Principal investigator Dr. Patrick Hsieh performed the implantation earlier this week, 82 hours after the patient’s spinal cord injury happened.
“The implantation of the neuro-spinal scaffold went smoothly and the patient is recovering well,” Hsieh said in prepared remarks. “I have now implanted 2 patients, and it is rewarding to be able to give spinal cord injury patients hope with novel investigational products that were not available previously. I look forward to following and communicating the patient’s progress.”
“We are pleased to hear that the implantation procedure was a success and that the patient is doing well,” chairman & CEO Mark Perrin added. “We now have 12 patients enrolled and in follow up in INSPIRE, and this enrollment marks another significant step toward completing enrollment in the INSPIRE study.”
In mid-January, the 1st U.S. Circuit Court of Appeals upheld the dismissal of a shareholder lawsuit against InVivo Therapeutics, saying that the plaintiff did not do enough to prove that the defendants committed securities fraud. The lead plaintiff, Edmond Ganem, accused InVivo and former CEO Frank Reynolds of inflating stock prices with false or misleading press releases regarding the company’s clinical trials.
The press releases in question date back to April and May 2013, when the company received approval from the FDA for its 1st clinical trial evaluating its biopolymer scaffold for spinal cord injury patients. Ganem alleged that statements in the press releases pertaining to the clinical trials’ projected timeline were false or misleading, and that InVivo left out details from the FDA’s approval letter such as the watchdog’s recommendation that the company modify its study design so it could serve as the basis for approval of a larger study.
After the 1st press release in April 2013 was published, InVivo’s stock price rose from $2.85 apiece to $3.19.
The appeals court ruled with the district court, concluding that the plaintiffs failed to prove that the omitted details delayed the timeline of the clinical trial.