Decontamination and infection control technologies that reduce the risk of healthcare acquired infections
Aseptium develops technologies that reduce the risk of infectious diseases transmitted directly through surgical instruments and medical equipment.
We created uSonic range of instrument washers for hospitals and dental clinics to address the problem of cleaning the most complex instruments used in medicine today. Cleaning of instruments is critical, otherwise sterilisation is not effective.
uSonics are based on our unique, patent pending technology that reduces the risk of cross-contamination between instruments. In addition, we will offer a range of accessories and consumables (detergents and cleanliness testing kits) as well as technical training, education and support services. We offer a dedicated, holistic solution to decontamination of complex instruments.
Beyond UK and EU we will expand our business to China and USA. We aim to license our IP to local manufacturers and supply our products through distributors of decontamination equipment globally.
According to WHO, 7% to 10% of all hospitalised patients will acquire at least one healthcare associated infection. Healthcare acquired infections are one of the key risks linked with invasive surgical and dental procedures. Sources of those infections vary. In case of invasive procedures unsafe instruments put infectious microorganisms directly into patient’s body offering them great conditions to grow and multiply – it is like planting seeds into a fertile soil.
As patients, we implicitly rely on hospitals and clinics to clean and sterilise reusable instruments. We trust they have the right equipment and processes in place to make them safe to use time and time again. The field of minimally invasive surgical instrumentation is continually advancing and is expected to grow at least 10% every year in the next five years. (Transparency Market Research 2013). The problem is not only the amount but the diversity and complexity of those instruments with robotic instruments leading the trend. We have found that reprocessing (cleaning, disinfection and sterilisation) has become a major challenge for healthcare, since these instruments have to be cleaned and sterilised not only outside but also inside, together with all internal channels, crevices and mechanisms.
Aseptium has developed a technology to address this exact problem. In our experience conventional reprocessing equipment relies on industrial processes that recirculate dirty water preventing complete cleaning, whereas our uSonic washers combine ultrasonic cleaning with non-recirculating flow (no reuse of dirty water) that prevents cross-contamination between instruments.
We are addressing a global problem, exacerbated by the rise in blood borne infections, antibiotic resistance and prion diseases such as Creutzfeldt-Jakob Disease (CJD).
We estimate the available global market for washers and washer-disinfectors in Europe China and North America alone is c.330,000 units but we intend to sell beyond these markets as well.
Substantial accomplishments to date
Aseptium filed a UK patent for our non-recirculating cleaning technology, with plans to extend it internationally.
We built several prototypes of uSonic washers which are being evaluated with different cleaning chemicals and instruments.
Our prototype was exhibited on our own stand at Medica (Nov 2015) and at CMEF in Shanghai (May 2016) with Laoken who is one of the market leaders in decontamination equipment in China.
We presented our technology at the annual conference of the Institute of Decontaminated Sciences (Blackpool, Dec 2015) and at a joint Decontamination and Infection Control Scientific Congress (London, Feb 2015). We also presented our technologies at conferences in Norway and Denmark. We were also invited to deliver a talk in Ireland (Nov 2016).
We secured interest from manufacturers in USA and China to licence our technologies.
We also put together a business development and manufacturing plan for both the machines and consumables.
Our business model is based on Aseptium’s ecosystem of products that complement each other.
On the technology side we offer uSonic washers together with cleaning and water processing chemicals, as well as test kits for process evaluation and periodic monitoring.
We believe the range of products will continually expand due to large diversity of surgical instruments and an increasing need for bespoke decontamination solutions. That includes ancillary equipment, accessories and consumables. Together with the machines we will also offer after sales support and spare parts.
Beyond technology and physical products we will provide technical training as well as online equipment monitoring and maintenance for uSonic washers. Products and services will be sold through a network of distributors and manufacturers globally.
Together with our European academic partners and industry partners, like Laoken, we will provide educational programmes delivered online and offline in the UK and internationally.
We will also provide contract R&D and consulting services to other companies form the decontamination and infection control global market.
Aseptium will generate revenue from the following:
1) Selling machines through a network of distributors in Europe and other counties that accept European CE regulations.
2) Licensing IP and generating royalties for machines sold in North America and China.
3) Selling accessories and consumables globally through distributors.
4) Selling online support and training packages.
5) Selling educational programmes.
Use of proceeds
We intend to use this initial seed round to achieve the following milestones:
1) Set up a new R&D and manufacturing base:
Currently Aseptium is based in a shared R&D lab in Essex where we have outgrown the available space. We now require a new location tailored to development of decontamination and infection control technologies. We need space that can accommodate the growing team as well as provide assembly and manufacturing area.
2) Certify Aseptium as an ISO 13485 manufacturer of medical devices:
This is a necessary step that will allow us to get our equipment CE marked, which is a requirement to put it on the market in the EU and most of other countries.
3) Finalise development of the uSonic washer with accessories and consumables:
We are currently optimising our designs for production in the UK and in China.
Please note, Aseptium has an outstanding unsecured loan of £12,000. The funds raised in this campaign will not be used to service this loan.
Our products and services are developed specifically for hospitals and dental clinics that use complex surgical instruments. From our experience 10%-25% of all instruments used in healthcare today are considered complex and this number is continually growing.
Modern complex instruments make procedures quicker, less invasive and less painful for the patient and also significantly reduce the recovery time. Unfortunately, if instruments are not decontaminated properly they are not safe to use and all that effort and investment goes to waste. This problem is especially serious with the rapidly increasing antibiotic resistance that is expected to cost 10 million lives annually by 2050 (WHO 2015). In addition, the consequences of hospital acquired infections are becoming more severe with the prevalence of blood-borne infections and prion related diseases.
We will focus on specialist hospitals and dental clinics that routinely use highly complex surgical instruments –like intra-abdominal procedures, ophthalmic and neurosurgeries as well as oral surgical procedures like implants and gum transplants.
In our experience each hospital and dental clinic using complex instruments will require at least one complex instrument washer (hospitals typically require two or more). We will first target countries with wealthier healthcare services like Scandinavian and western European countries. In China we will target those hospitals that are on the forefront of medical technologies.
Characteristics of target market
The market for minimally invasive surgery is growing at a rate of 10.5% per year. In regions we are targeting (Europe, North America and China) there are estimated over 50k hospitals and approximately 500k dental clinics using complex surgical instruments.
Machines of the type of uSonic cost between £7,500-£15000+ per machine depending on instrument complexity and accessories needed. In North America, the prices can be higher, but the machines are typically larger and require different certification.
We estimate the annual cost of consumables to be between 20% and 50%+ of the purchase price of the equipment. Consumables are a significant market in its own right. Additionally, hospitals must maintain and validate the equipment periodically. On top of that there are separate budgets for staff training and facilities support.
Prices of equipment will vary due to differences in legislation in different regions, local standards and type of operations particular hospitals perform.
Aseptium will deliver its products and services to the end user through a network of distributors and manufacturers in various countries.
In China, we intend to work with large existing companies with established sales and distribution channels such as Laoken, who has over 500 sales and support personnel across all provinces.
Collaboration with manufacturing partners will be based on market demand and type of equipment. We anticipate that Chinese partners will manufacture more standardised equipment in higher volumes while UK manufacturing unit will focus on more specialised, tailored equipment.
In Europe and North America we will aim to work with distributors having experience and infrastructure to support complex instrument decontamination equipment. The offering will be diversified depending on local standards, type of equipment and specific market needs. For North American markets we intend to license some of our technologies to local manufacturers because of significant differences in market needs and certification.
Since we exhibited uSonic at two major trade shows (Medica in Dusseldorf, Germany and CMEF in Shanghai, China), we have had many enquiries from potential agents and distributors as well as end-users from various countries around the world. We are currently negotiating agreements with several of these companies in addition to a wide collaboration agreement with Laoken. We expect these to be concluded by the end of Q3 2016.
In 2017 we are planning to launch Aseptium China to further explore the market and gain better control over distribution channels of our consumables and accessories as well as sourcing of raw materials and components.
In addition, our founder Pawel de Sternberg Stojalowski is a regular contributor to journals in the decontamination market and a frequent speaker at industry conferences and events building the brand globally.
Aseptium by design is focused on new product development, innovation and high level of expertise. We are positioning Aseptium as a technological leader in the field with a strong R&D focus. We develop technologies that reach beyond decontamination sciences to provide superior equipment and deliver higher quality service. We believe this differentiates us from other companies who mostly specialise in manufacturing and fabrication.
Majority of serious competitors, such as Medisafe, Miele and Steelco are using conventional cleaning technology based on recirculation - similar to dishwashers. Also, most of them are based in Europe and in our experience do not have a significant presence in China.
We do not compete nor intend to compete with established manufacturers of simple instrument cleaning equipment that are incompatible with complex instrumentation. There are a number of companies competing in that end of the market while we intend to target high end, advanced solutions for complex instruments.
We believe that one of the biggest problems in the industry are the aftersales service and maintenance of equipment. These are costly and difficult to maintain at a high level with relatively low volume of international sales. To address this problem Aseptium developed a unique control system for our washers that allows monitoring and troubleshooting problems remotely as well as predicting common faults. It will significantly reduce the cost of service, maintenance and equipment downtime, giving us a competitive advantage. Other companies in the field mostly use industrial control systems that do not provide such features.
Our strategy of licensing and collaborating with existing companies in Asia and North America will allow us to use their resources and local knowledge as well as sales channels and technical support. This way Aseptium will focus on our own sales activities in the UK and EU and will be able to deliver better value to its direct customers.