Endonovo Therapeutics Inc (ENDV)

[Biotech_Tradez]

It is approved by CMS for stage III and IV chronic wounds and the device is not covered only the cost to administer it.

No insurance covers it for wounds because it is not even approved for that use nor do they have any real clinical data, their medical policy states:

Electromagnetic therapy is unproven and not medically necessary for treating wounds including venous stasis ulcers, arterial ulcers, diabetic foot ulcers, chronic pressure sores and soft tissue injuries.

The available evidence regarding the use of pulsed high-frequency electromagnetic energy for the treatment of chronic wounds and soft tissue injuries is insufficient to support conclusions regarding the efficacy of this technology. The data from clinical trials are insufficient to prove efficacy, to define optimal treatment protocols, to establish patient selection criteria, or to evaluate the relative efficacy of this therapy compared with other treatment options. The available studies involved small numbers of subjects and because significant differences were noted between intervention and control groups, it is not possible to draw valid conclusions about the efficacy of this technology.

The same deal with arthritis:

Electrical stimulation and electromagnetic therapy for the treatment of osteoarthritis and rheumatoid arthritis is considered investigational.

Same deal with post-operative pain and edema/opioid reduction. Insurance companies want multiple large well controlled studies to demonstrate clinical efficacy, not some small 30 patient pilot study with no power to demonstrate significance of the clinical endpoints.

Furthermore, post-operative opioid management has greatly advanced. This technology was cutting-edge 10 years ago, not so much today. Here is a good read for those that are interested: Ultrarestrictive Opioid Prescription Protocol May Be Effective for Postoperative Pain Management

There is a reason they are having big problems generating sales and will likely not meet their own low-ball revenue guidance numbers. 1.) Payers do not cover the device so it is completely out-of-pocket. 2.) This company has the weakest management team of any commercial stage medical device company I have seen with no real accomplishments, no real scientists, no doctors and no key opinion leaders to really give it any true validity.

The real money for this tech is in treating ischemic strokes and TBI. No real treatments and the competition is still largely drugs which have big problems in this area.

The other issue is that there are now two different sources of dilution, the note holder which owns the tech and has over $5m in convertible notes to dump and 2.) the equity line that they are using to keep the lights on. It is no surprise that there are over 500 million shares out and counting. There is no real way to make an informed investing decision when you have no idea what the dilution rate and when it moves the game is stacked against the longs because the diluters have better terms (getting shares at a discount after the stock has moved up) and less risk.