Our client has developed a subcutaneous testosterone implant system that overcomes disadvantages with competing HRT products.
The system consists of 100mg pellets and a specialized implantation trocar.
The pellets offer the following advantages:
- 3-month slow release
- Much higher absorption rate than patches or gels
- Fewer pellets required to achieve the required dose
- Larger pellets are less likely to extrude through the skin
- Currently available testosterone dosage forms used for hormone replacement therapy (HRT) are inconvenient and may cause dangerous side effects.
- Testosterone gels and creams may cause adverse reactions at the application site, including burning, blistering, itching, soreness, swelling, redness, rash, dry skin, and acne.
- Additionally, gels and creams may transfer to others through contact with skin and clothing, which can be particularly dangerous for women and children.
- Existing 75mg testosterone implants require 2 to 6 pellets (150mg – 450mg total dosage) and are susceptible to extrusion through the skin at or near the implantation site.
- Our client is currently the sole manufacturer of this testosterone pellet formulation, with a manufacturing facility in the United States.
- The product is presently being exported to the United Kingdom.
- The companion implantation trocar was listed with the US FDA in 2017.
- Our client wishes to manufacture and supply the product to partners via supply or purchase agreements.
- All markets are available for partnering aside from the United Kingdom.