Research over the past 15 years has shown nitric oxide (NO) to be an essential natural molecule in the wound healing process. This research includes animal and human studies that clearly show that applying gaseous NO to a wound increases the rate of wound healing. NitricGen’s product, the eNOGenerator, is a simple, easy-to-use device that employs patent-pending technology to generate and deliver a safe, controlled dose of gaseous nitric oxide for the treatment of chronic wounds. By simply attaching an applicator, positioning the applicator over the wound and pressing start, caregivers or patients can complete the eNOGenerator’s short and simple course of treatment.
NitricGen’s key management have over 60 years’ experience in successfully developing novel medical technologies, obtaining patent protection and FDA approvals, managing new product introductions, and founding and managing a startup company to the point of exit through acquisition.
NitricGen’s president Duncan Bathe and executive-VP Fred Montgomery had previously created a startup which was successfully sold to Ikaria, where they started a device division and grew it from 5 to 52 people in Madison, WI over 7 years. They have a proven track record of innovation and commercialization of ideas with over 20 patents and over 10 nitric oxide medical devices in current clinical use or have had FDA approval.
The initial target market for the eNOGenerator are patients in the US who are suffering from chronic diabetic foot ulcers (DFU’s) that do not respond to the current standard of care. This population includes approximately 4% of the diabetics in the US or 900,000 patients per year with 80,000 per year ultimately requiring amputations. In the US, the total cost of both ulcer care and amputations exceeded $9 billion in 2001. Our annual sales target 5 years from product launch is 14% of the chronic DFU’s market in the US or $420 million per year. The number of US patients with diabetes in 2010 has more than tripled since 1980 to 25 million and is expected to double again by 2050.
As an example of the high demand for and market potential of advanced DFU therapies, Kinetic Concepts Inc.(KCI), a US-based company that commercialized the first negative pressure wound therapy system for the treatment of DFU’s, grew sales to $1.4 billion in a period of only10 years.
There is currently no direct competitor in the market for treating DFU’s with gaseous nitric oxide therapy. Indirect competition in the advanced therapy market consists of negative pressure wound therapy (NPWT) and hyperbaric oxygen treatment (HBOT). Although biological topical agents and skin substitutes exist, these have not materially changed patient outcomes and are minor players.
NPWT, is time intensive, requires the patient to wear bulky equipment 24 hours/day for 90 days, with only a marginal increase in healing. The second indirect competitor, HBOT, consists of 8 weeks of daily 90-minute treatments in a pressurized chamber where the patient breathes 100% oxygen generally via a facemask. This treatment is costly, time consuming, and requires daily travel to a sometimes distant HBOT clinic.
In comparison to current advanced therapies for the treatment of diabetic foot ulcers, the eNOGenerator is expected to provide superior efficacy with significant benefits in terms of ease of use, patient compliance and quality of life with a single 2 minute daily treatment for three weeks.
- NitricGen has developed an exciting new technology for generating nitric oxide from room air and has filed a patent for this technology in the US, Europe and Canada in 2012.
- NitricGen was the overall winner of the Wisconsin 2013 Governor’s Business Plan competition.
- NitricGen successfully secured $265K through an SBIR grant for a pre-clinical wound healing study in mice which was completed in 2014. Fully functioning prototypes of the eNOGenerator were used in this pre-clinical study, which demonstrated a 2 times rate of healing over placebo mice. A 2nd study in diabetic mice is planned for completion iby end July 2015.
- NitricGen has implemented an FDA compliant quality system in 2014.
The FDA has confirmed that the eNOGenerator will be regulated as a medical device under the jurisdiction of CDRH. As a result, the eNOGenerator will be regulated under Pre-Market Approval (PMA) regulations and the clinical trial under an Investigational Device Exception (IDE). NitricGen, has already consulted with a local contract research organization (CRO) to plan, budget, and manage the clinical study and these numbers are built into the milestones and business cost.
Growth Strategy and Roadmap
- Complete the patent process on key eNOGenerator innovations.
- Establish corporate identity, brand names and trademarks.
- Determine how FDA will regulate the eNOGenerator.
- Obtain grant money for pre-clinical study (SBIR).
- Implement an FDA compliant quality system.
- Obtain first-round financing for device development on humans and a pilot study via SBIR grants and/or angel capitol.
- Build staff, infrastructure, and retain consultants for pilot trial and compliance issues.
- Continue R& D and obtain FDA agreement for a pilot and clinical trial and device approval.
- Upon completion of a successful pilot study, obtain second-round financing via SBIR grants and/or venture capital funding to support the clinical trial and device development.
- Complete the clinical trial in chronic diabetic foot ulcers and gain FDA device approval for diabetic foot ulcer therapy.
- Obtain reimbursement codes for insurance and for Medicare/Medicaid.
- Obtain third-round financing via IPO or venture capital to implement a sales force, distribution network, and contract manufacturer.
- Market and sell for the treatment of diabetic foot ulcers.