Focal Medical acquired by Florida biopharmaceutical company

Raleigh-based Focal Medical, an oncology device company that received early funding from the North Carolina Biotechnology Center, has been acquired by a Florida biopharmaceutical company.

Financial terms of the sale to Continuity Biosciences of Bradenton, Fla., were not disclosed.

“After nearly a decade of R&D, we are excited to join the Continuity Biosciences family,” said Tony Voiers, acting chief executive officer of Focus Medical. “We are grateful to our founders, scientific collaborators and investors who have helped us reach this pivotal point.”

Under terms of the acquisition, Continuity will obtain Focal Medical’s patents, technology, equipment and licensing agreements with the University of North Carolina at Chapel Hill, where the technology was invented. Key scientific staff and leadership from Focal Medical will also join Continuity, according to a news release.

A research facility in Cary that supports Focal Medical’s platform and pipeline development is also part of the deal. Continuity said the facility would be expanded to support other drug-delivery platforms.

Precise drug delivery

Focal Medical developed a proprietary technology that uses mild electrical current to drive chemotherapy drugs into solid tumors. Its main focus was on pancreatic cancer, the third leading cause of cancer deaths in the United States.

“Partnering with Continuity ensures that this novel therapy moves forward into the clinic, where it has the potential to help patients facing one of the deadliest cancers,” Voiers said.

The company’s technology includes a small, surgically implantable device connected to an external pump, electrode and controller. The system delivers gemcitabine, an approved chemotherapy drug, directly into tumor tissue with an electrical field.

In addition to pancreatic cancer, the device could potentially be used to treat other solid tumors such as sarcomas, head and neck, and breast cancer, because it is compatible with most chemotherapy drugs. About any molecule with polar bonds in a water solution can be carried by an electrical current.

The device is intended to boost drug concentration in the targeted tissue but spare the rest of the body from toxic side effects, overcoming the limitations of traditional chemotherapy administration by mouth, injection or intravenous infusion.

More precise drug delivery could shrink pancreatic tumors enough for surgeons to remove them. While not typically curative, that improvement could extend patients’ life expectancy and improve their quality of life.  

The device proved successful in pre-clinical studies using lab mice.

In the mice treated systemically with gemcitabine, the drug slowed the rate of pancreatic cancer growth, but tumors still grew about 2.5 times their original size. In the placebo mice receiving no drug, tumors increased to several times their original size.

However, in the mice receiving the drug directly into the pancreas through Focal Medical’s device, tumors shrank by about 40 percent. 

Clinical trial planned

The technology was cleared for a human clinical trial by the U.S. Food and Drug Administration in 2023 through an Investigational New Drug application. A Phase 1b trial is expected to begin later this year in patients with locally advanced pancreatic cancer not suitable for surgery.

“Focal Medical’s approach to localized drug delivery aligns perfectly with our vision to improve bioavailability, reduce systemic exposure and deliver better outcomes for patients,” said Ramakrishna Venugopalan, chief executive officer of Continuity Biosciences. “We are thrilled to bring this promising platform into our portfolio and into the clinic.”

The acquisition supports Continuity’s strategy to become a leader in device-targeted therapeutics for intractable solid tumors, the company said.

Continuity launched in 2024 and develops advanced drug-delivery technologies for complex and chronic diseases. The company now has operations in Bradenton, Raleigh, Cary, Houston and Torino, Italy.

UNC roots

Focal Medical, originally known as Advanced Chemotherapy Technologies until a corporate rebranding in 2022, was founded in 2014 on technology developed at the UNC School of Medicine and the UNC Lineberger Comprehensive Cancer Center. The technology was invented by Jen Jen Yeh, M.D., a surgical oncologist and professor, and Joseph DeSimone, Ph.D., an award-winning chemistry professor and entrepreneur.

The company received a $250,000 Small Business Research Loan from NCBiotech in 2017 to help translate its medical device from mouse studies to human use. 

The funding was “just a godsend for a small startup company like this,” Voiers said in a 2018 profile of the company by NCBiotech.

“NCBiotech made one of the first investments at Focal Medical, providing funds that allowed the company to hit critical milestones on their journey to treating one of the most devastating forms of cancer," said Mike Carnes, vice president for Emerging Company Development at the North Carolina Biotechnology Center. "The acquisition demonstrates the value of Focal Medical’s approach and further showcases North Carolina as premier ecosystem for starting and growing medical technology companies.”

Before its acquisition, Focal Medical had raised over $20 million in research grants and investments from private and institutional investors, including Khosla Ventures, Spectrum Financial and Piedmont Capital Partners.