The Georgia Tech Research Institute (GTRI), the applied research arm of the Georgia Institute of Technology (Atlanta), is betting on Ireland as its gateway to the European market as it sets up its first applied research facility outside the U.S. later this year in the city of Athlone. Over the next five years, the Irish operation plans to build up a portfolio of research programs and collaborations with industry, which will include the medical device sector, predicted as valued in excess of $24 million. At full operation, the facility is expected to employ 50 researchers.

David Parekh, deputy director of GTRI, chief architect of the Ireland initiative over the past two years, told Biomedical Business & Technology that the country – with a population of about 4 million – has made significant investments in its universities and economy in recent years. That investment and openness to business innovation has enticed all types of companies to put new operations there, with the major names including Medtronic (Minneapolis), Boston Scientific (Natick, Massachusetts) and Johnson & Johnson (New Brunswick, New Jersey). Elan Pharmaceutical and Ericsson are both headquartered in Athlone.

GTRI is already partnered with some of these companies, hoping to extend these relationships into Ireland. The focus will be on biotechnology/biopharma initiatives and information technology, with its biotech research emphasizing medical devices for preventive and predictive medicine and manufacturing of medical devices.

“While we can contribute to the things like surgery that may involve larger scale technology solutions, what we really want to focus on is on the front end – things that would be in the home or clinic,” Parekh told BB&T. To do this, he said GTRI will take advantage of Georgia Tech’s “engineering, sensor [expertise] and other expertise” and “work alongside companies [that] understand medical problems” to find faster ways to conduct tests. Another example Parekh cited is those technologies enabling physical therapy in the home, such as providing a video Internet “so that doctors can actually work with patients in the home.” He added that the emphasis will be on the earliest stages of the healthcare continuum. “What we’re trying to do is to provide more and more capability at the front-end to help reduce the cost of healthcare.”

GTRI also will have a focus on radiofrequency identification technology and other advanced technologies in communication, but he said this will depend in large part on “which ones make the most sense to the corporations we work with there,” Parkekh said.

Ireland has also made significant funds available for investment and applied research and development, including such initiatives as creating the Science Foundation Ireland in 2000 – similar to the National Science Foundation in the U.S. and formation of the Ireland Development Agency.

Dr. Stephen Cross, Georgia Tech vice president and GTRI director, said the Ireland initiative “directly supports Georgia Tech’s vision to define the technological university of the 21st century.”

NHS Confederation backs lean operation

A variety of measures for leaner operation by Britain’s hospitals are being supported by the NHS Confederation, a group representing more than 90% of National Health Service organizations, in the face of current and potential personnel layoffs. Gill Morgan, MD, chief executive of the NHS Confederation, said that in order to “balance the books, some hospitals “have been looking at how they can work more productively by changing the way they organize and run services.”

Among the changes he suggested include more out-of-hospital care to reduce the number of beds needed “or using new and better technologies to treat patients more effectively” to reduce staffing needs. “For patients that are treated in hospitals, reducing the amount of days that they spend on the ward is good for them because they recuperate quicker at home but also means that bed, ward and staff numbers can be reduced.”

Additionally, “Introducing digital x-ray facilities, robotic pharmacists or applying lean manufacturing techniques to pathology services all save money and provide a more efficient service to patients.” Morgan defended the NHS, suggesting that such measures, while productive, are likely to draw unfounded criticism. “The NHS is castigated for not being productive and then castigated again when it takes action to improve productivity.”

The NHS Confederation represents more than 90% of the organizations that make up the NHS. Its members include the majority of NHS acute trusts, ambulance trusts, foundation trusts, mental health trusts, primary care trusts, special health authorities and strategic health authorities in England; trusts and local health boards in Wales; and health and social service trusts and boards in Northern Ireland.

Gambro reports on FDA meeting

Senior executives at Gambro (Stockholm, Sweden) last month said they had met with FDA officials to address the agency’s concerns about the safety of the company’s Prisma System and the adequacy and effectiveness of Gambro Renal Products’ (Lakewood, Colorado) quality program addressed earlier this year in a warning letter.

Gambro Dasco (Medolla, Italy), a production unit within Gambro Renal Products, reported receiving an FDA warning letter concerning the agency’s inspection of its Medolla facility which manufactures monitors and indicating concerns about the safety of the Prisma System and the adequacy and effectiveness of Gambro Dasco’s quality systems. It said that the FDA has issued an import alert calling for the detention of Gambro’s monitor products – Prisma, Prismaflex and Phoenix – shipped into the U.S.

Gambro in its statements on the device issue emphasized paying particular attention to the “Incorrect Weight Change Detected” alarm on the system. This alarm should never be overridden without first identifying and removing the cause of the alarm.

Gambro said that in mid-March it submitted a comprehensive Corrective Action Plan (CAP) to the FDA detailing the steps it will take to resolve the agency’s issues “as quickly and thoroughly as possible.” Among these is the hiring of quality systems experts. “Our goal is to ensure that Gambro products meet the highest standards for quality, safety and effectiveness,” said S ren Mellstig, president and CEO, Gambro.

Positron positioning for Canada trials

Positron (Houston) reported that it has received approval from Health Canada to use its mPower positron emission technology (PET) scanner in oncology and cardiology clinical trials in that country. Positron said it is developing a broad range of applications and upgrades to its mPower line and “will be rapidly expanding the approved uses of its mPower product in Canada.” Positron said it is positioning itself to take advantage of the Health Canada approval by offering its mPower product to Canadian healthcare providers as a more cost-effective solution to the more traditionally expensive PET and PET/CT products now available in the marketplace.

Joe Oliverio, president of Positron, said: “We believed for a long time that the Canadian market would be ideal for widespread use of PET scanning since many studies have shown to reduce overall healthcare expenditures to the government payers while improving patient outcomes.”

Positron manufactures positron emission tomography technology under the trade name Posicam. Posicam systems incorporate patented and proprietary software and technology for the diagnosis and treatment of patients in the areas of cardiology, oncology and neurology.

Stryker adds ‘flexible’ to endoscopy offerings

The recent purchase of Sightline Technologies (Haifa, Israel) by Stryker (Kalamazoo, Michigan) for $240 million in cash and stock brings to Stryker a flexible endoscope platform with four FDA-approved products for early diagnosis of tumors and abnormalities in the digestive tract. The purchase will help to broaden out from its current strength in flexible endoscopy.

“Sightline has developed a technology set to dramatically change standards in colonoscopy and endoscopy procedures, by our innovative, proprietary technology that should improve insertion of the device and for the first time, allow sterilization between colonoscopy and other endoscope procedures,” Avi Levy, CEO of Sightline, told BB&T.

Founded in 1994 inside tech powerhouse The Techno Entrepreneurial Incubator of the Techno Research and Development Foundation, Sightline attained its first $500,000 in sales of its endoscope products in 2004. Sightline says its platform brings three major advances to endoscopy: disposability in endoscopes, non-fiber optic light source and image processing.

“Stryker is a leader in the rigid endoscopy market. This acquisition allows us to apply our core competencies in visualization technology and sales and marketing to the flexible endoscopy market,” said Bill Inquest, president of Stryker Global Endoscopy. “Additionally, Sightline will potentially open up new markets for our Communications and Video Accessories businesses.”

Sightline developed the Colon Sight system, including the End Sight non-fiber optic colonoscopy, the disposable Colon Sleeve multi-lumen tube that is covered by a compressed protective sheath, and the electro-pneumatic System Control Unit (SCU) which powers the device. The company’s advanced IntraPull power-assisted disposable technology has been shown to improve the safety and speed of traditional colonoscopy systems, while the protective sheath places a disposable barrier between the patient, the EndoSightscope, and the physician.

Prof. Avi Ludomirsky, managing partner of Vitalife and chairman of Sightline’s board, said: “Sightline’s technology in identifying and treating colon cancer and other disease breaks a 20-year deadlock in colonoscopy. We have full confidence that Stryker will be able to maximize the potential of Sightline technology.”

ONI supporting MRI access in Denmark

ONI Medical Systems (Wilmington, Massachusetts), developer of MSK Extreme and OrthOne high-field, 1.0T extremity MRI systems, reported that it is working with health authorities in Denmark to reduce the time patients need to wait for an MRI. With the increase in the number of patients needing MRI, the waiting time for a scan in Denmark can be as long as six months. ONI bills itself as the only company that offers compact, high-field, open-extremity MRI systems which can be easily sited in hospitals, diagnostic imaging centers and orthopedic practices.

“The decision by the radiology community in Denmark to support the ONI solution validates the need for dedicated extremity MRI units in health systems with strong MRI utilization,” said Bob Kwolyk, founder of ONI. “MSK Extreme and OrthOne dedicated high-field extremity MRI systems will play an ever-increasing role in helping provide timely imaging services while containing soaring medical costs worldwide.”

At the end of 2004, Danish health authorities made a strong recommendation that no one should have to wait more than six weeks for an MRI exam. If the hospitals in the county where the patient lives cannot guarantee an examination within that time, the county will have to pay for the examination and transport, even to another country.

New UK blood service agreement for Pall

Pall (East Hills, New York) said it has been awarded a new long-term agreement with the UK National Blood Service (NBS) to provide blood collection systems incorporating the company’s filtration technology. Financial terms of the agreement were not disclosed.

“This is a major contract and incremental new business for our Leukotrap family of filter systems,” said Allan Ross, president of Pall Medical. “The NBS has always been on the leading edge in blood safety measures and we are pleased to be able to provide them with technologies to help fulfill their core purpose to save and improve patients’ lives.”

The NBS collects about 2 million units of blood each year. It is an integral part of the National Health Service and through its blood centers provides blood, blood components, products and tissues throughout England and North Wales.

Pall places itself as the leading global provider of filtration systems that reduce leukocytes from red cells, plasma and platelets, providing customers with what the company terms “maximum flexibility” in the manufacturing of blood products.

UltraShape raises $15 million

UltraShape (Tel Aviv, Israel), a privately held start-up specializing in noninvasive focused ultrasound devices that body contour by destroying fat cells, late last month reported the completion of a $15 million round of funding. Polaris Venture Partners led the round and was joined by previous investor Israel Seed Partners.

UltraShape, founded in 2000 by plastic surgeon Ami Glicksman, company president, and physicist, Yoram Eshel, CEO, has raised $12 million in two previous rounds. Israel Seed Partners invested $6 million; and the seed round was funded by Israel Seed Partners, in addition to the Israeli Office of the Chief Scientist and other investors.

The company’s flagship product, Contour 1, obtained CE mark clearance in July 2005 for the ultrasound device.

Eshel told BB&T, “UltraShape is currently selling in 37 countries throughout Europe, Asia and Africa and has several million dollars in sales, past our breakeven point,” adding, “We anticipate FDA approval in 2007 and hope to be on the U.S. market in 2007, where we have already set up a sales and marketing infrastructure from our U.S. office in San Ramon, California.” UltraShape said it plans to use the proceeds of the financing to expand commercialization of Contour 1.

EnzySurge device targets chronic wounds.

EnzySurge (Shoham, Israel) – which is focused on developing innovative hybrid medical devices that are disposable, implantable and centered on hard-to-heal chronic wound management – obtained FDA approval for DermaStream, its platform hybrid medical device. DermaStream, EnzySurge’s flagship product, gently debrides the wound through continuous, controlled irrigation of the patient’s skin with proprietary therapeutic solutions, an approach developed by EnzySurge founder Amihay Freeman, director of the Institute of Biotechnology of Tel Aviv University and an expert in the field of enzymatic processes.

Freeman, with Ramot, the technology transfer office at Tel Aviv University, founded EnzySurge in 2001 in the Misgav incubator. Freeman, chief scientist in the Ministry of Industry, Trade and Labor, said, “Our proprietary biotechnology, know-how and integrative approach embedded in our products, can provide healthcare professionals with the means to complete wound management faster and at lowered total costs of treatment.”

Allon Leibovitz, CEO of EnzySurge, told BB&T, “DermaStream treatment significantly accelerated healing, which reduces therapy time and, we expect, will lower staff intervention time and shorten hospitalization and overall cost of care.” The company anticipates receiving CE marking later in 2006. The wound management market is a rapidly growing market due to the massive increase in morbid obesity and diabetes.

EnzySurge has raised about $2 million from private investors led by Eli Gilboa of the Gilboa & Licht Investment House (Tel Aviv). Gilboa also serves as chairman of EnzySurge’s board.