Medovex Corporation (MDVX) (web site) develops medical devices primarily in the in the United States and Europe. It offers DenerveX device for the treatment of conditions resulting from the degeneration of joints in the spine, which cause back pain. The company serves healthcare providers, physicians, and third-party payors. Medovex Corporation is headquartered in Atlanta, Georgia.
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MDVX at a glance:
Shares Outstanding: 14 million
Insider Ownership: 38%
Float: 8 million
Closing Price 11/01/2016: $1.66
Market Capitalization: 23 million
Multi-Billion Dollar Market Opportunity
Osteoarthritis (OA) is the most common form of arthritis, affecting 27 million people in the United States and The Centers for Disease Control and Prevention lists low back pain as the second most common cause of disability in US adults. With the advancing age of the population and obesity epidemic, the prevalence of OA is also increasing:
- By 2030, 20% of Americans or about 70 million people age 65 and older, will be at risk for osteoarthritis
- Fifty percent of people age 65 and older already exhibit evidence of osteoarthritis in at least one joint
Osteoarthritis of the spine, known as spondylosis, is a degenerative disorder that can cause loss of normal spinal structure and function. Aging is the primary cause. Spondylosis can affect the cervical, thoracic and/or lumbar regions of the spine, and may involve intervertebral discs and facet joints, which can lead to disc degeneration, bone spurs, pinched nerves, and an enlargement or overgrowth of bone that narrows the central and nerve root canals, causing impaired function and pain. When spondylosis worsens, it may progress to spinal stenosis, a narrowing of spaces in the spine, which results in pressure on the spinal cord and/or nerve roots.
A related condition, degenerative spondylolisthesis (slippage of one vertebra over another) is caused by osteoarthritis of the facet joints. Most commonly, it involves the L4 slipping over the L5 vertebra, and is also related to aging, most frequently affecting people age 50 and older. Symptoms may include pain in the low back, thighs, and/or legs, muscle spasms, weakness, and/or tight hamstring muscles.
Approximately 31% of chronic low back pain is attributed to the facet joints, small stabilizing joints located between and behind adjacent vertebrae. Facet joints are in almost constant motion with the spine and quite commonly simply wear out or become degenerated in many patients. When facet joints become worn or torn the cartilage may become thin or disappear and there may be a reaction of the bone of the joint underneath producing overgrowth of bone spurs and an enlargement of the joints.
Chronic back pain caused by facet joint arthritis is a multi-billion dollar market opportunity that currently has no effective, long term/permanent solution.
Temporary Relief vs. Permanent Solution
Current treatment for chronic back pain caused by facet joint arthritis includes medications for pain relief, spinal injections, and radio frequency (RF) ablation.
Unfortunately for the many individuals suffering from chronic back pain due to facet joint osteoarthritis, these options are not permanent solutions.
Permanent Solution from Medovex
The DenerveX™ System developed by MDVX provides long-lasting relief from pain associated with facet joint syndrome.
Using a two-step procedure of facet joint capsular tissue removal and RF Ablation with the DenerveX™ System, MDVX demonstrated positive outcomes via a study of 174 patients:
- A total of 77%, 73%, and 68% of patients with cervical, thoracic, or lumbar disease, respectively, showed at least 50% improvement in pain at 3 year follow-up
- The majority of patients achieved a 75% to 100% improvement (VAS pain score) at 3 year follow up
- Overall, 76%, 60%, and 75% of patients with cervical, thoracic, or lumbar facet disease, respectively, had at least a 50% improvement in Oswestry Disability Index (ODI) scoring
- Most patients experienced a 75%-100% improvement at 3 year follow up
DenerveX™ System Represents Immense Savings for Patients and Health Care System*
*Estimates are for a 3 year period
CE Mark Approval in Europe Pending
MDVX management stated in a conference call yesterday (11/1/2016) that CE Mark approval in the European Union is expected in the first half of 2017, and that their recent presence at the EuroSpine 2016 Tradeshow in Berlin was very rewarding.
Medovex President and COO, Patrick Kullmann, recently stated:
“We conducted meetings and demonstrations with at least six potentially strategic companies that could open the door to future collaboration for distribution, investment, co-future development of future generations of the technology or even potential acquisition. Many of the spine surgeons and pain relief physicians visiting the booth stated that the DenerveX Design is very elegant, and represents a very new and creative approach in treating pain associated with the Facet Joint Syndrome. Their clear appreciation for our different approach in performing a new procedure by way of a posterior capsulectomy of the facet joint, compared to the less effective standard radio frequency ablation (Rhizotomy), gives us cause for continued cautious optimism going forward.”
Medovex has opened a European distribution service center, and already has a Diagnosis-Related Group (DRG) designation in Europe. The DRG designation is a very positive milestone for MDVX as it terms of future billing for DenerveX™ System treatment and reimbursement.
EU/Worldwide DenerveX™ System Commercialization
Investors should expect positive and frequent updates as MDVX moves along the commercialization timeline below:
High Insider Buying/Ownership
As the saying goes, there are many reasons why insiders might sell a stock, but there’s only one reason why they buy it.
MDVX Investment Highlights
- Founded by Steve Gorlin (Entremed, Medicis, Medivation, MiMedx) and James Andrews MD (world renowned orthopedic surgeon)
- Experienced and proven management team and board of directors
- High insider ownership (38%)
- Huge, highly opportunistic market opportunity
- Scalable high growth, recurring revenue model with strong margins and clean balance sheet
- Intellectual property portfolio (300 claims)
- Anticipated CE marking first half 2017 with already established international distribution
- Positive news flow over the coming weeks and months as company begins commercialization and revenue generation
Best wishes for profitable investing!