SA News • Fri, Oct. 31
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at MarketWatch.com (Oct 1, 2012)
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There are 4 articles on this stock available only to PRO subscribers.
Recent Developments Reaffirm Bright Prospects For Sunshine Heart's C-Pulse
- Since publication of the original article, implant of the first UK patient with a C-pulse has been announced. This update will open up discussion on that seminal event.
- Another new matter raised is a seemingly high proportion of non-ischemic to ischemic heart failure patients enrolled in the FDA-approved Sunshine Heart 20 patient C-Pulse Feasibility Trial.
- The Feasibility Trial showed outstanding results, with only 5% re-hospitalization rate at 6 months compared to expectations for OMT therapy of ~50%%, thus a reduction of 90% in re-hospitalization rates.
- Five of the 20 patients in the Feasibility Trial have become asymptomatic and weaned off C-Pulse. Could all five be from the non-ischemic group of HF patients?
- If so, what are the implications for the 388-patient Pivotal Trial if the proportion of non-ischemic versus ischemic patients is significantly lower than for the Feasibility Study?
Sunshine Heart C-Pulse: A Paradigm Shift In Heart Failure Therapy
- Only Sunshine Heart’s C-Pulse has achieved a significant reversal of Heart Failure in 60% of its FDA approved Feasibility Trial NYHA Class III and ambulatory Class IV heart failure patients.
- Only Sunshine Heart’s C-Pulse has achieved 25% of its FDA approved Feasibility Trial patients becoming asymptomatic for Heart Failure and being able to be weaned off the device.
- Improvements in optimal medical therapy (OMT) have resulted in slowing in the worsening of Heart Failure, a progressive disease with a prognosis worse than most cancers.
- Celladon’s Mydicar gene therapy, in conjunction with OMT, shows promise of further slowing the worsening of Heart Failure and further increasing the pool of NYHA Class III Heart Failure patients.
- Initial slow rate of pivotal trial enrollments has driven down the Sunshine Heart share price. Announcement of acceleration in enrollments on 12 August could be a nightmare for “Shorts”.
Micro Cap Sunshine Heart Faces Medical Device Industry Challenges, Hires Boston Scientific And Medtronic Superstars
- SSH announced the hiring of two new VPs to boost expertise in clinical research and R&D. The new VPs are former employees of industry giants Medtronic and Boston Scientific.
- Small medical device companies face major challenges taking a device from idea to market. SSH's new VPs have the experience and know-how to overcome those challenges.
- The ability to attract top talent shows SSH's long-term focus and desire to build a company that will compete with industry giants and not sell out before achieving its potential.
Will Sunshine Heart Get Schooled If Enrollment Disappoints Again?
- Investors will be keenly focused on May 13th's earnings report and the progress in pivotal trial enrollment.
- Management has taken multiple steps to facilitate better enrollment trends in the COUNTER-HF pivotal study.
- Single-digit market share in 2024 can support a share price of $12.50 today.
Sunshine Heart: Turning Into A One-Horse Race In The NYHA Class III Heart Failure Stakes
- The target market for NYHA Class IV heart failure (HF) in the US and EU is around 250,000 patients and is strongly contested by Thoratec (THOR) and HeartWare (HTWR).
- NYHA Class III heart failure, with ~5 million patients in the US and EU, is a much larger and hugely coveted prize with a tiny percentage share worth $billions.
- Sunshine Heart (SSH) C-Pulse is the only long-term mechanical circulatory support (MCS) device to successfully complete a pilot trial showing safety and efficacy in Class III HF patients.
- The Thoratec HeartMate II Revive-It trial and the Sunshine Heart C-Pulse Pivotal trial are the only current FDA approved trials of MCS devices for NYHA Class III Heart Failure.
- The C-Pulse trial, being a Pivotal trial leading to PMA application, is a quantum leap ahead of the HeartMate II Pilot trial which requires a subsequent Pivotal trial.
Sunshine Heart: The 2 Horse Race For First In The NYHA Class III HF Stakes
- NYHA Class III heart failure patients are ineligible for heart transplant. Therefore, any heart assist device for Class III must qualify as Destination Therapy (DT) or Bridge To Recovery (BTR);.
- A heart assist device for Bridge To Transplant (BTT) will be unacceptable for implant into a NYHA Class III HF patient. Hence HeartWare’s HVAD being dropped from the REVIVE-IT trial.
- For NYHA Class IV patients the risks from LVAD’s of stroke, bleeding etcetera are considered outweighed by the higher mortality risk if a patient is not implanted with a LVAD.
- There is an argument that potential significant improvements in quality of life (QOL) might justify the implantation of LVADs in less sick NYHA Class III HF patients despite the risks.
- The race for first to FDA approval for NYHA Class III HF is currently between REVIVE-IT trial using Thoratec’s HeartMate II and the COUNTER HF trial using Sunshine Heart’s C-Pulse.
Sunshine Heart: Kimberley Olesen - A Big Fish From A Big Pond
- As Vice President of Global Clinical Operations at Medtronic (Market Cap $58.8bn), Kimberly Olesen could be very definitely described as a “Big Fish in a Big Pond”.
- As newly appointed Senior Vice President Clinical Operations for Sunshine Heart (Market Cap $0.1bn), Kimberley Olesen has now moved to being a “Big Fish in a very Small Pond”.
- What Kimberly Olesen has done seems counter-intuitive. “Big Fish” generally move to a bigger pond, to allow for increased opportunity for career growth.
- Does Kimberly Olesen see this very Small Pond growing exponentially larger to equal or exceed Medtronic’s current market cap?.
- Is Medtronic the “mystery investor”, with observer status at Sunshine Heart Board meetings and with an interest in providing maximum support for the current pivotal trial?
- It is widely acknowledged that Sunshine Heart C-Pulse heart assist device is highly efficacious, has low technical risk and a multi-billion dollar market potential;
- Slow enrollment in the current Counter HF Pivotal trial is not unexpected. From the SSH 4th Quarter 2013 CC it is evident that the enrollment process is being handled well;
- American Heart Association guidelines require hospitals to use inotropes only as a bridge to more definitive treatment measures. C-Pulse is such a treatment measure;
- The massive market over reaction to the slow trial start has created an alpha opportunity, particularly for medium to long term investors.
Sunshine Heart: An Elementary Question Reveals A Profound Problem
- Sunshine Heart's Counter-HF pivotal phase 3 trial of their remarkable C-Pulse Heart assist system for Class III and IV heart failure patients is enrolling sluggishly at best.
- Investors should ignore the noise and laser focus on enrollment numbers moving forward.
- Criteria for enrollment might be too rigid, competition for patients too stiff and the device might work too well for patients to stay on the required 12 months of participation.
- The share price has been in steady downfall since a news release in mid-January of this year and short interest has been steadily rising.
- Most troubling of all, the stated goal of 4 years to completion of the Counter-HF trial may be flawed by design.
Fri, Oct. 31, 5:55 AM
Thu, Oct. 30, 5:54 AM
Tue, Aug. 12, 12:45 PM
Tue, Aug. 12, 12:07 PM| Comment!
Tue, Aug. 12, 6:02 AM
Tue, May. 13, 7:48 AM
Mon, Mar. 24, 8:57 AM| 16 Comments
Tue, Mar. 11, 1:03 PM
- Investors take umbrage at Sunshine Heart (SSH) today in response to its earnings report published this morning. Shares are down 16% on seven times normal volume.
- Some investors perceive that the company's patient enrollment for the C-Pulse system is proceeding at too slow a pace.
- 36 mutual funds have positions, up from 12 a year ago.
Tue, Mar. 11, 12:47 PM
Tue, Mar. 11, 5:58 AM
Thu, Feb. 20, 11:07 AM
- A fan of Sunshine Heart's (SSH -0.2%) technology, BTIG is concerned about the current pace of enrollment in the company's U.S. trial. "We think it could be several years before this trial is complete, pushing FDA approval to 2018 or beyond," writes analyst Sean Lavin, initiating coverage with a Neutral. "We believe the most meaningful thing to watch in 2014 is the pace of enrollment."
- "Taking U.S. share has proven more difficult than we initially thought," he writes, also starting Heartware International (HTWR) with a Neutral. "A DT label, especially in light of the recent NCD change and Q4 miss will be more important to taking U.S. share than we would have predicted a year ago."
- "We feel HTWR's pipeline is robust, but risky. HTWR is working on several products: MVAD, SYNERGY Surgical and Endovascular Systems, and Longhorn. MVAD is the most important. We believe MVAD offers greater technical advances than THOR’s HMIII but also greater risk as the devices are brought to market."
Dec. 31, 2013, 4:05 PM
- Summer Street is out with its "Alpha List" for 2014. Below are some of the firm's recommendations in the healthcare space.
- NPS Pharmaceuticals (NPSP) and Rockwell Medical (RMTI) are top picks, with the former propelled by Gattex and the latter buoyed by SFP optimism.
- Sunshine Heart (SSH) is a top MedTech play while Abiomed (ABMD), Heartware (HTWR), and Thoratec (THOR) get positive mentions as well, although these names aren't in the firm's coverage universe.
Dec. 17, 2013, 8:12 AM
- Leerink is out with some commentary on the MedTech space.
- Investors should "focus on companies with growth acceleration and/or upside surprise potential independent of (or at least less dependent on) a macroeconomic recovery [or, alternatively,] a higher and increasing percentage of sales derived from end-markets exhibiting above-average growth," Leerink says.
- Not surprisingly, the LVAD device market gets a mention, with Heartware (HTWR) recommended by name (remember, they just snapped up CircuLite which some think can compete with SSH's C-Pulse).
- Other names mentioned by Leerink: Covidien (COV) for neurovascular and energy devices; Stryker (SYK) for neurovascular and robotics; St. Jude's Medical (STJ) and JNJ for atrial fibrillation; Intuitive Surgical (ISRG).
- Thoratec (THOR) gets an LVAD mention as well, which is interesting considering Leerink's recent commentary on the NEJM manuscript which discussed possible thrombus formation with the HeartMate II.
Dec. 2, 2013, 12:11 PM
- HeartWare (HTWR -0.7%) has acquired CircuLite, maker of the SYNERGY system which treats ambulatory chronic heart failure patients.
- The deal is for $30M ($18M in HTWR stock and $12M in cash).
- Here's HTWR CEO Doug Godshall: "The partial-support system developed by CircuLite represents the industry's most intriguing platform for the treatment of patients with earlier stage heart failure." (PR)
- This raises some rather obvious concerns for Sunshine Heart (SSH -0.7%) and the C-Pulse system.
- "Circulite, like SSH, focuses on circulatory support for patients that have failed resynchronization therapy but are not yet sick enough for LVAD. This is a large market which we detail extensively in our SSH reports. Circulite is slightly ahead of SSH in commercializing their products in CE-Mark countries but have also run into problems and have had to pull the product," Summer Street's Mark Landy says, reiterating a Buy rating on SSH.
- "The main differences between Circulite and SSH are that Circulite's products are pumps that 'touch the blood' whereas SSH product does not and that Circulite's products are implanted in hybrid cathlab whereas SSH products as of now require surgery procedure in OR," Landy adds. SSH price target reiterated at $16.
Nov. 29, 2013, 8:35 AM
- Sunshine Heart (SSH) moves 2.7% higher in premarket trading.
- Investors are likely reacting to the NEJM and JHLT manuscripts which warn of device exchanges linked to thrombus occurring with HeartMate II (THOR) devices.
- SSH's C-Pulse system treats clinical symptoms associated with Class III and ambulatory Class IV heart failure.
- THOR is now -10% premarket
- For more on the journal manuscripts, THOR, and HTWR, see here and here
Nov. 11, 2013, 4:42 PM
SSH vs. ETF Alternatives
Sunshine Heart, Inc., is an early stage medical device company. It is engaged in developing, manufacturing and commercializing its C-Pulse Heart System for treatment of Class III and ambulatory Class IV heart failure.
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