RenovoRx Catheter Pinpoints Destination for Injected Fluids
Ask most people what the pancreas does, and few may have a ready answer. But many people are aware that tumors of the pancreas are among the hardest to treat—a fact well known from news stories about the deaths of celebrities such as Apple co-founder Steve Jobs.
San Jose, CA-based startup RenovoRx is preparing to market a fluid delivery catheter that may some day offer physicians better options for getting drugs to hard-to-reach places in the circulatory system. The RenovoRx catheter is designed to selectively direct fluids, such as drug infusions, to specific outer branches of the blood vessels that serve organs such as the pancreas.
Under current practice, many cancer drugs are injected into a vein, from which they can spread throughout the entire body. A commonly used chemotherapy drug, gemcitabine, is approved for pancreatic cancer. But the drug, when injected, doesn’t penetrate well into the pancreas, says RenovoRx board member Una Ryan.
“If you give a high enough dose to affect the cancer, you might kill the patient before killing the cancer,” Ryan says.
But if the drug could be confined to the region of the tumor, side effects to the rest of the body might be minimized, Ryan says.
Depending on future test results, this may become one of the possible uses of RenovoRx’s catheter, which was inspired by the challenge of treating pancreatic tumors, but could have a wide range of applications. Ryan, an active member of Silicon Valley angel investors’ groups, says the RenovoRx catheter might be used to direct radiological imaging fluids to specific organs for diagnostic purposes. It might also allow doctors to more safely send high concentrations of pain medication to specific sites in the body, such as the pancreas.
“Pancreatic cancer is very painful,” Ryan says. “It’s such a horrible disease that you want to do as much as you can palliatively.”
Ryan introduced RenovoRx to investment groups, and the company recently raised more than $1 million. Human trials have not yet been done with the device, but this year, the company hopes to work with clinicians interested in trying the catheter in patients.
The germ of the idea behind the specialized endovascular catheter came to RenovoRx co-founder Ramtin Agah when he was helping other doctors grapple with a challenging procedure involving the pancreas, says RenovoRx CEO Marta Gaia Zanchi.
“He was amazed by the uniqueness and complexity of the vasculature specific for this organ,” Zanchi says. Agah, a cardiologist at El Camino Hospital in Mountain View, CA, co-founded RenovoRx in 2009.
The twists and turns of the blood vessels serving the pancreas are part of the challenge of delivering cancer drugs there, because the pattern can be very different from one person to another.
The pancreas is a long, leaf-shaped organ behind the stomach and near the spine. People with diabetes in the family may be familiar with the organ’s role in the body. Specialized cells in the pancreas produce insulin and other hormones that regulate blood levels of glucose. Other cells in the pancreas produce enzymes that affect the digestion and use of nutrients.
Pancreatic cancer made up only 3 percent of new US cancer cases in 2013, but it was the 4th leading cause of US cancer deaths, according to the American Cancer Society. The five-year US survival rates for two much more common cancers, breast cancer and prostate cancer, have reached 90 percent or higher in this century. For pancreatic cancer, the five-year survival rate is 6 percent.
Fibrous cells in a tumor of the pancreas can make it tougher and more impenetrable to drugs, Ryan says. These fibers develop in other types of cancer as well, but “this is particularly bad in pancreatic cancer,” Ryan says.
RenovoRx developed a double balloon catheter that includes some commonly used components of catheters used in medical practice. By 2012, RenovoRx had lined up manufacturing partners, and the catheter had been tested in animals, says Zanchi, who joined the company as CEO that year.
RenovoRx is now seeking clearance from the FDA for the use of the RenovoCath catheter in humans as a fluid delivery device, Zanchi says.
If approved for patient procedures, the catheter would be inserted into the femoral artery in the leg, and then threaded through the artery until it reached the opening of a branch vessel that leads to a target site, such as a pancreatic tumor. The doctor operating the catheter would be guided by imaging technology that revealed the unique map of the patient’s blood vessels.
The next step would make sure that the drug or other fluid, carried through an inner line in the catheter, flowed only into the smaller blood vessel serving the tumor or other targeted tissue. Two balloons would be positioned in the artery on either side of the branch vessel’s opening, and then inflated, cutting off all the routes to the rest of the blood vessels.
“The fluid must go into the branch,” Zanchi says.
The hope is that the catheter, if used for the targeted delivery of drugs, would not only help reduce the overall toxicity to the body that is seen when the drugs are introduced into the whole system, but would also increase the effectiveness of the medicine, Zanchi says. But all this would need to be demonstrated in clinical trials, she says.
RenovoRx will begin by working with oncologists and interventional radiologists who are familiar with the company’s catheter, Zanchi says.
The company has raised more than $1.7 million in two funding rounds in 2013. The Series A investors included The Angels Forum, Halo Fund, Sand Hill Angels, and Golden Seeds. For the Series B round, those investors were joined by Astia Angels, a global network of investors who fund companies that include women among their leaders. The group is associated with the not-for-profit organization Astia, which nurtures women entrepreneurs.
Astia CEO Sharon Vosmek says she personally invested in RenovoRx.
“In early stage investing, you can never underestimate the importance of the team,” Vosmek says. “I have a high level of confidence in their ability to navigate the early stage medical device landscape.”
Zanchi is a former FDA Medical Device Fellow. Veteran medical device company manager Kamran Najmabadi co-founded RenovoRx with Agah. Najmabadi serves as chief operating officer and chief technology officer.
Pancreatic cancer is one of RenovoRx’s areas of focus. But the ability to pinpoint a delivery route by choosing a target vessel in the peripheral vasculature may some day prove useful in other areas of medicine, Zanchi says.
“Every time we present this technology to physicians, new applications are proposed,” Zanchi says.