1006 Kayla Rodriguez Graff: Healing Wounds with Honey

A ‘No’ Is Never an End: How ‘Operation Phoenix’ Changed the Game for SweetBio

The patent office said no. The FDA said no. Medicare said no. Kayla Rodriguez Graff’s company came back from all three devastating rejections and is now FDA-cleared, patented in almost 20 countries, reimbursed, funded, and healing wounds in clinics across the country with a dissolvable sheet made from manuka honey and collagen. 

Kayla is the CEO and co-founder of SweetBio, the Memphis biotech company she started in 2015 with her brother, biomedical tissue engineer Dr. Isaac Rodriguez, after a phone call in which she said, essentially, it’s going to fail anyway, so we might as well try. Their great-grandfather and a cousin had died of diabetic ulcers, the wounds SweetBio now treats. She had 4 questions for her brother: is the need big enough, will people pay, can we make it for less than we sell it for, can we protect it. Of course, the answer was “yes”, until it wasn’t.

Kayla, founder who treats a “no” like a routing instruction, shares the morning after the original FDA rejection, and the “Operation Phoenix” whiteboarding that got the team on the right trajectory. It involved a 12-month pivot into wound care, with a clear pathway to reimbursement, and then came $12 million in investment, two clearances, and patents in 20 countries.

We talk about why applying to the FDA is like sitting a final exam (your packaging, formulation and manufacturing are locked the day you submit), why entrepreneurs are a canoe that can turn (or turn over) with the tide, and the pre-mortem exercise Kayla runs every year: a mock New York Times headline about the sweetest unicorn passing a billion dollars, and the question “what broke?” We get into how the COVID test, a complex diagnostic taught to millions through pictures, inspired VERIS, the daily dissolving sheet patients apply at home. And we get into life: company in 2015, engaged the same year, married 2016, first baby 2017, “I’ve only known chaos”; the move from San Francisco to Memphis to prove you can build something extraordinary without killing yourself; her mother’s rule that when you run out of A, B, C and D you go to the Greek alphabet and then count on your toes; and why, if she was too busy for Washington, she’d be too busy to survive a regulation she missed.

More about Kayla Rodriguez Graff at www.sweetbio.com

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More about Kayla at SweetBio

Kayla Rodriguez Graff is reshaping innovation in healthcare and wound care as CEO and co-founder of SweetBio, a biotech company using patented, honey-based biomaterial technology to promote advanced healing.  Kayla has spearheaded multimillion-dollar fundraising efforts, guided SweetBio through product development, patenting, FDA clearance, and early commercialization, and championed the company’s mission to expand access to high-quality wound care. A passionate advocate for women entrepreneurs, diverse founders, and the life sciences ecosystem, Kayla serves on several national and regional boards supporting policy, innovation, and equitable economic growth, recently presented at the U.S. Senate on women’s entrepreneurship, and serves as Board Chair of Life Sciences Tennessee, representing a sector of nearly 4,000 companies and close to 50,000 employees statewide. 

Get the Transcript HERE