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This past year, three sheep in Canada have been wearing their kidneys on their sleeves. Or more aptly, in jackets on their fluffy backs.
These three sheep are part of an ongoing animal study run by the Buffalo, New York-based startup Qidni Labs, a company pursuing waterless and mobile blood purification systems. Qidni Labs was founded in 2014, has raised $1.5 million and is currently in the due diligence process leading up to another round of funding. Qidni Labs was also an award winner at the 2019 KidneyX Summit for developing an air removal system for a wearable renal therapy device.
The jackets are a prototype of Qidni’s mobile hemodialysis machine called Qidni/D. The idea behind Qidni/D is that it will be significantly smaller than a traditional hemodialysis setup and use fewer fluids, allowing patients to be more mobile.
“We see this device, and this technology, to be a bridge to a blood purification technology that allows the patients to be mobile, although we do not anticipate that to be the first product,” says Morteza Ahmadi, the founder and CEO of Qidni Labs.
Per the CDC, about one in seven people in the US have some type of chronic kidney disease. Over time, that could progress kidney failure, at which point it’s recommended that patients start dialysis or receive a transplant. That threshold is typically symptom based; people might experience weight loss, shortness of breath or an irregular pulse to name a few symptoms.
There are two major types of dialysis: hemodialysis or peritoneal dialysis. Hemodialysis passes blood through a filter and a liquid called dialysate, whereas peritoneal dialysis inserts fluid into the body, which absorbs toxins, then drains it out. Qidni/D is a hemodialysis machine that can fit into a sheep sized jacket, and uses its own cartridges and gel-based system to cut down on the amount of liquid needed to perform dialysis. (TechCrunch reviewed images of the device).
In an early animal trial – the results of which have not yet been published in a peer-reviewed journal – the device was able to reduce levels of urea in sheep’s blood at the threshold of an adequate dose of traditional dialysis. TechCrunch reviewed data from the study over Zoom.
These sheep had no functioning kidneys, and were hooked up to the machine for between four and eight and a half hours. Morteza adds that the data so far suggests that four hours of treatment should be sufficient to cleanse the sheep’s blood.
This is just one small animal study, so it’s hard to draw massive conclusions from it. It didn’t include an active control arm, for instance, and instead compared the amount of urea and electrolytes removed from the sheep’s blood to published standards from other studies on dialysis.
The study alone is far from enough to suggest that the technology is ready for market, but those within the company are taking it as a good sign that the design of Qidni’s mobile dialysis machine bears further testing.
“We can say that in this study, we could replace daily dialysis based on the data,” he says.
The team will continue to tweak the technology in more sheep-based studies this year, and is aiming to begin human trials in 2022. The overall goal is to file for FDA approval, provided that clinical studies can demonstrate safety and efficacy, by the second half of 2023.
The kidney treatment landscape is dominated by dialysis, which is an onerous treatment – despite the fact that a kidney transplant, in many cases, could relieve that burden.
At the moment, far more people with end stage renal disease are on dialysis than receive kidney transplants. The CDC estimates that 786,000 people in the US live with end stage renal failure, of which 71 percent are on dialysis and 29 percent have received transplants.
The kidney treatment landscape is also notable because it’s covered by Medicare, however, it remains expensive. Dialysis and transplants make up about seven percent of Medicare’s budget. Because of this complex landscape, startups have been pursuing alternatives like implantable kidneys.
Qidni’s current product is not an artificial kidney in that it could live forever in the body of a participant and replace a non-functional organ. Rather, it’s a more mobile take on dialysis. Qidni/D, the blood purification device, is the company’s main focus for the time being.
That said, Qidni/D does have some unique elements that may make it as “disruptive” as Morteza hopes it will be. Namely, its small size, and low water requirements.
During an average week of dialysis treatment, the average person is exposed to about 300 to 600 liters of water, per the CDC. Some of that water is used in the dialysate solution that helps to leach toxins out of the blood. Per Morteza, Qidni/D uses just one cup of water per treatment session, most of which is contained with the dialysate solution.
“In our understanding, this is probably one of the first times in the world that waterless technology is useful for blood purification over a long period of time in a large animal model,” he says.
Removing the liquid components of dialysis may streamline an already onerous process. Morteza, for one, hopes that this would make at-home dialysis more attainable (fewer stringent water safety requirements) and limit risks of infection (water-related infections sometimes occur during dialysis).
It’s also a small step towards creating an implantable kidney, which would, ideally, not require massive amounts of external fluid – though mobile dialysis remains Qidni’s current focus. The company’s upcoming round will be focused on testing their cartridge technology in small human trials.
“In this round of funding we would be raising $2.5 million, and that should take us to a point that we can test this technology in a small group of patients, connected to an existing dialysis machine using our own cartridges instead of existing dialysate,” he says.
It’s ultimately a step towards a machine that functions more like the organ it’s supposed to mimic, though the holy grail for patients is a solution that ends the need for dialysis in the first place.
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The home medical supply market in the U.S. is significant and growing, but the way that Americans go about getting much-needed medical supplies, particularly for those with chronic conditions, relies on outdated and clumsy sales mechanisms that often have very poor customer experiences. New startup Better Health aims to change that, with an e-commerce approach to serving customers in need of medical supplies for chronic conditions, and it has raised $3.5 million in a new seed round to pursue its goals.
Better Health estimates the total value of the home medical supplies market in the U.S., which covers all reimbursable devices and supplies needed for chronic conditions, including things like colostomy bags, catheters, mobility aids, insulin pumps and more, is around $60 billion annually. But the market is obviously a specialized one relative to other specialized goods businesses, in part because it requires working not only with customers who make the final decisions about what supplies to use, but also payers, who typically foot the bill through insurance reimbursements.
The other challenge is that individuals with chronic care needs often require a lot of guidance and support when making the decision about what equipment and supplies to select — and the choices they make can have a significant impact on quality of life. Better Health co-founder and CEO Naama Stauber Breckler explained how she came to identify the problems in the industry, and why she set out to address them.
“The first company I started was right out of school, it’s called CompactCath,” she explained in an interview. “We created a novel intermittent catheter, because we identified that there’s a gap in the existing options for people with chronic bladder issues that need to use a catheter on a day-to-day basis […] In the process of bringing it to market, I was exposed to the medical devices and supplies industry. I was just shocked when I realized how hard it is for people today to get life-saving medical supplies, and basically realized that it’s not just about inventing a better product, there’s kind of a bigger systematic problem that locks consumer choice, and also prevents innovation in the space.”
Stauber Breckler’s founding story isn’t too dissimilar from the founding story of another e-commerce pioneer: Shopify. The now-public heavyweight originally got started when founder Tobi Lütke, himself a software engineer like Stauber Breckler, found that the available options for running his online snowboard store were poorly designed and built. With Better Health, she’s created a marketplace, rather than a platform like Shopify, but the pain points and desire to address the problem at a more fundamental level are the same.
With CompactCath, she said they ended up having to build their own direct-to-consumer marketing and sales product, and through that process, they ended up talking to thousands of customers with chronic conditions about their experiences, and what they found exposed the extend of the problems in the existing market.
“We kept hearing the same stories again, and again — it’s hard to find the right supplier, often it’s a local store, the process is extremely manual and lengthy and prone to errors, they get the surprise bills they weren’t expecting,” Stauber Breckler said. “But mostly, it’s just that there is this really sharp drop in care, from the time that you have a surgery or you were diagnosed, to when you need to now start using this device, when you’re essentially left at home and are given a general prescription.”
Unlike in the prescription drug market, where your choices essentially amount to whether you pick the brand name or the generic, and the outcome is pretty much the same regardless, in medical supplies which solution you choose can have a dramatically different effect on your experience. Customers might not be aware, for example, that something like CompactCath exists, and would instead chose a different catheter option that limits their mobility because of how frequently it needs changing and how intensive the process is. Physicians and medical professionals also might not be the best to advise them on their choice, because while they’ve obviously seen patients with these conditions, they generally haven’t lived with them themselves.
“We have talked to people who tell us, ‘I’ve had an ostomy for 19 years, and this is the first time I don’t have constant leakages’ or someone who had been using a catheter for three years and hasn’t left her house for more than two hours, because they didn’t feel comfortable with the product that they had to use it in a public restroom,” Stauber Breckler said. “So they told us things like ‘I finally went to visit my parents, they live in a town three hours away.’”
Better Health can provide this kind fo clarity to customers because it employs advisors who can talk patients through the equipment selection process with one-to-one coaching and product use education. The startup also helps with navigating the insurance side, managing paperwork, estimating costs and even arguing the case for a specific piece of equipment in case of difficulty getting the claim approved. The company leverages peers who have first-hand experience with the chronic conditions it serves to help better serve its customers.
Already, Better Health is a Medicare-licensed provider in 48 states, and it has partnerships in place with commercial providers like Humana and Oscar Health. This funding round was led by 8VC, a firm with plenty of expertise in the healthcare industry and an investor in Stauber Breckler’s prior ventures, and includes participation from Caffeinated Capital, Anorak Ventures, and angels Robert Hurley and Scott Flanders of remote health pioneer eHealth.
The measure is likely to become the subject of negotiations later in the year over government spending and debt.
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Virtual health and wellness platforms have grown increasingly popular throughout the pandemic, but a new startup wants to focus that effort exclusively on senior citizens. Bold, a digital health and wellness service, plans to prevent chronic health problems in older adults through free and personalized exercise programs. Co-founded by Amanda Rees and her partner Hari Arul, Bold picked up $7 million this week in seed funding led by Julie Yoo of Silicon Valley-based Andreessen Horowitz.
Rees said in an interview that the idea for Bold came from time she spent caring for her grandmother, helping her through health challenges like falls. “I kept thinking about solutions we could build to keep someone healthier longer, rather than waiting for until they have a fall or something else goes off the rails to intervene,” she said. Rees started Bold to use what she’d learned from her own experience in dance and yoga to help her grandmother practice maintaining balance to prevent future falls. “My passion really was around ways to sort of widen the aperture, and make these solutions more accessible and built for older people.”
The member experience is pretty straightforward. Users fill out some brief fitness information on the web-based platform, outlining their goals and current baseline. From that information, Bold creates a personalized program that ranges from a short, seated Tai Chi class once a week, to cardio and strength classes meeting multiple times each week. “The idea is to really meet a member where they are, and then through our programming, help them along their journey of doing the types of exercises that are going to have the most immediate benefit for them,” said Rees.
Bold’s funding round comes at a time of concern around ballooning healthcare expenses for older populations, and a focus on how to reduce these costs for both current and future generations. While falls alone aren’t necessarily complex medical incidents, they have the potential to lead to fractures and other serious injuries. Bold’s preventative approach to falls is a more active solution than necklace or bracelet monitors that send a signal to emergency services when they detect a fall. And by offering virtual programs, they can help at-risk older populations engage in exercise while avoiding potential COVID-19 exposure at gyms.
Research shows that this works. Even simple, low-intensity exercise can improve balance and strength enough to reduce the incidence of falls, which is currently the leading cause of injury and injury death among older adults.
Fewer injuries would mean less need for medical care, which would lead to money saved for hospitals and health insurers alike. That’s why in addition to their seed funding, Bold has plans to start rolling out partnerships with Medicare Advantage organizations and risk-bearing providers, which will help make their exercise programs available to users for free.
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CoreCare, a provider of revenue management services for healthcare companies dealing with public health benefit providers, has raised $3 million in a seed financing round.
The company, which uses machine learning, automates large swaths of billing and revenue cycle management to reduce the burden on hospitals, according to chief executive, Dennis Antonelos.
Already, companies like Creative Solutions in Healthcare, a nursing facility operator in Texas, which operates nearly 80 locations has signed up for the service.
Antonelos started the company in January, had the first product up by March and was accepted to Y Combinator in April. It now boasts over a dozen customers in Texas.
With the new $3 million in hand from investors including Primetime Partners, Goat Capital, Funders Club and Liquid2Ventures, Antonelos said the company would look to expand its sales and marketing and product capabilities.
CoreCare automates processing of billing and paperwork and clinical notes by linking electronic health records and medicare and medicaid information services and payers.
“We’re going through the organization and eliminating administrative waste so the organization can invest newly found resources into patient care,” Antonelos said.
The company uses a standard software as a service payment model and charges somewhere between $300 to $500 per-facility, per-month, according to Antonelos.
“These initial results are outstanding,” said Gary Blake, president, and co-founder of Creative Solutions in Healthcare, and one of CoreCare’s early customers. “In only a matter of months working with CoreCare’s CoreAccess software, we’ve seen a notable impact on our financial position. It has truly exceeded our expectations. CoreCare has changed the way we work with Managed Care, from top to bottom. We have been able to streamline our entire billing process, reduce admin costs, shorten the number of accounts receivable (AR) days and free up cash for growth. Every healthcare provider that works with managed care should work with CoreCare.”
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Timothy Bouré and his co-founder Geoffrey Lucks were both near broke when they moved to Dallas to join the first accelerator they entered after forming VenoStent, a company that aims to improve outcomes for dialysis patients.
Failed dialysis surgeries occur in roughly 55% to 65% of patients with end-stage renal disease, according to the company. Caring for these patients can cost the Medicare and Medicaid Services system roughly $2 billion per year — and Bouré and Lucks believed that they’d come up with a solution.
So after years developing the technology at the core of VenoStent’s business at Vanderbilt University, the two men relocated from Nashville to South Texas to make their business work.
Bouré had first started working on the technology at the heart of VenoStent’s offering as part of his dissertation in 2012. Lucks, a graduate student at the business school was introduced to the material scientist and became convinced that VenoStent was on the verge of having a huge impact for the medical community. Five years later, the two were in Dallas where they met the chief of vascular surgery at Houston Medicine and were off to the races.
A small seed round in 2018 kept the company going and a successful animal trial near the end of the year gave it the momentum it needed to push forward. Now, as it graduates from the latest Y Combinator cohort, the company is finally ready for prime time.
In the interim, a series of grants and its award of a Kidney XPrize kept the company in business.
The success was hard won, as Bouré spent nearly three sleepless nights in the J-Labs, Johnson and Johnson’s medical technology and innovation accelerator in Houston, synthesizing polymers and printing the sleeve stents that the company makes to keep replace the risky and failure-prone surgeries for end stage kidney disease patients.
The key discovery that Bouré made was around a new type of polymer that can be used to support cell growth as it heals from the dialysis surgery.
In 2012, Bouré stumbled upon the polymer that would be the foundation for the work. Then, in 2014, he did the National Science Foundation Core program and started thinking about the wrap for blood vessels. Through a series of discussions with vascular surgeons he realized that the problem was especially acute for end stage renal disease patients.
Already the company has raised $2.4 million in grant funding and small equity infusions. and the KidneyX Prize from the Department of Health and Human Services and the American Society of Nephrology. VenoStent was one of six winners.
“It’s part of this whole ongoing effort by the executive office to improve dialysis,” said Bouré. “[They are] some of the most expensive patients to treat in the world… Basically the government is highly incentivized to find technologies that improve patient’s lives.”
Now the company is heading into its next round of animal testing and will seek to conduct its first human trials outside of the United States in 2021.
And while the company is focused on renal failure first, the materials that Bouré has developed have applications for other conditions as well. “This can be a material for the large intestine,” says Bouré. “It has tunability in terms of all its properties. And we can modify it for a particular application.”
In a sign of the growing importance and value of digital healthcare in the world of medicine, two of the industry’s publicly traded companies have agreed to a whopping $18.5 billion merger.
The union of Teladoc Health, a provider of virtual care services, and Livongo, which has made a name for itself by integrating hardware and software to monitor and manage chronic conditions like diabetes, will create a giant in the emerging field of telemedicine and virtual care.
“By expanding the reach of Livongo’s pioneering Applied Health Signals platform and building on Teladoc Health’s end-to-end virtual care platform, we’ll empower more people to live better and healthier lives,” said Glen Tullman, Livongo Founder and Executive Chairman. “This transaction recognizes Livongo’s significant progress and will enable Livongo shareholders to benefit from long-term upside as the combined company is positioned to serve an even larger addressable market with a truly unmatched offering.”
Under the terms of the agreement, each share of Livongo will be exchanged for 0.5920 shares of Teladoc health plus a cash payment of $11.33 for each share. The deal, based on Teladoc’s closing price on August 4, 2020, is roughly $18.5 billion. It’s an eye-popping figure for a company that was, at one point, trading below $16 per-share.
But the new reality of healthcare delivery in the era of COVID-19 rapidly accelerated the adoption of digital and remote care services like those Livongo was selling to its customers — and investor came calling as a result.
The combined company is expected to have pro forma revenue of $1.3 billion representing 85 percent year on year growth, on a pro forma basis. For 2020, the combined company expects adjusted EBITDA to reach $120 million.
“This merger firmly establishes Teladoc Health at the forefront of the next-generation of healthcare,” said Jason Gorevic, the chief executive officer of Teladoc Health, in a statement. “Livongo is a world-class innovator we deeply admire and has demonstrated success improving the lives of people living with chronic conditions. Together, we will further transform the healthcare experience from preventive care to the most complex cases, bringing ‘whole person’ health to consumers and greater value to our clients and shareholders as a result.”
The companies emphasized their combined ability to engage with patients and monitor and manage their conditions using technology. Teladoc Health’s flywheel approach to continued member engagement combined with Livongo’s proven track record of using data science to build consumer trust will accelerate the combined company’s development of longitudinal consumer and provider relationships, the companies said in a statement.
Teladoc currently counts 70 million customers in the United States with an access to Medicare and Medicaid patients that Livongo’s services could reach. The combined company also pitched the operational efficiencies that could be created through the merger. Teladoc estimated that there would be “revenue synergies” of $100 million two years from the close of the deal, reaching $500 million on a run rate basis by 2025, according to a statement.
Gorevic will run the combined company and David Snow will serve as the chair of the new board — which will be comprised of eight current Teladoc board members and five members of the Livongo board.
The company expects the deal to close by the end of the fourth quarter, subject to regulatory approvals. Lazard advised Teladoc on the transaction while Morgan Stanley served as the financial advisor to Livongo.
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