So You Have Some Questions About Sunshine Heart?

By Jake King

In May, following a $14M equity financing, PropThink outlined why Sunshine Heart (SSH) was an attractive opportunity at less than $6.00 per share and a $60M valuation. Namely the pricing disparity between Sunshine Heart and competing, larger LVAD players offers a clear picture of what Sunshine Heart might look like in five years. You can read the full article here. Additionally, earlier this month we laid out why we're still bullish on SSH following the company's first-ever quarterly conference call, here. Sunshine Heart has a number of catalysts upcoming, despite what looks like a relatively quiet few years as the company awaits key trial results from a domestic study of the C-Pulse device.

Considering the precipitous climb in Sunshine Heart's share price and increasing attention from the healthcare investing community in the last two months, PropThink.com is orchestrating an exclusive conference call and interview with Sunshine Heart Chief Executive Officer David Rosa for the afternoon of September 3rd. Much has been written about Sunshine Heart in the past month, and as with any rapidly appreciating healthcare stock, questions about the underlying technology and business have begun to materialize. Facilitating access to management for an oft-overlooked investing community - retail investors - is one of our goals at PropThink, thus this upcoming conference call will be structured around an open Q&A with Mr. Rosa - interested investors are invited to participate free of cost. Sunshine Heart has been a major win for PropThink since we suggested investors pick up shares around $5.25 in May of this year. SSH opened trading on Friday at $11.01 after hitting a new 52-week high of $13.80 on the 26th. Nevertheless, we continue to like the long-term potential in Sunshine Heart - at $130M, we believe the small company is still attractive in relation to its long-term prospects.

Sunshine Heart takes a novel approach to the treatment of late-stage heart failure in the development of its lead heart assist device, the C-Pulse system, which may mitigate the need for heart replacement surgery in patients with congestive heart failure. Unlike competing products developed by incumbents Thoratec (THOR) and Heartware (HTWR), Sunshine Heart's approach brings a much less invasive product, both in terms of surgical installation and function, to an ailing patient population. While most Left Ventricular Assist Devices (LVADs) used in late-stage heart failure patients improve heart function with a small, constant-flow or pulsatile impeller installed within the patient's bloodstream, the C-Pulse uses a thumbprint-sized balloon and cuff wrapped around the aorta to improve blood flow and reduce burden on the failing heart. With no direct blood contact, C-Pulse may eliminate the need for chronic anticoagulants and antiplatelets in this patient population - and reduce the occurrence of strokes. Furthermore, Sunshine Heart is tackling an unmet market in Stage III heart failure patients, those at risk of progressing to the final and most severe stage of the disease, Class IV. Study results to date indicate that Sunshine Heart's approach may be an ideal methodology.

Sunshine Heart has made significant progress in developing its lead product candidate since (and arguably because) Mr. Rosa joined the small company in 2009. C-Pulse IPO'd in 2004 on the Australian Securities Exchange (ASX), but progress at the firm had been disappointingly slow following a feasibility trial that began enrolling five years after the IPO, in 2009, had initiated just four of 20 planned patients when Rosa joined the company in October of the same year. Twelve months later, 16 patients had been implanted with the new device and SSH was well on its way to completing the design of a smaller external driver and powersource for the C-Pulse. By the time the company listed on the NASDAQ early in 2012, the company had compelling results from its small feasibility study in hand and was preparing for a sizable trial to begin in the U.S. The 388-patient COUNTER-HF trial, which began enrolling patients earlier this year, is designed to establish C-Pulse's safety and efficacy in a large population of Class III and IVa patients ahead of a Premarket Approval Application with the U.S. Food and Drug Administration. Likewise, C-Pulse was granted a CE Mark in Europe, and a 50-patient open-label trial was initiated this year.

Mr. Rosa joined Sunshine Heart in '09 from a position as President and CEO of Milksmart, a privately held agricultural technology firm. But Mr. Rosa's management background has centered predominantly on the cardiovascular medical device space. Prior to his time at Milksmart, Rosa spent four years as VP of Global Marketing for Cardiac Surgery and Cardiology at St. Jude Medical (STJ), and as CEO of the privately held A-Med Systems, a company that designs devices for acute heart failure. Likewise, from '95-'99 he held varying managerial positions at SCIMED Life Systems, another cardiovascular-centric and privately held company that was acquired by Boston Scientific in 1994, where it continues to operate as a subsidiary.

We invite investors to participate in this exclusive conference call with Mr. Rosa on Tuesday, September 3rd, at 3:00PM EDT. Mr. Rosa will offer his insight on the C-Pulse system and Sunshine Heart in a guided interview before the call is turned over to participants for an open Q&A. Details and free registration can be found at Propthink.com/SunshineHeartCall, or by clicking here.

Questions about the event can be directed to editor@propthink.com.

Disclosure: I am long SSH. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

Additional disclosure: PropThink is a team of editors, analysts, and writers. This article was written by Jake King. We did not receive compensation for this article, and we have no business relationship with any company whose stock is mentioned in this article. Use of PropThink’s research is at your own risk. You should do your own research and due diligence before making any investment decision with respect to securities covered herein. You should assume that as of the publication date of any report or letter, PropThink, LLC and persons or entities with whom it has relationships (collectively referred to as "PropThink") has a position in all stocks (and/or options of the stock) covered herein that is consistent with the position set forth in our research report. Following publication of any report or letter, PropThink intends to continue transacting in the securities covered herein, and we may be long, short, or neutral at any time hereafter regardless of our initial recommendation. To the best of our knowledge and belief, all information contained herein is accurate and reliable, and has been obtained from public sources we believe to be accurate and reliable, and not from company insiders or persons who have a relationship with company insiders. Our full disclaimer is available at www.propthink.com/disclaimer.

View the original article here

So You Have Some Questions About Sunshine Heart?

By Jake King

In May, following a $14M equity financing, PropThink outlined why Sunshine Heart (SSH) was an attractive opportunity at less than $6.00 per share and a $60M valuation. Namely the pricing disparity between Sunshine Heart and competing, larger LVAD players offers a clear picture of what Sunshine Heart might look like in five years. You can read the full article here. Additionally, earlier this month we laid out why we're still bullish on SSH following the company's first-ever quarterly conference call, here. Sunshine Heart has a number of catalysts upcoming, despite what looks like a relatively quiet few years as the company awaits key trial results from a domestic study of the C-Pulse device.

Considering the precipitous climb in Sunshine Heart's share price and increasing attention from the healthcare investing community in the last two months, PropThink.com is orchestrating an exclusive conference call and interview with Sunshine Heart Chief Executive Officer David Rosa for the afternoon of September 3rd. Much has been written about Sunshine Heart in the past month, and as with any rapidly appreciating healthcare stock, questions about the underlying technology and business have begun to materialize. Facilitating access to management for an oft-overlooked investing community - retail investors - is one of our goals at PropThink, thus this upcoming conference call will be structured around an open Q&A with Mr. Rosa - interested investors are invited to participate free of cost. Sunshine Heart has been a major win for PropThink since we suggested investors pick up shares around $5.25 in May of this year. SSH opened trading on Friday at $11.01 after hitting a new 52-week high of $13.80 on the 26th. Nevertheless, we continue to like the long-term potential in Sunshine Heart - at $130M, we believe the small company is still attractive in relation to its long-term prospects.

Sunshine Heart takes a novel approach to the treatment of late-stage heart failure in the development of its lead heart assist device, the C-Pulse system, which may mitigate the need for heart replacement surgery in patients with congestive heart failure. Unlike competing products developed by incumbents Thoratec (THOR) and Heartware (HTWR), Sunshine Heart's approach brings a much less invasive product, both in terms of surgical installation and function, to an ailing patient population. While most Left Ventricular Assist Devices (LVADs) used in late-stage heart failure patients improve heart function with a small, constant-flow or pulsatile impeller installed within the patient's bloodstream, the C-Pulse uses a thumbprint-sized balloon and cuff wrapped around the aorta to improve blood flow and reduce burden on the failing heart. With no direct blood contact, C-Pulse may eliminate the need for chronic anticoagulants and antiplatelets in this patient population - and reduce the occurrence of strokes. Furthermore, Sunshine Heart is tackling an unmet market in Stage III heart failure patients, those at risk of progressing to the final and most severe stage of the disease, Class IV. Study results to date indicate that Sunshine Heart's approach may be an ideal methodology.

Sunshine Heart has made significant progress in developing its lead product candidate since (and arguably because) Mr. Rosa joined the small company in 2009. C-Pulse IPO'd in 2004 on the Australian Securities Exchange (ASX), but progress at the firm had been disappointingly slow following a feasibility trial that began enrolling five years after the IPO, in 2009, had initiated just four of 20 planned patients when Rosa joined the company in October of the same year. Twelve months later, 16 patients had been implanted with the new device and SSH was well on its way to completing the design of a smaller external driver and powersource for the C-Pulse. By the time the company listed on the NASDAQ early in 2012, the company had compelling results from its small feasibility study in hand and was preparing for a sizable trial to begin in the U.S. The 388-patient COUNTER-HF trial, which began enrolling patients earlier this year, is designed to establish C-Pulse's safety and efficacy in a large population of Class III and IVa patients ahead of a Premarket Approval Application with the U.S. Food and Drug Administration. Likewise, C-Pulse was granted a CE Mark in Europe, and a 50-patient open-label trial was initiated this year.

Mr. Rosa joined Sunshine Heart in '09 from a position as President and CEO of Milksmart, a privately held agricultural technology firm. But Mr. Rosa's management background has centered predominantly on the cardiovascular medical device space. Prior to his time at Milksmart, Rosa spent four years as VP of Global Marketing for Cardiac Surgery and Cardiology at St. Jude Medical (STJ), and as CEO of the privately held A-Med Systems, a company that designs devices for acute heart failure. Likewise, from '95-'99 he held varying managerial positions at SCIMED Life Systems, another cardiovascular-centric and privately held company that was acquired by Boston Scientific in 1994, where it continues to operate as a subsidiary.

We invite investors to participate in this exclusive conference call with Mr. Rosa on Tuesday, September 3rd, at 3:00PM EDT. Mr. Rosa will offer his insight on the C-Pulse system and Sunshine Heart in a guided interview before the call is turned over to participants for an open Q&A. Details and free registration can be found at Propthink.com/SunshineHeartCall, or by clicking here.

Questions about the event can be directed to editor@propthink.com.

Disclosure: I am long SSH. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

Additional disclosure: PropThink is a team of editors, analysts, and writers. This article was written by Jake King. We did not receive compensation for this article, and we have no business relationship with any company whose stock is mentioned in this article. Use of PropThink’s research is at your own risk. You should do your own research and due diligence before making any investment decision with respect to securities covered herein. You should assume that as of the publication date of any report or letter, PropThink, LLC and persons or entities with whom it has relationships (collectively referred to as "PropThink") has a position in all stocks (and/or options of the stock) covered herein that is consistent with the position set forth in our research report. Following publication of any report or letter, PropThink intends to continue transacting in the securities covered herein, and we may be long, short, or neutral at any time hereafter regardless of our initial recommendation. To the best of our knowledge and belief, all information contained herein is accurate and reliable, and has been obtained from public sources we believe to be accurate and reliable, and not from company insiders or persons who have a relationship with company insiders. Our full disclaimer is available at www.propthink.com/disclaimer.

View the original article here

Know enough about your parents' health?

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e-newsletter keeps you up to date on a wide variety of health topics.

Sign up now By Mayo Clinic staff

Prepare for a family emergency by gathering important details about your parents' health. For each parent, create a medical reference file that includes birth date, doctors' names and phone numbers, and insurance information. Compile a list of allergies, medications, major health problems and surgeries. Also include advance directives, the legal documents that outline your parents' decisions about health care, such as whether to use life-support machines.

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'You'll always make mistakes ... it's about correcting them'

'There isn't a single measure of failure', says Jan Filochowski, who has 20 years of experience as an NHS chief executive.

For Jan Filochowski, failure is not the end. The chief executive of Great Ormond Street Hospital is trying to change a management culture where it is assumed there can be no return from failure. "I want failure to be a point and success to be a permanent long lasting state", he says. "If you get into that mindset, you approach things differently."

It is this message that permeates his recent book, Too Good to Fail?, and it is one that he wants more people to adopt.

Having managed organisations in all states from failing to world-leading, Filochowski was inspired to write about the patterns he identified which occur when things were going wrong. If left unchecked, his book argues, simple problems can multiply until they result in total failure. Too Good to Fail? covers the full spectrum of failure from minor mistakes to complete systemic collapse.

At a time when the NHS is perceived to be in crisis with negative stories hitting the headlines, Filochowski – who has 20 years' experience as an NHS chief executive and troubleshooter – wants to change the way people think about failing.

"[People ask] what's the perfect hospital? Who's the perfect manager?," he says. "I think that's wrong. One of the words I'm most suspicious of is 'best' or 'perfect' and words I like are better [are] 'good' because I don't think you can ever do anything well enough. And if you do, you've got a problem because things can only get worse.

"I don't think that's setting the bar too low," Filochowski adds. "It's setting the bar high enough so people have a chance at jumping over it. If no-one can, it's not the managers that are no good – it's the system that's misjudged how high it should be set."

But what is failure? According to Filochowski, "there isn't a single measure of failure". The parameters change depending on the views of patients, the government of the day or some intermediary body. But, he argues, there is a clear and predictable pattern to failure.

A clear warning sign is when management is convinced that they are right. Other indications of organisational collapse include misjudgement of the problems faced, a failure to respond to what customers are saying, blindness to the consequences of actions, and a lack of oversight of staff and skills.

Filochowski says that openness and listening are key to avoiding and overcoming failure. "If you know the answer already then you don't need to listen, but people rarely do," he says. "I think it's really important that people are consulted and able to give their view. That doesn't mean to say that people taking those decisions have to give way when someone disagrees with them, because you'd never take a decision."

Meanwhile, Filochowski thinks the culture of branding any problems as 'failure' must change. "I think individual organisations need to be able to own up to difficulties without that being seen as a failure. Owning up to problems is a mark of maturity and a real indicator that you are likely to make the best of things."

He recognises that NHS managers have an enormous task ahead of them. "You'll always make mistakes," he explains. "We're managing something incredibly complex and it's about seeing the mistake and correcting it before it becomes really big. I think a lot of the art of management is making the unpredictable, predictable."

As for the future of the NHS, Filochowski predicts a long and healthy life.

"I think the future holds an NHS that, with blips and ups and downs, will continue to improve. The fact that there are loads of things wrong with it doesn't mean it is in terminal failure. They can and will be put right. It will never be perfect. That's because it's good and it's getting better."

This article is published by Guardian Professional. Join the Healthcare Professionals Network to receive regular emails and exclusive offers.

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Longer waiting times for GP appointments predicted as concerned GPs raise fears about the impact of cuts for patient care, UK

Main Category: Primary Care / General Practice
Also Included In: Public Health
Article Date: 20 Aug 2013 - 1:00 PDT Current ratings for:
Longer waiting times for GP appointments predicted as concerned GPs raise fears about the impact of cuts for patient care, UK

Over 70% of GPs are forecasting longer waiting times for GP appointments within the next two years - as nearly half (47%) reveal that they have cut back on the range of services they provide for their patients.

In the latest survey by the Royal College of General Practitioners (RCGP) highlighting the growing crisis in general practice, more than 80% of respondents said that they now have insufficient resources to provide high quality patient care.

As well as the reduction in patient services, 39% of respondents to the ComRes poll also said they had cut practice staff and over half had experienced difficulty recruiting and retaining GPs.

Worryingly, four in five GPs were concerned that it will become increasingly difficult to deliver continuity of care to vulnerable elderly people - which has been highlighted as a priority by the English Health Secretary Jeremy Hunt. And 72% of GPs in England said that the amount of time they are able to spend on frontline patient care has been reduced as a result of the new clinical commissioning responsibilities they have been given.

The RCGP is now calling on all four Governments across the UK for an emergency package of additional investment for general practice - before there are disastrous consequences for patients.

Dr Clare Gerada, Chair of the RCGP, said: "The results of our survey paint a bleak picture for patients, the profession and the future of general practice. GPs are grappling with a 'double whammy' of spiralling workloads and dwindling resources, and big cracks are now starting to appear in the care and services that we can deliver for our patients.

"We are particularly concerned about the effect this is having, and will continue to have, on waiting times for GP appointments. We fully understand that patients are already frustrated - and GPs are doing their best to improve access to appointments - but the profession is now at breaking point and we do not have the capacity to take on any more work, without the extra funding and resources to back it up.

"GPs currently make 90% of patient contacts for only 9% of the NHS budget in England. Some GPs are making up to 60 patient contacts in a single day, which is not safe, for patients or GPs.

"We are working our hardest to make sure that patients are not affected but the status quo is no longer an option. We must have an emergency package of additional investment for general practice to protect GP services and protect our patients from even deeper cuts to their care and longer waiting times."

The RCGP survey is the latest in a series highlighting the growing crisis in general practice. The College is concerned that the current situation in A&E departments is overshadowing the very serious problems in general practice. A previous College poll by Research Now revealed that 85% of GPs now consider the profession to be 'in crisis' and half of GPs are no longer able to guarantee safe patient care.

Dr Gerada added: "General practice is the most cost-effective and efficient arm of the health service - GPs keep the rest of the NHS stable and secure. Once general practice starts to crumble, the entire NHS will follow with disastrous consequences for our patients.

"Last week the English Government announced an additional £500 million for A&E departments. What we need is our fair share of funding so that GPs can do more for our patients in their communities."

ComRes interviewed 206 General Practitioners online - 170 from England; 21 from Scotland; nine from Wales; and six from Northern Ireland - between the 7th August and 9th August 2013. Data are regionally representative by NHS Strategic Health Authority (SHA). ComRes is a member of the British Polling Council and abides by its rules. Full data tables are available on the ComRes website, www.comres.co.uk

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Doctors worried about influx of super-sized babies across the world

Deseret News Monday 19th August, 2013

Rising rates in obesity have increased the risk of having an overweight baby. Babies born weighing more than 13 pounds have recently made headlines, and the new trend is causing concern among doctors.

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What questions should we be asking about end-of-life preferences?

Ensuring people die at home is being used as a quick and easy proxy for a good death. Photograph: Layton Thompson

With the current focus on the Liverpool care pathway (LCP), there is a lot of talk about how people's end-of-life wishes are taken into account.

This is a very specific example of where a tool designed to improve co-ordination between professionals has sometimes been poorly implemented to the detriment of patients and their families.

But focusing on the LCP alone means we fail to see the wood for the trees.

The LCP is one element of a vast end-of-life care system, which has, since 2008, been geared up to help people achieve their preferred place of death. This has led to an underdeveloped system.

The fact is, ensuring people can die at home is currently being used – both by health and care professionals and by dying people themselves – as a quick and easy proxy for a good death.

In a way, this is understandable. Decisions about end-of-life care are often made under difficult circumstances and it can be hard for professionals to discuss the intricacies of medication and families' wishes. Under these circumstances, it is tempting to simplify the decision-making process, by making this into a choice about place.

But it is clear this has undermined the development of the end-of-life care system: it has led to a lack of proper scrutiny of the experience of dying at home and leaves other settings neglected when it comes to developing them as good places for people to die.

The result is a system where no single place is able to meet all of people's preferences.

Inevitable compromises ensue – which is most evident for people expressing a wish to die in their own home.

Successive surveys have found that around two thirds of people say that home would be the place they would want to die – but research recently carried out by Demos for the charity Sue Ryder reveals that although 78% of people surveyed said that dying without pain was important to them, only 27% felt that home was a place where they would be free from pain during their final days.

This suggests the public is switched on to the fact that pain relief and out-of-hours care in one's own home is an acknowledged weakness in the system.

Despite knowing this, people are still opting to die at home because it satisfies more of their preferences overall – such as being surrounded by loved ones, in familiar surroundings and having privacy and dignity.

Such a trade off – sacrificing pain relief to be with your family – is not acceptable in today's care system, and yet it goes unscrutinised due to a prevailing assumption that once someone dies at home, all their wishes have been taken into account.

In order to align the end-of-life care system with the rest of health and social care, we must shift the emphasis from where to how and think about what outcomes people value, regardless of where they end up.

This places a lot more responsibility on health and care staff to communicate honestly and sensitively with patients and their families about the kind of death they would like to achieve, and inform them of their options across all available locations.

This is not an easy conversation to have, and doctors, nurses and other health and care staff should be supported to ask the right kinds of questions – not where, but how.

This will require rethinking and adapting existing tools, such as advance care plans, to ensure that place is not viewed as the most important – or the only – choice that a person needs to make about their death.

We should be aiming for a system where a person can say "I want to die without pain" and know what their options are for achieving this – whether at home, in hospital or in hospice.

Perhaps Baroness Neuberger's more constructive recommendations will finally create such a system.

Jo Salter is a researcher at the thinktank Demos

This article is published by Guardian Professional. Join the Healthcare Professionals Network to receive regular emails and exclusive offers.

On 17 July 2013, this article was amended to correct a link to the research conducted by Demos for Sue Ryder

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