Minneapolis – June 6, 2016 – CVRx, a global medical device company, today announced that the first two patients have been treated with the BAROSTIM NEO® System in the Baroreflex Activation Therapy for Heart Failure Pivotal Clinical Trial (BeAT-HF). The procedures were done at the University of California San Francisco and Abrazo Arizona Heart Hospital in Phoenix, Arizona. More than 20 patients have been enrolled and are being evaluated for eligibility.
BeAT-HF is a Phase III randomized, controlled clinical trial that studies the safety and efficacy of BAROSTIM THERAPY, the only therapy that is designed to simultaneously reduce sympathetic nervous system activity while restoring parasympathetic activity, for the treatment of heart failure. The trial will randomize 480 patients who suffer from heart failure with a reduced ejection fraction and who have no additional treatment alternatives available. BeAT-HF has achieved Expedited Access Pathway (EAP) designation by FDA for its focus on this unmet clinical need.
“We are very excited by the enrollment and treatment of the first patients in the BeAT-HF Pivotal Clinical Trial. The patients we are including suffer from a very poor quality of life and an increased risk of heart failure-related hospitalizations, and they have no further treatment options,” said Michael Zile, M.D., Professor of Medicine at the Medical University of South Carolina and Chair of the BeAT-HF Executive Steering Committee. “BAROSTIM THERAPY has already demonstrated unprecedented symptom improvement through HOPE4HF, a Phase II randomized, controlled clinical trial, and we are looking forward to similar patient outcomes during BeAT-HF.”
And Hillary wants even more of them let into this country?
Does anyone remember the movie 'The Manchurian Candidate.' I wonder what the theme would be if the word 'Manchurian' was replaced with .....? I wonder if Trump was correct when he doubted someone's true religion and place of birth?
"due to the Barostim’s acceptance in the accelerated approval pathway, the FDA will likely allow commercialize to commence before then, as long as the device demonstrates safety during the trial."
What data was viewed by the FDA that resulted in "accelerated approval pathway"?
In addition, another trial to test the device on heart failure patients is recruiting subjects. Its primary endpoint of (the rate of cardiovascular mortality and heart failure morbidity) is scheduled to report in 2021. Crucially, due to the Barostim’s acceptance in the accelerated approval pathway, the FDA will likely allow commercialize to commence before then, as long as the device demonstrates safety during the trial.
In an email, CVRx CEO Nadim Yared said the company has not yet decided to comment on its Series G round.
Jun 18, 2016 at 7:00 AM
Minneapolis’ CVRx has raised $46 million from unnamed investors in support of its implantable neuromodulator to treat high blood pressure and heart failure, bringing its total equity funding to $237 million over 5 rounds, according to CrunchBase.
CVRx boasts the CE-marked Barostim Neo, an entrant into FDA’s Expedited Access Program for accelerated approval of innovative devices that “demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions.”
Neuromodulation is gaining ground as a therapy for reducing pain, but no one has yet harnessed it within the cardiology arena, putting the company in a unique position if the Barostim gains FDA approval and commercial success.
“Barostim Therapy is designed to activate the Baroreflex through the afferent (sensory) pathway causing a simultaneous reduction in sympathetic activity and increase in parasympathetic activity. Restoring autonomic balance leads to a reduction in symptoms and has the potential to significantly improve cardiovascular function and patient outcomes. This mechanism of action is unique to Barostim Therapy when compared to other neuromodulation-based therapies,” Dr. William Abraham, director of the division of cardiovascular medicine at The Ohio State University Wexner Medical Center, said in a statement when the device gained acceptance into the accelerated pathway.
New Enterprise Associates and Johnson & Johnson Development Corporation, co-led CVRx’s $42 million Series F round in 2013.
The device’s 310-patient pivotal trial is slated to conclude in September 2017, according to ClinicalTrials.Gov. The primary efficacy endpoint is a reduction in blood pressure six months after activation of the device compared to the medical management arm.
In addition, another trial to test the device on heart failure patients is recruiting subjects. Its primary endpoint of (the rate of cardiovascular and heart failure morbi
Cardiac Contractility Modulation (CCM) is a unique and innovative method for treating moderate to severe heart failure, by delivering non-excitatory electrical pulses to the heart.
Clinical trials have shown that CCM treatment significantly improves exercise tolerance and quality of life in a subset of symptomatic heart failure patients.
Impulse Dynamics N.V. is focused on the development of electrical therapies for the treatment of chronic heart failure. As a global leader in cardiac medical innovation, Impulse Dynamics has operations in the US, Europe, Asia and Australia.
Mt. Laurel, New Jersey, May 13 2016 – Impulse Dynamics, developer of the Optimizer™ IVs implantable device for treatment of chronic heart failure (CHF), announced today that the company has closed a $30 million financing round.
Adhesion & Dense Adhesion Between Aorta & C-Pulse Cuff as claimed by EU MDs is a non-starter IMO.
No announcements with time-passing is very bad. Time is the enemy under that scenario.
Big rally coming as I predicted. Will sell my auto stocks the fools sold to me yesterday either today or Wednesday.
It's now time to by GM & F. The dividend at GM $27.40 is huge. About 5.50% at that price. If a compromise is reached between EU and Britain, which I think they will, the immigrant hordes will be ejected. Trump has woken the world.
Same as what they did for Greece and then compromised. Britain is much more important.
Halt those morderers from entering. They don't assimilate with everyone else. Who needs them?
And that comes after STJ bought THOR.
What a miserable J@ckA-s EX1414 is. LOL!!!
1- I Thought CPXX would reach triple-digits as my following post suggests & will join a class-action if one materializes due to the low buyout price.
2- slowdownandthink • May 19, 2016 9:25 AM Remove
Prediction: VYXEOS FLT3--Mutation Therapy Will Eventually Move VYXEOS Into ..
other Leukemia indications. This is just the beginning!!
1- Reading comprehension counts. Here is what you posted just days before the buyout. LOL!!!
2- "'Slowdownandthink' is bozo stupid bigsmartass who has no money..,,
And no brains...,,do not listen to him.....you've been warned."
And yes there were others that also threw insults at those who posted counter arguments. Those arguments could have resulted in much lower losses.
gerbduge • May 24, 2016 7:44 PM
'Slowdownandthink' is bozo stupid bigsmartass who has no money..,,
And no brains...,,do not listen to him.....you've been warned.
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nowak_d • May 25, 2016 6:28 AM Flag
You need a little anger management.....................................
Sentiment: Strong Buy