SHC - Sunshine Heart

[Joe Blow]

Sunshine Heart, Inc (SHC) is a global medical device company, committed to the commercialisation of C-Pulse, an implantable, non-blood contacting, heart assist therapy for the treatment of people with moderate heart failure.

 

[WiseMum]

Great to see a thread started for SHC (thank you Joe). I have been interested in them for quite a while and am holding. As with many of these companies, they take some time to gain recognition, but do seem to be gathering momentum. Their C-Pulse clinical trials are going well with two new implants in the last couple of weeks. They have approval to start trials in Australia, have hired some new key staff and moved into new offices in Minnesota last month (also where headquarters of a number of other cardio companies like Medtronic are based). They will no doubt need to cap raise in the future to take it to completion, but I think they are a good long term investment for the future. Anyone else holding out there? Any other opinions?

 

[oztrades]

ASX Announcement 29 September 2010

Sunshine Heart
® to Develop Smaller Next Generation
Controller for its C-Pulse ® Heart Assist System

─ Advanced new controller is next step in C-Pulse evolution following
successful new minimally invasive surgical implantation techniques ─

SYDNEY Australia; 29 September 2010: Sunshine Heart Inc. (ASX: SHC), a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced that it has engaged two leading Australian-based international industrial design and software firms to develop the next generation electronic power and software driver for its C-
Pulse ® Heart Assist System. By miniaturizing the separately-housed controller and driver and combining them into one compact unit, Sunshine Heart is broadening future clinical and commercialization opportunities for C-Pulse.

The Company has entered joint development programs with Hydrix Services Pty Ltd. and Design + Industry to develop a smaller, quieter and lighter single-control system for use in the U.S. pivotal clinical trial, which is expected to commence once the FDA approved IDE feasibility study is completed. The new C-Pulse design will integrate the power driver and battery pack
into one unit, significantly reducing the size and the weight of external components. These external design changes will greatly improve mobility and comfort for the patient without altering C-Pulse implantable components or the way in which the device functions inside the body. The new single unit will also feature a number of software enhancements that are intended to allow medical professionals to collect additional data to improve patient management.

Sunshine Heart Chief Executive Officer Dave Rosa said, “Due to its small internal components, the C-Pulse can ideally be implanted through minimally invasive procedures as opposed to a full sternotomy procedure. Now, with the redesign of C-Pulse external components, the system will be more ergonomically appealing and comfortable for patients. Our ultimate goal is to make the C-Pulse a fully-implantable system which, much like a pacemaker, can be easily implanted and effortlessly managed by patients.”

Co-principal medical investigator for Sunshine Heart’s FDA approved IDE feasibility study, Dr. Bill Abraham from Ohio State University Heart Center in Columbus, Ohio said, “Reducing the size and bulk of the external system combined with a less-invasive surgical procedure will dramatically expand the use of the C-Pulse among physicians. This treatment has the potential
to transform the way in which heart failure is treated and I am eager to see this treatment reach
more patients.”

Mr. Rosa said the partnerships with Hydrix and Design + Industry will complement Sunshine Heart’s internal capabilities and help maintain the focus and speed needed to deliver on its aggressive clinical, product development and commercialization strategies.
The C-Pulse heart assist system is designed to treat patients suffering from the debilitating effects of moderate to severe heart failure caused by a failing left ventricle (the left heart chamber). The C-Pulse System features a unique balloon counterpulsation technology that is designed to assist the left ventricle by reducing the workload required to pump blood throughout
the body. In addition, it increases blood flow to the coronary arteries. Combined, these potential benefits may help reverse the heart failure process or maintain the patient’s current condition, thereby preventing the need for later stage heart failure devices, such as left ventricular assist
devices (LVADs), artificial hearts or transplants.

The C-Pulse System is an earlier intervention than other mechanical therapies, such as LVADs. This device does not make direct contact with patient’s blood and it can be turned on or off at any time allowing patients intervals of freedom to perform certain activities. The C-Pulse System can also be implanted as a minimally invasive procedure, thereby potentially reducing procedural time, hospital stays, overall cost and patient risk as compared to a traditional sternotomy.

About the C-Pulse ® Heart Assist System
The C-Pulse Heart Assist System uses proprietary balloon counterpulsation technology to increase the amount of blood pumped by the heart and to reduce the workload on the heart.
The C-Pulse System is implanted in the patient’s chest through a sternotomy or through a small incision when performed as a minimally invasively procedure. During the procedure, there is no need to place the patient on a heart-lung machine as the patient’s heart remains beating
continuously.

Once implanted, the C-Pulse cuff is positioned on the outside of the patient’s ascending aorta above the aortic valve. An ECG sense lead is then attached to the heart to determine timing for cuff inflation and deflation in synchronization with the heartbeat. The C-Pulse cuff and lead are
connected to a single line that is run through the abdomen to connect to a power driver outside the body. Because the C-Pulse System remains outside the blood system, there is potentially less risk of blood clots and stroke in comparison to other mechanical devices, such as left ventricle assist devices (LVADs).

About Sunshine Heart ®
Sunshine Heart ® (ASX: SHC) a global medical device company committed to the commercialization of the C-Pulse ® Heart Assist System, a minimally invasive, implantable, non-blood contacting, heart assist therapy for the treatment of moderate heart failure. C-Pulse ® relieves the symptoms of heart failure through the use of counterpulsation technology which enables an increase in cardiac output, an increase in coronary blood flow and a reduction in the heart’s pumping load. The Company has received approval from the U.S. Food and Drug Administration (FDA) to conduct a 20-patient U.S. clinical trial with the C-Pulse ® System and the study will reach seventy-five percent enrollment by September 30, 2010. Sunshine Heart is a
Delaware-based Corporation headquartered in Minneapolis with a subsidiary presence in Australia. The Company has been listed on the ASX since September 2004.

For more information: www.sunshineheart.com.