Two-year-old Pursuit Vascular, based in Blaine, Minnesota, is preparing to take the next step in marketing its device to prevent blood infection related to catheters.
The company, which has developed the ClearGuard technology, recently hired a CEO whose first order of business is to raise money to get the necessary regulatory approvals in U.S. and Europe by mid-2012. An equity fundraising round will begin in the fall. The amount raised will not exceed $5 million, said new president and CEO Doug Killion.
The ClearGuard technology will be first applied to hemodialysis catheters for patients who visit dialysis centers multiple times a week to remove impurities that their compromised kidneys cannot eliminate, Killion said. He added that blood infection from catheters, or what is known as catheter-related bloodstream infections (CRBSIs), are a huge drain on the healthcare system, not to mention a potentially deadly risk to dialysis patients who already have compromised renal function.
The Centers for Disease Control found in 2002 that one case of CRBSIs costs $56,000 to treat, “once the cost of pharmacy charges, catheter changes, lab tests and an additional day in the ICU are totaled up.” These infections typically occur when bacteria form and colonize on the inside of the catheters as opposed to outside, which can be easily cleaned.
Killion said that in the U.S., physicians and hospital workers use a variety of aseptic methods related to catheter care to try to prevent the occurrence of CRBSIs. But while catheters that are inside the patient for a shorter period of time are layered with an antimicrobial coating, longer-dwelling hemodialysis catheters do not contain such coatings because those antimicrobial properties last only a couple of weeks, he said. That’s where Pursuit Vascular’s ClearGuard technology can be a game changer.
Here’s how the device, which is compatible with all currently available hemodialysis catheters, is supposed to work, Killion said:
Currently, dialysis patients come in and have their catheter caps removed prior to the treatment beginning. Any stagnant fluid is removed with a syringe and the patient is then hooked up to the dialysis machine, which purifies the blood over several hours. Once the treatment is over, a heparin saline solution is injected into the catheter to push back any blood inside the catheter in the patient’s bloodstream. Then a new cap is put on the catheter and the process is complete. But until the next session, the patient is sweating and the catheter hub will get dirty, which increases the chance of an infection.
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.
But if the company’s device is used, instead of a regular cap to close the catheter after the dialysis is completed, the patient will get a cap whose tip swells when inserted in the catheter and elutes antimicrobial material into the catheter, which keeps it clean and free of bacteria.
Killion said in Europe an antimicrobial liquid is inserted following a dialysis treatment that is highly effective in reducing CRBSIs, but there are safety concerns because of fear that the liquid may seep into the patient’s bloodstream.
“That’s the reason the liquid is not approved in the U.S. and probably never will be,” he said.
But he believes that the ClearGuard would be able to replicate the efficacy of the product in reducing CRBSIs.
The ClearGuard has won some accolades already. It won first place in the biosciences division of the Minnesota Cup, a statewide business competition in 2009, and the technology’s founder Robert Ziebol won the 2010 Marketplace of Ideas Invention Showcase and Contest from a North Dakota group that promotes entrepreneurship.
Having proved itself in the marketplace of ideas, the company and its new CEO has to demonstrate viability in perhaps a more challenging marketplace of private equity.
