A Medical Device Daily
GI Dynamics (Lexington, Massachusetts), a company developing new approaches to treat obesity and metabolic disorders, said it has received ISO 13485:2003 certification for its Lexington facility, along with CE-mark approval for the EndoBarrier, its noninvasive device currently in clinical trials to treat obesity and Type 2 diabetes.
ISO 13485: 2003 is an international standard that specifies a quality management system for medical devices and related services.
"We are very pleased to ... have received both the ISO certification and the CE mark approval, which are important milestones as we continue to develop the EndoBarrier and lay the groundwork for future commercialization of the product," said CEO Stuart Randle. "Promising data continue to emerge from our clinical development programs in both obesity and Type 2 diabetes, and we look forward to conducting larger, longer-term trials with the EndoBarrier in the year ahead."
To date, more than 100 patients have received the EndoBarrier in clinical trials. In September, GI Dynamics reported data from a multi-center, randomized clinical trial of 37 patients suggesting that the EndoBarrier is well-tolerated, with promising short-term weight loss results in morbidly obese patients.
These data showed that 26 patients treated with the EndoBarrier lost on average, triple the weight of their diet control group (11 patients). Specifically, at just 12 weeks, the device group lost 13.7 kg (30.2 lbs) vs. 4.4kg (9.7 lbs) for the control group.
Also notable was evidence that a beneficial effect on Type 2 diabetes was observed through lower blood glucose levels and/or a reduction in diabetic medication.
Obesity affects an estimated 400 million people today and an estimated 700 million by 2015, according to the World Health Organization (Geneva, Switzerland).
U. of Zurich, Medrad in research accord
Medrad (Warrendale, Pennsylvania) said it has signed a research agreement with the University of Zurich in Switzerland to study dynamic PET imaging with the Medrad Intego PET Infusion System.
The researchers will utilize the Medrad technology to more precisely control the radioactive dose delivered during PET imaging procedures.
The study will examine patients with tumors in the chest or abdomen and compare standard quantitative techniques, such as standard uptake value (SUV), with more advanced kinetic and compartmental models.
Medrad said one of the primary goals of the research is to explore how controlled delivery technology can enable dynamic imaging by providing additional clinical utility and making these advanced techniques more practical.
"By enabling the benefit of repeatable infusion of the prescribed FDG dose to all subjects in the study, the Intego System is a key element in the research," the company said.
"The research will explore the clinical viability of dynamic imaging with PET," said Dr. Alfred Buck of the University of Zurich, which is a leading institution in dynamic PET research, and has licensed its proprietary FDG delivery technology to Medrad for use in the Intego PET Infusion System.
The company said the Intego system "automatically extracts a patient dose from a multi-dose vial and delivers it directly to the patient, virtually eliminating manual dose preparation and handling, and the corresponding radiation exposure to the technologist inherent in manual preparation."
It said that with the Intego System's dose-on-demand capability, the prescribed dose can be delivered when the patient and clinician are ready. "This enables the clinician to easily and efficiently respond to schedule changes, patient delays, and add-on patients".
Medrad said such features as real-time dose availability information, an integrated ionization chamber, and an optional weight-based dose calculation allow healthcare providers to more precisely customize each patient's dose.
1st RapidArc treatment in Italy
A pancreatic cancer patient has become the first person in Italy to be treated using a new, faster form of radiotherapy that potentially enables doctors to improve outcomes while extending more advanced care to more patients.
The Humanitas Clinic (Milan) delivered the faster treatment using RapidArc radiotherapy technology from Varian Medical (Palo Alto, California). With RapidArc, Varian's Clinac medical linear accelerator can target radiation beams at a tumor while rotating continuously around the patient.
RapidArc delivers a volumetric intensity-modulated radiation therapy treatment in a single arc or multiple arcs of the treatment machine around the patient. Radiotherapy studies correlate the ability to spare more healthy tissue with reduced complications and better outcomes.
"We see three major benefits with RapidArc," said Dr. Marta Scorsetti, lead clinician at Humanitas. "The short treatment time - under two minutes in this case - decreases the chances of the patient moving during treatment, which helps to improve precision. RapidArc enables us to spare more healthy tissue from receiving unnecessary dose and we believe this additional precision will enable us to increase the dose, which should contribute to a higher cure rate."
$19 million raised by Karolinska Development
Karolinska Development (Stockholm, Sweden), an investment company with a large portfolio of life sciences companies, reported closing on a fully subscribed new share issue, raising SEK 147 million ($19 million).
Its major shareholders – Karolinska Institutet Holding AB, Tredje AP-fonden; Ostersjostiftelsen; Nasudden; Foundation Asset Management; and Praktikerinvest – took their share of the new issue, while new investors participated with SEK 50 million.
Karolinska said the new issue, combined with current liquidity, secures its investment program for another two years.
"As a life science investment company with a focus on developing pharmaceutical and medical technology products, we have a compelling spread of investments in this area," said CEO Conny Bogentoft. "We currently have nine companies with projects in the clinical phase, facilitating as many exits if results from ongoing studies are positive."