Spermosens AB, MEDICON VILLAGE, Scheeletorget 1, Lund (2025)

25/06/2024

Spermosens AB Announces Revised Strategy
Spermosens announce a revised strategy emphasizing an ambitious clinical
study, commercial partnerships, and operational efficiency. Starting in Q3 2024, the company will initiate a clinical study at the Reproductive Medicine Center (RMC) in Malmö to demonstrate the diagnostic value of its unique JUNO-Checked product.

Spermosens will intensify business development globally to identify the right
commercial partners through license deals in key markets for its ground-breaking JUNO-Checked product, which has the potential to help couples struggling with infertility.

Spermosens is preparing for an upcoming clinical study conducted at RMC in Malmö with Dr. Ingela Liljeqvist Soltic as principal investigator. Based on power-analysis the study is set up to involve an estimated 250 couples with so-called unexplained infertility undergoing IVF treatment. The purpose of the study is to investigate the male fertility related to a molecular recognition between s***m cells and oocyte via binding of two important proteins. A
positive outcome from this study can enhance IVF treatments, become a valuable diagnostic tool for s***m banks and as well to help couples experiencing fertility challenges prior to IVF treatment.

Spermosens is attracting interest from several companies in the field of assisted reproductive treatments (ART) and are actively pursuing strategic partnerships through licensing deals in several attractive markets, including the US and Japan. This strategic shift enhance efficiency, reduce costs, and position Spermosens optimally for success.

Dr. Tore Duvold, CEO of Spermosens, comments: “I am genuinely excited about theopportunity to help people struggling to have their own children. Our technology stands out as it may offer a personalized and improved fertility treatment, potentially leading to better fertility rates and a simpler treatment process. After thoroughly analysing our technology, strategic options, organization, and R&D partners, it is clear that we must now focus all our efforts on demonstrating the diagnostic value of our product and
seeking the right commercial partners to successfully bring it to the market. This requires us at Spermosens to be both efficient and cost-conscious. A positive outcome from the clinical study will be immensely valuable to both patients and our shareholders.”

Full story: https://lnkd.in/dBzhv8pk

The company's shares are listed on the Spotlight Stock Market. The shares have ISIN code SE0015346424 and are traded under the short name S***M. For more information, see www.s***mosens.com

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18/01/2024

Spermosens AB receives patent approval in Australia.

Spermosens AB announces that the Australian Patent Office (IP Australia) has approved patent 2019325300. Spermosens thereby obtains protection in Australia for its medical technology product including the biosensor, and its use for the selection of s***m suitable for In Vitro Fertilization (IVF treatment). The patent provides for exclusivity in the Australian market until August 23, 2039.

In Australia, over 100,000 treatments were performed in 2021 according to the National Perinatal Epidemiology and Statistics Unit (NPESU)[i]. Spermosens has already received approval for its patent in key markets in Europe, as well as in the USA, Japan, South Korea, Hong Kong and South Africa.

The fertility services market in Australia and New Zealand generated USD 709 million in 2018 and is projected to reach USD 1,020 million by 2026, growing at a CAGR of 4.6% from 2019 to 2026[ii].

"Spermosens patent protection extends until 2039 and currently covers several key markets. Strong patent protection is valuable for our development," says Ulrik Nilsson, CEO of Spermosens.

[i] https://lnkd.in/d2H668QQ
[ii] https://lnkd.in/dFB3R6WD

06/12/2023

Millions of couples around the world suffer from involuntary childlessness.

At Spermosens AB we are developing a new GOLD standard to assist medical professionals in selecting the most appropriate ART treatment.

Last week our CEO Ulrik Nilsson and Dr. Jae Yen Shin, CTO made a site visit to FlexMedical Solutions. So much work done in a short period of time and great progress made, not the least demonstrated by finalizing Gen 1.

Intense days, when meeting with the fantastic team at FlexMedical Solutions, and reviewing planned activities. Preparation for scaling up the fabrication process in line with FlexMedical Solutions Design for Manufacturing philosophy, ensuring functional performance is maintained as we scale. Having the right team working on the right things is key.

Spermosen's JUNO-Checked System is based on patented technology already granted in Europe, US, Japan and more.

The Gen 1 System is used continuously for the collection of scientific data at the Reproductive Medicine Center in Malmö[i]. Spermosens conducts tests of practical use and accumulates additional valuable information, to further develop the system.

Annually, 3-4 million IVF treatments are performed globally[ii], of which, unfortunately, fewer than 1 in 5 are successful[iii]. With several million treatments and a retail price of $250 per cassette, Spermosens sees a very large sales potential for the JUNO-Checked System.

17/11/2023

Spermosens AB publishes first results from the use of JUNO-Checked

Spermosens publishes its first JUNO-Checked results from testing done with human samples and demonstrates differences in s***m binding ability between patients.

Spermosen's JUNO-Checked system, based on patented technology, is used continuously for the collection of scientific data at the Reproductive Medicine Center in Malmö[i]. Spermosens conducts tests of practical use and accumulates additional valuable information, to further develop the system.

Spermosen's product is based on patented technology and opens up completely new possibilities for diagnostics. Annually, 3-4 million IVF treatments are performed globally[ii], of which, unfortunately, fewer than 1 in 5 are successful[iii]. With several million treatments and a retail price of $250 per cassette, Spermosens sees a very large sales potential for the JUNO-Checked System.

The diagram demonstrates using JUNO-Checked differences in s***m binding ability between patients. The results are deemed to be able to provide completely new and valuable information regarding the selection of the most suitable IVF treatment.

CE-marked instrument technology from PalmSens is used during testing. The technology also enables the testing of several simultaneous samples, which is positive for further development.

"Our current limit of detection (LOD) is already within the requirement for clinical use. We are excited to continue developing a system that will help improve decision-making around choosing the best treatment." says Dr Jae Yen Shin, CTO of Spermosens.

"The results are very promising and confirm that through methodical work we are developing a completely unique diagnostic product with the opportunity to make a difference for millions of people who suffer from involuntary childlessness," says Ulrik Nilsson, CEO of Spermosens.

[i] RMC Malmö is one of the three largest public IVF clinics in Sweden; under the auspices of Region Skåne and performs just over 2,000 embryo transfers annually.
[ii] https://lnkd.in/gUmMjSJU
[iii] https://lnkd.in/dRrnicmD - Fact sheet January 2022

07/11/2023

Spermosens AB receives patent approval in South Korea

Spermosens AB announces that the Korean Intellectual Property Office has approved the patent KR 10-2594453. Spermosens thus obtains protection in South Korea for its medical device including the biosensor, and its use for the selection of s***m suitable for In Vitro Fertilization (IVF treatment). The patent provides for exclusivity in the South Korean market until August 23, 2039.

The increase in patients being treated for infertility in South Korea has increased significantly since October 2017, when national health insurance was introduced. In 2017, 12,569 patients were treated for infertility, to increase to 130,746 patients in 2020*.

"South Korea is an important market in Asia, and it is very positive that Spermosens now also has patent protection on the South Korean market that extends until 2039," says Ulrik Nilsson, CEO of Spermosens.

*https://www.medicalkorea.or.kr/en/infertilityart

27/10/2023

Spermosens AB's JUNO-Checked system ready for sale

Spermosen's JUNO-Checked system, which is based on patented technology, is ready for sale for research use. Research use provides an important steppingstone for diagnostic sales.

JUNO-Checked system Gen 1 consists of three main components: a disposable cassette, an instrument, and an algorithm. Gen 1 is intended for research use, to further collect scientific data, evaluate practical use and accumulate additional valuable information. With Gen 1, Spermosens intends to build a market presence together with selected customers.

The successful development collaboration between Spermosens and the Reproductive Medicine Center in Malmö (RMC)* will ensure development that aims to meet the customer's requirements. The results of testing validating the core technology and confirming the functionality of the JUNO-Checked System are now fully documented and the Gen 1 system ready for launch.

The Gen 1 system already has a detection limit better than WHO requirements, demonstrating its clinical utility. The cassette design has been updated to improve functionality and to reduce environmental impact and manufacturing costs. The GEN 1 cassette will be used in combination with a CE-marked instrument already on the market. Utilization of CE-marked technology is deemed to benefit the continued development of the JUNO-Checked System.

"The completion of the JUNO-Checked system Gen 1 and its functionality is a huge achievement and an important steppingstone for Spermosens continued development”. says Dr. Jae Yen Shin, CTO Spermosens.

"With Gen 1, we are opening up completely new possibilities for developing assisted reproduction. The results we see are very promising, we are following our plan and taking the next step in commercialization," says Ulrik Nilsson, CEO of Spermosens.

*RMC Malmö is one of the three largest public IVF clinics in Sweden; under the auspices of Region Skåne and performs just over 2,000 embryo transfers annually.

11/10/2023

Spermosens AB receives patent approval in the United States

Spermosens AB announces that the American patent office, the United States Patent and Trademark Office (USPTO), has approved patent US 11,782,052. Spermosens thus obtains protection in the USA for its medical device including the biosensor, and its use for the selection of s***m suitable for In Vitro Fertilization (IVF treatment). The patent provides for exclusivity in the US market until August 23, 2039.

The American market is one of the world's three largest markets for IVF. Based on the Centers for Disease Control and Prevention's 2020 Fertility Clinic Success Rates Report, there were 326,468 ART cycles performed at 449 reporting clinics in the United States in 2020. The in vitro fertilization (IVF) market size in the United States was valued at USD 4.9 Billion in 2020 and is expected to reach USD 5.6 Billion by 2027.

"With the USPTO's approval, Spermosens also receives patent protection on the commercially very important American market," says Ulrik Nilsson, CEO of Spermosens.

The technology is based on two independent research groups discovery of the so-called The JUNO protein in oocytes: in mice in 2014 and in human oocytes in 2018. In connection with the discovery becoming public in 2018 saw Spermosens founder Kush Punyani and Sudha Srivastavas, previously active in fertility research, the possibilities of the discovery and applied for patent protection for the JUNO protein which indicator of male fertility.

20/09/2023

Spermosens AB JUNO-Checked Cassette Gen 1 (RUO) using patented technology completed.

Successful development work and clinical research at Spermosens, including the collaboration with Reproduktions Medicinskt Centrum (RMC) in Malmö has led to major improvements in the biosensor performance and the measurement method. Our results validate the core technology and confirm the functionality of the JUNO-Checked cassette used in combination with a CE-marked instrument for the JUNO-Checked System. Spermosens has patent protection for its medical device including the biosensor and its use for s***m selection. The development of the JUNO-Checked System for diagnostic use continues in accordance with Spermosens planning.

"We are extremely proud of the progress we are making with the completion of developing the core technology of the JUNO-Checked system. With the design freeze of the Gen 1 Cassette, we are now taking the next step towards commercialization.", says Ulrik Nilsson, CEO of Spermosens.

“This first time ever developed biosensor meeting a growing market gap was made possible through the dedicated and joint team efforts of Spermosens, RMC and FlexMedical Solutions Ltd.", says Dr. Jae Yen Shin, CTO Spermosens.

RMC Malmö is one of the three largest public IVF clinics in Sweden; under Region Skåne's auspices and performs more than 2,000 embryo transfers annually.

07/07/2023

Spermosens AB's JUNO-Checked demonstrates s***m's binding capacity.

JUNO-Checked demonstrates the ability of s***m to bind, using electrochemistry. Tests are carried out at Reproduktions Medicinskt Centrum (RMC) in Malmö and show promising results.

Tests were carried out with human samples and the results confirm the functionality of the product JUNO-Checked. The results are ground-breaking for the JUNO-Checked system’s development and ongoing work is underway to optimize the cassette's performance according to Spermosens planning.

“I am proud of our team, which has implemented and shown promising results with human samples. Looking forward to continuing an effective collaboration with our partners FlexMedical Solutions and the Reproductive Medicine Center in Malmö," says Dr. Jae Yen Shin, CTO Spermosens.

"The opportunity to conduct trials in close collaboration with RMC Malmö provides Spermosens with good conditions for successful development," says Ulrik Nilsson, CEO at Spermosens.

RMC Malmö is one of the three largest public IVF clinics in Sweden; under the auspices of Region Skåne and performs just over 2,000 embryo transfers annually.

Through the collaboration with FlexMedical Solutions, Spermosen gets access to expert knowledge, which reduces the project's risk profile and increases the probability of success.

07/06/2023

Spermosens AB JUNO-Checked cassette prototype tested.

Completion of the prototype cassette is an important step towards completion of the JUNO-Checked system for research purposes.

The JUNO-Checked system consists of an instrument and a disposable cassette. The development of the cassette takes place in close collaboration with FlexMedical Solutions. Using the cassette prototype, the first tests of how the instrument and cassette work together have started. Work on improving the cassette's performance continues in parallel. Through the collaboration with FlexMedical Solutions Ltd, Spermosens gets access to a high-quality, flexible production capacity. Initial calculations show good opportunities to manufacture cost-effectively even at lower volumes.

-"Collaboration with the right partners increases the probability of success, and I look forward to completing the JUNO-Checked cassette for research purposes together with FlexMedical Solutions Ltd.", says Ulrik Nilsson CEO at Spermosens.

FlexMedical Solutions Ltd has solid experience from the entire product development life cycle and has helped bring several products to market. Spermosens has gained access to expert knowledge in a tailored way, which reduces the project's risk profile and increases the probability of developing a product that is both technically and commercially successful.

"We at FlexMedical Solutions are happy about the trust that we have been selected as a partner for Spermosens, which is developing a ground-breaking product. The development together with Spermosens follows our proven methodology and we assess that the technical risk in the project has been further reduced. We are nearing completion of Generation 1 of the JUNO-Checked cassette for research purposes. We strive to do everything we can to create a healthier tomorrow through the power of diagnostics. ” says Kevin Fallon, CEO of FlexMedical Solutions Ltd.

01/06/2023

Spermosens AB has been given a grant from Vinnova to Attract, integrate and retain international excellence.

We are happy to welcome Carolin Psotta to join our team and support us on our mission to provide innovative male fertility diagnostics and treatment solutions for assisted reproduction.

Carolin Psotta is a researcher from the Marie Skłodowska-Curie Actions (MSCA) Fellow. MSCA has been established by the European Union / European Commission to support research within the European Research Area (ERA). The Marie Skłodowska-Curie actions are one of Europe's most competitive and prestigious research and innovation grants.

-"Carolin's skills complement our existing team, and further accelerate development," saysDr. Jae Yen Shin , CTO at Spermosens.

-"We develop ground-breaking products. Therefore, it is gratifying to be selected and receive support to attract and integrate excellence from MSCA to Spermosens' team," says Ulrik Nilsson, CEO at Spermosens.

25/05/2023

Exciting news!
JUNO-Checked Instrument for research purposes completed. Spermosens AB has together with OIM Sweden AB completed and streamlined the production of JUNO-Checked Instruments for research purposes.

OIM has conducted mechanical development, software changes and streamlined the production of the JUNO-Checked Instrument. OIM Sweden AB has solid experience in the development and manufacture of medical technology products, which together with an ISO certification guarantees high-quality production. Production capacity is flexible and ready to meet global demand.

“Completion of the instrument for research purposes is a major step in the work with the JUNO-Checked system. We are now optimizing how the instrument and cassette work together to complete the JUNO-Checked system for research purposes.", says Ulrik Nilsson, CEO at Spermosens.

"We are very grateful to be able to produce and implement improvements to Spermosens' revolutionary instrument that will make it easier for many people. The improvements ensure high quality and significantly reduce the manual assembly time. It feels extremely gratifying to be able to deliver the first JUNO-Checked Instruments so that the market can experience a ground-breaking product.”, says Ali Jehanfard, Co-founder at OIM Sweden.

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