Current State of Affairs with Endonovo
Some people have asked what are the next catalysts for Endonovo. There are quite a few irons in the fire at the moment.
- Heart Study – The heart pre-clinical on rats was successful (improved cardiac function). Before moving to human clinical, ENDV is conducting a follow-up pre-clinical to study the BNP response (elevated levels).
- Designing a cardiovascular specific medical device to target the human heart.
- Pre-clinical for critical limb ischemia (CLI) was completed and showed significant improvement. What is next for CLI study? Is ENDV developing a device for human use before human clinical?
- In the Annual Report, it is mentioned ENDV is “preparing to evaluate” NASH (liver) and renal inflammation (kidney). The “preparing to evaluate” tells me they are now starting these studies and we could be in for a long wait to get results. The past PRs (2017) of initiating those studies may have been more of wishful thinking than actual initiating.
- A separate kidney disease study targeting reducing proteinuria via PEMF. This study was initially done in 2010 with only 4 patients. Details are in American Journal of Kidney Diseases. ENDV is going to do the study again with a larger study group. ENDV will need to get FDA approval for this device to bring to the market. The question is, what device will be used for this study?
- Upon completion of successful kidney study and ready for commercial use, ENDV will seek partnership with dialysis facilities (to reduce inflammation and improve glomerular filtration rate).
- ENDV is awaiting response from U.S. Patent Office on their method to treat organs and tissues using non-invasive electroceutical technology. This patent application was filed in March 2017.
- ENDV has FDA approved devices available for sale: Sofpulse and Ivivi Roma.
- The Ivivi Roma is targeting chronic wounds and pressure ulcers for the elderly at acute care and nursing facilities. Has CMS National Coverage for the treatment of chronic wounds. There is a current problem where this device is having part sourcing problems due to the age of the unit. ENDV is going to redesign with more readily available components and will market the device for increased sales.
- Sofpulse is currently the main source of revenue for ENDV. ENDV is working on creating a sales team, creating partnerships, finding distributors, and creating licensing agreements in the U.S., Europe, and Asia.
- ENDV acquired patented tPEMF items from Rio Grande. ENDV is redesigning the items before initiating human clinical trials. ENDV wants a new design that will be able to be used at home by the patient.
- ENDV has a patented device to study the effects of tPEMF in patients with Multiple Sclerosis (MS). This must also be under the re-design phase? A clinical study is slated to begin sometime this year.
- Upon re-design of the Rio Grande tPEMF devices, ENDV will initiate human clinical trials on concussion, traumatic brain injury, and stroke.
- There is a human clinical trial initiated/initiating any time now. Was PR’d in April. This study is looking at the effects of PEMF in patients with brain injury and an External Ventricular Drain (EVD). The EVD is used to remove excess cerebrospinal fluid (CSF).
- ENDV is seeking to enter the Central Nervous System (CNS) market via Humanitarian Device Exemption (HDE) for the treatment of encephalopathy in Lyme disease patients. It is important to note it is not for Lyme disease in general. The focus is on the “encephalopathy”.
How is ENDV getting the data to support the HDE? Is it a private study? What is the timeframe for the study they are conducting as support for the HDE application? Will we be able to see when ENDV files the application to the FDA?
- ENDV will also try to get HDE expansion to the other CNS disorders (concussion, TBI, MS, stroke). This will require conducting several clinical trials simultaneously. This will allow shorter and less costly regulatory process.
- ENDV has a desire to uplist to a higher stock exchange this year. Can it happen? Time will tell if any surprises are in store that would allow this to be possible.
- There is a clinical trial on clinical trials website: ClinicalTrials.gov Identifier: NCT03360214
A Comparison of Pulsed Electromagnetic Fields (PEMF) and Pectoral (PEC) Interfascial Blocks on Postoperative Pain Reduction in Patients Undergoing Mastectomy and Tissue Expander Reconstruction
This is not an ENDV sponsored study, but they are using our device (Sofpulse). Will be interesting to follow this. Completion ETA is end of 2019.
As you can see, human clinical trials can take up to 2 years, hence the need for some patience with your ENDV investment.
