A Medical Device Daily

Hillenbrand Industries (Batesville, Indiana) said its Hill-Rom (also Batesville) medical-products subsidiary has selected Singapore as the site for its Asia-Pacific Innovation Center.

The center will become the home base for new Hill-Rom teams focused on research & development projects for global applications and will become a center of excellence for microelectronics and embedded software products.

"Innovation is one of the keys to success for global medical technology companies. That's why last April we announced our first Global Innovation Center and based it at our headquarters location in Batesville," said Peter Soderberg, president/CEO of both Hillenbrand and Hill-Rom.

He added, "The early success of that idea has led us to announce the creation of this second center in a part of the world that offers us diverse thinking and approaches as we become a more technology-intensive company. As we looked at potential sites, we found that Singapore has an increasingly knowledge-based economy, great technical talent, sophisticated healthcare institutions, and strong government support to grow its healthcare and technology sectors."

Lim Siong Guan, chairman of the Singapore Economic Development Board, hailed Hill-Rom's action. "The new center will add to the growing cluster of product development activities in Singapore and further solidifies our position as one of the leading locations in the region for medical technology product innovation."

Hill-Rom said the establishment of the Singapore Asia-Pacific Innovation Center calls for as many as 17 new positions to be created in the first year, with additional positions to be added over the course of five years. The company said it ultimately expects to have as many as 50 to 60 people based at the Singapore site.

The U.S. firm had previously reported plans for a significant increase in corporate spending on R&D, aimed at ensuring that its products meet both the current and unanticipated future needs of caregivers and the patients they serve.

That acceleration of R&D led to the formation of the Global Innovation Center in Batesville, announced in April, along with the creation of about 80 new Indiana-based jobs. In addition, Hill-Rom has R&D work ongoing at sites located in Montpellier and Pluvigner, France.

The company said the Singapore center is complementary to these world-wide efforts and also will serve as an extension for Hill-Rom's investments in its Suzhou, China, location.

While emphasizing that Hill-Rom is committed to its home base in Indiana, Soderberg said the company also recognizes the need to leverage opportunities in lower-cost regions as well as to tap into the talents and strengths of a global workforce.

Hill-Rom is working to finalize details on a site selection within Singapore. The company is targeting a site with up to 10,000 square feet of space to be used for offices, R&D labs, a customer experience center, and sales and marketing. The first phase of developing the Asia-Pacific Innovation Center is expected to be completed and operational by March 2008.

The company is a provider of a wide range of medical products and related services, including patient support systems, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, and workflow information technology solutions.

Algerian subsidiary planned by bioMérieux

bioMérieux (Paris), a global in vitro diagnostics company, reported its plans to open a subsidiary in Algeria in early 2008. The new subsidiary, based in Algiers, will enhance bioMérieux's presence in Africa and illustrates the company's international expansion strategy.

The news was reported at an international biologists' congress in Paris, which was honoring Algeria this year. "Your country is making significant advances in its healthcare system. After over 30 years of collaboration, by creating this subsidiary in Algeria, we hope to play an integral role in its development," Alain Mérieux, president of bioMérieux, said to representatives of the Algerian Ministry of Health, Population and Hospital Reform.

As part of Algeria's 2005-2009 Healthcare Development Program, the country will create more than 100 healthcare facilities. bioMérieux said it will provide its expertise in the fight against infectious diseases and contribute to the scientific training of healthcare professionals.

In particular, bioMérieux said it intends to play a major part in protecting patients from healthcare-associated infections in Algeria, drawing on its unique offer in microbiology.

bioMérieux is represented in more than 150 countries through 35 subsidiaries and a large network of distributors. It provides diagnostic reagents, instruments and software.

Canada approves AFP's NewTom VG

AFP Imaging (Elmsford, New York) said it has been granted a medical device license from Health Canada to market the company's NewTom VG 3D Cone Beam Computed Tomography (CBCT) Scanner in Canada.

The company said the NewTom VG provides clinicians with detailed 3-D radiographic images of the teeth and jaws while allowing patients to stand, sit or remain in wheelchairs while being scanned. It said the unit's small footprint makes it "ideal for in-office examinations when space is limited."

The primary applications are for diagnosis and treatment planning in dentistry and otolaryngology (ENT), including dental implants, orthodonture and maxillofacial surgery, as well as ear, sinus and airway imaging.

AFP said NewTom VG uses the same technology and proprietary software as its NewTom 3G, which provides a horizontal support table to accommodate elderly, infirm or trauma patients and children. The company said it is the only CBCT scanning supplier to provide both vertical and horizontal configurations of this technology for dental and ENT markets.

The products are manufactured by AFP Imaging's wholly owned subsidiary, Quantitative Radiology (Verona, Italy).

Gary Lee, executive vice president, sales and marketing of Genexa Medical, the exclusive Canadian distributor for NewTom VG and NewTom 3G, said, "We are extremely excited that Health Canada has approved the latest 3D CBCT scanner from the company that actually invented cone beam scanning. The NewTom VG is a culmination of the key advances of previous generations of NewTom scanners."

No-embryo stem cells may bring controversy to an end

By ANETTE BREINDL

BioWorld Today Science Editor and Medical Device Dailys

Two early online papers in Cell and Sciencexpress, respectively, reported last week that by adding four factors to human fibroblasts via retroviral insertion, researchers have turned them into induced pluripotent stem cells, or iPS cells, that are almost indistinguishable from embryonic stem cells.

The work "changes everything and nothing," James Thomson, senior author of one of the papers, told reporters at a press conference.

The papers represent a breakthrough of rare magnitude in basic research, and have the potential to cut the Gordian knot of ethical and regulatory issue associated with human embryonic stem cells. But Thomson stressed that iPS cells are as unproven medically as human embryonic stem cells, though they open up a plethora of research possibilities and removing the controversy around embryonic stem cells likely will make the field more attractive to scientists and businesses alike.

Thomson said that human embryonic stem cells "unleashed a storm of controversy" when they were first isolated in his lab a decade ago. The new findings, he said, mark "the beginning of the end of that controversy."

For now, the technique is not ready for prime time, at least if one considers prime time to be its use inpatients: the retroviral vectors used to transform the cells present a major safety issue for their use on patients.

Shinya Yamanaka, senior author of the Cell paper, conceded the basic point, telling Medical Device Daily's sister publication, BioWorld Today, via email that "we have to find a way to avoid retroviruses before application in cell therapy."

But, he added, "The most immediate usage of iPS cells is in drug discovery and toxicology. For this purpose, the retrovirus is not a big problem."

The work also has an interesting scientific twist that goes even beyond its fundamental importance to stem cell research: it's not the same four factors in each paper.

In a publication that will appear in the Nov 30 print issue of Cell, Yamanaka and his colleagues reported that by adding Oct3/4, Sox2, KLF4 and the oncogene c-Myc to adult human fibroblasts via retroviral insertion they were able to make cells resemble embryonic stem cells in their ability to divide and turn into different cell types. The team had reported the same feat with mouse fibroblasts last year.

The paper in the Nov 21 issue of Sciencexpress, by Thomson and a group of colleagues also reports on transforming neonatal and fetal fibroblasts into pluripotent cells. Like the authors of the Cell paper, the authors of the Sciencexpress paper — which will appear in the Dec 21 print issue of Science — use Oct3 and Sox2 to coax their cells back into an embryonic stem-cell-like state. But instead of KLF4 and c-Myc, the cells in the Sciencexpress paper were transformed with Nanog and Lin28 in addition to Oct 3 and Sox2.

Thomson suggested his own group might not have used the four factors identified by the Cell paper in the correct ratios, which appear to be critical for success.

In response to reporter questions, Thomson strongly defended the continuation of human embryonic stem cell research, calling those cells the "gold standard" against which to measure iPS cells and noting that if the iPS cells proved to be as good as true embryonic stem cells, the research community would naturally switch to them over time.

And Yamanaka noted that the iPS cells create their own ethical problem by the very fact that they are so similar to embryonic stem cells. "It might be possible to generate sperm and eggs from skin cells, via iPS cells," he said. "This might help people with infertility problem, but it will be essential to have a proper regulation regarding the generation and usage of human iPS cells to avoid misusages of this technology."

Reaction to the research findings came from many sources:

• Geron (Menlo Park, California) President/CEO Thomas Okarma, MD, PhD, said, "These findings contribute to a better understanding of the molecular biology of cellular differentiation. The work will enable the generation of pluripotent lines from individuals who suffer from poorly understood genetic diseases. Such lines will be useful in understanding how certain abnormal genes induce dysfunction in particular cell types that lead to disease." He added, however, that the results "are unlikely to impact the development of stem-cell based therapeutics. The notion of using an individually derived pluripotent stem cell line as the source for the manufacturing of a therapeutic cell type used only for that individual is not only extremely labor-intensive and technically difficult, it is economically unfeasible." Moreover, said Okarma, "the often stated reason to make individual lines is to avoid immune rejection as in organ transplantation. However, immune rejection may not pertain to cells manufactured from hESCs, as we have shown recently with our OPC1 cells, our hESC-based therapeutic for spinal cord injury. These therapeutic cells made from hESCs are immune-privileged and are not recognized by the human immune system in vitro. "What is most important to recognize is that an undifferentiated stem cell is not a therapeutic cell," he said. "Geron has [a] global leadership position using our own patented technologies developed over many years to scalably and reliably manufacture therapeutic (differentiated) cells from pluripotent stem cell lines, regardless of their source. Indeed, one of the two labs successfully used Geron's proprietary methods in order to produce cardiomyocytes from their iPS cell lines derived from human skin."
• The Center for Genetics and Society (CGS; Washington), a public interest organization, said the research "shifts both the scientific terrain and the contentious political debate." "This is like an earthquake for both the science and politics of stem cell research," said CGS policy analyst Jesse Reynolds. The organization said the prospect of producing pluripotent stem cells without either eggs or embryos signals a "new chapter" in the politics of stem cell research. The center supports embryonic stem cell research but has long argued that cloning-based techniques pose novel risks. "Direct reprogramming promises to produce disease-specific stem cells for use in screening drugs and studying disease mechanisms, and patient-specific stem cells that researchers may learn to use for treatments and therapies — without relying on cloning and without requiring eggs from women," CGS said. "If these findings hold up, they could disconnect the stem cell debate from culture-war battles over embryo politics and abortion rights, and put an end to the use of embryonic stem cell research as a political wedge issue," said CGS Associate Executive Director Marcy Darnovsky. "Hopefully this will enable policy makers to move forward with much-needed oversight of emerging technologies, such as a federal ban on human reproductive cloning."
• Family Research Council (Washington) President Tony Perkins also praised the research, calling it "an historic achievement, and just as important, this breakthrough was accomplished without the destruction or cloning of human life. It is never necessary to compromise ethics by destroying life in order to achieve scientific aims." Perkins added, "Scientists around the world can now produce and work with embryonic-type stem cells without concern for crossing ethical lines involving the destruction of human life."