We help dentists and medical professionals sterilize equipment in a few minutes instead of an hour using special light instead of wasting water. An average dentist saves $100,000 and 2 million gallons of water each year.
Steam sterilizers take hours to sterilize, damage expensive assets over multiple cycles and can be a source for recontamination. Also, they require de-ionized water and significant amounts of electricity to operate and have become an increasing economic burden on oral and medical care.
Lumaegis provides a novel device and method to sterilize medical and dental instruments in a fast, efficient, thorough, and cost-effective manner. Lumaegis manufactures and sells the world’s fastest sterilization device "RadBox", utilizing a patented combination of electromagnetic radiation to sterilize instruments in less than 6 minutes.
The device increases productivity by a min of 3X, does not use any water or damage medical and surgical instruments even after multiple cycles. Finally, RadBox is space efficient by being 75% smaller and consumes 80% less power thereby, saving a minimum of $25,000 in operating costs per unit annually.
Sterilization market growth is driven by the rising incidence of healthcare-acquired infections and the growing number of surgical procedures. In 2024, the North America Healthcare Sterilization SAM is $3B, with a 5-year SOM of $353M, and a 8% CAGR. Specifically, dental sterilization is growing due to the prevalence of periodontal diseases, the rising need for cosmetic dentistry, the number of dental procedures, and the threats of cross-transmission.
Lumaegis' mission is to support global health security and reduce the tremendous environmental impact of the disinfection and sterilization processes globally. Underlying this is our core value of meeting the basic need of humans - the desire to be secure and safe. Our core values, culture, and technology development experience drives all we do in helping make the world a more secure place.
The co-founders John Morreale, Dr. Sudhir Subramanya, and Matthijs Keuper are the entrepreneurial team who drove the LED revolution resulting in adoption of LED lighting that reduced CO2 emission by 570M tons (DOE 2017).
Founders have a proven track record of transforming innovation into affordable products and delivering them to market such as First LED TV 46” Sony Qualia, 2003; First LED Headlamp Audi R8, 2004; First LED Cellphone Flash, Apple 2007. We also utilize our extensive network of vendors, suppliers and assembly partners to minimize capital investment.
Lumaegis will operate on a B-to-B model. Our go-to-market approach is to take our lead customers directly and receive user feedback, enabling quicker and timely refinement. As RadBox offers fast sterilization, a smaller footprint, and ROI in <4 months, it will drive eventual adoption of the RadBox in each operatory, in addition to a central sterilization room in oral care.
We will outsource the components and the sub-assembly manufacturing and integrate the final hardware and software in-house.
Our initial target customer segment is Dental Clinics. We have validated the demand in this space with our first three customers/partners, who have also been instrumental in RadBox's design, size, and user interface. We have received LOIs (Letters of Intent) to purchase our first production-ready products once FDA-approved. Just today, one of our periodontist's investors asked if we could supply him with a new unit to replace an aging Statim system. The demand is there!
We are also targeting veterinary clinics and laboratory/research environments where there is a need for improved infection control and sterilization and a lower barrier to entry. To this end, we prefer an investment partner with experience in the medical device environment who can help us partner with governmental, industry, and professional organizations, i.e., the American Dental Association and PhRMA.
Our first target is the oral care vertical. We chose this vertical as there is an urgent need for faster, cheaper, and sustainable sterilization. A further benefit is the ecosystem built around dental communities. Dental, medical, senior living, and rehab are co-located or nearby, easing introduction and interest in that space.
Lumaegis will quickly tap into a well-established distribution model in the oral care markets, targeting hungrier Tier 2 distributors in this space, e.g., Darby, Benco Dental & Safco Dental, and the ever-expanding Dental Service Organization, which is seeing 15% yearly growth.
Lumaegis needs to fill out the remaining $1.2M of our convertible note to get us to first sales, which means FDA De Novo approval as a sterilizer and all the associated claims that flow. The use of this funding will support the following tasks:
- Complete product development with lead Dental customers; build out team; achieve FDA De Novo certification; complete UL/CE certification; continue developing and executing our IP strategy and moat; MFG scale with our supplier, board manufacturers and assembly partners (ISO 13485 Medical Device QMS certification required)
- New customer development in Pharma/Research/Medical/Veterinary
- Independent Rep - Partner with a sales representative group specializing in medical device sales.
- Distribution/Service Providers - Channel development - partner with hungry Tier II dental distribution partners (Darby, Benco Dental & Safco Dental)
- Design, Pre-Prod Builds, Verification Testing - 1 Cycles of learning: $175,000
- Testing for FDA Validation and reliability on 4 units: $350,000
- Vendor/Supplier/Assembly Development: $150,000
- FDA De Novo certification process: $100,000
- UL/CE certification: $75,000
- Working Capital: $350,000
Total: $1,200,000
The initial pre-seed $1.5 CN is followed by a $4.0 equity raise for product proliferation, new customers, and new market development. Upon current projections, our financial model shows cashflow positive in month 27 after first sales.
For initial validation, the team tested the RadBox against the biological indicator bacillus pumilus, the reference pathogen for radiative sterilizing devices. We demonstrated a 6-log kill in less than 3 minutes, meaning we have a sterilizer in 6 min (2 x dose to achieve the 6-log kill) vs 85-90 min for the incumbent steam sterilizers.
Lumaegis has built the first pre-production set of RadBox and is preparing for FDA certification testing for a De Novo Class II sterilizer. We received a De Novo designation from the FDA in Jul 2024, De Novo meaning a premarket submission that uses a risk-based approach to classify novel medical devices or first of its kind.
Before marketing the device to healthcare professionals and first sales, we require our De Novo marketing clearance, the last step toward product/market release, and where most of the requested funding will be resourced.
With the FDA De Novo designation, Lumaegis will first need to perform testing to demonstrate the hierarchy of resistance of microorganisms to this new sterilization technology and thus determine our reference pathogen. This will be the pathogen all subsequent testing will be based on and will become the biological indicator used for ongoing verification in the field during use. Final instrument testing will be conducted by a third-party, FDA-approved lab and will form the basis for verification in our De Novo submission.
The RadBox has demonstrated better practitioner returns by delivering a faster, cheaper, and more sustainable method of medical instrument reprocessing.
Open Convertible Note for $1.5M - Raised ~ $300,000 of that sum to date, through Angels and Venture
