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PexyEazy® - an innovative surgical device for treatment of haemorrhoids.

Periodic Reporting for period 1 - PexyEazy (PexyEazy® - an innovative surgical device for treatment of haemorrhoids.)

Reporting period: 2019-09-01 to 2019-12-31

Haemorrhoids are recognized as one of the most common medical conditions in general population, effecting up to 33% of the population under the age of 50 and up to 50% of the global population aged over 50. Haemorrhoid cushions are naturally occurring vascular structures present in the anal canal that contribute to air and liquid control and prevention of incontinence. However, in haemorrhoids disease, these structures become swollen, most commonly when the mucosa falls down from its normal position. This causes pain, soiling, itching, soreness and bleeding, reducing the patients quality of life. Currently available surgical treatments are associated with postoperative pain, high frequency of relapse, stenosis (narrowing of rectum), faecal or air incontinence and long recovery time (up to 1 month). In severe cases, surgery is the only option. Modern surgical treatments focus on preserving and restoring the haemorrhoids, however they are expensive and not affordable for all the affected population.
Developeration AB is a Swedish medical device company founded in 2016 by CEO Dr. Johan Ungerstedt. The company aims to provide innovative solutions for medical and surgical application, in order to improve outcomes, reduce complications and lower costs. Currently, Developeration is focused on helping patients suffering with haemorrhoids through a new innovative device, PexyEazy®, for the surgical treatment of haemorrhoids. Developeration AB has developed a novel, simple-to-use medical device based on modern methods of treating haemorrhoids disease, while preserving the natural function of the haemorrhoid cushions. They key development and commercialization objectives are to manufacture PexyEazy® for clinical study, preclinical validation and clinical studies. To obtain CE mark. Developeration undertook the feasibility study to determine whether the PexyEazy® device and business model were scalable, cost-effective and profitable, and to identify any strengths and weaknesses moving forward.
During the project, Developeration defined the minimum viable development path for PexyEazy®, user requirements, product specifications, necessary steps for scale-up activities and clinical studies, evaluated the market opportunity with respect to size, customers and competitors, and finally confirmed the business model and commercialisation strategy. The Phase 1 feasibility assessment showed that the development plan for PexyEazy® is technically and commercially viable. SME EIC Accelerator funding could provide the correct amount of funding and support to allow the stated activities to be implemented successfully.
Using PexyEazy®, patients with moderate to severe haemorrhoids can undergo surgical treatment in less than 10 minutes without general anaesthesia and manual suturing. PexyEazy® makes haemorrhoid treatment surgery possible with low operative and post-operative pain, and reduces treatment cost by more than 70%! A successful development through clinical validation will advance PexyEazy® towards market approval, and ultimately positively impact the quality of life of patients.
Developeration’s highly innovative PexyEazy® will offer several medical and economic benefits to Europe and the world. More modern surgical treatments focus on preserving and restoring the haemorrhoids, but they are costly and not affordable for almost all population affected. Thus there is an unmet need for affordable, safe and effective treatments for haemorrhoids, which improve the quality of life and promote healthy well-being for all ages. Developeration aims to address this large unmet need by developing effective and safe surgical treatments, and thereby improve patient wellbeing. With PexyEazy, haemorrhoid treatment using mucopexy technique without the need for manual suturing is possible. Through PexyEazy, Developeration offers a lifechanging treatment for individuals suffering with grade II/III haemorrhoids, by providing a quick, effective and affordable solution.
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