Developeration


About the company

We have developed PexyEazy®, a minimally invasive surgical device for treating hemorrhoids – one of the world’s most common conditions. The procedure takes less than 15 minutes, requires no anesthesia, and can be performed as an office treatment, cutting costs dramatically while allowing clinics to double their patient throughput and reimbursement.

Clinical studies show outcomes comparable to the gold standard, but with only one day of sick leave instead of 3–4 weeks. Thanks to its purely mechanical, intuitive design, the device is easy to adopt, requires no special equipment, and works even in settings without electricity – making it scalable worldwide.

With a market projected to exceed $1,3 billion annually by 2030, we see PexyEazy® capturing 25–35% market share by offering a solution that is better for patients, clinicians, and healthcare systems alike.

We are now initiating a $10M Series A financing round in Q3–Q4 2025 to finance our planned market introduction in 2026 in the US and EU. 

 

Quick links: 

 

Website

Pitch deck

 

Contact: 

Johan Ungerstedt

CEO, Founder, MD, PhD, Consultant Surgeon.

Mail: johan.ungerstedt@developeration.se 

Phone: +46-709 427842

LinkedIn 

 

Capital need and valuation: 

Capital need: Series A Q3-Q4 2025: €10.000.000

 

Use of Funds

Continue strong product development while simultaneously building up Finalize CE-mark and FDA application (CE-mark application was sent in 2025-10-02 and FDA 510 (k) will be sent in within 2-4 weeks), market introduction in USA and EU in 2026 (office already established in Boston), comparative multi-center clinical investigation, establish local production in USA.

 

Financial forecast

  • Estimated turnover:
  • 2026: €640.000
  • 2027: €5.600.000
  • Business model: Business to business (device sold to clinics/hospitals)

 

Previous investments

  • €3,3M (€2,7M equity, €0,6M non-dilutive), Business angels.
  • €3,3M (€2M equity, €0,7M convertible loan, €0,6M non-dilutive).
  • Investor: Business angels, private investors (convertible loan)
  • Shareholder: Founders: 61,8%, STOAF (Stockholm business angels)
  • 14,8%, ALMI 14%, Rentability (chairman of the board) 4,1%, GAEU Venture 3,1%, Adiuvero 2,1%.

 

Vision and impact

  • Our vision is to make PexyEazy the new gold standard of treatment of hemorrhoid, which is substantiated by that PexyEazy  is faster, minimal invasive, increased patient throughput, doubled reimbursement and profit, less post operative pain, faster recovery and similar long-term results as today’s gold standard.
  • Moreover, our population is getting older, and the use of anti coagulative treatment is increasing.
  • PexyEazy enables treatment without general anesthesia and thereby patients that normally would have been rejected for surgery due to underlying diseases not suitable for general anesthesia.
  • Furthermore, can PexyEazy procedure be done at simple medical facilities, which enables advanced hemorrhoid surgery at remote areas in developing countries, making the market scalable worldwide.
  • We therefore fulfil the UN’s Sustainable Development Goals: 3 (Good Health and Well-beeing), 9 (Sustainable Industrialization), 13 (Climate Action – PexyEazy lowers CO2 emission by 185kg/procedure)). 

 

Risk Management

  • Adoption of new surgical method: Low – surgeons are already using the method that PexyEazy is based on: Mucopexy. PexyEazy enables a mucopexy in a faster, easier and better way and the device enables a steep learning curve.
  • US tariffs: With a 700% margin from COGS and a planned budget for local production in US, the tariff of 15% will not cause problems for the planned market introduction in USA.
  • It takes a long time to find first user: We had a meeting with the Co-Director Carmen Fong at the Hemorrhoid Center of America in the 1st of October and they are very interested in starting to use PexyEazy within their 17 clinics that are spread out around USA. So we have basically already fulfilled our first year goal of establishing 10 clinics in 2026. Carmen has also agreed to become our Key Opinion Leader (KOL).
  • Regulatory hurdles: CE-mark application was sent in to our notified body Intertek on the 2nd of October. It is estimated to take 1 year or less to get an approval. Our presub meeting with FDA showed that we can use the THD proctoscope as predicate device for a 510 (k) application. We estimate to get clearance in Q1 2026 (6 months).
  • Product is lost among others when promoted by distributors: We plan to establish our own sale force to have control of who start using PexyEazy to establish centers of excellences that also will work as education hubs for new clinics that wants to learn the technique. Once the PexyEazy is established we will use distributors and collaboration with strategic partners to reach larger markets.
  • .You need an established company in USA to get FDA approval: We will start an incorporated company in USA before the end of the year. We can use the shared office in Boston as the registered contact that is needed for the FDA application
  • Reimbursement does not cover the use of the device: We will be able to use the CPT code 46946 for the PexyEazy procedure. The reimbursement from Medicare will give a doubled reimbursement compared to other sdvanced methods due to the reduced cost when an operation room is not necessary. For the insurance covered patients, the Hemorrhoid Center of America will help us with to elucidate exact cost and reimbursement for the PexyEazy procedure.