10.30.15
Biomedical startup ReVivo Medical LLC has secured a grant to help develop the spinal surgery device the company plans to get to market in 2017. The grant is from the Small Business Innovation Research program and is administered by the National Institutes of Health.
Gary Mittleman, president and CEO of the Albany, N.Y.-based company, said that the $225,000 grant will be used to conduct efficacy testing of its spine device on animals. The device, which is a new type of plate to hold spinal vertebrae in place after a surgery for the healing process, must get U.S. Food and Drug Administration (FDA) approval before it becomes available commercially.
“We need to finalize a few pieces of the equipment before we start the testing,” Mittleman said. “We will be at least starting it before we start the FDA approval process.”
Mittleman said because the device is made of the same material as existing plates, a titanium alloy, and is similar to existing devices, the testing process for regulatory approval should only take about nine months.
The company will need to raise about $500,000 to $800,000 later on to cover the cost of that FDA testing and to invest in other products it is developing, Mittleman said.
ReVivo Medical was started by Albany Medical Center spinal surgeon Darryl DiRisio, M.D., and Eric Ledet and Glenn Sanders, two biomedical engineers. Ledet is an associate professor at Rensselaer Polytechnic Institute in Troy, N.Y. Sanders is on the faculty of Union Graduate College in Schenectady, N.Y., and is the principal investigator for the grant.
Gary Mittleman, president and CEO of the Albany, N.Y.-based company, said that the $225,000 grant will be used to conduct efficacy testing of its spine device on animals. The device, which is a new type of plate to hold spinal vertebrae in place after a surgery for the healing process, must get U.S. Food and Drug Administration (FDA) approval before it becomes available commercially.
“We need to finalize a few pieces of the equipment before we start the testing,” Mittleman said. “We will be at least starting it before we start the FDA approval process.”
Mittleman said because the device is made of the same material as existing plates, a titanium alloy, and is similar to existing devices, the testing process for regulatory approval should only take about nine months.
The company will need to raise about $500,000 to $800,000 later on to cover the cost of that FDA testing and to invest in other products it is developing, Mittleman said.
ReVivo Medical was started by Albany Medical Center spinal surgeon Darryl DiRisio, M.D., and Eric Ledet and Glenn Sanders, two biomedical engineers. Ledet is an associate professor at Rensselaer Polytechnic Institute in Troy, N.Y. Sanders is on the faculty of Union Graduate College in Schenectady, N.Y., and is the principal investigator for the grant.