BiBBInstruments expands patent protection to Japan
BiBBInstruments’ electric-driven biopsy instrument for advanced endoscopy, EndoDrill, has been market cleared in Europe and the US. The Swedish medtech is clearly aiming to expand its horizons as it has announced receiving a Decision to Grant from the Japanese Patent Office for the EndoDrill technology. BioStock reached out to CEO Fredrik Lindblad for a comment.
BiBBInstruments (“BiBB”) is on a hot streak with the development of their endoscopic ultrasound device for cancer diagnostics, EndoDrill. Last spring, the company received FDA 510(k) clearance for its gastro-intestinal product variant, EndoDrill GI, opening the doors to the world’s largest market for endoscopy.
Successful clinical cases with EndoDrill in the US
Recently, BiBB’s founder Dr Charles Walther and BiBB’s CEO Fredrik Lindblad travelled to UC Davis Health in Sacramento, California, where the first clinical cases with EndoDrill GI in the US were being conducted. After the procedures, Dr Antonio Mendoza Ladd, who is Medical Director of Endoscopy at the hospital, was so pleased with EndoDrill’s performance that he called the device “a game changer.”
Dr Walther came by the BioStock Studio to talk more about the US experience. Watch the interview here.
Since then, the hospital in California has published an article summarising the results from the first three patient cases and describing the advantages of EndoDrill GI compared to today’s standard of care, i.e. manually stabbing needle instruments. The key takeaway being that EndoDrill enables more accurate cancer diagnoses leading to improved treatment for patients, which can contribute to better patient outcomes. In the article, Dr Mendoza Ladd said:
“We are excited to offer our patients this novel endoscopic biopsy procedure that will allow us to reach more accurate diagnoses and, therefore, offer better treatment that could result in improved outcomes.”
Market approval in Europe
In the midst of all this, BiBB also received CE-certification according to MDR for market approval in Europe. This covers all three product variants (EndoDrill GI for detecting cancers of the gastrointestinal tract, EndoDrill EBUS for lung cancer and EndoDrill URO for muscle-invasive bladder cancer), and it gives the company the go-ahead to commercialise EndoDrill in Europe. According to Fredrik Lindblad, who commented on the decision in this BioStock interview, together with last year’s FDA market clearance EndoDrill GI in the US, said: “this is our single most important milestone yet.”
Expanding commercial horizons
BiBB is not stopping at only the US and Europe with regard to EndoDrill’s commercial prospects. The company has been looking towards other regions of the world to expand this intellectual property protection. The aim is to provide global patent protection for the market’s first electric-driven endoscopic biopsy instrument.
Last week, the company announced receiving a Decision to Grant from the Japanese Patent Office (JPO) for a patent that gives broad protection the whole EndoDrill system. According to BiBB, only a few additional formal steps will follow before a patent is finally issued. Then, the granted patent will be valid until October 2039.
Comments from the CEO
Once this patent is granted, it will support the company’s positioning ahead of future commercialisation, and it will give BiBB expanded opportunities to increase commercial value of the company and its cancer biopsy device moving forward.
BioStock contacted BiBB’s CEO Fredrik Lindblad to learn more.
Fredrik, how significant is this Decision to Grant by the JPO for BiBB?
– This announcement is of utmost strategic importance for our future sales growth as Japan is one of the largest markets and maybe the most advanced market for our prime segment, endoscopic ultrasound. Furthermore, the global market of reusable endoscopes is dominated by Japanese companies.
Does the patent cover all three EndoDrill product variants?
– Absolutely, this broad patent in Japan provides protection for all our three EndoDrill product variants.
What are the steps towards commercialisation of EndoDrill in Japan?
– Our overall global sales strategy is to partner with one of the largest distributors of endoscopic accessories. We plan to start marketing through our own local organisation later this year in Sweden and the rest of Scandinavia. After that, we want to launch EndoDrill in Europe and the US through the selected distribution partner. Registration and launch in other important regions, such as Japan, will follow.
Do you have other patent applications pending?
– Yes, we have patent pending in several important markets, such as the USA and China. We have three patent families for the EndoDrill technology, so we expect a series of patent approvals over the coming years.
Finally, both you and the company founder Charles Walther have bolstered your shareholdings in recent weeks. What message would you hope that this sends to the market?
– I hope that our owners and the market appreciate that we have achieved several value-adding milestones. We have taken important steps with a unique product in a fast-growing global market. Obtaining market clearances in the US and Europe within a year in an industry with increased regulatory requirements must be seen as a sign of strength. Through the recent first patient cases in the US, we have also received confirmation that we have developed a highly effective biopsy instrument, perhaps even a “game changer” as our first users have called the EndoDrill. In other words, we have laid a fine foundation for the coming commercialisation phase.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
