From BB&Ts

Israeli venture capital firm Jerusalem Global Ventures reported that it would launch JGV Growth Equity Fund at $200 million. The firm said the fund "will invest in private Israeli-related technology companies that are on a trajectory to an IPO within three years and have a proven business model." First closing is scheduled for April.

Shlomo Kalish, PhD, who founded Jerusalem Global in 1994, said, "Unlike the early stage VC investment model, where one expects multiple write-offs for every 'home run,' this fund's business model should produce quicker turnaround of money, lower risk and more predictable returns."

Jerusalem Global manages two sector funds launched in 1999. Yoseph Linde, PhD, who co-managed the prior funds, said, "Over the last several years, in the course of making investments for our early-stage VC fund, we were offered numerous opportunities to invest in late-stage technology companies. Although we rejected most of these offers as they did not fit our primarily early-stage focus, we did make two such investments resulting in two successful exits."

Linde, who was a serial entrepreneur before joining Jerusalem Global Ventures, said the fund's portfolio company, Mellanox (Yokneam, Israel/Santa Clara, California), which had a successful IPO earlier this year, "would be a perfect example of companies we'd fund."

The new fund is expected to invest $5 million to $20 million in companies with late-stage financing needs of $10 million to $50 million.

Kalish said, "Think of this fund as a barbell. On one end we have foreign financial institutions that do not have staff on the ground in Israel but have expressed interest in co-investing with us. On the other end, we have investment banks that would like to establish a strategic relationship in order to help prepare our portfolio companies for an IPO. The fund is the connecting rod in the middle, using the manager's network and expertise to source and invest in quality deals."

He added: "There are some interesting things going on in Israeli technology. The number of private companies with revenue of more than $10 million has exploded, and we see more in the pipeline. Yet, there is still pressure for such firms to exit too early. This fund will help successful companies bridge that gap and get to a point where they can realize their full value."

Kalish said a number of investors in the prior fund have committed to the new fund. Jerusalem Global said it also would be marketing the fund to major financial institutions, fund of funds, university endowments, and pension funds.

Report highlights future needs for med-tech in Sweden

Medical technology is seen as an industry for the future in Sweden. However, to exploit its potential, the industrial, academic and healthcare sectors will have to collaborate more closely on areas such as education and clinical research. That is the conclusion of a joint report commissioned by the Royal Institute of Technology (KTH), the Karolinska Institutet and Karolinska University Hospital (all Stockholm).

Sweden has a strong foundation of med-tech companies; Gambro, Getinge and Elekta are prime examples of companies that have been built up around Swedish innovations. The industry employs around 10,000 Swedes and has an annual turnover of some SEK 60 billion. However, the recently published report "Action MedTech Sweden - Key Measures for Growing the Medical Device Industry in Sweden" points to considerable untapped potential for enterprise and new jobs.

"The analysis is not only relevant to the Stockholm region but to the country as a whole," said Bo Norrman, senior lecturer at Karolinska Institutet's Unit for Bioentrepreneurship. "But if we want medical technology to contribute to the Swedish economy and to human health in the future, we have to act now."

The objective of the report was to identify what needs to be done to generate industrial growth with the cooperation of the academic and healthcare sectors. Its conclusions include the following:

• Technical and medical faculties should identify and run joint research projects with development potential.

• The health authorities and university hospitals should create incentives for doctors and other healthcare personnel for conducting research in the med-tech field, while identifying the development needs of everyday clinical practice.

• Universities and the health authorities should cooperate more closely with industry on different key areas, such as the establishment of common professorships and education programs.

• The government should release more financial resources for long-term needs-based research projects in the med-tech field.

The conclusions of the report were based on some 50 interviews and four workshops with Swedish entrepreneurs, scientists, clinicians and financiers, an international benchmarking study and data from previous studies and reports.

Long-term results of LASIK positive in European research

A 10-year follow-up study by researchers in Spain and Turkey on patients who had laser surgery to treat high myopia (short- or near-sightedness) found the treatment was safe and effective in the long term, with a retreatment rate of less than 30%. The study, published in the January 2008 issue of the American Journal of Ophthalmology, was carried out at the Miguel Hernandez University Medical School (Alicante, Spain) and the Ankara University School of Medicine (Ankara, Turkey).

Laser surgery for eye problems has been around since the early 1990s. There are two main types for correcting myopia: PRK, Photorefractive Keratotomy, for low to moderate myopia; and LASIK, laser in situ keratomileusis, for high myopia. And there have been over 18 million LASIK operations worldwide, with controversies arising concerning the maximum correction possible and the long-term effects of the technique. This new study indicates that in the long term, LASIK was a safe and effective procedure for patients with preoperative myopia of over -10 D.

The researchers evaluated 196 eyes of 118 patients that needed at least 10 diopter (10 D) corrections to achieve 20/20 vision before receiving laser surgery. The extent of the preoperative myopia was a mean of -13.95 plus or minus 2.79 D.

The patients all received LASIK surgery at the Instituto Oftalmologico de Alicante between April 1992 and December 1995, coming back for check-ups after three months, and one, two, five and 10 years.

The results showed that:

• After 10 years, 42% of eyes were within plus or minus 1.00 D.

• 61% of eyes were within plus or minus 2.00 D.

• 27.5% of eyes were retreated because of under-correction or regression, or both.

• Myopic regression in eyes that were not retreated occurred an average of -0.25 plus or minus 0.18 D per year.

• 5% of eyes lost more than two lines of best spectacle corrected visual acuity (BSCVA).

• 40% of eyes showed a postoperatively uncorrected visual acuity of 20/40 or better.

• 1% of eyes with more than 15 D myopic correction developed corneal ectasia (bulging).

• The retreatment rate was 27%.

The researchers concluded that LASIK for myopia over -10 D "is a safe procedure with myopic regression that slows down with time and a high rate of BSCVA increase in the long term."

Jorge Alio, lead investigator, called the results "extremely encouraging considering that this refractive correction implies the maximum limit of application of this technique. This study has allowed us to demonstrate that, in spite of the prejudices about the limits of LASIK technique, the results regarding predictability, efficacy and safety for high myopic patients are very good in the long term." And he stressed that the optimum limit of predicatability for this type of surgery appears to be around 10 D of myopia.

In an editorial in the same issue, George Waring, MD, of Emory University and Inview (both Atlanta), supported the findings and said that LASIK and other vision correction procedures have improved significantly in the last 10 years, with some recent studies on LASIK reporting correction to plus or minus 0.5 D in more than 90% of eyes.

France reports spending for in-home devices doubles

The Caisse Nationale d'Assurance Maladie (CNAM), France's national health insurance plan, reported last week that spending for in-home medical devices and equipment increased from €800 million in 2000 to €1.6 billion in 2006, or $2 billion adjusted for currency rates that year.

For 2006, France reported total reimbursements of €4.2 billion ($5.25 billion) for medical devices and equipment with almost two-thirds of the devices now being prescribed by general practitioners. As of July 2007, the trend was continuing with a 13% increase year-to-year. France counts more than 3,000 different devices in this category, ranging from bandages to wheelchairs and including devices such as protheses and tests for diabetics. Medications are not included.

Patients considered handicapped and those receiving implantable devices, such as hip replacements and cardiac valves, accounted for €1.4 billion ($1.75 billion) of the spending.

Self-treatment devices used by diabetics, including glucose meters and syringes, accounted for €385 million ($482 million) according to the agency, which during a press conference criticized the absence of generic test strips in France, which it said could significantly reduce the reimbursement expense to the state for daily monitoring by diabetics.

France is facing a record deficit for the national health plan of €12 billion ($18 billion) and CNAM notes that with the country's aging population and the increased use of new treatments, the deficit is expected to increase another €2 billion in 2008.

French health ministry maps radiotherapy action plan

A road map to bring French radiology out of a crisis of confidence set off by the death of five patients undergoing radiotherapy was reported by the Minister of Health, Youth and Sport during the recent congress of the Société Française de Radiothérapie Oncologique. (Paris).

Health Minister Roselyne Bachelot unveiled 32 measures to address problems identified in an investigation she launched in September as the scandal widened to reveal that up to 6,000 patients may have been over-radiated as far back as 1987.

In vivo dosimetry will be required for all of France's 179 centers performing radiation therapy and the ministry is providing €3 million ($4.5 million) to buy the needed equipment and another EUR 2 million ($3 million) has been allocated for funding training centers for radiotherapy physicians, whose number will be doubled to 300 according to a previous announcement.

Bachelot said during a press conference that the tragedy at the Jean-Monnet Hospital in Epinal is as much a human disaster as a health crisis. She also reported a present for the 500 patients most severely affected by improper treatment at the Epinal hospital: a payment of €10,000 ($15,100) to be awarded immediately. Those patients received radiation greater than the prescribed dosage.

The payments, which total €5 million ($7.5 million), "in no way influences nor is a substitute for the legal remedies that will continue," she said, calling it instead "a gesture of solidarity with these families."

French news media called it an attempt to head off criticism that the government has not kept any promises to these victims, some tragically mutilated, who face a long and uncertain journey in the French legal system.

Some 100 lawsuits have been filed against the center and attorneys estimate compensation could reach more than €20 million ($30.2 million). France does not recognized class action as a remedy.

André-Claude Lacoste, head of the Autorité de Sûreté Nucléaire (Nuclear Safety Authority) said that almost 90% of the country's 179 radiation treatment centers had been inspected as part of the investigation, and that the remainder would be visited before the end of this year. Twenty-four centers already have been brought up to the new standards set by the Institut National du Cancer (INCA) and the rest will progressively be brought into conformity by the end of 2008, he said.

Among the 280,000 French citizens diagnosed each year with a cancer, 200,000 undergo a form of radiation therapy, according to INCA.

All English trusts now reported to have PACS

The UK Department of Health said digital technology that has revolutionized the way the National Health Service (NHS) captures, records and uses patient X-rays and scans is now being used in every hospital trust in England. Picture archiving and communications systems (PACS) are replacing the traditional methods of capturing X-rays and scans on film and paper, enabling clinical images to be stored electronically and viewed on screen.

The Department of Health said the roll-out of PACS has been a major element in the National Program for IT, "which is helping the NHS to deliver better, safer care to patients via new computer systems and services."

Using the PACS technology, healthcare professionals can look at images at the touch of a button. X-rays and scanned images are available to view on screens in different locations such as X-ray departments, outpatient clinics, operating theaters and inpatient wards simultaneously.

The NHS said the system also gives clinicians instant access to old X-rays and scans, enabling the comparison of old images with new. "This is especially useful when treating long-term conditions. Images can also be rotated, enlarged and manipulated in other ways, helping clinicians diagnose conditions more quickly and accurately."

Health Secretary Alan Johnson said that the benefits of PACS "in terms of improved patient care are massive. This innovative technology speeds up and improves the accuracy of diagnosis, saves time and improves the quality of care."

He said that NHS trusts "are reporting that the time taken for radiologists and radiographers to issue reports to clinicians have typically been halved from more than six days to less than three, and these report that turnaround times continue to fall, with some hospitals reporting all imaging within 24 hours."

The introduction of PACS also is saving money, Johnson said, with trusts reporting an average saving of 250,000 in their first year of using the technology.

The UK government introduced the program to implement PACS in all English trusts in 2004. The final trust to receive a PACS as part of the national program was Leeds Teaching Hospitals Trust in December, marking the completion of a three-year process that has seen 127 trusts across England receive PACS.

European Commission in research staff exchange plan

The European Commission (EC) has launched a call for proposals for a new program designed to create closer links between staff working in research organizations in Europe and their counterparts in other international partner countries.

The program, dubbed the International Research Staff Exchange Scheme, has a budget of E25 million for 2008 that will support staff exchanges of up to 12 months per staff member.

Staff from research organizations in 29 different countries can participate and the program is open to all fields of research, the EC said.

The announcement of this program comes as the EC launches calls for proposals for more than E1 billion worth of research funds to be allocated next year.

The EC said the new program would open the benefits of the Marie Curie approach to staff working in research organizations in all of the 29 countries with which the EU either has a science and technology agreement or which are part of the European Neighborhood Policy.

bioMérieux plans to close site in Netherlands

bioMérieux (Marcy L'Etoile, France) reported last month that it will phase out activities at its site in Boxtel, the Netherlands by the end of 2009. The Boxtel facility develops and manufactures reagents for molecular biology and immunoassay microplate product lines.

bioMérieux said 287 employees work at the Dutch site today. It said this decision would result a non-recurring charge of about EUR 32 million in 2007 financial results.

Varian Medical to equip new hospital in UK

Varian Medical Systems (Palo Alto, California) said it has been selected to provide radiotherapy equipment for a major new hospital in Portsmouth, UK.

In what the company said is one of the country's largest replacement projects since the investment waves of the UK government's Cancer Plan earlier this decade, the new Queen Alexandra Hospital will receive four high-energy Clinac iX linear accelerators equipped with On-Board Imager devices for advanced image-guided radiation therapy (IGRT) treatments.

Due to open in summer 2009, the hospital will enable all acute services currently spread across three sites to be brought together under one roof. This includes the current oncology center at St. Mary's Hospital. The new facility will serve a population of 600,000 people.

Clinicians at St. Mary's are about to introduce highly-conformal intensity modulated radiotherapy (IMRT) treatments, and that program will be expanded once the new machines are installed. An Acuity simulator at the current facility will be transferred to the new site next year and will have Varian's 4-D respiratory compensation functionality added.

Several firms report new international subsidiaries

The following companies last month reported opening a new subsidiary:

• bioMérieux (Marcy L'Etoile, France), a global provider of in vitro diagnostics, reported the opening of a subsidiary in South Africa, based in Johannesburg. The new subsidiary will provide support to all of sub-Saharan Africa.

The subsidiary is bioMérieux's 36^th, representing what the company termed "another milestone" in its international expansion.

The company said that the move highlights the importance of South Africa for it. bioMérieux said its diagnostics solutions have been sold there by an exclusive distribution partner, Omnimed (Quebec), since 2001. The Omnimed in vitro diagnostics team will be integrated into the new subsidiary and the two companies will continue to work closely together.

• Phase Forward (Waltham, Massachusetts), a provider of data management solutions for clinical trials and drug safety, said it has established a subsidiary, Phase Forward Software Services India (Hyderabad).

In developing the new subsidiary, Phase Forward said it would be working with current partner Virtusa (Westborough, Massachusetts), a global information technology services company. Phase Forward's Hyderabad center will be situated within Virtusa's facilities there. Phase Forward's activity in India will be led by Steve Powell, senior VP of worldwide sales.

• SpineVision (Paris), a developer of motion-preservation and fusion devices for the spine surgery market, has established a direct sales subsidiary, SpineVision Singapore.

Hee-Kit Wong, MD, chief of orthopedic surgery at National University Hospital (Singapore), is leading a SpineVision-sponsored PediGuard training program at the National University of Singapore.

Regulatory approvals in Japan, Canada, and Europe

The following companies last month reported winning regulatory approvals in Japan, Canada, or Europe:

• Axiom Worldwide (Tampa, Florida) received Japanese certification as a medical device manufacturer, meeting quality management system requirements and other regulations for the manufacture and sale of medical devices. Axiom makes its flagship products, the DRX9000 True Non-Surgical Spinal Decompression System, DRX9000C and DRX9500, in medical markets around the world. It also makes an all-digital "electroceutical" device, the EPS8000, for use in relieving pain and in muscular rehabilitation.

• Conceptus (Mountain View, California) reported the approval of its third-generation Essure permanent birth control system by Health Canada. System modifications include changes to the delivery system that reduce the number of steps a physician is required to perform during a placement procedure, the company noted. Also, hysteroscopic visualization of the implant and placement markers was significantly improved, Conceptus said. A new DryFlow Introducer, which alleviates distension fluid loss, a major safety concern of hysteroscopists, is packaged with the product.

• Criticare Systems (Milwaukee) said it received the last required approval by the Japanese Pharmaceutical and Medical Device Agency (PMDA) to market its Veris MR Vital Signs Monitoring system in that country. The device is made by Criticare and will be marketed through an agreement with Medrad (Warrendale, Pennsylvania).

• CSMG Technologies (Corpus Christi, Texas) said its Live Tissue Connect (LTC) subsidiary has received CE-mark certification for its VAD-400 RF Generator. LTC's surgical tissue bonding/welding device is a platform technology that bonds and reconnects human soft tissue through fusion, in contrast with conventional wound closing devices such as sutures, staples, sealant, or glues, the company said.

• Medical Acoustics (Buffalo, New York) said it has registered its Lung Flute as a Class 1 medical device for sale in the European Union. The company said it now is qualified to apply the CE mark for marketing the Lung Flute in the EU, for both diagnostic and therapeutic applications.

The flute-shaped device is designed to create a specific low-frequency sound when the user blows into it, which creates vibrations in the airways and lung, which cause deep lung secretions to thin and be expelled.

• Micrus Endovascular (San Jose, California) received approval from Japan's Ministry of Health, Labor and Welfare to market its full line of stretch-resistant microcoils for the endovascular treatment of cerebral aneurysms in that country. The line includes the Cashmere, Presidio, HeliPaq and UltiPaq stretch-resistant embolic coils. Sales of the microcoils will be managed by Goodman

Additionally, Micrus Endovascular's exclusive distributor in the Japanese market, Qiagen (Venlo, the Netherlands), a provider of sample and assay technologies, and BioOne Capital (Singapore), a biomedical investment management company, have entered into a joint venture to establish Dx Assays in Singapore. Dx Assays is expected to be one of the first centers in Singapore for assay development in which molecular diagnostics for infectious and genetic diseases will be developed. The center is expected to be fully operational by early 2008, employing more than 30 scientists.