View Future GrowthBiBBInstruments 過去の業績過去 基準チェック /06BiBBInstrumentsの収益は年間平均-7.6%の割合で減少していますが、 Medical Equipment業界の収益は年間 減少しています。収益は年間0.2% 49.9%割合で 増加しています。主要情報-7.56%収益成長率7.63%EPS成長率Medical Equipment 業界の成長4.25%収益成長率49.92%株主資本利益率-50.31%ネット・マージン-3,470.38%前回の決算情報31 Mar 2026最近の業績更新お知らせ • Apr 23BiBBInstruments AB to Report Q1, 2026 Results on May 22, 2026BiBBInstruments AB announced that they will report Q1, 2026 results on May 22, 2026お知らせ • Jan 13BiBBInstruments AB to Report Fiscal Year 2025 Results on Feb 10, 2026BiBBInstruments AB announced that they will report fiscal year 2025 results on Feb 10, 2026お知らせ • Oct 09BiBBInstruments AB to Report Q3, 2025 Results on Nov 07, 2025BiBBInstruments AB announced that they will report Q3, 2025 results on Nov 07, 2025お知らせ • Jul 24BiBBInstruments AB to Report Q2, 2025 Results on Aug 22, 2025BiBBInstruments AB announced that they will report Q2, 2025 results on Aug 22, 2025お知らせ • Mar 31BiBBInstruments AB to Report Q1, 2025 Results on Apr 29, 2025BiBBInstruments AB announced that they will report Q1, 2025 results on Apr 29, 2025お知らせ • Jan 30BiBBInstruments AB to Report Fiscal Year 2024 Results on Feb 28, 2025BiBBInstruments AB announced that they will report fiscal year 2024 results on Feb 28, 2025すべての更新を表示Recent updatesお知らせ • May 22BiBBInstruments AB Presents Clinical Experience With EndoDrill GI At ESGE Days 2026BiBBInstruments 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.Board Change • May 20Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 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 company's minority of independent directors is a risk according to the Simply Wall St Risk Model.お知らせ • Apr 23BiBBInstruments AB to Report Q1, 2026 Results on May 22, 2026BiBBInstruments AB announced that they will report Q1, 2026 results on May 22, 2026お知らせ • Feb 10BiBBInstruments 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お知らせ • Jan 13BiBBInstruments AB to Report Fiscal Year 2025 Results on Feb 10, 2026BiBBInstruments AB announced that they will report fiscal year 2025 results on Feb 10, 2026お知らせ • Dec 05Bibb Strengthens Its Presence in the American MarketBiBBInstruments 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,.お知らせ • Oct 09BiBBInstruments AB to Report Q3, 2025 Results on Nov 07, 2025BiBBInstruments AB announced that they will report Q3, 2025 results on Nov 07, 2025お知らせ • Sep 04Bibbinstruments AB Appoints Peter Vilmann as Scientific AdvisorBiBBInstruments 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.お知らせ • Aug 13Bibbinstruments AB Announces That Henry Ford St. John Hospital Reports First U.S. Liver Biopsy Cases with Endodrill GiBiBBInstruments 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.お知らせ • Jul 24BiBBInstruments AB to Report Q2, 2025 Results on Aug 22, 2025BiBBInstruments AB announced that they will report Q2, 2025 results on Aug 22, 2025お知らせ • Jun 24BiBBInstruments AB Receives Decision to Grant from the Japan Patent OfficeBiBBInstruments 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.お知らせ • Mar 31BiBBInstruments AB to Report Q1, 2025 Results on Apr 29, 2025BiBBInstruments AB announced that they will report Q1, 2025 results on Apr 29, 2025お知らせ • Feb 22BiBBInstruments AB Initiates Clinical Evaluation Of EndoDrill GI In The USABiBBInstruments 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.お知らせ • Jan 30BiBBInstruments AB to Report Fiscal Year 2024 Results on Feb 28, 2025BiBBInstruments AB announced that they will report fiscal year 2024 results on Feb 28, 2025お知らせ • Jan 23BiBBInstruments 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お知らせ • Nov 15BiBBInstruments AB Announces Clinical Introduction of EndoDrill® GI at Sahlgrenska University Hospital in SwedenBiBBInstruments 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.お知らせ • Oct 10BiBBInstruments AB to Report Q4, 2024 Results on Nov 08, 2024BiBBInstruments AB announced that they will report Q4, 2024 results on Nov 08, 2024お知らせ • Oct 02BiBBInstruments AB Announces New Peer-Reviewed Clinical Case Series in the U.S. Shows 100% Diagnostic Accuracy with Endodrill GiBiBBInstruments 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.お知らせ • Sep 02BiBBInstruments AB Announces Successful Introduction of EndoDrill GI at University Hospital Center Sestre Milosrdnice in Zagreb, CroatiaBiBBInstruments 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.お知らせ • Jul 23BiBBInstruments AB to Report Q2, 2024 Results on Aug 21, 2024BiBBInstruments AB announced that they will report Q2, 2024 results on Aug 21, 2024お知らせ • May 18BiBBInstruments AB Announces Successful Case Studies with EndoDrill GI Continue in Norway and SwedenBiBBInstruments 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.お知らせ • Apr 17BiBBInstruments AB Announces Successful Clinical Pilot Study with EndoDrill GI Published in Peer Reviewed Scientific JournalBiBBInstruments 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.お知らせ • Apr 05Bibbinstruments AB First Clinical Tissue Acquisition Procedures with Endodrill® Gi At Karolinska University Hospital in Stockholm Have Been Successfully PerformedBiBBInstruments 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.お知らせ • Apr 04BiBBInstruments AB to Report Q1, 2024 Results on May 03, 2024BiBBInstruments AB announced that they will report Q1, 2024 results on May 03, 2024New Risk • Feb 12New major risk - Financial positionThe 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).お知らせ • Feb 02Bibbinstruments AB Announces First US Clinical Cases Successfully Conducted with Endodrill GIBiBBInstruments 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.お知らせ • Jan 11BiBBInstruments AB to Report Fiscal Year 2023 Results on Feb 09, 2024BiBBInstruments AB announced that they will report fiscal year 2023 results on Feb 09, 2024お知らせ • Oct 12BiBBInstruments AB to Report Nine Months, 2023 Results on Nov 10, 2023BiBBInstruments AB announced that they will report nine months, 2023 results on Nov 10, 2023お知らせ • Sep 05Bibb Receives Approval of Two Patents in Europe for EndodrillBiBBInstruments 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 21Less than half of directors are independentNo 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.お知らせ • Jul 28BiBBInstruments AB to Report Q2, 2023 Results on Aug 25, 2023BiBBInstruments AB announced that they will report Q2, 2023 results on Aug 25, 2023Board Change • Jul 19Less than half of directors are independentNo 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.収支内訳BiBBInstruments の稼ぎ方とお金の使い方。LTMベースの直近の報告された収益に基づく。収益と収入の歴史DB:V0R 収益、費用、利益 ( )SEK Millions日付収益収益G+A経費研究開発費31 Mar 260-1761131 Dec 250-156930 Sep 250-135830 Jun 250-135831 Mar 250-135831 Dec 240-135830 Sep 240-125730 Jun 240-125731 Mar 240-114731 Dec 230-114730 Sep 230-114730 Jun 230-114731 Mar 230-114731 Dec 220-114730 Sep 220-115630 Jun 220-115731 Mar 220-104631 Dec 210-104630 Sep 210-105630 Jun 210-105531 Mar 210-116531 Dec 200-137630 Sep 200-187630 Jun 200-187731 Mar 201-187731 Dec 190-156630 Sep 191-107730 Jun 190-96731 Mar 190-95631 Dec 180-85630 Sep 180-74530 Jun 180-64531 Mar 180-53431 Dec 170-42330 Sep 170-31230 Jun 170-11131 Mar 17001031 Dec 160001質の高い収益: V0Rは現在利益が出ていません。利益率の向上: V0Rは現在利益が出ていません。フリー・キャッシュフローと収益の比較過去の収益成長分析収益動向: V0Rは利益が出ておらず、過去 5 年間で損失は年間7.6%の割合で増加しています。成長の加速: V0Rの過去 1 年間の収益成長を 5 年間の平均と比較することはできません。現在は利益が出ていないためです。収益対業界: V0Rは利益が出ていないため、過去 1 年間の収益成長をMedical Equipment業界 ( 10.9% ) と比較することは困難です。株主資本利益率高いROE: V0Rは現在利益が出ていないため、自己資本利益率 ( -50.31% ) はマイナスです。総資産利益率使用総資本利益率過去の好業績企業の発掘7D1Y7D1Y7D1YHealthcare 、過去の業績が好調な企業。View Financial Health企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/06/30 20:51終値2026/06/19 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社の Github ページ でご覧いただけます。また、レポートの使い方に関する ガイド や YouTube の チュートリアル もご用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋BiBBInstruments AB 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。0
お知らせ • Apr 23BiBBInstruments AB to Report Q1, 2026 Results on May 22, 2026BiBBInstruments AB announced that they will report Q1, 2026 results on May 22, 2026
お知らせ • Jan 13BiBBInstruments AB to Report Fiscal Year 2025 Results on Feb 10, 2026BiBBInstruments AB announced that they will report fiscal year 2025 results on Feb 10, 2026
お知らせ • Oct 09BiBBInstruments AB to Report Q3, 2025 Results on Nov 07, 2025BiBBInstruments AB announced that they will report Q3, 2025 results on Nov 07, 2025
お知らせ • Jul 24BiBBInstruments AB to Report Q2, 2025 Results on Aug 22, 2025BiBBInstruments AB announced that they will report Q2, 2025 results on Aug 22, 2025
お知らせ • Mar 31BiBBInstruments AB to Report Q1, 2025 Results on Apr 29, 2025BiBBInstruments AB announced that they will report Q1, 2025 results on Apr 29, 2025
お知らせ • Jan 30BiBBInstruments AB to Report Fiscal Year 2024 Results on Feb 28, 2025BiBBInstruments AB announced that they will report fiscal year 2024 results on Feb 28, 2025
お知らせ • May 22BiBBInstruments AB Presents Clinical Experience With EndoDrill GI At ESGE Days 2026BiBBInstruments 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.
Board Change • May 20Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 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 company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
お知らせ • Apr 23BiBBInstruments AB to Report Q1, 2026 Results on May 22, 2026BiBBInstruments AB announced that they will report Q1, 2026 results on May 22, 2026
お知らせ • Feb 10BiBBInstruments 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
お知らせ • Jan 13BiBBInstruments AB to Report Fiscal Year 2025 Results on Feb 10, 2026BiBBInstruments AB announced that they will report fiscal year 2025 results on Feb 10, 2026
お知らせ • Dec 05Bibb Strengthens Its Presence in the American MarketBiBBInstruments 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,.
お知らせ • Oct 09BiBBInstruments AB to Report Q3, 2025 Results on Nov 07, 2025BiBBInstruments AB announced that they will report Q3, 2025 results on Nov 07, 2025
お知らせ • Sep 04Bibbinstruments AB Appoints Peter Vilmann as Scientific AdvisorBiBBInstruments 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.
お知らせ • Aug 13Bibbinstruments AB Announces That Henry Ford St. John Hospital Reports First U.S. Liver Biopsy Cases with Endodrill GiBiBBInstruments 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.
お知らせ • Jul 24BiBBInstruments AB to Report Q2, 2025 Results on Aug 22, 2025BiBBInstruments AB announced that they will report Q2, 2025 results on Aug 22, 2025
お知らせ • Jun 24BiBBInstruments AB Receives Decision to Grant from the Japan Patent OfficeBiBBInstruments 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.
お知らせ • Mar 31BiBBInstruments AB to Report Q1, 2025 Results on Apr 29, 2025BiBBInstruments AB announced that they will report Q1, 2025 results on Apr 29, 2025
お知らせ • Feb 22BiBBInstruments AB Initiates Clinical Evaluation Of EndoDrill GI In The USABiBBInstruments 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.
お知らせ • Jan 30BiBBInstruments AB to Report Fiscal Year 2024 Results on Feb 28, 2025BiBBInstruments AB announced that they will report fiscal year 2024 results on Feb 28, 2025
お知らせ • Jan 23BiBBInstruments 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
お知らせ • Nov 15BiBBInstruments AB Announces Clinical Introduction of EndoDrill® GI at Sahlgrenska University Hospital in SwedenBiBBInstruments 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.
お知らせ • Oct 10BiBBInstruments AB to Report Q4, 2024 Results on Nov 08, 2024BiBBInstruments AB announced that they will report Q4, 2024 results on Nov 08, 2024
お知らせ • Oct 02BiBBInstruments AB Announces New Peer-Reviewed Clinical Case Series in the U.S. Shows 100% Diagnostic Accuracy with Endodrill GiBiBBInstruments 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.
お知らせ • Sep 02BiBBInstruments AB Announces Successful Introduction of EndoDrill GI at University Hospital Center Sestre Milosrdnice in Zagreb, CroatiaBiBBInstruments 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.
お知らせ • Jul 23BiBBInstruments AB to Report Q2, 2024 Results on Aug 21, 2024BiBBInstruments AB announced that they will report Q2, 2024 results on Aug 21, 2024
お知らせ • May 18BiBBInstruments AB Announces Successful Case Studies with EndoDrill GI Continue in Norway and SwedenBiBBInstruments 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.
お知らせ • Apr 17BiBBInstruments AB Announces Successful Clinical Pilot Study with EndoDrill GI Published in Peer Reviewed Scientific JournalBiBBInstruments 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.
お知らせ • Apr 05Bibbinstruments AB First Clinical Tissue Acquisition Procedures with Endodrill® Gi At Karolinska University Hospital in Stockholm Have Been Successfully PerformedBiBBInstruments 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.
お知らせ • Apr 04BiBBInstruments AB to Report Q1, 2024 Results on May 03, 2024BiBBInstruments AB announced that they will report Q1, 2024 results on May 03, 2024
New Risk • Feb 12New major risk - Financial positionThe 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).
お知らせ • Feb 02Bibbinstruments AB Announces First US Clinical Cases Successfully Conducted with Endodrill GIBiBBInstruments 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.
お知らせ • Jan 11BiBBInstruments AB to Report Fiscal Year 2023 Results on Feb 09, 2024BiBBInstruments AB announced that they will report fiscal year 2023 results on Feb 09, 2024
お知らせ • Oct 12BiBBInstruments AB to Report Nine Months, 2023 Results on Nov 10, 2023BiBBInstruments AB announced that they will report nine months, 2023 results on Nov 10, 2023
お知らせ • Sep 05Bibb Receives Approval of Two Patents in Europe for EndodrillBiBBInstruments 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 21Less than half of directors are independentNo 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.
お知らせ • Jul 28BiBBInstruments AB to Report Q2, 2023 Results on Aug 25, 2023BiBBInstruments AB announced that they will report Q2, 2023 results on Aug 25, 2023
Board Change • Jul 19Less than half of directors are independentNo 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.