EXINI Diagnostics AB

Introducing aPROMISE

aPROMISE (automated PROstate Specific Membrane Antigen Imaging SEgmentation) is a medical device software developed by EXINI Diagnostics AB. aPROMISE is a PACS platform that offers quantitative analysis and standardized reporting of PSMA PET/CT image assessments. The software has a solution for automated body segmentation and marking, quantifying and reporting of regions of interest (ROIs) considered as suspicious lesions 1,2. The automated segmentation of reference organs and detection of ROIs with high local intensity uptake, so called hotspots, provide enhanced consistency in quantitative analysis and intend to increase efficiency of PSMA PET/CT image assessments.

In prostate cancer, PET tracers targeting the Prostate-Specific Membrane Antigen (PSMA) have demonstrated high diagnostic accuracy for the detection of both regional and distant metastatic prostate cancer. The higher sensitivity and specificity of the PSMA PET in detecting metastatic prostate cancer, may have strong implications in management of patients.

The aPROMISE software automatically analyzes the CT image to segment anatomical regions, including the liver and the thoracic part of the aorta as reference organs. Subsequently, the PET image is analyzed to detect target hotspots, regions of locally elevated PSMA tracer intensities indicative of suspicious tumor tissue and metastasis. ROIs are marked by selecting from predefined hotspots or by manually drawing and are then labeled with type and location and quantified in terms of standard uptake values (SUVs) for tracer uptake intensities and their respective volumes. The standardized aPROMISE report provides consistent and quantitative assessments of PSMA PET/CT.

As of December 2020, aPROMISE is provided as a secure and compliant web application readily available from a web browser by logging in to apromise.psmaix.com. In Europe, the device is CE-marked according to the MDR 2017/745, and is available for clinical use in Sweden and Ireland.

  1. Deep Learning-Enabled Comprehensive Detection and Quantification of 18FDCFPyL (PyL-PSMA) PET/CT. Brynolfsson J, Johnsson K, Sahlstedt H, Richter J, et al, OP-548, 1006: Cutting Edge Science Track – TROP Session: AI -Radiomics and Modelling, EANM 2020.
  2. miPSMA Index: Comprehensive and Automated Quantification of 18F-DCFPyL (PyL-PSMA) PET/CT for Prostate Cancer Staging. Johnsson K, Sahlstedt H, Brynolfsson J, et al. J Nucl Med. 2020;61(1):1435.

GDPR

When you use aPROMISE to process patient information related to a patient who is a resident of the EU, you
are responsible for ensuring that your organization complies with GDPR. In terms of GDPR you, as the user of
aPROMISE, are the data controller and EXINI, as the service provider, is the data processor. In advance of
processing data with aPROMISE, be sure that you have explicit consent from the patient whose data you are
capturing. When data is sent to aPROMISE, it is stored in a secure manner, and is encrypted in transit and at
rest.

Our Commitment

EXINI (‘we’ or ‘us’ or ‘our’) are committed and dedicated to ensuring the security and protection of the
personal information that we process, and to provide a robust, continuous and consistent approach to data
protection. Our objectives for GDPR and HIPAA compliance include the development and implementation of
data protection roles, policies, procedures, controls and measures to ensure continuous safeguarding of the
personal information under our remit.

How we are implementing GDPR and HIPAA

  • Policies & Procedures – Data protection policies and procedures to meet the requirements and
    standards of the GDPR and any relevant data protection laws, including HIPAA, are in place
  • Data Retention & Erasure – we have retention policies and are applying the privacy by design
    principle, meaning we store only data that is needed for the current task and only store it for as long
    as needed
  • Data Breaches – as a medical device manufacturer we have breach procedures in place that ensure
    safeguards and measures to identify, assess, investigate and report any personal data breach at the
    earliest possible time
  • International Data Transfers & Third-Party Disclosures – when EXINI stores or transfers personal
    information outside the EU, we have robust procedures and safeguarding measures in place to secure,
    encrypt and maintain the integrity of the data
  • Processor Agreements – when we use a third-party to process personal information on your behalf,
    we have data processor agreements and/or business associate agreements in place