The most important factor to reliably form bone that is under the surgeons control is to maximize the number of stem cells in the matrix.
The current standard of care for bone and spinal fusion procedures, autograft, is an open surgical procedure to harvest autogenous (patient’s own) bone from the iliac crest. Of all the bone graft options available to clinicians, autograft has the highest number of nucleated cells per milliliter and is consequently still considered the gold standard of bone grafting, despite its associated morbidity.
The cellular content of autograft is high because the cells are embedded into the cut bone which, when ground to shape, also serves as a functioning matrix. The autograft procedure, while clinically effective because of the high cellular content of the graft, requires a second open surgery, and exposes the patient to increased blood loss, risk of infection, significant chronic pain and extended hospital stay. The autograft failure rate increases significantly in patients who have comorbidities such as diabetes and osteonecrosis.
Lastly, in multi-level spinal fusion procedures, not enough autograft can be harvested from the patient. As a result of these limitations, there is a growing market for less invasive alternatives to autograft for bone grafting procedures with improved clinical outcomes. Marrow aspiration is a much less invasive way to harvest nucleated cells compared to autograft, but current aspiration techniques result in excess peripheral blood that dilutes the number of cells.
Technology that increases the number of cells in the aspirate by reducing peripheral blood contamination or allows the clinician to perform a secondary procedure to remove the excess peripheral blood to increase the concentration of cells in the treating composition to mimic autograft in a less invasive manner will improve surgical outcomes.
Increasingly plastic surgeons are looking to fill in areas to bulk the underlying tissue to remove wrinkles or to replace a void due to trauma such as a mastectomy. Products that allow a surgeon to more easily aspirate and improve the cellular content of the graft will improve those surgical outcomes.
There are some 1 million bone grafting procedures done annually in the US, with spinal fusions, representing the largest segment at approximately 450k procedures. Use of bone marrow aspirate to stimulate bone growth in spinal fusion surgery is a standard of care. The aspirate is typically mixed with a matrix to form a three dimensional scaffold that is then transplanted into the patient.
There are three segments in the bone graft matrix market: allografts, including demineralized bone matrices (DBMs); synthetics, and bone morphogenetic proteins (BMPs). Allografts, DBM and synthetic bone substitutes, provide a scaffold for bone growth and are ideal for saturating with bone marrow aspirate and or concentrated bone marrow. BMP’s are being phased out due to safety and efficacy concerns.
There are over 500,000 orthopedic bone graft procedures performed annually in the US. Several authoritative studies have demonstrated that the success of a bone graft is highly correlated to the number of nucleated cells contained in the graft.
The following quote, from a letter to EndoCellutions from Dr. Thomas Einhorn, Chief of Orthopedic Surgery at Boston University Medical Center and Professor of Orthopedic Surgery at the Boston University School of Medicine, summarizes the emerging perspective of a leading clinician: “…with adequate development capital, your technology provides a framework which will meet the ideal product specification for the or, namely over 85% volume reduction of the marrow aspirate while capturing [a substantial majorityof the target cells in the concentrate.”
A rapidly growing field of internal medicine is devoted to treating injuries related to sports or athletics by treating trauma using growth factors and or stem cells. The treating biologics used in these procedures is typically PRP, bone marrow aspirate, concentrated bone marrow aspirate, adipose tissue or combinations thereof.
The fastest growing procedure in plastic surgery today is enhanced fat grafting using centrifuged fat aspirate. This fat is often combined with other biologics such as PRP. We have interest from a number of groups for our adipose and PRP concentrate devices. The primary target market for the adipose grafter and the SVF concentrate tool is the plastic surgery market with a secondary market being sports medicine. The EC PRP device can be used in the hospital market for sternal closure in the cardiac space, in sports medicine, and for plastic surgery.
Changing Healthcare Economics
Increasingly, expensive options to treat patients are being squeezed from the healthcare system due to cost constraints. This is leading to a two-tier system where more economically advantaged patients are seeking better care through self-pay clinics. Whether in the hospital setting or the private clinic, procedures that rely on tissue from the patient are always going to me more affordable than other synthetic or pharmaceutical options.