Announcement • Apr 23
BiBBInstruments AB to Report Q1, 2026 Results on May 22, 2026 BiBBInstruments AB announced that they will report Q1, 2026 results on May 22, 2026 Announcement • Feb 10
BiBBInstruments AB has filed a Follow-on Equity Offering in the amount of SEK 60 million. BiBBInstruments AB has filed a Follow-on Equity Offering in the amount of SEK 60 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Transaction Features: Rights Offering Announcement • Jan 13
BiBBInstruments AB to Report Fiscal Year 2025 Results on Feb 10, 2026 BiBBInstruments AB announced that they will report fiscal year 2025 results on Feb 10, 2026 Announcement • Dec 05
Bibb Strengthens Its Presence in the American Market BiBBInstruments AB has recently completed a successful tour across the United States - an important step in the initial commercialization of EndoDrill®? GI in the world's largest market for ultrasound-guided endoscopic tissue sampling (EUS/EBUS). During the trip, BiBB met with representatives from six leading hospitals and supported TaeWoong Medical USA ("TaeWoong") in education and clinical introductions of Endo Drill®? GI. The Company also received further confirmation of the clear clinical need for high-quality core biopsies, while both ongoing studies and a planned randomized multicenter study were discussed. The targeted launch has now begun, and TaeWoong has already sold EndoDrill®?GI to four university hospitals ahead of a broader rollout in 2026. This applies both to current clinical practice, where adequate diagnostic material is critical for treatment decisions, and looking ahead, where biopsies increasingly need to enable tumor genetic analysis to support individualized therapy. This is an area where EndoDrill®? is clearly at the forefront, illustrated by the ongoing project at Mayo Clinic in Jacksonville, FL, which aims to determine whether core biopsies such as those obtained with EndoDrill®? can become key enablers within the rapidly growing field of precision oncology. Clinical Studies as Value Drivers: During the trip, BiBB discussed both its ongoing clinical collaborations and the planning of a forthcoming randomized multicenter study of EndoDrill®®? GI in the U.S. and Europe. This study, coordinated by BiBB's new advisor, Professor Peter Vilmann, is planned to begin in 2026 to further strengthen the clinical evidence for EndoDrill®? ahead of broader adoption and represents a central part of the Company's long-term market strategy. Beyond the GI area, discussions also included the upcoming product variants EndoDrill®? EBUS and EndoDrill®? URO. These will enable future expansion into the diagnosis of lung cancer and bladder cancer, two large and globally growing markets with significant commercial potential. Launch Gaining Clear Momentum: The targeted U.S. launch of EndoDrill®™? GI is now underway, with TaeWoong focusing on establishing regular use at five major reference hospitals. These centers will form the foundation for a broader nationwide rollout in 2026. TaeWoong has already sell EndoDrill®? instruments to four U.S. university hospitals, and additional installations are expected according to the joint launch plan. BiBB continues to support TaeWoong with training, clinical support, and evidence-building activities to ensure a successful commercial introduction of EndoDrill® the,. Announcement • Oct 09
BiBBInstruments AB to Report Q3, 2025 Results on Nov 07, 2025 BiBBInstruments AB announced that they will report Q3, 2025 results on Nov 07, 2025 Announcement • Sep 04
Bibbinstruments AB Appoints Peter Vilmann as Scientific Advisor BiBBInstruments AB announced that Professor Peter Vilmann, a world-renowned pioneer who performed the first endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) in 1991, will serve as Scientific Advisor. He brings extensive expertise in endoscopic ultrasound-guided biopsy and therapy and will provide scientific support to the Company while contributing to its clinical roadmap. Professor Peter Vilmann is a world-renowned pioneer in endoscopic ultrasound (EUS). In 1991, he performed the first EUS-guided fine needle aspiration biopsy (FNA) and co-invented the first dedicated EUS biopsy needle. His work has been central to establishing EUS-guided biopsy, as well as EBUS-TBNA, as recognized global gold standards in cancer diagnostics.With more than three decades at the forefront of innovation, Professor Vilmann has authored numerous scientific contributions, trained generations of endoscopists, and delivered over 400 international lectures. His current research continues to focus on advancing diagnostic and therapeutic EUS procedures, with a strong focus on pancreatic lesions. Announcement • Aug 13
Bibbinstruments AB Announces That Henry Ford St. John Hospital Reports First U.S. Liver Biopsy Cases with Endodrill Gi BiBBInstruments AB announced that Henry Ford St. John Hospital & Medical Center in Detroit has reported the first U.S. case series with EndoDrill®? GI that includes endoscopic ultrasound-guided (EUS) liver biopsies. The evaluation, led by Dr. Mohammed Barawi and conducted with his team at Henry Ford St. John Hospital, was presented at a regional medical conference and demonstrated the device's ability to obtain diagnostic tissue from both the liver and pancreas. The series comprises four patients, three with suspected liver conditions and one with a suspected pancreatic tumor, who underwent EUS-guided biopsy. In all cases, the motorized 17G instrument yielded diagnostic tissue samples, including one case where prior percutaneous tissue sampling had been non-diagnostic. Diagnoses included autoimmune hepatitis, cirrhosis, and pancreatic adenocarcinoma. Dr. Barawi's team highlighted both the diagnostic performance and procedural safety of EndoDrill®?GI in their abstract. The authors concluded: The use of the EndoDrill device demonstrated strong diagnostic utility across an array of clinical presentations. Due to the clinical necessity for adequate tissue samples to establish molecular pathology, EndoDrill yielded safe and effective results in this limited sample size. Announcement • Jul 24
BiBBInstruments AB to Report Q2, 2025 Results on Aug 22, 2025 BiBBInstruments AB announced that they will report Q2, 2025 results on Aug 22, 2025 Announcement • Jun 24
BiBBInstruments AB Receives Decision to Grant from the Japan Patent Office BiBBInstruments AB announced that the Company has received a Decision to Grant from the Japan Patent Office (JPO). This means that the JPO has decided to approve BiBB's third patent application in Japan for EndoDrill. A few formal steps remain before the patent is finally granted, after which it will be valid until 2041. Once the process is finalized, this will become the third granted patent in Japan for the EndoDrill technology. has received a decision from the JPO to grant patent JP 2022-560348, part of the Company's third patent family. The patent provides the EndoDrill product series with protection for the instrument and its drive system in the Japanese market. The Company has three international patent applications for EndoDrill that have entered national/regional phases, with patents granted to date in the USA (Notice of Allowance), Europe, Japan, India, and China. Remaining applications are being pursued toward approval to secure global protection for the market's first motorized endoscopic biopsy instrument. Announcement • Mar 31
BiBBInstruments AB to Report Q1, 2025 Results on Apr 29, 2025 BiBBInstruments AB announced that they will report Q1, 2025 results on Apr 29, 2025 Announcement • Feb 22
BiBBInstruments AB Initiates Clinical Evaluation Of EndoDrill GI In The USA BiBBInstruments AB announced that Dr. Mohammed Barawi, Medical Director of the Endoscopy Unit at Henry Ford St. John Hospital & Medical Center, has initiated a clinical evaluation of EndoDrill GI. With support from BiBB's team, Dr. Barawi performed tissue sampling in the liver and pancreas on three patients. Liver biopsy is a rapidly growing indication within endoscopic ultrasound (EUS), while pancreatic biopsy is currently the largest indication. In all patient cases, high-quality core biopsies were obtained, and Dr. Barawi will continue evaluating EndoDrill GI. Henry Ford St. John Hospital in Detroit is the second hospital in the USA, after UC Davis Health in Sacramento, to initiate a clinical evaluation of the powered biopsy instrument EndoDrill G. After a brief introduction to EndoDrill gastrointestinal by BiBB's on-site representative, Dr. Barawi was able to perform biopsies on three patients, one in the pancreas and two in the liver. The samplings resulted in true core tissue biopsies, i.e., intact tissue samples with preserved architecture. These samples will now be evaluated to determine diagnostic outcomes. EndoDrill GE is the world's first market-cleared powered biopsy instrument for endoscopic ultrasound (EUS). The instrument is used for EUS-guided tissue sampling for various indications in the gastrointestinal tract, e.g. pancreas, stomach, esophagus, lymph nodes, and liver. EndoDrill GI received FDA 510(k) clearance in the USA in 2023 and CE approval in Europe in early 2024. The product is currently undergoing clinical evaluation in both the USA and Europe. The commercialization phase began in early 2025 when a first order was received from UC Davis Health in the United States. Announcement • Jan 30
BiBBInstruments AB to Report Fiscal Year 2024 Results on Feb 28, 2025 BiBBInstruments AB announced that they will report fiscal year 2024 results on Feb 28, 2025 Announcement • Jan 23
BiBBInstruments AB has completed a Composite Units Offering in the amount of SEK 27.6 million. BiBBInstruments AB has completed a Composite Units Offering in the amount of SEK 27.6 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Transaction Features: Rights Offering Announcement • Nov 15
BiBBInstruments AB Announces Clinical Introduction of EndoDrill® GI at Sahlgrenska University Hospital in Sweden BiBBInstruments AB announced that the first clinical tissue sampling procedures with EndoDrill®? GI at Sahlgrenska University Hospital in Gothenburg have been successfully completed. Expanded market studies at several hospitals in Europe and the USA are an important part of the Company's strategy and represent the first step in the launch of EndoDrill® GI. BiBB's founder, Dr. Charles Walther, has this week introduced EndoDrill®? gastrointestinal at SahlgrenskaUniversity Hospital in Gothenburg, one of Northern Europe's hospitals. Gastroenterologists Dr. Per Hedenstrom and Dr.iadh Sadik are pioneers in endoscopic ultrasound in Sweden, both in terms of research studies and clinical practice. This experienced team conducted four initial patient cases with EndoDrill®®? GI sampling. Overall, high-quality tissue samples were collected, and the team will now continue the clinical evaluation independently. The introduction at Sahlgrenska University Hospital follows BiBB's strategy of carrying out expanded clinical market studies of EndoDrillGI in the USA and Europe. Just like at Sahlgrenska, new hospitals and users in the USA and Europe are continuously given the opportunity to evaluate EndoDrillGI, with the aim of gathering clinical data and increasing product awareness. These market studies represent the final step before a directed launch of EndoDrillGI to selected hospitals. Announcement • Oct 10
BiBBInstruments AB to Report Q4, 2024 Results on Nov 08, 2024 BiBBInstruments AB announced that they will report Q4, 2024 results on Nov 08, 2024 Announcement • Oct 02
BiBBInstruments AB Announces New Peer-Reviewed Clinical Case Series in the U.S. Shows 100% Diagnostic Accuracy with Endodrill Gi BiBBInstruments AB announced that the first eight patient cases using EndoDrill®? GI in the U.S. have been scientifically published in Endoscopy International Open. Biopsies were sampled in the pancreas, esophagus, stomach, and small intestine. In all cases EndoDrill®?GI obtained 100% diagnostic accuracy after only one needle pass. In four patients, both EndoDrill®? gastrointestinal and conventional needle instruments were used to sample the same lesion, in which EndoDrill®? GE showed superior tissue samples. The authors analyze that these initial patient cases indicate that sampling with EndoDrill®? G is effective and safe. In January 2024, Dr. Antonio Mendoza Ladd, medical director of endoscopy at UC Davis Health in Sacramento, California, started a clinical evaluation of the FDA-cleared EndoDrill®?GE, which is still ongoing. The results from the first eight patient cases have now been published in the article "Initial Experience With The Transmural Use Of A New Endoscopic Ultrasound Electric Core Needle Biopsy Device: A Case Series" in Endoscopy International Open1. These patient cases represent the first transmural (through the wall of the gastrointestinal tract) biopsies using an EUS-CNB instrument (EndoDrill® GI) on tumors in the pancreas (n=5), retroperitoneum (n=2), and mediastinum (n=1). In all eight patient cases, a diagnosis was achieved using tissue biopsies taken with EndoDrill® GI (100% diagnostic accuracy) after a single needle pass. In four of these cases, patients had first undergone biopsies using manual EUS-FNA/FNB needle instruments (the current "gold standard"), which provided insufficient tissue samples for diagnosis. In all these cases, tissue samples obtained with EndoDrill GI resulted in a complete diagnosis. The samples from EndoDrill® GI showed less blood contamination, fewer artifacts, and more intact tissue cores compared to what is typically seen with standard EUS-FNA/FNB instruments. The only noted adverse effect was one case of mild bleeding, which was successfully controlled. The authors' impressions after the initial cases with EndoDrill® GI are that the tissue sampling method is effective, safe, and easy to install and use. They conclude by recommending a randomized clinical study comparing EndoDrill® GI with standard EUS-FNA/FNB needle instruments to further assess the product's efficacy and safety. Announcement • Sep 02
BiBBInstruments AB Announces Successful Introduction of EndoDrill GI at University Hospital Center Sestre Milosrdnice in Zagreb, Croatia BiBBInstruments AB announced that the University Hospital Center Sestre Milosrd nice in Zagreb, Croatia, has started a clinical evaluation with EndoDrill® GI. This makes the hospital the first in southern Europe to test EndoDrill® GI. Dr. Tajana Pavic, Head of Interventional Gastroenterology Unit, performed the patient cases. The EndoDrill® GI instrument provided high-quality core tissue biopsies in all four patient cases, including three solid pancreatic tumors and an enlarged lymph node in the stomach. Announcement • Jul 23
BiBBInstruments AB to Report Q2, 2024 Results on Aug 21, 2024 BiBBInstruments AB announced that they will report Q2, 2024 results on Aug 21, 2024 Announcement • May 18
BiBBInstruments AB Announces Successful Case Studies with EndoDrill GI Continue in Norway and Sweden BiBBInstruments AB informed that clinical evaluation with EndoDrill® GI has started at two additional hospitals in Scandinavia. Several patient cases have been successfully performed at Haukeland University Hospital in Bergen, Norway, as well as at the University Hospital in Örebro. This means that EndoDrill® GI is now being evaluated in Sweden (Karolinska University Hospital and Örebro University Hospital), Norway (Haukeland University Hospital) and the USA (UC Davis Health, Sacramento). The evaluations have so far provided a clear picture of a user-friendly, safe, and effective biopsy instrument that has been called, among other things, a "game changer". Further case studies are planned at more hospitals in the US and Europe. BiBB's team has recently been on site introducing EndoDrill® GI in Norway and Sweden. Dr. Khanh Do-Cong Pham at Haukeland University Hospital in Bergen became the first user to evaluate EndoDrill® GI in Norway. Dr. Pham himself writes about his impression of EndoDrill® GI on LinkedIn* and he has also posted a video, in which Dr. Pham describes that he managed to obtain a core biopsy of a recurrent gastric cancer to demonstrate deeper infiltration. He further explains that the instrument did not cause any bleeding and can be considered atraumatic (gentle). The evaluation in Bergen will now continue. During the week, several patient cases were performed at Örebro University Hospital. Dr. Robert Glavas, who previously participated in a pilot study with EndoDrill® GI, was well acquainted with the instrument. It was the first time BiBB used the new industrialized motor unit, which is significantly more compact than its predecessor. The cases were varied and challenging, involving pancreatic tumors, lymph nodes, and the gastric wall. Sampling with EndoDrill® GI provided a series of true core biopsies. The evaluation at Örebro University Hospital will now continue. Announcement • Apr 17
BiBBInstruments AB Announces Successful Clinical Pilot Study with EndoDrill GI Published in Peer Reviewed Scientific Journal BiBBInstruments AB announced that the pilot study EDMX01 with EndoDrill GI has been published in the peer reviewed Scandinavian Journal of Gastroenterology. The study results show 100% diagnostic accuracy when sampling with EndoDrill GI and superseded samples taken in the same tumors with a leading standard biopsy instrument. The authors concluded that the EndoDrill device was safe and easy to use, could obtain true core biopsies in a single pass, with a potential of reducing the need of multiple samplings. Currently, FDA-cleared, and CE-marked EndoDrillGI is being evaluated at hospitals in the US and Sweden. The results from BiBB's Swedish clinical pilot study, EDMX01, with EndoDrill GI, were announced in the form of a poster presentation at Digestive Disease Week (DDW) in San Diego on May 21-22, 2022. Now, an original article with more details has been published in the peer reviewed Scandinavian Journal of Gastroenterology titled "The advent of the first electric-driven EUS-guided 17-gauge core needle biopsy - A pilot study on subepithelial lesions" (F. Swahn et al.). The pilot study compared tissue sampling using the EndoDrill GI vs. standard fine needle instrument in deeply situated gastric tumors in 7 patient cases. In each tumor, tissue samples were taken in randomized order with electric-driven EndoDrill GI and with leading fine needle instruments, EUS-FNB (Medtronic, SharkCore(TM)). With the EndoDrill GI, a rotating needle cylinder cuts out tissue samples, and with the standard EUS-FNB, samples are taken with a manual stabbing motion. It was a broad group of patients (n=7, 28-75 years) with 6 different types of tumors in the upper gastrointestinal tract and with a tumor size from 17 mm to 90 mm, that is a significant challenge for endoscopic sampling. For EndoDrill, samples of visible "core biopsies" were obtained in 7/7 cases (100%) while manual EUS-FNB resulted in 5/7 (71%) samples of ditto. Histological diagnosis was obtained in 7/7 cases (100%) with EndoDrill and in 6/7 cases (86%) with EUS-FNB. No serious complications were noted after the examinations. EndoDrill was rated as "simple" or "very simple" in terms of handling (7/7), preparation (7/7), adjustment of the needle (7/7), and sampling performance (6/7, one difficult case). The research team concludes that the pilot study has shown that EndoDrill GI can safely be used to obtain true core biopsies (CNB, Core Needle Biopsy) in a single needle puncture, reducing the need for a second sampling. The authors write that the EndoDrill GI obtained coherent histological tissue samples that superseded conventional FNB samples, in both amount and quality. It is also noted that the EndoDrill needle is hyperflexible, which was particularly beneficial in one of the cases. The researchers write that EndoDrill GI takes core biopsies that resemble the tissue samples taken with rigid core needles in breast and prostate cancer. If this can be applied to other tumor areas, EndoDrill will also have the potential to become a valuable tool for effective tissue sampling and precise diagnostics beyond the gastrointestinal tract. The authors conclude by stating that they are confident that the learning curve to use EndoDrill GI is relatively short and that the technology can be applied in routine clinical practice. The article is "peer reviewed" meaning that experts and researchers in the field have reviewed the study and its scientific quality before it is accepted for publication. Announcement • Apr 05
Bibbinstruments AB First Clinical Tissue Acquisition Procedures with Endodrill® Gi At Karolinska University Hospital in Stockholm Have Been Successfully Performed BiBBInstruments AB announces that the first clinical tissue acquisition procedures with EndoDrill® GI at Karolinska University Hospital in Stockholm have been successfully performed.BiBB is now planning to initiate more evaluations at a series of Scandinavian hospitals. In February, BiBB announced that the entire EndoDrill® product portfolio had received CE certification in accordance with MDR, i.e. market approval for the European market. This meant that the Company could begin clinical evaluations of the first product variant, EndoDrill® GI, which is used for sampling in the GI tract, e.g. pancreatic tumors, and submucosal tumors in the stomach. This pre-commercial evaluation has now been initiated at Karolinska University Hospital in Stockholm. In late March, doctors at Karolinska University Hospital performed tissue samplings on two patients with tumors in the pancreas and stomach, respectively. In both cases, histological core biopsies (CNB, Core Needle Biopsy) were taken, which have now been shown to provide diagnoses in both cases. The instrument was called "FNB on steroids" in the endoscopy room as a sign that it takes larger, more informative, biopsies compared to the latest generation of existing manual EUS biopsy instruments (EUS-FNB). High-quality biopsies are essential to establish a complete diagnosis for personalized treatment. The evaluation at Karolinska University Hospital has continued and the doctors have now independently performed another successful patient case without on-site support. The trials in Stockholm will be followed by more evaluations at a series of Scandinavian hospitals. The launch of EndoDrill® GI in Sweden is expected to take place later this year. Announcement • Apr 04
BiBBInstruments AB to Report Q1, 2024 Results on May 03, 2024 BiBBInstruments AB announced that they will report Q1, 2024 results on May 03, 2024 New Risk • Feb 12
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr15m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr15m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (€8.41m market cap, or US$9.06m). Minor Risk Shareholders have been diluted in the past year (16% increase in shares outstanding). Announcement • Feb 02
Bibbinstruments AB Announces First US Clinical Cases Successfully Conducted with Endodrill GI BiBBInstruments AB announced that the first US clinical procedures with EndoDrill® GI have successfully been performed by Dr Antonio Mendoza Ladd and his team at UC Davis Health, Sacramento, California. BiBB received 510(k) clearance from the US FD for EndoDrill® GI in 2023 and clinical marketing activities will continue in the US. Announcement • Jan 11
BiBBInstruments AB to Report Fiscal Year 2023 Results on Feb 09, 2024 BiBBInstruments AB announced that they will report fiscal year 2023 results on Feb 09, 2024 Announcement • Oct 12
BiBBInstruments AB to Report Nine Months, 2023 Results on Nov 10, 2023 BiBBInstruments AB announced that they will report nine months, 2023 results on Nov 10, 2023 Announcement • Sep 05
Bibb Receives Approval of Two Patents in Europe for Endodrill BiBBInstruments AB announced that the European Patent Office (EPO) has finally approved two patent applications for EndoDrill®. The patents provide broad protection of the EndoDrill® system until 2038 and 2039, respectively. The approvals relate to patent applications EP19780264.8 and EP18199230.6 from patent family 1 and follow previous Intention to Grants from the EPO announced in First Quarter 2023. The patents protect the EndoDrill® product series, the market-cleared electric-driven biopsy instrument for endoscopy. BiBB also has three international patent applications for EndoDrill®, which has entered the national/regional phase. EndoDrill® is in clinical phase and approaching commercialization. The product family is aimed at hospitals working with advanced ultrasound endoscopy (EUS/EBUS), to improve diagnostics in some of the most serious cancers, such as stomach, pancreas, liver, lung, and bladder cancer. FDA-cleared 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 100% diagnostic accuracy when analyzing the samples. EndoDrill® utilizes a patented electric-driven rotating needle cylinder that provides high-precision tissue samples of higher diagnostic quality than existing manually handled EUS biopsy instruments. Board Change • Aug 21
Less than half of directors are independent No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 2 experienced directors. 2 highly experienced directors. 1 independent director (3 non-independent directors). Independent Director Sara Lindroth was the last independent director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Announcement • Jul 28
BiBBInstruments AB to Report Q2, 2023 Results on Aug 25, 2023 BiBBInstruments AB announced that they will report Q2, 2023 results on Aug 25, 2023 Board Change • Jul 19
Less than half of directors are independent No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 2 experienced directors. 2 highly experienced directors. 1 independent director (3 non-independent directors). Independent Director Sara Lindroth was the last independent director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. 