Memorandum

JDRF funds Capillary Biomedical and TJU to test highly novel seven-day wear subcutaneous insulin infusion catheter in swine – August 12, 2016

Executive Highlights

  • Last week, Capillary Biomedical announced a collaboration with Thomas Jefferson University (TJU), supported with $1.5 million in funding from JDRF. The research aims to develop a novel subcutaneous insulin infusion catheter that: (i) can be worn for seven days or more; (ii) infuses insulin from multiple small holes along the catheter (like a sprinkler); (iii) uses a “non-cutting,” lower trauma design to reduce site inflammation; and (iv) adds a vibration and warming device on top of the catheter to increase local circulation. The company expects more rapid and consistent insulin absorption.
  • The prototype catheters will be tested in a swine model for 14 days at TJU. Capillary targets a first commercial device by 2020, and believes the focus on biomechanical design changes (multiple holes, atraumatic insertion, heating, vibration) reduces the project complexity and timeline relative to other approaches (coatings, excipients).

Startup Capillary Biomedical just announced a research collaboration with Thomas Jefferson University (TJU), supported with $1.5 million in funding from JDRF. The program aims to develop a novel subcutaneous insulin infusion catheter that: (i) can be worn for seven days or more; (ii) infuses insulin from multiple small holes along the catheter (like a sprinkler); (iii) uses a “non-cutting,” lower trauma design to reduce site inflammation; and (iv) adds a device on top of the catheter to provide “gentle warming” (increases local circulation, similar to InsuPad) and “soft vibrations” (to break up tissue obstructions).

The project is still preclinical, and the prototype catheters will be tested in a swine model for 14 days at TJU. The company targets a first commercial device by 2020. Capillary believes the focus on biomechanical design changes (multiple holes, atraumatic insertion, heating, vibration) reduces the project complexity and timeline relative to other infusion set approaches (coatings, excipients). JDRF’s Dr. Vincent Crabtree shared that Capillary has a “highly innovative approach” and the short time to market was perceived positively relative to pharmacological approaches.

Capillary expects more rapid and consistent insulin absorption, as the catheter will “significantly increase the distribution and surface area of insulin in contact with surrounding vascular tissue.” This will be tested in PK-PD studies, micro-CT imaging, and tissue histology moving forward. Pictures of the prototype are pasted below– Capillary’s approach to the catheter itself is similar in theory to BD’s dual-port FlowSmart catheter, though with many more infusion holes along the catheter. Of course, the on-body form factor is critical for any infusion set, particularly if a warming/vibration device is added.

TJU’s Dr. Jeffrey Joseph (an expert in this domain) and Paul Strasma (formerly of Glumetrics and Abbott) founded Capillary Biomedical in 2014. We first heard about the startup in Dr. Joseph’s talk at IDF last December, but this announcement is the first mention of work in subcutaneous infusion sets. The company’s long-term goal remains a “long-term, fully implantable” closed-loop system (glucose sensing + insulin delivery). We love the combination idea to improve subcutaneous insulin infusion sets, which still need lots of innovation to fully reap the benefits of automated insulin delivery.

  • Notably, these technologies are used in other medical applications (anesthesia, dermatology), and Capillary aims to apply them to insulin delivery in a scalable manner. We do wonder how hard it will be to manufacture a catheter with many holes; we assume it took BD some time to add just one extra hole with the FlowSmart set.
  • It will be interesting to see how BD/Medtronic’s MiniMed Pro set with FlowSmart technology fares once it launches (roughly later this year, per BD 2Q16). Will patients observe real-world benefits with the dual-port catheter? How sticky are infusion sets as a product – will patients readily try a new one?
    • We’d note that BD had a microneedle infusion set program – with many of the same purported advantages as Capillary – but the program has not advanced forward to our knowledge. We assume there were difficulties with getting the microneedle technology to work (e.g., pain, stickiness, etc.).
  • In addition to the BD set, Medtronic has six other infusion set projects slated to launch over the next three years. As noted in our June 2016 Analyst Day report, these include: an extended wear set, two different combo CGM-insulin delivery combo sets (one with seven-day wear, slated to launch by April 2021), a new Quick-serter insertion device, and two unknown innovations.

Pictures of Capillary’s Technology

 

Close Concerns Questions

Q: Will this technology actually improve insulin absorption speed?

Q: How difficult will it be to manufacture a catheter will multiple holes?

Q: Would Capillary ultimately license the IP to an established infusion set maker (Unomedical, BD)?

Q: Will patients accept the potential form factor tradeoffs of a warming/vibration device on top of the set?

Q: Where will infusion sets be in four years? Are we entering a renaissance period of innovation for the technology?

-- by Adam Brown and Kelly Close