A Medical Device Daily

A method of producing synthetic bone, using techniques normally used to make catalytic converters for cars, is being developed by researchers at WMG at the University of Warwick, UK.

The team is working closely with Warwick Ventures, the university's technology transfer office, to find a suitable partner to help commercialize the technology. It presented its work last week at the national university technology showcase event, Bioversity, organized by the London Biotechnology Network.

WMG's Dr. Kajal Mallick is developing the technique along with James Meredith, a postgraduate researcher. They said they believe it could offer "substantial clinical benefits" to patients undergoing bone implant surgery.

The technique involves extrusion of the implant material through a mould, to produce a 3-D honeycomb texture, with uniform pores throughout. The material can then be sculpted by the surgeon to precisely match the defect.

After implantation, bone cells will be transported into the implant and begin to form new bone.

"We worked with a Japanese company which manufactures catalytic converters and used their facility to produce samples which we could then test in the laboratory," Mallick said.

"We found that we were able to use calcium phosphates a family of bioceramics that are routinely used in bone implant operations, but by using this technique we were able to improve significantly both the strength and porosity of the implant."

Mallick said that at present, "There is no product available in the market place that satisfies both these key properties simultaneously. It is nearly an ideal scaffold structure for efficient blood flow and formation of new bone cells."

The increased strength of the material means it could be used in spinal surgery, or in revision hip and knee operations, where currently non-degradable materials such as titanium or steel may be used. The advantage of increased and interconnected porosity is that the implant can quickly be filled with blood vessels, resulting in a more rapid healing process.

Meredith, who is working to complete an engineering doctorate in this research area, said the synthetic bone being developed "is as strong as normal healthy bone yet porous enough to allow bone cells to inhabit it and generate new bone. Over a period of time, we expect the synthetic bone will reabsorb, leaving only natural bone."

ISO certification for CircuLite

CircuLite (Saddle Brook, New Jersey) reported receiving ISO 13485 certificate of registration from BSI Group for the quality management systems at its facilities in Saddle Brook and in Aachen, Germany, for the design, manufacture and distribution of the Synergy Pocket Micro-pump for the treatment of chronic heart failure.

"The successful completion of the ISO registration process is a significant achievement for CircuLite and an important milestone toward achieving our goal [of] bringing the Synergy micro-pump to patients," said President/CEO Paul Southworth. "The ISO registration reflects our commitment to the highest standards of manufacturing, quality assurance, and safety, and comes at a crucial time as we approach completion of the European registration trial for the long-term use of Synergy in patients with chronic heart failure and pursue CE-mark approval and the initiation of U.S. IDE studies in 2009."

The Synergy Pocket Micro-pump represents a new approach to mechanical circulatory support that can transform chronic heart failure management by providing a less-invasive, elective treatment option for patients before their disease state becomes emergent.

CircuLight said Synergy is "the first implantable system designed to provide partial circulatory support (PCS) for long-term use in millions of unserved patients that have NYHA Class IIIb/early IV disease."

The micro-pump provides up to 3L/min of flow, which increases total cardiac output and offloads the heart allowing it to rest, potentially enabling beneficial recovery of heart function. The size of a AA battery, the device is small enough to be implanted subcutaneously in a "pacemaker-like" pocket through a minimally-invasive procedure.

READNA consortium under way

Oxford Nanopore Technologies (Oxford, UK) said it is participating in the Revolutionary Approaches and Devices for Nucleic Acid (READNA) analysis project. The newly-launched READNA consortium includes researchers from 16 academic and industrial institutions and will receive 112 million in funding over four years, under the European Union's Seventh Framework Program (FP7).

As part of the consortium, Oxford Nanopore will receive €730,000 in grant funding to support the development of its nanopore technology into an early exonuclease/nanopore DNA sequencing system.

The company said it also will work on projects to integrate protein nanopores and solid-state materials for the further progression of nanopore sequencing, the development of a new technique that uses nanopores for genome-wide methylation studies, and the development of droplet-based bilayer arrays for rapid, multiplexed genotyping.

Oxford Nanopore will collaborate closely with researchers from the University of Oxford, including Professor Hagan Bayley's Chemical Biology group, the Biological Physics group and the Wellcome Trust Centre for Human Genetics.

The university will receive €2 million to support READNA projects.

"We are [pleased] to be part of the READNA project, which includes representatives from Europe's leading research institutions and developers of genomic technologies," said Oxford Nanopore CEO Dr. Gordon Sanghera. "The consortium aims to revolutionize nucleic acid analysis."

He added, "Our role as the developer of a new generation of sequencing technology, based on nanopores, is critical to the project. With support also being given to our academic collaborators, we believe we are in the best position to deliver a meaningful improvement in sequencing technology with our label-free, single-molecule nanopore system."

Overall, the project aims to progress toward a target of sequencing a complete human genome for €1000, with the promotion of new sequencing technologies being central to that goal.