- Biotech company Next Science (NXS) has been placed in a trading halt pending an upcoming capital raising
- The company will remain in the halt until September 18, or when the announcement is made
- On September 7, Next Science provided an update on the FDA approval process for its XPerience Surgical Rinse
- The rinse removes biofilms, bacteria and viruses in the surgical field and the company expects to launch it in the U.S. market in the first half of 2021
- Next Science has now received written notification from the FDA of additional requirements needed to obtain a 510(k) Class II clearance
- This clearance is needed to state that a device is safe and efficient to use, and to achieve this, the company will need to undertake further studies and tests
- Shares in Next Science last traded for $1.32 on September 15
Biotech company Next Science (NXS) has been placed in a trading halt pending an upcoming capital raising.
The company will remain in the halt until the earlier of September 18, or when the announcement is made.
While Next Science has not announced how much it will be raising, it has announced it will be undertaking both a placement and share purchase plan.
On September 7, the company provided an update on the Food and Drug Administration (FDA) approval process for its XPerience Surgical Rinse.
The rinse removes biofilms, bacteria and viruses in the surgical field, and Next Science expects to launch it in the U.S. market in the first half of 2021.
Next Science has now received written notification from the FDA of additional requirements needed to obtain a 510(k) Class II clearance for XPerience.
This clearance is needed to state that a device is safe and efficient to use, and to achieve this, Next Science will need to undertake further animal studies and laboratory tests.
However, the company anticipated this and is already undertaking additional studies, which it expects will be completed in time to lodge another 510(k) submission in November.
Shares in Next Science last traded for $1.32 on September 15.