Damage control? Near bottom of message...."distribution is rapidly expanding worldwide with major companies looking to partner and distribute the product." Andy maybe looking for a different direction?
BioElectronics: Given today's events, this backgrounder will be of interest...
Pain
Pain is one of the most common medical complaints, has significant consequences on patient quality of life and has a huge associated cost, which has been reported to be $635 billion annually1 (more than cardiovascular disease and diabetes combined). The effects of pain on quality of life are widespread effecting productivity, sleep, relationships, employment, increases depression and consequently increased suicide rates. Despite its prevalence, impact on quality of life, economic cost, high use of healthcare resources pain is inadequately treated.
Analgesic Pain Medication
To date the most widely used method of pain management has been the widespread use of analgesic pain medications both over the counter and prescription drugs. Over the last 20 years, the FDA allowed rapid expansion, with little prior clinical evidence, of narcotic based drugs for chronic pain, this has led to major problems with high rates of dependence, addiction, diversion, abuse and death through overdose which have reached epidemic proportions.
· From 1999 to 2010, the number of U.S. drug poisoning deaths involving any opioid analgesic (e.g., oxycodone, methadone, or hydrocodone) more than quadrupled, from 4,030 to 16,651, accounting for 43% of the 38,329 drug poisoning deaths.
· It is now understood, that for most patients, narcotic pain pills show very little effectiveness after 12 weeks of use.
· Estimates indicate 4.7 million Americans or 2% of the population are addicted to or are dependent on narcotic pain pills.
Narcotic pain pills were introduced as current options are very limited to treat moderate to severe chronic pain. The over the counter (OTC) pain pills, such ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen are widely used for mild or moderate pain. However for many conditions, such as lower back pain their effectiveness is very limited. Though thought to be safe OTC pain drugs with long term use are associated with many adverse side effects, some of which can be serious. NSAIDs are thought to course 100,000 hospitalizations through gastrointestinal complications, coursing death between 5000 -16500 users a year. Cardiovascular adverse effects are also a signification problem with NSAIDs, whereas acetaminophen is the leading course of liver failure in the USA.
With the major complications associated with prescription narcotics, lack of effectiveness of OTC pain pills and adverse effects, economical and effective pain therapies are urgently needed. One such therapy is a medical device made by BioElectronics (Frederick, MD), the ActiPatch. ActiPatch is an innovation of a widely used and researched medical therapy that has been employed as a pain therapy for many decades.
Facts About ActiPatch
· ActiPatch is a drug free, non-invasive pain and healing therapy
· The technology is based on a widely studied clinical therapy, which traditional devices are class II around the world including the USA
· Low power devices like ActiPatch are class II around the world with the exception of the US where they are class III.
· ActiPatch received a medical innovation award from the Wall St Journal.
· ActiPatch is currently distributed in 57 countries as a class IIa OTC medical device, including Canada and the European Union.
· 500,000 devices have been sold over the last ten years which equates to well over 10 million days of treatment.
· No significant adverse effects have been reported.
· Clinical data, user data and a long history of distribution confirms that ActiPatch is a valuable, safe alternative pain therapy
· Because of this, distribution is rapidly expanding worldwide with major companies looking to partner and distribute the product.
The introduction of ActiPatch as a safe an alternative pain therapy, therapies which are urgently needed has been repeatedly blocked by the FDA. ActiPatch remains a class III medical device in the US.
AI
