Medical device company passes key FDA milestone
Tool that treats heart failure, worsening kidney function recognized as breakthrough
A Houston medical device company received a special designation from the U.S. Food and Drug Administration that should speed its development of a pump that treats both heart failure and worsening kidney function.
The designation as an FDA Breakthrough Device is major milestone for Procyrion, a 14-year-old company that has spent years developing the Aortix pump to help failing hearts rest and improve blood flow to the kidneys, which improves their function. The Breakthrough Devices Program aims to quicken the development, assessment and review of medical devices that could address unmet clinical needs for treating or diagnosing life-threatening or irreversibly debilitating conditions.
As of July 1, there were 178 devices accepted into the Breakthrough Devices Program or its predecessor program, the Expedited Access Pathway Program.
“The FDA recognizes that this is an important innovation,” said Dr. Eric Fain, chief executive of Procyrion, “that has the potential to improve the outcome of these very, very sick patients.”
Of the more than 1 million patients with heart failure admitted to U.S. hospitals every year, 25 percent to 30 percent also have worsening kidney function. These patients are typically the most difficult to treat and tend to have
high mortality and rehospitalization rates, Fain said.
So Procyrion created the Aortix pump. It’s important to improve kidney function (in addition to preventing the organ’s failure) because heart failure symptoms such as shortness of breath, inability to lie flat to sleep and ankle swelling are caused by having too much fluid in the body.
This pump, placed between the heart and kidneys, improves blood flow to the kidneys and increases urine output. This removes excess fluid from the body, easing the heart failure-related symptoms and reducing overall workload on the heart.
Thinner than pencil
The Aortix pump, thinner than a pencil, is placed inside the body in less than 10 minutes using a catheter inserted in the femoral artery near a patient’s groin. A wire exits the artery and connects the pump to a control unit that provides power.
The product is designed for use in a patient for up to seven days in a hospital. It’s hoped that future versions could be used longer and in patients’ homes.
The Breakthrough Devices Program provides Procyrion with more frequent feedback and interaction with the FDA, benefiting both the device maker and the regulatory agency.
“Breakthrough device innovations that are highly novel can be challenging and more complex for the FDA to assess,” FDA spokeswoman Alison Hunt said. “We know from experience that more frequent interactions with device developers during product development can result in identifying more efficient ways of evaluating these novel devices’ benefits and risks and facilitate a timelier premarket review, which is especially important since timely patient access is critical with these types of devices.”
The Aortix pump was conceived in 2005 by cardiologist Dr. Reynolds M. Delgado III, medical director of Mechanical Support Devices in Heart Failure at the Texas Heart Institute. He brought the technology to Fannin Innovation Studio in 2007.
Fannin Innovation Studio, also founded in 2005, works with academics and researchers who have medical device or drug development ideas but don’t wish to leave their positions to commercialize those ideas.
Fannin uses a management team of entrepreneurs, scientists and engineers who help develop the technology and the business case for a product. When a product advances to a point that it requires a full-time management team and Fannin can bring in outside investors, the product is spun out into its own company.
Typically, the studio and the products’ original researchers take an equity in the company and receive royalties.
Daunting process
Tackling medical devices and drug development can be a long and daunting process. For example, the likelihood that a drug entering clinical testing will eventually be approved is less than 12 percent, according to Pharmaceutical Research and Manufacturers of America, which represents biopharmaceutical researchers and biotechnology companies.
Still, Fannin Innovation Studio has soldiered along that path for years. It has brought about 30 projects into the studio, but spun out only three into companies.
Procyrion was spun out in 2010. It kept its offices at Fannin Innovation Studio until it outgrew the space late last year and moved three floors above Fannin. It has raised more than $59 million, with its latest venture capital round of $30 million announced in July.
Pulmotect, another Fannin portfolio company developing a drug that’s inhaled to protect people from getting pneumonia, was spun out in 2012. Both companies have conducted human trials, considered an important milestone in the development of drugs and medical devices.
Procyrion’s FDA designation is the latest step toward getting a Fannin-backed product into the hands of patients.
“It’s a major step forward with the technology that we believe is going to make a major impact on people’s lives,” said Dr. Atul Varadhachary, managing partner of Fannin Innovation Studio.
Proving technology
Procyrion has completed animal testing and a human study — not with people experiencing heart failure and worsening kidney function, but with patients undergoing another heart procedure — to validate the Aortix pump.
Within the next six months, it plans to begin a pilot study in patients with heart failure and worsening kidney function. Within the next few years, a larger study that would become the basis for eventual FDA approval is expected to get under way.