Osteotech has signed an exclusive U.S. distribution agreement with Harvest Technologies, a privately held company based in Plymouth, MA, for its Bone Marrow Aspirate Concentrate (BMAC) System.
The BMAC System concentrates autologous stem cells from bone marrow aspirate in approximately fifteen minutes.
In May 2007, Harvest was granted an Investigational Device Exemption by the FDA to commence a 48-patient ‘feasibility’ trial using the BMAC System to treat patients with critical limb ischemia (CLI).
CLI is a late-stage form of Peripheral Arterial Disease, which involves clogged arteries — commonly in the legs — that can result in toe or foot amputation. It is anticipated that the delivery of a composition of autologous bone marrow cells to the affected limbs of these patients will reduce the possibility of amputation and improve symptoms.
A promising study presented at the International Symposium on Perioperative Blood Management in October supports these conclusions.
The trial examined 51 patients with CLI. Nearly all of these patients were scheduled for leg amputation. After the injection of a concentrate of autologous bone marrow stem cells, amputation was avoided in more than half of patients; under normal circumstances the amputation rate in this population is >90% within one year.
Provided Harvest can make a case for BMAC, the product should fit synergistically within Osteotech’s bone regeneration portfolio.
Through two distinct operating segments, Osteotech provides Demineralized Bone Matrix and Base Allograft Bone Tissue.
Osteotech’s demineralization process creates a product which, when applied to cortical bone, yields allograft bone tissue with osteoinductive (the process by which bone is induced to grow) and osteoconductive (the matrix provided by allograft bone tissue into which the host bone can grow) properties.
In its Base Allograft Tissue Segment, Osteotech processes allograft bone tissue into mineralized weight-bearing forms. The variety of forms includes femoral cross sections, fibula wedges and cortical struts.