Kelvin: One does not increase salaries and bonuses if one expects a negative outcome from the FDA. Director Cathy Friedman would not be eligible for a bonus but her $20K purchase of ETRM stock post ADCOM speaks volumes. If you look at the 8-K the executive salaries they are reasonable for a $100M cap company.
Read director Cathy Friedman's bio. She bought $20,000 of ETRM to put in her trust at a HIGHER price than you can buy today(but not for long). I predict a GREEN finish on Thursday as the downward drift is about stopped. The next news for ETRM should be positive.
We are seeing a great entry point for new buyers. Per Barrons the stock continues under gradual accumulation. Buy now in the 1.60s, lower than director Catherine Friedman, who has all the inside dope on VBLOC's prospects.
It will only get better and more dependable through succeeding generations, which can only be accomplished by a pro-active partner. This is where the technology is headed:
In a move that could draw attention from the world's top cardiac devicemakers, researchers in Korea have developed a self-powered artificial cardiac pacemaker that operates without battery power.
A team from the Korea Advanced Institute of Science and Technology (KAIST) designed a cardiac pacemaker implant that runs on a piezoelectric nanogenerator, rather than traditional batteries. Pacemaker batteries typically last seven years on average, and require frequent replacements--putting patients at risk for infections or severe bleeding during operations, Medical Xpress reports. The flexible nanogenerator from South Korean researchers directly stimulated a living rat's heart using electric energy converted from small body movements, forgoing the need for battery replacement.
"For clinical purposes, the current achievement will benefit the development of self-powered cardiac pacemakers as well as prevent heart attacks via the real-time diagnosis of heart arrhythmia," lead researcher Professor Keon Jae Lee told Medical Xpress. "In addition, the flexible piezoelectric nanogenerator could also be utilized as an electrical source for various implantable medical devices."
Approval could come even sooner. The fact that we haven't had huge price swings(up big one day, down big the next day) is stabilizing for a micro cap like ETRM. Even on down days, Barrons still shows gradual accumulation.
bagelong2: All you nee to know is that directors are often hired because of their contacts. Cathy Friedman worked 23 years at M & A heavyweight Morgan Stanley. She knows ETRM inside and out and has been privy to any past or present partnership discussions. She bought $20,000 for her trust.
oozhe: You do know, I know you know, that the FDA has approved many drugs, especially by large companies, with modest efficacy. Medical devices get quite a bit more leniency than drugs-even Alan Feirstein said so.
Last year the company was predicting a 4th qtr 2013/1st qtr 2014 ADCOM. I think a possible reason the FDA postponed the ADCOM to 6/17/14 was to give the company time to show the 24-month data, which confirmed the melting away of the outsized sham effect.
The FDA is desperate to stem the obesity-diabetes epidemic. Medical device approval is a much lower hurdle than with drugs and the expectation is that VBLOC results will only improve with time.
rodtross: NO company gears their PRs and timing of same to complaints on message boards. All you need to know is that a director with 23 years at M & A king Morgan Stanley bought $20,000 worth for her trust-you don't put stock into a trust short-term, but for what happens in the next 2-3 years. A partnership post ADCOM and pre-approval is not out of the question: a number of deals have been struck with staggered payments for upfront, upon FDA approval, product launch and sales milestones.
We need to start discussing my post as the WL percentages dicussions have been beaten to death. More than half, probably about 70% of the future VBLOC patients will be women. They will take smaller sizes for dresses, jeans, slacks, shorts anyday over actual poundage loss. The weight scale never leaves the house, but clothes sitting for years in a closet that now can be worn and shown off to girlfriends and workmates does get out in public.
I'm surprised that this board has not been impressed with the 5 to 7 inch waistline reduction offered by VBLOCK.
What is significant is that the company received permission from the FDA to show the 24-month slide data SHOWING SUPER SUPERIORITY. Of course, the data is informational only, but it confirms what the FDA expected to see in the 12-month data: A REDUCED SHAM AFFECT.
Folks, when we try to lose weight we all use our closet of various-sized slacks and jeans to spur us on. Women especially are conscious of this as their wardrobe costs a lot more than those of women.
Morgan Stanley is a heavy hitter in M & A. They shopped Encysive when they were sold to Pfizer in 2007-08. In the SEC documents it showed MS sent out hundreds of pitch books, got about 80 responses and a dozen companies signed confidentiality agreements, with five serious bidders.
Believe me, Ms. Friedman has her ear to the rail and hears a money train coming.
lobsterpot: Don't you get email alerts from Enteromedics? I did and it was for a Form 4. Cathy Friedman, director purchased 11,800 shares for her trust on 6/19 at avg price of 1.70(1.68-1.73 range).
The late Steve Allen composed the song "This Could Be The Start of Something.' As Louie Nye used to say on Allen's show, "Hi Ho, Steverino!"
Also, what no one on the board besides me has said that there will be user friendly improvements to VBLOC Maestro system in the next 5-10 years, just as there were to the first PCs, iPods, TVs, etc.
If enteromedics wanted to drive the Market nuts they could sign a co-research pact with the likes of Apple, google, Amazon, Microsoft to work on improvements. Even if ETRM didn't get any upfront money the prestige would be enormous.
I'm surprised that uber boosters like adeiifig are not picking up on the fact a big partner could improve Maestro and make the implant smaller and eventually wireless. My first laptop in 1997,at GE Capital, a Compaq, had a 4GB hard drive( the IT guy said we didn't need the 8 GB upgrade, and obviously it had no wi-fi.
Companies like Medtronic, St Jude Medical could push development years faster than ETRM.
VBLOC will only become a big presence in the WL business when its 2nd and 3rd generation successors make the device smaller and charging eventually wireless-this requires a deep pocket partner like:
Medtronic ($MDT) successfully implanted its tiny leadless cardiac pacemaker in its first patients as part of a global clinical trial, chalking up another victory for the device on its path toward regulatory approval.
Results from a single-arm, multicenter study showed that at one and three months, four patients outfitted with the company's Micra Transcatheter Pacing System (TPS) had no major complications postimplant. The study began in December 2013, and the four individuals who received the device were between the ages of 74 and 83. Medtronic plans to enroll 780 patients at approximately 50 centers worldwide to evaluate its cardiac pacemaker, and has already recruited 80 individuals to take part in the study, the company said in a statement.
"We are encouraged by these preliminary results and are hopeful that this less invasive procedure will provide similar outcomes for all patients in the Trial," said Dr. Clemens Steinwender, head of cardiology at the Linz General Hospital in Linz, Austria, who presented the data at Cardiostim 2014.
The Minneapolis-based device giant touts its Micra system as the world's smallest pacemaker, about one-tenth the size of a conventional pacemaker and roughly equivalent in size to a large vitamin. Unlike traditional pacemakers, the device does not require surgical incision or the use of wires, or "leads," to connect to the heart. Instead, physicians deliver Micra to the heart through a catheter inserted into the femoral vein, and securely attach the device to the heart wall using small tines. An electrode at the end of the pacemaker delivers electrical impulses to the heart.