ST.LOUIS – Acera Surgical, Inc., a Washington University startup co-founded by former WU student Dr. Matthew MacEwan, received 510(k) clearance from the Food and Drug Administration (FDA) for its first clinical product, the Cerafix® Dura Substitute. With the approval from the FDA, Cerafix® is the first nanofabricated tissue scaffold approved for clinical use in the United States. Cerafix® is indicated for the repair of the dura mater following routine neurosurgical procedures. It is presently used by numerous top academic neurosurgical clinics around the country.
The initial FDA clearance was secured in March of 2016, and since then, Acera has secured a secondary clearance to expand the indications for the product. Acera also signed an exclusive national distribution agreement with Mizuho America, a medical device distributor headquartered in Union City, CA.
“This new line of nanofabricated dura substitutes originated from Washington University intellectual property,” MacEwan said. “Our product offers a strong yet compliant material to assist in brain surgery, and we’re excited about the prospect of it being utilized in some of the best neurosurgical centers across the country.”
Acera Surgical partnered with Washington University in 2012 to develop a portfolio of nanofabricated surgical materials for soft tissue repair. Although the first product is used exclusively in neurosurgical setting, Acera has intentions of applying the technology in multiple clinical specialties, including wound repair, hernia repair, and reconstructive surgery.
Acera has successfully raised a $4.0 million seed round and is currently raising a series A equity offering. The company is seeking strategic partners that may serve as potential licensees, distributors, end acquirers, and /or co-development partners.
Acera continues to work closely with Washington University, Washington University School of Medicine, and the Office of Technology Management (OTM) which originally licensed the intellectual property to Acera in 2012.
Acera is run by a dynamic and diverse team with deep roots within the St. Louis and Washington University community. “We’ve built a network that ranges across the US, but our headquarters are still right here in St. Louis,” MacEwan added. “We want to create a lasting company in St. Louis’ entrepreneurial ecosystem that serves the community, improves patient care, and motivates the next generation of WU entrepreneurs.”
For more information on Acera Surgical, please visit the company’s website at www.acera-surgical.com.