Company

Our team is dedicated to developing transformative technologies

IC Surgical is a medical technology company focused on innovative concepts to address complex issues associated with surgery. The company’s first innovation is a transformative new technology, Interi™ System, which was developed to reduce the risk of seroma and other post-surgical complications caused by tissue damage.

Our vision is to transform clinical outcomes with novel technologies aimed at eradicating complications associated with internal tissue damage in surgery.

IC Surgical is a privately held corporation founded by a team of four individuals with the passion and experience to bring their vision of changing the face of surgery to fruition. The company was founded by the former CEO of LifeCell Corporation, a world renowned Plastic Surgeon who invented the concept and 2 former executive leaders from Baxter Healthcare.

Over the last 3 years, the company has made significant advancements in the development of this technology platform and the Interi System.

Company Leadership

Lisa Colleran, CEO

Experienced senior leader in the healthcare industry, and served as CEO, President and Board Member for LifeCell Corporation, a high growth $400M medical device company. Ms Colleran has a proven track record for delivering strong business results and significant shareholder value. She specializes in market creation for high revenue growth, operational excellence, and M&A. Currently a Board Member at Establishment Labs (NASDAQ: ESTA) - an innovative breast implant company and TelaBio (NASCAQ: TELA) a medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials. Ms. Colleran also served as a board member for Novadaq Technologies, Inc., helping to oversee its $700M sale to Stryker Corporation.

Brad Bengtson, MD, Medical Director

Inventor of the product concept, and an internationally renowned plastic surgeon with a large clinical practice in Grand Rapids, Michigan. Dr. Bengtson is known to the plastic surgery community as a leader in advancing surgical techniques and an expert in tissue healing and regeneration. He has invented several innovative medical devices, has received multiple honors for his clinical practice and his research portfolio, including nearly 200 papers and presentations.

Ron Novotny, COO

25+ years of experience in product development, marketing leadership, market development, sales management, and finance for healthcare and technology companies. Mr. Novotny has extensive experience in managing product development activities, and has been involved in the development of several therapeutically-focused medical devices that have successfully transformed clinical practice.

Sheryl Mueller, VP Commercial Operations

Experienced healthcare commercialization expert, with 20+ years of experience in new product commercialization, market feasibility assessment, strategic planning, and patient marketing. Ms. Mueller has been involved in numerous product launches that have successfully changed clinical and surgical approaches in the treatment of challenging issues in a broad range of therapeutic areas.

Our partners

Battelle

Battelle, a global applied science and technology development company headquartered in Columbus, OH, is IC Surgical's research and development partner. IC Surgical engaged with Battelle as our product development partner for the Interi System. Battelle brings world-class multidisciplinary expertise across a wide range of science and engineering disciplines to support IC Surgical's technical development, design, prototyping, testing and transfer to manufacturing.

www.battelle.org

M Squared Associates

M Squared Associates serves as IC Surgical’s regulatory, quality and clinical research experts. M Squared provides a full range consulting services to US and international medical technology firms. With their specialized expertise in devices and combination products that are reviewed by FDA's Center for Devices and Radiological Health (CDRH), M Squared is ideally suited to support ongoing regulatory and clinical initiatives for IC Surgical.

www.msquaredassociates.com

Phillips-Medisize

Phillips-Medisize, a Molex company, is a global leader focused on providing end-to-end innovation, development and manufacturing solutions to pharmaceutical, diagnostics and medical device customers. IC Surgical has partnered with Phillips-Medisize in the molding and assembly of our Interi Therapy Units to deliver consistently produced devices that meet our design specifications for technical performance and ease of use.

www.phillipsmedisize.com

A brief company history

IC Surgical was formed by 4 co-founders with a vision to address surgical complications, especially issues related to tissue disruption. In 2015, the company acquired the design history file and a robust patent portfolio associated with a proprietary internal Manifold conduit in “peel apart” configuration, and methods for drawing tissues together using negative pressure and an internal conduit.

In 2016, the company submitted an Investigational Device Exemption (IDE) application to the FDA for clearance to study an internal tissue closure system in human subjects. After correspondence with the agency, FDA designated the system as a non-significant risk device and therefore an IDE was not required.

The IC Surgical Clinical Pilot Study was submitted and approved by Western Institutional Review Board (WIRB), a third-party national IRB (Protocol # 20162287). The Pilot Clinical Study enrolled its first subject enrolled 2/15/2017, and 24 of 24 subjects completed follow-up 8/2/2017.

Development work on the Interi System was initiated in 2017 after completion of Series A raise. The work to date has encompassed comprehensive product development of all components as well as system validation of the entire Interi System. Specifically, the effort has focused on: design and development of the proprietary Therapy Unit, validation of the Manifold, design and development of the novel one-way Connector, overall System integration, manufacturing scale-up, and process verification and validation.

Financing to-date consists of co-founders investment and several private investors. The company continues to build on its patent portfolio with a total of 11 patents issued, 4 patents pending, and several provisional patent applications.