A Medical Device Daily

Advanced Medical Diagnostics Holding (AMD; Waterloo, Belgium), a privately held company committed to providing computer-aided solutions (HistoScanning) that improve the diagnostic interpretation of ultrasound scans, reported the completion of a Series C round investment securing a total financing package of €7.5 million.

HistoScanning is a tissue characterization technology that has been developed to differentiate, characterize and visualize solid organ tissue types based on the analysis of backscattered ultrasound. It is designed to support the physicians' diagnosis and treatment decisions.

Prostate HistoScanning, released in Europe, is a specific product to support the management of men suspected of or presenting with prostate cancer. HistoScanning products for breast, thyroid and ovaries are under development.

Experience of users supports the finding that Prostate HistoScanning provides clinically relevant information not available through standard techniques.

Johan Braeckman, Urologist at the University Hospital of the Free University of Brussels and an early clinical investigator and user of Prostate HistoScanning summarized his experience: "Since I started using HistoScanning routinely for the clinical assessment of my prostate patients I have developed a better perspective on prostate cancer and the context of the biopsies I do. For a substantial number of my patients HistoScanning has revealed information which led to discovery of clinically relevant prostate cancer. The benefits suggested by the clinical studies done to date, do indeed translate into routine clinical practice."

Today Prostate HistoScanning has active users in Belgium, the Netherlands, Germany, Finland, the UK and Czech Republic, and the company is continuing to add new markets to its distribution network. AMD has a commercial relationship with BK Medical for the distribution and promotion of Prostate HistoScanning.

UK to ban private organ transplants

The British government said that it plans to ban private organ transplants from dead donors to allay fears that prospective recipients can buy their way to the front of the line. A government-commissioned report recommended that organs donated within the state-run National Health Service should stay within the public health system.

Very few Britons have private transplants, so in practice the new rules will stop overseas patients from coming to Britain and paying privately for a transplant.

The report by Elisabeth Buggins, former head of the Organ Donation Taskforce, was commissioned after a media storm over cases in which foreign patients were given transplants from dead Britons.

Buggins said that for most people, "financial gain from the transplant of donated organs feels morally wrong."

She said most people who wanted to donate their organs assumed they would be given to people on an NHS waiting list, and the idea of "queue-jumpers" could deter donors.

"While I found no evidence of wrongdoing in the way organs are allocated to patients, there is a perception that private payments may unfairly influence access to transplant, so they must be banned," Buggins said.

Citizens of other European Union countries will still be entitled to publicly funded transplants in some circumstances, but the report said these should be tightened and clarified.

The ban does not affect transplants from living donors such as kidney transplants which can still be carried out privately as long as no money changes hands.

The report also said there should be greater transparency in the way organs are allocated.

The government said it accepted the recommendations and hoped to enact the ban by October.

There are currently about 8,000 people waiting for organ transplants in Britain. In the past year, about 3,500 patients received transplants but another 1,000 on the waiting list died.

France rescinds ban on Osteotech subsidiary

Osteotech (Eatontown, New Jersey), a developer of biologic products for regenerative healing, reported that the French regulatory agency, afssaps, has rescinded its Dec. 17, 2008 order establishing restrictions on the importation and distribution of tissue products processed from donors procured by TB OsteoCentre Bulgaria EAD (OCBG), a subsidiary of Osteotech. During its inspections, afssaps obtained and tested a number of samples of Osteotech's Grafton DBM processed from OCBG donor tissue and found no instances of contamination. As a result of this favorable outcome, Osteotech lifted its self-imposed temporary suspension and will begin distributing tissue grafts processed from OCBG donors to its foreign distributors immediately.

"The results of the afssaps inspections and testing demonstrate the safety and effectiveness of Osteotech's proprietary processing technologies," stated Sam Owusu-Akyaw, Osteotech's president/CEO. "Over the last 17 years, Grafton has been proven to outperform competitive bone grafting solutions, a position that is supported by extensive clinical studies that have demonstrated efficacy and safety. Based upon our superior processes and dedication to quality, we have successfully distributed more than four million tissue grafts, including 8 million ccs of Grafton, without a confirmed case of disease transmission."

The afssaps action came after a re-inspection of OCBG by afssaps in which OCBG successfully closed the audit deficiencies associated with donor record maintenance and traceability with the OCBG procurement program. Osteotech's processing facilities, which process the OCBG donor tissue into implantable tissue products, were also inspected by afssaps, and the agency indicated that its inspection resulted in no audit findings.

"None of the audit issues raised by afssaps was a result of product contamination or deficiencies in the tissue grafts," said Greg Cannedy, VP of Regulatory Affairs at Osteotech. "Our goal was to resolve the deficiencies cited in the afssaps audit report as soon as possible. With this decision by afssaps we continue to build upon our excellent safety track record. Osteotech remains dedicated to providing proven technology and safe products that patients and surgeons can rely on to deliver superior outcomes to the patient."