Recent Minnesota transplant Mardil — a startup in the fast-growing structural heart defect market — is trying to raise up to $12 million for its device that treats sloppy mitral valves short of doing open-heart surgery.
Mardil is near the starting line of companies creating new innovative medical devices for the structure heart valve market. The field is dominated by companies like St. Jude Medical (NYSE:STJ), which last month bought another giant in the industry, AGA Medical, for $1.3 billion.
Mardil, which has seven full-time employees, will use $2.8 million recently raised in an ongoing Series B investment round to “fund the next generation clinical studies on the BACE (Basal Annuloplasty of the Cardia Externally) device … and to fund product development of the next generation of the device and the minimally invasive deployment of the device,” said Jim Buck, who joined the company as CEO in September, moving it to Orono, Minnesota.
Buck hopes to raise between $10 million and $12 million for his company during its B Round. Over its seven-year life, Mardil has raised about $10 million, he said. Its investors include Kardia Capital Partners, an investment company in Raleigh, North Carolina.
Mardil was launched seven years ago in Morrisville, North Carolina, by pharmaceutical and healthcare industry veteran Gopal Muppirala, and cardiothoracic surgeon and inventor Dr. Jai Raman.
Raman, who is professor of surgery and director of Adult Cardiac Surgery & Cardiothoracic Surgical Research at University of Chicago Medical Center, as well as Mardil’s chief scientific officer, got his first patent for Mardil’s BACE device in December 2004. The device acts like a tension band around the heart, supporting the mitral valve leaflets so they close properly and treating the back flow of blood known as “regurgitation.”
Many of us have some level of mitral valve regurgitation. However, if the regurgitation is prolonged and severe enough, it can contribute to heart failure — a condition that cost the U.S. healthcare system $35 billion to treat in 2005, according to Mardil’s Web site.
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.
“This is a fantastic technology,” Buck said. “Mitral valve surgical repair is a very effective surgery, but it has big risks associated with it.” Some of those risks are thrombosis, stroke and infection that can occur when devices are implanted inside the heart.
By implanting and then tightening a band around the outside of the heart, Mardil can provide a solution that has a far lower risk profile and could have similar effectiveness, Buck said.
Mardil is aiming its BACE device at the structural heart defect market, which is estimated to be a $2 billion market in the early stages of development, according to Medical Device and Diagnostic Industry.
Muppirala, the former Mardil CEO who remains on the company’s directors’ board, said in a 2005 interview that 2 million people in the United States alone have mitral valves that don’t work well enough. “Capturing just a small share (about 4 percent to 5 percent) of these 2 million patients will generate strong revenues of over $250 million,” Muppirala said.
Though Mardil has a few competitors, none have taken its device approach. “A couple other companies have tried extracardiac approaches for heart failure, but we’re the only one that has a belt-like approach around the heart,” Buck said.
