Medical Device Daily and Staff Reports

Boosted by strong uptake for its products in the U.S., French spinal implant manufacturer Medicrea (Lyon) reported 2007 sales growing 24% year-on-year.

But the costs associated with posting that vigorous top-line growth cost the company on the bottom. On total sales of €3.1 million ($4.4 million), Medicrea reported a loss of €2.1 million ($3 million).

The cost of launching sales in the U.S. was a smaller loss compared to that for securing and consolidating control of distribution within the French market from Zimmer France (Montbeliard). Now established, the company’s subsidiary, Medicrea Europe Francophone, plans to accelerate its business development in French-speaking Belgium and Switzerland.

In the U.S., demand for the company’s C-Jaws cervical compressive staple accounted for a fourth of Medicrea’s sales for the first half of this year, six months after the product came on the market.

Anticipating a continued “market response already well above target” through the remainder of the year, Medicrea projects sales for the second half to be up 42% year-to-date, including another $1 million in sales of C-Jaws.

The U.S. market for spinal implants accounts for 85% of worldwide sales.

Medicrea also is counting on scoring big in the fourth quarter with PASS2, a polyaxial articulated spinal system that will be introduced at the annual meeting of the North American Spine Society (NASS; Burr Ridge, Illinois) in Austin, Texas, later this month.

This second generation of the company’s flagship spinal line was redesigned for American surgeons and approved by the FDA in October 2006.

Earlier this year, Medicrea reported sales revenue down 24% at $7.7 million (Medical Device Daily; May 18, 2007).

$8.5M financing round for AirInSpace

AirInSpace (Paris), which bills itself as the leading supplier of mobile “catch and kill” bioprotection devices in the French medical market, reported closing on a €6 million ($8.5 million) Series B round of financing, led by Matignon Technologies II, with Oddo AM as a second investor.

“This financing ... provides key financial resources to fuel our company’s growth in the U.S., Asia and Europe [and] brings additional invaluable industry experience to our board of directors,” said Laurent Fullana, company CEO. “We are now in a position to ramp up international sales and support more hospitals all over the world with new technology that ensures safe air for better health.”

AirInSpace said its “one-of-a-kind” technology can “significantly reduce” airborne microbial contaminants.

The technology stems from research aimed at protecting Russian cosmonauts and equipment in space.

AirInSpace has adapted its technology for air treatment in healthcare facilities, introducing a new line of products that lowers the levels of airborne pathogens in order to reduce incidences of nosocomial infections. The company said its solutions are “more cost-effective and flexible than traditional air-treatment technologies.”

AirInSpace’s flagship product is a mobile air-decontamination unit called Plasmair. The company said the Plasmair unit’s performance “has been clinically proven to lower airborne biological loads and is now being used to combat nosocomial infection to protect patients, staff and products in high-risk areas of more than 100 hospitals and clinics throughout France, including hematology wards, ICUs, pharmacies and operating theaters.”

“During our evaluation of the technology, we were very impressed by the added value delivered,” said Dr. Thierry Chignon, partner in Matignon Technologies. “One hospital we interviewed had previously closed down one operating room that did not meet the air quality standards. In just a few days, a Plasmair unit was installed, and the operating room could be used again. The alternative for the hospital was to do massive reconstruction of its ventilation system that would have taken many months and cost much more.”

Studies: positive results with TRC technology

Aastrom Biosciences (Ann Arbor, Michigan) said positive interim results from two separate research groups using autologous stem cell products manufactured with the company’s Tissue Repair Cell (TRC) Technology platform were presented at last week’s 2nd Congress of the German Society for Stem Cell Research in Würzburg, Germany.

The first study reported positive results from the use of Aastrom Vascular Repair Cells (VRCs) in the treatment of chronic diabetic foot wounds associated with critical limb ischemia (CLI).

In another presentation, positive results from the use of Aastrom Bone Repair Cells (BRCs) in the treatment of osteonecrosis of the femoral head were presented.

Dr. Bernd Stratmann of the Diabetes Center at the Heart and Diabetes Center of North Rhine-Westphalia Center (Bad Oeynhausen, Germany), presented interim results from the first 13 patients treated in a multi-arm Phase I/II single-center clinical trial to evaluate the safety of VRCs and normal bone marrow cells in the treatment of chronic diabetic foot wounds associated with CLI.

Twelve months post-treatment, all patients in the interim analysis who were treated with VRCs reported no major amputations, no cell-related adverse events, and healing of all open wounds.

“These encouraging results indicate that VRCs are safe for therapeutic use and could offer potential advantages over the current standard of medical care in closing chronic wounds and in reducing the risk of amputation for diabetic patients with CLI,” said Stratmann, a primary investigator in the trial.

In a second presentation, Ulrich Nöth, MD, of the Orthopaedic Institute at the University of Würzburg, reported results involving the first use of Aastrom BRCs to treat patients suffering from osteonecrosis of the femoral head, which in many cases leads to total hip replacement.

Nöth reported on four patients that he said tolerated the procedure well, have reported a reduction in hip pain with no signs of disease progression, and were back at work within six months after treatment. No cell-related adverse events were observed and none of these patients have required hip replacement surgery.

“There are currently no effective treatment options for terminating or reversing this disease process,” Nöth said. “The use of cell-based therapies has great potential and could play an important role in the treatment of femoral head necrosis in the future.”