Tethered Antimicrobial Peptide Coating on Medical Devices

AMProtection: Tomorrows’ Antimicrobials, Today. We provide antimicrobial coatings for medical devices that do not promote resistance.

With an economic burden to the of $1 billion annually in the U.S. ($1000 per incidence), catheter-associated urinary tract infections (CAUTIs) have considerable market pain points. In addition to reduced patient quality of life, CAUTIs increase hospital stays by 0.63 days and are classified as unreimbursed healthcare expenses known as never events – hospital acquired conditions that should never have happened. Further, the rise of antibiotic resistance threatens efficacy of the gold standard CAUTI treatment of administering antibiotics. Our coating product will significantly reduce CAUTIs and the clinical use of gold standard antibiotics to fight them. Our target customers will be urinary catheter manufacturers, companies such as Bard, Boston Scientific, Cook Medical and Teleflex.

AMProtection, LLC is a university startup currently operating in laboratory space at Worcester Polytechnic Institute’s (WPI) Gateway Park in central Massachusetts. The founders are two WPI graduate students and their faculty advisor. The founders are mentored by scientific and business experts. AMProtection is a technology-based company in the biomanufacture of antimicrobial peptide (AMP) coatings that can be tethered to a wide variety of medical devices for a wide variety of antimicrobial uses. AMProtection will seek to license its first product as a coating for urinary catheters.  Our current innovation is a patent-pending, novel therapeutic agent – a naturally derived AMP that is covalently bound (“tethered”) to surfaces. Our AMP coating is biocompatible, is broad-spectrum, and kills bacteria directly, clearing infection through unique biophysical mechanisms. With further development, AMPs are on course to quench the antibiotic resistance crisis and change the future of medicine’s reliance on traditional antibiotics.

Value Proposition: Competition among catheter manufacturers to differentiate their antimicrobial urinary catheter products will escalate as antibiotic resistance worsens and CAUTI never event costs increase. The unaddressed clinical and economic burdens of CAUTIs, as well as the grand challenge to address antibiotic resistance, create tangible opportunities for AMProtection to introduce its platform antimicrobial technologies. Our patent-pending antimicrobial coating is substantially differentiated from current catheter products that use toxic (e.g. silver) or ineffective release of antibiotics because we can covalently bind (“tether”) AMPs uniformly onto catheter surfaces. Tethering of AMPs onto catheter surfaces allows maximized antimicrobial activity at the surface of the device where infection is most likely to occur.

Per 10,000 coated catheters sold, our research indicates that use of our AMP coating product will reduce 80% of CAUTIs, 200 patient hospital days, and tens of millions of dollars in never event expenses. Our regulatory path is the FDA Class II, 510k medical device. While CAUTIs are unreimbursed never events, our preventative antimicrobial coating will be reimbursable. Competitively priced AMPs will provide maximum social and economic broader impact, shielding patients from devastating resistant infections and hospitals from never event costs and giving catheter manufacturers a new product that will differentiate them from their competitors.  

AMProtection is a startup in the biomanufacture of antimicrobial peptide (AMP) coatings that can be tethered to a variety of medical devices to combat infection. AMProtection seeks to license its first patent-pending product as a Foley catheter coating to prevent catheter-associated urinary tract infections. Current antimicrobial catheter coatings are toxic, leach from the surface, or promote antibiotic resistance. The AMProtection technology based on covalently bound ("tethered") AMPs, thus it will not leach from the catheter, is broad spectrum, will not promote antimicrobial resistance, and will be delivered in the right place, at the right time and in the right dosage.

The broader impact of this antimicrobial peptide (AMP) coating is the development of a commercially viable platform to be applied to a variety of medical devices to prevent infection and combat resistance. Technologies that do not promote resistance, such as this AMP coating technology are urgently needed; however cytotoxicity and cost is an issue. One way to solve those problems is to covalently bind AMPs to a surface which has proved challenging. We have found a way to successfully bind AMPs to a device surface that eliminates the problems of cytotoxicity and cost without effecting the activity of the peptide.

Our goal is to complete the pre-clinical work necessary for an IDE meeting with the FDA as a class II medical device. This includes developing a regulatory strategy, finishing some benchtop testing (such as leachable and extractables), small animal and large animal studies. These studies will allow for us to establish strategic partnerships with our potential customers.

We have a vision to become the premier biotech offering platform coating technologies to prevent antimicrobial resistance. Our aim is to “develop tomorrow’s antimicrobials, today.” Our five-year vision is to commercialize our urinary catheter coating and continue to develop our coating technology for the next highest need catheter segments (e.g. central venous (CVCs, $300 million U.S. market) and peripherally-inserted central (PICCs, $850 million globally by 2019)). These catheters are similar in material makeup but may have different FDA classifications. We plan to expand our patent portfolio to similar tethered AMP coating technologies in the wound healing and acne treatment industries.

We plan to reach our customers through our licensing partners who already have existing distribution and sales channels in place to reach our end customers/users the patients and nurses.

Currently we are serving zero people as our product require FDA approval before we can sell our product.

In twelve months we will still be in the process of obtaining FDA approval. In three years we anticipate reaching approximately 10 million patients and increasing numbers year after year.

Lindsay Lozeau and Todd Alexander are experts in designing and evaluating functional antimicrobial peptides who have the skills necessary to continue to develop the product for clinical success. Their team of advisors includes regulatory experts who have gotten similar devices approved, successful entrepreneurs, as well as quality and manufacturing experts.

Typically, large medical device companies gain market share through licensing and/or acquisition of smaller companies. The AMProtection licensing approach will be by field of use to urinary catheter manufactures for coating Foley urinary catheters. The impact and total addressable market depends on the licensee (BARD, Boston Scientific, Teleflex or Cook Medical), but may reach as high as $42.5 million. A license will demonstrate technological feasibility in order to establish AMProtection as a coating technology company, rather than a catheter coating company, allowing us revenue and pursuance of additional markets in similar catheter technologies as well as orthopedics and wound care.

 We anticipate multiple licensing revenue streams from multiple applications of our platform. This includes applications for PICCS, CVCs and orthopedic knees and hips all of which are billion dollar markets where infection is a major problem. Additional we plan to develop other AMP based technologies for other healthcare applications. Currently we have another AMP based technology for dermatology and wound care applications which promises even more licensing revenue streams.

We believe that the network that Solve will open up for us, both mentoring and financial, will allow us to get out our first product to patients quicker. This will allow us to have a faster and broader positive impact on the patient populations we hope to serve and begin development for other applications.

We believe that participating in Solve will allow us access to a vast network that will help us to expand our own networks, establish strategic partnerships and relationships with other startups in the medical device space. We also would like to connect with funding sources and people in the Cambridge area who will be able to be a part of the business side of our team.