We are on a mission to advance the development and adoption of medical, health and environmental applications of our low- to ultra-low radio frequency energy (RFE) technology that are determined by the FDA (or other applicable regulators) to be non-toxic, non-invasive, non-ionizing, safe and effective. We have invented and patented what we believe to be a groundbreaking technology that utilizes RFE precisely targeted at the low and ultra-low ends of the RFE spectrum (ulRFE®) to specifically regulate signaling and metabolic pathways on the molecular and genetic levels – without chemicals, radiation or drugs – delivered via a simple-to-use non-invasive therapeutic system. (Please see the prospectus for an explanation of how the technology works.)
The human indications that we are initially targeting in our product pipeline include: (i) GBM (glioblastoma multiforme, one of the most aggressive types of brain cancer) and DMG (diffuse midline glioma) in the field of oncology, (ii) acute and chronic pain in the field of pain management, and (iii) PTSD, ADHD, anxiety and depression in the mental health field. The companion animal indications that we are initially targeting in our product pipeline include solid tumor cancers in the field of oncology, acute and chronic pain in the field of pain management, and anxiety in the mental health field.
We expect that, for regulatory purposes, the EMulate Therapeutics ulRFE® therapeutic system will be evaluated by the FDA as a Class III medical device requiring approval of a PMA (see discussion below regarding FDA Premarket Clearance and Approval Requirements).
Our device has been used in feasibility studies (phase 1 and phase 2 trials) to treat patients with GBM and DMG cancers, and will, consistent with FDA regulation, be used in pivotal clinical trials to treat GBM and DMG patients. These uses are the first of many product expressions of the Company’s underlying ulRFE platform technology. Our therapeutic medical device has potential treatment applications in a wide range of diseases, including cancer, acute and chronic pain management, mental health conditions, among others.
We currently are not conducting active clinical trials, but we have completed studies with respect to two brain cancer indications: feasibility studies for the glioblastoma multiforme (GBM) indication and a compassionate use study for the diffuse midline glioma (DMG)/diffuse intrinsic pontine glioma (DIPG) indication. In each of these indications, we are ready to initiate pivotal (phase III) trials, the results of which will be submitted to the FDA for commercialization approval. Initiation of these trials will depend, in part, on trial design (number of patients and the extent to which the trial is controlled and blinded) and cost. We anticipate that the pivotal trial for DMG, based on these factors, will be undertaken sooner than the pivotal trial for GBM.
**Note: Royalty revenue and net loss figures are for the 12 months that ended June 30, 2023.
(**Note: “Prior to effectiveness of the registration statement of which this prospectus forms a part, we expect to effect a reverse stock split of our issued and outstanding shares of common stock at a ratio of 1 for 2.5 (“Common Stock Reverse Split”). All common stock per share numbers and prices included herein have been adjusted to reflect this Common Stock Reverse Split, unless stated otherwise.”)
(Note: EMulate Therapeutics cut the size of its IPO by about 8 percent to 2.3 million shares – down from 2.5 million shares – and kept the price range at $4.00 to $6.00 to raise $11.5 million, according to an S-1/A dated Sept. 6, 2023.)
(Note: EMulate Therapeutics filed its S-1/A on Jan. 4, 2023, and disclosed terms for its IPO: 2.5 million shares at $4.00 to $6.00 to raise $12.5 million. EMulate Therapeutics filed its S-1 on Aug. 16, 2022; the company filed confidential IPO documents with the SEC on May 6, 2022.)