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Monday, 09/12/2016 3:08:54 PM

Monday, September 12, 2016 3:08:54 PM

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FDA Approval Season Starts Now/ 09-12-2016
Christian DeHaemer Photo By Christian DeHaemer
Written Monday, September 12, 2016

Some researchers estimate that the global market for back pain therapy is over $60 billion a year and is growing at more than 5.5% a year.

And it's no wonder: never before in human history have we been so old. In 1930, old people were 5.4% of the population. Today, one in three Americans is over 50. By 2030, one in five will be over 65. Old people now represent 12.9% of the population.

And if you are like most people, you know that growing old brings a host of medical problems including chronic back pain. A study in 2010 placed chronic back pain at number three of the most burdensome conditions in the U.S. — only behind ischemic heart disease and chronic obstructive pulmonary disease.

We know what causes it. From the National Institutes of Health (NIH):

The lower back where most back pain occurs includes the five vertebrae (referred to as L1-L5) in the lumbar region, which supports much of the weight of the upper body. The spaces between the vertebrae are maintained by round, rubbery pads called intervertebral discs that act like shock absorbers throughout the spinal column to cushion the bones as the body moves. Bands of tissue known as ligaments hold the vertebrae in place, and tendons attach the muscles to the spinal column. Thirty-one pairs of nerves are rooted to the spinal cord and they control body movements and transmit signals from the body to the brain.

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The FDA just approved its method. It's rolling out as we speak.

This simple method will save millions of babies —

Most of us know the grinding pain of the lower back. A few years ago, I was getting slothful and fat sitting at my desk trading stocks, and my damn back hurt. Not so shockingly, the cure for me was to go on a diet and hit the gym. Within a year I had dropped 20 pounds and increased my core strength and didn't have any more back pain. This is a fairly common story. It happens every day.

But that's not what we are talking about...

We are talking about people who have spinal discs that are smashed, bashed, or otherwise broken due to aging, genetics, or injuries.

For these people, the usual remedy is spinal fusion surgery, epidural steroid injections, or lots of pain medications.

Millions and Millions

In fact, over 4 million patients in the United States alone suffer from CLBP. Their discs lack the capacity to act as a fluid-filled cushion between vertebrae. Ongoing damage causes swelling and a growth of nerves that results in chronic pain. This combination results in CLBP and functional disability.

Existing therapies treat the symptoms of the disease, but they don't cure the underlying cause. As a result, the most significant unmet need is a therapy that not only can improve the patient’s pain and function but also has the ability to reverse, halt, or slow disease progression.

We need to fix the discs and bring back the rubberlike flexibility.

One company believes that by treating the cause of CLBP with a unique application of stem cells, it could rejuvenate those flat and warped discs so that they act like shock absorbers again.

What is this stem cell treatment?

Well, the company describes it as:

A tier 1 product candidate which consists of a unit dose of 6 million mesenchymal precursor cells (MPCs). It is injected by syringe directly into a targeted damaged disc in an outpatient procedure.

Mechanism of Action

Extensive preclinical studies have established that MPCs have anti-inflammatory effects and secrete multiple paracrine factors that stimulate new proteoglycan and collagen synthesis by chondrocytes in vitro and by resident cells in the nucleus and annulus in vivo. MPCs have also been shown to produce anti-inflammation factors. Together these effects offer the potential to strengthen the load bearing function of the disc by increasing its water content, improving disc anatomy and stability, while also reducing inflammation and pain.


FDA Approval Season Starts Now
Christian DeHaemer Photo By Christian DeHaemer
Written Monday, September 12, 2016
Some researchers estimate that the global market for back pain therapy is over $60 billion a year and is growing at more than 5.5% a year.

And it's no wonder: never before in human history have we been so old. In 1930, old people were 5.4% of the population. Today, one in three Americans is over 50. By 2030, one in five will be over 65. Old people now represent 12.9% of the population.

And if you are like most people, you know that growing old brings a host of medical problems including chronic back pain. A study in 2010 placed chronic back pain at number three of the most burdensome conditions in the U.S. — only behind ischemic heart disease and chronic obstructive pulmonary disease.

We know what causes it. From the National Institutes of Health (NIH):

The lower back where most back pain occurs includes the five vertebrae (referred to as L1-L5) in the lumbar region, which supports much of the weight of the upper body. The spaces between the vertebrae are maintained by round, rubbery pads called intervertebral discs that act like shock absorbers throughout the spinal column to cushion the bones as the body moves. Bands of tissue known as ligaments hold the vertebrae in place, and tendons attach the muscles to the spinal column. Thirty-one pairs of nerves are rooted to the spinal cord and they control body movements and transmit signals from the body to the brain.

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One tiny company you never heard of has the answer to the mosquito-borne Zika virus that is plaguing places like Miami and Texas.

This company genetically alters male mosquitoes so that their babies don't live to maturity. They can't breed again! Take that, bugs.

The FDA just approved its method. It's rolling out as we speak.

This simple method will save millions of babies — and bring over 6,780.85% returns to early investors. Don't wait.

Click here and start making money tomorrow.

Ouch, My Back!

lower back pain

Most of us know the grinding pain of the lower back. A few years ago, I was getting slothful and fat sitting at my desk trading stocks, and my damn back hurt. Not so shockingly, the cure for me was to go on a diet and hit the gym. Within a year I had dropped 20 pounds and increased my core strength and didn't have any more back pain. This is a fairly common story. It happens every day.

But that's not what we are talking about...

We are talking about people who have spinal discs that are smashed, bashed, or otherwise broken due to aging, genetics, or injuries.

For these people, the usual remedy is spinal fusion surgery, epidural steroid injections, or lots of pain medications.

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A One-Year-Old Girl and a Crazy Profit Story

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Millions and Millions

In fact, over 4 million patients in the United States alone suffer from CLBP. Their discs lack the capacity to act as a fluid-filled cushion between vertebrae. Ongoing damage causes swelling and a growth of nerves that results in chronic pain. This combination results in CLBP and functional disability.

Existing therapies treat the symptoms of the disease, but they don't cure the underlying cause. As a result, the most significant unmet need is a therapy that not only can improve the patient’s pain and function but also has the ability to reverse, halt, or slow disease progression.

We need to fix the discs and bring back the rubberlike flexibility.

One company believes that by treating the cause of CLBP with a unique application of stem cells, it could rejuvenate those flat and warped discs so that they act like shock absorbers again.

What is this stem cell treatment?

Well, the company describes it as:

A tier 1 product candidate which consists of a unit dose of 6 million mesenchymal precursor cells (MPCs). It is injected by syringe directly into a targeted damaged disc in an outpatient procedure.

Mechanism of Action

Extensive preclinical studies have established that MPCs have anti-inflammatory effects and secrete multiple paracrine factors that stimulate new proteoglycan and collagen synthesis by chondrocytes in vitro and by resident cells in the nucleus and annulus in vivo. MPCs have also been shown to produce anti-inflammation factors. Together these effects offer the potential to strengthen the load bearing function of the disc by increasing its water content, improving disc anatomy and stability, while also reducing inflammation and pain.

Results from the Phase 2 study were proven successful:

fff2 smallClick Image to Enlarge

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Ongoing Phase 3 Trial

A Phase 3 clinical program is currently enrolling chronic back pain patients. The first of two Phase 3 clinical trials will use a primary endpoint that comprises both pain relief and improved function, consisting of a 50% reduction in lower back pain as measured by Visual Analog Score and a 15-point improvement in the Oswestry Disability Index, with no additional interventions.

Needless to say, a positive Phase 3 result will send the stock price much higher.

I'm not just whistling Dixie. It happens all the time. New procedures, drugs, and FDA approvals are creating huge gains for biotech investors.


Relypsa, Inc. (RLYP)
Cyclacel Pharmaceuticals, Inc. (CYCC)
Portola Pharmaceuticals (PTLA)

Biotech stocks are moving because new mega-data-crunching computers are teaming up with stem-cell innovation and changing the health care industry as we know it.

It's the biggest boom in medical knowledge since they invented vaccines. Heck, it's even bigger. Stem cells will cure everything from degenerative disc back pain to heart attacks to mosquito-borne diseases like Zika ($1.1 billion in congressional Zika funding will hit at any moment).




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