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Acera Surgical Inc.
Location: St. Louis, MO
Sector: Life Sciences .
Acera Surgical, Inc. (“Acera”) is a bioscience company commercializing a portfolio of implantable nanomedical scaffolds for regenerative medical applications. Acera’s products exhibit a structure similar to native extracellular matrix (ECM) and thus promote rapid and effective healing. The FDA cleared Acera’s first product, Cerafix®, in March 2016 and its second product, Restrata™, in April 2017, both via 510(k), granting commercial access to markets exceeding $1.2B in revenue.
Acera is developing products that serve as resorbable scaffolds for regenerative medical applications within multiple clinical specialties, including neurosurgery, advanced wound care, breast reconstruction, and hernia repair. Acera’s initial offering, the Cerafix® Dura Substitute, is designed for use in neurosurgical procedures and is currently used in clinics throughout the US following its FDA regulatory clearance under a 510(k) application in 2016. Acera received FDA clearance for its second product, the Restrata™ Wound Matrix, in April 2017 and is initiating a soft launch in the US in 2017.
Acera is expanding its product portfolio by:
1) expanding clinical claims for Cerafix® within neurosurgery,
2) securing new clinical indications for the Cerafix®/ Restrata™ material in other surgical specialties, and
3) developing new material configurations to address clinical needs in targeted clinical specialties.
Competitive Advantage / Market Opportunities:
Acera has developed a portfolio of fully synthetic materials constructed from resorbable nano-scale fibers that address the shortcomings of conventional biologic and macro-scale synthetic tissue scaffolds. Due to the structural similarities between Acera’s nano-fiber scaffolds and native extracellular matrix, new cells and vasculature are better able to proliferate throughout the material and integrate into surrounding tissue, thus promoting effective tissue repair and regeneration. Acera’s products also undergo complete resorption in vivo once the tissue has regenerated and the defect has been repaired, thus eliminating the risk of long-term infection and/or scarring. The unique architecture also offers a combination of strength and flexibility for improved intraoperative handling.
The global market for Acera’s nanofabricated materials in 2020 is projected to be >$10B, growing 9% annually. Acera entered the neurosurgery market (>$150M) in 2016 and is leveraging the same material for additional clinical fields of use, including the advanced wound care market (~$1B). In parallel, Acera is working to develop new materials for use in the hernia repair and breast reconstruction markets (>$3B). Trends driving significant growth in these markets include aging patient populations, increasing numbers of surgical procedures, growing number of minimally invasive procedures, and entry of innovative technologies / materials.
Advisory Board and Strategic Partners / Go-to-Market Strategy:
Acera’s Neurosurgical Clinical Advisory Board is comprised of five leading academic neurosurgeons, including the former Chairman of the American Association of Neurosurgeons, Dr. Ralph Dacey. Acera’s Neurosurgical Advisory Board guided the design of the Cerafix® Dura Substitute to optimally address the unmet needs of contemporary neurosurgeons. The Wound Healing Clinical Advisory Board is chaired by Dr. Matthew Regulski, a triple board certified foot and ankle surgeon practicing in New Jersey, the Medical Director of the Wound Care Institute of Ocean County in Toms River, NJ, and Director of the Kimball Medical Center Wound Care Center.In addition to clinical advisors, Acera is backed by a large network of experts in biomedical engineering, bio-entrepreneurship, healthcare, and business finance.
In 2015, Acera executed a distribution agreement with Mizuho America, a leading medical device stocking distributor with established sub-distributor relationships in both domestic and international neurosurgical markets, and Acera worked closely with Mizuho to successfully execute the national launch of the Cerafix® Dura Substitute. Acera has contracted with a US-based manufacturing partner with expertise in resorbable polymer technologies that will be an instrumental partner in expanding the technology into new clinical areas. Finally, Acera is in discussions with multiple strategic partners who may serve as potential end acquirers, commercialization partners for RestrataTM, and/or co-development partners.
Acera Surgical, Inc. holds exclusive rights to the proprietary technology utilized in the design, production and use of its innovative non-biologic nanofabricated products under a licensing agreement with Washington University and an intellectual property agreement with its parent company, Retectix, LLC for the following fields of use: neurosurgery, general and minimally invasive surgery, otolaryngology/head and neck surgery, plastic reconstructive surgery, obstetrics and gynecology, and soft tissue repair. Acera’s technology is protected under 30 patent applications and 6 issued/allowed patents filed by Armstrong-Teasdale, LLP, Knobbe, Marten, Olson, and Bear, LLP, and Stinson Leonard Street LLP. Freedom to operate opinions and landscape analyses performed by Polsinelli-Shughart, LLP and The Global Patent Group, LLP suggest Acera has freedom to operate.
Dr. Matthew MacEwan – President / Chief Scientific Officer, Board Member
Dr. Matthew is responsible for research and product development, pre-clinical/clinical testing, regulatory compliance and clinical/medical affairs at Acera Surgical, Inc. Matthew is an MD/PhD Candidate at the Washington University School of Medicine in St. Louis, Missouri where he recently completed his PhD in Biomedical Engineering. Matthew has received multiple awards for his scientific and entrepreneurial work in the life science community, including the 2011 Olin Cup Award (Olin School of Business, Washington University), Grand Prize at the 2011 LES Global Business Plan Competition (International Licensing Executives Society), First Place at the 2011 I2P Global Competition (I2P, University of Texas), and Top 40 Under 40 in St. Louis (St. Louis Business Journal). Matthew graduated summa cum laude with a degree in Biomedical Engineering from Case Western Reserve University in Cleveland, Ohio with a specialization in polymer biomaterials / biomaterial biocompatibility.
Agnès Rey-Giraud – Chief Executive Officer, Board Member
Agnes is responsible for corporate strategy, corporate finance and business development at Acera Surgical, Inc. Agnès is a former Officer of Express Scripts, Inc., where she served in multiple roles in Product Development, Supply Chain, Corporate Strategy and International Operations. Agnès joined Express Scripts in 1999, and quickly became a driving force behind many of the company’s key strategic initiatives and an influential player in the transformation of the company from a $4 billion enterprise to a $44 billion enterprise. In her most recent role as President, International Operations, Agnès led the company’s movement into Asia. Agnès earned a Master of Science in Mechanical Engineering from Ecole Nationale d’Ingénieurs de Saint Etienne and a Master of Management in Operations Management from Ecole de Management de Lyon, both in France, as well as an MBA from the University of Chicago. Among numerous other awards and accolades, she is a 2011 St. Louis Business Journal Most Influential St. Louisan and a 2009 St. Louis YWCA Leader of Distinction.
Julie Cochran – Chief Operating Officer
Julie is responsible for product development, sales and marketing, business development and strategic planning, legal and regulatory affairs/compliance, finance, human resources and operations at Acera Surgical, Inc. Prior to joining Acera Surgical, Inc., Julie served multiple roles at Express Scripts, Inc., including Vice President of Strategic Planning, Vice President of Product Development, and Senior Director of e-business Product Management. Prior to Express Scripts, Julie was a consultant at McKinsey and Company, Inc., working with biotechnology, medical device, pharmaceutical and payer organizations. Julie graduated summa cum laude with a Bachelors of Science in Engineering in both Biomedical Engineering and Electrical Engineering from Duke University and earned an MBA from the Stanford Graduate School of Business.