Chicago-based public benefit corporation Neopenda LLC secured the CE mark for its wireless, wearable vital signs monitor and picked up $1.4 million in new funding led by Assiduity Capital and the Sorenson Impact Foundation. The organization developed Neoguard to monitor critically ill infants in resource-poor regions, but adapted it last year to meet the monitoring needs of adult patients with COVID-19. The CE mark approval covers adult, pediatric and neonatal patients.

Neopenda will be more than doubling its team with the new funding and has already brought on Brittany Stubbs as business operations lead and Vivian Mwanza as business development leader in Kenya. Another five members will be added by the end of 2021 to support growth in five countries and development of new products, Neopenda Chief Technology Officer Tess Cauvel told BioWorld.

Adapting to COVID-19

"This new funding will help expand the impact of Neoguard,” said Neopenda CEO Sona Shah. “Now that we've been granted a CE mark, we can widen our distribution and save more lives." The approval will enable Neopenda to market its newly developed application of the technology for adults just as Europe experiences another brutal wave of COVID-19 infections.

“Vital signs monitors, including pulse oximeters like the Neoguard device, have been under high demand due to the pandemic,” said Cauvel. “Monitoring vital signs helps to identify suspected COVID-19 cases for further testing, monitor COVID-19+ patients for signs of clinical deterioration or improvement, and triage high risk individuals to prioritize their care and allocation of scarce resources like ventilators and oxygen.”

Neopenda has trials related to COVID-19 in process in the U.S. and in Africa. In one pilot that monitored COVID patients recovering at home, Neoguard identified asymptomatic hypoxia in time for patients to obtain potentially life-saving hospital care. The company also conducted a trial involving 30 Ugandan adults that demonstrated the device’s feasibility and acceptability in that market.

Preventing neonatal mortality

While the pandemic has created new opportunities for Neopenda, the company has primarily focused on reducing infant mortality since its founding in 2015. Of the nearly 3 million newborn deaths tallied globally each year, approximately 75% result primarily from preventable causes, often because of critical shortages in health care workers and limited availability of medical equipment that works in communities that may lack reliable electricity let alone internet connectivity. Staff shortages and insufficient monitoring equipment increase the risk of errors and delays in identifying early warning signs of patients in distress.

Neopenda’s low-cost, battery-powered device reduces the burden on overtaxed healthcare workers in neonatal units by continuously monitoring four vital signs ‒ temperature, pulse rate, oxygen saturation, and respiratory rate ‒ with an integrated, reusable monitor worn in a band on the forehead. The Neoguard “uses a reflectance pulse oximeter sensor, located centrally on the rear surface of the device. It shines light into the skin, through the blood vessels within the tissue, and measures the light that reflects back. Neopenda’s algorithms use the resulting photoplethysmograph waveform to calculate pulse rate, blood oxygen saturation (SpO₂), and respiratory rate. The device also contains a temperature sensor, which functions independently of the pulse oximeter sensor,” explained Cauvel.

A central monitoring tablet continuously received vital sign measurements from the bands and displays readings for up to 15 newborns wearing devices. If a patients' vital signs exceed the preset upper and lower limits, the system triggers real-time visual and audio alarms to alert health care workers to the need for prompt intervention.

The company’s initial testing locations enabled it to avoid one of the most common and troubling problems with pulse oximeters, the inability to accurately determine oxygenation levels in individuals with darker skin. “Because the majority of Neopenda’s clinical research has taken place in East Africa, calibration and optimization of the sensors for patients with darker skin has been part of the development of the Neoguard device from the beginning,” Cauvel noted. “Performance across a range of skin tones is a very important issue in the medical device space and a topic that Neopenda will continue to be mindful of as more scientific literature emerges.”

Neoguard is already available in Kenya for infant monitoring and the company has pilots or clinical trials underway in Uganda, Tanzania, Nigeria and Rwanda. Neopenda expects to launch the device in all four countries during 2021. The device has also been tested on neonates in the U.S.