Madison, WI-based Stealth Therapeutics recently raised more than $450,000 from investors, which will fund a study of the clinical performance of the startup’s lead medical device.
Stealth was founded in 2006 by Bradley Glenn, an interventional radiologist who lived in Green Bay, WI, and has since moved to California, Stealth general manager Sam Adams says. (Adams works in Madison.) Glenn invented the Invisiport, which the company says is a less invasive device for delivering chemotherapy, antibiotics, and nutrients to patients intravenously.
Traditional chest ports require invasive surgery for insertion, are clearly visible beneath the skin, and tend to leave scars, Stealth says. Another IV option is a peripherally inserted central catheter (PICC), which is easier to implant in the arm, but the ends of the PICC hang outside the skin and can be a nuisance, Adams says.
Stealth’s Invisiport, on the other hand, offers the stability of a chest port, but requires a smaller incision and less anesthesia during insertion. The Invisiport is implanted via the arm, like a PICC (pictured above). But unlike a PICC line, Invisiport resides under the skin. PICC technology works for patients who need central venous access while in a hospital or clinic for a short period, but it isn’t convenient for long-term use outside the clinic, Adams says, because the hanging components could snag on something.
The Invisiport has retractable “wings” that self-deploy after insertion. A small bump on the inner arm indicates the device’s location beneath the skin.
“We see that there’s a gap in the marketplace between the large port that’s traditionally implanted in the chest for chemotherapy, and a PICC line which is in the arm, which is very convenient, but not ideal for outpatient use,” Adams says.
Stealth has so far raised more than $2 million, primarily from Fitchburg, WI-based Kegonsa Capital Partners and angel investors, Adams says. Glenn also invested some of his own money.
Invisiport received FDA approval in 2011, and the company began selling it in 2012. So far, it has been implanted in about 30 patients, primarily in California, Adams says. Part of the barrier to gaining broader market adoption has been the fact that Stealth is a young company with just one product and less brand recognition than larger competitors who sell multiple products, he says.
Now, Stealth intends to reach more patients. To gain wider acceptance by healthcare providers, the company will soon begin a 50-patient clinical performance study of Invisiport funded by Stealth’s recent capital infusion. The study will involve patients in Wisconsin and, potentially, a nearby state, Adams says, attempting to show that the device gives patients the flexibility to remain active while undergoing treatments.
“Our goal is to demonstrate our lifestyle benefits for a range of patient needs,” Adams says. Invisiport “could make a great difference in the lives of patients who now don’t have a great solution for therapy, whether they’re having a port that’s too big in their chest, or a PICC line that’s dangling outside their skin and doesn’t allow them to swim or bathe or other normal things that people do.”
Stealth is essentially a virtual company, with Adams and Glenn the only two people working on day-to-day operations. The company has hired outside consultants and contractors to handle manufacturing, regulatory compliance, and clinical research, Adams says. There are no immediate plans to grow staff, he adds.