Innovation & Business Idea
In the case of aortic valve reconstruction, the surgical result is only checked manually during the operation. The results are imprecise and therefore prone to errors. Errors are often detected only postoperatively by the swallow echo, which may lead to reoperation. This increases the ischemia time and thus the risk of escalation. The result are high mortality and morbidity rates. Klavant's IDA significantly improves the intraoperative check of the tightness of the aortic valve. Errors are reliably detected, reoperations are avoided and the risk of escalation is reduced.cted, reoperations are avoided and the risk of escalation is reduced.
Customers / Target Market
A total of around 200,000 conventional aortic valve surgeries take place worldwide p.a.. The market is over EUR 20 B, of which a roughly 15% share is from the field of aortic valve reconstructions; the market potential on top of the existing market just for the use of IDA is EUR 0.5 B.
No comparable products are known to date neither in clinical practice nor based on the patent research carried out. Standard is to use a ruler to measure certain parameters of the aortic valve (e.g. geometric, effective, cusp heights). Or it is simply the hand and eye of the surgeon when pressing the left ventricle to observe the opening behaviour of the valve or when NaCl is instilled to observe its closure. Therefore, the habit of the surgeons is certainly an important hurdle that IDA has to overcome. That is why Klavant ist cooperation with many international KOLs.
Intellectual Property Status
IDA is patented in Germany. Patent applications have been filed in all relevant markets.
Development Status & Future Steps
The proof of principle was successfully provided in summer 2020. The preclinical tests are currently being prepared in the human heart together with the University of Heidelberg and in pigs with cooperators from the University of Leipzig. The demonstrator level should be reached until mid 2021. Klavant is supported by leading international heart centers, MedTech research instituts and industry partners.
Klavant can be acquired before market entry (2024) or later. Potential exit partners are companies whose products are used in the rapidly growing cardiovascular surgery market, from conduits to imaging devices or heart-lung machines. However, several possible follow-up products have already been identified that Klavant would develop strategically from a one-product company to a portfolio company in the field of conventional cardiac surgery. Klavant is already in close contact with many potentially strategic partners in the fields of development, regulatories and sales.
MD: Dr. Rüdiger Schulze - serial entrepreneur (10+yrs) => Finance, Regulatiory, Strategy
MD: Michael Bogatzki - serial entrepreneur (15+yrs) => Product Dev. & Business Development
F.J. Carrero Gomez, M.D Heart surgery, Thorax & Visceral => Medical advisor to clinical trails & product mgt
Dennis Schuldt: PhD in electrical engineering (3D endoscopy)
Thomas Utpatl: HW/SW Full stack developer, expert in prototyping + HIS/PACS interfaces
Dr. Jan Rüterbories: Medical engineer, technical advisor
Several advisors in development, regulatroy and clincial trails
Pre-Seed (Q1-Q2/2021): up to 500k€ => Demonstrator ready
Seed: (Q3/2021): 3,0-3,5m€ => Prototype development ready for certification process
A-Round (Q4/2022): 5-6m€ => certification FDA, CE, preparation for market entry USA, GER, start of development of futher products,
B-Round (Q1/2024): 10€ => Market entry USA (2024), Other (2025ff.), certification for other markets (Japan, China), development, certification, marekt entry of further products
Searching forFunding, Collaboration