Etfs Stim Discussion Threads

[bamboo2] 05/4/2015 10:25

EndoStim LES Stimulation therapy demonstrates long term safety and efficacy results in treating reflux patients
By PR Newswire, March 25, 2015, 09:34:00 AM EDT


ST LOUIS and the HAGUE, Netherlands, March 25, 2015 /PRNewswire/ -- EndoStim announced publication of two-year results of LES Stimulation therapy for chronic gastro-esophageal reflux disease (GERD) in the March issue of the journal Surgery [Surgery. 2015; 157(3):556-567], establishing the long term safety and efficacy of its minimally-invasive therapy.

The study included 25 patients with severe GERD with an average duration of 11 years and taking prescribed daily proton pump inhibitor (PPI) medication for an average duration of 5.6 years prior to the study. The study highlights significant improvements in patients' quality of life, GERD symptoms including heartburn and regurgitation, and objectively measured esophageal acid exposure; results were consistent with previously reported outcomes in the same cohort of patients after one year of therapy [Endoscopy. 2013; 45:595-604].

Patients' median esophageal pH decreased from 10% at baseline to 4% after two years of continuous stimulation therapy. Quality of life measured by the validated GERD-Health Related Quality of Life questionnaire also significantly improved from a median score at baseline of 23.5 without PPI and 9 with PPI to 0 at two-year follow-up (score 0 = no disruption of quality of life disruption due to GERD symptoms, 45 = maximum disruption of quality of life due to GERD symptoms).

After two years of EndoStim therapy, 90% of patients were able to eliminate their dependence on PPI medications1 (76% of patients were completely free of PPI use, and 14% reduced PPI use to <50% of days).

"Esophageal acid exposure, an objective and robust measure of GERD, improved significantly from baseline to two years, demonstrating a sustained long-term effectiveness of LES stimulation therapy and confirming that LES stimulation can be recommended for management of GERD in patients looking for an alternative to traditional antireflux surgery," explained Dr. Edy Soffer, Professor of Clinical Medicine in the Gastroenterology Division at the University of Southern California'sKeck School of Medicine.

In an accompanying editorial, Professor Stephen Attwood, Surgeon at North Tyneside General Hospital and Honorary Professor at Durham University, comments that "the improvements are profound," and are "backed by objective testing with pH monitoring." He further remarks that "There is no other therapy for GERD with this magnitude of effect or lack of side-effects." [Surgery. 2015; 157(3):568-569]

In the study, no serious adverse events related to the procedure, device, or therapy were reported. Additionally, no patients reported gastrointestinal side effects, such as new-onset dysphagia (difficulty swallowing), bloating, inability to belch, or diarrhea, which are often reported with traditional anti-reflux procedures, further supporting the excellent safety profile of LES stimulation that was already reported at one year.

Preliminary results of an ongoing international multicenter trial in 10 sites worldwide have confirmed the positive outcomes of this trial.

About EndoStim

EndoStim is a venture-backed medical device company based in St. Louis, Missouri, and the Hague, the Netherlands.

EndoStim's neurostimulation therapy is a minimally-invasive, long-term treatment for severe reflux patients that directly targets the patient's weak or dysfunctional lower esophageal sphincter (LES) muscle between the stomach and the esophagus - often the underlying cause of reflux.

The EndoStim system is CE Marked for patients with gastro-esophageal reflux disease with symptom duration of 6 months or longer. EndoStim is available in a number of countries throughout Europe, Latin America, and Asia Pacific. The EndoStim system is not approved for sale in the US and is limited by US federal law to investigational use only.

About Reflux Disease

Gastroesophageal reflux disease is a chronic disease that affects hundreds of millions of patients worldwide, and often requires lifelong treatment with acid blocker medications. Symptoms generally occur when weakness or dysfunction in the lower esophageal sphincter muscle allows stomach contents to flow backward into the esophagus causing esophageal inflammation and damage. Acid reflux causes heartburn, regurgitation and can lead to Barrett's esophagus and esophageal cancer. Millions of patients continue to suffer from bothersome GERD symptoms despite maximal medical therapy.

For more information and news about EndoStim, please visit www.endostim.com.

================================================================

NIJMEGEN, Netherlands and ST. LOUIS, May 18, 2015 /PRNewswire/ -- EndoStim announces CE Mark approval and the European launch of the EndoStim II, its second generation LES Stimulation System to treat gastroesophageal reflux disease (GERD).

Photo - hxxp://photos.prnewswire.com/prnh/20150518/216616

The EndoStim II device is 25% thinner and 40% less volume compared to EndoStim's first generation device, designed to achieve best patient comfort, acceptance and aesthetics. The EndoStim II device also has improved MRI conditional compatibility for head and extremity imaging procedures, adding support for 3T MRI machines in addition to the 1.5T MRI machines.

EndoStim's minimally-invasive therapy for severe reflux is indicated for patients with chronic GERD with symptom duration of 6 months or longer. Published results through three years of treatment have continually demonstrated an excellent safety profile and ability to control reflux. Additionally, therapy can be wirelessly customized and optimized to fit individual patients as needed.

"It is our goal to continue innovation on the device as well as the therapy to fulfill the needs of patients searching for more optimal long-term solutions for their reflux," comments Paul Goode, Ph.D., Chief Technology Officer at EndoStim. "We thank our surgeons for their important role in the design of our technology."

"The new generation EndoStim device will allow even more patients to benefit from the therapy," explains Dr. Henning G. Schulz, Chief of Surgery at Evangelisches Krankenhaus in Castrop-Rauxel, Germany. "The form of the device – with one rounded edge – allows easy placement and will lead to better aesthetics for the patient."

EndoStim's second generation device is now available in select European markets.

[bamboo2] 02/11/2014 17:41

I'm not sure where this leaves the planned clinical study.

===============================================
23 Oct 2014

EndoStim, a St. Louis-based medical device maker, postponed its $35 million initial public offering on Thursday due to "poor market conditions," research firm Renaissance Capital reports.

It's now unclear when the initial public offering will occur. Company officials could not be reached for comment.

The company, led by CEO Bevil Hogg, makes an implantable device used to treat severe acid reflux by electrically stimulating an abdominal muscle.

The company had planned to sell about 3.2 million of its common stock for between $10 and $12 per share as part of its IPO, announced earlier this month.

[bamboo2] 06/10/2014 22:44

Endostim gets its device manufactured by CCC. CCC have recently been aquired by Greatbatch.

Greatbatch Acquires CCC Medical Devices; Advances Medical Device Strategy

FRISCO, Texas, Aug. 12, 2014 (GLOBE NEWSWIRE) -- Greatbatch, Inc. (NYSE:GB) today announced that it has acquired CCC Medical Devices (CCC), the globally-respected active implantable medical device (AIMD) systems developer and manufacturer, effective immediately.

Based in Montevideo, Uruguay, CCC designs and produces a range of devices for some of the world's top medical device companies, including implantable pulse generators, programmer systems, battery chargers, patient wands and leads.

"Our acquisition of CCC is ideal by all accounts. It allows Greatbatch to more broadly partner with medical device companies, complements our core discrete technology offerings and enhances our medical device innovation efforts," said Thomas J. Hook, president and chief executive officer, Greatbatch. "Combining the knowledge, talent and customer base of both companies will produce better products for the medical community and better lives for people worldwide."

Financial terms of the transaction were not disclosed.

About Greatbatch, Inc.

Greatbatch, Inc. (NYSE:GB) provides top-quality technologies to industries that depend on reliable, long-lasting performance. The company develops and manufactures critical medical device technologies for the cardiac, neuromodulation, vascular and orthopaedic markets; and batteries for high-end niche applications in the portable medical, energy, military, and environmental markets. Additional information is available at www.greatbatch.com.

Centro de Construcción de Cardioestimuladores del Uruguay (CCC) is dedicated to the development and manufacturing of complete real-time medical systems, including active implantable medical devices such as neuro & cardiac stimulators, programmer systems, battery chargers, patient wands and leads. CCC has over 35 years of experience in the medical devices field and are expanding activities to other safety-critical systems.

[bamboo2] 06/10/2014 21:56

Get rid of reflux: EndoStim sets terms for $35 million IPO



9/30/14

EndoStim, which is developing a neurostimulator that treats gastroesophageal reflux disease (GERD), announced terms for its IPO on Tuesday. The St. Louis, MO-based company plans to raise $35 million by offering 3.2 million shares at a price range of $10 to $12. At the midpoint of the proposed range, EndoStim would command a fully diluted market value of $99 million.

EndoStim has entered pivotal-stage trials in the US for its device, which stimulates a patient's dysfunctional lower esophageal sphincter to reduce GERD, which causes stomach contents to enter the esophagus. It received the CE Mark in 2012 and the next year began commercializing its devices in Europe. EndoStim will initially target a subset of GERD patients who experience symptoms while on medication, which the company claims represents 5% of all GERD patients, or 21 million people worldwide.

Primary shareholders include Chairman Douglas French, Director Jeffrey McDonnell and Prolog Capital.

Another neurostimulator company, NeuroSigma (NSIG), recently launched a $50 million IPO expected to price during the week of October 6, 2014.

EndoStim, which was founded in 2009 and booked $520,000 in sales for the 12 months ended June 30, 2014, plans to list on the NASDAQ under the symbol STIM. Wedbush PacGrow is the sole bookrunner on the deal.
Keywords / Tickers: STIM, GERD

[bamboo2] 06/10/2014 17:50

Endostim is already generating income from international sales which will go some way to capping the rate of cash burn during the US medical trial.

A clinical trial has been mooted in the UK, but this seems to have gone by the wayside for the moment, possibly because the team behind the trial wanted to include those with Barretts.

I am following the progress of patients who are early adopters of this technology, to see if their experience is as good as those on the first trial in Chile.

Endostim has a great oppertunity to both help refux patients, and make a very successful business.

[bamboo2] 06/10/2014 12:07

We are a medical device company focused on the development and commercialization
of a novel neurostimulation system for the treatment of severe gastroesophageal
reflux disease, or GERD. Severe GERD is a debilitating condition that
significantly disrupts patients’ quality of life, work productivity and sleep.

Based on several international third party studies, we believe the impact of
severe GERD on quality of life can be worse than that of chronic back pain or
urinary incontinence, two other chronic conditions that are successfully treated
with neurostimulation. Moreover, the impact of severe GERD on work productivity
has been shown to be significantly greater than that attributable to back pain.
Our innovative approach targets the main cause of GERD — a dysfunctional lower
esophageal sphincter, or LES, a muscle at the junction of the esophagus and
stomach. The EndoStim neurostimulation system, which has a form and function
similar to a pacemaker, delivers low energy electrical stimulation to the LES.
In our clinical trials to date, this stimulation has been shown to improve the
tone and function of the LES, thereby significantly reducing the pathological
reflux symptoms of GERD. Our laparoscopically implantable neurostimulation
system is minimally-invasive, reversible and preserves the anatomy of the
esophagus and stomach.

GERD Therapy Gap

In patients with GERD, a dysfunctional LES allows gastric contents, including
stomach acid and bile, to pass inappropriately from the stomach into the
esophagus. As a result, patients often suffer from heartburn, regurgitation,
chest pain, and difficulty swallowing, among other symptoms, which can severely
impact their quality of life. In more serious cases, GERD can result in a
precancerous condition called “Barrett’;s esophagus” that can lead to esophageal
cancer. Patients who suffer from daily GERD symptoms experience a sevenfold
increase in the risk of esophageal cancer, for which the World Health
Organization reported 456,000 new cases worldwide in 2012.

Today, GERD is most often treated with chronic medication, specifically proton
pump inhibitors, or PPIs, such as Nexium and Prilosec, which suppress the
production of acid in the stomach. However, PPIs do not address the main cause
of GERD, a dysfunctional LES. Therefore, PPIs do not prevent the regurgitation
of stomach contents into the esophagus. As a result, 38% of patients taking PPIs
to treat GERD reported continuing symptoms that were not resolved by their
medication, according to a 2010 study of over 1,000 patients by the American
Gastroenterological Association. We expect to initially target a subset of these
patients who experience severe symptoms while on medication, and whose GERD can
be confirmed by an esophageal acid test. We estimate this subset to comprise
approximately 4.6% of all GERD patients, or about 21 million patients worldwide.

The traditional alternative for patients with continuing symptoms on PPIs has
been fundoplication, a surgical procedure where the top of the stomach is
wrapped and secured around the lower esophagus to augment the LES in order to
create a mechanical barrier to reflux. This is a highly invasive procedure which
permanently changes the anatomy, can result in a number of side effects and is
difficult to correct or reverse. As a result of these concerns, fewer than 1%
of patients who are unsatisfied with PPIs are treated with fundoplication.

Several competing therapies have been developed and evaluated in clinical trials
in attempts to address this therapy gap. These include the LINX Reflux
Management System (Torax Medical), EsophyX (EndoGastric Solutions) and Stretta
(Mederi Therapeutics). Each of these therapies employs a different treatment
modality: mechanical constriction (LINX), transoral partial fundoplication
(EsophyX) or thermal remodeling of the anatomy (Stretta), with the ultimate
objective of preventing the migration of stomach contents into the esophagus.
Most therapies have shown a lower efficacy in suppressing esophageal acid than
is achieved using our neurostimulation device, or have led to unwanted side
effects such as difficulty swallowing (LINX). We believe that our therapy offers
superior clinical efficacy in controlling esophageal acid and also offers a
better safety and side effect profile by preserving normal anatomy and swallow
function.

[bamboo2] 06/10/2014 12:06

Another NASDAQ healthcare IPO.



This company has been restricted to private investors until now.

I have been aware of Endostim for some years, following their succesful trials based in South America.

After the CE mark was granted this paved the way for trials closer to home in Europe [Holland, Germany etc], and further afield in New Zealand and India. These are ongoing, long term clinical trials.

Endostim is now available privately in most countries outside USA and Canada.

Some of the cash raised will be used to fund trials in USA, with a view to obtaining permission from the FDA to sell the device into the American marketplace.