What We Do

Comprehensive Collaborative Development

BI’s coatings are based on a new hybrid materials technology using metal-organic precursors to create both metal oxide and polymer coatings from liquid solutions. Each component of the coating is already in common use in other medical devices. The prospective coatings are optimized using an innovative rapid screening cell culture platform, inspired by the approaches used by large pharmaceutical companies for new drug discovery.  These promising in vitro results (Figure 1) have been followed by several small animal studies conducted at both Brown University and Rhode Island Hospital (Figure 2).  Early applications that have been considered include catheters, fracture fixation devices, and transcutaneous osseointegrative devices (bone-anchored prosthetics for limb replacement).

Figure 1: In vitro results with glass discs with no coating (A), Hybrid #1 coating (B), amorphous Titanium Dioxide only (C), and Hybrid #2 coating (D) incubated in Petri dish with E. Coli-coated agar. Note large zone of bacterial inhibition surrounding disc coated with Hybrid #1 and smaller zone surrounding disc coated with Hybrid #2 (arrows). Right image is a close up view of bacteria free zone around Hybrid #1.

Figure 2: Pictures and X-Ray image from a small animal study evaluating coated metal pins used as transcutaneous osseointegrative devices (TCOIDs).

Our hybrid technology uses dilute liquid solutions to form coatings.  This gives BI the ability to rapidly formulate optimal compositional variations and apply them using inexpensive, low technology methods, such as dip and spray coating.  The dip coating process may be integrated with existing manufacturing process lines.  This is a great cost saving benefit over other coating technologies which often require high temperatures, special atmospheres, vacuum or high energy inputs (e.g. chemical vapor deposition, ion beam, or plasma spray processes).

The solutions react with atmospheric moisture to rapidly form thin, solid, and durable coatings at room temperature (Figure 3).  Our precursors have reactive components to ensure even chemical bonding with the surface of medical implants.  Our selections of solvents, mostly isopropyl alcohol, are in response to new FDA recommendations and preempt future regulatory requirements.  These solvents are suitable for normal cleaning and rinsing steps used during device manufacture.

Figure 3: Picture of BioIntraface antimicrobial hybrid coated external fixation pins.

While the original impetus for our research sprang from a need to better treat US soldiers suffering from combat injuries, BI’s coating technology also will have a significant impact on the civilian population. The BioIntraface coating will not promote bacterial drug resistance or inhibit healing yet is able to resist bacterial biofilm formation while minimizing caregiver intervention. These factors make our coating a compelling option for patients, clinicians, and hospitals, while simultaneously giving our manufacturing partners a significant marketing distinction. More specifically, the value of BI’s technology to the various constituencies includes:

• Patients: fewer infections; fewer trips to operating room
• Medical Device Manufacturers (BI’s customers): marketing distinction; easily integrated into current manufacturing lines
• Physicians: better patient care; lowered complication rate
• Hospitals: decreased costs against a fixed level of reimbursement
• Nurses: decreased time spent caring for pins to prevent tract infections
• Insurance Companies: cost savings from reimbursing fewer pin exchanges
• US Military: better care for injured servicemen; decreased return to action

BI will be working with our clinical advisory board and industry partners to quantify these benefits because the expected cost savings will be a key component to promoting this product.

We have tested the abilities of the coatings to improve outcomes in repairing bacterial contaminated fractures (Figures 4-7).

Figure 4: BioIntraface surface treated fracture repair nail compared to bare control.

Figure 5: BioIntraface surface treated and control bone screws, 20mm (left) and 25 mm (right).

Figure 6: The fracture nailing system’s unique design allows for implantation without the use of X-rays. This makes it useful for repairing traumatic bone injuries in developing nations and disaster relief efforts.

Figure 7: Clinical Advisory Members surgically implanting the BioIntraface treated and control fracture nailing system in a preclinical model.

Competition

Based on our conversations with both clinicians and medical device representatives, having published, peer-reviewed clinical data is the most important determining factor as to whether a clinician will try a new product. Therefore, apart from the obvious barrier to entry of regulatory approval, the key aspect to adoption of our technology by orthopedic traumatologists is being able to provide convincing clinical data. More specifically, the clinicians are most concerned about reducing infections without hindering healing, so efficacy data is vitally important. Efficacy data can be broken down into a reduction in the rate of inflammation and infection as well as healing rates. BI also recognizes that reducing the amount of additional care by nurses and other caregivers will be important for other stakeholders (e.g. hospitals).

With fracture fixation, BI will be competing primarily against the status quo: plain stainless steel or titanium devices without any anti-bacterial. Additionally, there are several existing or potential coatings for pins: silver-based, plain hydroxyapatite (HA), HA eluting chlohexidine, and aerogel eluting other antibacterial drugs). Drug-based coatings carry the negative consequence of potentially contributing to bacterial resistance, silver-based treatments inhibit the healing process, and creams are unable to penetrate the bacterial biofilm effectively and require higher levels of caregiver intervention (Table 1).

Table 1: Competitive matrix for external fixation pins

The BioIntraface coating will not promote bacterial drug resistance or inhibit healing yet is able to resist bacterial biofilm formation while minimizing caregiver intervention. These factors make our coating a compelling choice for patients, clinicians, and hospitals while simultaneously giving our manufacturing partner a significant marketing distinction. BI is planning to address both market segments for fracture fixation.