Sean Fenske, Editor03.09.16
Healthcare associated infections (HAI) have become a huge issue ever since it was announced that hospitals would not be reimbursed for care provided to a patient as a result of contracting an HAI during their stay in a facility. As a result, device manufacturers have moved quickly in developing technologies that address these issues as well as designing products that reduce the risk of infection. From utilizing antimicrobial coatings on devices to employing durable materials that stand up to the harsh cleaners used by hospitals, medical device manufacturers are trying to do their part in the effort to reduce HAIs.
Scott Epstein, the founder of Q Urological—a wholly owned subsidiary of Natick, Mass.-based Boston Scott Corporation has taken a slightly different approach. Epstein, who has been involved in the medical industry for over 30 years, developed an entirely new material that exhibits diminished build-up of biofilms. With a goal to develop and market novel medical products that fill specific, well-defined needs, Epstein has secured several patents on the technology and one application solution has already earned a 510(k) clearance from the U.S. Food and Drug Administration.
MPO took time out to speak with Epstein about his technology, the applications for which it is being indicated, and how it compares to products on the market addressing the same clinical needs.
Sean Fenske: Can you please explain the technology you’ve developed?
Scott Epstein: pAquamedicina structural hydrogel technology is a disruptive technology providing a competitive advantage intended to exhibit diminished biofilms. Exceeding ISO, ASTM, and biocompatibility testing, pAquamedicina devices exhibit diminished biofilms and thrombolytic events, addressing immediate market needs. Initially approved for Q Urological Persistent ureteral stents and marketed as antifouling technology, the foundation has been laid for a cost-effective platform technology that will quickly leverage a broad range of vascular, urological, and GI products in the marketplace.
Fenske: Can you please further discuss the medical applications for this technology?
Epstein: There is an array of potential applications for this technology, but for now, I’m going to focus on the urological applications. Using pAguaMedicina structural hydrogel as a raw material, a finished, fully hydrated-in-saline device is about 90 percent aqueous—similar to human tissue and the basis for why nothing sticks to it. This soft, compliant material is not a coating. It actually constitutes the entire device and exhibits significant mechanical characteristics similar to conventional thermoplastic elastomer devices.
Using this elastic material, Q Urological Persistent ureteral stents have been designed and FDA approved with a bulbous shape at each end serving as an anchoring device. The soft compliant nature of pAguaMedicina ureteral stents allows for a better anchorage system compared to conventional (dynamic) pigtail anchorage profiles, which essentially unwind and wind. Alternatively, pAguaMedicina ureteral stent bulbous or trumpet anchorage profiles absorb physiological and peristaltic energy, exhibiting a static compliant system that contributes to a diminished likelihood of migration. In this manner, the pAguaMedicina Persistent ureteral stent acts like a shock absorber, maintaining position placed in the renal collection junction.
Fenske: How does this differ from other available alternatives for this application?
Epstein: The diminished likelihood of biofilms means less bacteria and infection. Unlike antimicrobial devices, which lose effectiveness over time, pAguaMedicina does not due to its high aqueous content. In this manner, pAguaMedicina devices do not require antimicrobial additives or coatings to prevent the build-up of biofilms. While the Q Urological pAguaMedicina Persistent ureteral stent is similar to predicate devices in delivery, anchorage, and retrieval; it will not distort or buckle compared to commercially available ureteral stents.
Fenske: Are there other inherent advantages to the technology?
Epstein: Supported by testing indicating no biofilm on the surface of pAguaMedicina structural hydrogel samples or, for example, inflammation of tissue exhibited, suggests a broad use where infection is of paramount concern. Expansion into lower urinary tract devices eliminating associated UTIs will be immediately pursued with a focus on using pAguaMedicina structural hydrogel as the raw material. This type of application addresses the “holy grail” pursuit, as it typically isn’t the device design that leads to complications as much as it is the material.
Perhaps even more important, however, is that vascular tests in animals show no indications of blood clotting, even in small lumens. Using pAguaMedicina structural hydrogel as a raw material for vascular access and repair will diminish many issues related to patient quality of life and corresponding heathcare costs. For example, central venous access for drug delivery or hemodialysis typically presents with infection at the entrance site and/or thrombolytic events at the distal end of the catheter. Knowing blood cells will not adhere at the distal tip of the catheter and biofilms will not form and migrate at the entrance site will offer a dramatic improvement.
Used in difficult to maintain environments, pAguaMedicina structural hydrogel is also well suited in the GI system where its very high aqueous content biocompatibility suggests a successful long implant life. Ultimately, pAguaMedicina structural hydrogel is likely to be an alternative to conventional thermoplastic extruded catheter processing and materials.
Fenske: Have you conducted research to compare your technology to materials currently used in these same applications?
Epstein: ISO testing exceeded any testing previously required by the FDA for urology device clearance [i.e., 510(k)]. For example, while ASTM and FDA guidelines indicate samples can be submersed in either distilled water or urine, typically every cleared urology device on the market was only tested in water while my devices had to be tested in urine.
Further, in excess of any requirements, in an effort to substantiate eventual claims, several bench tests were accomplished internally at Q Urological and independently published by urologists at Boston Children’s Hospital. In each case, data indicated a significant reduction in biofilm after 14 days.
An acute animal study that was also conducted by urologists at Boston Children’s Hospital indicated significant inflammation of the ureter by a well-known thermoplastic ureteral stent while no inflammation was observed in the ureter where a Q Urological pAguaMedicina Persistent ureteral stent was used.
As far as testing for vascular applications, we have the basis for several short term applications but in an effort to identify long term opportunities, an acute vascular animal study indicated pAguaMedicina is likely to be as good as ePTFE, and more importantly, when used in small lumen applications, the material is less likely not to become occluded.
Fenske: Are there application areas you are exploring and still researching that may benefit from this technology?
Epstein: The currently 510(k)-cleared (#082805) Q Urological pAguaMedicina ureteral stent is being updated for additional (adult) sizes. Moving forward (late 2016), lower urinary drainage products and central venous access devices are anticipated to be approved and ready for market while emphasis continues validating long-term applications. Similarly, any application that can benefit from a reduction in infection made otherwise from conventional material is a candidate for our product development efforts.
Also, as drug delivery and wound care are typical hydrogel market applications, any application comprised of pAguaMedicina can have a drug delivery system integrated, exhibiting a reservoir significantly greater than any known drug-eluding technology.
Fenske: Before concluding, do you have any additional comments you’d like to share?
Epstein: I believe pAguaMedicina to be an ideal biomaterial, whether used for short- or long-term applications. Accordingly, USPTO #8048350 and #9180028, which encompass the novel aspects of the process for making as well as their utility for structural hydrogel products, can lead to a new way to make medical devices.
Scott Epstein, the founder of Q Urological—a wholly owned subsidiary of Natick, Mass.-based Boston Scott Corporation has taken a slightly different approach. Epstein, who has been involved in the medical industry for over 30 years, developed an entirely new material that exhibits diminished build-up of biofilms. With a goal to develop and market novel medical products that fill specific, well-defined needs, Epstein has secured several patents on the technology and one application solution has already earned a 510(k) clearance from the U.S. Food and Drug Administration.
MPO took time out to speak with Epstein about his technology, the applications for which it is being indicated, and how it compares to products on the market addressing the same clinical needs.
Sean Fenske: Can you please explain the technology you’ve developed?
Scott Epstein: pAquamedicina structural hydrogel technology is a disruptive technology providing a competitive advantage intended to exhibit diminished biofilms. Exceeding ISO, ASTM, and biocompatibility testing, pAquamedicina devices exhibit diminished biofilms and thrombolytic events, addressing immediate market needs. Initially approved for Q Urological Persistent ureteral stents and marketed as antifouling technology, the foundation has been laid for a cost-effective platform technology that will quickly leverage a broad range of vascular, urological, and GI products in the marketplace.
Fenske: Can you please further discuss the medical applications for this technology?
Epstein: There is an array of potential applications for this technology, but for now, I’m going to focus on the urological applications. Using pAguaMedicina structural hydrogel as a raw material, a finished, fully hydrated-in-saline device is about 90 percent aqueous—similar to human tissue and the basis for why nothing sticks to it. This soft, compliant material is not a coating. It actually constitutes the entire device and exhibits significant mechanical characteristics similar to conventional thermoplastic elastomer devices.
Using this elastic material, Q Urological Persistent ureteral stents have been designed and FDA approved with a bulbous shape at each end serving as an anchoring device. The soft compliant nature of pAguaMedicina ureteral stents allows for a better anchorage system compared to conventional (dynamic) pigtail anchorage profiles, which essentially unwind and wind. Alternatively, pAguaMedicina ureteral stent bulbous or trumpet anchorage profiles absorb physiological and peristaltic energy, exhibiting a static compliant system that contributes to a diminished likelihood of migration. In this manner, the pAguaMedicina Persistent ureteral stent acts like a shock absorber, maintaining position placed in the renal collection junction.
Fenske: How does this differ from other available alternatives for this application?
Epstein: The diminished likelihood of biofilms means less bacteria and infection. Unlike antimicrobial devices, which lose effectiveness over time, pAguaMedicina does not due to its high aqueous content. In this manner, pAguaMedicina devices do not require antimicrobial additives or coatings to prevent the build-up of biofilms. While the Q Urological pAguaMedicina Persistent ureteral stent is similar to predicate devices in delivery, anchorage, and retrieval; it will not distort or buckle compared to commercially available ureteral stents.
Fenske: Are there other inherent advantages to the technology?
Epstein: Supported by testing indicating no biofilm on the surface of pAguaMedicina structural hydrogel samples or, for example, inflammation of tissue exhibited, suggests a broad use where infection is of paramount concern. Expansion into lower urinary tract devices eliminating associated UTIs will be immediately pursued with a focus on using pAguaMedicina structural hydrogel as the raw material. This type of application addresses the “holy grail” pursuit, as it typically isn’t the device design that leads to complications as much as it is the material.
Perhaps even more important, however, is that vascular tests in animals show no indications of blood clotting, even in small lumens. Using pAguaMedicina structural hydrogel as a raw material for vascular access and repair will diminish many issues related to patient quality of life and corresponding heathcare costs. For example, central venous access for drug delivery or hemodialysis typically presents with infection at the entrance site and/or thrombolytic events at the distal end of the catheter. Knowing blood cells will not adhere at the distal tip of the catheter and biofilms will not form and migrate at the entrance site will offer a dramatic improvement.
Used in difficult to maintain environments, pAguaMedicina structural hydrogel is also well suited in the GI system where its very high aqueous content biocompatibility suggests a successful long implant life. Ultimately, pAguaMedicina structural hydrogel is likely to be an alternative to conventional thermoplastic extruded catheter processing and materials.
Fenske: Have you conducted research to compare your technology to materials currently used in these same applications?
Epstein: ISO testing exceeded any testing previously required by the FDA for urology device clearance [i.e., 510(k)]. For example, while ASTM and FDA guidelines indicate samples can be submersed in either distilled water or urine, typically every cleared urology device on the market was only tested in water while my devices had to be tested in urine.
Further, in excess of any requirements, in an effort to substantiate eventual claims, several bench tests were accomplished internally at Q Urological and independently published by urologists at Boston Children’s Hospital. In each case, data indicated a significant reduction in biofilm after 14 days.
An acute animal study that was also conducted by urologists at Boston Children’s Hospital indicated significant inflammation of the ureter by a well-known thermoplastic ureteral stent while no inflammation was observed in the ureter where a Q Urological pAguaMedicina Persistent ureteral stent was used.
As far as testing for vascular applications, we have the basis for several short term applications but in an effort to identify long term opportunities, an acute vascular animal study indicated pAguaMedicina is likely to be as good as ePTFE, and more importantly, when used in small lumen applications, the material is less likely not to become occluded.
Fenske: Are there application areas you are exploring and still researching that may benefit from this technology?
Epstein: The currently 510(k)-cleared (#082805) Q Urological pAguaMedicina ureteral stent is being updated for additional (adult) sizes. Moving forward (late 2016), lower urinary drainage products and central venous access devices are anticipated to be approved and ready for market while emphasis continues validating long-term applications. Similarly, any application that can benefit from a reduction in infection made otherwise from conventional material is a candidate for our product development efforts.
Also, as drug delivery and wound care are typical hydrogel market applications, any application comprised of pAguaMedicina can have a drug delivery system integrated, exhibiting a reservoir significantly greater than any known drug-eluding technology.
Fenske: Before concluding, do you have any additional comments you’d like to share?
Epstein: I believe pAguaMedicina to be an ideal biomaterial, whether used for short- or long-term applications. Accordingly, USPTO #8048350 and #9180028, which encompass the novel aspects of the process for making as well as their utility for structural hydrogel products, can lead to a new way to make medical devices.