Technology Platform: Polymer Therapeutics, LLC (PRx) is a medical polymer company that has developed a novel class of biocompatible/bioabsorbable drug-eluting polymers (BDEP™) having broad applications in the medical device coating and fabrication industries. With this proprietary chemistry, the polymer actually becomes the drug. BDEPs™ are formulated to release their therapeutic agents from the polymer backbone over a broad range of time and dosage levels, thus allowing for targeted site drug delivery and decreased systemic side effects. Through the process of hydrolytic degradation, the active drug compounds elute from the polymer in a controlled manner, directly at the site of injury, to promote healing. PRx intends to formulate its first generation BDEPs™ with common drug compounds, such as NSAIDs (e.g., salicylic acid (SA)), which are already FDA-cleared GRAS compounds that possess well documented antimicrobial, antibiofilm and analgesic properties. PRx's technology can also be used to deliver a wide range of other therapeutic compounds for use in a number of different applications in several diverse fields of use.
Coated Medical Device Market: Opportunity and Unmet Need: Medical device-related bacterial infections represent a significant concern among surgeons and accounts for nearly half of all nosocomial infections in the US (i.e., Hospital Associated Infections (HAI) and Surgical Site Infections (SSI)). As a result, alternative antimicrobial delivery methods are greatly needed to improve the current state of medical device-mediated bacterial infection treatment. The medical device coating industry continues to grow rapidly: the current global market is expected to reach $7.5B in 2013 with a CAGR of 12.4%. PRx is focused on products for aesthetic surgery, the fastest growing segment of the $7B (9.5%CAGR) surgical device market, as its market entry strategy and will expand its product portfolio to include general and vascular surgery while its long term growth will occur in the urological catheter market, orthopedics and wound care.
Aesthetic Surgery as a Market Entry Strategy: Aesthetic medical devices are used in body contouring, breast augmentation, dermal tightening, dermal resurfacing, facelifts, acne treatment and prevention, the reduction of pigmented skin blemishes, age-related vascular/dermal lesions, etc. The aesthetic market has several drivers: (i)the globally aging population that has created a rapidly expanding customer base whose desire to retain a youthful appearance is driving growth in the number of aesthetic procedures (155% in the last decade); (ii) improved biomaterials have made treatment procedures safer, more efficacious and have reduced costs; (iii) many aesthetic surgeons are expanding their practices with procedures that are paid for directly by patients thereby eliminating the uncertainty of managed care and reimbursement restrictions; and (iv) in addition to core users such as plastic surgeons and dermatologists, many other practitioners, such as gynecologists, family practitioners, primary care physicians, physicians offering aesthetic treatments in non medical offices ("medi-spas"), are offering aesthetic procedures. Core end-users in the aesthetic market will experience enhanced safety, efficacy and performance with PRx polymer-coated medical devices used in their procedures, thereby creating a compelling market entry opportunity for PRx and its partners. Recent market research shows that the growing popularity of aesthetic procedures is the main driver behind notable revenue growth in the global wound closure market which bodes well for PRx's lead product candidate of SA-coated surgical sutures.
Business Model: Polymer Therapeutics intends to build parallel revenue channels to serve the coated medical device market through strategic partnerships and licensing agreements with key market leaders: Market Entry Strategy: 1) PRx management is developing strategic partnerships with leading specialty distribution companies and CMOs who directly serve core end-users in the aesthetic surgery market. Growth Strategy: 2) Product-Specific Applications: develop custom polymer applications to meet device manufacturers' new product development needs, enhance the performance of existing products or to create product line extension strategies. 3) Manufacturing and Supply: Focus on PRx's core expertise of developing and manufacturing its proprietary formulations to supply established medical polymer companies in the industry by specific application or FOU.
Regulatory Strategy: Polymer Therapeutics' SA-medical polymer has passed ISO 10993 testing for pyrogenicity and cytotoxicity while Proof of Concept of SA's antimicrobial and antibiofilm properties has been established in 19 preclinical studies (data on file). Based on evidence from these studies, and following direct correspondence and dialogue with FDA regarding the appropriate regulatory submission pathway, Management, with guidance from its consultants, has focused on developing products in the surgical space with SA-coated surgical sutures as the leading Indication For Use. The current understanding with FDA is as follows: (i) SA coated sutures will be a 510(k) submission with the likely indication statement being: antimicrobial surgical suture for soft tissue approximation to reduce incidence of SSI and biofilm production. (ii) SA-coated surgical sutures will be viewed as a "combination" medical device. (iii) Two appropriate predicate devices have been identified and accepted. (iv) One additional in-vitro study has been recommended by FDA and is currently being designed. (v) Target submission: early Q2 2013. Strategically, this pathway is important as it will create a "510(k) predicate device" reference for future medical device applications that are developed using PRx's medical polymers.
Manufacturing: PRx medical polymers are synthesized using a high yield, straightforward and readily scalable manufacturing process that is cost-effective resulting in favorable COGs.
Features and Benefits:
- Choice of FDA-cleared GRAS agents as the initial therapeutic compounds minimizes regulatory barriers and creates a clear, near term market entry opportunity.
- BDEPs™ can be engineered with high drug loads, up to 90+% by weight, with desirable pharmacokinetic elution profiles lasting from as little as a few days to nearly two years with no burst effect.
- BDEP™ platform technology is scalable and adaptable to numerous device applications:
- Coatings: surgical sutures, staples, clips, meshes, wound care, catheters.
- Fabrication or coatings: orthopedic screws, plates and rods, reparative bone fillers.
- Delivery systems: hydrogels, sheets, tapes, films, microspheres, nanoparticles.
- Ability to formulate BDEPs™ with a wide range of other drug compounds in addition to NSAIDS
Patent Estate: PRx's BDEP™ platform is protected by an integrated portfolio of 29 patents, issued and pending, in the USA and international territories that include broad composition of matter, polymer chemistry & linker molecules, manufacturing methods, and various drugs. 20 patents have been optioned by PRx covering a broad range of medical device coating applications with additional patents available to Polymer Therapeutics through Rutgers University. PRx has recently concluded an assessment of its patent portfolio with IP counsel to reexamine and validate its patent strategy.
Competitive Landscape: While a number of companies market various surgical sutures, there is only one other antimicrobial suture on the market, Ethicon's' Vicryl Plus; however, Vicryl Plus does not have a compelling track record of efficacy. Polymer Therapeutics will be the sole provider of BDEP™-coated sutures that offer cost effective, therapeutic benefits through their antimicrobial and analgesic properties. PRx's coated suture is further distinguished by having the additional claim of inhibition of biofilm formation, thereby giving it a notable competitive advantage in the market.
- Enhanced performance of coated medical devices realized through advanced biomaterials that deliver antimicrobial and antibiofilm protection while controlling local pain.
- Cost-effective means of managing health care expenses associated with complications of repeat implantable device procedures, untoward side effects, SSIs and HAIs.
- Ability to develop custom polymer formulations that meet customers' new product application needs and to enhance and differentiate the performance of existing products already in the market.
- Well documented history of safety and efficacy of NSAIDs as GRAS compounds aids in product acceptance and adoption.
- Compliant with SHEA guidelines for managing the incidence of SSIs and HAIs.
For Investors and Partners:
- Clear and growing market opportunity with multiple revenue channels.
- Achievable business metrics due to clear, low risk regulatory submission pathway and strong IP portfolio.
- Market entry strategy focuses on rapidly growing, patient-driven aesthetic surgery sector with its private-pay patients creates early revenue stream.
- Increased number and broader range of procedures by aesthetic surgeons creates potential for deeper, more rapid market adoption and penetration.
- Multiple product options in different therapeutic fields delivered directly to core end users through partnerships with leading specialty distribution networks
- Readily scalable and low cost manufacturing with favorable COGs.
- Segue to a broad range of coated or fabricated medical device applications - with multiple drug candidates - creates a deep product pipeline to ensure future growth.
Management: PRx is distinguished by its seasoned management team that has amassed more than 95 years of experience in the biotechnology and device industries including founding and securing funding for several early stage companies. Specific skill sets include product development, clinical trials management, operations, manufacturing, finance, regulatory, patent management and all aspects of polymer technology specific to the Company's IP portfolio.