I keep hearing about the uplist, hydrogel, etc, etc, but nothing is happening. This supposed uplisting that is suppose to be happening as of yesterday isn't happening. Hmmmmmmm. Wouldn't feel so secure with my shares, that's for sure.
Published information regarding Invivo Issues
The U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational Device Exemption (IDE) to begin human studies to test its biopolymer scaffold product, a technology developed to treat patients with acute, traumatic SCI.
InVivo intends to commence a first-in-man clinical study in the next few months that will test safety and performance of its biopolymer scaffold in five patients. The Company expects the study to occur over approximately 15 months. There are currently no treatment options approved by the FDA, or in clinical trials, to intervene directly in the spinal cord following SCI. The trial will be conducted at multiple U.S. hospitals, and work to gain Institutional Review Board (IRB) approval at Massachusetts General Hospital in Boston is already underway.
The Company was also recently granted approval from the FDA on its Humanitarian Use Device (HUD) designation request. HUD designation is reserved for devices designed to treat rare diseases or conditions. InVivo has received this designation for the treatment of recent complete spinal cord injury (no motor or sensory function) that does not involve penetrating injury or complete severing of the spinal cord. The HUD designation and clinical trial data are required to support a Humanitarian Device Exemption (HDE) application to the FDA with the goal of commercializing the scaffold in the United States sooner than a Pre-Market (PMA) approval would allow.
Exercise of Warrants - Said Frank Reynolds, InVivo Chief Executive Officer, “We are pleased with the addition of $15.6 million of cash from the warrant call which strengthens our balance sheet. With the resultant elimination of the $24.6 million warrant liability from our books, the last major impediment to up-listing to a national securities exchange has been removed. We expect that an up-listing to a national securities exchange will increase liquidity and unlock inherent value in our stock.