Local angel investors inject $287,000 to help medical device startup grow, shortly prior to receiving news of FDA clearance
FAIRWAY, Kan. – (February 20, 2017) – The Mid-America Angels investment network (MAA) announced a $287,000 investment in Voxello, an Iowa-based medical device company. The company’s primary product, called the noddleTM, is a pioneering solution that detects voluntary gestures in hospitalized patients who would otherwise be unable to communicate. Today, the company also announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the noddleTM .
“Effective communication between patient and provider is critical to the delivery of safe, high-quality health care. Voxello is leading the way in assisting severely impaired patients to express their needs and wishes to caregivers. Mid-America Angels is excited to be coming aboard as an engaged partner,” said Rick Vaughn, Managing Director of Mid-America Angels.
The noddle provides the patient the ability to access the nurse call and speech generation with any voluntary gesture they can make, such as a tongue click, eye blink, or small movement. Phase I and II clinical trials were conducted and confirmed that the noddle positively impacted patient satisfaction with statistical significance.
The company undertook the rigorous FDA clearance process and was able to complete its submission in October, 2016. A typical clearance can take up to 120 days. Voxello’s submission was reviewed and cleared by the FDA in 78 days.
“Voxello is very pleased to have Mid-America Angels as a partner. They offer more than just financing with their broad experience of entrepreneurial companies in the Midwest region. At Voxello, our mission is to provide an effective and universal means to overcome communication barriers faced by hospitalized and long-term care patients. Today 3.9 million hospitalized patients each year are unable to communicate through traditional means, which results in an estimated three billion dollars in preventable adverse events each year. The FDA clearance of the noddle brings us one step closer to offering a solution for this urgent unmet need”, said Rives Bird, CEO of Voxello.
This marks MAA’s second deal of 2017. The network has already injected over $400,000 of funding into regional early-stage companies this year. It ended 2016 with a record fifteen deals, and injected $3.6 million into the local early-stage community.
Voxello provides solutions for impaired hospitalized patients who cannot communicate by traditional means. The company’s first product, the noddleTM, detects voluntary gestures such as clicking sounds made with the tongue or an eye blink to control nurse call and speech generation devices. For more information about Voxello, please visit www.voxello.com.
About Mid-America Angels
Mid-America Angels, LLC is an angel investor network focused on early-stage, high-growth companies in the Midwest. Since its inception in 2006, the angel group has made 85 investments totaling over $21 million. Individuals interested in more information about becoming a member of MAA or applying for funding may visit www.midamericaangels.com.