Endonovo Therapeutics Inc (ENDV)

[Biotech_Tradez]

Too bad ENDV doesn't have studies on chronic pain...

Acute post-operative pain is not the same as chronic pain, hence why the 510k is for post-operative pain and edema. So yes it can be prescribed for chronic pain and used off-label for it, but it does not have studies to back it which would support its use and gain medical reimbursement from insurance providers and medicare.

As for opioid addiction following surgery, it depends on the procedure and what is the biggest issue is the amount of opioids prescribed, surgeons are simply too lenient with their prescription pad. For example About 12 Percent of Patients Who Fill an Opioid Prescription After Common Cardiac Implants Develop Persistent Opioid Use

The significance of this study is to make other electrophysiologists aware that even a low-risk procedure like a pacemaker or a defibrillator can lead to chronic opioid use and that physicians may want to be more conservative in prescribing opioids after surgery.

Because opioids include a variety of medications containing oral hydrocodone, oxycodone, hydromorphone, tramadol, codeine and other drug types, the researchers converted the initial post-procedure opioid script—the prescribed dose multiplied by the total number of pills—into oral morphine equivalents to have a standardized measurement. They found that patients who received an initial dose of postoperative opioids exceeding 135 oral morphine equivalents—or 18 tablets of five-milligram oxycodone—were at higher risk for persistent opioid use.
With this prescription amount generally being lower than more invasive cardiac procedures, such as open-heart surgery, Frankel said it’s important for physicians to understand the risk of opioid dependence even with more minor procedures and that excessive opioid prescriptions increase the risk of subsequent dependence.

The study, he said, supports lower opioid doses at discharge and using alternative pain management strategies, such as longer-lasting regional anesthesia during procedures, known as peripheral nerve blocks, or nonopioid medications like Tylenol and Advil after surgery. Patients should also receive clear counsel, Frankel said, to expect a few days of pain and to emphasize that experiencing this pain is normal and that it should get better.

Look, SofPulse is great but that was 15 years ago when it received its 510k, since then there are numerous post-op pain interventions and strategies including simply combining NSAIDs and Tylenol. That is why I was bullish when they were developing the device for treating traumatic brain injuries and post-concussion syndrome.