OrthoMimetics (OM; Cambridge, UK), the first technology spin-out from the Cambridge-MIT Institute (CMI), last month reported completing a Series A funding round totaling $9.6 million (£5 million) net of costs last month.

Led by Andrew Lynn, founder and CEO, a team of surgeons, scientists and engineers from the University of Cambridge (Cambridge, England) and the Massachusetts Institute of Technology (Cambridge, Massachusetts) helped OM bring to market a medical device technology that it says has the potential to reduce the need for joint-replacement surgery.

"Closure of this funding round provides OrthoMimetics with a sound financial basis to move forward swiftly with its development program to bring the first of its products through clinical trials to CE-mark approval," said Lynn.

The company said that completion of the funding round would enable it to advance the first two products derived from its orthobiologics scaffold platform towards market approval. ChondroMimetic, the company's flagship product for cartilage repair, and LigaMimetic, OM's pipeline product for ligament repair, address a combined yearly global market in excess of $1 billion, OrthoMimetics said.

Durect, Nycomed sign deal for Posidur

Durect (Cupertino, California) has signed a collaboration agreement with Nycomed (Roskilde, Denmark), a pharmaceutical company, to jointly develop Durect's Posidur post-operative pain relief depot.

Posidur is a long-acting local anesthetic under development for the treatment of post-surgical pain. It is meant to be injected during surgery to continuously release therapeutic levels of bupivacaine in a controlled fashion, providing up to 72 hours of uninterrupted local analgesia.

Durect's Saber delivery system is an injectable, biodegradable drug-delivery technology that allows for less post-injection burst than is typical of polymer-based systems. Posidur is in Phase II clinical development and is expected to move into Phase III this year.

Nycomed will pay Durect an up-front license fee of $14 million, with additional payments of up to $188 million upon achievement of certain milestones.

Nycomed will have exclusive commercialization rights in Europe and other select countries, and Durect will retain full ownership of Posidur in the U.S., Canada, Asia and other countries.

"We believe that Posidur has the potential to play a major role in addressing post-surgical pain," said Hakan Bjorklund, CEO of Nycomed. "The strategy of employing local post-surgical pain management to reduce the need for systemic pain relief is consistent with current trends to reduce the use of narcotics and associated side effects, as well as hospital stays and associated costs."

The companies will jointly direct and equally fund a development program for Posidur intended to secure regulatory approval in the U.S. and the European Union.

HPV DNA testing covered in France

Digene (Gaithersburg, Maryland) reported that as of December French insurer MAAF Sante (Niort)began paying for HPV DNA testing of all women in France age 30 to 65 who are most at risk of developing cervical cancer. The insurer also will fund HPV DNA testing for women of all ages whose Pap results are inconclusive or as a "test of cure" for women treated for cervical disease.

Digene said this marks the first time in France and the second time in Europe that reimbursement for HPV testing for all uses — including routine, primary screening to identify women at risk of cervical cancer — is being offered by a major insurer.

The Digene HPV Test, which uses the company's Hybrid Capture II (hc2) technology, is the only clinically validated, FDA-approved and CE-marked test for detecting the presence of high-risk types of the human papillomavirus (HPV), the cause of cervical cancer, the company said.

"Only the combination of a negative (normal) Pap and a negative HPV test can provide a full guarantee that the risk of developing cervical cancer within the next three years is equal to zero," MAAF Sante said in reporting its new policy.

"This announcement in France — coming after a parallel decision by a major insurer in Germany earlier [in 2006] — is an important milestone for cervical cancer screening and prevention programs globally and should trigger similar shifts in the standard of care elsewhere in France, Europe and around the world," said Rob Lilley, senior VP, global sales and marketing at Digene.

The first HPV vaccine was approved recently by the FDA for girls and young women age 9-26, but Digene said screening will continue to be important, since the vaccine protects against just two types of the virus responsible for 70% of cervical cancers, and has only been shown to be effective in women not yet exposed to the targeted types of HPV.

CE mark for International Spine PDS System

Interventional Spine (Irvine, California) reported that its Percutaneous Dynamic Stabilization system for early-age treatment of spinal disorders has received CE mark approval.

The company said it believes the PDS system is the only procedure available that can provide dynamic stabilization of the spine via a percutaneous access puncture. It said all other dynamic stabilization systems and procedures require a major or minimally invasive surgical incision to provide pain relief to patients with degenerative spinal disc disease.

Dynamic stabilization is an alternative to medical management, corticosteroid injections and, when indicated, invasive surgical fusion therapies, to roughly 500,000 patients worldwide who suffer from degenerative disc disease of the spine, according to Interventional Spine.

The procedure is intended to provide relief from the pain of degenerative disc disease while maintaining greater motion compared to patients of spinal fusion surgery.

In addition to providing the least-invasive approach to dynamic stabilization, the results from the company's initial pilot clinical study indicate that the PDS system provides greater relief from pain for individuals suffering from spinal disc disease than any other dynamic stabilization product or procedure.

Interventional Spine said it intends to conduct a series of extensive clinical trials and continue to prove the clinical value. Interventional Spine also has FDA clearance and CE-marking for its PLS system, which allows the least-invasive method of providing fixation of the vertebral structures following conventional spinal fusion procedures. The PLS system can accomplish fixation with one small percutaneous-access puncture.

Interventional Spine's products for the treatment of degenerative spinal disc disease as well as a range of orthopedic applications, are based upon its Clasp and Teleport Access technologies.

Misonix in device distribution pact in China

Misonix (Farmingdale, New York), a developer of ultrasonic device technology for the treatment of cancer and other chronic health conditions, said it plans to bring the Sonatherm 600, used for high-intensity focused ultrasound (HIFU) treatment of soft tissue, including cancerous tissue in the kidney, into China. In its strategy to enter China, it formed an agreement with Acton Medical Device (Guangzhou, China), which has a sales team of 156 covering more than 20 provinces.

Acton will be responsible for conducting clinical studies and acquiring all necessary government approvals for the sale of the Sonatherm in China. Misonix will make the device at its facilities in Farmingdale and will ship it to Acton for use by its partners in the Chinese medical community for satisfying regulatory requirements as well as establishing regional branding, the company said.

The Sonatherm has been developed by Misonix in connection with the worldwide rights that it acquired from Focus Surgery (Indianapolis), a HIFU developer. Based on clinical studies conducted for Misonix in other parts of the world, the Sonatherm has been demonstrated as an advanced product for minimally invasive procedures that ablate cancerous tissue without the need to puncture the kidney organ.

VeriChip cites Italian study results

VeriChip (Delray Beach, Florida) last month reported the results of a clinical study on its VeriMed System for patient radio frequency identification (RFID) conducted by the Spallanzi National Institute (Rome) and sponsored by the Italian Ministry of Health. The two-year, 10-patient study was designed to evaluate the safety and efficacy of the VeriMed implantable RFID microchip and the functionality of the VeriMed System in the management of patients with chronic infectious diseases undergoing care at the institute.

The study reported no complications or side effects related to the insertion procedure, flawless access of the ID number using a hand-held reader, and universal acceptance within the patient study group. Based on the results of the study, VeriChip's distributor for Italy said it plans to petition the Italian Ministry of Health for full availability of the VeriMed system through the Italian National Health Service.

VeriChip is a subsidiary of Applied Digital Solutions.

Asset 2 electronic 'toolkit' for stroke in UK

A new electronic "toolkit" for the staff of the National Health Service, launched by the UK Department of Health, is intended to help transform the lives of stroke sufferers, according to Health Minister Rosie Winterton.

The computer-based program, called Asset 2, has been developed to assist healthcare commissioners in modernizing their services, preventing thousands of strokes in the process. Aimed at Primary Care Trusts and general practitioners, the web-based system identifies levels of demand for services in an area, benchmarks current services against other organizations, identifies best practices and demonstrates the impact of changes.

The guide encourages four key changes:

• Increasing stroke unit capacity.
• Providing quicker access to transient ischemic attack (minor stroke) services.
• Rapid scanning to enable greater use of clot-busting drugs.
• Early supported discharge.
• If all services made these changes, then each year 840 strokes would be avoided, and 3,900 sufferers would regain their independence rather than facing the prospect of death or long-term dependency, the developers have said. Another 20,000 strokes could be avoided through preventive work on high blood pressure, irregular heartbeats, smoking cessation and wider statin use.

Johns Hopkins part of Egypt cardiac program

Johns Hopkins Medicine International (Baltimore) and Sanofi-Aventis Egypt have signed an agreement for educational and consultative services through the Johns Hopkins Division of Cardiology. The agreement calls for assistance with the development of new national guidelines on cardiovascular disease prevention. Other services will include support in training of primary care physicians and cardiologists.

In Egypt, this initiative is referred to as the Delta-C Project, a model for change. According to Johns Hopkins, Egypt has among the highest incidences in the world of hypertension, obesity, smoking, Type 2 diabetes and other risk factors leading to heart disease.

The Delta concept was originated by Innovara (Hadley, Massachusetts), a healthcare consulting firm that has facilitated the relationship between Johns Hopkins and the Egyptian cardiology community.

Last month a physician re-education event hosted by Sanofi-Aventis Egypt launched the guidelines while also training cardiologists to train primary care physicians throughout the country. The two-day event included case studies, medical training in cardiovascular disease prevention, advances in the use of new cardiovascular medicines in disease prevention, and plans for a patient intervention study to measure the effect of prevention education on cardiovascular disease outcomes.

Maha Ibrahim, professor of radiology at Cairo University, said that two complementary prevention strategies are needed in Egypt, one directed to the whole population to decrease the risk profile of the community and another that approaches individuals in high risk of cardiovascular disease. The guidelines also call for complete smoking cessation and education on the hazards of an increasingly unhealthy dietary style.

The Delta-C project is licensed from Innovara by Sanofi-Aventis Egypt for use by the Egyptian Hypertension Society. Innovara also serves as advisor to the project.

Talecris Biotherapeutics opens Europe office

Talecris Biotherapeutics (Research Triangle Park, North Carolina) last month established Talecris Biotherapeutics (Frankfurt, Germany) to serve as its European headquarters. The new European subsidiary represented the second expansion in 2006 for the biotherapeutics manufacturer, completing the next phase in the company's global expansion plan.

"Our expansion into Europe signifies another key milestone demonstrating the strategic growth we have planned for our company," said president/CEO Alberto Martinez, MD. "We established Talecris Europe to deliver tailored sales and support services to our European customers, and our European leadership team brings the knowledge, experience and dedication to do exactly that."

With the new German offices, Talecris said it is now positioned to work closely with physicians and their patients to improve clinical care of primary immune deficiency patients.

In business for just 20 months, Talecris already has achieved annual sales of more than $1 billion and has grown to employ more than 3,000. The company supplemented its business with the acquisition of Precision Pharma Services, which provides additional fractionation capacity, and by acquiring 58 plasma collection centers from International BioResources to complete the vertical integration of the business.

England goes smoke-free

All enclosed public places and workplaces in England will become smoke-free beginning July 1, according to Health Secretary Patricia Hewitt, who last month said, "This is a triumph for public health and a huge step forward for health protection. Thousands of people's lives will be saved and the health of thousands more protected."

"Smoke-free legislation will protect everyone from the harm of secondhand smoke when working, socializing and relaxing and will provide a more supportive environment for smokers who wish to give up," Hewitt said.

Hewitt said the scientific and medical evidence "is clear — second-hand smoke kills, causing a range of serious medical conditions including lung cancer, heart disease and sudden infant death syndrome. This legislation will help to prevent the unnecessary deaths caused every year from second-hand smoke, and recognizes that there is absolutely no safe level of exposure."

She said that no other health issue has created as much debate in Parliament, across government, through the business and the voluntary sectors, and among the general public. "And the more it has been debated, the more people have responded and pushed the limits to ensure that enclosed public places and workplaces in England will become wholly smoke-free," she said.

The Health Secretary also launched a new Smokefree England campaign intended to help the country's 3.7 million businesses prepare for the implementation of the legislation.