On February 09, ENDRA Life Sciences Inc. (NDRA) announced U.S. regulatory strategy update for its TAEUS® System. Consequently, the stock suffered a hit in the after-hours on Wednesday.
During the regular trading session, the stock remained in the green with a gain of 4.56%. NDRA closed the regular session at $0.5600 with over 738.6K shares exchanging. Following the announcement, the stock plunged down to $0.4031 per share in the after hours. Thus, NDRA lost a huge 28.02% after the strategy update was announced in the after hours.
The medical imaging technology developer, ENDRA Life Sciences Inc. was founded in 2007. Currently, the company has a market capitalization of $22.58 million. Its 42.17 million outstanding shares presently stand at a year-to-date loss of 19.05%. NDRA stock subtracted a value of 75.97% last year.
ENDRA’s TAEUS® Update
On Wednesday, the company announced a regulatory strategy change in the U.S. for its Thermo Acoustic Enhanced UltraSound (TAEUS®). NDRA has decided to opt for the De Novo pathway for the TAEUS system, building on the content of the completed 510(K) application.
After extensive discussion with the U.S. FDA, the company had decided on De Novo as the better path forward for TAEUS market claims in the U.S. According to the company, the remaining efforts in the 510(k) would be equivalent to all for the De Novo pathway. Furthermore, NDRA believes the De Novo pathway will lead to a better market position and competitive advantage for the TAEUS system. Thus, the company is planning to withdraw its 510(k) application and pursue the De Novo pathway.
Expansion into China
On January 24, the company announced its expansion into China through a partnership with Shanghai General Hospital. NDRA received Institutional Review Board approval from the hospital for its first clinical study of the TEAUS device. The clinical study will evaluate TAEUS for Non-Alcoholic Fatty Liver Disease (NAFLD) in the market. This marks the first clinical research partnership of the company in Asia and eighth worldwide.
Additionally, the study is expected to commence in 2022.
NDRA: Financials
On November 15, the company declared its financial results for the third quarter of 2021.
In Q3 2021, the company suffered a net loss of $2.7 million, against $3.3 million in the prior-year period. Resultantly, the net loss per diluted share was $0.06 and $0.15 in Q3 2021 and 2020 respectively.
Furthermore, NDRA ended the quarter with cash and cash equivalents of $11.8 million.
