Bidvest Heart team
Bidvest Heart team upbeats one year on...
Our investment of R18 million in equity funding at Strait Access Technologies Holdings (SATH) was our contribution to the development of costeffective alternatives to expensive open-heart surgery.
The aim is to assist those suffering from rheumatic heart disease (RHD) by replacing damaged heart valves with reliable devices that are cheap to make and easy to insert. There are 78 million RHD suffers worldwide, but the victims most at risk come from low-income groups and live in developing countries.
Expensive procedures and sophisticated monitoring systems might be an option in advanced economies, but they are simply unaffordable in marginalised communities in poor countries. SATH and its operating subsidiary Strait Access Technologies (SAT) intend to change all that.
SAT chief operations officer Heather Coombes points out: "Currently, millions of RHD patients go untreated because open-heart surgery is too costly and not generally accessible in developing nations. "The challenge is to develop solutions that are cheap to implement and do not rely on monitoring equipment as poor rural areas lack facilities and resources.
"Another key constraint is the lack of specialist skills; specifically, the dearth of cardio-thoracic surgeons in the health services of many Third World countries. Therefore, our devices must be relatively easy to insert."
Since our investment, SAT has brought together a fully functioning team of highly motivated specialist engineers and technologists.
They are based in Cape Town and work closely with UCT. Research at the university first highlighted the possibility of a new low-cost approach to RHD treatment. Subsequently, UCT became one of the shareholders in SATH.
The other shareholders – along with Bidvest – are co-founders: Prof Peter Zilla, head of UCT's Christiaan Barnard Department of Cardiothoracic Surgery, and the other researchers who pioneered initial development work, Dr Deon Bezuidenhout and Prof David Williams.
SAT is currently working on three promising developments
The objective is to develop a device that can deliver a prosthetic heart valve without having to open a patient's chest and can be used without having to hook the patient to expensive monitors. The device has to be so simple to use there is no need to call in a cardio-thoracic surgeon.
One year on, the SAT team has developed the first prototypes.
Two systems are in development. The original mechanical expander design is in its second prototype design. Another option, a balloon design, allows those treating the patient to approach the heart through the femoral artery – the big artery in the thigh.
This is a much less invasive procedure than an open-heart operation. However, monitoring equipment is necessary as well as specialist training. This does not disqualify the approach from further development as it could have broad applicability in the First World. "The prototypes have been tested on the bench in an explanted heart rig," says Heather. "We will begin animal trials in October." Intellectual property rights have been secured for both of these designs.
The team is also working on a synthetic valve designed to be crimped down on to the deployment device. The first prototype has already been finished and patents have been filed on the design of key valve components.
These include design of the stent and the leaflets. The stent is the frame that the leaflets (or flaps) of the valve are attached to. The stent provides support to the leaflets and secures the device in the correct position within the heart.
The valves are designed to cure the regurgitation or "back flow" that is a major problem for RHD sufferers and can be life threatening.
A patent has also been filed on the polymer material used in the valve's manufacture. The polymer was developed with the help of Dr Art Coury, a leading expert on polymers and biotechnology.
Heather notes: "We have also designed a pericardial valve as this has become the industry standard for artificial heart valves and success here will ensure speedy access to the market.
"We are working on the second prototype of both the polymer and the pericardial leaflet design while we are prototyping the third stent design.
"We are testing the prototypes in a pulse duplicator (which mimics the functioning of the heart) and plan to conduct two sets of animal trials later this year."
This is a clip to be fitted to a mitral heart valve (so-called because the dual flaps of the valve look like a mitre). The device under development at SAT would clip the two leaflets together near the point where regurgitation occurs without having to open the patient's chest and without the need for sophisticated monitors.
After only a year, the team is ready to test the proof of concept for what the SAT technologists call "the navigation and orientation system". This means the method of positioning the device over the mitral valve while locating the area where regurgitation is taking place.
SAT has filed a patent on the navigation, orientation and anchorage systems.
Testing equipment has been designed and set up to simulate a functioning heart. This customised set-up is ideal for prototype testing.
Several prototypes have been developed, confirming the proof of concept for this approach. The team is about to integrate the designs into a single device and is set to start animal testing in October.
SAT is currently applying for further official funding on all projects. Last year, the government's Technology Innovation Agency helped the project get under way by committing R12 million in funding.
Our CE, Brian Joffe, is heartened by progress to date.
He says: "It's gratifying that the SAT team has managed to develop prototypes and file for patents so soon after beginning work on the commercialisation of these life-saving devices.
"We are Proudly Bidvest and we can certainly be proud of the progress made by this new generation of South African heart pioneers."