The FDA and Health Canada cleared a couple medical devices while other companies touted their device studies. Here are 7 medtech stories we missed this week but were still worth mentioning. 1. FDA clears Medela’s neonatal enteral feeding device Medela has received 510(k) clearance from the FDA to market its ENFit Low Dose Tip eternal […]
InVivo Therapeutics
InVivo enrolls another patient in Inspire trial
InVivo Therapeutics (NSDQ:NVIV) said today that it enrolled a new patient in the Inspire study of its neuro-spinal scaffold. 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 […]
PixarBio investors sue over InVivo takeover bid
PixarBio (OTC:PXRB) investors launched a securities class action suit against the Massachusetts-based biotech yesterday, alleging that the company lost its investors millions of dollars by issuing false statements about the prospects of a merger with InVivo Therapeutics (NSDQ:NVIV). The case was brought on behalf of investors who purchased or acquired PixarBio stocks between October 31, 2016 through […]
InVivo touts 6th patient conversion in regenerative spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) said today that a patient enrolled in December in its Inspire study has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury. This is the 6th patient from the 11-patient group to have an AIS grade improvement at the 1-month follow-up mark. The Cambridge, Mass.-based […]
UPDATE: SEC suspends trading in PixarBio shares as bizarre InVivo takeover bid ends
UPDATED Jan. 30, 2017, with comment from Pixarbio; and Jan. 23, 2017, with news of SEC suspension. The U.S. Securities & Exchange Commission today suspended trading in shares of PixarBio (OTC:PXRB) due to possible “manipulative or deceptive activities” and due to questions about the accuracy of claims made by the company in press releases and SEC […]
Zimmer Biomet elevates Delp to Americas prez | Personnel Moves | January 22, 2017
Zimmer Biomet (NYSE:ZBH) said this week it tapped Robert Delp as its new Americas president, lifting him from his previous position as VP of US sales. Delp will replace former Americas prez Stuart Kleopfer, who is retiring from the position but will continue to work with the company while Delp transitions into his position. The shift […]
InVivo adds patient to regenerative spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) said today that it enrolled a new patient in the Inspire study of its neuro-spinal scaffold. Principal investigator Dr. Travis Dumont performed the implantation earlier this week, 67 hours after the patient’s spinal cord injury happened. “The implantation procedure of the neuro-spinal scaffold was successful, and the patient is doing well,” Dumont said […]
InVivo beats shareholder suit, adds another clinical site
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 […]
InVivo adds Canada’s St. Michael’s Hospital to Inspire study
InVivo Therapeutics (NSDQ:NVIV) said today it added Toronto, Canada’s St. Michael’s Hospital as the 28th clinical site in the Inspire study of its neuro-spinal scaffold. The Cambridge, Mass.-based company’s neuro-spinal scaffold is designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting. “My research focuses on engineering […]
PixarBio CEO Reynolds ups the ante to $100m in pursuit of InVivo Therapeutics
PixarBio (OTC:PXRB) and CEO Frank Reynolds today upped the ante in their pursuit of InVivo Therapeutics (NSDQ:NVIV), the regenerative medicine company Reynolds co-founded and led until his 2013 ouster. In a lengthy, nearly 2,700-word press release yesterday, PixarBio and Reynolds cited a -41.7% slide in the price of NVIV shares since January 2016 in making their case for the merger […]
Former InVivo Therapeutics CEO Reynolds mounts $77m takeover bid
Updated to include a response from InVivo. Frank Reynolds, the PixarBio (OTC:PXRB) CEO who co-founded and led InVivo Therapeutics (NSDQ:NVIV) before his 2013 ouster, is mounting a $77 million takeover bid for his old company. In a lengthy, nearly 2,700-word press release issued today, PixarBio and Reynolds cited the -41.7% slide in the price of NVIV shares since January […]