The platform can be leveraged in hospital patient rooms, operating suites, or clinics. The company already has 18 health system customers, comprising more than 100 hospitals. She predicts that in the next five years every med-surg room in the US will be equipped with a camera, speaker and microphone to support virtual nursing, patient safety monitors, and telehealth visits.