Bionorica SE

A real-world evidence study published in JMIR reports results on a survey of 3,546 women in Germany, Austria, and Poland showing high pain burden but low diagnosis rates; targeted online campaigns demonstrated strong ability to engage affected, often undiagnosed, populations AUSTIN, Texas, Sept. 23, 2025 /PRNewswire/ -- SubjectWell, the patient experience platform driving predictable clinical trial recruitment and patient retention, announced the publication of a peer-reviewed paper in the Journal of Medical Internet Research (JMIR) underscoring the company's commitment to advancing the science of clinical trial recruitment and improving patient access, this time in women's health, focusing on menstrual pain and dysmenorrhea. "Millions of women live with significant menstrual pain but remain unseen by the healthcare system," said Fred Martin, CEO of SubjectWell. "This work shows that digital, patient-first outreach can meet people where they are, listen at scale, and invite them into research, ultimately expanding equity and accelerating evidence generation in women's health." The real-world evidence study, conducted via targeted Google and Facebook outreach across Germany, Austria, and Poland, examines diagnosis patterns, pain burden, and clinical-trial readiness among women experiencing menstrual cramps. Findings indicate a large diagnostic gap for dysmenorrhea despite substantial pain levels and show that direct-to-patient (DTP) communication can engage broad, diverse populations who are often missed in traditional medical settings. Key findings include: Significant diagnostic gap despite high pain Among respondents reporting symptoms consistent with dysmenorrhea, only 4.6% reported receiving a diagnosis even though 88.5% of affected women in Germany and Austria reported pain ≥6/10, with even higher pain levels observed in Poland. Digital outreach accurately finds the right patients Targeted online campaigns demonstrated high specificity, with 94.6% of surveyed respondents meeting symptom criteria for dysmenorrhea, supporting DTP strategies as efficient tools for surfacing under-recognized patients. Why diagnoses are missed Approximately 90.3% of women had not sought medical advice, were unsure of their diagnosis, or said their symptoms weren't recognized as pathological. Among those diagnosed, nearly half with dysmenorrhea-like symptoms were labeled PMS only, highlighting potential under-recognition of dysmenorrhea. PMS recognition is comparatively higher Of diagnosed cases, 77.3% reported a PMS diagnosis, and 8.6% of women with PMS symptoms reported being diagnosed, nearly double the dysmenorrhea diagnosis rate in the same population. The findings reinforce SubjectWell's evidence-driven approach to patient-centric recruitment. By quantifying reach and diagnostic gaps, the study suggests DTP strategies can broaden clinical-trial awareness among women who are undiagnosed or not currently seeking care, while providing researchers with a more inclusive view of real-world symptom burden. "We set out to understand how direct-to-patient communication could improve access for those experiencing menstrual pain," said Matthias Roos, Director of Scientific Affairs at SubjectWell. "The data clearly show digital strategies can connect with the right patients quickly and respectfully, laying the groundwork for more inclusive women's health research." This project was funded by and conducted in collaboration with Bionorica SE in the context of assessing clinical trial patient recruitment strategies and is acknowledged as such in the publication. The full article is available here: For more information on SubjectWell's patient recruitment solutions, visit . About SubjectWell As the premier Patient Experience Platform, SubjectWell drives predictable trial enrollment and improves retention by enhancing the patient journey from protocol design through study completion. Powered by technology, global reach, full-service creative, and a suite of services to reduce site burden—SubjectWell drives intelligence and efficiency for sponsors, CROs, sites, and site networks. From protocol development through recruitment, enrollment, retention, and post-trial real-world evidence studies, SubjectWell supports the entire clinical lifecycle. To learn more, visit . MEDIA CONTACT: Alysha Swisher / Haylee Elmore Interdependence PR [email protected] 6023501455 SOURCE SubjectWell WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Red Leaf Medical and Bionorica Announce Strategic Partnership to Launch Canephron in Canada, Offering a Breakthrough First-Line, Non-Antibiotic UTI Treatment. Mississauga, Ontario, Canada and Neumarkt, Germany — September 5, 2025 — Red Leaf Medical Inc., a leading Canadian healthcare company specializing in the field of urology, and Bionorica SE, one of the world’s foremost producers of scientifically researched phytopharmaceuticals, today announced their exclusive partnership to bring Canephron to the Canadian market. This innovative herbal medicine is a unique first-line, non-antibiotic treatment for acute uncomplicated urinary tract infections (UTIs), and holds the potential to significantly reduce antibiotic use and combat the rising threat of antimicrobial resistance (AMR). Currently marketed in over 41 countries, Canephron has earned global recognition as a clinically proven, first-line, non-antibiotic treatment for UTIs. With over two decades of growing sales and success, Canephron is the market leader in OTC market for UTI in Germany and has gained market share from antibiotics in countries like, Austria, Switzerland and Greece. A Novel Mechanism of Action with Proven Results Canephron’s unique formulation provides anti-inflammatory, anti-adhesive, analgetic and spasmolytic properties. This multi-target mechanism not only alleviates UTI symptoms such as dysuria, urgency, and frequency, but also helps normalize the host’s immune response by reducing inflammatory markers like IL-6 and IL-8, comparable to standard antibiotic therapy1. In a landmark Phase III randomized controlled trial2, Canephron demonstrated non-inferiority to fosfomycin, a first-line antibiotic, in managing acute UTIs. 83.5% of patients treated with Canephron did not require additional antibiotics, underscoring its potential as an effective first-line option. In a retrospective cohort study based on data from the IMS® Disease Analyzer database (IQVIA)3 in Germany, real-world evidence confirmed fewer recurrent UTIs, lower rates of additional antibiotic prescriptions, and reduced sick leave days among Canephron users versus those treated with antibiotics. A Public Health Opportunity to Combat AMR With urinary tract infections affecting nearly half of all women at least once in their lives and growing resistance to commonly used antibiotics, the introduction of Canephron in Canada marks a vital step toward improving patient care and advancing antimicrobial stewardship. “We are excited to partner with Bionorica to launch Canephron in Canada,” said Charles Ko, CEO of Red Leaf Medical. “This product addresses a critical clinical need with an evidence-backed, non-antibiotic solution. Its ability to deliver clinical efficacy while reducing reliance on antibiotics makes it a timely and powerful addition to our portfolio.” Red Leaf Medical intends to file a Product License Application to Health Canada in Q4 of 2025. Once approved, Canephron will be available to purchase without a prescription . About Canephron Canephron (BNO 1045) is a well-established phytopharmaceutical approved in 41 countries for the treatment and prevention of urinary tract conditions. Its clinically validated herbal formulation has demonstrated non-inferior efficacy to an antibiotic(fosfomycin) for the treatment of acute UTIs, symptom relief, microbiota preservation, and reduction in recurrence of UTIs. About Bionorica SE Bionorica SE is a global leader in evidence-based herbal medicine, headquartered in Neumarkt, Germany. The company integrates modern pharmaceutical research with traditional botanical knowledge to produce clinically effective, plant-based therapies. About Red Leaf Medical Inc. Red Leaf Medical is a Canadian healthcare company committed to delivering innovative, best-in-class therapies and services in urology. With a strong track record of commercializing novel products, Red Leaf Medical is trusted by urologists and urology nurses across the country. Media Contact: Red Leaf Medical Inc. info@redleafmedical.com +1 (905) 569-7771 Bionorica SE info@bionorica.de [i] Council of Canadian Academies, 2019. When Antibiotics Fail. Ottawa (ON): The Expert Panel on the Potential Socio-Economic Impacts of Antimicrobial Resistance in Canada, Council of Canadian Academies. [ii] Foxman B, Barlow R, D’Arcy H, et al. Self-reported incidence of urinary tract infection and associated costs. Ann Epidemiol 2000;10:509-15. https://doi.org/10.1016/S1047-2797(00)00072-7. [iii] Epp A, Larochelle. ASOGC clinical guidelines for rUTI. J Obstet Gynaecol Can 2017;39:e422-31. https://doi.org/10.1016/j.jogc.2017.08.017 [iv] Nicolle, L. (2013). Urinary Tract Infection. In J. F. M. Nunez, J. S. Cameron & D. G. Oreopoulos (Eds.), The Aging Kidney in Health and Disease. London, United Kingdom: Spring Science+Business Media. [v] Wagenlehner F, Wullt B, Ballarini S et al: Social and economic burden of recurrent urinary tract infections and quality of life: a patient web-based study (GESPRIT). Expert Rev Pharmacoecon Outcomes Res 2018; 18: 107-117. [vi] Nickel JC, Lee JC, Grantmyre JE, Polygenis D. Natural history of urinary tract infection in a primary care environment in Canada. Can J Urol 12:2728-2737, 2005. [vii] Renard J, Ballarini S, Mascarenhas T et al. Recurrent lower urinary tract infections have a detrimental effect on patient quality of life: a prospective, observational study. Infect Dis Ther 2015; 4: 125-135. [i] Anger J, Lee U, Ackerman AL. Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline. J Urol 2019;202:282-289.

Gleiss Lutz has advised the Japanese company Daicel Corporation.Daicel Corporation sold its German subsidiary Lomapharm GmbH to Bionorica SE by way of an auction process. The…