About Cipher Surgical
The OpClear is an innovative new technology with a clear perceived need in laparoscopy – minimally invasive abdominal surgery including General & Colorectal Surgery, Urology and Gynaecology.
The Problem – how to clean laparoscope optics during surgery
During laparoscopy, the lens of the scope is covered in fluids, blood, tissue, fat and condensation all of which can impair the surgeon’s view as projected on the external screen. In order to clean the lens, the scope must be removed from the patients’ abdomen. Critically, the surgeon’s work flow and concentration is broken, their control over the situation momentarily impaired and there is a recognised risk to patient safety since the surgeon can no longer see the operating field. Often, this can occur at a critical moment in the surgery, for example, when there is a bleed. A 2013 study at Kings College Hospital indicated that on average removal for cleaning occurs 13 times per procedure and despite repetitive cleaning, 37% of total operative time is spent with suboptimal vision. Previous attempts to solve this problem have been only partially successful at best.
The Company is confident that the OpClear is the only device on the market or in development that clears the laparoscope of all contaminants without its removal from the patient during an operation.
The Solution – the OpClear
The OpClear is a patented device comprising a single use disposable sheath that clips onto a laparoscope. On press of a footswitch, a mix of medical carbon dioxide gas (CO2) and saline fluid is supplied from a Control Unit at a flow rate and shape to clear the lens.
 Cleaning the windshield: An observational study of laparoscope distal lens cleaning, D Eldred-Evans, N Yong, J Sakathevan, E Pearce, P Grange, Kings College Hospital, Kings Learning Institute, July 2013
Despite an annual spend estimated at $44bn in an industry that relies upon visual acuity, the directors believe that there is no current solution to the contamination problem other than removal of the scope for cleaning.
What sets Cipher Surgical apart?
The key strengths of Cipher Surgical may be summarised as follows:
Design and functionality of the OpClear
The Company’s key claim is that the OpClear is the only device that will clear a laparoscope of all contaminants without its removal from a patient during a procedure. In this respect, it has a clear first mover advantage.
Potential for Scale
The OpClear is a single use device in a very large and growing market (13m+ laparoscopic procedures pa growing at over 4%) – which is both genuinely global (laparoscopic practice is similar worldwide) and also, even for a small Company, accessible through a network of specialist sales distributors.
Experienced comprehensive management & clinical expertise
Andrew Newell (Managing Director), Tony King (Sales & Marketing Director) and Justin Buch (Operations Director) have a significant track record in all aspects of medical device development, sales, manufacture, regulation and finance.
Protection of Competitive Position
The Company has a strong portfolio of four patents and design rights with global coverage to protect its position against new entrants.
Unusually Strong Business Case
Management believes that the OpClear enjoys an unusually strong business case for hospitals based on reducing risk, saving money and improving patient outcomes whilst at the same time providing a device that surgeons could value highly.
Costs to market represent a barrier to entry
The average cost of bringing a low-to-medium cost medical device to market is currently estimated at $31m by the US Medical Manufacturers Association (Nature Biotechnology September 2015) , whilst only *£5.4m has been spent on the OpClear to this stage.
Favourable Outlook for Future Funding
Compared to biopharmaceutical companies or more complex medical devices, the Company has a relatively low requirement for further funds needed to achieve desired sales scale. Additionally, the Company has a large shareholder base which should help to support further funding if required.
Flexible Supply Chain
The OpClear manufacture is outsourced in the UK; comprises just three key suppliers (for the disposable sheath, the control unit and logistics) and is scalable to sales volume. The availability of alternative suppliers provides leverage to reduce costs over time, to improve margins and, therefore, price competitiveness.
Whilst new product development is integral to the medical device industry, the directors understand that in direct response to clinical need and to investor pressure, large medical companies have for some time been reducing their direct spend on R&D programmes to focus on sales and marketing. This means that to fill product pipelines they acquire rather than develop new products.