Making Kidney Biopsies Safer for All Patients

Team: SealCore

Program: Biomedical Engineering

Kidney biopsy procedures are one of the most common procedures in patients with renal disease. Findings from kidney biopsy procedures are the gold standard in diagnosing, characterizing, and monitoring the progression of kidney disease. Although renal disease is one of the most common diseases in America, only about 60,000 procedures are performed on an annual basis. This is because there are significant risks associated with the procedure. Of these 60,000 procedures performed annually, almost 75% cause some degree of bleeding and about 5-10% of the time major hemorrhage events occur. Major hemorrhage events may result in prolonged hospitalization, further intervention, occasional loss of kidney function and, in rare cases, even death. These risks often prevent physicians from performing biopsies on patients that are considered to be high risk. High bleeding risk patients typically include those that are anticoagulated patients, obese, receiving or have received chemotherapy, have liver disease, and many others. We estimate there to be several million CKD patients for whom biopsy is currently deemed prohibitively risky, leaving concrete diagnosis impossible and their treatment pathway unclear. These patients are now treated based on clinical evaluation alone which is subjective and largely affected by the clinician’s experience. Providing these patients a safe method of biopsy will afford them a chance to receive truly optimal kidney care, ultimately reducing painful, costly complications and unnecessary mortality.

This is where SealCore comes in. The device SealCore is developing is unique in that it consists of two main components: the needle and a hydrogel that will provide a method of hemostasis. There is no other competitor on the market that includes a hemostasis method. Our needle will be placed into the lower pole of the kidney through a percutaneous approach, meaning through a minor incision on the skin. Via ultrasound guidance, a sample will be taken from the site for pathology analysis. This part of the procedure is identical to the typical kidney biopsy procedure performed by nephrologists and interventional radiologists. The latter typically take between two and five passes to get adequate tissue in the sample. This increases the risk of bleeding in patients, especially in those who are already vulnerable and at late stage of kidney disease. Our company solves this problem by providing a method of hemostasis after tissue extraction. Following the extraction of the sample, the needle will dispense a hydrogel that, once activated, stops bleeding.