Three years, two rounds and one ‘market reprioritization later,’ SweetBio is poised to enter the $10 billion wound care market this year. While FDA work continues on a first in kind pre-implant dental application of its Manuka honey and collagen derivative membrane product Apis, the company has pivoted to a planned, but previously secondary market. Why? A faster regulatory pathway and larger addressable market.

SweetBio Co-founder and CEO Kayla Rodriguez Graff was kind enough to share nearly an hour with Write2Market VP of Healthcare Paul Snyder. They talked about the company’s progression, ‘market reprioritization,’ learnings and more in the nearly four years since we first featured them following SEMDA 2015.

Kayla Rodriguez, MBA – Co-founder & COO, SweetBio

Paul: “What drove your reprioritization from a first in kind dental implant regenerative product to wound care in general?”

Kayla: “Our baseline technology, which we call MXTECH, is a true platform. While the first manifestation of MXTECH was a regenerative membrane for dentistry, we quickly discovered the direct translatability and extreme market demand in adjacent markets, including wound care. As honey has never been cleared for use in dental, the regulatory pathway became more difficult. Because we had already examined the wound care market and heard from early customer discovery that our product is ‘exactly what they have been looking for,’ we were confident in this pivot.

“We were grateful to be working with world renowned wound care clinicians, including Dr. Lillian Nanney and Dr. Jeffrey Davidson at Vanderbilt University, who provided incredible feedback as we prepared for the wound care industry. Because of the background work completed on the safety and efficacy of MXTECH, and because there are currently over a dozen Manuka honey wound care products commercially available, we were able to translate our dental regulatory documentation into over a 1,000 page wound care 510K application in just 40 days. We expect to our first product to enter the $10 billion wound care market – with solid, existing reimbursement opportunities in place – this year.”

Paul: “SweetBio recently closed a new funding round. What messages resonated most with your investors?”

Kayla: “A $10 billion market and an investable opportunity with high growth return potential. There is also strength in our multiple bottom line message. We are able to demonstrate a proven record of delivering on dollars received including spending plans, accountability, clear messages and consistent communication with our investors. We are an investable company with high growth potential and a diverse, woman-led company.  

“Because we stand for better healing, everyone has a relatable story, which usually involves witnessing a painful healing experience with an aging loved one or even a beloved pet. We are also tackling a problem with an on-trend natural solution without having to sacrifice performance for ingredients.”

Paul: “What have you learned about the FDA process that could be useful to very early stage innovators – like yourselves three years ago?”

Kayla: “First, understand your claims and pathway. Word choice is monumentally important. Just one or two words in your claims can push a 510k to a PMA. Next, find the right partner, especially regulatory consultants that are experienced in your product class and FDA branch to communicate that word choice. Then, finalize your product design in a way that enables you to manufacture at scale with economics that make sense. The last thing you want to learn is that you have $100 product COGS that can only retail for $20.

Paul: “What would you do differently?”

Kayla: “Hire full-time, high quality consultants up front. Pay them to work every day as early as possible with complete focus on, and enthusiasm for, what you are doing. Conversely, move faster on removing bad partners. They might not be bad people, but if they are misaligned with your vision, remove them swiftly.”

Paul: “What makes clinicians (potential customers) more likely to engage with a pre-FDA healthcare startup?”

Kayla: “Referrals are the way we get early interest from clinicians. We don’t succeed at cold calling. Even clinicians follow the common diffusion of innovation curve – people are either innovators, early adopters, in the majority or laggards. Understand your value proposition for each group, then find early adopters willing to try something different and are excited about it. The value proposition and strategic alignment with innovators or early adopters lies in an existing interest in innovation and industry leadership, which includes being part of the research and publishing.

Paul: “How did you get to be part of Prudential’s ‘State of Us’ commercial happen?”

Kayla: “That was absolutely amazing. Their own team picked cities with statistics that drove unique financial decisions. They picked Memphis due to its massive increase in the number of  women owned businesses. We had no contact with them prior to being asked to participate. I believe that our visibility in the entrepreneurial and life sciences ecosystems, serving on boards including Epicenter and New Memphis Institute, participating in community activities as mentors, our mission and diversity helped them find us. After eight rounds of interviews, we got the gig!

Paul: “What’s the lesson there?”

Kayla: “When you serve, good things happens. What happens outside of your office or lab is equally as important as what happens inside of it. You won’t see immediate results. Do it from a different place, a place of service. In our case, our commitment to our community and service ultimately helped raise money, connect to clinicians, gain access to more boards and other resources like our new office at the University of Memphis CommuniTech Research Park initiative.”

Paul: “What has been most surprising about your journey to date?”

Kayla: “How my role has changed. Each day, I focus on identifying the right work that aligns with strategic objectives and putting the right people on that right work. It has shifted from putting processes in place for projects with more partners and help the business run more efficiently. Axel Strombergsson, our new chief operating officer, was built for that. With Axel on operations and myself on the future activities of the company, it frees up our co-founder and Chief Science Officer, Dr. Isaac Rodriguez, to soar at his strengths – reinforcing the scientific credibility of SweetBio. The culture of our company is strong and I am proud of it – we each have the opportunity to soar at our strengths while we drive incredible progress for the company.

“We plan on doubling our team in next 12 months while ensuring we’re operating in a way that’s energizing. I’ve been spending and enjoying more time focusing on the team and our culture – different and surprising for me – and I’m highly energized by it.”

Paul: “What do you need next?”

Kayla: “Two things. First, interview around 100 wound care experts for customer discovery. Second, identify and learn from business mentors who have done what we are hoping to do: to build, launch and scale a company both nationwide and globally.”

Paul: “What are you interested in learning from the collective ‘medtech’ community?”

Kayla: “The New Memphis Institute, a community leading nonprofit in Memphis, does a ‘speed mentoring’ event. I’m interested in more one-on-one knowledge sharing from the Randy Scotts and Bob Crutchfields of the world in a low-risk environment. There are always questions about reimbursement, resource recommendations and what are the top questions to ask distributors in contracts? Having access to mentoring from these inspirational leaders can be company altering for a scale-up company.”

Follow SweetBio on LinkedInTwitter and Facebook.