A Medical Device Daily

Aastrom Biosciences (Ann Arbor, Michigan) and Orthovita (Malvern, Pennsylvania) reported signing an agreement to develop products for the orthopedics market using Vitoss, Orthovita's synthetic ceramic matrices and ceramic-collagen matrices, and Tissue Repair Cells (TRC), Aastrom's bone marrow-derived product.

The companies said that the combination of Vitoss and TRCs would benefit a broad range of orthopedic indications to regenerate tissue. No financial terms for the agreement were disclosed.

Orthovita's Vitoss scaffolds are marketed for providing non-load-bearing geometric support during new tissue growth. Aastrom's TRCs, a mixture of stem, stromal and progenitor cells produced from the patient's own bone marrow, are being used in Phase I/II clinical trials evaluating the regeneration of new bone and blood vessels in patients.

Antony Koblish, president and CEO of Orthovita, said, “Autologous TRCs and Vitoss are two clinic-ready technologies that potentially represent a major step toward the future for combinations of autologous bone marrow-derived stem cell and biomaterial driven therapies for orthopedic and spine treatments.“

The first phase of this collaboration is under way, with Orthovita's Vitoss scaffolds being used for patient treatment in Aastrom's Phase I/II clinical trial in Barcelona, Spain, for severe non-union fractures. The companies said they are exploring additional indications that could benefit from the combination of TRCs and Vitoss, adding that they expect to expand the collaboration into a longer-term relationship sometime this year.

Aastrom's TRC products contain large numbers of stem, stromal and progenitor cells that are produced from a small amount of bone marrow cells originating from the patient. Its Replicell System is an automated cell product manufacturing platform, developed for the production of standardized, patient-specific TRC products. The company recently reported positive interim clinical trial results for its TRCs demonstrating both the clinical safety and ability of TRCs to induce healthy new tissue growth.

Orthovita provides technologies for commercialization of synthetic, biologically active, tissue engineering products for orthopedic and neurosurgical applications.

In another tissue repair agreement, OsteoBiologics (OBI; Sans Antonio, Texas) and Alphatec Spine (Carlsbad, California) said they have signed an agreement in which Alphatec will have the exclusive U.S. marketing rights for certain spine products manufactured from OBI's PolyGraft material technology. The Alphatec products will be available in various forms for use in bone void filling applications in the spine, especially in the cervical and lumbar regions of the spine.

“The spine represents the most significant market opportunity for bone void-filling products,“ said Fred Dinger, president and CEO of OBI.

OBI manufactures bioabsorbable polymeric scaffolds, films and related instrumentation for the repair and replacement of bone, soft tissue and articular cartilage.

Alphatec says its competitive advantage is its R&D focus in combination with an ability to manufacture spinal implant devices and related instrumentation.

In another agreement, Kurve Technology (Bothell, Washington), a developer of nasal drug delivery devices, reported an agreement with Schering-Plough (Kenilworth, New Jersey) for use of Kurve's Controlled Particle Dispersion (CPD) technology platform and ViaNase device line.

Kurve's ViaNase electronic atomizer – using CPD tech – intranasally delivers topical, systemic and nose-to-brain therapies better than traditional nasal delivery devices, according to the company, calling ViaNase the first nasal drug delivery device that saturates the entire nasal cavity, thus enabling delivery to the paranasal sinuses.

Kurve also has an office in Research Triangle Park, North Carolina.