A Medical Device Daily
Medical Device Daily recently reported eight companies “in the hunt” to commercialize an artificial disc and overtake Depuy Spine (Raynham, Massachusetts), the only company so far to win product FDA approval in what is expected to be a fast-growing and important sector once the technology is fully mature (MDD, June 10, 2005).
Add one more to that list of eight.
Medical device firm Ranier Technology (Cambridge, UK) has reported receiving $7.3 million ( 4 million) in a second institutional funding round. The funding was provided by FNI Venture Capital, an investor in Ranier’s first funding round in 2002.
Ranier said that the new funding will be used to push forward the development, through clinical trials, of its spinal disc implant, CAdisc.
Dr Geoffrey Andrews, CEO of Ranier, said that the financing will provide enough money “to ensure CAdisc progresses to become a leading contender for the next-generation artificial lumbar disc.”
CAdisc is a polyurethane disc based upon Ranier’s patented Precision Polyurethane Manufacture (PPM) bio-materials technology. It is designed to mimic and restore the physiological properties and bio-mechanics of the natural spinal disc. Ranier says that it offers “improved device durability, motion restoration and minimal stress on adjacent spinal segments, which will result in significant benefits for patients.”
Peter Wolfers, of FNI Venture Capital, said about the CAdisc: “It is a very promising device, backed by strong intellectual property and technology. We are confident that the CAdisc development program will lead to a new standard of treatment for total disc replacement.”
Ranier puts the worldwide spinal implant market at more than $3.7 billion dollars a year and growing at more than 12% annually. It estimates the total disc replacement market at growing to $1.4 billion by 2010.
FNI Venture Capital is the UK venture capital investment arm of the German-based Renate Nixdorf Verwaltungsgesellschaft.
Nephros launches studies in 5 countries
Nephros (New York) recently reported the launch of supplemental clinical trials across five countries of Europe to demonstrate the effectiveness and cost savings achieved through the use of its OLpur MD190 filter product in providing therapy for chronic end stage renal disease (ESRD). The trials are being initiated in the UK, France, Germany, Italy and Sweden.
Nephros describes the OLpur MD190 as a cartridge that refines the process of hemodiafiltration “by combining two forms of therapy known as post-dilution and pre-dilution diafiltration into a single filter. . . . OLpur MD190 combines the superior clearance of small molecular weight toxins, such as urea, attributed to post-dilution hemodiafiltration, with the superior clearance of middle-molecules, such as beta 2 microglobulin, associated with pre-dilution hemodiafiltration.” The OLpur MD190 is designed for use with existing hemodiafiltration machines and is CE-marked.
Nephros said it will conduct three separate trials with durations ranging from six to 12 months. Enrollment of the studies is now underway, with a total of about 250 patients, including 150 patients for whom the participating clinics will purchase Nephros filters, and 100 additional control patients.
Nephros said that the studies will, among other things, examine the effectiveness of the OLpur MD190 in removing a range of toxins from the patients’ blood; changes in patients’ prescription drug usage for anemia, phosphatemia and other conditions; potential cardiovascular benefits of the therapy; and other factors contributing to overall therapy cost and patient well-being, such as hospitalizations and nursing care.
“We believe that by offering a marked improvement in clearing toxins, particularly ‘middle molecules,’ from the blood, our MD190 filter can reduce hospitalization, medication and care costs as well as improve overall patient health, with a concurrent reduction in drug requirements,” said Norman Barta, CEO of Nephros. “We believe these clinical trials will validate, and expand upon, the excellent results we achieved in our 2003 study in France.”