Insightra Medical has raised $5 million in a new round of equity financing, according to an SEC filing posted last Friday.
The Irvine, Calif.-based medical company develops devices and technology that focus on inguinal and ventral hernias.
The money comes from 7 unnamed investors according to the SEC filing, and Insightra is looking to raise another $2.5 million to close the round with $7.5 million, according to the filing.
In May, the FDA warned Insightra about how it handles reporting and investigating failure complaints concerning its intra-aortic balloon catheters.
An FDA investigator inspected Insightra’s Irvine, Calif., facility in February and issued a Form 483 detailing the company’s failure to adequately establish procedures for receiving, reviewing, and evaluating complaints, according to a May 21 warning letter posted on the FDA’s website this week.
Earlier in May, Insightra won FDA 510(k) clearance for its Octomesh ventral hernia system designed to reduce the amount of post-operative pain in hernia patients.
“The system simplifies and standardizes the well-recognized sublay and retro-rectus approach to ventral hernias. It has been used for years outside the USA. A 5-year follow-up of 41 of the first 65 patients (mean 36 months, range of 12-72 months) has shown no recurrences and 37 patients have been completely pain-free, the others having only very little to some pain. Insightra is pleased to bring this proven technology to the United States,” global marketting senior director Oliver Pokk said in a press release.
