Montmed Inc. Announces Issuance of US Patent for SiteSmart™ Pen Needles

MONTREAL, January 10, 2020 /CNW Telbec/ – Montmed, Inc., a company dedicated to enabling people with diabetes to do more without adding to the burden of managing their diabetes, today announced that the United States Patent and Trademark Office (USPTO) has issued US Patent 10,485,919 covering the company’s novel technology to help people easily and seamlessly develop and implement healthy injection site rotation practices.

Insulin users inject themselves anywhere from 1 to 6 or more times daily. This daily repeated administration of exogenous insulin, a growth hormone, combined with the repeated trauma of needle micro-injury, can lead to a serious complication called lipohypertrophy which is defined as an abnormal accumulation of fat underneath the surface of the skin, leading to sub-optimal insulin absorption. Lipohypertrophy has been shown to have important repercussions on glycemic control, such as an elevation in HbA1C, increased glucose variability, increased unexplained hypoglycemia as well as an increase in insulin requirements1. Studies have shown that the lack of injection site rotation is the largest risk factor in developing lipohypertrophy, which is present in up to 65% of people with diabetes who inject insulin2. Adopting healthy injection site rotation is a key clinical recommendation for all insulin users that has been shown to have important clinical and financial benefits. As of today, there is no simple and intuitive way to help health care professionals teach, and patients adhere and maintain a structured site rotation routine, resulting in sub-optimal clinical and financial outcomes.

Montmed’s patent specifically covers distinctively marked injection devices, including insulin pen needles, in combination with a user-defined association tool that allows the user to create and implement a personalized injection site rotation plan, and thus reduce the risk of developing lipohypertrophy.

Montmed has developed the SiteSmart™, a novel pen needle system designed to favor adherence to a healthy injection site rotation regimen. Each package of SiteSmart™ contains 100 insulin pen needles distinctively marked with 4 colors, along with educational messages and an association tool labeled directly on the packaging that allows the user to simply and easily create a personalized structured injection site rotation plan, in which each of the four colors of pen needle is associated with a distinct injection area, seamlessly instructing the insulin user where to inject at each injection. Positive clinical data from a randomized controlled trial were released in October 2019, which demonstrated that the sole dispensing of Montmed’s SiteSmart™ pen needles system by a retail pharmacist resulted in a significant improvement in injection site rotation, delivering a 134.7% increase in the likelihood to improve site rotation over conventional pen needle.

Amir Farzam, chief executive officer of Montmed, commented, “We are very pleased that the USPTO has recognized our innovation. Issuance of the US patent paired with positive clinical data last quarter have been major milestones in our journey. We believe SiteSmart™ has the potential to transform the utility of an insulin pen needle beyond a simple insulin delivery device, to a clinically valuable tool that can improve health outcomes and reduce costs by helping insulin users seamlessly integrate healthy injection site rotation into their daily routine, and importantly, at no additional direct cost to the healthcare system”.

Although diabetes is the primary use case for the technology, Montmed’s patent is applicable to any medical condition that requires frequent injections and where injection site rotation is recommended. “Our patent not only covers pen needles, but other injection devices such as syringes and infusion sets. The labeling for several products in several therapeutic categories advocate that patients implement a healthy injection site rotation plan for optimal clinical outcomes. Our granted patent simply aims at making it easy for users to adhere to this key recommendation.”

About SiteSmart™
Montmed has developed SiteSmart™, a pen needle system that brings clinical value by helping insulin users seamlessly adopt a healthy site rotation routine, which can reduce the risk of lipohypertrophy, improve insulin action and consequently, clinical outcomes, at no additional direct cost to the healthcare system. The SiteSmart™ package contains 100 insulin pen needles distinctively marked with 4 colors (4X25), along with an association tool labeled directly on the packaging and on a web app, that allow the user to create a personalized structured injection site rotation plan, in which each of the four colors of pen needle is associated with an injection area. Once the plan is developed by the insulin user or with the help of a health care professional, the user simply picks a pen needle in the box, and injects in the area corresponding to color of the pen needle on his /her plan. And that’s it! No tracking, no logging, no need to remember where the last injection was given. The simplicity of SiteSmart™ makes it easy for any insulin user to get the most out of their insulin by integrating a healthy injection site rotation routine without adding to the cognitive burden associated with diabetes management. The SiteSmart™ packaging also serves as a counselling tool to favor a rapid and concise educational intervention on site rotation by health care professionals, including prescribers, diabetes educators, and retail pharmacists. SiteSmart™: Change Colour, Change Site™.

1. Frid A, et al. Worldwide Injection techniques questionnaire study. Mayo Clinic Proc. 2016;91(9):1212-1223. doi: 10.1016/j.mayocp.2016.06.011.
2. Blanco M, et al. Prevalence and risk factors of lipohypertrophy in insulin-injecting patients with diabetes. Diabetes Metab. 2013;39(5)445-53. doi: 10.1016/j.diabet.2013.05.006.
3. Forum for Injection Techniques (FIT).

SOURCE Montméd

For further information: Montmed Media Contact:, 514-6951222

Related Links