Patent-Pending Drug Implants
Hera Health Solutions is developing a biodegradable drug delivery implant.
This device is implanted under a person’s skin, and is made of materials that absorb into the body. This patent-pending technology is designed to eliminate the need for painful, risky implant removal procedures.
Hera's first implant is a contraceptive device for women. With this device, the company is targeting the $22 billion global market for contraceptives.
The company has developed a prototype of this product and completed initial studies on its effectiveness. Now it’s conducting further tests and working to gain approval from the FDA and World Health Organization (WHO).
Hera expects to receive approval by December 2020 and aims to launch its initial product by April 2021.
As of 2017, more than half of Americans take at least one prescription medication daily. But according to the FDA, many medications aren’t taken as prescribed. In fact, 20% to 30% of prescriptions are never filled at the pharmacy.
One alternative to replacing a daily pill regimen is using subcutaneous, or under-the-skin, implants that provide continuous doses of medication. These are part of the implantable drug delivery devices market, which, according to Market Research Engine, is projected to surpass $34 billion by 2024.
The problem is that, with these implants, once the drug is consumed, the device must be removed via expensive and potentially painful surgical procedures.
These procedures can leave patients with bruising and scarring. And some patients require invasive surgery to recover migrated or lost implants.
Hera's biodegradable implants solve these issues.
The company’s first implant is called Eucontra. This is a contraceptive device for women that prevents pregnancy for 12 to 16 months.
Hera Health has developed a prototype of this device and completed “bench studies,” a form of laboratory research. Preliminary batches of Eucontra have been produced by the company’s manufacturing partner, Nanofiber Solutions.
Once on the market, Hera aims to sell the device in the U.S. for $800, which is competitively priced for similar implants. The company is aiming for the device to be reimbursable through health insurance, which could lower the price for consumers. At this price point, Hera Health estimates to achieve 98.5% gross product margins.
Internationally, the company will sell the device to non-profit organizations that distribute to countries with limited access to healthcare. According to the World Health Organization, there are 214 million women in developing countries who want to avoid pregnancy but aren’t using a modern method of contraception.
With respect to FDA and WHO approval, Hera Health is submitting an Investigational New Drug Application through what’s called the “505b pathway.” This is an expedited hybrid approval process for drugs and devices that are similar to current products already approved by the FDA. It allows drug companies to use research data from similarly approved products and helps alleviate the burden of duplicating time-consuming, costly studies.
WHO approvals are similar to the FDA, but on a case-by-case basis. If the product is found to meet WHO’s requirements and complies with good manufacturing processes, it and the company will be added to the WHO’s prequalified list of medical devices. Hera Health’s manufacturing partner, Nanofiber Solutions, is already approved as a good manufacturing process facility.
To achieve these milestones, the company plans to hire a consulting group to help facilitate and complete the FDA approval process. It will also hire an R&D specialist, FDA regulatory expert, and medical device manufacturing expert.
In the meantime, Hera has achieved considerable progress:
It’s completed the Zeroto510 medical technology accelerator program, and the BioExcel accelerator program. BioExel is an Ireland-based program that aims to boost the “med tech” startup community. It’s backed by the Western Development Commission, the Galway University Foundation, and the Bank of Ireland Seed and Early Stage Equity Fund.
Hera Health is one of BioExel’s first American companies. Through this partnership, it received a $105,000 investment, access to EU regulatory landscape consultants, and working laboratory and office space.
Along with BioExel, Hera Health received a total investment of $100,000 from venture capital firms Innova Memphis and MidSouth Sustainable Energy Solutions.
Hera Health has captured several awards at competitions including SXSW Startup of the Year Competition, the Global Entrepreneurship Summit, the Get Started Louisiana Pitch Night, and the International Design of Medical Device Competition.
Idicula has a background in product development, as well as a focus in biotechnical research.
Prior to starting Hera Health, he worked as an engineering co-op for General Electric (NYSE: GE). While there, he focused on supply issues and finding ways to increase efficiency with the company’s assembly lines.
He co-founded CrossX, a social media platform promoting safe exercise habits for fitness enthusiasts. In addition, he served as an innovations analyst for AT&T Foundry, a subsidiary of AT&T that enables aspiring entrepreneurs to collaborate on projects and ideas.
Idicula was an undergraduate researcher at the University of North Texas, where he worked in the school’s biotechnology research lab and focused on DNA testing.
He earned a Bachelor’s degree in Bioengineering from Georgia Tech.
Garrett has direct experience developing medical technology devices.
He was a biomedical engineering intern for United Sciences, a health-related startup that manufactures 3D scanners for ears. In addition, he spent more than two years working at the Biomedical Engineering Design Lab at Georgia Tech.
Garrett earned his Bachelor’s degree in Biomedical Engineering.
An accelerator program focused on boosting “med-tech” related startups. Provides access to health regulation consultants, working capital, and office space.
A VC firm investing in early-stage businesses focused on the biosciences, healthcare, and technology industries. Successful “exits” include Rescue Forensics, Qpass, and OptiSource International.