Tens of thousands of head and neck cancer patients every year survive months of radiation treatments, only to be stricken with a debilitating dry mouth that has no cure. But UCSF HIVE researcher Chelsea Bahney, PhD, co-founded a company that is bringing a one-of-a-kind regenerative treatment for the medical condition caused by salivary gland dysfunction. Hydronovo recently received news of accelerated funding from the federal Small Business Innovation Research (SBIR) program, meaning help will be here faster for these patients.
“You don’t typically think of dry mouth as such an impactful disease, but patients who have it are miserable — you can’t eat, sleep, or talk without saliva. We’ve even seen one patient who can’t say more than three words without stopping to drink something,” says Bahney, an associate professor in UCSF’s Department of Orthopaedic Surgery and a member of UCSF’s Health Innovation Via Engineering (HIVE) center. “Patients and clinicians are eager for a treatment, since there currently isn’t one available.”
Xerostomia, the medical term for dry mouth, can be caused by a variety of factors, including radiation therapy for head and neck cancer, autoimmune diseases like Sjögren’s, diabetes, or aging, and it’s a known side effect of more than 50,000 medications. The condition is more common than you’d expect, in fact, it affects nearly 1 in 5 adults over the age of 50, yet existing treatments are limited to temporary relief, without addressing the underlying cause of salivary gland dysfunction.
Taking an idea from concept to clinic
Bahney met the company co-founder and her scientific partner Sarah Knox, PhD, professor of cell and tissue biology in UCSF’s School of Dentistry, several years ago at a UCSF conference and realized they were both studying the role of nerves in tissue generation — Bahney in bone and Knox in salivary glands.
“We realized there were synergies in our work, and we started a collaboration that led to our start-up, Hydronovo,” explains Bahney, who is serving as chief executive officer of the company alongside Knox as the chief scientific officer. “Sarah’s laboratory focuses on the mechanism behind diseases, and their research discovered the salivary gland stem cell. While as a bioengineer, I tend to look for ways we can develop therapies built on novel druggable targets. Together we’ve developed and are translating — or moving the therapy from the research lab to the clinic — a solution to the unmet clinical problem of xerostomia that has the potential to significantly improve patients’ lives.”
The concept behind Hydronovo’s product, Ceviginate, is to restore the body’s native biology that gets disrupted by radiation therapy. Specifically, radiation therapy harms the sympathetic nerves near the salivary gland, which in turn causes the stem cells to die. Ceviginate replaces the role the nerve plays in maintaining the salivary gland stem cells through an injectable hydrogel solution to allow the drug to be released slowly over time within the damaged tissue. This allows the stem cells to start to proliferate and consequently restore the function of the gland. This delivery method further prevents the negative systemic side effects that can happen when this drug activates the nervous system throughout the body. While the final dosing protocol still needs to be determined through clinical trials, it’s expected that patients will receive an injection of Ceviginate into their salivary gland by their clinician or dentist four times per year.
“What makes Hydronovo’s solution unique is that we are regenerating the stem cells and triggering re-innervation by restoring nerve signaling locally after it is lost due to radiation therapy,” Bahney says. “It’s a simple solution, which is why it’s working so well.”
The Hydronovo team received their first funding from the National Institute of Health’s C-DOCTOR (Center for Dental, Oral, and Craniofacial Tissue and Organ Regeneration) grant and have sponsored multiple UCSF/UC Berkeley Master of Translational Medicine capstone teams that have been key in moving the product from concept to reality. These successes led to additional translational funding from the California Institute for Regenerative Medicine in 2024.
Most recently, the company received a direct to phase 2 funding from the federal Small Business Innovation Research (SBIR) program — skipping the traditional first phase based on their substantial evidence and progress to date. With this newest investment, the team is now preparing for large-scale manufacturing, developing packaging, and completing the safety studies that will allow them to turn their investigational new drug application into the FDA next year, with hopes of beginning a clinical trial in 2027.
Sharing her success with HIVE
Bahney says her growth as a translational scientist motivates her engagement and commitment to HIVE. “The best medical innovations begin when engineers and clinicians come together to brainstorm novel solutions to healthcare’s toughest challenges. The HIVE community connects cutting-edge technology with urgent medical needs that currently have no solutions. By bringing together leading minds from engineering and medicine, we’re creating breakthrough technologies that directly improve patient lives.”
As Hydronovo moves towards clinical trials, Bahney looks forward to sharing gained insight in manufacturing and regulatory science with her HIVE peers. “A lot of times in academics we have technologies but have not honed them for a real clinical issue, or we don’t know how to bring solutions to market,” she says. “One of the great things about HIVE is that it brings together our collective experiences to strengthen the community. Through Hydronovo, I’ve learned so much about starting a company and the complicated steps involved in going from an idea to product. I look forward to sharing what I’ve learned with the HIVE community in order to amplify UCSFs impact on human health.”