Duyuru • Jul 28
BiBBInstruments AB Receives Intention To Grant For Fourth And Fifth EndoDrill Patent In Europe And Is Granted Second Patent In India BiBBInstruments AB announced that the Company has received two Intentions to Grant from the European Patent Office (EPO) as well as a patent grant from the Indian Patent Office (IPO). The European patents will be granted following the completion of certain formalities, after which they will be valid until 2040 and 2041, respectively. The patent in India is valid until 2041. The protection is based on three international EndoDrill patent families with granted patents in Europe, the United States, Japan, India and China. The two Intention to Grant in Europe relate to patent applications No. 20719144.6 and 21716219.7 respectively. These patents belong to BiBB's second and third EndoDrill patent families and provide additional protection for the Company's powered biopsy technology in Europe. Previously, BiBB has been granted three patents in Europe that are valid until 2038 and 2039, and the new patents will extend the protection until 2040 and 2041, respectively. The second granted patent in India (No. 596371) belongs to BiBB's third EndoDrill patent family and provides robust protection for the Company's powered biopsy technology in India. The first granted patent is valid until 2039, while this patent will be valid until 2041. EndoDrill is designed to obtain core needle biopsy (CNB) samples with high diagnostic accuracy and aims to improve the diagnosis of cancer in, among other organs, the stomach, pancreas, liver, lungs and urinary bladder. The product portfolio addresses the global market for ultrasound-guided endoscopic biopsy instruments (EUS/EBUS), one of the most advanced and fastest-growing segments within modern endoscopy. BiBB received FDA 510(k) clearance for EndoDrill GI in 2023 and CE marking under the MDR for EndoDrill GI, EndoDrill EBUS and EndoDrill URO in 2024. EndoDrill is therefore the first powered biopsy system to be market-cleared in the United States and CE-marked in Europe. The U.S. launch of EndoDrill GI commenced during the second half of 2025 together with TaeWoong Medical USA. The European launch begins in 2026 with the Company's partner, Palex Medical Spain. The EndoDrill system consists of sterile single-use instruments and a proprietary drive system. Duyuru • Jul 23
BiBBInstruments AB to Report Q2, 2026 Results on Aug 21, 2026 BiBBInstruments AB announced that they will report Q2, 2026 results on Aug 21, 2026 Duyuru • May 22
BiBBInstruments AB Presents Clinical Experience With EndoDrill GI At ESGE Days 2026 BiBBInstruments AB announced that physicians at Mayo Clinic in Jacksonville, Florida, presented clinical experience with EndoDrill GI at ESGE Days 2026. The presented case demonstrated successful endoscopic ultrasound-guided core biopsy using EndoDrill GI of a lesion adjacent to the rectum. The biopsy resulted in ample tissue acquisition in a single pass and without reported adverse events. The presentation by authors from the Division of Gastroenterology and Hepatology at Mayo Clinic, Jacksonville, Florida, entitled EndoDrill-Assisted EUS Biopsy: Unmasking an extrinsic rectal mass, describes a case involving a 72-year-old patient with a pelvic mass extending toward the rectum. Histopathology and immunohistochemistry from the EndoDrill GI biopsy confirmed high-grade urothelial carcinoma. The authors noted that this is, to their knowledge, the first reported use of EndoDrill GI for tissue acquisition in the lower GI tract. According to the authors, ample core tissue was obtained in a single pass without adverse events. The authors further conclude that EndoDrill GI demonstrates significant potential to enhance diagnostic yield of EUS-CNB. In 2025, Mayo Clinic researchers presented a poster demonstrating the potential of EndoDrill GI to obtain high-quality tissue cores from pancreas lesions with lower blood contamination compared with conventional needles. EndoDrill GI is the world's first market-cleared powered biopsy instrument for endoscopic ultrasound (EUS), with both FDA 510(k) clearance and CE marking. Unlike conventional manual biopsy needles, EndoDrill uses a powered rotating needle tip designed to obtain intact core tissue samples for histopathology and molecular analysis. The system is currently being commercialized in the United States together with distribution partner TaeWoong Medical USA. Duyuru • 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 Duyuru • 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 Duyuru • 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 Duyuru • 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,. Duyuru • 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 Duyuru • 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. Duyuru • 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. Duyuru • 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 Duyuru • 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. Duyuru • 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 Duyuru • 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. New Risk • Feb 01
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 52% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. 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 (-kr17m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (kr114.6m market cap, or US$10.3m). Duyuru • 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 Duyuru • 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 Duyuru • 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. New Risk • Nov 08
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: kr108.1m (US$9.99m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (13% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (kr108.1m market cap, or US$9.99m). Minor Risk Shareholders have been diluted in the past year (10% increase in shares outstanding). Duyuru • 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 Duyuru • 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. Duyuru • 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. Duyuru • 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 Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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 Recent Insider Transactions • Mar 25
Independent Director recently bought kr58k worth of stock On the 22nd of March, Sara Lindroth bought around 13k shares on-market at roughly kr4.55 per share. This transaction increased Sara's direct individual holding by 14x at the time of the trade. In the last 3 months, there was an even bigger purchase from another insider worth kr101k. Insiders have collectively bought kr474k more in shares than they have sold in the last 12 months. 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 (15% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (kr94.4m market cap, or US$9.06m). Minor Risk Shareholders have been diluted in the past year (16% increase in shares outstanding). Recent Insider Transactions • Feb 12
Chief Executive Officer recently bought kr101k worth of stock On the 9th of February, Fredrik Lindblad bought around 28k shares on-market at roughly kr3.55 per share. This transaction amounted to 6.7% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Fredrik has been a buyer over the last 12 months, purchasing a net total of kr319k worth in shares. Duyuru • 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. Duyuru • 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 Duyuru • 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 Duyuru • 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. Duyuru • 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 New Risk • Jul 09
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: -kr16m 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 (-kr16m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings have declined by 7.0% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (kr109.8m market cap, or US$10.1m). Recent Insider Transactions • Jun 18
Chief Executive Officer recently bought kr102k worth of stock On the 15th of June, Fredrik Lindblad bought around 29k shares on-market at roughly kr3.54 per share. This transaction amounted to 7.3% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Fredrik has been a buyer over the last 12 months, purchasing a net total of kr218k worth in shares. New Risk • Jun 15
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 16% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (23% average weekly change). Earnings have declined by 10% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr15m). Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (kr114.1m market cap, or US$10.8m). Duyuru • Jun 08
BiBBInstruments AB Reports Positive Results from Clinical Pilot Study with EndoDrill URO BiBBInstruments AB reported that the first clinical study with EndoDrill® URO for muscle-invasive bladder cancer has been scientifically published in European Urology Open Science. The study shows that EndoDrill® URO safely can take treatment-based tissue samples earlier in the care chain in case of suspicion of deep-growing tumors in the urinary bladder. The research group concludes that it is now warranted to follow up the pilot study with a randomized efficacy study, which is already planned and regulatory approved. The study has now been published in the scientific journal European Urology Open Science 53 (2023) 78-82 titled "Urodrill - a novel MRI-guided endoscopic biopsy technique to sample and molecularly classify muscle-invasive bladder cancer without fractionating the specimen during transurethral resection" (note that "Urodrill" is identical to the product EndoDrill® URO). The purpose of the study was to investigate whether it is possible to take tissue samples of deep-growing tumors for the first time already at the initial endoscopic examination of the bladder. With an early diagnosis, the more invasive standardized surgical procedure (TURB) could be avoided and treatment of patients with MIBC could be started earlier. The study compared biopsies taken with EndoDrill® URO with tissue samples taken during the surgical procedure. The publication shows good results with the new biopsy instrument EndoDrill® URO. EndoDrill® URO managed to take a biopsy in 9 out of 10 examined patients and in the tenth case the tumor was very close to large blood vessels, which meant that user could not go so deep in the individual case. In 6 out of 9 cases, muscle-invasive bladder cancer could be confirmed and in 7 out of 9 cases, the muscle layer of the bladder wall, i.e., deep growth, could be assessed. In 8 cases, genetic mutation analysis was performed and in 7 of these, the analysis was technically successful. No complications related to tissue sampling with EndoDrill® URO were noted. The large research team concluded that it is possible to take treatment-based tissue samples with EndoDrill® URO early on if bladder cancer is suspected. Recent Insider Transactions • Mar 17
Chief Executive Officer recently bought kr55k worth of stock On the 14th of March, Fredrik Lindblad bought around 24k shares on-market at roughly kr2.28 per share. This transaction amounted to 6.5% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger purchase worth kr60k. Fredrik has been a buyer over the last 12 months, purchasing a net total of kr116k worth in shares. Recent Insider Transactions • Mar 10
Chief Executive Officer recently bought kr60k worth of stock On the 7th of March, Fredrik Lindblad bought around 22k shares on-market at roughly kr2.69 per share. This transaction amounted to 6.4% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Fredrik's only on-market trade for the last 12 months. Duyuru • Jan 12
BiBBInstruments AB to Report Fiscal Year 2022 Results on Feb 10, 2023 BiBBInstruments AB announced that they will report fiscal year 2022 results on Feb 10, 2023 Board Change • Nov 16
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. Duyuru • Oct 13
BiBBInstruments AB to Report Q3, 2022 Results on Nov 11, 2022 BiBBInstruments AB announced that they will report Q3, 2022 results on Nov 11, 2022 Duyuru • Jul 29
BiBBInstruments AB to Report Q2, 2022 Results on Aug 26, 2022 BiBBInstruments AB announced that they will report Q2, 2022 results on Aug 26, 2022 Recent Insider Transactions • Jun 07
Chairman of the Board recently bought kr64k worth of stock On the 3rd of June, Erik von Schenck bought around 10k shares on-market at roughly kr6.40 per share. In the last 3 months, there was an even bigger purchase from another insider worth kr69k. Erik has been a buyer over the last 12 months, purchasing a net total of kr137k worth in shares. Duyuru • May 17
BiBBInstruments AB, Annual General Meeting, Jun 14, 2022 BiBBInstruments AB, Annual General Meeting, Jun 14, 2022. Duyuru • May 14
BiBBInstruments Develops the CE-Marked Electromechanical Biopsy Instruments for Endoscopic Use BiBBInstruments developed the CE-marked electromechanical biopsy instruments for endoscopic use, which aims to improve the current diagnosis of serious and difficult-to-diagnose tumours. The directed share issue, conducted earlier this year, creates opportunities for the company to continue its development and present several clinical news in the coming year. Board Change • Apr 27
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. Duyuru • Apr 07
BiBBInstruments AB to Report Q1, 2022 Results on May 06, 2022 BiBBInstruments AB announced that they will report Q1, 2022 results on May 06, 2022 Recent Insider Transactions • Mar 23
Founder recently bought kr69k worth of stock On the 21st of March, Charles Walther bought around 10k shares on-market at roughly kr6.90 per share. This was the largest purchase by an insider in the last 3 months. Charles has been a buyer over the last 12 months, purchasing a net total of kr116k worth in shares. Duyuru • Nov 27
BiBBInsumentsts Cancer Study Comes to Early End After Convincing Data BiBBInsumentsts announced that first clinical study with EndoDrill Model X in deep tumours of thupper gastrointestinal tract h has been completed earlier than expected after an interim analysis showed that the objective of the study has been achieved already in seven out of the planned 20 patients. Preliminary results indicate that the product safely enables effective sampling of core biopsies when examined with endoscopic ultrasound. After this success, the company is now awaiting further results from its second clinical trial, EDUX02, which is expected to be completed later this year. Recent Insider Transactions • Sep 02
Chairman of the Board recently bought kr73k worth of stock On the 31st of August, Erik von Schenck bought around 10k shares on-market at roughly kr7.30 per share. This was the largest purchase by an insider in the last 3 months. This was Erik's only on-market trade for the last 12 months. Duyuru • Mar 17
BiBBinstruments AB Initiates Clinical Trial in Bladder Cancer BiBBInstruments AB announced the recruitment of the first patient in a second trial targeting bladder cancer. The company’s electric endoscopic biopsy device could prevent patients with muscle invasive bladder cancer from undergoing a major procedure called TURBT (Transurethral Resection for Bladder Tumour) and thus shorten the time to treatment. TURBT is an invasive surgical procedure currently used for diagnosis and treatment. Is New 90 Day High Low • Dec 29
New 90-day high: kr9.50 The company is up 121% from its price of kr4.30 on 30 September 2020. The Swedish market is up 5.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 10.0% over the same period. Is New 90 Day High Low • Dec 12
New 90-day high: kr8.12 The company is up 59% from its price of kr5.10 on 11 September 2020. The Swedish market is up 6.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 2.0% over the same period. Is New 90 Day High Low • Nov 24
New 90-day high: kr6.14 The company is up 6.0% from its price of kr5.80 on 25 August 2020. The Swedish market is up 8.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Medical Equipment industry, which is up 2.0% over the same period. Duyuru • Oct 17
BiBBInstruments AB to Report Q3, 2020 Results on Nov 13, 2020 BiBBInstruments AB announced that they will report Q3, 2020 results on Nov 13, 2020 Is New 90 Day High Low • Oct 05
New 90-day low: kr4.16 The company is down 3.0% from its price of kr4.29 on 06 July 2020. The Swedish market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment industry, which is up 14% over the same period. Duyuru • Sep 12
BiBBInstruments AB to Report Q2, 2020 Results on Aug 28, 2020 BiBBInstruments AB announced that they will report Q2, 2020 results on Aug 28, 2020