Tag: Medical device

For many patients, especially those with chronic or life-threatening diseases, treatment is not a single intervention but a relentless routine.

Cancer patients can spend years tethered to infusion schedules, returning weekly for IV therapies that dictate where they can live, travel, and work. Children with rare metabolic disorders may rely on frequent enzyme infusions, with entire rooms of supplies needed to sustain their care. And for patients in low-resource settings, life-saving biologic drugs often remain out of reach altogether due to cost and infrastructure.

These realities highlight a critical challenge in modern medicine: some of the most potent therapies are the most difficult to deliver, necessitating repeated dosing at centralized locations.

Duracyte, a newly launched biotechnology company, is pioneering a potentially transformative approach to medicine by developing a “living pharmacy” inside the human body. Its core technology, the Hybrid Advanced Molecular Manufacturing Regulator (HAMMR), is an implantable bioreactor designed to produce biologic drugs directly within patients. This innovation could fundamentally change how medicines are manufactured, delivered, and even conceived.

The founding team combines expertise across bioengineering, medicine, and biotech. Omid Veiseh, PhD, is a Rice University professor and RBL LLC managing partner focused on implantable cell therapies, while Paul Wotton, PhD, is a veteran biotech CEO with deep commercialization experience. Jonathan Rivnay, PhD, of Northwestern specializes in bioelectronics; Robert Langer, ScD, and Daniel Anderson, PhD, are MIT leaders in drug delivery and gene therapy; and Siddharth Krishnan, PhD, of Stanford, contributes expertise in wireless power and implantable devices.

Duracyte is the third venture created by RBL LLC, a Houston-based biotech studio founded by Rice University in 2024. Operating from Helix Park, RBL focuses on rapidly translating breakthrough research into real-world therapies, particularly in areas like oncology and autoimmune disease. Duracyte’s progress is further supported by ARPA-H’s THOR project, a nationwide collaboration aimed at advancing implantable biohybrid therapies from research to clinical application.

Honey, I shrunk the bioreactor

Biologic drugs, including antibodies, hormones, and enzymes, have become a cornerstone of modern medicine. They now represent a substantial share of the pharmaceutical market, treating conditions ranging from cancer to autoimmune diseases. But their production and delivery remain cumbersome.

Traditionally, biologics are manufactured in large-scale industrial bioreactors, purified, stabilized, and shipped to clinics, where they are administered via injection or intravenous infusion. This process is expensive, logistically demanding, and often burdensome for patients, who may require frequent hospital visits over months or years.

Veiseh, a professor of bioengineering at Rice University, has spent much of his career questioning whether this paradigm could be fundamentally reimagined. “What if we could bring this biomanufacturing to the patients and develop implantable bioreactors or injectable bioreactors whereby the biologic could be produced in the body?” Veiseh told Inside Precision Medicine. That question now underpins HAMMR.

At its core, HAMMR is a miniaturized, implantable bioreactor. Roughly the size of a small medical implant, the device houses genetically engineered human cells capable of producing therapeutic proteins. Unlike traditional drug delivery systems, which release pre-manufactured compounds, HAMMR generates biologics inside the patient’s body.

To accomplish this, the device replicates key functions of industrial bioreactors, but in a compact, implantable form. It supplies nutrients and oxygen to the cells, supports their viability, and allows for controlled production of therapeutic molecules.

One of the key technological innovations lies in how HAMMR generates oxygen. Using electrolysis—a well-established chemical engineering process—the device splits water molecules into hydrogen and oxygen. This hybrid oxygenation bioelectronics system for implanted therapy (HOBIT) component provides a steady, localized oxygen supply to sustain the embedded cells. “We’ve got a way to do electrolysis with low power and in a safe manner that actually allows this to be viable for the engineered cells,” Veiseh explained.

Real-time, feedback-controlled medicine

The device also incorporates electronic controls and sensors. Electrical signals can activate or deactivate the cells, effectively turning drug production on or off. Meanwhile, onboard sensors monitor pharmacokinetic and pharmacodynamic data.

This data is transmitted wirelessly to an external interface, enabling clinicians to adjust dosing in real time. Veiseh said, “The implanted device also communicates with an app that allows us to control dosing and get a lot of data from the patient as far as their physiological conditions, meaning the impact the drug is having on the body.”

One of the most transformative aspects of HAMMR is its potential to enable feedback-controlled drug delivery. Rather than administering fixed doses on a set schedule, clinicians could tailor therapy dynamically based on continuous biological data. “For the first time ever, we can create feedback drug delivery systems where you can dose to a pKa level or, better yet, to a pharmacodynamic level, which allows for that precise dosing for every patient,” said Veiseh.

This capability could be especially impactful in oncology, where patients often receive complex combinations of biologics. Current regimens may involve multiple drugs administered on different schedules, requiring frequent clinic visits and careful coordination.

Veiseh described a typical scenario: patients receiving checkpoint inhibitors such as ipilimumab and nivolumab, along with additional biologics like bevacizumab. These therapies often require weekly infusions over extended periods. “The vast majority of patients are getting IV infusions weekly and they are living longer, which is great,” he said. “But now you have patients that are on this regimen for three years.”

HAMMR aims to replace this model with a single implanted device capable of producing multiple drugs, with dosing adjusted digitally rather than through repeated clinical visits. “We’re moving away from physical prescriptions to a world of digital prescriptions,” Veiseh said.

The convergence of components

The idea of implantable bioreactors has been explored for years, but only recently have the necessary technologies matured enough to make it feasible. According to Veiseh, advances in several fields have converged: electronic miniaturization, wireless power transfer, synthetic biology, and biomaterials engineering. Together, these innovations enable the integration of complex functionalities into a small, biocompatible device.

By leveraging established technologies and adapting them for medical use, the team aims to reduce development risk and accelerate regulatory approval.

Wotton, a seasoned biotech executive working with the team, emphasized that many of the underlying components are not entirely new; they are adapted from existing technologies. “One of the advantages here is that these guys have been really intelligent when they’ve taken off-the-shelf technologies,” Wotton told Inside Precision Medicine. “The oxygen technology is lifted from what’s already used in submarines… The battery charging work is being done… The RPE cell lines that we work with… have successfully gotten into the clinic.”

Looking ahead, the team envisions integrating artificial intelligence into the platform. With continuous data collection from implanted devices, machine learning algorithms could identify patterns in treatment response and optimize therapy over time. “You can imagine… this device could now cycle through different therapies, and as it starts seeing efficacy responses, it starts learning,” Veiseh said.

Such a system could enable highly personalized medicine, adapting treatment strategies based on real-time data and accumulated experience across patients.

The HAMMR platform is built around the preparation of polymer-encapsulated cells, obtained from the human immortalized retinal pigment epithelia (RPE) cell line ARPE-19, which has already been used to generate cytokines for treating intraperitoneal tumors with oversight from the U.S. Food and Drug Administration (FDA). This provides a regulatory advantage, as the cells have an established safety profile. These preparations of ARPE-19 cells can be engineered to produce a wide range of biologics beyond cytokines.

A cost-cutting catalog

Veiseh noted that there are more than 300 FDA-approved biologics in the United States, and his team has already created versions of over 150 within this system. “This platform has the potential to really disrupt the biotech market as it exists today,” he said.

The implications extend beyond oncology. Wotton highlighted potential applications in autoimmune diseases, infectious diseases, and metabolic disorders. “There are so many applications of this technology,” he said. “Whether it’s in oncology… or… delivering antibodies like Humira to treat chronic diseases… there are applications where you can treat type two diabetes… HIV.” In each case, the goal is the same: replace repeated injections or infusions with a long-lasting implant that continuously produces therapeutic proteins.

HAMMR could have significant implications for the cost and accessibility of biologic therapies. Biologics are among the most expensive treatments in medicine, with some costing hundreds of thousands of dollars per year. Much of this cost stems from manufacturing, purification, and distribution. By producing drugs directly inside the body, HAMMR could dramatically reduce these costs. “The cost of goods is actually quite low relative to manufacturing today,” Veiseh said. “This is like one-tenth of the price.”

Wotton echoed this point, suggesting that the platform could replace expensive annual treatment regimens with lower-cost implantable devices. “Imagine what you could do if you could replace the $250,000 a year injectable schedule,” Wotton said.

This cost reduction could be particularly impactful in low-resource settings. Veiseh noted that the Gates Foundation has supported the project in part because of its potential to expand access to biologics in developing countries. “Biologics are way too expensive for sub-Saharan Africa,” he said. “But a device that can produce HIV treatments… once yearly… now it becomes… practical for that world too.”

Houston, we have clinical liftoff

Backed by more than a decade of research funding exceeding $100 million from agencies and organizations including DARPA, ARPA-H, the NIH, and the Gates Foundation, Duracyte is preparing to bring its first device into clinical trials. Duracyte plans to initiate a Phase I clinical trial this year evaluating patients with recurrent ovarian cancer. The company has already held multiple meetings with the FDA and completed a pre-IND (Investigational New Drug) meeting. “We have a clear plan as to what it takes to file an IND,” Veiseh said. “We’re on track to actually file… before the end of this year.”

If all goes as planned, the first patients could receive the implant by late this year or early next year. The trial will be conducted in Houston, leveraging partnerships with leading medical institutions, including the renowned MD Anderson Cancer Center. “Our partners at MD Anderson… will be running the first clinical trial,” Wotton said. “Taking advantage of the ecosystem down in Houston.” The proximity of Veiseh’s lab to the clinical site has helped accelerate development, enabling close collaboration between researchers and clinicians.

Despite its promise, the HAMMR platform faces significant challenges. Integrating multiple complex technologies into a single device is inherently difficult, and clinical validation will be critical. Execution risk remains high, particularly in selecting initial indications and navigating regulatory pathways. “We can’t do everything all at once,” Veiseh said. “It’s really thinking about what the value creation is at early stages.”

Prioritization will be key, given the platform’s broad potential. With hundreds of possible biologics and numerous disease targets, choosing the right starting point could determine the company’s trajectory. Wotton emphasized this challenge as well. “What are the challenges we have? Making the right choices with respect to where we go next,” Wotton said.

If successful, HAMMR could mark a fundamental shift in how medicines are delivered and even defined. Instead of prescribing drugs as physical products, physicians could prescribe programmable devices that manufacture therapies on demand. In this model, the distinction between drug and device blurs, giving rise to a new category of therapeutics. “This is so different than what pharma does,” Veiseh said. “I think it’s really interesting to see whether they are also eager to imagine a future of medicine, which gets away from the injectables.”

For now, that future remains speculative. But with clinical trials imminent and a strong foundation of research behind it, Duracyte’s “living pharmacy” is poised to test whether the idea can move from concept to clinical reality.

As Wotton put it, “This is just the tip of the iceberg.”

The post It’s HAMMR Time: Duracyte Launches with “Living Pharmacy” Platform appeared first on Inside Precision Medicine.