Leading Australian fertility group Genea to run first independent clinical study of JUNO-Checked

Källa: Cision
Positiv

Sammanfattning

Spermosens AB inleder ett samarbete med australiska Genea för en oberoende klinisk studie av bolagets JUNO-Checked diagnostik. Studien syftar till att utvärdera JUNO-Checkeds association med befruktningsresultat inom IVF.

Analys

Detta är ett viktigt steg för Spermosens kommersialisering då det är första gången JUNO-Checked utvärderas av en extern klinikgrupp. Samarbetet breddar bolagets kliniska program till en internationell marknad, Australien, som är en av världens mest avancerade IVF-marknader. Studien är prospektiv och observationsbaserad, och förväntas starta under mitten av 2027, beroende på etiskt godkännande.

Insikter

  • • Samarbetet med Genea, en ledande aktör inom fertilitetsbehandling, ger trovärdighet åt JUNO-Checked.
  • • Australien är en strategiskt viktig marknad med befintligt patent för JUNO-Checked.
  • • Studien fokuserar på att koppla JUNO-Checkeds resultat till IVF-utfall, vilket är centralt för produktens marknadsgodkännande.
Fundamental påverkan
Neutral

Avtalet med Genea är ett steg mot marknadsgodkännande för JUNO-Checked, men den direkta finansiella påverkan är initialt begränsad då parterna bär sina egna kostnader.

Omfattning: 3/10Liten påverkan
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Spermosens AB has signed a collaboration framework agreement with Genea Pty Ltd (Genea), one of Australia's leading fertility groups, which plans to conduct an independent clinical study of the Company's JUNO-Checked diagnostic in IVF cycles, subject to ethics approval and a separate study agreement. This is the first time JUNO-Checked will be evaluated by an external clinic group.

Male factor contributes to around half of all infertility cases, yet standard semen analysis says little about whether sperm can bind to and fertilize an egg. JUNO-Checked measures sperm binding to JUNO, the protein on the egg surface that sperm must bind to for fertilization. The study is an important step in Spermosens' path to market and broadens the Company's clinical program from its ongoing work in Sweden into an international setting. Australia is one of the most advanced IVF markets in the world, and one where JUNO-Checked is protected by a granted patent.

The prospective, observational study will run at one or more of Genea's clinics in Australia and will assess whether JUNO-Checked results are associated with fertilization outcomes in IVF. The study will include consenting patients undergoing IVF. Genea will provide the clinical laboratory team, IVF infrastructure and research governance, including ethics approval. Spermosens will supply the JUNO-Checked instrumentation, sensors and software. JUNO-Checked results will not be used to guide patient treatment during the study.

Each party carries its own costs. Commercial terms will be negotiated following achievement of study milestones.

The study is expected to start following Human Research Ethics Committee (HREC) approval, anticipated in mid 2027. Timing and results depend on several factors and cannot be guaranteed.

Tore Duvold, CEO of Spermosens, comments: “Australia is one of the most advanced IVF markets in the world. Being evaluated inside Genea's clinics puts us at the centre of clinical practice, which is where a diagnostic has to prove itself. In the end this is about helping couples who struggle to conceive get the right diagnosis and the most effective fertility treatment.”

Dean Morbeck, Chief Scientific Officer, Genea, comments:“Many couples with a normal semen analysis still experience poor or failed fertilization in IVF, and we have very few ways to predict it. A test of the sperm’s ability to bind to the egg targets part of that gap. Before any new test is offered to patients, we want to see how it performs in clinical IVF cycles, and this study is designed to show exactly that.”

For more information, please contact:

Tore Duvold, CEO

E-mail: info@spermosens.com

About Spermosens AB

Spermosens AB is a pioneering biotechnology company based in Sweden, focused on advancing fertility diagnostics through science driven solutions. The company develops cutting-edge technologies designed to improve fertility outcomes and streamline treatment pathways for individuals and couples facing infertility. The proprietary product, JUNO-Checked, provides a novel diagnostic approach that enhances precision and evaluations by measuring the sperm-egg binding capacity. JUNO-Checked supports more informed clinical decisions and individualized treatment strategies. Driven by a strong commitment to scientific excellence and patient care, Spermosens collaborates with leading research institutions to deliver transformative fertility diagnostics to the global market.

The company's shares are listed on the Spotlight Stock Market under the name SPERM (ISIN code SE0015346424). For more information, see www.spermosens.com.

About Genea Fertility

Backed by more than 40 years of experience, Genea’s national network of fertility clinics offers a complete range of services including fertility testing, IVF and ICSI, donor and surrogacy programs, and fertility preservation. At Genea, our vision is to provide a personalised approach to each individual who walks through our doors. We’re continuously committed to bringing together the best cutting-edge science with heartfelt patient care, delivering leading patient outcomes and IVF success rates. For more information visit genea.com.au

Genea media enquiries and interviews with Genea spokespeople: media@genea.com.au

This disclosure contains information that Spermosens is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 09-11-2026 08:06 CET.

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