BIBB informs about the status of the CE marking process according to MDR
The cancer diagnostics company BiBBInstruments AB (“BiBB” or the “Company”), which develops and manufactures a new type of electric-driven endoscopic biopsy instrument, EndoDrill®, hereby provides a status update on the CE mark approval process of the product portfolio EndoDrill®. In summary, after discussions with BiBB’s notified body, the Company expects a CE certificate according to MDR in approximately 3–6 months. The upcoming CE certificate according to MDR means an extended indication and includes all three instruments in the product family EndoDrill®.
At the turn of the year 2021/2022, BiBB applied for CE certification according to MDR of EndoDrill® to the Company’s notified body, i.e., submission of an application for a certificate according to the new EU regulation to be able to market and sell CE-marked EndoDrill® instruments on the European market. The application includes previously CE-marked (according to former directive MDD, expired in August 2022) biopsy instruments for the upper gastrointestinal tract (EndoDrill® GI), and for the lungs (EndoDrill® EBUS), and now also instruments for the urinary tract (EndoDrill® URO).
After a lengthy review process, one issue remains to be addressed to obtain approval. The remark concerns a process in the final stages of manufacturing managed by an external partner. Following discussions between BIBB and the notified body, there is now an agreed plan to close the remaining nonconformity and thereby obtain approval for the EndoDrill® product family. The Company estimates that it will take about 3–6 months until a new CE approval according to MDR can be in place.
CE marking according to MDR will mean that planned clinical activities in Sweden will begin immediately. On March 30, 2023, BiBB announced that it had received market clearance for its most important product variant EndoDrill® GI on the US market. With the obtained FDA 510(k) clearance, BiBB plans to also begin clinical market activities in the US.
About EndoDrill®
EndoDrill® gives endoscopists increased opportunities to take high-quality coherent core biopsies in suspected tumors. An intact tissue sample contains more information, which can be crucial for accurate and complete diagnosis as well as the earliest possible start of treatment. The completed clinical pilot study with EndoDrill® GI (EDMX01) showed one hundred percent diagnostic accuracy when analyzing the samples.
EndoDrill® utilizes a patent-pending electric-driven rotating needle cylinder that provides high-precision tissue samples of higher diagnostic quality than existing manually handled EUS biopsy instruments.
About the EU Regulation MDR
The Medical Device Regulation (MDR) is an EU regulation (2017/745) that ensures the safety and performance of medical devices. The aim is to improve patient safety through stricter methods of assessment and monitoring on the market. The regulation updates the rules on which medical devices may be on the market, as well as how to provide and use these such products. It also contains rules for how medical device companies conduct product evaluations within the EU. This ensures that unsafe and non-compliant equipment does not end up on the market.
This is a translation of the Swedish press release. If there should be any discrepancies, the Swedish language version prevails.
For more information about BiBB, please contact:
Fredrik Lindblad, CEO
E-mail: fredrik.lindblad@bibbinstruments.com
Phone: +46 70 899 94 86
www.bibbinstruments.com
About BiBBInstruments AB
BiBBInstruments AB is a medical device company that develops and markets diagnostic instruments under the brand name EndoDrill® for early detection of cancerous tumors. EndoDrill® is the world’s first CE-marked and FDA 510(k) cleared electric-driven endoscopic biopsy instrument. The product is designed to provide larger and more high-quality tissue samples (core biopsies) of suspected tumors than existing products. The product family will include biopsy instruments for many of the most serious cancers, such as stomach, pancreas, liver, lung and bladder cancer. EndoDrill® targets the global market for endoscopic biopsy instruments with a focus on the ultrasound-guided biopsy instruments (EUS-FNA/FNB, EBUS-TBNA) segment, which is the fastest growing area in endoscopy. The company was founded in 2013 by Dr Charles Walther, cancer researcher at Lund University and chief physician in clinical pathology at Skåne University Hospital in Lund.
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BIBB receives market clearance for EndoDrill GI in the US
The cancer diagnostics company BiBBInstruments AB (“BiBB” or the “Company”), which develops and manufactures a new type of electric-driven endoscopic biopsy instrument, EndoDrill®, announces that the Company has now received a 510(k) market clearance from the US Food and Drug Administration (FDA) for EndoDrill® GI. The clearance means that BiBB can now market and sell EndoDrill® GI in the US, which is by far the largest market in the world for tissue sampling with endoscopic ultrasound (EUS). EndoDrill® GI is BiBB’s most important product variant, with the widest indication range, that improves tissue sampling and the possibilities for faster diagnosis of a variety of tumors in the upper gastrointestinal tract, such as stomach, esophagus, pancreas, lymph nodes and liver. Initially, the 510(k) clearance will be used to begin market studies in the United States.
“With the 510(k) clearance, the world’s largest market is opened up to our most important instrument in the product portfolio. This is of course very good news for BiBB, but more importantly, American patients and doctors get access to a groundbreaking biopsy instrument that can improve the prospects for many patients through earlier diagnosis and treatment start. This milestone is the result of an extensive and purposeful regulatory work that has engaged the BiBB team for over a year. This means that EndoDrill® will now be the first electric-driven EUS biopsy instrument to be cleared in the US. The next step will be to conduct clinical market studies in the US and in parallel discussions are ongoing with potential global distribution partners. Together with previously achieved milestones, we have created a fantastic starting point for future commercialization in the US”, says Fredrik Lindblad, CEO of BiBB.
The FDA 510(k) clearance means that BiBB can now plan and initiate clinical activities in the US. The journey to bring EndoDrill® to users and patients thus takes a big step forward.
About EndoDrill®
EndoDrill® gives endoscopists increased opportunities to take high-quality coherent core biopsies in suspected tumors. An intact tissue sample contains more information, which can be crucial for accurate and complete diagnosis as well as the earliest possible start of treatment. The completed clinical pilot study with EndoDrill® GI (EDMX01) showed one hundred percent diagnostic accuracy in the analysis of the samples.
EndoDrill® utilizes a patent-pending electric-driven rotating needle cylinder that provides high-precision tissue samples of higher diagnostic quality than existing manually handled biopsy instruments. In addition to the mentioned indications in the upper gastrointestinal tract for EndoDrill® GI, the EndoDrill® product family also includes biopsy instruments for lung cancer (EndoDrill® EBUS) and muscle invasive bladder cancer (EndoDrill® URO).
This is a translation of the Swedish press release. If there should be any discrepancies, the Swedish language version prevails.
For more information about BiBB, please contact:
Fredrik Lindblad, CEO
E-mail: fredrik.lindblad@bibbinstruments.com
Phone: +46 70 899 94 86
www.bibbinstruments.com
This disclosure contains information that BiBBInstruments AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on March 30, 2023.
About BiBBInstruments AB
BiBBInstruments AB is a medical device company that develops and markets diagnostic instruments under the brand name EndoDrill® for early detection of cancerous tumors. EndoDrill® is the world’s first CE-marked and FDA 510(k) cleared electric-driven endoscopic biopsy instrument. The product is designed to provide larger and more high-quality tissue samples (core biopsies) of suspected tumors than existing products. The product family will include biopsy instruments for many of the most serious cancers, such as stomach, pancreas, liver, lung and bladder cancer. EndoDrill® targets the global market for endoscopic biopsy instruments with a focus on the ultrasound-guided biopsy instruments (EUS-FNA/FNB, EBUS-TBNA) segment, which is the fastest growing area in endoscopy. The company was founded in 2013 by Dr Charles Walther, cancer researcher at Lund University and chief physician in clinical pathology at Skåne University Hospital in Lund.
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BiBB receives another Intention to Grant notice for EndoDrill in Europe
Today, the cancer diagnostics company BiBBInstruments AB (“BiBB” or the “Company”) announces that the Company has received an additional Intention to Grant from the European Patent Office (“EPO”). The announcement means that the EPO intends to approve the Company’s first patent family in Europe for EndoDrill®, the world’s first CE-marked electric-driven endoscopic biopsy instrument. This is the second Intention to Grant notice from the EPO in Q1 2023 relating to the EndoDrill® patent portfolio and includes important characteristics of the method. A few formal steps will follow before a final notice of approval can be issued, after which the granted patent will be valid until October 2038.
BIBB has received an Intention to Grant from the EPO to approve the EPC application 18199230.6 in Europe regarding the first patent family (“Patent family No. 1”) for the electric-driven EndoDrill® system. In January 2023, it was communicated that the Company’s first patent application in Europe had received an Intention to Grant, and now a second Intention to Grant has been received, meaning that also the first patent family is intended to be approved in Europe. Patent family No. 1 complements the initial European patent and provides additional protection for the motorized biopsy system. In addition, two other patent families have entered the national phase, where BiBB expects injunctions and announcements during 2023–2024.
“We continue to build a robust foundation for the upcoming commercialization of EndoDrill®. We have developed the market’s first electric-driven EUS biopsy system with very promising performance according to the doctors who have evaluated the product so far. During Q1 2023, we have received Intention to Grant notice for two patent applications in Europe, which will give us a strong position as we commercialize our unique biopsy system in Europe”, says Fredrik Lindblad, CEO of BiBB.
The EndoDrill® system is currently in clinical phase and the product family will be offered to hospitals working with advanced endoscopy, so-called endoscopic ultrasound (EUS), to improve diagnostics in some of the most serious cancers, such as stomach, pancreas, liver, lung and bladder cancer.
This is a translation of the Swedish press release. If there should be any discrepancies, the Swedish language version prevails.
For more information about BiBB, please contact:
Fredrik Lindblad, CEO
E-mail: fredrik.lindblad@bibbinstruments.com
Phone: +46 70 899 94 86
www.bibbinstruments.com
This disclosure contains information that BiBBInstruments AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on March 7, 2023.
About BiBBInstruments AB
BiBBInstruments AB is a medical technology company that develops and markets diagnostic instruments under the brand name EndoDrill® for early detection of cancerous tumors. EndoDrill® is the world’s first CE-marked electric-driven endoscopic biopsy instrument. The product is designed to provide larger and more high-quality tissue samples (core biopsies) of suspected tumors than existing products. The product family will include sampling instruments for many of the most serious cancers, such as stomach, pancreas, liver, lung and bladder cancer. EndoDrill® targets the global market for endoscopic biopsy instruments with a focus on the ultrasound-guided biopsy instruments (EUS-FNA/FNB, EBUS-TBNA) segment, which is the fastest growing area in endoscopy. The company was founded in 2013 by Dr Charles Walther, cancer researcher at Lund University and chief physician in clinical pathology at Skåne University Hospital in Lund.
Download press release (PDF)
BiBB receives an Intention to Grant for electric-driven EndoDrill in Europe
The cancer diagnostics company BiBBInstruments AB (“BiBB or the “Company”) announces that the Company has received an Intention to Grant from the European Patent Office (EPO). This means that EPO intends to approve the Company’s first patent application in Europe for EndoDrill®, the world’s first CE-marked electric-driven endoscopic biopsy instrument. A few additional formal steps will follow before a final notice of approval can be issued, after which the granted patent will be valid until October 2039.
BIBB has received an Intention to Grant from the EPO for its patent application EP 19780264.8, which provides a broad protection of the EndoDrill® system, the Company’s latest electric-driven biopsy instrument for advanced endoscopy. In addition to this application, BiBB has three pending international patent applications for EndoDrill®, which have entered the national/regional phase. These applications will be pursued with the intention of providing global IP-protection for the market’s first electric-driven endoscopic biopsy instrument. The Company intends to file additional patent applications with new features and advantages discovered during the continuous development and clinical evaluation of the EndoDrill® system. The EndoDrill® system is currently in clinical phase and the product family will be offered to hospitals working with advanced endoscopy, so-called endoscopic ultrasound (EUS), to improve diagnostics in some of the most serious cancers, such as stomach, pancreas, liver, lung and bladder cancer.
“This advance notice is very positive and important for us as a company and for patients and care providers in Europe! Patent approval in Europe gives us a valuable edge in the commercialization of our EndoDrill® product portfolio. EUS examination is the fastest growing segment within endoscopy, and we see a great interest among physicians for new biopsy instruments that can offer improved sampling of tumors”, says Fredrik Lindblad, CEO of BiBB.
This is a translation of the Swedish press release. If there should be any discrepancies, the Swedish language version prevails.
For more information about BiBB, please contact:
Fredrik Lindblad, CEO
E-mail: fredrik.lindblad@bibbinstruments.com
Phone: +46 70 899 94 86
www.bibbinstruments.com
This disclosure contains information that BiBBInstruments AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on January 5, 2023.
About BiBBInstruments AB
BiBBInstruments AB is a medical technology company that develops and markets diagnostic instruments under the brand name EndoDrill® for early detection of cancerous tumors. EndoDrill® is the world’s first CE-marked electric-driven endoscopic biopsy instrument. The product is designed to provide larger and more high-quality tissue samples (core biopsies) of suspected tumors than existing products. The product family will include sampling instruments for many of the most serious cancers, such as stomach, pancreas, liver, lung and bladder cancer. EndoDrill® targets the global market for endoscopic biopsy instruments with a focus on the ultrasound-guided biopsy instruments (EUS-FNA/FNB, EBUS-TBNA) segment, which is the fastest growing area in endoscopy. The company was founded in 2013 by Dr Charles Walther, cancer researcher at Lund University and chief physician in clinical pathology at Skåne University Hospital in Lund.
Download press release (PDF)
