Power-Assisted Ultrasound Tech Aims to Simplify Hemodialysis Access, Reduce Complications

Wallingford, CT – X9, Inc., a Connecticut-based medical device startup, is developing a novel ultrasound-guided system with power-assist technology aimed at streamlining the creation of vascular access for hemodialysis patients. The company, emerging from the ExploraMed incubator, hopes its innovation will improve patient outcomes, reduce complications associated with access procedures, and ease burdens on healthcare providers.

Currently, creating reliable vascular access – typically an arteriovenous fistula (AVF), graft (AVG), or central venous catheter (CVC) – remains a significant challenge in hemodialysis. Complications, including infection, stenosis, and thrombosis, are common, leading to increased healthcare costs and reduced quality of life for patients. Approximately 69% of patients receiving in-center dialysis have an AVF or AVG, highlighting the importance of reliable access creation and maintenance.

“The process of creating vascular access can be technically challenging, requiring significant skill and precision,” says one anonymous vascular surgeon familiar with the technology. “Anything that simplifies the procedure and improves accuracy is potentially beneficial.”

X9’s system builds upon existing ultrasound guidance technology – the company already has a 510(k)-cleared ultrasound device – but adds a key differentiator: power assistance. “Traditional ultrasound-guided access creation often requires two hands – one to manipulate the ultrasound probe and the other to insert the needle,” explains Eb Bright, CEO of X9, Inc. “Our system allows the operator to control the needle insertion with power assist, freeing up one hand and potentially improving precision.”

The company is currently conducting clinical investigations with its latest iteration of the technology, which combines ultrasound imaging, power-assisted insertion, and machine learning to streamline the process. While details remain proprietary, X9 claims the system’s machine learning capabilities assist with real-time vessel alignment, further enhancing accuracy.

Addressing a Growing Need

The global hemodialysis market is substantial and growing, driven by the rising prevalence of kidney disease. Over 808,000 Americans currently live with end-stage renal disease (ESRD), and the number continues to increase, fueled by aging populations and rising rates of diabetes and hypertension. The need for improved vascular access technologies is becoming increasingly urgent.

“The demand for AVFs and AVGs is high, but creating them isn’t always straightforward,” says an anonymous interventional radiologist. “Stenosis and thrombosis remain significant challenges, and repeat procedures are common. A technology that could reduce these complications would be a welcome addition to the toolkit.”

Competition and Innovation in Vascular Access

The vascular access market is competitive, with established players like B. Braun, BD (formerly Bard), Cook Medical, and Fresenius Medical Care offering a range of devices. Innovations in the field include endovascular AVF creation, early cannulation grafts, and improved ultrasound surveillance techniques. However, X9’s integration of power assistance and machine learning appears to set it apart.

“While ultrasound guidance is increasingly common, the addition of power assistance and machine learning could be a game-changer,” says one industry analyst. “It has the potential to make the procedure more accessible to a wider range of healthcare providers and improve outcomes for patients.”

Navigating Regulatory Hurdles and Future Outlook

While X9 has already received 510(k) clearance for its ultrasound-only system, the power-assisted device remains in the investigational phase. The company is currently conducting clinical trials to gather data to support a future regulatory submission to the FDA.

“Gaining regulatory approval is always a challenge for medical device companies,” notes an anonymous regulatory consultant. “But X9’s innovative technology and the potential benefits for patients could give them a competitive edge.”

Beyond regulatory approval, X9 faces the challenge of scaling up manufacturing and distribution. The company is currently a small startup with limited resources, but it has secured initial investment from ExploraMed, an incubator focused on developing medical technologies.

“We are committed to bringing this technology to market and improving the lives of hemodialysis patients,” says Bright. “We believe our system has the potential to transform vascular access procedures and reduce the burden on healthcare providers.”

The development of X9's technology is part of a broader trend toward more minimally invasive and precision-based medical interventions. As the demand for hemodialysis continues to grow, innovations like this will be critical to ensuring that patients receive high-quality care. The company is currently seeking further investment and partnerships to accelerate its development and commercialization efforts. The potential benefits for patients and the healthcare system could be significant, making X9 a company to watch in the growing field of vascular access technologies.