ENTELLUS MEDICAL, INC. (NASDAQ:ENTL) Files An 8-K Other Events
Item8.01.
| Other Events. |
On April12, 2017, Entellus Medical, Inc. (the Company) announced
the Company has received 510(k) clearance from the United States
Food and Drug Administration (FDA) for use of its XprESS ENT
Dilation System in patients with persistent Eustachian tube
dysfunction. A copy of the press release announcing the clearance
is attached hereto as Exhibit 99.1 and is incorporated by
reference herein.
The Company also received 510(k) clearance from the FDA for its
Reinforced Anesthesia Needle for use in injecting local
anesthetics into a patient to provide regional anesthesia.
Finally, the Company received a warning letter dated April6, 2017
from the FDA related to two observed non-conformities relating to
the Companys prospective, multicenter study of children with
chronic rhinosinusitis treated with the XprESS Multi-Sinus
Dilation System. As previously disclosed, in September 2016, the
FDA issued a Form 483, List of Inspectional Observations
containing two observations related to study deviations which
occurred when some physicians decided due to medical necessity to
treat sinuses outside of the scope of the study protocol, thereby
avoiding the need for a follow-on procedure. The FDA warning
letter acknowledges the actions already taken by the Company to
address the observations and requires the Company to notify the
parents/guardians of the subjects under the age of 12 who
received treatment of the frontal and sphenoid sinuses that they
were not treated according to the FDA approved protocol or IRB
approved informed consent form. The Company intends to complete
such notifications within the deadline imposed by the FDA. The
warning letter does not restrict production or shipment of the
Companys products or require the withdrawal of any products from
the marketplace. Nor does it restrict the Companys ability to
seek 510(k) clearance of products. The Company takes these
matters seriously, will respond timely and fully to the FDAs
requests, and believes that the FDAs concerns can be resolved
expeditiously, readily and without any material impact on the
Companys business or financial results.
This Current Report on Form 8-K contains forward-looking
statements within the meaning of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements
generally can be identified by the use of words such as intends,
expects, anticipates, believes, could, will, continue, future,
other words of similar meaning and the use of future dates.
Forward-looking statements in this report include the Companys
expectations regarding the resolution of the FDA warning letter
and its effect on the Companys business or financial results.
These forward-looking statements are based on the current
expectations of the Companys management and involve known and
unknown risks and uncertainties that may cause the Companys
actual results to be materially different from any future results
expressed or implied by the forward-looking statements. Such
risks and uncertainties include, among others, risks associated
with regulatory actions, including the FDA warning letter. Other
factors that could cause actual results to differ materially from
those contemplated in this report can be found under the caption
Risk Factors in the Companys Securities and Exchange Commission
reports, including its Annual Report on Form 10-K for the fiscal
year ended December31, 2016. The Company undertakes no obligation
to update or revise any forward-looking statements, even if
subsequent events cause its views to change.
| Item9.01. | Financial Statements and Exhibits. |
| (d)Exhibits. |
|
Exhibit No. |
Description |
|
| 99.1 | Press Release issued on April12, 2017 (filed herewith) |
About ENTELLUS MEDICAL, INC. (NASDAQ:ENTL)
Entellus Medical, Inc. is a medical technology company. The Company is focused on the design, development and commercialization of products for the minimally invasive treatment of patients who are suffering from chronic sinusitis. The Company’s XprESS family of products is used by ear, nose and throat (ENT) physicians to treat patients with symptomatic inflammation of the nasal sinuses by opening narrowed or obstructed sinus drainage pathways using balloon sinus dilation. The Company’s XprESS family of products is used to treat patients with inflammation of the frontal, ethmoid, sphenoid and maxillary sinuses. Its XprESS Multi-Sinus Dilation family of products consists of its XprESS Pro device, its XprESS LoProfile device and its XprESS Ultra device. The Company’s PathAssist tools provide ENT physicians with a way to confirm sinus location and XprESS device placement. Its FocESS Sinuscopes provide ENT physicians with a solution for endoscopic visualization during a sinus procedure. ENTELLUS MEDICAL, INC. (NASDAQ:ENTL) Recent Trading Information
ENTELLUS MEDICAL, INC. (NASDAQ:ENTL) closed its last trading session down -0.06 at 13.45 with 65,780 shares trading hands.