VQ Biomedical’s Oxygen Delivery Device Offers Hope in ARDS Care, Relief for Strained ICUs

VQ Biomedical is an Apex-based medical device company. It is building a catheter that delivers oxygen directly into the bloodstream for patients with acute respiratory distress syndrome, or ARDS. The company was founded in 2023 by Dr. Tobias Straube, Stewart Farling, and Galen Robertson. Galen currently serves as the Chief Executive Officer.

VQ’s lead product is an intravascular oxygenation catheter that's used to deliver partial or total respiratory support without the aid of mechanical ventilation or extracorporeal membrane oxygenation (ECMO). It is meant to be used in intensive care units to care for patients whose lungs are in such a state of sickness or damage that they cannot carry out gas exchange efficiently.

Product and Use Case

VQ’s device is a single catheter inserted into a central vein that delivers oxygen into the blood, without the use of the lungs at all. In contrast to ECMO, with its need for extracorporeal blood circulation and labor-intensive monitoring by an experienced team, the catheter used by VQ is meant to be used at the bedside with quick setup and staff.

The catheter does not take away or return blood. Rather, it has a hollow-fiber gas exchange system that is integrated into the body of the catheter through which oxygen diffuses into the blood. It is regulated by one dial that controls flow rates. The system is closed and compact and less subject to errors and infection.

The product is being developed by the company to meet the needs of hospitals that lack the resources to run ECMO systems or require less complicated solutions for oxygenation support. It can also be employed to minimize the need for ventilators in some situations.

Clinical Rationale

ARDS is an illness that is defined by the rapid-onset inflammation of the lungs, which restricts the function of the lungs to exchange gases. It occurs in approximately 390,000 patients in the United States and European Union every year. In critical cases, mechanical ventilation or ECMO is necessary, although these are very high-risk and expensive.

Mechanical ventilation is known to induce ventilator-induced lung injury when provided for protracted periods. ECMO, though better at oxygenation, is present in only a minority of hospitals and usually needs an accompanying team of nurses, perfusionists, and respiratory therapists to be able to provide it.

VQ seeks to provide a third choice – a product that can oxygenate effectively but with decreased complexity, lower cost and fewer staff. The company places its catheter as a product that can be deployed earlier in care, when ventilation is starting to fail but ECMO is not yet indicated or not possible.

Founders and Leadership

Galen Robertson, co-founder and CEO, co-founded 410 Medical, where he led the creation and FDA clearance of numerous emergency-use devices for adult and pediatric critical care. He has over a decade of experience with medical product design, regulatory crossing and clinical introduction.

Dr. Tobias Straube, chief medical officer and co-founder, is a practicing emergency medicine physician and Duke University School of Medicine faculty member. He conceived the idea for the catheter when he was treating ARDS and similar respiratory patients and found the shortcomings of conventional interventions.

Stewart Farling, engineering director and co-founder, is a biomedical engineer specializing in gas transfer systems. He was involved in the first design and prototyping of the catheter during his research leading to a doctoral degree in biomedical engineering.

In addition, the company has scientific advisors affiliated with Duke University and having background experience in gas-liquid transfer, blood biocompatibility and biodesign.

Current Stage and Development Roadmap

VQ is in preclinical development. It is putting the finishing touches on a commercial-grade version of the catheter and has started testing in large animal models to assess safety, biocompatibility and performance. These studies are set to continue through this year.

Subject to positive preclinical findings, the company aims to submit regulatory filings for permission to begin human clinical trials during 2027. Initial trials will be feasibility and safety trials in ARDS or other types of acute hypoxemic respiratory failure patients.

In tandem with this, VQ is developing miniaturized forms of the catheter suitable for possible field deployment, commensurate with defense agency contracts issued to the company. Adaptations for military, emergency response or rural applications are possible.

Manufacturing and Usability Considerations

The catheter is being designed to fit into existing ICU workflows. It can be stored, transported and used without requiring specialized equipment. According to the company, it does not rely on blood pumps or extracorporeal circuits and is intended for use by a single clinician without surgical intervention.

The design is centered on minimizing user steps necessary for operation and on reducing training time for ICU personnel. Some of the major safety features involve in-line pressure monitoring, automatic flow control and thermal control.

Position in the Market

The intended users of the device are hospital ICU-based intensivists, critical care nurses, and respiratory therapists. VQ’s catheter is proposed to be a supplemental or alternative method for use when ventilator support is not adequate or ECMO is not available or not warranted.

Hospitals that cannot sustain full ECMO programs might find that the less burdensome technical and manpower needs of the catheter are useful to them. The device can also assist in the minimization of ventilator days, thereby decreasing the risk of such complications as ventilator-associated pneumonia.

Even in hospitals with ECMO installed, VQ’s catheter can prove to be useful as a bridging option or in milder cases of hypoxemia where ECMO is not required.

Support and Recognition

VQ in its first year received funding and backing from venture firms, university-related investors and U.S. government agencies with interests in biomedical innovation. That money is now being tapped to grow the engineering, improve the product and conduct preclinical trials.

The company is based in Apex, North Carolina, and has partnerships with academic labs, device makers and research institutions to fund its product development and plans for manufacturing in the future.

Goals and Outlook

VQ Biomedical’s immediate objectives are to finish preclinical testing, complete its commercial prototype and prepare for human clinical trials. Within the next two years, it plans to submit data to regulatory approval and start collaborating with clinical partners to verify performance in actual care settings.

In the longer term, the business intends to make the catheter widely available to hospitals of varying geographies and budgets, with an emphasis on ease of use and accessibility. Other versions of the catheter can be created for particular applications in emergency care and trauma.

Galen explained the company’s philosophy as one based on a simple principle: “Our job is to take something that’s very complex and make it easy to use.”

Galen Robertson, CEO, VQ Biomedical

VQ’s catheter is proposed to be a supplemental or alternative method for use when ventilator support is not adequate or ECMO is not available or not warranted.

Even in hospitals with ECMO installed, VQ’s catheter can prove to be useful as a bridging option or in milder cases of hypoxemia where ECMO is not required.