Production Process
Metal microneedles are made using cold processing, a traditional manufacturing method. Commercialized by Becton Dickinson, they’ve only recently begun to expand their market in the vaccine field. Johnson & Johnson has taken a titanium alloy approach, which they have been developing for the past twenty-five years. This R&D process has cost over $300 million U.S. dollars and the product has yet to be released into the market.
Unlike either of these microneedles, our NanoChips are made from silicon wafers and are manufactured using nano-processing methods suitable for mass production. Because of this, we are the first and only company capable of producing an annual supply of 30 million NanoChips.
- Our NanoChips are made from high purity (99.9999%) single crystal silicon, which is harder than stainless steel.
- Each NanoChip is made up of a NanoTip array and each dot on the array has a tip that is 1,000 times smaller than a human hair, resulting in non-invasive, but effective skin absorption.
- Our products and production process solve obstacles that industry experts believed were insurmountable, including easy fracture and the high cost of silicon production.
Due to the differences in materials, the final shape and form of the single crystal silicon NanoChip is very different from the polymer-soluble micro-needles.
- Because of the nature of silicon materials, they can be made with a precise height and nanosize to ensure skin contact is both painless and non-invasive. And even more importantly, the reversible microscale absorption channels created by these single-crystal silicon NanoTips close themselves within 20 to 30 minutes (measured by transepidermal water loss (TEWL)) to ensure both efficacy and safety. Currently, this patented production technology is mature and ready for mass production.
- Due to polymeric material’s limitations, it cannot achieve the same nanoscale and precise height that can be reached with silicon. As a result, skin stings after contact. Additionally, the needle needs to dissolve into the skin after contact is made, which is a non-reproducible process due to the fact that skin's moisture level varies from individual to individual. Due to the differences in this dissolution curve, it is difficult to control the dosage and speed of drug release. At present, it is only marketed in the form of cosmetics, such as hyaluronic acid microneedle eye patches that have been marketed in South Korea and Japan.
Since Deminuage™ has created solutions for the fragility of materials and high costs of production, our product can be widely used.
Production Equipment
The Deminuage™ team has an extensive background in physics, chemistry, engineering, materials, medicine, and other fields. The founder of the company participated in founding the United State’s first Nanoscale Science & Engineering College at the State University of New York's Albany campus. His team has created one-of-a-kind NanoChips through the world’s most efficient production line. Involving more than 100 procedures, this customized and automated line can produce up to 10,000 NanoChips an hour, while still ensuring both purity and high quality.
Production Facilities
Our 20,000 sq. ft. class 100,000 cleanroom features two independent air purification systems to avoid cross-contamination in the production process. And to ensure product quality we follow a very strict GMP compliant quality management system.
Clinical Validation
Before our research and development began, the world’s leading micro-needle company only had 20,000 documented clinical applications. We have sold over 30 million disposable cartridges globally and over 10,000 public hospitals and private enterprises have adopted various services based on NanoChips. Our products are both safe and effective and have been proven by more than a dozen randomized double-blind, self-controlled clinical studies and peer-reviewed publications in recognized international academic journals.