Dr. Femida Gwadry‐Sridhar, CEO and Founder

As founder and CEO of closely-held Pulse Infoframe, a leading cloud-based healthcare data insights company, Dr. Femida Gwadry‐Sridhar’s resume boasts a deep background as a pharmacist, epidemiologist and methodologist with over 25 years of experience in clinical trials, disease registries, knowledge translation, health analytics and clinical disease outcomes. She founded the first knowledge translation health informatics lab in North America in 2006, creating a global, collaborative ecosystem for interdisciplinary research. In 2008, she funded a team to develop a physical and virtual platform to support multidisciplinary research, which led to the creation of Pulse Infoframe in 2011. Her brainchild, the healthie platform, has evolved to enable the integration of clinical, imaging and histopathology data as well as patient reported outcomes and natural histories. In this interview with BioTuesdays, Dr. Gwadry‐Sridhar discusses the importance of collaborative data sharing to optimize discovery and improve patient outcomes and advance care.

What was the problem you attempted to solve?

When I was involved in conducting clinical trials, I found that data from physicians, researchers and clinicians was in silos, which made it difficult to find patients to enroll in clinical trials because I couldn’t access all of their data in order to determine whether they were eligible for the study.

How did you approach solving that problem?

We decided to build a platform technology, which we named, healthie, which leverages the commonality across different diseases. Healthie stands for health informatics experience. Today, our focus is on different cancers and rare diseases. Even though each cancer has its own unique elements, the reality is that there is a lot of commonality in cancer and we collect data elements that are common across different cancers. More recently, we have collaborated with international funding agencies advancing the requirements for rare disease registries. Collecting relevant and actionable data for a rare disease is particularly important because there are so few people around the world to provide data for research and improvements in healthcare treatment. Because Pulse has invested in addressing relevant questions about data sharing, governance, ontologies and patient reported outcomes, we are able to provide platform users with high quality, real world evidence.

How do you collect data?

Our intuitive data entry and integration tools collect patient demographic, lifestyle, clinical, genomic, common registry elements, and data across multiple diseases. Our inclusive registries enable actionable insights into patient outcomes, research, value-based pricing, new therapies, and evidence-based protocols. In essence, we have created a data ecosystem focused around specific diseases and disease types.

healthie Platform

What happens with the data you collect?

The platform connects specialists from around the world in self-configuring networks. This connection enables research through applications and processes, providing clinicians and researchers with patient records and real-time analytics. The platform is designed as a unified, multi-tenant system for easy, secure, cost-effective, multi-site collaboration across health systems and specialist communities globally. And we manage security in accordance with HIPAA and GDPR privacy and security standards. To gain insights at a glance, healthie displays data in real-time charts and graphs. It also provides data that allows users to harness the power of the information for more relevant and accurate decisions.

The vision

How would you summarize your vision?

We believe that medical advances are made when patients, researchers, clinicians, and pharmaceutical and biotechnology companies collaborate and share data across boundaries. We view all of these groups as our stakeholders. Through this data sharing, the use of the platform can increase the speed of clinical trial recruitment, find new treatment regimens and cures in cancer and rare diseases, and establish real-world evidence by supporting patients and patient-advocacy groups.

How does Pulse Infoframe differentiate itself from competitors?

Firstly, we have expertise not only from a technology perspective but we also understand the diseases we focus on. We have deep clinical expertise, employ data scientists and understand how data can help our stakeholders do a better job. Plus, we work globally. Secondly, we work with our stakeholders strategically to figure out the best approach to utilize our technology. And finally, we’ve future-proofed the technology and made it more efficient. As a result, drug developers don’t have to buy different software technologies to run different diseases; they’re all available on our healthie platform.

Can you discuss your business model?

We operate on software-as-a-service model. Our clients are able to request subscription reports and finally, the registries are used to conduct epidemiological research as well as prospective real-world research.

What’s the size of your addressable market?

A conservative estimate puts the market at $2.5-billion. As a software-as-a-service model, more than half of our revenue recurs annually.

Can you sum up your value proposition?

As we move into an era of precision medicine, it becomes more important to uncover and understand the commonality between different diseases. New drugs are now looking at multiple genetic mutations and because they are so specific and targeted, not only at a gene-level, but at a metabolic pathway level, we try to make sure that we’re collecting the correct data to determine which patients will benefit the most from a given treatment. This approach also could reduce the cost of drugs over time by focusing their use for conditions where there is higher certainty that there will be a therapeutic effect. And by collecting healthcare data in a single place, the data can also be used to help the drug development process, patients and patient advocacy groups.

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Gino Fallone, Co-Founder and CEO

Closely-held MagnetTx Oncology Solutions filed a 510(k) application with the FDA in September for its Aurora RT device, which combines the accuracy of magnetic resonance imaging (MRI) with linear accelerator (linac) technology for radiation therapy required by cancer patients.

“We are the first to successfully merge linac, which provides the radiation beam, with MRI, which we believe represents the future of radiation therapy to treat any solid tumor,” Gino Fallone, co-founder and CEO, says in an interview with BioTuesdays. “Today, these machines must be 10 feet apart from each other.”

Some 50% of people in the developed world who contract cancer will be treated with radiation so Aurora RT “represents a tremendous opportunity to improve the quality of life for millions of people by increasing the accuracy of radiation and reducing the number of treatments,” he adds. “We believe Aurora RT also has the potential to be cost effective for hospitals.”

Aurora RT has been the subject of more than 60 scientific peer-reviewed articles, which Mr. Fallone says were required to receive research grants in the past. The technology is protected with more than 20 issued patents and others pending.

Aurora RT™

The company achieved proof-of-concept of linac in combination with MRI in 2008 and built its whole-body prototype in 2013-14, which was followed by optimizing Aurora RT’s design. “One of the features of our device is that the space for a patient is much larger than that of a typical MRI system,” he adds.

MagnetTx also is in the process of seeking to raise $50-million in several tranches from U.S. venture capital and institutional investors to carry the company to the installation of its potential first sale in 2020-21.* The order cycle takes one-to-two years complete installation, including hospital renovations.

Proceeds of the financing would be used to expand senior management, sales and marketing, technicians and installation engineers, and build a radiation-shielded vault for system testing in 2019. Mr. Fallone also figures the Aurora RT initially would sell for the combined price of a conventional radiotherapy linac and an MRI.

All cancers reside in soft tissue, which are best seen in MRI. “Imaging currently provided on a linac by an on-board CT (computed tomography) scan does not show contrast between soft tissues anyway close to what an MRI shows and, can only be performed before and after treatment,” Mr. Fallone points out.

This results in an error-margin on the position and the shape of the tumor, he contends. There is even greater error if the tumor moves, such as a lung tumor when the patient breathes. As a result, he says patients must have many treatment sessions with lowered doses at each session.

“With Aurora RT, we have combined MRI and linac so that continuous MRI imaging at say, four frames a second, can be performed to see a tumor and adjoining tissue during radiation delivery,” he adds. “Our solution is designed to improve clinical outcomes by irradiating less healthy tissue, leading to fewer side effects and lower heath care costs.”

Mr. Fallone says linac machines typically have a 10-to-12 year clinical life. There are about 12,000 linac machines in the world now, with about 1,000 replacements required annually, of which 600 replacements are required in North America and Europe, representing a $3-billion market.

Fueled by demand in China and a growing need in developing markets, he cites a 2015 study in The Lancet Oncology, which claimed that more than 20,000 new linacs would be needed by 2035.

There are two competing combination linac and MRI scanners on the market: Elekta and ViewRay. “We have several major clinical advantages,” Mr. Fallone claims, noting that Aurora RT has the potential to treat tumors irrespective of where they are in the body.

“Our very large patient opening, which measures 110 cm by 60 cm, allows us to move the patient couch significantly in a lateral direction so that the tumor will always be in the iso-center of the radiation beam no matter where the tumor is.” As a result, he says Aurora RT has the potential to treat peripheral tumors optimally and perform standard whole breast treatments.

In addition, he points out that Aurora RT’s radiation beam is parallel to the MRI’s magnetic field, resulting in negligible changes in dose distribution due to the MRI’s magnetic field avoiding potential side effects, such as skin burns. “The magnetic field does not affect the distribution of the radiation dose in our system so we can use conventional treatment planning.”

According to Mr. Fallone, conventional MRIs are too large to be installed through the door of the examination room and usually require removal of a wall or ceiling. Conventional MRIs also require liquid cryogens, such as helium to operate. Since liquid cryogens can instantly convert to gas for system failures, emergency venting is required to release the gas out of the building to avoid any danger to a patient and staff.

For MRIs within treatment bunkers, this results in a large vent opening through six-to-seven feet thick concrete to travel out of the building, requiring additional radiation-shielding to prevent radiation escaping to adjoining space, he adds.

Mr. Fallone notes that Aurora RT can be installed in standard treatment rooms using conventional methods through the door of the room. Aurora RT also uses a high-temperature superconducting MRI, which does not require liquid cryogens. “So we have no need for helium venting.”

And while turning conventional MRIs off/on must be performed by the vendor with special equipment and through a long process, he points out that this operation for Aurora-RT can be performed by an off/on switch in a very short time for servicing the equipment or removing metallic items that may have been accidentally drawn to the MRI from a patient or staff.

2018/2023 Timeline

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*This article does not constitute an offer to sell or the solicitation of an offer to buy any securities of MagnetTx, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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To connect with Rgenix, or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com.

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Dr. Masoud Tavazoie, CEO

Closely-held Rgenix has identified novel cancer targets regulated by microRNA pathways, which are key drivers of cancer progression, and developed first-in-class treatments that have the potential to modulate these targets.

“We’re discovering cancer targets that essentially are not altered at the DNA level but are regulated at the RNA level,” Dr. Masoud Tavazoie, CEO, says in an interview with BioTuesdays.

“We’re looking one step beyond DNA and have operationalized this approach in the lab to reveal RNA-regulated targets in virtually any solid tumor type,” he adds.

“We’re not developing drugs against RNA but instead, we’re making small molecules and antibodies against proteins that are regulated by these microRNAs.”

Dr. Tavazoie says the discovery platform has identified novel regulators of tumor growth and metastasis across cancers of high unmet need, including drug-resistant cancer. The scientific approach has been published in peer-reviewed journals, such as Cell, Nature Cell Biology and Nature.

Rgenix Discovery Platform

Dr. Tavazoie, a physician-scientist, started his career as a dermatologist focused on melanoma and immunotherapy. But after repeatedly seeing patients whose cancers couldn’t be treated with traditional therapies due to the lack of drugable targets in their tumors, he joined forces with his two brothers, also research scientists, to identify novel cancer pathways.

Their research led to the formation of Rgenix, with the RNA target discovery platform licensed from The Rockefeller University, where Dr. Sohail Tavazoie originally validated the discovery approach in his laboratory.

Rgenix’s pipeline includes lead clinical candidate, RGX-104, an oral small molecule immunotherapy in development for the treatment of solid tumors, including drug-resistant malignancies; RGX-202, an oral small molecule modulator of cancer metabolism, in development for gastrointestinal (GI) tumors; and RGX-019, a monoclonal antibody in preclinical development, which targets a key pathway that drives tumor progression and metastasis of several cancer types, including triple-negative breast cancer.

Pipeline

In an earlier Phase 1a dose escalation study in relapsed and refractory solid tumors and lymphoma, 40% of patients treated with RGX-104 achieved either partial response or had stable disease, Dr. Tavazoie says.

Rgenix is currently studying RGX-104 in a Phase 1b/2 trial in combination with nivolumab, an immunotherapy, in patients who are either resistant/refractory to checkpoint inhibitors, or are receiving them for the first time. The study includes patients with lung cancer, renal cell carcinoma and other solid tumor types, with the potential to incorporate an ApoE-pathway biomarker to enrich patient selection.

“The clinical focus of our Phase 2 expansion program will likely be RGX-104 as a combination therapy in select cancers, depending on interim Phase 1b readouts next year,” Dr. Tavazoie suggests. “Once these patients have progressed on standard of care and checkpoint inhibitors, there are very few therapeutic options open to them.”

At the ASCO conference in June, Rgenix presented early-stage data demonstrating that RGX-104 is capable of generating immunologic and anti-tumor activity in patients with refractory malignancies. RGX-104 also was well tolerated across dose cohorts in a Phase 1a study, with no autoimmune toxicities.

Dr. Tavazoie explains that RGX-104 is a small-molecule targeting the liver-X nuclear hormone receptor (LXR), which modulates the innate immune system by activating the ApoE gene. Low ApoE expression in tumors has been associated with reduced survival in cancer patients. ApoE becomes silenced in these tumors by microRNAs.

In animal models, the small molecule depletes myeloid derived suppressor cells and stimulates dendritic cells, activating anti-tumor immunity as a single agent as well as in combination with adoptive T-cell therapy or checkpoint inhibitors, he adds.

“We also demonstrated this mechanism of action in a broad array of cancer patients in our Phase 1a trial, as we outlined at ASCO,” Dr. Tavazoie points out.

“There is a clear rationale to combine LXR agonists with checkpoint inhibitors or T-cell immunotherapies to enhance efficacy and convert non-responders to achieve durable anti-tumor activity.”

Pharma originally developed LXR agonists for cardiovascular disease but that development stopped largely because of the success of statins at the time. “We tested these LXR agonists from Pharma against ApoE. We identified the ones from GlaxoSmithKline to be very potent anti-tumor compounds and so we in-licensed GSK’s LXR agonist patent portfolio, including a compound that we developed into RGX-104.”

While Rgenix’s lead program focuses on cancer immunity, its second RNA-regulated target program, RGX-202, focuses on modulating cancer metabolism, specifically inhibition of the SLC6a8 pathway. The SLC6a8 pathway gets activated in GI cancers when microRNAs that usually curtail its expression get shut off in tumors.

Dr. Tavazoie explains that RGX-202 has been designed to block a channel, SLC6a8, in the tumor microenvironment that imports creatine, starving the ability of a cancer cell to generate adenosine-5-triphosphate, a producer of tumor energy, and leading to cell death.

In multiple preclinical studies, RGX-202 has demonstrated complete tumor regressions, including in colon cancer models with KRAS mutations, which represents a high-unmet medical need in colon cancer patients, he adds.

Rgenix is initiating a clinical dose escalation study of RGX-202 as a monotherapy in GI malignancies using a biomarker and in combination with chemotherapy in gastric and colorectal cancers. Interim data will be reported in 2019.

The third program derived from Rgenix’s target discovery program is RGX-019, a high affinity monoclonal antibody inhibiting the MerTK pathway on the surface of cancer cells and tumor macrophages.

According to Dr. Tavazoie, the MerTK pathway is a key driver of several cancers, including triple-negative breast cancer, which is currently treated with standard-of-care chemotherapy. Rgenix hopes to begin human testing of RGX-019 by the end of 2020 with a partner.

“We are driving innovation in cancer medicine and remain focused on patients who have cancers of high unmet need,” he adds.

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John Lem, CEO and Co-Founder

Closely-held Lobo Genetics is readying the initial launch in the current quarter of 2018 of its Lobo Cube DNA testing device to bring the science of cannabis genetics to doctors and consumers.

“While cannabis has many potential therapeutic applications, your genetic makeup can influence how you respond to cannabis,” CEO and co-founder, John Lem, says in an interview with BioTuesdays.

“Genetics affects the speed at which your body metabolizes tetrahydrocannabinol (THC) and cannabidiol (CBD), two active compounds in the cannabis plant,” he adds. “It can also affect your predisposition to short- and long-term side effects.”

Mr. Lem says the initial launch of the Lobo Cube, the world’s smallest and portable DNA testing device that fits in the palm of a hand, would target medical clinics, researchers and select partners. In the first quarter of 2019, the company plans a full launch aimed at the general public through cannabis retailers, pharmacies and direct online sales.

“We aim to be the leader in cannabis genetic testing and personalized medicine, including pharmacogenetics, patient risk profiling, strain identification and cultivation testing,” Mr. Lem says.

The world’s smallest and portable DNA testing device

Lobo Genetics, which licensed the Cube platform from Spartan Bioscience, also is exploring to go public before the end of 2018. “We are actively talking to investment bankers and are targeting to be out marketing before the end of the year.”

Mr. Lem notes that Lobo has the potential to broaden its applications by partnering with drug companies to test and develop therapeutics in areas such as pain, anxiety, sleep disorders and epilepsy. Lobo also is building a data and analytics platform with the latest cannabis research and an e-commerce platform for sales to consumers.

“Unlike producers or distributors of cannabis products, direct-to-consumer advertising for cannabis genetic testing is permitted in Canada,” he points out. That would facilitate marketing online and through social media; traditional print and television; key opinion leaders like doctors, pharmacists, celebrities and associations; and publication of research studies and having an impact on public policy.

Mr. Lem explains that genetic testing with the Lobo Cube involves collecting a cheek swab, which is inserted into the device. DNA is extracted from the swab and amplified billions of times using polymerase chain reaction technology to detect a specific gene target.

“Results of the analysis are available in 45 minutes, compared with days to weeks in a central lab,” he contends. The test, which is expected to cost under $100, will enable walk-in DNA testing at any retail location, with results available on the spot. “Lobo Cube testing could also help consumers select safe products based on their genetic profile and risk,” he adds.

Despite targeting the cannabis market with the Lobo Cube, Mr. Lem contends that Lobo Genetics’ long-term goal is to be a healthcare technology company.

“There are broader applications for our diagnostic, such as partnering with a drug company to use biomarkers to optimize therapeutic dosing and determine how people might respond to a drug in development before they are enrolled in a clinical trial.”

According to Mr. Lem, genetic cannabis testing represents a huge market opportunity. In Canada, where legalized recreational use of marijuana is set to begin this fall, industry estimates suggest that more than 750 cannabis stores and 150 cannabis clinics could be in operation by 2020, as well as up to 11,000 pharmacies eventually dispensing medical cannabis in some form over the long term.

In the U.S., nine states and the District of Columbia have legalized marijuana for recreational use for adults over the age of 21. Medical marijuana is legal in 30 states after voters in Oklahoma approved a ballot initiative to legalize medical marijuana in June.

Legalization of cannabis also is spreading in Europe, with eight countries currently allowing medicinal use.

But Mr. Lem notes that cannabis is a psychoactive drug that manipulates brain chemistry. “As legal use of cannabis for medicinal and recreational use accelerates globally, the medical community and consumers must realize that it is not without risks,” he warns.

Some estimates put worldwide users of cannabis at more than 200 million people and growing rapidly. But Mr. Lem points out that no major multi-year population studies have been done on the implications of long-term use of cannabis because it has been illegal for so long.

Mr. Lem explains that cannabis has known side effects with both short- and long-term risks, which can cause harm if used improperly.

Cannabis Has Known Potential Side-Effects

“There are overdose short-term risks that can lead to hallucinations, paranoia, rapid heart rate and panic attacks, which are more prevalent with edible cannabis because of varying rates of metabolism,” he points out.

And because cannabis affects dopamine levels in the brain, there are long-term risks such as psychosis, addiction and what’s known as unmasking schizophrenia, he warns. “People with a predisposition to schizophrenia, but are not schizophrenic, can move into that state with chronic use of cannabis.”

Specifically, Mr. Lem explains that the CYP2C9 gene metabolizes psychoactive THC into its non-active form, “bringing you down from a high,” and is found in 80% to 85% of the population.

However, 15% to 20% of the population carries the CYP2C9*1/*3 genotype, who metabolize THC up to two times slower than the average person and have an increased risk of THC overdose, he adds. And 1% of the population carries the CYP2C9*3/*3 genotype, who metabolize THC up to three times slower and have a much higher risk of overdose.

In addition, Mr. Lem points to two other genes, AKT1 and COMT, which are important in dopamine signalling and clearance in the brain. “Too much use of cannabis causes changes in levels of dopamine in the brain and for 20% of the population with these genetic mutations, there is an increased risk of psychosis and schizophrenia.”

Mr. Lem says the Lobo Cube also has a role in the genetics of CBD, the non-psychotropic compound in cannabis, which has been shown to have applications in epilepsy and as an anti-anxiety agent. The CYP2C19 gene metabolizes CBD. However, 30% of the population carries the CYP2C19*2 and *3 mutations that metabolize CBD into its inactive form slower than normal, thus requiring lower dosing, he explains.

“CBD also can have drug-to-drug interactions, either amplifying or inhibiting other drugs, depending on how your body metabolizes CBD, so dosing is very important”

Mr. Lem says Lobo Genetics is in an interesting part of the market. “We’re not trying to get people to do more cannabis. We’re saying that if you wish to do it, and it’s your choice as an adult, you should be fully informed with your genetic information as it relates to cannabis.”

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John Erb, Chairman and CEO

CHF Solutions (NASDAQ:CHFS) has expanded its U.S. commercial team to 13 sales territories for its Aquadex FlexFlow system, an ultrafiltration treatment for patients with fluid overload who have failed diuretic therapy, along with expanded distribution in Europe and Asia.

“As we’ve been able to raise money, we’ve been able to invest in our commercial effort, which now stands at 18 people, including five field clinical specialists,” chairman and CEO, John Erb, says in an interview with BioTuesdays, noting that the company has achieved double-digit revenue growth, year-over-year, for the past five quarters.

“Congestive heart failure is the leading cause of fluid overload and is our primary disease target, representing approximately 75% of the total U.S. fluid management market,” he adds.

Aquadex therapy is 510(k) cleared by the FDA and sold internationally with a CE Mark. Historically, CHFS has had an installed base of more than 500 consoles in some 300 U.S. hospitals, with more than 60,000 successfully treated patients.

Using distributors, the Aquadex system is now available in the UK, Italy, Spain, Singapore and Hong Kong, with recently announced market entries in Germany and Thailand, he adds.

“What drew us to the international market were customers who had used the therapy before Baxter bought the business in 2012 and subsequently shut it down,” he recalls. “So when they heard that CHFS was bringing the aquapheresis therapy back to the market, we started getting many phone calls and emails, and we realized there was a segment of market demand in place.”

CHFS was a venture capital startup in 2001 and Mr. Erb was the company’s first CEO. In 2010, CHF was acquired by Gambro for $75-million. Two years later, Baxter acquired Gambro and Baxter put the CHFS business up for sale.

“I was able to acquire the business from Baxter for $4-million in 2016 and since then we’ve been reviving the business and re-engaging with cardiologists and hospitals,” he adds. CHFS also has moved manufacturing the Aquadex system from Baxter to its plant in Eden Prairie, Minn.

The therapy consists of the Aquadex console, which is about the size of a home coffee maker and has a list price of $31,000; a blood circuit set, which is a one-time use disposable and lists for $980; and a dual lumen venous catheter.

Mr. Erb explains that the dual lumen catheter is placed in a patients arm; one lumen withdraws blood, which is filtered to remove water, with the blood then returned to a patient through the second lumen. “Only about 33 cubic centimeters of blood is outside the body at any one time, which is far less than dialysis.” In addition, a blood circuit set is approved for 72 hours of use in a hospital and up to eight hours for an outpatient treatment.

Aquadex Product Overview

According to Mr. Erb, there are 6.5 million patients with heart failure in the U.S., representing the largest driver of Medicare costs, of which more than one million are hospitalized annually. And approximately 90% of heart failure hospitalizations result from fluid overload.

Diuretic drugs are standard of care for patients with fluid overload but fail to provide optimal outcomes in many patients, he adds. “Diuretics impact the kidneys over time and patients develop resistance to these drugs, with some two-thirds of patients discharged from hospital with residual excess fluid.” In addition, diuretics increase the risk of an electrolyte imbalance in the body, lowering magnesium and potassium.

Mr. Erb points out that the majority of all 30-day readmissions to hospital result from heart failure and the Affordable Care Act carries Medicare penalties for early patient readmissions, which is driving growth of the outpatient market.

CHFS has published results of five clinical trials with its Aquadex system in peer-reviewed journals, demonstrating that the treatment can remove 40% more fluid than conventional diuretic drug therapy over the same period of time, without any clinically significant impact on electrolyte balance, blood pressure and heart rate.

Mr. Erb also says the studies found a 53% reduction in the risk of re-hospitalization with the Aquadex system, compared with patients treated solely with diuretics, after 90 days and fewer re-hospitalizations because of a cardiovascular event.

Citing a study in the Journal of American College of Cardiologists, Mr. Erb suggests another benefit of the Aquadex system is precise control of the rate and amount of fluid removal.

“Diuretic patients have to have their dose increased in steps until their kidneys pick up the rate of voiding excess body fluid. With our device, we dial in the rate of filtration and the speed, so that treatment for 300-pound patient with 100 pounds of excess fluid and a 120-pound patient with 20 pounds of excess fluid can be customized based on the clinical goals set by a physician,” he contends.

“Ultrafiltration also can restore the body’s responsiveness to diuretic drugs and can result in more effective decongestion and fewer heart failure events, compared with diuretics,” he adds.

An independent study of the Aquadex system with 67 heart failure patients conducted by Good Samaritan Hospital in Cincinnati found no readmissions for volume overload after 30 days; the length of hospital stay reduced to two days from the national average of six days; readmission rates from before aquapheresis down to 4% from 12% the year before; and an average of six liters of fluid removed per patient.

An analysis of costs savings by a health economics-consulting group found that a hospital could save about $4,000 per admission using Aquadex, compared with diuretics, over a 90-day period. “That’s significant because the average hospital in the U.S. has 600 heart failure admissions a year,” Mr. Erb contends.

The American College of Cardiology/American Heart Association, the Heart Failure Society of America, the European Society of Cardiology and Heart Failure Association, and the Canadian Cardiovascular Society have published clinical guidelines supporting the use of ultrafiltration.

Last month, CHFS announced results of an independent study presented by Britain’s National Health Service of 13 patients who underwent ultrafiltration between 2014 and 2017. Among other things, the data showed greater weight loss over a shorter treatment period with ultrafiltration, compared with IV diuretics alone, without impacting renal function.

In July, CHFS received a five-year up to $6.5-million contract from the Tampa, Florida Veterans Affairs medical center for Aquadex consoles and blood circuit sets. The Tampa VA is using the therapy in an outpatient setting instead of admitting patients into hospital.

“This is meaningful because of all the doors it will open for CHFS throughout the VA as well as a potential expansion of our outpatient market,” Mr. Erb says.

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