A panel of the UK's National Institute for Health and Clinical Excellence (NICE) last month denied an appeal filed by Cordis (Miami Lakes, Florida), a unit of Johnson & Johnson (J&J, New Brunswick, New Jersey), regarding reimbursement for drug-eluting stents (DES) used to treat coronary artery disease.

NICE issued a guidance in February recommending DES use as a "possible treatment" for coronary artery disease patients but only if two conditions are met:

The artery to be treated is less than 3 mm in diameter or the affected section of the artery is longer than 15 mm — conditions that indicate a patient is at high risk of requiring further interventions if a conventional bare-metal stent (BMS) is used; and

The additional cost of a DES over a BMS device is no more than $600.

Cordis appealed the guidance, saying it was too restrictive and arguing that NICE was seeking to fix or control the price of the stents or to establish procurement policy for the UK's National Health Service. It cited evidence that DES devices are cost-effective at price premiums up to $800 to $900 over the cost of BMS devices, saying this should be reflected in the guidance.

The appeals panel released its decision late last month.

At about the same time, NICE re-released its final guidance, confirming the criteria it set forth in the February guidance.

"We're disappointed that NICE's appeal panel did not uphold our appeal, and we're in the process of evaluating our options regarding the appeal panel's ruling," said Christopher Allman, a J&J spokesman.

Andrew Dillon, CEO of NICE, in a statement said, "The guidance is the result of careful consideration of the evidence, as well as comments received during consultation and further economic modeling. The independent Appraisal Committee took into account the risks and benefits of the different types of stents, and the significant additional costs involved in the use of drug-eluting stents compared to bare-metal stents."

Dillon said that this decision, guiding the recommendation for use of DES, will ensure that, despite their higher cost, they still will continue to be an important treatment option for patients "who would be at high risk of requiring further interventions if a bare-metal stent was used instead."

According to NICE, J&J could challenge the decision by applying to the High Court for permission to apply for judicial review.

Japanese may be loosening restrictions

Reports indicate that Japan, which historically has had perhaps the slowest medical-device approval process globally, is eyeing steps to speed up its lengthy approval processes.

Philip Agress, VP for global strategy and analysis at the Advanced Medical Technology Association (AdvaMed; Washington), said new reimbursement measures were adopted this past spring, and talks between the two governments and trade groups concluded last month indicate that companies may no longer be subjected to a full approval process required for even slight changes in products.

"Japan's regulatory approval process is the slowest in the industrialized world," Agress said. "A one- or two-year delay is not at all unusual, sometimes more."

Japan is the top international market for U.S. medical-device firms, with products representing some $20 billion in spending.

The possibility of having a smoother, speedier approval process in place marks a significant change in the way the Japanese government has looked at review processes for medical devices.

In many cases, Japan has required that clinical trials be conducted for certain products, even though other nations have not required them. Oftentimes when companies have conducted trials elsewhere before gaining approval in those markets, Japanese authorities have required that clinical trials be conducted on Japanese patients before products can be sold in that country.

"On paper, the requirements are the same for all companies [whether Japanese or otherwise]," Agress said, "but in practice, sometimes foreign companies have increased burdens."

Changes in the way products are approved now may allow U.S. companies greater access to the Japanese market.

NHS sets 3 new biomedical research units

The National Health Service in the UK reported the formation of three new biomedical research units that it said would be at the forefront of a 10 million drive to prevent, diagnose and treat illnesses such as heart disease, asthma and obesity.

The new National Institute for Health Research (NIHR) biomedical research units to be located in Liverpool, London and Nottingham — will focus on "translational research" that will take advances in basic medical research out of the laboratory and into the hospital clinic. The NHS said this means that patients will benefit more quickly from new scientific breakthroughs.

Each of the new units will receive 3.4 million over the next four years.

NHS said that the new units would complement the existing twelve NIHR biomedical research units in Bristol, Leeds, London, Nottingham, Oxford, Sheffield and Southampton, and the 12 NIHR biomedical research centers in London, Oxford, Cambridge, Liverpool, Manchester and Newcastle.

"People who suffer from illnesses such as heart disease, gastrointestinal infections and pancreatic disease will really benefit from these new NIHR biomedical research units," said Public Health Minister Dawn Primarolo. "The new funding will enable high quality research to flourish in these small but excellent research groups and will strengthen our drive to put the UK at the forefront of vital health research, as well as enhancing the nation's international reputation as a center for excellence."

DaVita opens new dialysis clinic in India

Bridge of Life DaVita Medical Missions, a non-profit organization founded by DaVita (both El Segundo, California) that focuses on bringing kidney dialysis services to developing countries, has opened the doors to its newest dialysis clinic in India.

The new clinic is in the Mishirmal Bafnal Parmarath Hospital (Jodhpur) and is the first of two clinics that Bridge of Life-DaVita Medical Mission's partner, International Health Benefit Services, plans to open in India this summer with the support of the non-profit organization.

The dialysis clinic will treat kidney patients at a minimal cost, bringing relief to the region's government hospitals.

In partnership with several healthcare providers and local physicians, Bridge of Life-DaVita Medical Missions also held a "Renal Awareness Camp" in Jodhpur, India, in late April, providing free healthcare screenings, early detection and education materials on kidney disease and kidney failure to more than 150 residents.

Bridge of Life-DaVita Medical Mission translated many of the kidney care resources available in the U.S. and customized them for the Indian diet, lifestyle and culture. That provides a comprehensive toolkit to ensure that the people of Jodhpur are better educated on end-stage renal disease and chronic kidney disease.

DaVita specializes in kidney care, providing dialysis services and education for patients with chronic kidney failure and end-stage renal disease.

China CRO closes on 'A' round

Contract research organization Tigermed Consulting (Shanghai, China) said it has closed its Series A financing from Qiming Venture Partners (also Shanghai).

With the capital injection, Tigermed said it has entered into a period of rapid expansion. It already is one of the largest CROs in China.

"Over the past six years, we have established a globally competitive team with more than 100 professionals. We have set up 13 offices in both the U.S. and China, with 150 business customers from both home and abroad," said Dr. Ye Xiaoping, CEO/founder. "Our leading management and service system and our data management system have laid a solid foundation for the rapid development of [the company]."

Tigermed was founded in 2002, operating 12 branch offices in Shanghai, Hangzhou, Beijing, Guangzhou, Chongqing, Chengdu, Xi'an, Shenyan, Nanjing, Changsha, Wuhan and Ji'nan and one liaison office in California.

Distribution pact for ActiPatch

BioElectronics (Frederick, Maryland) BIEL) reported a new distribution agreement with India-based Piramal Healthcare (Mumbai) has been made for distribution of BioElectronic's ActiPatch product.

ActiPatch is a drug-free patch with an embedded battery-operated microchip that delivers weeks of continuous pulsed RF therapy for less than $1 a day. BioElectronics says that the patented ActiPatch system is designed to provide a cost-effective, home use method for reducing soft tissue pain and swelling, and to accelerate healing.

Piramal will distribute ActiPatch in the Indian market both on medical and retail levels beginning this month.

Large HC investment seen in India

Venture capitalists (VCs) and private equities (PEs) are expected to invest more than $8.5 billion in India in the next five years in at least five identified areas, such as biotechnology and life sciences, logistics, clean technology, film production and education, according to a new report.

A joint Assocham and Deloitte paper, "Indian venture capital — a future scenario," reveals that VCs and PEs, which, for long, have been choosing IT for investment purposes, have found huge investment opportunities in these five areas as regulatory barriers are gradually disappearing.

The report says it is anticipated that biotechnology and life sciences will attract about $1.5 billion in VC and PE investments by 2012.

Sajjan Jindal, president of Assocham, said that India has large opportunities in biotechnology and life sciences on the lines of retail and real estate. This sector has been attracting specialist VCs from global and domestic funds.

The U.S.-based Life Sciences Fund has recently invested about $20 million in a Hyderabad-based pharmaceutical company. Devices and diagnostics are other areas where investors are active.

Abiomed to open Irish plant

Abiomed (Danvers, Massachusetts) said it would open a new manufacturing facility in Athlone, Ireland, that will create 250 jobs over the next 18 months.

The plant will make Abiomed's Impella 2.5 product for patients suffering acute heart failure, and it will be based at the site of the former Conor Medsystems (Menlo Park, California) factory, which closed with the loss of 165 jobs in May 2007.

The company will be moving portions of its manufacturing facility in Aachen, Germany, to Athlone. It said it expected the first manufacturing line in Athlone to be in production within 18 months.

Abiomed said its longer-term plans will be to designate Ireland as its global center of excellence for high-volume disposable product manufacturing.

Curative licenses bone regrowth tech

Inion (Tampere, Finland) has signed an outlicensing agreement with Curative Biosciences (Waltham, Massachusetts), covering certain of its bioactive technologies for the promotion of bone regrowth and repair when treating patients undergoing orthopedic surgical procedures.

Curative will pay Inion a small up-front fee, plus development and sales milestones of up to $2,025,000 and royalties on revenues generated from any products developed using the technology.

The licensed technology is based on the use of N,N-dimethylacetamide (DMA) and its pharmaceutically acceptable salts and prodrugs, either alone or incorporated in resorbable polymer structures such as plates, membranes and screws for implantation in patients.

Patent applications covering this technology in the UK and internationally have been filed and are pending.

Inion is focused on the development and commercialization of biodegradable and bioactive surgical implants in selected orthopedic market segments, including biodegradable plates, screws, pins and membranes, which are used to enhance the healing of bone or soft-tissue injuries, such as those caused by trauma or by reconstructive surgery.

The company's implants are made from its Optima family of biomaterials, with properties tailored for specific surgical applications in terms of strength, flexibility and rate of degradation. Inion also is focused on developing new bioactive and biodegradable biomaterials that promote bone healing and accelerate patient rehabilitation.

ISO for Endosense, Applied Biosystems

Endosense (Geneva, Switzerland), a company focused on enabling the broad adoption of catheter ablation for the treatment of cardiac arrhythmias, has been awarded ISO 13485:2003 certification for its quality management system by the certification authority NSAI.

The international standard for the medical device industry, ISO 13485:2003 verifies the company's ability to provide devices and related services that consistently meet customer needs and regulatory requirements.

Endosense's flagship product is the TactiCath, which it terms "the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure."

The company said that without this measure, electrophysiologists have had to estimate and frequently guess the level of contact force required, as too little force may render the procedure ineffective and too great a force may perforate the heart wall.

The TactiCath is an 8.5 Fr sheath compatible, open irrigated, steerable catheter that integrates Endosense's Touch+ fiber-optic sensor technology at the catheter tip.

Applied Biosystems (Foster City, California) also reported last month that its Singapore facility has received an ISO quality certification, enhancing the company's ability to serve its customers.

The British Standards Institution Americas has awarded the company with an ISO 13485:2003 certification for in vitro diagnostic medical devices. This globally recognized management system standard enables CE marking to the In-Vitro Diagnostics Directive 98/79/EC of products for sale within the European Community.

Applied Biosystems, which currently markets instrument systems for research use only, obtained the certification to support its increased focus on commercial applications of molecular technologies. These include quality and safety testing, human identification, food and environmental testing, forensics, pharmaceutical manufacturing and clinical testing among others.

Applied Biosystems is a global provider of instrument-based systems, consumables, software and services for the life sciences market. The company also makes systems and reagents for DNA sequencing, real-time polymerase chain reaction and mass spectrometry.

Regulatory approvals

A sampling of regulatory approvals in Europe, China, and Japan reported last month:

Angiotech Pharmaceuticals (Vancouver, British Columbia) reported receiving the CE mark for the HemoStream Chronic Dialysis Catheter, allowing it to begin marketing the device in Europe.

The CE-mark approval follows by a year Angiotech's receipt of FDA approval for the catheter.

Angiotech entered into an agreement with Rex Medical (Conshohoken, Pennsylvania) in April 2007 granting it an exclusive license to market and distribute HemoStream worldwide.

CompuMed (Los Angeles) said it has received approval from China's State Food and Drug Administration to market its OsteoGram system for screening, diagnosing and monitoring osteoporosis.

The approval enables CompuMed to sell the OsteoGram product as an approved clinical device in China and will allow the company to work with its Chinese OEMs to target a market with "substantial strategic importance."

NeuroMetrix (Waltham, Massachusetts) said it has completed the CE technical file for its Advance system. With this regulatory step, NeuroMetrix intends to begin marketing Advance to neurologists, clinical neurophysiologists, hand surgeons, and other specialists in the EU.

NeuroMetrix says that Advance is a platform for the performance of traditional nerve conduction studies and needle electromyography procedures. The technical specifications include a precision electrical stimulator and dual recording channels for acquiring nerve conduction responses. A third channel is available for recording needle electromyography signals.

Nexgen Spine (Whippany, New Jersey) reported receiving CE-mark approval for its Physio-L lumbar artificial disc.

The Physio-L is an elastomeric disc prosthesis designed for use in the lumbar spine for patients suffering from degenerative disc disease. The device's elastomeric technology enables the disc to closely mimic the mechanical properties of the natural disc and represents a significant advance over current designs of disc prostheses.

St. Jude Medical (St. Paul, Minnesota) reported receiving both regulatory approval and reimbursement approval from the Japanese Ministry of Health, Labour and Welfare for its Durata defibrillation lead, which it calls a next-generation high-voltage lead.

The Durata lead incorporates a soft silicone tip with a larger surface area and a slightly curved right ventricle (RV) shock coil intended to enhance ease of use and handling for physicians implanting an implantable cardioverter defibrillator system in patients at risk for dangerously fast heart rhythms.