CPTS' Essure In Sync with Novasure - Analyst Blog
November 11 2011 - 11:40AM
Zacks
Recently, Conceptus (CPTS) received an
Approvable Letter from the US Food and Drug Administration (FDA).
The letter suggests compatibility between the company’s surgical
permanent birth control system, Essure and
Hologic’s (HOLX) Novasure, which treats women
suffering from excessive menstrual bleeding.
In the approval letter, FDA stated that the safety of Essure
procedure will remain intact while performing Novasure RF
endometrial ablation. However, the approval is subject to
concurrence with a post-approval study (PAS). The company is
presently working to fulfill the requirements as per the PAS
protocol to obtain the final approval of the proposed labeling
change.
Earlier in July 2008, Conceptus received the CE Mark approval
for similar labeling changes related to the addition of GEA
technologies (i.e. NovaSure) for effective implementation with
Essure.
Conceptus derives a major share of its revenue from Essure,
which is approved in many countries, including the US, Europe,
Australia, Canada, Mexico, Central and South America, and New
Zealand. However, during the third quarter of 2011, domestic sales
of Essure plunged 5.5% year over year to $25.8 million, mainly due
to the on-going macroeconomic pressure that resulted in lower
patient visits to OB/GYN offices and prior-year direct-to-consumer
advertising campaign, which was not repeated in the reported
quarter.
In a bid to retrieve the situation, the company is expanding its
sales coverage and gradually witnessing success in reducing the
impact of competition, particularly from physicians’ trialing other
competing products. In September this year, the FDA approved the
removal of nickel hypersensitivity contraindication from the Essure
procedure Instructions for Use (IFU), which will further enable
Conceptus to gain traction in its domestic business.
Moreover, sales of the Essure system also depend on the number
of physicians trained to perform the procedure. Conceptus is
striving toward enhancing the availability of the system worldwide
by raising consumer and physician awareness as well as imparting
training to the physicians for performing the procedure.
Conceptus currently retains a Zacks #3 Rank (Hold) short term,
at par with Hologic.
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