MEDICAL DEVICE INNOVATION - Medical Device Daily

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150 Vital Therapies pushes ELAD past funding roadblocks By OMAR FORD Medical Device Daily Staff Writer Vital Therapies (San Diego) might be closer to bringing the Extracorporeal Liver Assist Device (ELAD) to market with its recent report of starting a third clinical phase trial for the device in September, but funding is still a concern for the small med-tech company, which has run out of cash twice in the past. “Is funding an issue, it’s always an issue with any small med-tech company,” Terry Winters Vital Therapies CEO told Medical Device Daily. “We’re not a Medtronic or a Pfizer. But I think we’ll overcome any funding issues because we’ve got some of the best investors in the medical device industry.” Since Winters joined the company back in 2003, nearly $40 million of funding has been raised. The latest round of funding occurred in 2007, when the company raised $28 million. ELAD, which has garnered the support of investors such as Versant Ventures (Menlo Park, California), is more of a biological machine than a device, according to Winters. It peforms the liver’s functions outside of the body, creating essential proteins and cleaning toxins from the body – a key difference from other devices in the past. “In no sense of the word is this a filtration device,” he told MDD. The device is about the size of a refrigerator, but there are plans in the future to scale the machine down and get something more convenient for the clinical setting. If ELAD gains FDA clearance, then it could provide an alternative to liver transplants. It could also buy patients time until a donated organ could become available. Previous trials of the company have seen more than 120 patients treated in the U.S., UK, China and Singapore. The company said that the study in China has shown improvement in survival without transplant in some patients. The company applied for marketing approval in China in 2007. Winters said if everything goes according to plan then the device could be on the market in the U.S. by the end of 2011. “The best we could do to get this to market in the U.S. is in two years, and that’s if nothing goes wrong,” Winters said. But there have been difficulties in the past. The company is on its third iteration and previous iterations of the company have gone bankrupt twice. The first bankruptcy came during the first ELAD clinical trial and then the second came during the second phase of clinical trials. Vital Therapies isn’t the only company that has had difficulty in trying to bring a liver assisted device to market. In August of last year Arbios Systems (Waltham, Massachusetts) suspended its operations in a move that it MEDICAL DEVICE INNOVATION 2010 said was a way to conserve cash while seeking financing to fund clinical trials for its Sepet Liver assist device. The device was intended as a bridge-to-transplant for patients waiting for a new liver – a list that is more than 17,000 names long. Sepet is a sterile, disposable cartridge containing microporous hollow fibers with permeability characteristics. When a patient’s blood is passed through these fibers, blood plasma components of specific molecular weights are expressed through the micropores, thereby cleansing the blood of harmful impurities (hepatic failure toxins as well as various mediators of inflammation and inhibitors of liver regeneration). Sepet was designed for use with standard blood dialysis systems available in hospital intensive-care units. There are still some med-tech companies who haven’t quite run into the funding roadblocks that Vital Therapies and Arbios have. Both Hepalife (Boston) and HepaHope (Irvine, California) are also developing devices to assist in the liver’s functions. But despite problems and competition, Winters is still hopeful for the device which had its beginnings at Baylor College of Medicine in Houston back in 1991. Winters said it was a difficult plight that small med-tech companies found themselves in, when it came down to funding. “I don’t think any small company should be afraid to say that (funding is an issue),” he said. “But we’ve got the clinical data and results to back up [ELAD’s] effectiveness.” (This story originally appeared in the Aug. 17, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 VisEn technology enables ‘key’ scientific discovery By AMANDA PEDERSEN Medical Device Daily Staff Writer VisEn Medical (Bedford, Massachusetts) is not surprised that its imaging technology has been used to generate “very useful data” enabling scientists to discover a new biologic pathway, according to Jeffrey Peterson, PhD, VP of Applied Biology at VisEn. But what Peterson is really pleased about is the fact that the research, published in the July 31 issue of Science, proves the imaging technology produces “more than just a pretty picture.” VisEn said researchers at the Massachusetts General Hospital’s (Boston) Center for Systems Biology have discovered a key disease-related biologic pathway using an integrated and “innovative” array of in vitro readouts and advanced in vivo imaging technologies. According to the company, the newly reported biologic pathway relates to monocyte deployment from the spleen to inflammatory sites, including myocardial infarction. The findings are expected to open up new areas of research and potentially advance therapeutic approaches to key disease areas including inflammation and myocardial injury, VisEn said. Peterson told Medical Device Daily that the paper validates the company’s technology. “What this paper says is ‘we’re not at the level of imaging anymore where we’re just satisfied with making pretty pictures’ and really that’s where imaging started . . . we’re moving well beyond that and have been moving well beyond that for a number of years,” Peterson said. In the Science report, titled “Identification of Splenic Reservoir Monocytes and Their Deployment to Inflammatory Sites,” the researchers found that monocytes were held in concentration in the spleen and released to injured tissue sites in the body to participate in wound healing. As presented in the findings, the reporting scientists discovered and detailed the biologic pathway through the use of a series of advanced and integrated in vitro assays, microscopic readouts, and in vivo imaging methodologies, including magnetic resonance (MR) imaging combined with quantitative fluorescence molecular tomographic (FMT) imaging. Used together in a series of “novel” scientific models, the researchers developed correlated data sets to both identify this previously unidentified splenic reservoir of monocytes, and demonstrate the monocyte deployment to inflammatory sites in vivo. In the in vivo data analysis, non-invasive, quantitative FMT imaging using novel fluorescent molecular imaging agents, combined with MR imaging, clearly demonstrated not only the location, but also the biological activity of the recruited splenic monocytes at the disease site, thus helping to confirm “unambiguously the fate of monocytes from the 151 spleen to the heart,” according to the paper. “FMT technology is quantifiable, [it’s] not just about making a pretty picture. You can answer important questions about important disease biology,” Peterson said. According to VisEn, its in vivo fluorescence imaging technologies, including its Fluorescence Agent Portfolio and its FMT imaging systems, provide robust fluorescence molecular imaging performance in identifying, characterizing and quantifying ranges of disease biomarkers and therapeutic efficacy in vivo. VisEn’s FMT systems and agents are used by research institutions and pharmaceutical companies worldwide in applications including cancer research, inflammation, cardiovascular, skeletal and pulmonary disease, the company said. VisEn said it also works with large pharmaceutical and clinical partners to design ranges of tailored molecular imaging agents and applications designed for their specific pre-clinical and clinical research areas. “We see the integration of in vitro and in vivo readouts becoming increasingly important in research today, and we are extremely pleased that our FMT quantitative in vivo imaging technology and activatable in vivo imaging agents were able to help the research team answer some of the key questions about this important biologic pathway in vivo,” Peterson said. “When cardiac molecular imaging data from the FMT was combined with MRI imaging, the researchers were able to create a fused molecular and anatomical imaging map of the heart to identify and quantify biomarkers of monocyte activity in vivo. These results enabled an important data correlation that further enhanced the integrated array of in vitro assays and microscopy-based readouts of this important pathway.” Peterson noted the importance of being able to simultaneously image multiple different types of biology by using the right types of imaging agents and said that is a big part of what VisEn does. “We are generating and developing new research tools . . . this particular paper highlights looking at two different types of biologies . . . you can even go more diverse than that,” he said. “We have four lasers now being put on our imaging system, so you can look at three or four different biologies at the same time which gives you a much more clear, albeit complex, picture of disease biology,” Peterson said. (This story originally appeared in the Aug. 3, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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