NeoDynamics granted Chinese patent for FlexiPulse needle design

Rhea-AI Summary

NeoDynamics AB (Nasdaq First North Growth Market Stockholm: NEOD.ST) announced the granting of a Chinese patent for its innovative FlexiPulse needle design, a significant step towards commercial launch in China. This front-loaded, open-tip sampling needle maximizes tissue yield while minimizing patient trauma, targeting the technically challenging axillary lymph nodes. Previously, a US patent was granted in August 2021, followed by FDA clearance in September 2022. CEO Anna Eriksrud highlighted the potential of the Chinese breast biopsy market, valued over USD 100 million and growing at approximately 10% annually.

Positive

• Chinese patent granted for FlexiPulse needle design, enabling potential commercial launch in China.
• FDA clearance received in September 2022 supports product approval process in China.
• Targeting a breast biopsy market in China valued over USD 100 million, growing around 10% annually.

Negative

• None.

STOCKHOLM, March 6, 2023 /PRNewswire/ -- NeoDynamics AB (publ) (Nasdaq First North Growth Market Stockholm: NEOD.ST), a medical device company dedicated to advancing the diagnosis and care of cancer, today announced that the Company has been granted a Chinese patent for the needle design employed in the NeoNavia® FlexiPulse™ probe.

The front-loaded, open-tip sampling needle is designed to enable maximum tissue yield, with minimal patient trauma. The patent is an important milestone that opens up for a future commercial launch in China and strengthens the protection of the NeoNavia biopsy system. NeoNavia with FlexiPulse is uniquely positioned to address biopsies in the axillary lymph nodes which is a technically and anatomically challenging site due to the proximity to blood vessels and nerves.

The Chinese patent is yet another important milestone that comes on top of a similar patent granted in the US in August 2021, followed by US FDA clearance received in September 2022.

"The novel needle design has shown great results in PULSE, our German multi-center study evaluating safety and performance of the device in the axillary lymph nodes of breast cancer patients," says Ph.D. Kai-Uwe Schässburger, Director Clinical Development and Medical Affairs, NeoDynamics AB.

"We are very pleased to have reached another important milestone. We expect that the process of product approval in China will be aided by the FDA clearance in the USA. The Chinese market is potentially very interesting with a breast biopsy market above USD 100m growing around 10% annually," says CEO Anna Eriksrud, NeoDynamics AB.

For further information, please contact:

Anna Eriksrud, CEO NeoDynamics AB, phone +46708 444 966 or e-mail anna.eriksrud@neodynamics.com   
Aaron Wong, CFO NeoDynamics AB,  phone +46735 972 011 or e-mail aaron.wong@neodynamics.com

 

View original content:https://www.prnewswire.com/news-releases/neodynamics-granted-chinese-patent-for-flexipulse-needle-design-301763176.html

SOURCE NeoDynamics

FAQ

What is the significance of the Chinese patent granted to NeoDynamics (NEOD) for the FlexiPulse needle design?

The Chinese patent allows NeoDynamics to pursue a commercial launch of its FlexiPulse needle in China, enhancing its market presence.

When did NeoDynamics (NEOD) receive FDA clearance for its biopsy system?

NeoDynamics received FDA clearance for its biopsy system in September 2022.

What is the projected growth rate of the breast biopsy market in China?

The breast biopsy market in China is projected to grow around 10% annually.

How does the FlexiPulse needle design benefit patients during biopsies?

The FlexiPulse needle design maximizes tissue yield while minimizing trauma to patients.

Who is the CEO of NeoDynamics AB (NEOD)?

The CEO of NeoDynamics AB is Anna Eriksrud.