Synapse Biomedical Inc. in Oberlin, Ohio, has received Humanitarian Use Device approval from the Food and Drug Administration for its NeuRx Diaphragm Pacing System in certain ALS patients.
Under the approval, the device that stimulates the diaphragm to contract — simulating a breathing motion — can be used for amyotrophic lateral sclerosis (ALS) patients who have stimulatable diaphragms and inadequate breathing.
Humanitarian Use Device (HUD) designation establishes NeuRx DPS as a medical device intended to help treat a disease or condition that affects fewer than 4,000 U.S. patients per year. The designation is a step toward getting a full-blown Humanitarian Device Exemption (HDE), for which Synapse Biomedical applied on Friday.
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Now, the FDA will review the company’s HDE application to determine whether NeuRx DPS is safe and has probable benefit for ALS patients who meet certain criteria. “We anticipate that the HDE initial review will take 75 days, although FDA questions can result in additional review cycles,” said Mike Fritz, Synapse’s vice president of clinical and regulatory affairs, in a release.
“The HUD approval and our subsequent HDE submission today now put the FDA review in the path to our next steps,” said Synapse President and CEO Tony Ignagni, in an email to a reporter. “Hopefully, we will get good news by year’s end. At any rate, this is a critical next step for us and our growth.”
Commonly called Lou Gehrig’s disease, ALS is an incurable and fatal neuromuscular disease that robs patients of the ability to move their muscles. About 30,000 patients live with the disease in the United States.
As the disease progresses, patients lose their ability to breathe. Through electrical stimulation, NeuRx DPS continues to exercise the diaphragm muscles of ALS patients, delaying diaphragm atrophy and the need for mechanical ventilation.
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Launched in 2002, Synapse Biomedical commercialized NeuRx from technology developed largely by Dr. Ray Onders over two decades at Case Western Reserve University and University Hospitals Case Medical Center in Cleveland. Paralyzed people — like late actor Christopher Reeve, rendered a quadriplegic by a horseback riding accident — to breathe on their own without using a ventilator.
In June 2008, Synapse Biomedical got a Humanitarian Device Exemption from the FDA to use NeuRx for spinal cord injury patients. In January, Ignagni said his company had raised more than $433,000 from investors on its way to $1.2 million to repay debt and get ready to supply its diaphragm pacing techn0logy to a new market: ALS patients.
In late 2008, Synapse Biomedical suspended its C Round of financing because of crises in the economy and financial markets. Instead of raising new equity, the company raised some debt from existing investors.