Approaching the market – registration in focus
Second quarter 2019
Significant events during the second quarter
Significant events after the period
Invitation to Audiocast
The half year report will be presented in an audiocast today at 10.15 (CET) by CEO Anna Eriksrud and CFO Jörgen Vrenning.To participate in the Audiocast, please select:
Approaching the market – registrations in focus
Our product development journey with NeoNavia is in the final phase and work on verification, validation and documentation for registration in the EU and the US are underway. We are approaching the market at rapid pace.
In Europe, the MDD (Medical Device Directive) has been replaced by the MDR (Medical Device Regulation) bringing registration requirements more in line with US FDA legislation. Consequently, all Notified Bodies must undergo a new authorization by authorities. We are well prepared to be among the first to have a product approved according to MDR requirements. Exactly when this will happen is not only dependent on us but also on when our Notified Body, Intertek, will be authorized by the Medical Products Agency. Our goal is to submit our CE-application to Intertek by the end of 2019.
In parallel work is underway to document our 510 (k) application with the US FDA (Food & Drug Administration).
In China, we are also getting closer to registration. We are ready to begin registration work during the first quarter of 2020. Since 2016, we have Boai NKY Medical as a shareholder. We have now deepened the relationship with Boai who has the right expertise and staff that match market requirements including departments for clinical programs, registration, marketing and sales.
Data from the recent market survey give an idea of the size of the Chinese market. In Beijing alone, about 100 large hospitals, of which many carry out as many biopsies per month as major European hospitals perform in a year. We have interviewed both radiologists and distributors and conclude that the market in China for tissue sampling by needle biopsy is large and growing. We note that the Chinese biopsy market is becoming more similar to the European market and that prices of imported biopsy needles are in line with prices in Europe, which is very positive for us.
During the summer we appointed a Country Manager for the US market, Anna Forsberg. She is highly qualified with many years of US experience where she has worked throughout her career. She will focus on our clinical work, the application for the FDA-registration and initiate our work in the US market. An important task for her will be to develop our network at the major cancer clinics to prepare the launch of NeoNavia in 2020.
In Germany, studies are underway at seven prominent cancer centres and recruitment is proceeding according to plan. NeoNavia was presented with two scientific posters at the Senology Congress in Berlin, the largest annual national breast radiology meeting of the year.
It is worth highlighting that we have added strong regulatory expertise through the recruitment of Petra Lindholm, PhD with experience from regulatory processes in different med tech companies. She has previously been responsible for managing both EU registration authorities as well as US FDA. She will be instrumental during the upcoming intensive registration work.
To further leverage our expertise in product development and clinical areas, we founded as minority owners however with potential to grow, a company together with a Swedish dermatologist at Karolinska Hospital to develop a new skin biopsy instrument for skin cancer. This is a promising project that has already been granted financial support by the Swedish Innovation Agency,
Through the capital injection announced in a separate press release today, the company is adequately financed until the beginning of 2020 after the planned submission of regulatory applications.
CEO Anna Eriksrud
For further information about NeoDynamics, please contact:
Anna Eriksrud, CEO NeoDynamics AB (publ), telephone: +46 8 522 79 667, e-mail: email@example.com, or
Jörgen Vrenning, CFO/IR NeoDynamics AB (publ), Telephone: +46 708 519 648, email: firstname.lastname@example.org
This information is information that NeoDynamics AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation.
The information was submitted for publication by the contact person above on 28 August 2019
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 micro-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.
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 the micro-pulses 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 micro-pulse technology
The patented micro-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.