Medical Device Daily Contributing Writers
The news that President Barack Obama is lifting the ban on federal funding for stem-cell research was a boost for stem cell companies in the UK, with ReNeuron Group (Guildford, UK) seeing its shares rise by 18% following the announcement.
The company's lead product, ReN001, which is based on fetal neural stem cells, was put on hold by the FDA in January 2007. However, UK regulators gave permission for a clinical trial in treating stroke, late in 2008.
The hope is that the new funding coming into stem cell research in the U.S. will put the FDA under increasing pressure to approve trials of stem cell products, and ReNeuron will be able to go back to the FDA armed with safety data from the UK trial.
The end of the eight-year funding embargo also was good news for shareholders in Stem Cell Sciences (Cambridge, UK), who saw the value of the proposed takeover of the company boosted by a 43% increase in its share price, to close at $1.96 on Monday. Last week, when StemCells Inc. agreed to acquire the company in return for waiving a $715,000 loan and issuing 2.6 million shares, the price was $1.56 per share.
The UK has the most liberal regime in the world for embryonic stem cell research. Now the concern is that after attracting leading U.S. stem cell scientists to work there, the UK will be subject to a reverse brain drain, as American nationals and others, are attracted back to the U.S.
A leading British scientist, Paul Nurse, president of Rockefeller University (New York), said it is "good news" that there will be federal support for research into more human embryonic stem cell lines. He noted that there is significant support for stem cell research in the UK, adding, "I would not expect there to be a significant brain drain from the UK with the lifting of these restrictions."
One U.S. scientist who came to the UK because of the federal funding ban, Roger Pedersen, director of the Medical Research Council's Centre for Stem Cell Biology and
Regenerative Medicine at Cambridge University, said Obama's announcement was good news that will put U.S. researchers on an equal footing with stem cell scientists elsewhere to study the entire range of stem cells with potential therapeutic benefit.
VBLOC Therapy is CE-marked
EnteroMedics (St. Paul, Minnesota), a developer of medical devices using neuroblocking technology to treat obesity, its associated co-morbidities, and other gastrointestinal disorders, said it has received CE-mark approval of VBLOC Therapy delivered via the Maestro System for the treatment of obesity.
The company said the Maestro System is the first to treat obesity using neuroblocking technology and represents a less-invasive alternative to existing surgical weight loss procedures, "which alter digestive system anatomy, lifestyle and food choices and may present significant risks."
VBLOC Therapy is delivered via the Maestro System through laparoscopically implanted leads to intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. The therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.
President/CEO Mark Knudson, PhD, said, "Obesity is a growing epidemic worldwide [and] VBLOC Therapy is a treatment innovation that offers individuals the promise of significant weight loss without having to accept nutritional, lifestyle and safety compromises."
He said, "CE-mark approval represents a major milestone for EnteroMedics and is the first step in our global commercialization strategy."
The approval gives EnteroMedics the ability to market the Maestro System to countries of the European Economic Area.
VBLOC Therapy is undergoing clinical testing in the U.S. and Australia in a pivotal trial known as the EMPOWER study. EnteroMedics plans to use data from the EMPOWER trial to support a premarket approval application for the Maestro System, which it expects to submit to the FDA late this year.
1st MitraClip procedures done in Switzerland
Evalve (Menlo Park, California), a developer of devices for the percutaneous repair of cardiac valves, reported that the first series of patients have been successfully treated with the company's MitraClip system at the Cardiocentro Ticino (Lugano, Switzerland).
The MitraClip system is the only medical device commercially available in the European Union that provides a non-surgical mitral valve repair option for patients suffering from the effects of functional and degenerative mitral regurgitation (MR).
Evalve said mitral regurgitation is the most common type of heart valve insufficiency in Europe and the U.S., affecting millions of people worldwide. In most patients, the MR is untreated, requiring the heart to work harder and ultimately leading to heart failure.
The first patients in Switzerland were treated by a team led by T. Moccetti, MD, who said, "Until now, many heart failure patients with associated functional MR had no therapeutic options except medical management when surgery was not possible either because they have already had heart surgery, or presented with important renal insufficiency or lung disease, all of which significantly increase the risk of a second or a third operation."
Evalve initiated commercial sales of the MitraClip system in Europe under the CE mark last September. The company said it is employing a direct sales strategy and is taking a "disciplined and measured approach to the initial commercial roll-out."
The MitraClip device is being implanted in Germany, Italy, the UK, the Netherlands and now Switzerland.