Congratulations are in order for management and staff and long-term shareholders of Nephros, Inc. (OTC:NEPH) who have brought an important treatment on-line for people afflicted with kidney disease.

Nephros, is a medical device company that makes and sells filtration products for therapeutic applications, infection control, and water purification. The Company’s hemodiafiltration (HDF), system is designed for the End-Stage Renal Disease (ESRD) patient while addressing the critical financial and clinical needs of the care provider. 

The Nephros HDF system removes a range of substances known as middle molecules. These molecules have been found to contribute to such conditions as dialysis-related amyloidosis, carpal tunnel syndrome, degenerative bone disease and, ultimately, mortality in the ESRD patient. 

Nephros ESRD products are sold and distributed throughout Europe and are being used in over 50 clinics in Europe.

And now it’s onward to opening up the market in the U.S. 

The Company announced yesterday it has received 510(k) clearance from the Food and Drug Administration ("FDA") to market its Hemodiafiltration ("HDF") system for the treatment of chronic renal failure when used with UF controlled dialysis machines capable of producing ultrapure dialysate in accordance with current AAMI/ANSI/ISO standards in the United States.

"HDF represents an alternative treatment option for chronic renal failure, and I am excited that patients in the United States will now have the opportunity to be treated with this important therapy," said Leonard Stern, M.D., Medical Director at Columbia University Dialysis Center, and Associate Clinical Professor of Medicine, Columbia University, College of Physician and Surgeons. 

"Nephros can now offer the only on-line HDF therapy available in the U.S.," said John C. Houghton, President and CEO of Nephros, Inc. "Nephros will first pursue a limited launch of its HDF system before expanding into the broader market. In parallel, Nephros will evaluate opportunities to leverage the resources of a strategic partner to most effectively address the market."

Not just another mouthwash; I really like bio-tech when companies bring an “Important Treatment Device” to market that will make a big difference in the lives of patients. That’s what NEPH has done.

Shares are trading today on the news at $1.70. 

I haven’t, don’t, and do not intend on holding any of the companies mentioned in this article.

...

Health Minister Doug Currie was in the hot seat today when the Opposition Tories focused all of question period on concerns over the closure of rural dialysis clinics, as well as wait times in addictions and mental health.

Opposition MLA Hal Perry sparked fireworks when he grilled Currie on why no consultation was held on government’s announcement last week to discontinue offering hemodialysis treatment in Souris and Alberton.

He said the residents of Souris and West Prince are being treated as second class citizens when it comes to health care.

Currie reiterated statements he made when questioned on this issue last week, saying continuing dialysis services in four locations across the province is not sustainable.

“We’ve seen in the last three years a 75 per cent increase in the demand on dialysis,” he said.

“We are responding to the demand, but it’s unrealistic to expect that we’re going to have services of that nature and that magnitude in every community in this province. It’s not sustainable.”

Currie pointed out expansions that have been made to the Charlottetown and Summerside hospitals and said Islanders who need dialysis treatment will now be receiving state-of-the-art care.

“We know that if the member for Tignish-Palmer Road is in cardiac arrest at two o’clock in the morning, where does he want to be heading to?” Currie said.

“Definitely not in an ambulance ride an hour away,” Perry shot back.

During another part of question period, Opposition health critic James Aylward questioned Currie on the 2012 auditor general’s report where the lack of an overall plan to address increasing problems in mental health and addictions in the province was identified.

Aylward said he has received countless calls from Islanders who need services in these areas but are told there are long waiting lists and no beds.

“They don’t know where to turn, they don’t know what to do. They feel abandoned,” Aylward said.

“Minister, can you tell us what we can tell these individuals?”

Currie said he too has been getting calls and emails and even messages via social media from Islanders expressing the same concerns. He reiterated government’s commitment, announced in the recent throne speech, to conduct a comprehensive review of the current needs in mental health and addictions. That review will include a plan for improving access and wait times.

“This government recognizes we are facing unacceptable wait times and challenges with mental health and addictions. We realize the complexity of addictions today is different than it was five years ago,” he said.

“(Health P.E.I.) has undertaken a review called ‘A Pathway Forward’ where they’re looking at initiatives and efficiencies.”

...

Opposition MLA Hal Perry believes the closure of dialysis clinics in Souris and Alberton is a foreshadowing of the imminent closure of these rural hospitals.

Health Minister Doug Currie was in the hot seat Tuesday in the legislature when the Opposition Tories raised continued concerns over upcoming changes to the dialysis clinics at Souris Hospital and Western Hospital in Alberton.

Last week, Currie announced a consolidation of hemodialysis services from four current locations to two expanded ones in the Charlottetown and Summerside hospitals.

Perry questioned Currie on why these changes were made with no prior consultation with patients or staff.

“People in this area are getting tired of being treated poorly by this government. They want a government which doesn’t throw them underneath the bus. Dialysis is not only necessary to survival, but it’s time-consuming and appointment times are very important to people,” Perry said.

He asked whether the loss of these services is an indication of future closures at the Souris and Alberton hospitals.

“Minister, what’s next? Seriously, what is next? The ER in Alberton, or perhaps Western Hospital closed?”

Currie didn’t directly answer this question. Instead, he responded by saying his government is being forced to make some tough decisions.

“At times, difficult decisions need to be made in respect to the sustainability of maintaining health care in this province, and we’re going to continue. The only difference is this government has a vision and a plan. That government didn’t.”

Perry said he’s received countless calls from patients who receive dialysis treatment and their family members who say the additional time and expense in traveling to Charlottetown and Summerside will be a major burden on their lives.

“They’re outraged because they feel they’re being attacked… this is a major attack on Western P.E.I.,” Perry said.

Outside the rail, Currie said it would not only be rural Islanders affected by these changes. He pointed out there are currently 11 dialysis patients receiving treatment in Souris and eight in Alberton – and some of these patients are from Charlottetown and Summerside who travel to the rural hospitals for their treatment.

With the number of Islanders developing kidney disease expected to double in the next few years, an expansion of services in centralized areas is the best way to keep a sustainable level of care, Currie said.

“We’ve seen a 73 per cent increase in demand on the hemodialysis service and in the next three years we anticipate the same level of growth, which will almost double the number of Islanders who need dialysis, so that’s intense growth,” Currie said.

“This basically is about meeting the challenge and the demand for that service.”

Nonetheless, Perry thought it was telling Currie wouldn’t directly answer the question of whether there are plans in the works to close the Souris and Alberton hospitals.

“We think, with the minister skirting around the question on the closure of Western Hospital, what’s next?”

Twitter.com/GuardianTeresa

...

The intense competition for the best treatment of runaway hypertension looks like it’s about to heat up. Word is that Massachusetts-based Covidien, which has been on a buying spree, is going to acquire early stage California medical technology company Maya Medical.

Renal denervation is the potential solution for the 12 million people who can’t control their high blood pressure despite using an array of drugs. The treatment uses a catheter to widen the areas around the nerves that line renal arteries. The Cleveland Clinic called renal denervation the No. 1 healthcare innovation of 2012.

A Covidien spokesman wouldn’t comment on what he described as “market rumors and speculation,” but conceded that the company is in “partnership with Maya on a new technology.” The spokesman, Bruce Farmer, went on to add that Covidien makes strategic investments from time to time and “is a recognized market leader in RF ablation technology, with numerous products in both its vascular and surgical portfolios. …”

RF ablation is what Maya Medical’s solution is all about.

In about two weeks, Covidien is sponsoring a panel at the EuroPCR conference in Paris that will highlight Maya Medical’s OneShot technology. In a separate panel, Maya Medical’s s own chief medical officer, Michel Accad, will talk about OneShot as the “next generation balloon-based, radio frequency renal denervation system.”

A call to Maya Medical wasn’t immediately returned. The company is currently conducting a phase 2 clinical study in Belgium and The Netherlands, although the medical centers are not recruiting patients yet.

While Covidien is sponsoring Maya Medical’s OneShot panel, Medtronic and St. Jude Medical are sponsoring renal denervation panels that highlight technologies they actually own.

A source in the renal denervation industry with knowledge of the deal between Covidien and Maya Medical said that device firms do not sponsor panels unless they own the technology being discussed or have an interest in it.

Covidien’s interest in Maya Medical’s renal denervation technology is understandable. An analyst who covers Covidien said that early clinical data on renal denervation is very promising and that the market is large.

“It’s in the billions of dollars and there is a huge need,” said Michael Matson, an equity analyst with Mizuho Securities USA.

He added that Covidien typically buys companies in new growth platforms with acquisitions at around $500 million or less. The company has bought four companies in 2012 that fit this description. One exception is ev3, which Covidien bought for more than $2.5 billion in 2010.

The Maya Medical deal, if and when it happens, will bring Covidien into competition with Medtronic and St. Jude Medical. Medtronic is the leader in the renal denervation field with its prescient acquisition of Ardian for $800 million in late 2010. While the system works, it is hard to manipulate, said analyst Debbie Wang of Morningstar. She said that Medtronic will have to buy another renal denervation firm developing the next generation of these devices to remain ahead. Medtronic’s Simplicity renal denervation system is approved in Europe and the company is currently enrolling patients in a U.S. clinical trial that will be used for wining regulatory approval here.

St. Jude Medical is also developing a renal denervation system and expects to get the CE Mark by the end of the year.

And there are a whole host of small, private companies that are also developing solutions — ReCor Medical, SeptRX and Apex Nano Therapeutics, all of whom will be discussing their technologies at the upcoming EuroPCR conference in mid May. Vessix Vascular just received a CE mark for its renal denervation system.

[Image from flickr user BostonTX]

...