Biocarpet

Highlights

• Over 3 million Americans have advanced peripheral arterial disease (PAD) with no durable and effective
• The Biocarpet is a flexible, personalized, conformable, and fully biodegradable endovascular scaffold that can significantly reduce the vascular wall stress and decrease the need for re-interventions.
• The Biocarpet substantially improves patients’ outcomes and reduces healthcare costs.
• PInCh funding will be used to conduct animal studies for proof-of-concept delivery and post-surgical monitoring.
• Recipient of $35,000 PInCh Award + $15,000 Bonus Award for Engineering Good Health.

Problem

It is estimated that over 10 million Americans have peripheral arterial disease (PAD), with 30%-40% presenting with advanced disease. If untreated, PAD will lead to critical limb ischemia and eventual amputation.

Clinical treatment of PAD typically begins with smoking cessation, increased exercise, and antiplatelet therapy. However, symptoms continue in nearly 35% of patients, which requires major surgical or endovascular procedures: balloon angioplasty, stent placement, or vascular bypass.

Balloon angioplasty and drug eluting stents physically expand blocked arteries, which increases blood flow but causes damage to the blood vessel. This damage leads the body to re-narrow the vessel during healing, a process called restenosis. Restenosis leads to repeated surgeries for 50% of angioplasties and 60% for drug-eluting balloons.

80 to 90% of patients with advanced PAD present with disease in the leg (femoral and popliteal arteries) – where constant knee motion is common. These complex bending forces make treatment challenging, given that current stents are rigid  and inflexible – and often lead to stent breakage and increased restenosis.

The unacceptable failure rates of all PAD treatments clearly demonstrate the critical need for a more durable and personalized treatment of PAD.

Solution

Biocarpet is the next generation endovascular device to treat PAD. The Biocarpet is a fully biodegradable, electrospun sheet that rolled tightly around a deflated balloon catheter. The device is endovascularly delivered via small incision, and inflated to unfurl into the specific shape of the patient’s vessel.

It is then heated, attaching to the adjacent layers. After cooling to body temperature to lock the device in place, the balloon is deflated and removed from the patient – leaving a scaffold taking the shape of the patient’s vascular anatomy.

This delivery approach not only imposes significantly reduced mechanical stress to the vascular wall during deployment, but also allows the Biocarpet’s natural zero-stress state to be the specific shape of the patient’s artery.

We have performed preliminary computational simulations as well as bench-top testing of the device, with preliminary data showing that the compressive resistance of Biocarpet is comparable to commercial stents while the Biocarpet has outstanding features such as personalized conformability to patients’ anatomy, degradability, and flexibility resulting in reduced vascular wall stress and reduced restenosis rates.

Team

• Jonathan Vande Geest, PhD, Professor of Bioengineering, Mechanical Engineering and Material Science, University of Pittsburgh.
• William Wagner, PhD, Professor of Bioengineering and Chemical Engineering, University of Pittsburgh.
• John Pacella, MD, Associate Professor of Medicine and Cardiologist, University of Pittsburgh and UPMC.
• Ali Behrangzade, PhD, Post-Doctoral Research Assistant, University of Pittsburgh.

Path to Impact Plan

We plan to use the PInCh award to provide a strong foundation for our future effort in translating our novel technology into the clinics to provide utmost treatment of the patients.

Using the PINCH award, 1) we create a quality prototype of our thermal balloon catheter delivery system, and 2) this prototype will be used to deploy the endovascular Biocarpet into an animal model as a proof of concept for device delivery.

We are planning to submit an NIH Catalyze grant from Pitt and an NIH SBIR grant from EV2 Technologies, Inc., a startup that we formed to commercialize the Biocarpet device. We will also work with Dr. Michele Migliuolo, who is a serial entrepreneur, and Michael Nilo who is an FDA regulatory strategist (CEO of Nilo Medical Consulting) to follow the right path to commercialization. Using all these fundings, we will establish the safety and efficacy of our class III device and seek pre-seed and seed funding to conduct a human factory study and early feasibility study (EFS) which will provide further support to plan for extensive clinical trials. We also plan to establish strategic partnerships with medical device companies.

Frequently Asked Questions

• Mechanically, how does the Biocarpet device deploy, unfurl, and inflate? Our device will be wrapped around an un-inflated thermal balloon catheter and held in place during device advancement using a fine suture. Once across the lesion, the suture will be removed, and the balloon will be inflated to unfurl our device into the patient’s complex anatomy.
• What is the timeline of restenosis, and will secondary intervention be required? The timeline of restenosis (~0.5 to 1yr) is well within the expected timeline for degradation of our device. If successful, no secondary interventions will be required.
• How does Biocarpet degrade and affect elastosis? We expect that cell infiltration and host remodeling will stabilize our device in-vivo before biodegradation occurs to the point where large fragments of our device are released systemically. Thermoforming will occur slightly into the melting range of the polymer, allowing us to tailor crystallinity and resulting mechanical and degradation properties.
• How is this device novel compared to other available devices? Prior paving technologies (e.g., Focal PEGDA gels) were not structurally supportive and used to reduce acute thrombosis. A structurally supportive and fully biodegradable unfurling device that can be thermoformed in-vivo is novel.