EXINI news

On July 27^th, EXINI Diagnostics AB, was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its digital application, aPROMISE™. aPROMISE was developed to quantify and standardize assessments of PSMA PET/CT images and will support the use of PYLARIFY® (piflufolastat F 18) in the U.S. aPROMISE is a convenient software platform that offers quantitative analysis and standardized reporting of PSMA PET/CT image assessments.

“With FDA clearance of aPROMISE, EXINI continues on the path to improve clinical management of prostate cancer patients with innovative and clinically relevant imaging biomarkers.” Aseem Anand, Vice President and Site Manager of EXINI Diagnostics AB, Sweden.

The EXINI devices, aBSI and EXINI bone, are now available in the United Kingdom again. EXINI Diagnostics has performed the necessary actions to be able to provide the devices to the UK customers after Brexit. QAdvis UK Ltd has been appointed as responsible person (UKRP) in the UK. Thereby we are able to continue to provide our innovative CE marked devices aBSI and EXINI bone to our UK customers.

The new European Medical Device Regulation 2017/745 (MDR) which replaces the Medical Devices Directive (93/42/EEC) will be mandatory from May 25^th 2021. EXINI Diagnostics has through hard work and dedication received our MDR-certificate through our Notified Body TÜV SÜD.


“We are proud to be certified for MDR and look forward to enhancing the care of cancer patients with digital AI-solutions”
Dr. Aseem Anand. Vice President EXINI Diagnostics AB.

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the use of EXINI’s artificial intelligence enabled automated bone scan index (aBSI) on GE Healthcare’s Xeleris platform. EXINI has entered into a global software licensing agreement with GE Healthcare for the rights to EXINI bone, a vendor neutral stand-alone variant of aBSI that is enabled with artificial intelligence. Under the terms of the non-exclusive agreement EXINI will receive tiered licensing fees per license sold. 

Automated Bone Scan Index (aBSI) 

The automated Bone Scan Index (aBSI) technology, developed by EXINI Diagnostics AB, gives a fully quantitative assessment of bone scans that incorporates inferred masses of all lesions. As of 2017, aBSI is provided as a secure and compliant web application readily available from a web browser by logging in to www.bonescanindex.com.  In Europe, the device is CE-marked according to MDD 93/42 EEC, and is available for clinical use in Austria, Denmark, France, Germany, Ireland, Netherlands, Sweden, Switzerland, and UK. As of October 2019, aBSI is also available for clinical use in the United States with a 510(k) clearance (K191262). aBSI is also available for local installation under the name EXINI bone. As of January 2019, EXINI bone is CE marked according to MDD 93/42 EEC. 

EXINI Diagnostics AB 

EXINI Diagnostics AB was established in 1999 to commercialize AI methods for automated analysis of diagnostic images developed by a research group at Lund University. As a certified medical device manufacturer, EXINI has developed automated analysis platforms for cardiac, brain and bone scans. The company has always been innovative, developing web-based systems in the early 2000s. EXINIs most widely distributed platform is used to calculate the automated Bone Scan Index, which quantifies the bone tumor burden in patients with metastatic prostate cancer. This platform has been installed at about 1,000 hospitals worldwide. In 2015, EXINI was acquired by Progenics Pharmaceuticals Inc. for developing patient centric AI technologies for PSMA-targeted theranostic agents. In 2020, Progenics Pharmaceuticals, Inc. was acquired by Lantheus Holdings, Inc.

 

Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. (“LMI”), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced that it has completed its previously announced merger with Progenics Pharmaceuticals, Inc. (“Progenics”) (Nasdaq: PGNX), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer. The merger agreement was first announced on October 2, 2019.

In August, EXINI received 510(k) clearance from the FDA to market aBSI for clinical use in the U.S. The clearance of a cloud based software as a medical device is an essential step towards the further development and clearance of the PSMA(PyL) AI product. In October, we were able to release aBSI 3.5.0 as the first FDA cleared aBSI version.

“The FDA clearance is a validation of our approach in using AI technology to solve clinically relevant problems in disease management of patients with prostate cancer” said Aseem Anand, Vice President and Site Manager of EXINI Diagnostics AB, Sweden.

On July 25, 2019, EXINI a fully owned subsidiary of Progenics Pharmaceuticals, entered into collaboration with the Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS), United States, on its AI research program. The collaborative program aims to apply machine learning to medical imaging modalities, enabling standardized, information-driven healthcare practices in prostate cancer. The project is the nation’s first collaborative effort to validate cutting-edge machine learning tools for improving treatment management of Veterans with prostate cancer.

June 24, at Anaheim, CA – EXINI team presented the performance of PSMA-AI device in an independent and prospectively defined study. The work was selected for an Oral presentation at SNMMI2019 and was picked for discussion in the highlight summary session. 

In a prospectively defined independent study, the data demonstrated that the AI-device assisted reads were better than manual only read in terms of speed, precision and diagnostic accuracy. The data is part of continual effort to enhance the clinical utility of imaging biomarkers with standardized and accurate assessment. 

Our focus remains on using technology to address clinically relevant questions for treatment management of Prostate Cancer. 

As of June 18, 2019, EXINI, a wholly owned subsidiary of Progenics Pharmaceuticals Inc. has entered into a licence and transfer agreement with FUJIFILM Toyama Chemical Co, Ltd. (FFTC) for the rights to Automated Bone Scan Index (aBSI) product in Japan for use under the name BONENAVI.

aBSI has become an integral component of prostate cancer practice patterns in Japan, and we are delighted to continue our relationship with FFTC, a leading Japanese pharmaceutical and diagnostic company, to offer this optimized and quick response technology solution to support physician treatment decisions for prostate cancer patients.