A Medical Device Daily
EndoGastric Solutions (EGS; Redmond, Washington), which is focused on reconstructive intragastric surgery, said its EsophyX device is now approved for commercialization in the European Union and is ready for limited commercial release to 40 leading European centers during 2006.
The technology created by EGS enables gastroenterologists and surgeons for the first time to perform true endoluminal fundoplication procedures for the treatment of gastroesophageal reflux disease (GERD), completely thro-ugh a trans-oral approach, without any incisions. What makes this procedure unique is that it is based on the proven surgical principles of anti-reflux surgery such as the Nissen fundoplication, enabling complete reconstruction of the natural anti-reflux barrier.
Dr. Guy-Bernard Cadiere, professor and chief of surgery at Centre Hospitalier Universitaire St-Pierre, the first surgeon to evaluate this new technology as part of EGS's clinical studies initially conducted at Hospital St. Pierre and Clinique du Parc Leopold – CHIREC in Belgium, said, “The limited commercial release of the EsophyX product represents a milestone for trans-oral incisionless surgical repair of the anti-reflux barrier and provides the first promising alternative to traditional laparoscopic fundoplication for the definitive treatment of GERD.”
EGS has been testing the EsophyX device and improving the Endoluminal Fundoplication (ELF) procedure since June 2005. Six-month follow-up results using the first-generation EsophyX device in a Phase I study have approached those obtained with more traditional laparoscopic Nissen fundoplications in terms of success at eliminating Proton Pump Inhibitor (PPI) drug dependence and protecting the esophagus from acid exposure (pH results).
Cadiere, the lead investigator, said, “The preliminary results to date for EsophyX are very encouraging. Over 80% of patients have normal or near-normal pH at six months post-ELF procedure despite discontinuing their GERD medications. Over 90% of patients show an improvement in quality of life and a reduction in GERD symptoms . . . and over 80% of patients remain off of PPI drugs at an average follow-up period of 10 months post-procedure.”
“If these results continue to hold up,” he said, “we could easily imagine that up to 20% of all GERD patients worldwide could benefit from natural orifice surgery such as the EsophyX procedure.”
Thierry Thaure, president and CEO of EndoGastric Solutions, said, “We believe that we are well on our way to being able to prove that it is not only possible but also easier to complete an endoluminal fundoplication procedure from inside the stomach.”
Allergan consolidates operations in UK
Allergan (Marlow, UK) has relocated its UK-based operations to a new site, Marlow International, as part of the consolidation of its European research and development and select commercial support operations to the UK to enhance global product development.
The company said its decision to consolidate these operations is in keeping with its long-term strategic plan to focus its resources on developing new products with high market potential, and to continue its growth and increase its competitiveness as a global specialty pharmaceutical and medical device company.
“The relocation of Allergan Ltd. UK operations to Marlow is part of the evolution of Allergan's business model. This is driven by the discovery, development and approval of innovative new medicines, devices and procedures as well as a deep focus on the needs of specialty physicians and their patients,” said David Endicott, Allergan corporate vice president and president of the company's Europe, Africa and Middle East region.
“Allergan is constantly searching for ways to increase operational efficiencies and synergies to accelerate product development and commercialization,” he said. Noting that there has been a recent trend in the internationalization and outsourcing of research and development, he said, “Allergan is committed to solidifying these activities in the United Kingdom.”
Allergan commercializes products in ophthalmology, neurosciences, medical dermatology, medical aesthetics and other specialty markets.
PuriCore raises £30 million in IPO
PuriCore (Malvern, Pennsylvania), a developer of pathogen-killing technology that mimics the human body's natural anti-microbial, hypochlorous acid, reported the initial public offering of its parent holding company, PuriCore plc (Stafford, UK), on the London Stock Exchange.
In the offering, PuriCore plc sold 45.5 million new shares at an initial offering price of 66 pence per share, for an aggregate of £30 million.
The company's shares are expected to begin trading on the London Stock Exchange's main market on June 30 under the ticker symbol PURI.
Nomura Code Securities served as sponsor, financial adviser, joint bookrunner and joint lead manager for the offering. Nomura International was joint bookrunner and joint lead manager.
PuriCore is focused on the development and commercialization of its proprietary technology that mimics the production by the human immune system of its natural anti-microbial, hypochlorous acid, which protects the body from infection. Hypochlorous acid is effective at killing pathogens such as bacteria, viruses and fungal spores.
The company markets a portfolio of systems that produce hypochlorous acid solutions on-site at a customer's location from water, electricity and common salt.
PuriCore's solutions have applications in a wide range of markets where it is important to control microbial contamination, including medical device disinfection, food safety, dental equipment, hospitality, water safety, wound management and other applications intended to limit the spread of infectious disease, including such global disease threats such as influenza, tuberculosis, MRSA, norovirus, hepatitis A, legionnella and E. coli.