High viscosity biologic drugs generally require syringe injections, but many patients are extremely uncomfortable around long needles and injection times can create a great deal of anxiety. Portal Instruments, a company out of Cambridge, Massachusetts, has developed a nearly automatic needle-free injector that reminds us of something doctors in science fiction movies would use. We spoke with Patrick Anquetil, CEO of Portal Instruments to find out exactly how a viscous liquid can be made to enter the body without a needle, what this means for the treatment of different diseases, and what additional features the company’s technology offers.
Medgadget: To start off, how does the Portal Instruments injector work?
Patrick Anquetil: We are using a breakthrough technology developed at MIT by Prof Ian Hunter which allows us to deliver a digitally controlled, needle-free rapid injection that is safe, reliable, and convenient. The injection is administered through the skin via a jet the size of a human hair. The core technology of the injector is a computer-controlled linear actuator that allows us to pressurize the drug and form a very fine jet with the drug. The jet exits the device at high speed (200 m/s – 450 mph) and creates enough pressure on the skin to gently pierce it. The control algorithm in the device allows us to control injection depth and fill the drug at that particular tissue location, ensuring optimal patient comfort.
Medgadget: What drugs does it work with or “should” work with?
Anquetil: There is an unmet need for patients suffering from chronic conditions such as rheumatoid arthritis, multiple sclerosis, hemophilia, irritable bowel diseases, etc. where for a long time drug delivery has been sub-optimal. At the heart of the issue is that the most efficacious drugs to address those conditions can only be formulated as an injectable needing administration with a needle and syringe. Self injection leads to tremendous patient anxiety, and in some case patients are not able to reach the outcomes that they wish and feel better. In addition, those drugs typically require a high dose volume (1 ml which corresponds to 2-3 vaccines) and tend to be viscous. We are the only closed-loop feedback controlled needle-free drug delivery device and can perform a 1 mL needle-free injection needle-free. Legacy needle-free devices typically are only able to deliver 0.2 to 0.5 mL
Medgadget: How would you describe the feeling during injection?
Anquetil: During our clinical studies we discovered that sensation is very much subject dependent. In my case, when I participated as a subject to our clinical studies, it felt like a small tickle. Also the injection is ultra fast as it takes us only 0.3 seconds to inject the full 1 ml dose.
Medgadget: What about pediatric patients?
Anquetil: There will be great patient benefits for pediatric patients. Injections can be traumatic for children. In some case it might even be the first time they see another human being inflicting pain to them. Our plan is to address this segment in time.
Medgadget: How does it compare in size, usability, and other features to existing products?
Anquetil: Because our device contains more technology than a traditional needle and syringe it is bigger in size than a typical needle and syringe. This will change as we continue to miniaturize the device further. On the other hand, what is unique with our device are the safety features enabled by the sensors and the ARM computer and sensors that are in the device. The needle free experience is also unique and removes the anxiety typically associated with an injection. Our key design considerations have been the following: ease of use, comfort, and giving a positive emotion about the overall therapy / treatment.
Medgadget: What does the app do and what are its benefits? Does the injector require the use of the app?
Anquetil: The Injector does not require the smartphone app to function. On the other hand, the app can augment the patient experience and be used to track injection data in real time. These data can be captured and reported instantly to the patient and can be shared to care team at the right time. We think this information will be valuable information that can improve compliance and inform the design and development of future therapies
Medgadget: What stage is the injector at? Is it cleared by the FDA in the U.S. or CE Marked in Europe?
Anquetil: The injector is currently in development. Our plan is to begin pilot production in Q1 2018 to support clinical studies with our Pharma partners.
Medgadget: Who do you expect to be the customers for the injector? Consumers, drug manufacturers, clinics?
Anquetil: For now our business model is to partner with Pharma companies to enable them to better deliver their medicines. However, we anticipate that given the potential for this technology to transform the patient experience in chronic diseases, there will be a patient pull that could lead to rapid adoption.
Medgadget: Can you give a summary of the history of Portal Instruments and where the company is headed?
Anquetil: Portal was founded in late 2012 and obtained Series A funding in Feb 2014 and together with its Series B raised $36 million in financing. The original platform was developed at MIT over a 5 year period by Prof. Hunter and his team at the MIT BioInstrumentation lab. Portal licensed the technology from MIT in 2014. Portal is a unique place to work at. Our strategy and philosophy is to equip our engineers with state of the art prototyping tools and machines such that they can develop innovative designs and solutions quickly. At the heart of this philosophy is the idea that shortening the iteration cycle fosters innovation. With the right tools and mindset, our engineers can design, build, test and then iterate quickly. On average we have developed a new device platform every 6 months. Since 2014, we’ve gone through 7 generations of the device, including two clinical grade devices. Our vision is that one day we will enable a needle-free world.
Link: Portal Instruments…