In-Office MRI Guided Diagnosis & Treatment
In 2020 alone, 1.4 million new cases of prostate cancer were diagnosed and 375,304 deaths worldwide (Cancer Journal for Clinicians, 2021). Following an elevated prostate specific antigen (PSA) level, the current standard of care consists of a systematic but random 10-12 core transrectal ultrasound-guided standard biopsy (SBx). It has been established in the scientific and clinical community that the cancer detection rate (CDR) with SBx is less than 40%. Subsequent repetition of such procedures often continues to miss these cancers due to large grid spacing or errors associated with poor anterior gland sampling. In addition, there is an increased risk of infection from the transrectal approach and clinical data suggests post procedure infection rate of about 8%. This is one of the reasons that the European Urological Association published a position paper in 2020 strongly recommending transperineal biopsies. MRI is gaining traction in prostate cancer detection pathway, but its usage remains limited due to lack of access to MRIs in urologists’ offices and the complexity of performing procedures under a conventional MRI. MRI-ultrasound fusion pathway is convoluted and invasive for patients and physicians and has no additional reimbursements. Promaxo has developed an FDA cleared MRI and AI platform that enables safer and more effective prostate biopsy and treatment procedures in a physician’s office. The Promaxo Viewer allows radiologists to review and annotate screening images prior to a procedure, and Promaxo MRI system uses these annotations to provide guidance to suspicious lesions inside the prostate leveraging a transperineal approach.
The Promaxo MRI system is an image guidance platform used for the detection, targeting, and treatment of prostate cancer. The core technology is a compact open-faced, single-sided MRI for prostate imaging, and targeted biopsy and treatment conducted in an office or ASC setting. The MRI system consists of a low-field permanent magnetic field generated in a specifically optimized pattern for a predefined imaging field of view, gradient coils for positional encoding of the object, and top-of-the-line computing and instrumentation devices for digitizing and reconstructing the imaging data from low field data sources. Imaging capabilities are enhanced using machine learning based image enhancement techniques to reduce systemic noise patterns inherent to the low field environment. Promaxo’s platform is transforming the current standard of care with its: Office-based MRI placement without the construction costs, shielding requirements or hazardous cryogenic materials associated with regular MRIs Targeting lesions identified as high risk using the Promaxo MRI system compared to the blind grid-based approach used in the standard of care transrectal or transperineal ultrasound biopsy Standardized positioning and transperineal guidance Secured patient data management and computer aided diagnostics and treatment planning Enhanced visualization and navigation tools including 3D reconstruction, multi-layout views, target planning, on-screen biopsy template, image registration and image editing Compressed sensing and AI-based image reconstruction and enhancement The products in pipeline include: Tissue characterization to automatically classify suspicious regions within the prostate Robotic guidance tools to automate needle position and orientation for navigation Machine-learning based sampling approaches for data acquisition to accelerate imaging
Promaxo’s MRI and AI platform creates a point of care shift and enables targeted diagnostic biopsy and treatment of prostate cancer in a physician’s office. This translates into faster treatment decision and overall better patient care and outcomes. Truly open single-sided configuration combined with quiet operation and no endorectal coils provides a comfortable patient experience. The MRI system is portable and can be easily transported in an office elevator and through doorways. It has a limited fringe field and can be placed in a room with no shielding or extensive power requirements - it does not require costly facility upgrades. Compared to conventional MRIs and other low field MRIs, Promaxo’s MRI system has the following competitive advantages: The only truly open single-sided configuration Portable Compact Low cost of acquisition and operation Compatible with conventional robotics No cryogenics Low power requirements Quiet operation For our beachhead market of urology, the following distinguishes Promaxo’s MRI system from the current standard of care: Streamlined live MR guided interventions Minimally invasive transperineal biospsies under live MRI with less infections than the transrectal ultrasound approach Targeted biopsies and treatment in an office, ambulatory surgery center or OR setting Ability to guide radiation treatments such as LDR, HDR and fiducial localization for EBRT Enable focal treatment using ablative procedures (laser, aqua ablation, vaporization) Compatibility with surgical robotics and confirmation scans intra- and post-robotic treatment Established reimbursement pathway (existing CPT codes) and additional revenue streams to practices and physicians compared to ultrasound guided or MR-ultrasound fusion guided biopsy
Mississippi Urology has been using one of our first clinical systems for transperineal biopsy under MR guidance. Prior to acquiring our system, they have used transrectal ultrasound to perform 12-core biopsies (SBx). Since the arrival of Promaxo’s office-based MR guided Targeted biopsy system (MRgTBx), 18 consecutive males of average age (67.5 + 8.1 years) underwent the procedure. 14 out of these 18 patients were found to have cancer by MRgTBx while remaining 4 were diagnosed to have benign lesions. These 18 patients also underwent SBx immediately after MRgTBx and SBx diagnosed cancer in only 6 of the 14 patients detected by MRgTBx. Hence the effective cancer detection rate of MRgTBx is found to be 78% while it was 33% with SBx. A major clinical highlight of MRgTBx is that only an average of 3 biopsy cores were taken from the suspicious area marked with PIRADS score of 3 and above benefiting the patient immensely. SBx on the other hand had an average of 12 cores. With MRgTBx done transperineally, the risk of infection is none compared to SBx. Several of the patients who were found to have cancers with Gleason score of 7 and higher by MRgTBx and missed by SBx had favorable care pathways with months of head-start in managing prostate cancer. The change in care management triggered by MRgTBx has favorable economic impact for the patients, providers and payers and more importantly on the psychosocial state of the patients. The link to a patient testimonial is provided below https://promaxo.com/one-of-promaxos-first-patients-opens-up-on-his-experience/
Promaxo has made MRIs more accessible to patients and physicians, and adaptable to interventions. Company boasts a proven team supported by global corporate and academic partners. Promaxo’s robust IP portfolio and strong sales pipeline with established reimbursement plan and lucrative customer ROI model creates a scalable and attractive commercialization pathway.