A Minnesota startup is hoping that its heart assist device will provide an alternative to congestive heart failure patients using traditional ventricular assist devices to help the heart pump blood properly.
NeoCardial Technologies is getting ready to begin animal trials on its extra ventricular assist device next week, said Allan Robinson, one of four co-founders and a co-inventor of the technology.
The implantable device, made of a co-polymer urethane silicone material, wraps around the heart and gently squeezes it to help the heart pump the blood. It is currently being developed to temporarily help in the heart’s pumping function in an emergency situation for up to 30 days. For instance, when the pumping mechanism of the heart is compromised in a patient who is suffering from an infection such as myocarditis.
The idea for the device came to Robinson when he had to undergo triple bypass surgery in 2008. He teamed up with his surgeon Dr. Theodore Lillehei who agreed with him that there wasn’t really a good VAD (ventricular assist device) for congestive heart failure patients.
Traditionally, centrifugal pumps are used and they work, but they require a hole to be cut in the heart as well as the aorta.
“The problem we have with a centrifugal pump is that it needs to connect directly into the heart and you are already dealing with a heart that has had a major insult and you are causing more damage by cutting a hole …,” Robinson said. “When you have direct blood contact with a foreign surface like that, you have some destruction of that blood” that requires constant monitoring of the patient’s blood.
NeoCardial’s new innovative medical device, on the other hand, wraps around the heart and can be triggered by the patient’s own electrocardiogram or by a pacemaker.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Robinson expects the company will eventually have to apply for a pre-market approval from the U.S. Food and Drug Administration. Since the company is just about to begin its animal studies, getting to a clinical application will likely take six years, Robinson said. He said he hopes to raise around $100,000 in angel investment in the next couple of weeks.
More aggressive fundraising will follow once milestones are reached — the first being the proof of concept through the animal studies. Other heart assist devices took about six to 10 years to develop and an investment of $60 million to $100 million, Robinson said.
Since the company was founded in early 2009, Lillehei and Robinson have bootstrapped the operation. Robinson is the only full-time employee.
“We have raised a small amount of outside investment; most of it has been Allan’s and my time and money,” Lillehei said.
Robinson put it more bluntly.
“We have a lot of skin in the game,” he said.
