1. The strategic plan was laid out nicely during the last analyst conference.
2. Hopefully management is running the business.
3. Accountability to shareholders? Well lets give them the chance. We are waiting for approval aren't we?
4. Your worst investment? You must of had a short term outlook. We have yet to even hear if it's going to be approved for use yet. Did you somehow think money would magically appear with no sales?
BUT of course it's frustrating to watch especially if you thought it was buy at higher levels, we all did, But it didn't turn out to be the case. So ask yourself this. Is this company really only worth $70M with approval already around the globe and possibly soon to be U.S..?
Doubt it but this parts interesting isn't it?
"Mr. Jansz is a director and major shareholder of The Medical Finance Company, which provides finance programs for patients undertaking bariatric procedures in Australia."
I think Gary just misspoke. I think what he's saying is if they get a denial without additional studies being done. Because there will most certainly as you noted be post marketing studies/trials done.
Not true. I didn't buy in March but did buy in June and several times since. I'm underwater for now but not worried. I personally think there are a lot of weak hands here, but who am i to judge one's investments. I believe approval will come and more importantly think there's a good chance at success for the company. There's a place for VBLOC in the space imo. It's either take pills which so far doesn't seem like consumers want to date. Then there's the choice have having your insides altered or worse ripped apart. I'm either going to lose all of what I've put into this investment or look like a genius along with the rest of the REAL longs!
The most important and positive points about VBLOC therapy is that it addresses the lifelong challenge of obesity without compromising safety, nutrition, lifestyle, or undergoing irreversible anatomical disfigurement. It does not require a pre or post implant diet, and patients are able to eat normal, healthy meals without food restrictions. VBLOC Therapy minimizes side effects and follow up burden especially that there are no surgical alteration of the anatomy of the stomach or intestines. Furthermore, the Maestro System can be deactivated, reactivated or completely removed if desired. Patients maintain control of their lifestyle, while being supported in their effort to lose weight safely. With VBLOC Therapy, many social environments that are otherwise inaccessible are comfortable and available to the individual, making it easier to accept and commit to long-term treatment.
Maestro System, an implantable device intended to address the underlying causes of obesity through the nerve that controls much of the activity of the digestive system is your answer. This new weight loss therapy, called VBLOC, is an alternate bariatric surgical procedure for individuals who have had little or no success losing weight and keeping it off. Unlike other types of bariatric surgery that alter the stomach’s anatomy, VBLOC Therapy is delivered by an implantable device. Through implanted electrodes, the device delivers high-frequency, low-energy electrical impulses to block signals conveyed through the vagal nerves. The vagal nerve function appears to play a significant role in enabling multiple mechanisms including:
Expansion of the stomach as food enters
Stomach contractions that break food into smaller particles.
Release of gastric acid to continue food processing.
Emptying of the stomach contents into the small intestine.
Secretion of digestive pancreatic enzymes that enable absorption of calories.
Sensations of hunger, satisfaction or fullness.
Studies have shown that by blocking the vagal nerve signals, VBLOC Therapy helps patients control hunger sensations and results in early fullness at meals compared to before they received the device. In this way, VBLOC Therapy may aid in weight loss.
VBLOC Therapy has both external and implanted components. This device may be turned off and is designed to be reversible, programmable, and adjustable non-invasively.
Since the nervous system is adept to accommodating the complete loss of the information provided by nerves, such as the vagal nerves, VBLOC Therapy has been designed to provide intermittent blocking. This intermittent blocking effect is intended to prevent accommodation.
We need more Doctors like this:
Two years ago, Jean Hilsman was overweight and fighting numerous health battles.
"It made it even more difficult to get around and then I started developing high blood pressure, cholesterol issues, lack of energy. Just a little bit more sedentary then I should have been," said Hilsman.
She also developed atrial fibrillation, an irregular heartbeat that can lead to a stroke. Hilsman underwent a procedure to fix the problem, but her physician had some other advice.
"He looked at me and said, 'Jean, you really oughta lose some weight. Would you like to?' I said, 'Would I like to? I would love to,'" she recalled.
Instead of giving her a lecture on exercise and diet, Dr. Strouse a cardiac electrophysiologist at MedStar Heart Institute - did something a little unusual "I wrote this prescription for her and I gave it to her," he said.
Dr. Strouse says it's a new method to get patients to listen to him: writing prescriptions for weight loss.
"The power of physically writing a prescription for a patient and giving it to them from a doctor seems to carry more weight,"
Each script has instructions on how many pounds a patient should lose and advice on how to do it. Dr. Strouse says since he started the prescription program two years ago, he's noticed that patients are more successful.
He found about 60 percent of those who get prescriptions lose the weight as opposed to just 10 percent of those who only got verbal instructions. "The most amazing thing is when people realize by taking that step for themselves and losing weight, they realize they're in so much more control of so many elements of their health," said Dr. Strouse. "The blood pressure went way down, off the medication, The cholesterol went way down too!" "When he gave me that prescription, it was symbolic of commitment and that commitment is what I needed," she said.
Vbloc is an option in between pills and having your insides altered or worse ripped apart. The Fda has said "There is a gap in innovation between pills and baratric surgery. I think this fits the bill!
Johns Hopkins: Expert Panel Concludes: Neurostimulation Can Be Life-Changing Therapy for Obesity, Alzheimer’s and Chronic Pain,
The International Neuromodulation Society selected members of the international scientific community to analyze scientific evidence for current and future innovations related to neurostimulation and to use clinical experience to fill in any gaps in information. The experts determined that currently approved neurostimulation techniques and technologies have expanded physicians’ ability to treat patients in a more effective and specific fashion. However, there are several additional promising technologies and potential applications for neurostimulation that could move this field forward and expand its applicability. For example, neurostimulation therapy may be able to help treat a number of nonpain states, including obesity, Alzheimer’s disease, obsessive compulsive disorder and addiction. This project was supported by the International Neuromodulation Society.
Results from the DM2 ENABLE study of reversible vagal nerve blocking with the implantable Maestro Rechargeable System continue to demonstrate both medically meaningful weight loss as well as improvement in diabetes control in obese subjects with Type II Diabetes Mellitus.
“Most significantly, the benefits of VBLOC Therapy are sustained through the 36 month follow up period of the trial with continued excellent overall and cardiovascular safety profiles. “These data continue to support the widely accepted role of bariatric surgery in the treatment of metabolic disorders.”
“At 36 months, HbA1c levels dropped from 7.6% at baseline to 7.0% (p=0.04), which according to the American Diabetes Association, is the reasonable target for many adults with diabetes and has been shown to reduce microvascular complications of diabetes,” says the company. “Furthermore, 83% of the patients who were being treated with one or more diabetic medications at the start of the trial reported no change, a decrease or discontinuation of their medication suggesting that the progression of their diabetes had been modified."
Trial design "First of it's kind" was a farce and outdated imo since it was agreed to years ago before obesity was front & center:
In negotiating the design of their pivotal trial with FDA, the company agreed to conduct the first ever sham controlled study of such a device. One out of three patients in the trial had surgery to implant an inactive version of this vagal blocking system. They agreed to a super superiority standard of 10% better efficacy for their device versus the sham (Again first of it's kind). They knew their device would help people lose about 25% of their excess weight and they thought that the sham group would lose about 5%. Wrong on the last point. The sham group did very well, losing 16% at 12 months (But it was just that a sham. Anytime you have someone monitoring their weight daily you will u sally be more successful)
Statisticians argued that you can’t change the standard after the fact. But panel member Karen Woods summarized what appears to have emerged as the consensus:
There are two ways to look at this.
1. The device didn't meet the standard of super superiority.
2. But it did beat the sham control. Considering need for treatment options, this device has value. And, indeed, that view is reflected in the final vote
FDA own words:
Novel technology addressing unmet medical need in assessing benefit and risk, FDA considers whether a device represents or incorporates breakthrough technologies and addresses an unmet medical need. A device may address unmet medical need by providing a clinically meaningful advantage over existing technologies, providing a greater clinically meaningful benefit than existing therapy, posing less risk than existing therapy, or providing a treatment or means of diagnosis where no alternative is available.
It is not unusual for novel devices that address an unmet medical need to have relatively small probable benefits, and FDA may determine the novel device to be reasonably safe and effective even though the applicant demonstrates a relatively small probable benefit. In addition, the development of innovative technology may provide additional future benefits to patients. With subsequent iterations of the device its benefit-risk profile may change (e.g., the benefits may increase or the risks may be reduced), the expected level of safety and effectiveness may change, and later versions may offer significant advantages over the initial device. In these circumstances, in order to facilitate patient access to new devices important for public health and to encourage innovation, we may tolerate greater uncertainty in an assessment of benefit or risk than for most established technologies, particularly when providers and patients have limited alternatives available.
Yes, but I believe there's something that will. Just haven't found it yet. maybe ETRM holds the golden ticket. Who knows but i'm taking the risk!
If that's what makes you feel better Edi. Better yet and just to be sure put me on ignore where many have. I have always been staunch supporter of Belviq and would never short Arena so I don't no what your problem is. I know only positive opinions are most welcome here!
Jd another poster I respect. All I can say regarding VBLOC is I feel like I've done enough DD to disagree. As far as Doctors not on board with pills, I sadly agree. GL