In-utero procedures can yield better long-term outcomes for the baby. However, fetal surgery relies on instruments developed for other disciplines. An early-stage startup in Maryland is developing in-utero instruments to improve outcomes for both fetus and mother.

Fetal Therapy Technologies CEO Selena Shirkin joins Key Tech’s Andy Rogers for Episode 42 of the MedTech Speed to Data podcast to discuss startup innovation in fetal surgery.

Need to know

• Fetal surgeries carry risks — In addition to uterine damage complicating future pregnancies, 40% of surgeries have a risk of preterm birth.
• Few specialized tools are used — In the field’s forty-year history, the FDA has only approved the Karl Storz Fetoscope for use in fetal surgeries.
• Off-label device use is widespread — Equipment borrowed from adjacent fields like laparoscopy and neurosurgery weren’t indicated for use in the uterus.

The nitty-gritty

Shirkin and Chief Technology Officer Eric McAlexander founded Fetal Therapy Technologies as students in Johns Hopkins University’s biomedical engineering graduate program. While shadowing surgeons, they saw how off-label instruments complicated procedures.

“I watched a surgeon using a grasper and suture,” Shirkin recalled. “The suture was falling out of the grasper because they didn’t fit. It took time in the surgery to make sure that didn’t occur.”

Observations like these led the team to wonder why the field lacked optimized tools. “As biomedical engineers,” Shirkin says, “we asked ourselves what if we created those purpose-built instruments that actually make these procedures safer?”

They quickly ran into the commercial limits of a market as small as fetal surgery. With only one device FDA-approved for in-uterine procedures, surgeons have no choice but to use devices off-label. So Fetal Therapy Technologies is flipping the script by leveraging the broader applications of an instrument designed for fetal surgeries.

“In a way, our company solves two problems at once,” Shirkin says. “A company that creates a fetal innovation [that] also raises a much broader market of general microsurgery.”

Their first product is a uterine port. “Similar to laparoscopic surgeries,” Shirkin explains, “that involves inserting a port through the abdomen into the uterus. [The new] port is designed to leverage the elastic properties of the uterine environment to make entry safer than the current clinical standard.”

For broader commercialization, they aim to demonstrate equivalence to predicate devices and qualify as a 510(k) Class II device following benchtop and animal studies. Approval for fetal surgeries is a longer journey, but the company can build on its data before entering human trials.

Data that made the difference:

Shirkin offered insights for other students considering an entrepreneurial future in MedTech.

• Leverage university resources. “We work incredibly closely with the Johns Hopkins Center for Fetal Therapy,” Shirkin says. We’ve also gotten opportunities from Johns Hopkins Technology Ventures.”
• Build a network of advisors. “We are supported by a very broad variety of clinical, technical, and business mentors across the Johns Hopkins ecosystem and beyond.”
• Tap into local funding sources. “There’s a lot of collegiate business plan competitions that we’ve been very successful [raising] non-dilutive funds that way. There are also state-level grants. We just received a Baltimore Innovation Initiative grant.”