Medical Device Daily Contributing Writer
and MDDs

Axordia (Sheffield, UK) reported plans for the clinical application of one of its proprietary stem cell lines in a next-generation stent that will prevent restenosis without the increased risk of late-stage thrombosis that can occur with existing drug-eluting stent (DES) devices.

The company will collaborate with Lombard Medical Technologies (Oxford, UK) in the development of the so called “regenerative” stent. The project will involve combining Axordia's stem cell-derived endovascular cells with Lombard's polymer coating, which can be programmed for the timed release of the active ingredient.

The current generation of DES devices is designed to restrict local vascular repair following angioplasty. That prevents restenosis, an inflammatory thickening of the artery. However, recent evidence suggests that there are higher rates of thrombosis, where a clot forms at the end of the stent. It is believed clot formation is linked to the delayed healing of the blood vessel.

Axordia said the endovascular cell line will promote healing at the site where the stent is implanted while at the same time reducing inflammation and creating a localized immune-privileged site to prevent the body from rejecting the stent.

Alistair Taylor, chairman of Lombard, said there is significant potential for a regenerative stent that will reduce restenosis without prompting late-stage thrombosis. “A system that engenders normal healing of the tissues may well reduce these late complications.”

It would be the first clinical application of Axordia's stem cell technology. The company, which spun out of Sheffield University , has concentrated on developing cell lines for use in drug discovery and in refining and developing GMP-grade manufacturing processes for stem cells.

Paul Gerskowitch, CEO of Axordia, said the collaboration is evidence that the company is in a leading position in delivering safe clinical applications for stem cells. Another UK stem cell company, NovaThera , is taking a similar approach to commercializing clinical applications of stem cells, by working with manufacturers of artificial lung and heart machines.

Axordia and Lombard agreed to collaborate on the project over the next 2-1/2 years, but did not reveal the terms of the agreement. The current global market for DES devices is estimated at $6 billion.

UK fair-trade office eyes U.S. firms

The UK Office of Fair Trading (OFT) has received a complaint about three Minneapolis-area companies allegedly involved in price fixing, but hasn't started a formal investigation yet, a spokeswoman said on Sunday.

London's Sunday Times reported the OFT is looking into whether Medtronic (Minneapolis), St. Jude Medical (St. Paul, Minnesota) and Boston Scientific 's Guidant division (also St. Paul) allegedly colluded to boost the prices paid by the UK's National Health Service for pacemakers.

The UK Department of Health recently sought bids for pacemakers, and none of the three companies that control an estimated 90% of the U.S. market submitted “valid'” bids, according to the Sunday Times.

A Boston Scientific spokesman told the newspaper the company's actions were appropriate and in the best interests of doctors and patients. A Medtronic spokesman said the allegations “are wholly fabricated.”

A spokeswoman for the Department of Health said Monday the agency has asked the Office of Fair trading to “consider issues relating to the operations of the market,” but declined to comment further.

UK company acquired by Sigma-Aldrich

Sigma-Aldrich (St. Louis) reported that it has acquired Pharmorphix (Cambridge, UK), a company that offers solid-form research services to the global pharmaceutical and biotech markets.

It said the addition of Pharmorphix will broaden SAFC Pharma 's manufacturing services customer base and enhance its technology services offering for existing customers.

Terms of the purchase, which were not disclosed, were paid in cash.

All current employees, including the existing Pharmorphix management team, will remain with the company.

Pharmorphix operates in facilities in Cambridge Science Park near London.