ABSTRACT
Gastrointestinal (GI) bleeding is a life-threatening condition that affects millions of American
citizens every year, resulting in 500,000 hospitalizations, more than 2 million hospital days, and over
$5 billion in direct costs. GI bleeding often originate from lacerations created following surgical
interventions, such as after polypectomies. The established method to prevent GI bleeding involves
the use of endoscopic clips, which was invented in 1975. However, clips are unable to provide
wound shielding, are technically challenging to apply, and are limited to small lesions only. Novel
powder-based hemostatic products have been suggested; Yet, they lack proper adhesion to
mucosal tissues being quickly dissolved post application, and can only work in actively bleeding
lesions which is not often the case for GI lacerations that bleed days post-surgical intervention. To
address this need, BioDevek has been focusing on the research and development of GastroShield
- a sprayable biocompatible adhesive biomaterial for endoscopic management of GI lesions.
GastroShield is formed by cross-linking of biodegradable polymer solutions (amine-terminated
Poloxamer and oxidized Dextran), designed to be easy-to-use, fast, and also less dependent on
operator skill. Prior to this direct-to-Phase II application, Biodevek obtained critical de-risking
milestones of the technology, including the (1) Identification of the optimal formulation for
gastrointestinal mucosal adhesion, (2) Performing mechanical studies of the technology ensuring
its conformability to the GI features and the catheter spraying application (3) Confirming wound
protection of GastroShield against acid and catabolic agents (4) Conducting preliminary in vitro and
In vivo biocompatibility studies (5) Confirming the acute homeostatic effect and (6) the chronic
protection of gastrointestinal submucosal in a pilot porcine in vivo model. The direct-to-Phase II
project will focus on achieving critical pre-clinical results and quality control levels to support the
regulatory submission. Also, the performance of a pre-submission meeting with the FDA to confirm
the regulatory pathway and design of preclinical studies. Aligned with this goal, we aim at the
completion of key Go/no-Go milestones: I) Scale-up manufacturing of the product and the
development of quality control methods, II) Conducting complete safety studies under GLP
conditions, III) executing an FDA pre-submission meeting to validate the selected in-vivo pre-clinical
model and predicate device for 510(k) submission IV) Conducting efficacy studies comparing
GastroShield to FDA-validated predicate device. Successful execution of these aims will allow
Biodevek to initiate the regulatory approval of GastroShield.
