Dialysis industry news

Stories from the dialysis comunity across the globe.



New smaller dialysis machine purifies water, creates dialysate - NephrologyNews.com PDF Print

"<photocredit>Business Wire</photocredit>" Outset Medical has secured $91 million in equity and debt funding for its Tablo dialysis machine. The machine, which is just 35 inches, includes wireless connectivity and real-time integrated water purification. The machine alsoproduces dialysate, takes blood pressure and delivers medication. The machine is designed to reduce the set up and management time of performing dialysis, the company said.  

The company will use proceeds from the financing to begin a controlled commercial introduction this year and to pursue expanded FDA clearance to allow patients to use Tablo at home. The FDA recently approved an investigational device exemption (IDE) trial to evaluate the safety and efficacy of Tablo in this setting.

“Dialysis is a life-sustaining therapy that has changed very little in the last few decades,” said Glenn M. Chertow, M.D, Norman S. Coplon/Satellite Healthcare Professor of Medicine and Chief of the Division of Nephrology at Stanford University School of Medicine. “I am excited about the ways Tablo can offer expanded choices for dialysis patients. Many patients who receive dialysis want more control over the experience and want to live fuller, more independent lives. These patients are extremely capable, and with improved technology, could take the lead in their own dialysis care with minimal assistance. Other areas of medicine suggest that when people are directly engaged in their care, they live longer and feel better.”

The equity and debt funding came from Fidelity Research and Management Company, Warburg Pincus, The Vertical Group, Partner Fund Management LP, Perceptive Advisors, and CRG.

“We are gratified by the strong showing of support from existing and new investors who share our vision of expanding where, how and who can perform hemodialysis,” said Leslie Trigg, Outset Medical’s CEO. “Today, hemodialysis is labor-intensive and expensive to provide, and many patients lack flexibility and control over the experience. Tablo uniquely enables new care delivery models that may offer significant cost reduction opportunities for providers while substantially improving the experience for patients.”

 

...

 
Point 72 Takes A 5% Stake In NxStage Medical (NXTM) - Seeking Alpha PDF Print

By Jay Smith

According to SEC filings, Steve Cohen's Point 72 has accumulated 3,163,744 shares in NxStage Medical (NASDAQ:NXTM). 3.16 million shares is 5% of NxStage Medical's float and is a major position relative to the average daily volume of 486,000 shares. Cohen joins James Flynn's Deerfield Management and Justin Ferayorni's Tamarack Capital Management as major holders of NxStage Medical.

Following the picks of hedge funds can generate significant alpha. Our research shows that the 15 most popular small-cap stocks among hedge funds have outperformed the market by nearly a percentage point per month between 1999 and 2012. We have been forward testing the performance of these stock picks since the end of August 2012. These stocks managed to return more than 132% over the ensuing 2.5 years and outperformed the S&P 500 Index by nearly 80 percentage points (read the details here).

NxStage Medical is a medical device company that manufactures products for end stage kidney failure. The company has three segments, a segment that sells a home dialysis product named System One, a services segment that provides dialysis services at NxStage owned dialysis centers, and a segment that sells blood tubing sets and needles to non-NxStage dialysis centers.

NxStage's home dialysis product, System One, accounts for the majority of the company's revenues. It accounted for 71% in 2014 while the segment that sells blood tubing and needles to other dialysis centers accounted for roughly 26% of total revenues in 2014.

System One is the first and only portable hemodialysis system approved for home use by the FDA. It is also the first and only system cleared for home nocturnal hemodialysis by the FDA. The product has successfully delivered ten million treatments to thousands of patients with end stage renal disease. It has also delivered better health outcomes than alternatives. According to NxStage Medical's annual report, a study showed that more frequent application of System One lowers mortality by 16%, lowers hospitalization outcomes by 8%, and ensures better patient compliance versus the other home therapy alternative, peritoneal dialysis. Patients that use System One five to six times a week better mimic natural kidney behavior than patients that do dialysis three times a week at traditional dialysis centers.

Because of System One's value proposition, NxStage revenues have grown around 14-15% year over year, growing from in $149 million in revenues in 2009 to $301 million in revenues in 2014.

While NxStage revenues have increased, the company is not profitable. Analysts expect the NxStage Medical to lose $0.36 per share in 2015 and to lose $0.26 per share in 2016. NxStage's customer base is also concentrated. Because Medicare rules require all chronic end stage renal disease patients to be under care of a dialysis clinic, NxStage sells System One to dialysis clinics even though the patients are using System One for home treatment, making the dialysis chains DaVita and Fresenius NxStage Medical's largest customers. In 2014, DaVita represented 30% of System One sales and Fresenius represented 22% of sales. The large concentration gives DaVita and Fresenius pricing power, lowering NxStage's margins.

NxStage hopes to be profitable and cash flow positive in three years. It plans to do this by increasing demand for System One by doing more direct customer advertising, selling internationally, and by adding more features into System One to broaden the product's addressable market to a larger subset of patients among the chronic and critical care dialysis markets. If this occurs, System One's gross margins should rise above 50% and make the company profitable. In the medium term, NxStage also plans to launch a new peritoneal dialysis product.

NxStage shares are difficult to value because the company is not profitable and the validity of management's roadmap is uncertain without knowing the added features NxStage hopes to introduce in System One. Also, although the company is targeting a multi-billion dollar market in treating ESRD and has a superior and differentiated product, home hemodialysis has not replaced peritoneal dialysis as the standard of care for home dialysis. Establishing home hemodialysis as the standard of care requires the medical community to change its views and upgrade its infrastructure, which will take significant amounts of time. Medicare also only pays for dialysis three times a week, not the five or six times a week that System One requires to generate better healthcare outcomes. Because of these factors, NxStage's upside is uncertain.

Disclosure:The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it (other than from Seeking Alpha). The author has no business relationship with any company whose stock is mentioned in this article.

...

 
Central Venous Access Devices Market in the US to grow at a CAGR of 7.85 ... - Medgadget.com (blog) PDF Print
Central-Venous-Access-Devices

About Central Venous Access Devices

Central venous access devices are inserted into the central venous system to administer medication or fluids, draw blood, and measure central venous pressure. These devices are made up of a non-irritant material such as silicone, so that they can be left in place for several weeks or months. Central venous access devices are recommended when there is difficulty to obtain peripheral venous access or in case of certain intravenous therapies such as chemotherapy, total parenteral nutrition, prolonged medication, repeated transfusions of blood or blood products, and frequent blood sampling. These devices are inserted either by surgeons or interventional radiologists with or without the use of general anesthesia. CVCs, PICCs, and implantable ports are the most common types of central venous access devices.

Central venous access devices market in the US to grow at a CAGR of 7.85% over the period 2015-2019.

Covered in this Report
The central venous access devices market in US is divided into four segments: PICC, CVC, dialysis catheters, and implantable ports.

Central Access Devices Market in US 2015-2019, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects in the coming years. The report also includes a discussion of the key vendors operating in this market.

Key Vendors
• AngoDynamics
• B.Braun Medical
• C.R. Bard
• Teleflex

Other Prominent Vendors
• Argon Medical Devices
• Medical Components
• Merit Medical Systems
• Medtronic
• Vygon

Request For Sample Report Here:
http://www.marketresearchstore.com/report/central-venous-access-devices-market-in-the-us-18469#requestSample

Market Driver
• Increasing Aging Population
• For a full, detailed list, view our report

Market Challenge
• High Risk of Vein Thrombosis
• For a full, detailed list, view our report

Market Trend
• Growing Incidence of CABSI
• For a full, detailed list, view our report

Key Questions Answered in this Report
• What will the market size be in 2019 and what will the growth rate be?
• What are the key market trends?
• What is driving this market?
• What are the challenges to market growth?
• Who are the key vendors in this market space?
• What are the market opportunities and threats faced by the key vendors?
• What are the strengths and weaknesses of the key vendors?

Our analyst researched the following companies as the key players in the Central Venous Access Devices Market in the US 2015-2019: AngoDynamics, B.Braun Medical, C.R. Bard and Teleflex

Other Prominent Vendors in the market are: Argon Medical Devices, Medical Components, Merit Medical Systems, Medtronic and Vygon

Commenting on the report, an our analyst said: “Power-injectable PICCs are used to inject contrast media into the vein during CT imaging. This technique enhances visualization during diagnostic imaging procedures. A catheter used for such procedures must be sturdy and able to withstand pressures higher than 300 psi. Power-injectable catheters are used for CT imaging, as they are made of polyurethane. The material is stronger than silicone and can withstand high pressures with only a small decrease in flexibility. For example, the PowerPICC devices offered by C.R. Bard combine the efficacy of PICC access and power injection into one catheter, thereby allowing their use in CT scans for injecting contrast media.”

According to the report, the US Census Bureau has projected that the number of Americans aged 65 and above will increase by 2020. The physiological changes associated with aging include a higher risk of developing chronic diseases such as ESRD and various types of cancer, which might require critical care. This leads to an increased demand for venous access devices for delivering drugs, supplying nutrient-rich fluid, and collecting blood samples.

Further, the report states that the insertion of central venous access devices increases the risk of deep vein thrombosis inhibits market growth.

The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors.

...

 
Prognosis of Japanese patients with previously untreated metastatic renal cell ... - UroToday PDF Print
image

A multicenter cooperative study was conducted to clarify the prognosis of Japanese patients with metastatic renal cell carcinoma in the era of molecular-targeted therapy and the clinical usefulness of the Japanese metastatic renal cancer (JMRC) prognostic classification.

Of 389 consecutive patients for whom treatment was started between 2008 and 2010 at 23 hospitals in Japan, 357 patients who received vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI) or cytokine as initial systemic therapy were the subject of the present study. Patients were classified into three prognostic groups according to the JMRC prognostic classification. The endpoints were progression-free survival (PFS) and overall survival (OS) after the start of the initial treatment. The median PFS and OS for the entire cohort of 357 patients were 9.1 and 27.2 months, respectively. VEGFR-TKI were selected for patients with multiple organ metastases, those with liver metastasis, and those with bone metastasis. The median PFS and OS were 11.0 and 23.2 months and 5.4 and 38.2 months in the VEGFR-TKI group and the cytokines group, respectively. The JMRC prognostic classification was useful as a prognostic model for PFS and OS (c-indexes: 0.613 and 0.630 in patients who initially received VEGFR-TKI and 0.647 and 0.642 in patients who received cytokines, respectively). The present study showed for the first time the prognosis of Japanese patients with metastatic renal cell carcinoma in the era of molecular-targeted therapy. The JMRC prognostic classification may be clinically useful as a prognostic model.

Written by:
Shinohara N, Obara W, Tatsugami K, Naito S, Kamba T, Takahashi M, Murai S, Abe T, Oba K, Naito S.   Are you the author?
Department of Renal and Genitourinary Surgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan; Department of Urology, Iwate Medical University, Morioka, Japan; Department of Urology, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan; Department of Urology, Graduate School of Medicine, Yamagata University, Yamagata, Japan; Department of Urology, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Urology, Graduate School, University of Tokushima, Tokushima, Japan; Department of Biotatistics, School of Public Health, University of Tokyo, Tokyo, Japan.

Reference: Cancer Sci. 2015 May;106(5):618-26.
doi: 10.1111/cas.12646


PubMed Abstract
PMID: 25711777

UroToday.com Renal Cancer Section

...

 
Controlling blood sugar for many years reduces diabetes patients' heart risks - NephrologyNews.com PDF Print

For diabetes patients, keeping blood sugar levels under good control for many years can reduce the risk of suffering a heart attack, stroke, heart failure or amputation by about 17%, according to a new study published in the June 4 issue of the New England Journal of Medicine.

Patients may not have to keep their blood sugar levels super-low to reap most of the cardiovascular benefit. The authors concluded that a long-term average of about eight on the measurement called A1C hemoglobin was enough to achieve most of the benefit, but that many patients can be safely lowered to around 7

The study was conducted by a team from three VA hospitals, the VA Center for Clinical Management Research and the University of Michigan Medical School. They show what happened to nearly 1,800 veterans with Type 2 diabetes nearly 10 years after they signed up for a six year blood sugar study that randomly assigned them to either get help achieving “tight” blood sugar control, or regular care.


Read also:

Early detection and treatment of type 2 diabetes may reduce heart disease and mortality


 “Taken together with findings from other large studies, we see that controlling blood sugar in diabetes can indeed decrease cardiovascular risk, though we continue to see no effect on risk of dying during the same time period,” said lead study author Rodney Hayward, MD, of the VA Ann Arbor Healthcare System and U-M. “This finding reinforces the importance of combining good blood sugar control with control of other cardiovascular risk factors for a combined effect.”

Hayward notes that for anyone with Type 2 diabetes, a growing body of research supports the idea of taking four medications to help their hearts: metformin to control blood sugar, a statin to control cholesterol and other blood lipids, a blood pressure medication, and aspirin.

This quartet of drugs, combined with diet, stopping smoking and exercise, could help millions of people stave off the heart attacks, strokes, heart failure and amputations due to poor circulation that cause so much premature death and disability among people with diabetes. They may also help prevent the other issues that can arise from the effect of diabetes on small blood vessels, including blindness, nerve pain or numbness, and kidney failure.

But striving for even lower A1C levels in all people with diabetes may not increase cardiovascular benefit enough to be worth the effort, Hayward notes —especially if patients receive newer drugs with unclear long-term safety, already take many other medications, or experience medication-related issues such as weight gain or frequent low blood sugar reactions.

“Once someone has his or her A1C around 8%, we need to individualize treatment to the patient, balancing his or her individual cardiovascular risk based on personal and family history, his or her age and life expectancy, smoking history and medication side effects,” he says. “If you want to determine what the best A1C number is for you, and when should take another medication to lower it, you should decide with your doctor.”

More about the study
The data for the new analysis came from 1,791 veterans who enrolled in the Veterans Affairs Diabetes Trial or VADT. For the new paper, the researchers dug through VA and Medicare records to find out how the veterans were doing more than five years after the study, called ended.

The finding of a statistically significant reduction in cardiovascular events -- heart attack, stroke, new diagnosis of heart failure or gangrene-related amputation—among the intensive control group is similar to what has been seen in other studies. Interestingly, the original VADT study did not find a significant cardiovascular benefit from tight glucose control after only five to six years of follow-up, and this finding only emerged after longer follow-up.

But the size of the benefit from good blood sugar control was smaller than what other studies have shown about the impact of keeping blood pressure and cholesterol under control in diabetes. That’s why it’s important to look at an individual’s underlying cardiovascular risk and why blood pressure medications and statins are particularly important for preventing heart attacks and strokes in people with diabetes.

The researchers note that their results should not be used to justify an across-the-board A1C target of seven for all people with diabetes. Rather, they say, any quality measure for doctors and hospitals that use A1C as a measure of blood sugar control should also take into account a patient’s risk of cardiac events, of low blood sugar reactions, and what additional medications would be needed to lower A1C further.

In addition to Hayward, the study’s authors are Peter D. Reaven, MD, Wyndy L. Wiitala, PhD, Gideon D. Bahn, PhD, Domenic J. Reda, PhD, Ling Ge, MS, Madeline McCarren, PhD, William C. Duckworth, MD, and Nicholas V. Emanuele, MD.

...

 
<< Start < Prev 171 172 173 174 175 176 177 178 179 180 Next > End >>

Page 175 of 4210
Share |
Copyright © 2025 Global Dialysis. All Rights Reserved.