LD Micro Conference
After eleven years of researching companies, writing reports, and putting our own capital on the line, LD MICRO is pleased to announce its sixth annual conference on December 3rd, 4th and 5th, 2013.
The "Main Event" has become the Iron-Man of micro-cap.
We've invited 233 companies in the small and micro cap space. Last year, over 1,000 people registered for the event.
The conference will be held at the beautiful Luxe Sunset Bel Air, rated one of the premier hotels of Southern California.
Thursday, December 5, 2013, at 11:30 AM PST / 2:30 PM EST.
The three-day event will host 235 companies in the micro-cap space at the Luxe Sunset Bel Air in Los Angeles, California.
CTI President & CEO Conrad Mir will present to investors the CTI's 2013 - 2014 corporate business plan. He
will be available for one-on-one meetings during the conference.
Sentiment: Strong Buy
STATEN ISLAND, NY--(Marketwired - Nov 5, 2013) - Calmare Pain Relief Solutions (the "Company"), a chronic pain treatment medical practice, will increase its Calmare Pain Therapy clinic network by 70% in the Tri-state area in 2014. This expansion is in response to the U.S. Food and Drug Administration's (FDA) position regarding the benefits of using a non-narcotic solution for the relief of chronic pain. This position was highlighted in a recent New York Times article entitled "FDA Shift on Painkillers was Years in the Making."
With the increased acceptance of Calmare Pain Therapy by nationwide insurance companies, there has been an increase in new, chronic pain patient visitors to the Calmare Pain Relief Solutions' network of clinics. Their search for a non-invasive and non-narcotic pain relief regimen has resulted in the Company's redesigned corporate website. The site now offers chronic pain sufferers a web portal that houses a repository of information on the Calmare technology (commonly known as "Scrambler" technology). Visitors can view media reports and videos on the potential benefits gained from this alternative therapy versus a traditional biochemical solution. They can also read articles and research documents that may assist patients and healthcare providers in assessing the benefits of this technology.
"We wanted to offer patients and insurance companies a very informative website on the Calmare pain relief therapy," said David J. Palmieri, healthcare consultant to Calmare Pain Relief Solutions. "We often get requests for well-referenced information from patients and insurance providers and our new website is a direct response to those requests."
Sentiment: Strong Buy
It has been very hard to prevent and treat CIPN because a
variety of drugs and supplements including glutamine, vitamin
E, and glutathione have been disappointing. A recent study
of a topical combination of the drugs baclofen, amitriptyline,
and ketamine (which some doctors actually recommend) for
treating CIPN showed some benefi t for sensory and motor
neuropathy. Another study showed some promise for a
patient-specifi c electro stimulation device (MC5-A Calmare;
Competitive Technologies, Wakefi eld, RI). Th is Calmare®
medical device is being further tested
currently. Th is device sends a no-pain message to the nerve
from surface electrodes applied to the skin in the area of the
patient’s pain. Next, the perception of pain is apparently
cancelled when the no-pain message replaces that of pain, by
utilizing the same pathway through the surface electrodes. If it
sounds a little confusing well it is but think of it like a message
distorting device. Th e average treatment time is from 20-
60 minutes. It sounds interesting and I really hope it works
because CIPN needs help now!
Sentiment: Strong Buy
Why not tell the truth. It says in the update final data expected to be gathered by March 2014. Everyone cares what The Mayo clinic has to say.
Sentiment: Strong Buy
MedlinePlus related topics: Peripheral Nerve Disorders
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
Change in pain on a 0-10 numerical rating scale. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Changes in neurologic function will be done by Neurometer Current Perception Threshold (CPT) testing and with a Rydel-Seiffer graduated tuning fork. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Patients will also undergo neurologic function testing. This will be done in an exploratory measure to try to correlate changes in the patient reported outcome instrument data with changes in the different measures of neurologic function. The two measures will be Neurometer Current Perception Threshold (CPT) Testing and testing with a Rydel-Seiffer graduated tuning fork.
Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
This pilot clinical trial studies scrambler therapy in treating pain and peripheral neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy
Other: scrambler therapy
Other: questionnaire administration
Procedure: management of therapy complications
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Open Access Trial
Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy
This study is currently recruiting participants.
Verified September 2013 by Mayo Clinic
Information provided by:
First received: March 30, 2011
Last updated: September 5, 2013
Last verified: September 2013
History of Changes
Once the safety labeling changes are finalized, modifications will also be made to the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), to reflect the updated information. Originally approved in 2012, the ER/LA Opioid Analgesics REMS requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/ LA opioids.
In addition to the safety labeling changes and postmarket study requirements, the FDA has issued responses to two related citizen petitions.
“The FDA remains committed to improving the safety of opioids and to continuing to engage in efforts to evaluate and mitigate the risks associated with opioid use,” said Dr. Throckmorton. “Today’s safety labeling changes reflect the FDA’s current understanding of the risks and benefits of these products. The FDA will evaluate the results of the postmarket studies, continue to monitor relevant safety data, and take further safety action, as warranted.”
“The FDA’s primary tool for informing prescribers about the approved uses of medications is the product labeling,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs.”
Recognizing that more information is needed to assess the serious risks associated with long-term use of ER/LA opioids, the FDA is requiring the drug companies that make these products to conduct further studies and clinical trials. The goals of these postmarket requirements are to further assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death.
The FDA is also requiring a new boxed warning on ER/LA opioid analgesics to caution that chronic maternal use of these products during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening and require management according to protocols developed by neonatology experts. NOWS can occur in a newborn exposed to opioid drugs while in the mother’s womb. Symptoms may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.
In addition, the FDA is notifying ER/LA opioid analgesic application holders of the need for changes to the following sections of drug labeling: Dosage and Administration; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information, and the Medication Guide.
FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics
New boxed warning to include neonatal opioid withdrawal syndrome
The U.S. Food and Drug Administration today announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.
“The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities,” said FDA Commissioner Margaret A. Hamburg, M.D. “Today’s action demonstrates the FDA’s resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain.”
Given the serious risks of using ER/LA opioids, the class-wide labeling changes, when final, will include important new language to help health care professionals tailor their prescribing decisions based on a patient’s individual needs.
The updated indication states that ER/LA opioids are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The updated indication further clarifies that, because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief.
Sentiment: Strong Buy