2020-07-06 Regulatory

NeoDynamics restarts patient recruitment to UK COMPULSE Study to optimize diagnosis of breast cancer

STOCKHOLM - July 6, 2020. NeoDynamics AB (Spotlight Stock Market: NEOD), announces that the Company restarts patient recruitment to the UK COMPULSE Study following a temporary pause imposed by the COVID-19 pandemic.

COMPULSE is a comparative study to investigate the potential benefits of NeoNavia, the first pulse biopsy system, compared to current standard of practice. It is a follow-on study derived from the ongoing German PULSE study. Patient recruitment has restarted in selected UK hospitals. The first hospitals to recruit patients are the Nightingale Centre in Manchester and Addenbrookes Hospital in Cambridge.

 “Despite challenging circumstances, we are excited to finally get the COMPULSE study underway”, said Dr Anthony Maxwell, Principal Investigator at the Nightingale Centre in Manchester. “The new system offers potential benefits compared to current standards of practice and we are keen to see how our breast cancer patients and diagnostic services potentially could benefit”.

The UK COMPULSE Study will run in parallel with the launch of NeoNavia, a complete ultrasound guided pulse biopsy system.

“By introducing the pioneering pulse biopsy technology for ultrasound guided biopsy in the breast and axilla we have the potential to advance biopsy techniques and improve patient outcomes. We anticipate that the versatile pulse biopsy system, including three needle options for the most demanding biopsy procedures, will transform the standard of practice long-term”, says Anna Eriksrud, CEO of Neodynamics.

For additional information please contact:                            

Anna Eriksrud, CEO NeoDynamics AB (publ). Phone +46 +46 (0) 708 444 966, e-mail: anna.eriksrud@neodynamics.com

Kai-Uwe Schässburger, Director Clinical Development & Medical Affairs, +49 (0)151 688 092 41 or + 46 (0)762 386 153. e-mail:                                   kai-uwe.schassburger@neodynamics.com   

The information in this press release is information that NeoDynamics is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above on July 6, 2020 at 08.50 (CET).

Breast cancer in UK

Breast cancer is the most common cancer among women in the UK. With around 55,000 cases, it represented 15% of all new cancer cases in 2017. It is critical that new biopsy technologies can offer a controlled way for lesion targeting as well as accurate and reliable diagnosis through high quality tissue samples.

About NeoDynamics

NeoDynamics AB (publ) is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of breast cancer. The company has an innovative biopsy system, NeoNavia in late stage development. The precision biopsy system is built on a patented pulse technology, based on research at the Karolinska Institutet in Sweden. The system is designed to offer clinicians and patients accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment. NeoNavia is evaluated at leading clinics in UK, Germany and Sweden. A commercial launch is expected in 2020.

About NeoNavia

NeoNavia is the brand name for the entire biopsy system intended to be used under ultrasound guidance.  NeoNavia consists of a base unit, a handheld driver and three different types of biopsy needles. Each needle type is driven by a pulse technology enabling high precision and control when inserting and positioning the biopsy needle in a suspicious lesion. The system is designed to offer accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment.

About the pulse technology

The patented pulse technology is based on a pneumatically driven mechanism that enables high precision and control when inserting and positioning the biopsy needle, independent of tissue type. The pneumatic driver that generates micro-pulses is placed in a handheld instrument. With power from the base-unit, the driver accelerates the needle with great control even over a short distance, enabling its distinct stepwise insertion without the risk of destroying surrounding tissue. This facilitates ease of access and flexibility in sampling, even in very small lesions in delicate and difficult locations.