CARLSBAD – Doctors and patients will soon have a new method of significantly reducing the risk of contamination and infection of intravenous access ports after federal regulators granted De Novo Classification to medical technology company HAI Solutions.
HAI received the U.S. Food and Drug Administration’s blessing for its QIKCAP system, the first and only ultraviolet light-based microbial contamination reduction device for needle-free luer connectors, which are typically used in medical settings to join catheters, syringes and tubing.
The QIKCAP device’s UV light decontamination process takes just 10 seconds, while the QIKCAP cap can physically shield a luer connector from environmental contamination for up to a week if unused.
“The U.S. market, I think, is ripe for a change, it’s not had to change for over 10 years,” HAI CEO Nick Perrenoud said. “I think it’s time for an improvement, and we’ve been able to sort of prove that we can provide that.”
The system as a whole is designed to reduce the risk of contamination for IV access ports like central venous catheters – long, thin tubes that are inserted into a vein near the heart to provide medication or draw blood from a patient.
Addressing a $2.3B Problem
Central venous catheters, also called central lines, are typically used for the long-term IV delivery of specialized medicine and treatment like chemotherapy and dialysis. Perrenoud initially co-founded the company after he and his wife adopted a son who had a central line and experienced more than a dozen central line infections in the first three years of his life.
Some 250,000 cases of bloodstream infections from central line contaminations affect patients in the U.S. each year, costing as much as $2.3 billion to care for those patients.
Standard disinfection and decontamination procedures for IV access ports involve scrubbing a port with an alcohol pad for at least 15 seconds or placing a sterilizing cover over the port for at least a minute, both of which are cumbersome when patients require vital medication via IV.
“I think (for) clinicians and the workforce, there isn’t the tools that would provide them with the ability to do what we’re going to be bringing to the market,” Perrenoud said.
HAI submitted its request for FDA approval in early 2025 and spent much of the year providing additional data about the QIKCAP system’s efficacy and safety in reducing the risk of infection, including further testing of the system with Loma Linda University, where Perrenoud is a certified registered nurse anesthetist, and Montana State University’s Center for Biofilm Engineering.
Preparing for Commercial Distribution
The FDA ultimately granted QIKCAP’s De Novo Classification – a regulatory pathway the agency grants for low-to-moderate-risk medical devices for which there are no similar devices already on the market – two days before Christmas.
“Our team did an incredible job, all hands on deck for most of the summer and then, unfortunately, all the way through the holidays, but it paid off,” Perrenoud said.
HAI is now ramping up its manufacturing efforts and distribution partnerships, with the goal of producing upwards of one million units in 2026 and two million in 2027.
According to Perrenoud, the company expects QIKCAP to be available to doctors and patients as soon as late April or early May.
The company also plans to begin raising a Series B funding round later this year to aid in its change from research and development to manufacturing and commercialization. HAI’s previous Series A totaled roughly $2 million and the company has operated with enough capital efficiency to have plenty of funding for its initial QIKCAP distribution.
“I think that this year is going to be exciting, I think it may be one of those opportunities that once it catches on, we’re just going to hold on and enjoy it and bring it to the patients,” Perrenoud said. “And really, that’s what we’re all about at the end of the day, we’re all about making a safer place for patients to be taken care of.”
HAI Solutions
FOUNDED: 2015
CEO: Nick Perrenoud
HEADQUARTERS: Carlsbad
BUSINESS: Medtech
EMPLOYEES: Four
WEBSITE: hai-solutions.com
CONTACT: [email protected]
NOTABLE: Perrenoud is a certified registered nurse anesthetist with Loma Lista University Health.
Eli is an award-winning reporter primarily covering the tech and life sciences industries. He previously worked as the San Diego City Hall reporter for the regional wire City News Service. He has also covered public health, transportation and state and local politics in the San Francisco Bay Area for Local News Matters, the nonprofit arm of the regional wire Bay City News Service, where he also oversaw the development and daily content management of the outlet’s public health and COVID-19 news and resource webpage. He is also a contributing writer covering Minor League Baseball for the analysis and commentary website Baseball Prospectus. Eli is a graduate of San Francisco State University and a native of Northern California.
