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BIO Innovation Zone Company Snapshots: Actuated Medical

June 4, 2014
Later this month at the BIO International Convention, BIO will be partnering with the National Science Foundation (NSF) and the National Institutes of Health (NIH) to host the first-ever BIO Innovation Zone. The Zone will feature Small Business Innovation Research (SBIR) funded early-stage biotech companies.

The SBIR/STTR program provides U.S. federal funding to small businesses engaged in research with the potential for commercialization. Companies are rigorously vetted through the NIH and NSF SBIR review process prior to receiving the funding. The majority of participating companies in the Innovation Zone have received SBIR Phase II grants, which provide up to $1 million dollars in funding to engage in R&D that has the potential for commercialization.

Over the new few weeks, we will feature snapshots of a few of the companies who will participate in the Zone. Today we interviewed Roger Bagwell, a co-founder and the director of R&D for Actuated Medical, a small business based in Bellefonte, PA which is supported by NSF’s SBIR program. 

What is your company’s lead product or technology? 

Actuated Medical has two NSF-SBIR sponsored products we are featuring at BIO 2014.  The first is TubeClear® which is concluding its Phase II B funding from NSF.  TubeClear®, a device that clears clogged feeding tube in patient, in minutes, is being manufactured by Actuated Medical, Inc. and distributed worldwide by Corpak MedSystems (Buffalo Grove, IL).  Our newest technology, just awarded a Phase II, is the Grip-Act-Reposition (GAR) system - which will improve success rates in treating Atrial Fibrillation by allowing the clinician to grip the tissue wall inside a beating heart, and hold position or move reliably to a new location as needed.

How has the NSF SBIR program helped your company grow?

The NSF SBIR program has been critical to our growth.  We were first funded with a Phase I in 2008 for what became the TubeClear Product.   NSF support, from Phase I through Phase II B, which is just concluding, was critical to bringing an innovative medical device to market that will improve patient outcomes.   Besides the financial support, lessons learned at conferences and workshops, plus the rigor of commercialization planning, were extremely important to Actuated Medical’s success.   The technology also had enormous credibility and validation, from potential investors and partners, from passing through the NSF review and evaluation process.  NSF SBIR also offers additional supplement awards that were wonderful for allowing us to hire interns, many of whom later became full-time employees.

What are the upcoming milestones and long-term priorities for your company?

Actuated Medical has grown to 26 employees and outgrown its 9000 sq.ft. facility.  We are looking at moving into a 20,000 sq.ft. facility by the end of summer, which will include expanded manufacturing space for our TubeClear and other product lines.  We have also signed a worldwide distribution agreement with Corpak MedSystems for the TubeClear product, and need to be able to meet their demand.   Our long term goal is to use SBIR funds to development clinically relevant and commercially viable devices that are too high-risk for larger companies to attempt – then manufacture them in our Bellefonte, PA facility, and distribute them through partners in that market space.

What do you hope to gain out of your participation at the 2014 BIO International Convention?

We would certainly like to see more contacts and customers for our existing product lines.   We are also expanding our Contract Development and Manufacturing services, and plan to reach out to potential partners, including assisting Biomedical SBIR companies with their manufacturing needs.  Actuated Medical is ISO 13485 and ISO 14971 certified - thus compliant to FDA cGMP.   Finally, we realize that the GAR system, in a cardiac application, is going to require significant funds and backing from the right investment group, and we would love to make contacts in that area.

Tell us something about your company that investors might not know. 

We integrate controlled Innovative Motion™ (i.e., actuation) into medical devices to give them new functionality and enable new procedures - resulting in improved patient outcomes.  We look for a healthy mixture of diverse projects and products, but with enough focus to make sure devices make it to market.  Maintaining that balance is a challenging, fun, and rewarding process.   Actuated Medical has a wonderful, diverse engineering team that have the mission to improve patient outcomes.