Integra LifeSciences Agrees to Acquire Surgical Innovation Associates

Integra LifeSciences Holding Corporation, a global medical technology company, has entered into a definitive agreement to acquire Surgical Innovation Associates (SIA), which develops, markets and sells DuraSorb, a resorbable synthetic matrix for plastic and reconstructive surgery.
 
This acquisition will advance Integra’s global strategy in breast reconstruction, expanding plans to access the U.S. market with devices specifically approved by the FDA for use in implant-based breast reconstruction (IBBR) procedures. The transaction is expected to close by the end of the year, subject to the satisfaction of customary conditions.
 
The addition of DuraSorb’s resorbable synthetic technology will further strengthen Integra’s plastic and reconstructive surgery portfolio, which includes SurgiMend PRS, a xenograft surgical matrix. Today, there are no surgical matrices approved by the FDA specifically for use in IBBR. With SurgiMend PRS, Integra is the first and, to date, the only manufacturer to submit a pre-market approval (PMA) application for a surgical matrix for use as soft tissue support in IBBR. Integra’s PMA application for SurgiMend is currently under review with the FDA. Concurrently, SIA is conducting an investigational device exemption study in the U.S. evaluating the safety and effectiveness of DuraSorb with the goal of obtaining a PMA in IBBR.
 
“The global breast reconstruction market represents an attractive growth opportunity for our surgical reconstruction business,” said Robert T. Davis, Jr., executive vice president and president, Tissue Technologies, Integra LifeSciences. “By offering two distinct product solutions, SurgiMend and DuraSorb, to plastic and reconstructive surgeons, we aim to address various clinical, contracting, and economic needs across different sites of care. We look forward to welcoming the SIA leadership and colleagues who will continue to drive the team’s success.”
 
According to Breastcancer.org, one in eight women will develop breast cancer in her lifetime. For women undergoing a mastectomy and opting for a breast reconstruction procedure today, surgical matrices are commonly used to provide support in a majority of IBBR procedures. Shifts in procedural techniques and trends towards value-based care are expected to increasingly favor xenograft and resorbable synthetic matrices in IBBR surgeries.
 
“We are excited to work with Integra and contribute our resorbable synthetic technology to its strong soft tissue reconstruction capabilities, with a view to providing surgeons with greater access to FDA-approved devices to support breast reconstruction,” said Josh Vose, M.D., chief executive officer, SIA. “Integra’s global reach and commercial strength will help enable us to achieve our joint mission to improve outcomes in women’s health.”

Financial Highlights

Integra will purchase SIA for $50 million at closing, subject to customary purchase price adjustments, and pay up to an additional $90 million upon the achievement of certain revenue and regulatory milestones. The acquisition is expected to support Integra’s long-term organic growth and financial goals. Integra does not expect this acquisition to have a material financial impact in 2022.
 
2022 revenue for DuraSorb is expected to be approximately $5 million. Following closing of the transaction, DuraSorb sales will be reported within Integra’s Tissue Technologies segment as part of its Wound Reconstruction and Care franchise along with Integra’s SurgiMend product, which is expected to record 2022 revenues of approximately $45 million.