Modular Mask for High-Flow Oxygen Therapy

In a hospital room, the difference between a patient needing a breathing tube and avoiding one can come down to the oxygen mask on their face. The standard high-flow nasal cannula, while effective, is a tangle of tubing and a single-use plastic frame. It works, but it is not designed for modularity, for monitoring, or for shielding clinicians from aerosolized particles during certain procedures. This is the clinical gap ScopeMed, a quiet Ohio-based hardware startup, is attempting to address with a pair of modular mask systems [ScopeMed, Unknown].

Founded and led by Tosan Ugbeye, a Medicare-enrolled Anesthesiologist Assistant practicing in Cleveland, the company is developing from the ground up with a clinician's understanding of the procedural and bedside realities of respiratory support [Medicarelist, Unknown] [LinkedIn, 2026]. The public record shows no disclosed funding rounds or named hospital customers, placing ScopeMed firmly in the pre-seed, prototype-validation phase typical of many medtech hardware ventures. Its ambition, however, is specific: to make the delivery of high-flow oxygen and airway management more adaptable, less wasteful, and safer for the care team.

The Hardware Wedge

The company's initial focus is on two core products, both detailed on its website but not yet independently validated in peer-reviewed literature or public case studies. The first is the O2rizon, an open mask designed to deliver between 28% and 95% oxygen at flow rates of 1 to 15 liters per minute. A key claimed feature is integrated sidestream capnography, allowing for continuous sampling of end-tidal carbon dioxide (EtCO2) without an additional nasal cannula [ScopeMed, Unknown]. In practice, this could provide real-time feedback on a patient's respiratory status, a data point clinicians use to assess whether intubation is necessary.

The second device is the S.C.O.P.E. Respirator, framed as an aerosol-filtering mask with interchangeable caps. The concept appears aimed at creating a protective barrier for healthcare providers during aerosol-generating procedures, potentially reducing exposure to respiratory pathogens while maintaining patient access [ScopeMed, Unknown]. The modular design philosophy suggests a goal of reducing single-use plastic waste and inventory complexity by allowing components to be swapped rather than replacing entire assemblies.

Navigating a Regulated Niche

The respiratory care equipment market is mature and heavily regulated, dominated by large, entrenched players like Philips, Medtronic, and Fisher & Paykel. For a new entrant, the path to market is neither short nor cheap. Each device would require clearance from the U.S. Food and Drug Administration, most likely through the 510(k) pathway, which demands substantial testing to demonstrate substantial equivalence to a predicate device. ScopeMed's website notes it holds one issued patent and has others pending, a necessary but early step in establishing intellectual property in a crowded field [ScopeMed, Unknown].

The most significant hurdle beyond regulation is commercial proof. Without published pilot studies or named early-adopter hospitals, the clinical value proposition remains theoretical. The company's trajectory will depend on its ability to secure non-dilutive grant funding, such as from the Medical Technology Enterprise Consortium (MTEC) where it is listed as a member, or angel investment to fund the costly prototyping and clinical testing required before a sales cycle can even begin [MTEC, Unknown].

The Patient Population and Standard of Care

For Pulse Raman, the story is always about the patient population first. ScopeMed's tools are aimed at adults in hospital and clinic settings who require non-invasive respiratory support. This includes patients with acute hypoxemic respiratory failure, those in post-anesthesia recovery, and individuals with exacerbations of chronic obstructive pulmonary disease (COPD). Avoiding intubation in these cohorts is a critical clinical goal, as mechanical ventilation carries risks of lung injury, infection, and prolonged ICU stays.

The current standard of care is fragmented. For high-flow oxygen, it typically involves a dedicated air-oxygen blender, heated humidifier, and a single-use nasal cannula or face mask. Monitoring EtCO2 usually requires a separate nasal sampling line. For aerosol protection, clinicians rely on N95 respirators, face shields, and sometimes disposable plastic hoods. ScopeMed's bet is that an integrated, modular hardware system can consolidate this stack, improve ergonomics for staff, and deliver richer patient data through built-in sensors. It is a hardware play in a software-dominated digital health era, betting that thoughtful physical design can still carve out a niche in the hospital supply closet.

Sources

1. [ScopeMed, Unknown] ScopeMed company website and product pages | https://scopemedicine.com
2. [Medicarelist, Unknown] Tosan Ugbeye professional listing | https://www.medicarelist.com/nurse/amuyirigboritse-tosan-ugbeye-cleveland-oh/
3. [LinkedIn, 2026] Tosan Ugbeye LinkedIn profile | https://www.linkedin.com/in/tosan-ugbeye-76085a47/
4. [MTEC, Unknown] ScopeMed MTEC membership page | https://mtec-sc.org/members/scopemed