Surgical Innovation Associates (SIA) Announces Definitive Agreement to be Acquired by Integra LifeSciences

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Surgical Innovation Associates (SIA) today announced that it entered into a definitive agreement to be acquired by Integra LifeSciences Holding Corporation (Nasdaq: IART), a leading global medical technology company.

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Thursday, December 1, 2022
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Research, General Health, Oncology, Medical Devices, Other Manufacturing, Science, Surgery, Chemicals, Plastics, Biotechnology, Medical Supplies, Manufacturing, Health, Warning, Growth, TCC, Weakness, Use, ICP, Sulfoxide, Merck KGaA v. Integra Lifesciences I, Ltd., Northwestern University, Ideation, Acquisition, Health, Physician, Patient, Integra, BofA Securities, Proskauer, Federal Food, Drug, and Cosmetic Act, PMA, News, Bank of America, Surgeon, CE, Entrepreneurship, Mastectomy, PRS, FDA, Health insurance, Medical device, Medical imaging, EU
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ILLINOIS, UNITED STATES, NORTH AMERICA, CHICAGO, SIA, US, USA
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SURGICAL INNOVATION ASSOCIATES, SURGICAL INNOVATION ASSOCIATES (SIA), INTEGRA LIFESCIENCES
Summary
Key Points: 
  • Surgical Innovation Associates (SIA) today announced that it entered into a definitive agreement to be acquired by Integra LifeSciences Holding Corporation (Nasdaq: IART), a leading global medical technology company.
  • The transaction is expected to close by the end of the year, subject to the satisfaction of customary conditions.
  • Today, there are no surgical matrices approved by the FDA specifically for use in implant-based breast reconstruction (IBBR) for mastectomy patients.
  • Integra is the only manufacturer so far to submit a premarket approval (PMA) application for this soft tissue support in IBBR.


Surgical Innovation Associates (SIA) today announced that it entered into a definitive agreement to be acquired by Integra LifeSciences Holding Corporation (Nasdaq: IART), a leading global medical technology company. SIA manufactures and sells DuraSorb®, an absorbable monofilament mesh for plastic and reconstructive surgery, which launched commercially in 2020, and has had 80-100% annual revenue growth since. This acquisition will facilitate the product’s continued adoption in the United States and broaden its availability around the world. The transaction is expected to close by the end of the year, subject to the satisfaction of customary conditions.

Integra will purchase SIA for up to $140 million, comprising $50 million at closing, subject to customary purchase price adjustments, and up to $90 million upon the achievement of certain revenue and regulatory milestones.

“Integra LifeSciences warrants great respect among physicians, and shares SIA’s origins in plastic surgery," said Alexei Mlodinow, Co-founder and Board Director, "We are excited to align with them as we continue our journey to make DuraSorb a leading option within the surgeon’s armamentarium for soft tissue reconstruction."

The addition of DuraSorb’s absorbable 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 implant-based breast reconstruction (IBBR) for mastectomy patients. Integra is the only manufacturer so far to submit a premarket approval (PMA) application for this soft tissue support in IBBR. Similarly, SIA is pursuing a goal of obtaining a PMA for that indication, and has achieved over 70% enrollment in its clinical evaluation of DuraSorb in IBBR, under an investigational device exemption.

“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.”

Dr. Vose – as well as Todd Cruikshank, Co-Founder and Chief Operating Officer, and Jason O’Hearn, Chief Commercial Officer – will continue their leadership roles as part of Integra.

“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, DuraSorb and SurgiMend, 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.”

Advisors

BofA Securities acted as exclusive financial advisor to SIA.

Proskauer served as legal advisor to SIA.

Wyrick Robbins acted as legal advisor to Integra.

About Surgical Innovation Associates (SIA)

SIA is a Northwestern University spin-out founded in 2016 by Alexei Mlodinow, Todd Cruikshank, and technology inventor Dr. John Kim. SIA created the DuraSorb® product family and has brought it from ideation through FDA 510k clearance, CE marking, and into the operating room. The company is based in Chicago, IL (USA) and has both commercial and experimental products in the United States and several other markets.

Use of DuraSorb®, like any implantable medical device, carries risk of complications that may arise from the surgical implantation procedure or from the device itself. A full list of Warnings and Precautions is available in the Instructions for Use documents for US and EU surgeons. In the United States, the device has been cleared only for use in reinforcement of soft tissue where weakness exists, and remains investigational for specific applications in breast reconstruction and aesthetics.

Learn more at sia.health

About Integra LifeSciences

Integra LifeSciences is a global leader in regenerative tissue technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel®, Bactiseal®, BioD™, CerebroFlo®, CereLink® Certas® Plus, Codman®, CUSA®, Cytal®, DuraGen®, DuraSeal®, Gentrix®, ICP Express®, Integra®, Licox®, MAYFIELD®, MediHoney®, MicroFrance®, MicroMatrix®, NeuraGen®, PriMatrix®, SurgiMend®, TCC-EZ® and VersaTru®. For the latest news and information about Integra and its products, please visit integralife.com.

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