MedTech IGNITE CASE STUDIES

Flex Biomedical    MX Orthopedics Corporation

Flex Biomedical - Embedding MedTech Expertise, Building a Network

Entrepreneur: Sal Braico    Coach: Don Freeman
Sal Braico was referred to MedTech IGNITE by IGNITE board member Dean Banks, formerly of Highland Capital Partners. In late 2007, Sal was moving to the Boston area to join Flex's scientific founders after having raised $8.3 million to launch a biotech start up in Wisconsin. Sal was keen to build up a network of advisors and investors in the Boston area and Dean suggested that Sal apply to the IGNITE program. "What was particularly appealing to me about IGNITE was the opportunity to connect with a pool of high-caliber, experienced medtech leaders," notes Sal. "I also liked the fact that the mentoring was provided by current and former CEOs. It was important to me work with someone who had an in-depth understanding of what it takes to raise capital and shepherd a new technology to market."

Flex Biomedical is developing a polymer-based, injectable technology to treat osteoarthritis. The technology was initially developed at Boston University in the laboratory of Mark Grinstaff, an associate professor of biomedical engineering who had spun out two other companies from his research. In addition to Dr. Grinstaff, Flex's scientific advisors included Dr. Brian Snyder, an orthopedic surgeon at Children's Hospital in Boston and Dr. Michel Wathier, a senior scientist in Dr. Grinstaff's lab. Joining Sal as Chief Operating Officer was Hideki Suzuki, who had worked with Sal at his previous startup. Sal comments, "Our team members all came from a very strong scientific background, so part of the value of what MedTech IGNITE offered was the opportunity to deepen our business and industry knowledge."

When Flex was accepted into the IGNITE program in December 2007, the company was due to receive $200,000 in seed funding from Boston University. Sal notes, "One of the first issues Don and I worked on was the distribution of that initial funding. I wanted to make sure that we spent it wisely and sought out Don's guidance on how much we should spending testing our lead product and how much to allocate on developing our follow-on technologies." Prior to joining IGNITE, Sal and his team had done extensive research to understand their market opportunity and their development pipeline. He comments, "We had a good feel for how to proceed with our product development process, but it was helpful to confirm with Don that we were on the right track. He gave us some good advice on the biocompatibility data investors would want to see, which helped inform our pre-clinical strategy."

Above all, Sal reports that he gained the biggest benefit from Don's deep expertise in the medtech industry, "Coming from the drug development industry, I had assumed that the product development process and fundraising approach in medtech would be similar. I quickly discovered that neither was the case and particularly that medtech investors look at very different criteria than biotech investors. Don's expertise and guidance in these areas was invaluable as he helped me structure my clinical pathway and hone my value proposition for investors."

As the final step in his IGNITE process, Sal presented his case for investment before an audience of early stage investors and advisors on July 10, 2008. Providing feedback to Sal and his team was a customized panel of industry leaders with expertise in polymer development, biochemical engineering, intellectual property, and reimbursement. Reviewers recommended that Sal evaluate his collaborations with Boston University carefully, to ensure that he maintains ownership over the critical elements of his technology's IP. They also suggested that Sal and his team collect the data necessary to claim a compelling clinical endpoint, such as eliminating the need for joint replacement.

Sal states, "Being part of IGNITE definitely helped me save time and money. Had I not had Don's network and the resources of the IGNITE staff to tap into, I would have probably ended up spending a substantial amount of money hiring consultants and had my time eaten up with networking and establishing connections in the area. Having the resources of the IGNITE program at my disposal allowed me to focus my time and energies on driving my company forward in an effective, efficient way."

MX Orthopedics Corp. - Building on a Concept with a First-Time CEO

Entrepreneur: Matthew Fonte    Coach: Don Freeman
When Matt Fonte first applied to the IGNITE program in the spring of 2007, he had the skeleton of an idea to apply a new materials concept to the orthopedic market. While completing his doctoral work at Tufts in Material Science and Manufacturing Processing, Matt had written a paper on the benefits of using shape memory material in place of traditional orthopedic implants. Matt comments, "I thought this concept could have some real clinical value, but wasn't sure how to go about validating the idea. A search of the MassMEDIC website led me to MedTech IGNITE and my first conversation with Aaron and Don."

Aaron Sandoski, a venture capitalist and MedTech IGNITE board member and Don Freeman, an experienced medtech CEO and IGNITE coach, interviewed Matt about his business concept and offered their guidance on his next steps. "That initial interview with Aaron and Don was incredibly valuable," Matt notes. "What they really drove home for me was how important it was going to be to build clinician buy-in in order to get this idea off the ground. Also, I had started scheduling meetings with some large players in the orthopedics market to get their take on this concept and Aaron and Don strongly advised against that until my intellectual property protection was locked down. That was an important piece of advice and I would definitely recommend that other entrepreneurs be sensitive to the protections they may and may not have from their IP filings."

A few months after his initial discussion with Don and Aaron, Matt returned with an update on his extensive work creating a Scientific Advisory Board of leading orthopedic surgeons; further solidifying his patent protection; and developing prototypes of his technology. Upon his re-application, Matt was accepted into the IGNITE program and began working with Don to build his business model and engage investors and advisors in his groundbreaking technology concept.

Don and Matt spent several months working on a business plan and establishing a path to commercialization. Matt reports, "Don was extremely helpful was in helping me map out the milestones I needed to reach to engage two constituencies: the FDA and VCs. Don and I spent a lot of time crafting my value proposition so that it was aligned with the interests of potential investors. We also created a product development process designed to collect the necessary data to get me to regulatory approval. With Don's coaching, I was able to spend my time and money wisely. He helped me figure out where to spend my energies and wasn't at all shy about telling me when he thought I was going off-track!"

A key component of Don's coaching was to help Matt shape his financing strategy. "In my own experience with fundraising, I've found that a successful pitch to an angel is very different than one to a VC and vice-versa," Don notes. "So we worked extensively on Matt's business plan, making sure that it presented a compelling case to each type of investor. I also advised him on how to time his fundraising efforts and the elements of his business model and product development process that needed to be nailed down before he started approaching investors."

Don also played an important role in helping Matt engage outside advisors and investors in his idea. "Having Don with me lent a tremendous amount of credibility to my concept, whether I was trying to enlist an orthopedic surgeon to join my scientific advisory board or I was pitching a potential investor," reports Matt. "Don helped introduce me to some important orthopedic thought leaders and I was able to leverage those connections to get in to see some VCs, which then led to referrals to other VCs, so the networking connections Don brought to the table were incredibly valuable."

As the final step in his IGNITE coaching process, Matt presented his case for investment before an audience of early stage investors and advisors on July 10, 2008. Providing feedback to Matt and Don was a customized panel of industry leaders with expertise in medtech reimbursement and regulatory pathways, intellectual property, and orthopedic sales and marketing.

The panelists and audience members offered guidance on Matt's commercialization strategies, business model, regulatory pathway, as well as the format and content of his presentation. One of the major points raised during the discussion was that Matt should explore a platform technology approach for his shape memory alloy. Reviewers also recommended that Matt develop a comprehensive strategy to drive adoption of his technology, as orthopedic surgeons can be reluctant to embrace new approaches.

Reflecting on his experience with IGNITE, Matt says, "I couldn't be where I am today, this quickly, without the help of Don and MedTech IGNITE. I've been working on launching this company while also holding down a full-time job and despite the fact that I'm doing a lot on my own, I've felt like I've had a full team behind me."



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