Palpation alone to determine the appropriate needle trajectory is recognized as a contributing factor in the acquisition of non-diagnostic BMTB specimens [1, 2].
CHARLOTTESVILLE, VA, May 20, 2020 — RIVANNA announced that the company was awarded a $1.5M research grant from the National Cancer Institute of the National Institutes of Health to commercialize a low-cost, 3D image-guidance system explicitly designed to facilitate bedside bone marrow and trephine biopsy (BMTB) procedures. The developmental platform, Accuro 3S, will build on patented BoneEnhance® and SpineNav3D™ technologies, designed to automate and improve needle guidance. 3S-series innovation serves to expand the Accuro product line, addressing needs in additional healthcare markets, including orthopedic and emergency and diagnostic medicine.
NON-DIAGNOSTIC BIOPSIES
BMTB is the gold standard for diagnosing and monitoring hematological disorders and malignancies [3, 4]. Although bone marrow biopsies rarely cause serious adverse events [4, 5-7], it is essential to minimize the number of non-diagnostic biopsies as repeated testing delays diagnosis and treatment, consumes additional healthcare resources and causes unnecessary patient anxiety and discomfort [8, 9-11]. Core length from bone marrow biopsy is a critical determinant in making an accurate diagnosis [4, 12, 13]. World Health Organization guidelines recommend that core lengths exceed 1.5 cm. However, multiple studies have reported that 20 – 50% of core lengths are ≤ 1.0 cm [14-19, 12], suggesting that these clinical recommendations are not regularly met.
Two contributing factors in the acquisition of non-diagnostic BMTB specimens are inter-operator variability among healthcare providers and challenging needle placement in obese patients [14-20, 1, 21-22, 12]. These factors stem directly from the difficulty associated with relying on palpable surface anatomical landmarks to guide needle placement to the posterior iliac crest, which may be as deep as 10 cm in obese subjects [1, 2]. Unfortunately, reliance on palpation alone to ascertain the appropriate needle trajectory often results in biopsy retrieval from thin sections of the crest or the sloped surface of the ilium, yielding short trephine [23- 26]. In the absence of bedside image-guidance options, obese patients, and otherwise difficult cases are instead sent to interventional radiology for a high-cost CT-guided procedure [2, 27].
COST-EFFECTIVE IMAGE GUIDANCE
Conversely, ultrasound is a cost-effective image-guidance solution readily deployed at the bedside. It has improved success rates for a wide range of bedside procedures, including soft-tissue biopsy [33-35] and regional anesthesia [36]. However, despite the widespread availability of conventional 2D ultrasound, it has not been investigated for BMTB guidance due to its steep learning curve and the perceived difficulty of interpreting 2D ultrasound images of bone anatomy [25, 28].
RIVANNA’s flagship device, Accuro®, automates ultrasound image detection of spinal landmarks, thereby eliminating conventional ultrasound’s steep learning curve. It guides users to the optimal spinal location and depth for needle placement during neuraxial anesthesia. Unlike conventional ultrasound systems, it enables even novice users to use precise image guidance to augment blind palpation for needle placement [29-30].
“The Accuro spinal navigation device improves the interpretability of boney anatomy within 2D and 3D ultrasound images,” says Will Mauldin, PhD, co-founder and CEO of RIVANNA. “Our intension is to introduce this technology to the hematology/oncology community to help overcome the ultrasound learning curve and extend the proven benefits of real-time ultrasound guidance to patients and practitioners of BMTB procedures.”
The use of an effective bedside guidance solution, such as Accuro 3S, is anticipated to significantly reduce the cost of administering BMTBs due to decreased utilization of interventional radiology services. Of the 660,000 annual BMTB procedures, approximately 160,000 (25%) are performed using CT guidance [2, 31]. According to the 2018 CMS Physician and Hospital Fee Schedules, CT guidance increases the fee of each BMTB procedure by $2900 ($1400 vs. $4300 [32]). Thus, the added cost borne by US healthcare payers for CT-guidance of BMTB procedures is approximately $480 M each year.
“We’re responding to the clinical need for easy-to-use bedside guidance with 3D bone imaging performance of CT, and automated image interpretation to promote adoption by novice users,” says Mauldin. “We expect this will yield more positive patient outcomes and reduce reliance on high-cost CT-guided procedures following bedside failures.”
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