Get ready for a wave of new stem-cell therapies in Florida.
A new state law allows companies making certain stem-cell treatments to offer their products in Florida under tight rules, before those therapies get approval from the US Food and Drug Administration (FDA). The aim: to speed relief to suffering patients.
An Israeli biotech company is among the first to avail of the new law, partnering with an FDA-registered manufacturer in New Jersey and FDA-registered lab-distributor in South Florida to offer its innovative treatment. The venture, Cytora, is expected to seek funding for expansion at the GoForIsrael investment conference set for this fall in Miami Beach.
Cytora has developed a stem-cell therapy that can be used for diabetic foot ulcers, a wound often difficult to heal. Patients with those ulcers sometimes suffer amputations. Early clinical trials in Israel show its treatment promotes healing, said CEO Yona Geffen. Plans call for offering the product in Florida in 2027. Cytora also aims to boost clinical trials and apply for FDA new-drug approval, a process that often takes years.
“We are pioneers in using this new legislation, and I know that after us, there will come many more companies to offer new stem-cell therapies for patients in Florida,” Geffen said in a videochat from Israel.
New law seeks to help patients with tough conditions
The Florida law that took effect July 1 lets physicians licensed in the state provide stem-cell treatments not yet approved by the FDA in three areas of significant patient demand: orthopedics, wound care, and pain management. The therapies must be made in the US in FDA-registered plants, among other strict regulations.
Today, US patients suffering such conditions as hard-to-heal diabetic foot ulcers often seek treatments overseas, sometimes traveling to Central America or Asia to facilities with unclear oversight, Geffen said. The new law aims to bring those services into Florida, with therapies made in the US at FDA-registered plants.
U.S. health insurance won’t immediately cover the new treatments, however. Geffen said insurers typically don’t cover therapies not yet approved by the FDA, so patients initially would pay out of pocket. With more extensive US clinicals trials, some carriers may cover the treatment. And once FDA approvals come through, insurers hopefully will cover costs completely, she said.
Cytora: an innovator in stem-cell therapies in Israel
Based in Yokneam, some 50 miles north of Tel Aviv, Cytora grew out of observations by Sandu Pitaru, a dentist and medical-school scientist. Professor Pitaru recognized that certain wounds in the mouth heal quickly without scars. He worked with researchers to isolate the oral-mucosa stem-cells linked to that healing, produce doses and use them in therapies.
Founded in 2018, Cytora so far has raised roughly $17 million, Geffen said. Funding includes $12 million in equity from Israeli investors and $5 million in grants from Israeli authorities and from pharmaceutical company Merck. The venture now employs 12 people, she said.
Cytora is seeking to raise another $5 million to begin manufacturing in the US to provide treatments in Florida. It also seeks another $10 million to $15 million to complete its Phase 2b clinical trials in the US to move toward FDA approvals, said Geffen.
“We believe in the first quarter of 2027, we can start to sell a few batches in Florida to treat some 100 patients, and with greater distribution, can reach an inflection point … to fund clinical trials,” she said. “There’s a huge opportunity for patients with diabetic ulcers to have access to this product, instead of facing amputation.”
Teaming with South Florida’s Zeo ScientifiX for distribution
Cytora has partnered with Made Scientific in Princeton, NJ to produce its stem-cell therapy. It also is working with Zeo ScientifiX, based at Nova Southeastern University’s Center for Collaborative Research, to commercialize the treatment. Zeo is a biotech company active in research, manufacturing and distribution of new biologics. Geffen said Cytora chose Zeo for sales and marketing, because the Davie-based company already works with a network of clinics, doctors, and other buyers across Florida for its own biotech products.
Ian T. Bothwell, who leads Zeo, said he’s enthusiastic about the partnership, because he sees Cytora’s diabetic-ulcer treatment as both unique and promising, given the success of its early clinical trials in Israel. “We’re excited about the opportunity to provide therapies to benefit patients that are now suffering,” Bothwell said.
Indeed, he’s upbeat generally about the new law that makes Florida probably the most open market of any state for certain stem-cell treatments not yet FDA approved.
“Stem cell therapy has long existed in a gray zone, caught between scientific promise and regulatory gaps,” Bothwell wrote recently. “SB-1768 introduces structure where there was once ambiguity.” He expects other states to watch Florida’s moves and perhaps follow its lead.
“There is so much potential in regenerative medicine,” Bothwell said. “I think this partnership with Cytora will lead to many more opportunities to bring stem-cell therapies to Florida.”
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