Precision Biopsy. Redefined.
NeoNavia AB is a privately held, founder-led Swedish MedTech company focused on advancing breast cancer diagnostics. NeoNavia® is the brand name of its biopsy system.
NEODOC-8-1517_01.00
NeoNavia is a breast biopsy innovation that builds on patented Pulse Technology, based on research at the Karolinska Institutet in Sweden.
INTRODUCING
Precision You Can Control. Utilizing Pulse Technology to enable precise and controlled needle insertion in ultrasound-guided biopsy procedures. One System. Three Needle Options. The Click-and-Go System supports three needle options VacuPulse™, FlexiPulse™ and CorePulse™ addressing a wide range of clinical scenarios. More Tissue. More Confidence. Thoughtfully engineered to support maximized tissue yield for demanding diagnostic procedures.
One system for all ultrasound-guided biopsies with the flexibility of three needle options, with pulse control: FlexiPulse™, VacuPulse™ and CorePulse™
Pulse Technology for Ultimate Precision and Control During Insertion
Control and precision during needle insertion 2 - 4 Maintained control throughout the procedure 2 - 4
Patented Pulse Technology is based on a pneumatic needle insertion mechanism that generates high needle acceleration and velocity. 1 In combination with a short stroke length, in the order of millimeters, and the ability to apply multiple consecutive pulses , the physician can insert the biopsy needle in a stepwise and controlled manner without noticeable deformation or displacement of surrounding tissue on the ultrasound image and irrespective of tissue properties.
Stabilization of lesion during insertion 2 - 4
Causes deformation of surrounding tissue during needle insertion TRADITIONAL METHODS
PULSE TECHNOLOGY
Insertion is precise and controlled and surrounding tissue is stablaized
Easy Click-and-Go System With Three Different Needle Options
FlexiPulse (14G): Unique open-tip needle with vacuum for high tissue yield. Pulse control for ultimate accuracy in challenging locations 2
Allows clinicians to select the ideal tool for each diagnostic scenario.
VacuPulse (10G): VAB needle with pulse control and high tissue yield
3.
CorePulse (14G): CNB needle with pulse control and high tissue yield
2.
1.
1. FlexiPulse 2. VacuPulse 3. CorePulse VAB ; Vacuum assisted biopsy, CNB ; Core needle biopsy.
Significantly Greater Tissue Yield With All Three NeoNavia Needles Compared to Standard Devices
FlexiPulse vs. standard 14G CNB
VacuPulse vs. standard 10G VAB
CorePulse vs. standard 14G CNB
299% higher yield 5
12%
37% higher yield 5
higher yield 5
800 700 600 500 400 300 200 100 0
10000
300
8000
200
6000
4000
100
2000
0
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14G FlexiPulse 14G CNB
14G CorePulse 14G CNB
10G VacuPulse 10G VAB
Adapted from Thill et al., 2021. 4 Difference was significant in all cases (p<0.0001). Pre-clinical study to benchmark NeoNavia needles against standard biopsy needles. Sampling tests were performed in the most commonly used tissue model (turkey breast) in a test box arrangement. Thirty samples were obtained with the 14G CorePulse, 14G FlexiPulse and comparison 14G standard core needle biopsy needle (BD Achieve), respectively. Twenty-five samples (five samples per incision, five incisions) were obtained with the 10G VacuPulse and comparator 10G vacuum- assisted biopsy needle (Mammotome elite), respectively. Studen ´ ts t-test, significance level of 5% (two-sided test), was used for analysis.
NeoNavia FlexiPulse (14G) A new way of tissue sampling
1. FlexiPulse features an open-tip sampling needle and a retractable dissection tip. Pulses are used to advance the needle through healthy tissue towards the lesion 2. When the needle has reached the lesion, the dissection tip is retracted and the open-tip sampling needle faces the lesion 3. Pulses are used to advance the sampling needle into the lesion, thereby filling the chamber with tissue. Vacuum suction assists in increasing sampling yield
4. The tissue sample is cut off by a rotation of the sampling needle
5. The biopsy needle is withdrawn. The tissue sample is ejected by extending the dissection tip into its initial position
Standard Core Biopsy Needle
FlexiPulse Needle
30 mm full core sampling chamber Sampling length can be determined freely by length inserted into lesion
Blood vessel
Blood vessel
≈19 mm core sampling chamber Sampling length cannot be determined freely
Front-loaded hollow needle design
Vacuum assistance
NO DEAD SPACE
Pulses are used to advance the needle into the lesion, thereby filling the sampling chamber with tissue
14G needle diameter
14G needle diameter
Tissue samples can be collected to the end of the open-tip needle. There is no dead space, which allows for maximum tissue yield and optimal targeting of challenging lesions
Extraordinary sampling yield compared to standard device in bench testing. Sampling Performance Benchmarks
Clinical Results - PULSE multicentre trial Proven success in challenging biopsies of axillary lymph nodes
Percentage of patients with one, two or three risk parameters 6
Sampling performance in bench model
96% success rate for tissue sampling from axillary lymph nodes with ≥1 major risk parameter (48/50 patients) 6
6% (3/50)
800 700 600 500 400 300 200 100 0
32% (16/50)
62% (31/50)
299% greater mean sample weight with FlexiPulse compared to standard CNB 4
Risk parameters:
One Two Three
Major risk parameters defined as: lymph node (LN) proximity to vessel <5 mm, LN proximity to muscle <5 mm, LN proximity to thoracic wall <5 mm, LN size <10 mm.
Multiple samples were obtained from a single insertion
Pulses shown to optimise needle control
14G FlexiPulse 14G CNB
In 63% of cases (73/115), multi-sampling, i.e. more than one sample per single insertion, was performed by the operator 5
Pulses facilitated control during needle insertion in 87% of cases (100/115) 5
87%
63%
Adapted from Thill et al., 2021. 4 Difference was significant (p<0.0001) Pre-clinical study to benchmark NeoNavia needles against standard biopsy needles. Sampling tests were performed in the most commonly used tissue model (turkey breast) in a test box arrangement. Thirty samples were obtained with the 14G FlexiPulse and comparison 14G standard core needle biopsy needle (BD Achieve), respectively. Studen ´ ts t-test, significance level of 5% (two-sided test), was used for analysis.
Interim results from PULSE (NCT03975855), a prospective, single-arm multicentre study evaluating performance characteristics of NeoNavia FlexiPulse in adult female patients with clinically/sonographically suspicious axillary lymph nodes.
NeoNavia VacuPulse (10G) VAB needle with pulse control and high tissue yield
1. VacuPulse features an outer needle with a side-notch and an inner cutting cannula. Pulses are used to advance the needle through healthy tissue towards the lesion
2. Pulses further advance the sampling needle into the lesion
4. The inner cutting cannula moves forward and separates the sample from surrounding tissue. The sample is transported to the back of the probe into a collection chamber. The sampling procedure can be repeated to obtain multiple samples with a single insertion 3. The inner cutting cannula is retracted and vacuum suction assists in increasing sampling yield. Tissue enters the side-notch
CorePulse (14G) CNB needle with pulse control and high tissue yield
1. CorePulse features an inner needle with a side-notch and a spring-loaded outer cannula. Pulses are used to advance the needle through healthy tissue towards the lesion
2. Pulses further advance the sampling needle into the lesion
4. The outer cannula is fired, and the sample is separated from surrounding tissue. The biopsy needle is withdrawn, and the tissue sample is collected similarly to other core needles 3. When the needle has reached the target area, the outer cannula is retracted. Tissue enters the open side-notch of the inner needle
Set a New Standard in Biopsy Care With NeoNavia Biopsy System.
For further information or a demonstration of the system, please visit www.neonavia.se
References: 1. Schässburger K-U, Paepke S, Saracco A, Azavedo E, Ekström C, Wiksell H. High velocity pulse biopsy device enables controllable and precise needle insertion and high yield tissue acquisition. Physica Medica. 2018;46:25-31. doi:10.1016/j.ejmp.2017.12.014 2. Thill M, Schässburger K, Paepke S. P086. Novel pulse biopsy platform incorporating adaptive open-tip sampling needle increases sampling yield and needle control. European Journal of Surgical Oncology. 2021;47(5). doi:10.1016/j.ejso.2021.03.090 3. Azavedo E. Tools for precision medicine: Novel open-tip pulsed biopsy needle used to monitor neoadjuvant treatment response. Poster presented at: SBI/ACR Breast Imaging Virtual Symposium 2021 4. Thill M, Peisker U, Paepke S, Olsen M, Schässburger KU. New biopsy system with three different needle options delivers higher tissue yield compared to standard biopsy devices. Poster presented at: Austrian Society of Senology Annual Meeting 2021 5. Thill M, Kühn T, Peisker U, Stachs A, Reinisch M, Malter W, Gruber I, Paepke S, Olsen M, Schässburger KU. New pulse biopsy device proved to be safe and effective in axillary lymph nodes with pulsed insertion facilitating enhanced needle control: Initial results from the German multi-center PULSE study. Presented at: British Society of Breast Radiology Virtual Annual Scientific Meeting 2021, 8 November 2021. PULSE data. 6. Thill M, Kühn T, Peisker U, Stachs A, Reinisch M, Malter W, Gruber I, Paepke S, Olsen M, Schässburger KU. New pulse biopsy device safe and effective in challenging cases of axillary biopsies: Subgroup analysis of initial PULSE data for lymph nodes of small size and difficult anatomic location. Oral Presentation, SBI/ACR Breast Imaging Symposium 2022, 15 May.
NEODOC-8-1517_01.00 Legal Manufacturer: NeoNavia AB, Stolp-Ekeby 11, 18695 Vallentuna, Sweden
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