SoftWaves to drastically reduce opioid addiction and to helpaddicts in their recovery and withdraw.

SoftWaves are electro hydraulically generated acoustic waves focused into a
patient via a parabolic lens. The first shockwave patient was treated over 30
years ago for the first FDA approved indication, kidney stones. The treatment
does not require any analgesia and can be performed in any doctor’s office or
health center. The risks are nearly nonexistent and the proven mechanisms of
SoftWaves in medicine are well understood. The mechanisms of action that are
of interests in our discussion regarding opioid and other pharmaceutical
addictions are as follows:
1. SoftWaves immediately modulate inflammation, pain, and swelling and
cause an immediate increase in the blood supply in the targeted area. This
will immediately reduce pain and inflammation in most patients. The basic
science is documented and includes certain cellular receptors (TLR3), an
increased permeability of cellular surfaces, and the release of exosomes
containing proteins and RNA that trigger a biologic cascade.
2. A permanent increase in blood supply beginning as soon as 4 weeks after
treatment and continuing to improve up to a period 12 weeks after
treatment. It is proven that there is a 300% increase in small, medium, and
large blood vessels in the targeted ischemic or pathologic tissue.
3. SoftWaves are proven to recruit, activate, and cause a patient’s own stem
cells to differentiate. This biologic cascade described is identical to the
cascade that results after a patient is injured. The mechanism is self-
healing. In the vast majority of instances when a patient is injured,
regardless of rather it is a wound, trauma, fracture or sports injury, a body
will heal itself sufficiently within a maximum of 12 weeks. In those cases
where a chronic injury or trauma persists after 12 weeks, and the body’s
own healing effort has ceased, a SoftWave therapy will make the body
react as if a fresh injury has occurred and initiate another 12 week healing
cycle.

The benefits of these 3 mechanisms of actions (and others to a lesser extent) can
be utilized in several ways to support the reduction of opioid addiction. The first
group of patients that would benefit from Softwave therapy are those patients
that become addicts as a result of surgery, post-surgical complications, or just by
taking the prescription pain meds as prescribed by the surgeon. Examples of the
proven benefits are as follows:

It is estimated that 2 million opioid addicts are created annually as a result of
elective surgeries alone. Plastic surgery is a large percentage of these cases. This
number grows dramatically when you include all surgeries. In randomized
controlled clinical trials, it was proven that when Softwaves are applied to a
patient’s surgical incision during surgery (after it is closed), the post surgery
recovery time is reduced, there are fewer complications, and most importantly
pain is reduced post-surgery requiring less medication and fewer prescription
medications.

Most plastic surgery (elective) patients return to their doctor’s office shortly after
surgery, in severe pain, demanding prescription pain medications. Historically,
doctors prescribed these meds for an extended period of time. Studies have
shown that even a few days of these prescription medicines can lead to long term
addiction. In a recent small clinical trial, plastic surgery patients who returned to
their doctor for their first examination demanding prescription pain medications
were offered a SoftWave treatment at the surgical site before a prescription was
written. 75% of these patients obtained immediate pain relief such that they no
longer required prescription pain meds.

It is reasonably believed (and easily proven) that the combination of a SoftWave
treatment during surgery, and one or two additional treatments post-surgery
could reduce the number of pain medicine prescriptions by at least 50%. There
are additional benefits as well: shorter recovery time, reduced scaring, fewer
complications, and an improved appearance of the scar. Conservatively, the
therapy could reduce the number of addicts created as a result of post-surgery
pain medicines by at least 50%. If this therapy is available to surgeons and a
reasonable reimbursement established, the number of new addicts created post
operatively each year will be dramatically reduced. Even though surgeons know
this works, or even believe it may work, they will not offer this technology if they
are not paid to do so. The average cost of this therapy in the US is less than $500
including the technician. This cost is often less than the cost of prescription meds
that it is replacing.

It is also understood that a huge percentage of addicts became addicted as a
result of an accident, trauma, or injury that created chronic pain such that they
required prescription pain meds to treat the chronic pain. For lack of technology,
insurance, and numerous other factors many of these patient’s progress to opioid
use and addiction to manage the chronic pain.

SoftWave therapy is the best technology in the world to manage acute and
chronic pain. Every day it is utilized to successfully treat the highest level
professional athletes. Over 200 NBA players have been successfully treated for
chronic pain including the biggest names in the league. We are regularly flown to
the Emirates to treat Royal family members. There are 10,000 devices in use
worldwide for acute and chronic pain. It is safe, relatively painless, non-
pharmaceutical, and can be delivered quickly, safely, and inexpensively.
In the recovery center setting, SoftWaves can be added to the standard of care to
support the recovering addict. If an addict’s chronic pain is not addressed during
rehabilitation, a patient’s is very likely to return to addiction after the program is
completed.

It is also understood that acute pain often presents during the detoxification and
rehab process. This pain can also be managed.
Additionally, a patent pending process of targeting a patient’s reflexology points
on the hands and feet during recovery may greatly reduce the side effects felt by
the patient during the withdraw period. Generally, the patient’s feel much more
calm and relaxed after these treatments. This is a very exciting discovery but the
results are very preliminary. In the 20 plus cases that I have witnessed the
outcomes most often produce amazing tearful responses. Again, this can be
quickly and safely proven or not. And, it is understood by the doctors and therapist dealing with addiction that a huge percentage of males suffering from opioid addiction suffer from erectile dysfunction. This ED causes depression and prevents an obstacle to recovery.

Shockwaves (SoftWaves) therapy is the new patented standard of care for the
treatment of ED with over 50,000 patients successfully treated last year.
Finally, based on our related research, we believe that we will have a strong
benefit when we treat the teeth and gums of meth addicts. We are supporting
the first such trial and will apply for an IRB within 90 days to treat the first
patient’s. Any improvement that we can make to the teeth, gums, and mouth of
these patients would lead to an increased self-esteem and surely benefit in their
recovery.

Our final grand plan to support this horribly afflicted section of our society is to
create thousands of outstanding jobs for the recovered addicts. Jobs offer hope,
and hope is the key to prevent a recovered addict from relapsing. After this
program is launched on a national level, thousands of jobs will be created to
identify, recruit, and treat the millions of addicts and to train the technicians to
provide this therapy. I would hope that we try to fill these new positions with as
many recovered addicts as possible. The application of this technology is safe and
simple. With some limited job training post recovery (critical part of the
program), recovered addicts would make ideal SoftWave technicians and trainers.
Who better to recruit, treat and support other addicts through the process than
somebody who has already completed the journey?
Most readers of this summary will want to attack individual claims and find
reasons not to believe. The most frequent one I hear is it is too good to be true.
Every once in a while, it is not too good to be true.

The most exciting thing is that every claim is easily proven. The pain benefits are
almost immediate. Patients get off the pain meds immediately. Any plastic
surgeon can prove these claims very quickly. Even if we are only successful in half
of the cases this would be an astounding clinical, social, and historic success.