A Medical Device Daily
eResearchTechnology (Philadelphia) and nSpire Health (Longmont, Colorado) reported an alliance to provide integrated cardiac safety and pulmonary core lab services to clinical researchers worldwide.
eResearch provides centralized electrocardiographic (ECG), eClinical technology, ePRO, and other services to the pharma, biotech medical device and related industries.
nSpire is a provider of respiratory clinical trials services, including cardiopulmonary exercise testing, high-definition pulmonary diagnostics systems, spirometry, and home monitoring.
nSpire and eRT will deliver a combined solution for cardio/pulmonary safety/efficacy services during clinical trials, ranging from project planning and set-up through study conduct, management, and data delivery for primary and secondary cardiac and respiratory clinical trial endpoints.
"This alliance addresses a growing need in clinical research to offer comprehensive, best-in-class services in these two closely related areas of clinical study," said Michael McKelvey, president/CEO of eRT. "eRT and nSpire Health approach the market in the same way ... . We are both metrics driven and process oriented to ensure on-time, on-budget, reliable data delivery on a global scale."
In other agreements: Orthovita (Malvern, Pennsylvania), a spine and orthopedic biosurgery company, reported obtaining rights to distribute an absorbable hemostat product developed by Medafor (Minneapolis). Financial terms were not disclosed.
The product is approved for use as a hemostat in certain surgical procedures under a pre-market approval granted by the FDA in 2006 and a CE Mark granted in 2003. Orthovita said it will rebrand the product as Vitasure Absorbable Hemostat.
Vitasure's mechanism of action is based on Medafor's microporous polysaccharide hemosphere technology. Vitasure acts as a molecular sieve to instantly extract fluids from blood, creating a powerful osmotic action that causes the particles to swell and concentrates serum proteins, platelets, and other formed elements on its surface. The Vitasure particles and their coating of compacted cells then create a matrix for the formation of a tenacious fibrin clot. The VITASURE particles are fully absorbed and enzymatically cleared within 24 to 48 hours.
Under its distribution agreement with Medafor, Orthovita has the non-exclusive right to sell Vitasure in the spine and orthopedic field in the U.S., and certain territories outside of the U.S. Medafor has responsibility for manufacturing and maintaining regulatory approvals for the product.