Endoscopic sampling is a method of taking tissue samples (biopsies) without surgical intervention. The technique is often used for the diagnosis of diseases of the gastrointestinal tract, respiratory tract, and other hard-to-reach organs. By inserting an endoscope, a narrow, flexible instrument with a camera and specialized instruments, doctors can both visualize and take tissue samples from specific areas.
Lund-based BiBBInstruments has developed a series of biopsy instruments for ultrasound endoscopy, an advanced method that combines visual endoscopy with ultrasound technology. The technology provides a detailed image of changes in the deeper structures of the organs and surrounding tissue, allowing tissue samples to be taken with fine-needle instruments under ultrasound guidance. Tissue samples are central to the diagnosis and staging of suspected tumor changes. Over a million biopsies of this type are performed each year, representing a growing multi-billion dollar market.
Contributes to better sample quality compared to existing biopsy instruments
BiBBInstruments has developed a family of biopsy instruments called EndoDrill. What sets EndoDrill apart from today's sampling instruments is the electrically powered rotating drilling cylinder. With today's technology, the doctor needs to use a manual chopping motion to take their sample, which means it is easily damaged and mixed with blood. Even if the doctor is skilled, it sometimes takes several attempts before you get a sample that is good enough for the pathologist to make a good assessment.
The idea behind EndoDrill is to make it easier for doctors to take high-quality samples, known as core biopsies. The pathologist will in turn be able to make better diagnoses, which will lead to the patient receiving exactly the care they need.
Approved in the USA and Europe
The company's product family currently consists of three variants, EndoDrill GI for sampling the gastrointestinal tract; EndoDrill EBUS for respiratory tract and lungs and EndoDrill URO for the bladder. EndoDrill GI is FDA-approved and the entire family is CE marked according to the new European MDR regulations.
With regulatory approvals in place, the company is focusing on clinical validation. First and foremost, it wants to get important feedback from clinics ahead of an upcoming market launch, but the aim is also to generate interest and continue to gather clinical evidence for the product.
Several hospitals are evaluating
First up is EndoDrill GI, which is being tested at several hospitals in the US and Europe. BiBBInstruments has reported successful clinical introductions during the year. For example, it carried out Dr. Antonio Mendoza Ladd vid UC Davis Health in Sacramento, California, a clinical case series of patients with suspected gastrointestinal cancer, including pancreatic cancer.
The results demonstrated 100 percent diagnostic accuracy, meaning that all samples resulted in high-quality core biopsies after a single needle puncture. This is an unusually good outcome for this type of diagnosis.
Great interest among medtech giants
The good results are generating great interest, both among clinics and potential distributors. Several of the major players in the field have contacted BiBBInstruments about potential collaboration and several discussions are ongoing. The company's strategy is to carry out a targeted launch under its own management to selected hospitals in Europe and then an international launch can be initiated in partnership with one or more distributors.
Discussions are ongoing, and securing commercial-scale production is a necessary first step towards a partnership agreement. Therefore, the company recently announced that it has begun the process of moving the manufacturing of the sterile single-use instruments to the Swedish contract manufacturer. GenoaThis is expected to be completed by mid-2025.
Rights issue to finance market launch
BiBBInstruments is now taking significant steps towards the market and is conducting a rights issue of units, which could initially raise up to approximately SEK 36,5 million. The proceeds from the capital raising are primarily intended to be used for marketing and clinical activities, scaling up production and continuing the development of the next product in the series, EndoDrill EBUS, for lung cancer.
The issue is secured to approximately 75,5 percent by subscription commitments, subscription intentions and guarantee commitments. To finance the operations until the completion of the issue, BiBBInstruments is taking out a bridge loan of SEK 3 million from the existing owner Tibia Consultant, which will be paid back once the issue is completed.
The issue also includes warrants of series TO 1, which, if fully exercised at the end of May 2025, could provide an additional approximately SEK 11,9 – 21,9 million. This additional proceeds will mainly be used for marketing purposes.
Summary of the issue
| Terms & conditions | One existing share entitles to one unit right. Eight unit rights entitle to subscription of one unit, which consists of four newly issued shares and one warrant series TO 1. Each warrant then gives the right to subscribe for one new share in the company during the period May 22 – June 5, 2025. |
| Subscription period | January 7 – 21 |
| Subscription price | SEK 10 per unit, corresponding to SEK 2,50 per share |
| Volume | Maximum approximately SEK 36,5 million |
| Pre-money valuation | Approximately SEK 73 million |
| Subscription commitments, subscription intentions and guarantee commitments. | 75,5 percent |
Prospectus & subscription
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