VisionTech Portfolio Company NeuroFx Clears FDA Hurdle for Stroke Drug Candidate
The American Heart Association reports that stroke is a leading cause of long-term disability, claiming the life of someone in the United States every four minutes. There are very few treatment options for stroke, and the window of time to deliver treatment is very small. The National Institutes of Health estimates the total cost of stroke in the United States ranges from annual health care expenses of $15 billion to $30 billion when the patients’ lost wages are included.
When VisionTech Angels was approach by NeuroFx, an Indianapolis-based regenerative medicine company founded by successful Indiana University entrepreneur Dr. Keith March about a potential therapeutic solution to stroke, we were quick to listen. Here’s why.
NeuroFx is developing an innovative, cell-free therapeutic factor concentrate derived from adult adipose stem cells called NFx101. This drug candidate has demonstrated, in animal tests, to have great potential to halt brain injury caused by stroke, promote regeneration and repair of brain tissues, and, most impressively, re-establish normal brain function. After thorough due diligence and interest from VisionTech Angels members, we went forward with NeuroFx this year.
Since our investment, NeuroFx has had encouraging interaction with the U.S. Food and Drug Administration (FDA) A recent pre-IND (Investigational New Drug) meeting established that the FDA agrees with NeuroFx’s manufacturing and research plans, paving the way to the company’s its first human clinical trial of NFx101. The FDA also indicated that safety data collected during the first IND study—a step critical for a new therapeutic’s path to clinical trials—would be considered as contributing valuable safety data for selected future indications prioritized by NeuroFx.
Passage of this major milestone led Elevate Ventures to extend a deal that aims to close NeuroFx’s Series A round. The offer promises an investment upon commitments filling the entire raise, thus de-risking the offering for new investors. The remaining total funding ($1.2 million) ensures manufacturing scale up, completion of the IND-enabling study and IND submission. Dr. Jim Hermiller, an interventional cardiologist at St. Vincent, has agreed to be the lead investigator of NeuroFx’s Phase 1 trial, which will evaluate the safety of NFx-101 and provide an approach to identify early signals of efficacy.
VisionTech and other qualified investors interested in more information about NeuroFx should contact Karen Momper at firstname.lastname@example.org. NeuroFx will be presenting to VisionTech’s new affiliate investing group, AngelBom, this month.