Over four years ago, the venture capitalist Olav Bergheim assembled a roundtable of leading cardiologist and electrophysiolgists to talk about their ideas for responding to two significant problems: heart failure and a rapid and irregular heart beat that puts patients at risk for stroke known as atrial fibrillation. 

 

The idea was to come up with alternatives to the current invasive and tissue-damaging approaches to treating these conditions and instead address the ailments with the use of biopolymers. In 2003, Laguna Hills, California-based Symphony Medical was born. The company’s intellectual property was licensed and the company sponsored university researchers, including several who participated at that initial white board discussion, to see which of the ideas would hold promise and warrant additional investment.

 

It was an unusual way to start a company, but this different tack has produced unique methods of treating serious conditions with large market opportunities. Today, Symphony Medical is entering the clinic with its first product—Plexisyl-AF—an inert polymer injected into nerve nodes on the surface of the heart to prevent post-surgical atrial fibrillation. The polymer provides pressure on the nerve nodes and blunts the aberrant signals that cause atrial fibrillation. The polymer—made of polyethylene glycol—dissipates over about a 90-day period. There are 600,000 annual cardiac surgical procedures in the United States representing a potential $260-million a year market in the United States alone. There is currently no approved therapy for post-surgical atrial fibrillation.

 

“Our idea is pretty simple. If we can mitigate the onset of atrial fibrillation, post surgery, than we solve the basic problem,” said Ray Cohen, CEO of Symphony Medical. “We decrease length of stay, save the patients issues and discomfort, and eliminate that cohort of patients who never get converted.”

 

The company hopes to take safety data from a study now under way in Germany to the U.S. Food and Drug Administration in the fourth quarter to get approval to begin a pivotal study of Plexisyl-AF. The polymer is considered a medical device because it has no bioactivity and works in a mechanical way. 

 

But the bigger opportunity for Symphony may lie in its second product, Algisyl-LVR, which is being developed for patients with heart failure. That polymer is made from seaweed-derived alginate and remains present in the heart for much longer periods. In heart failure, the heart enlarges and the wall of the left ventricle thins as the chamber expands and becomes less efficient as a pump. By injecting the polymer into the walls of the left ventricle—the workhorse of the heart—the company believes it will be able to remodel the heart and restore lost function. It could serve as an alternative to jackets that remodel the heart by wrapping around it.

 

An estimated 5 million people in the United States suffer from heart failure and more than half a million new patients are diagnosed annually. The condition contributes to 300,000 deaths each year. Though early forms of heart failure can be treated with drugs, they do not halt the progression of the disease. Symphony’s product will target some 2 million patients a year who no longer respond to drug therapy, but are not so progressed that a transplant or implanted pump would be needed.

 

“When it started, the primary focus was on arrhythmias. This idea of heart failure was a small idea at the time,” said Jim Broderick, a partner with Symphony Medical investor Morgenthaler Ventures. “It turned out once we started experimenting with these various biomaterials in the heart, it became apparent that probably the best fit for this approach was heart failure. The markets are gigantic, and really need a new solution.”

 

Symphony Medical has raised $20 million to date and said it will need to raise an additional $20 million to $30 million to push the products through to approval. The company expects to enter into partnerships with commercial companies that are positioned to market the products. The company’s Cohen said he expects to begin those talks soon if human data from the trial in Germany is positive.

But what remains unclear is how long the effects of its polymer injection in patients with heart failure will last. Animal testing has shown that the material is able to stay around for up to six months and that the benefits occur early and continue throughout the duration. But there is hope that the presence of the polymer could allow for healing and remodeling of the heart that extends beyond its absorption into the body. That, says Hani Sabbah, Herny Ford Health System’s director of cardiovascular research, is the hope.

 

“What we do know is we have an influence over the entire ventricle even though the therapy has been introduced locally. There is something going on that we don’t understand fully,” said Herny Ford Health System’s director of cardiovascular research Hani Sabbah, who has been refining the product and performing pre-clinical work in animals. “What is clearly understood, at least in the early studies, is the therapy does improve the shape of that ventricle and does improve the size—makes it smaller—and in doing so makes it better."