Platform
A polymer is a schedule you can hold in your hand.
Bioresorbable polyesters degrade by hydrolysis at rates set by their chemistry. Choose the polymer, the copolymer ratio, the molecular weight and the geometry, and you have chosen how long the implant stays strong, how fast it gives up its payload, and when it is gone. Every EIG program is the same engineering problem solved with different settings.
How a Guard™ product behaves in situ
Four stages, in order.
Place
Deployed during the index procedure — into a resection cavity, along a mucosa, or across a defect. No separate intervention and no change to the operation already planned.
Protect
The construct does mechanical work: managing dead space, maintaining a cavity for imaging, lining tissue against luminal contents, or covering an exposed surface.
Release
Payload leaves the matrix by diffusion first and polymer erosion after, producing weeks of sustained local concentration with minimal systemic exposure.
Resorb
Ester bonds hydrolyse to metabolites the body already clears. Nothing remains to retrieve or explant.
Materials
The polymer sets the clock.
We build from medical-grade bioresorbable polyesters with decades of clinical history as sutures, screws and scaffolds. Selection is driven by the window each indication demands.
| Polymer | Strength retention | Full resorption | Why we reach for it |
|---|---|---|---|
| PLGA | Days → months | ≈ 1–6 months | The most tunable option and the workhorse for elution. Copolymer ratio and molecular weight move degradation across a wide range. |
| PDO | ≈ 4–6 weeks | ≈ 6 months | Flexible and tough, with a strength curve that holds through an early dwell window. Long clinical history as monofilament suture. |
| PLA / PLLA | Months | ≈ 12–24 months | Used as a modifier to fine-tune degradation rate and adjust mechanical behaviour rather than as a standalone body. |
| PCL | Months | ≈ 2–3 years | Slow, ductile and low-melting. In a blend it supplies elastic recovery and compressibility, and moderates burst release. |
Figures above are published ranges for these polymer families, not EIG specifications. Each program commits to its own composition and geometry, established by bench and animal testing and disclosed under agreement.
Payload
Dose the tissue, not the patient.
A resection bed is a compartment. Releasing an agent into that compartment from a matrix sitting inside it produces local concentrations systemic dosing cannot reach, at systemic exposures systemic dosing cannot avoid.
We work with agents that are already approved and characterised. That is a deliberate choice: it removes novel-molecule risk from the program and puts the innovation where it belongs — in the delivery.
Release is shaped, not accepted. Payload loading, layer thickness, matrix porosity and surface area are all design inputs, and together they determine the size of the initial release and the length of the plateau that follows. Payload selection is program-specific and is not disclosed publicly.
Regulatory posture
Device-led, and argued that way from the start.
A drug-eluting bioresorbable implant is a combination product under 21 CFR Part 3. Which FDA centre leads review shapes the evidence package, the timeline and the cost of everything downstream — so we engage the Office of Combination Products early and in writing rather than discovering the question late.
EIG's position across the portfolio is that the therapeutic effect originates with the device. The construct determines where the payload goes, how long it stays and what mechanical work happens meanwhile. On that reading the most significant safety and effectiveness questions — degradation kinetics, retention, biocompatibility, mechanical integrity, manufacturing — are device questions, and CDRH is the appropriate lead centre with CDER consulting on the drug constituent.
Center assignment is determined by FDA, not by the sponsor. The positions described here are EIG's proposed analyses under 21 CFR 3.2(m) and 3.4(b) and are not FDA determinations.
Development path
The same five steps for every program.
Programs enter at different points depending on maturity, but the sequence does not change. Each step is designed against what the next submission will require.
Formulate
Polymer selection and payload loading committed to a single specification; release measured in vitro across the target window.
Characterise
Mechanical handling, degradation kinetics, sterilisation compatibility and stability, run to written protocol with independent test houses.
Qualify
GLP biocompatibility to the ISO 10993 series, plus disease-relevant animal models measuring local and systemic exposure and tissue response.
First in human
Feasibility study under IDE: safety, wound healing, device handling and placement, local pharmacokinetics and early biological signal.
Pivotal
Randomised trial of standard of care with and without the device, powered on a local-control endpoint, supporting a De Novo submission.
Intellectual property
Issued and building.
The platform is covered by an issued U.S. patent granted in November 2025, with further applications pending across platform chemistry, device geometry and indication-specific configurations.
Development follows FDA design-control expectations, with biocompatibility testing planned to the ISO 10993 series, terminal sterilisation validated to ISO 11135, and preclinical work run through established contract research organisations.
Want the technical detail behind any of this?
Formulations, release data and program specifics are shared with qualified parties under confidentiality.