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product, FG001, is designed to enhance surgical accuracy by illuminating cancer cells
intraoperatively using fluorescent light. FG001 binds to the uPAR receptor, widely expressed
in most solid cancer types. It is anticipated that FG001 will decrease both the incidence of
local recurrence after surgery and surgical complications, improving cancer treatment and
outcomes for patients, while also reducing healthcare costs.
Beyond its ability in guiding surgery, FG001 is being evaluated preclinically for another
significant benefit; the potential ability to directly eliminate cancerous cells in the body. In
addition to helping surgeons see and remove tumors more precisely, FG001 can also
function as a photosensitizer as demonstrated pre-clinical. When exposed to specific wave
lengths, FG001 can either generate heat and burn the cancer cells (Photothermal Therapy,
PTT) or produce molecules that destroy the cancer cells (Photodynamic Therapy, PDT). A
technique that spares healthy surrounding tissue from damage, offering a direct therapeutic
effect of FG001, further benefiting patients undergoing cancer surgery.
FG001 has demonstrated effectiveness in removing cancerous cells effectively in aggressive
brain cancer (High Grade Glioma) and demonstrated its ability to light up head and neck
(Oropharyngeal Squamous Cell Carcinoma) and lung cancer (Non-Small Cell Lung Cancer).
The clinical trial application for a head and neck cancer trial is being evaluate and first
patient is planned enrolled in first quarter next year. The first interim result of this trial is
anticipated in second half of next year, being the key decision point for regulatory and
partnering discussions within the head and neck program. The plan is to initiate a combined
phase II/III trial in head and neck cancer on the back of anticipated positive result.
Currently an investigator-initiated trial in meningioma and low-grade glioma is ongoing and a
trial in high glioma is planned based on feedback from FDA.
FluoGuide entered a non-exclusive agreement with the worlds leading robot company –
Intuitive Surgical earlier in 2024.
AcuCort is an innovative biotechnology company that identifies, develops and commercializes smart drugs that meet the patient's needs for a user-friendly and effective treatment.
Potential drug candidates are based on existing and well-documented substances in indication areas where there is a great medical need and commercial interest in new and innovative products that bring benefits, such as simple administration. The approved drug is commercialized in partnership with a global network of licensees and distributors. In November 2022, AcuCort signed its first commercial agreement for Zeqmelit® with Kamada Ltd. for the Israeli market. Zeqmelit® is approved in Sweden, Denmark, Norway and Finland for, among other things, the treatment of acute and severe allergic reactions, croup in children, nausea and vomiting during chemotherapy treatment, and for patients with COVID-19 who need complementary oxygen therapy. The drug was previously named ISICORT in Sweden.
Registration processes are ongoing for other prioritized markets and during the year and the commercialization team has been geared up. AcuCort's ambition is to commercialize Zeqmelit® and in the future complement it with other well-proven substances that fit the company's business model in indication areas where there is currently a great medical need for new innovative treatments.
AcuCort AB was founded in 2006 and its head office is located at Medicon Village in Lund, Sweden.
Prostatype Genomics is a Swedish based medtech company active in the field of prostate
cancer, the most common form of cancer among men in Western Europe and USA. Annually
approximately 1.4 million men are diagnosed with prostate cancer globally. Prostatype
Genomics is a spin-off from researched performed at Karolinska Institute in Stockholm,
Sweden.
Prostatype Genomics AB specializes in the development, manufacturing, and marketing of
the prognostic genetic test Prostatype®. Prostatype® is a genetic test that provides a
comprehensive assessment of the aggressiveness of prostate cancer. By minimizing over-
and under-treatment, the quality of life for patients can be improved and substantial
resources can be saved within the healthcare systems. Most importantly, Prostatype aids the
health care and patients to take the correct treatment decision for each and every individual
patient. Prostatype® is a strong example of precision medicine and brings a significant health
economy benefit overall.
Using prostate tissue from the biopsy obtained at the time of diagnosis, the Prostatype® test
system combines gene expression information from three stem genes with currently used
clinical parameters (PSA, Gleason Score, and Tumor Stage) and calculates the so-called P-
score, which shows the risk of actually dying from prostate cancer.
In most countries around the world, over treatment of prostate cancer, especially in low- and
intermediate cases, is and has been a challenge for the health care sector. The risk of dying
from prostate cancer in the low- and immediate risk group is very low, but unfortunately a lot
of men are still undergoing radical treatments, such as surgery, in many cases causing life
long side side effects such as impotence and incontinence. As a consequence, these side
effects significantly reduces the quality of life for affected patients and relatives.
Prostatype® is CE-marked and is already commercially launched in selected European
countries. Prostatype® is also approved for sales in USA where the subsidiary Prostatype
Genomics Inc. holds a so called CLIA-license and have established a partnership with
ResearchDX, Irvine, California, as the provider of lab services for the US market.
Prostatype® is expected to be commercially launched in USA during 2025 pending
reimbursement from Medicare, the largest provider of insurance coverage in USA. USA is by
far the world's largest market for prognostic biomarkers with an annual value of
approximately 200 MUSD.
The website of Prostatype Genomics can be found at https://www.prostatypegenomics.com/.
Lipidor AB is a Swedish, Stockholm based, company developing topical treatments offering unique lipid-based formulation opportunities for Pharma companies. Lipidor develops improved versions of already marketed products in order to cover either unmet medical needs or improve the quality-of-life of the patient. Our formulation is in the form of a fast-drying spray. Current focus is on psoriasis treatments where we aim to present HLR from a new Phase III study already by Q1-2025.
Acarix is a Swedish medical device company that innovates solutions for rapid AI-based rule out of coronary artery disease (CAD). The CE approved and FDA DeNovo cleared Acarix CADScor®System is intended for patients experiencing chest pain with suspected CAD and designed to help reduce millions of unnecessary, invasive and costly diagnostic procedures. The CADScor System uses advanced acoustics and AI-technology to rule out CAD non-invasively in less than 10 minutes, with at least 96% certainty. The CADScor System has been used on more than 29,000 patients and is recommended as a first-line diagnostic aid as outlined in the clinical workflow developed in collaboration with the American College of Cardiology (ACC). Acarix is listed on the Nasdaq First North Premier Growth Market in Stockholm (ticker: ACARIX).
SenzaGen (Nasdaq Stockholm First North: SENZA) is seizing high-growth opportunities in the in vitro
toxicology testing market, driven by the shift from animal testing to human-relevant solutions. With
both organic and acquisition-driven growth strategies, the company achieved over 500% growth
from 2020 to 2023, with continued momentum as demand for accurate, ethical alternatives
accelerates.
At the core of SenzaGen's offerings is GARD®, a pioneering testing method powered by genomics and
machine learning, delivering accurate, human-relevant results. This unique technology meets
rigorous industry standards and addresses unmet customer needs, positioning SenzaGen to capture
significant value in a rapidly expanding market. With capital dedicated to innovation, acquisitions,
and R&D, the company is advancing its offerings and scaling operations as it continuing its high
growth trajectory.
https://senzagen.com/