普通外文研报
Integra Lifesciences: Vegas takes
研报英文原文证据摘录
Integra Lifesciences: Vegas takes
Braintree coming online in June
Braintree expected to operationalize in June. Braintree is expected to avoid the physical
limitations experienced in the Boston facility. IART also invested in a new quality
manufacturing system to replace some manual processes seen in the Boston facility.
The entire process was subjected to a rigorous validation protocol and IART invested in
new leadership at Braintree to ensure ability to sustain complex manufacturing
requirements of PMA products. IART expects to build inventory in Q3 to support relaunch
of SurgiMend in Q4.
SurgiMend launch on track for Q4
Surgical matrices and breast reconstruction is a $800m market with DD growth. The
market has moved away from human ADM as matrices to xenografts and resorbable
synthetics, which likely favor SurgiMend and DuraSorb. Procedural changes also resulted
in larger sizes required (favors IART’s portfolio). IART still expects to be the first
company to receive a PMA label for implant-based breast reconstruction (PMA label
expansion for SurgiMend and DuraSorb expected in 2027). IART expects DuraSorb to
help with SurgiMend uptake following Q4 launch.
Primatrix launch consistent with expectations
IART expanded the launch in Q1. IART said it has seen some prior users return. Some
users indicated they would like to see more demonstration on sustainable supply. IART
says it has been able to show differentiation and has found ways to gain access. IART
also previously noted it expects to leverage learnings from the Primatrix relaunch
experience to support SurgiMend’s return to market. IART does not believe it needs to
meaningfully change price in order to return products to market and regain share.
Wound care opportunities from reimbursement changes
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