Rooted In Research, Aimed At The Future: The Story Of Trace Biosciences

Breakthroughs in medicine often begin quietly - in a lab, with a question no one else is asking and a team willing to pursue it. For Trace, that question was deceptively simple: What if surgeons could see nerves in real time? The answer, and the path to bring it from concept to reality, has encompassed a decade-long journey spanning academic discovery, mentorship, entrepreneurship, and now, clinical translation.

In this blog post, we explore Trace's journey through the perspective of its co-founders Connor Barth, Ph.D. and Summer Gibbs, Ph.D., stemming from their mentee and mentor relationship in graduate school at OHSU to today, looking at how Trace came to be, and where it is headed next.

Meet the Trace team [left to right]: Harsh Sant, Veronica Torres, (Ph.D.), Logan Stone, (Ph.D.), Connor Barth (Ph.D.), Bryce Timm (Ph.D.), Hanna Adler, Diego Jacho (Ph.D.), and Grace Hubbell (Ph.D.)

The Origins Of A Nerve-Specific Vision

The roots of Trace’s nerve imaging technology trace back to Summer’s early work as a postdoctoral fellow at Harvard, where she began exploring molecular approaches to nerve visualization. That work matured as she developed her own research group at OHSU, and the foundation of Trace Bio was born through a key collaboration with organic chemist and Trace cofounder Lei Wang, Ph.D. With their combined effort they were able to unlock a major breakthrough: red-shifting nerve-targeting molecules into the near-infrared (NIR) space.

This shift was critical. Near-infrared fluorescence enables deeper tissue penetration and clearer contrast in surgical settings, capabilities essential for real-world clinical use. Together, the team developed their first successful near-infrared dye with clinical translation in focus, marking a turning point from conceptual science to translational potential.

Connor joined Summer’s lab as a graduate student during this period, drawn by both the ambition of the science and Summer’s leadership. What began as a traditional PI–graduate student relationship would eventually evolve into something far less conventional.

Building a Lab—and Leaders—Together

Summer’s lab culture emphasized collaboration, independence, and intellectual rigor. Rather than directing every step, she encouraged trainees to think critically, take ownership of ideas, and work as a team. For Connor, this environment laid the foundation not just for scientific growth, but for leadership.

Over time, the conversation in the lab expanded beyond publications and grants to include commercialization. Early industry interest and OHSU’s encouragement made it clear that this technology could—and perhaps should—move beyond academia.

Summer watched with pride as Connor and others transitioned from graduate students into scientific leaders, underscoring what would become defining themes of Trace:

• Collective Strength: support from Connor's mentors, scientific collaborators, and interested surgeons catapulted Trace into a successful startup with a clear vision.

• Building Trust: as leaders in the field of fluorescent guided surgery, Trace's team began building relationships and trust within the scientific community through rigorous science and open discussion with key opinion leaders.

• Shared Purpose: to help minimize and one day eliminate nerve injury during surgery!

From The Bench, To A Startup

After Connor completed his PhD, the collaboration between him and Summer entered a new phase. Together, they formed an LLC, pursued SBIR funding, and began the process of translating academic research into a viable clinical product.

As Trace took shape, their roles naturally diverged. Summer continued to anchor the academic and scientific vision, while Connor leaned into commercialization and clinical translation. The transition required learning new skills: regulatory strategy, business development, and FDA engagement, but both saw parallels between running a lab and building a company.

“The science doesn’t stop,” Connor noted. “But now, every experiment has to answer a much bigger question: will this work in patients?”

Designing For The Clinics

The Science Behind Seeing The Nerves:

Trace’s technology builds on years of small-molecule dye development, beginning with oxazine 4 in 2014. Oxazine 4 demonstrated nerve specificity, while oxazine 1 offered near-infrared fluorescence but lacked tissue selectivity. Bridging that gap became a central challenge.

With Lei’s expertise in organic chemistry, the team created an extensive library of compounds designed to balance competing constraints: small enough to penetrate nerves, yet bright and stable enough for NIR imaging. The result is a rich structure–activity dataset for nerve targeting small molecule fluorophores, applicable across both the peripheral and central nervous systems - even in the face of formidable challenges like delivery across the blood-nerve and blood-brain barriers.

Clinical Translation:

Clinical translation demands more than promising fluorescence. When Trace brought their first R&D scientist, Bryce Timm, Ph.D. onto the team in 2023 to expand the technology and translate the lead candidates, the goal was clear: develop the technology into products that were safe, water-soluble, nerve-specific, and robust enough to survive the realities of human trials.

The team validated compounds in vivo across species and nerve models, rigorously stress-testing them to ensure they would be “bulletproof” for clinical development. As Connor emphasized, once a program enters the clinic, there is little room for failure and every decision must be backed by data.

The applications in surgery range in multiple avenues such as:

• Neurosurgery

• Prostatectomy

• Orthopedic Surgery

• Plastic and Reconstructive Surgery

The Time Has Come - Phase I Begins

That discipline paid off. Trace recently achieved a landmark moment: FDA investigational new drug (IND) approval to dose their first patient in Phase 1 clinical trials. Starting at a low dose to prioritize safety, the trial marks the transition from years of preparation to real-world impact.

Significant pre-clinical optimization and rigorous safety assessment under strict regulatory standards enabled this milestone, with two additional agents advancing along the same roadmap. Positive and collaborative communication with the FDA has helped de-risk the clinical stage, allowing the team to think more concretely about commercialization and scale.

The Future of Trace's Nerve-Specific Dyes

The future of nerve-specific dyes in surgical practice is promising. As research continues, we can expect expansion of the technology's applications and creation of a rigorous clinical trial dataset. Additionally, the integration of these dyes with emerging technologies, such as autonomous surgical robotics, could further enhance surgical precision.

Our focus for the future is on:

• Ongoing Collaborations: with both industry and academic partners

• Continue Clinical Studies: to prove safety and efficacy in patients

• FDA Approval & Reimbursement: to bring this revolutionary solution to every OR

• Commercialize The Dyes: expanded application of our dyes as research tools for nerve-focused research

• Expanding Areas Of Interest: chronic pain treatment, neurodegenerative disease, and sports medicine

Conclusion

Nerve-specific dyes are transforming the landscape of surgical precision, offering surgeons the ability to visualize and protect critical nerve structures during operations. As these dyes continue to evolve, they promise to enhance patient outcomes and reduce complications across every surgical field. Stemming from the exciting "what if" questions of early days in an academic research lab, Trace Biosciences has since blossomed into a successful startup ready to begin their first clinical trails, bring their dyes into the OR, and improve patient outcomes.

The future of surgery is bright, and with tools like nerve-specific dyes, we are moving closer to achieving the highest standards of care.