Rochester startup given a greenlight by FDA to start selling its medical device
The U.S. Food and Drug Administration has given a greenlight to the young Rochester startup, Pneumeric, to start selling its medical device typically for use in emergency medical situations.
ROCHESTER — The U.S. Food and Drug Administration has given a greenlight to a young Rochester startup Pneumeric to start selling its medical device typically for use in emergency medical situations.
“We’ve made extraordinary headway in the past year and some change. Hopefully, we maintain that progress in the next year moving forward, but the outlook is bright,” said CEO and co-founder Dr. John Aho.
Pneumeric, led by Aho and co-founder Sasha Gentling, makes a small tube-like device to help medical teams know if the treatment for pneumothorax, a condition that happens when a patient’s lung collapses and air leaks into the space between the lung and the chest wall, is successful.
To treat pneumothorax, a needle angiocatheter is typically used to poke a hole in the patient’s chest to release the trapped air. The procedure is called a needle thoracostomy. The only way to know if the procedure was successful and doesn’t need to be done again was to listen for the “gushing” sound of the air being released.
Pneumothorax is usually a traumatic emergency situation, which means the treatment is often administered in an ambulance or a helicopter or even on a battlefield. A needle thoracostomy needs to happen quickly in environments that are usually noisy.
Pneumeric’s device makes it possible for medical staff to visually determine if a needle thoracostomy worked instead of relying on sound.
Aho created a clear plastic tube or straw with a piece of litmus paper in it that attaches to a needle angiocatheter. He calls it the Pneumeric Capnospot.
“We were judging our success or failure on a procedure based on some auditory signal in an auditory loud environment. … A visual realm is much more obvious,” said Aho. “There's no doubt that the procedure either worked or it did not work.”
Now Pneumeric has been given 510(K) certification from the FDA, the firm can start selling its products to distributors that provide equipment and materials for emergency medical departments, ambulance services and even the military.
That’s where another award-winning Med City startup comes in. Nanodropper, which makes and sells a precision eye dropper that universally fits on most eye medicine bottles, has agreed to handle fulfillment of Pneumeric at its Rochester distribution center.
“We are just supporting a fellow entrepreneur who also wants to improve the standard of care,” explained Nanodropper’s Communications Director Robbie Spencer.
The leadership of both Pneumeric and Nanodropper have committed to grow their companies in Rochester.