MELBOURNE, Australia, March 12, 2024 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) is pleased to announce the appointment of Dr. Darren Patti as Group Chief Operating Officer (COO), effective 11 March 2024.

Dr. Patti joined Telix in March 2021 to lead the Company’s United States (U.S.) operations. Over the past three years as U.S. Chief Operating Officer and General Manager for the Americas region he has overseen the successful launches of Illuccix® in the U.S. and Canada, has led ongoing market development for Telix in Brazil and the Latin America (LATAM) region, and has been a key figure in the launch preparations for Telix’s follow-on imaging products Zircaix®^[1] and Pixclara™^[1]  (subject to regulatory approval). Prior to joining Telix, Darren held a variety of roles at Sofie Biosciences over a period of 15 years, most recently as Vice President of Operations leading the operationalisation of the Sofie-Lantheus PSMA-PET imaging program.

Darren holds a Doctor of Pharmacy (Pharm.D.) from the University of Illinois at Chicago and is an Authorised Nuclear Pharmacist.

Dr. Christian Behrenbruch, Managing Director and Group CEO commented, “Darren has been an exemplary leader in our Americas region and fundamental to the success of our commercial operations and vertical integration strategy. Darren’s deep experience in radiopharmacy network management and operations, combined with an intricate understanding of the Telix business makes him the ideal leader for our global operations function as we expand into new commercial markets and bolster our manufacturing capabilities to support our therapeutic and imaging programs. I am looking forward to continuing to work closely with Darren in this new role as we prepare to bring additional diagnostic products to market and drive towards our next phase as a leader in therapeutic radiopharmaceuticals and precision medicine.”

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.

Telix’s lead imaging product, gallium-68 (⁶⁸Ga) gozetotide injection (also known as ⁶⁸Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA),^[2]  by the Australian Therapeutic Goods Administration (TGA),^[3] and by Health Canada.^[4] Telix’s miniaturised surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, has attained a marketing authorisation in the U.S., having been registered with the FDA and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area for the intra-operative detection of sentinel lymph nodes (SLNs). With the exception of Illuccix® and SENSEI® as noted above, no Telix product has received a marketing authorisation in any jurisdiction.

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

Legal Notices

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. The information contained in this announcement is subject to change without notification.

This announcement may contain forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “outlook”, “forecast” and “guidance”, or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical studies, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix’s product candidates, if or when they have been approved; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the ASX or on our website.

To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions.

©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals, Illuccix®, SENSEI®, Zircaix®^[1] and Pixclara™^[1] names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

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OSAKA, Japan, March 11, 2024 /PRNewswire/ — Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President and CEO: Gyo Sagara; “Ono”) today announced that it entered into a five-year, university-wide strategic research alliance agreement with Harvard University (Cambridge, MA, USA; “Harvard“) aiming at validating novel therapeutic targets.

In this alliance, as part of our ongoing open innovation initiative to collaborate with external partners, the request for proposals will be for research projects focused on the validation of novel therapeutic targets from labs across Harvard University in Ono’s priority research areas of oncology, immunology, neurology, and specialty with high unmet medical needs. Working together with Harvard’s Office of Technology Development (OTD), Ono will support and fund research projects that are jointly selected. With the combined expertise and resources of both Ono and Harvard, this strategic alliance will promote our innovative drug discovery efforts.

Ono has been dedicated to the drug discovery and development of innovative drugs, focusing on priority areas of oncology, immunology, neurology, and specialty areas to fulfill unmet medical needs. Ono has generated a number of innovative medicines, by proactively promoting “open innovation” by working with external partners. Through our unique drug discovery approach based on open innovation, we will be committed to creating innovative drugs.

“We are pleased to work together with Harvard University, a leading institution developing cutting-edge technologies and advancing research through strategic alliances such as this one,” stated Toichi Takino, Senior Executive Officer / Executive Director, Discovery & Research at Ono Pharmaceutical. “Our alliance with Harvard University leverages the complementary strengths to accelerate the validation of novel therapeutic targets that would lead to the discovery of new drugs. We will continue to work hard to deliver innovative drugs for patients with unmet medical needs.”

“Harvard’s alliance with Ono underscores the university’s commitment to advancing our understanding and treatment of some of today’s most pressing health issues,” stated Vivian Berlin, Executive Director, Harvard Medical School in Harvard’s Office of Technology Development. “The alliance will support research projects that pave the way for a future where complex diseases are better understood and more effectively treated.”

“Strategic alliances  bring together academic discovery with industrial capabilities,” stated Isaac Kohlberg, Senior Associate Provost and Chief Technology Development Officer at Harvard University. “Not only accelerating the translation of groundbreaking discoveries into tangible innovations but also enriching academic research with real-world applications.”

About Harvard University’s Office of Technology Development

Harvard’s Office of Technology Development (OTD) promotes the public good by fostering innovation and translating new inventions made at Harvard University into useful products that are available and beneficial to society. Our integrated approach to technology development comprises sponsored research and corporate alliances, intellectual property management, and technology commercialization through venture creation and licensing. More than 100 startups have launched to commercialize Harvard technologies in the past 5 years. To further bridge the academic-industry development gap, Harvard OTD manages the Blavatnik Biomedical Accelerator and jointly oversees the Harvard Grid and the Climate and Sustainability Translational Fund. For more information, please visit https://otd.harvard.edu.

Source: Ono Pharmaceutical co., ltd.

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• Sensodyne has expanded its fastest growing Advanced range of Sensitivity and Gum with its latest innovation that helps relieve Sensitivity, restore Gum Health & strengthen Enamel.
• All-year round NEW awareness campaign to educate consumers on the importance of dealing with Enamel erosion and Gum problems – the two leading causes of tooth Sensitivity – in collaboration with healthcare professionals, social creators, and influencers.
• With the aim to unite Malaysians under the banner of a #BetterOralCareNation, Sensodyne offers one month of free dental check-ups – to be conducted across 1000 clinics in Malaysia in collaboration with the Malaysian Dental Association.

KUALA LUMPUR, Malaysia, March 11, 2024 /PRNewswire/ — This World Oral Health Day, Sensodyne, the #1 Sensitivity Toothpaste brand in Malaysia*, launched Sensodyne Sensitivity Gum & Enamel, a clinically proven, ground-breaking innovation with a specialized triple mode of action formula that provides long-lasting sensitivity relief, helps restores gum health, and strengthens enamel in two weeks. Its innovative Micro Foam technology effectively delivers the active ingredient (Stannous Fluoride) in hard-to-reach areas between teeth and along the gumline.

Oral health problems are considered to be largely preventable through effective oral hygiene, yet their prevalence remains high. In Malaysia, 94% of Malaysian adults have gum problems, 71% suffer from tooth sensitivity, and nearly 46% experience yellowing of teeth, which may be due to the loss of enamel, according to a 2021 Kantar study. These findings highlight a significant consumer need for solutions addressing a range of oral health concerns in Malaysia.

Sensitivity in teeth is primarily caused by gum issues and enamel erosion. Enamel is the outer most protective layer of the tooth which may weaken with time due to acids in common food and beverages, whereas gum problems stem from plaque bacteria accumulation.

“While many Malaysians face tooth sensitivity, gum problems, and enamel issues, solutions exist”, says Bryan Wong, General Manager, Malaysia, Singapore and Brunei (MSB), Haleon. Bryan added,  “Nine out of tens adults are at risk of enamel loss due to acidic foods, yet so many people are unaware of the effect it can have on our teeth. At Haleon, we believe that healthy teeth should not be an exclusive privilege. Through the introduction of Sensodyne Sensitivity Gum & Enamel and the #BetterOralCareNation campaign, we aim to inspire Malaysians to prioritize their oral health by presenting accessible solutions.”

Sensodyne is continuing its movement of #BetterOralCareNation to raise oral health awareness across Malaysia and motivate Malaysians to prioritize their oral health for healthier gums and teeth. The campaign includes a captivating television commercial, eye-catching outdoor advertising, engaging on-ground activities, and informative content across Sensodyne Malaysia’s website, social media channels, and traditional media platforms. By collaborating with healthcare professionals, social media creators, and influencers, Sensodyne aims to deliver channel-relevant reliable information.

The campaign officially launched on 1^st March, with the first event taking place on 7^th March at Sunway Velocity Mall in Kuala Lumpur, with free dental check-up (sensitivity, gum and enamel tests). As part of the engagement activities, the popular #BetterOralCareNation anthem is brought back on social media to inspire Malaysians to improve their oral health awareness and practices.

Sensodyne Sensitivity Gum & Enamel toothpaste can be found in pharmacies, dental clinics, minimarkets, supermarkets, and hypermarkets across Malaysia.

To learn more about the campaign, visit www.sensodyne.com.my or follow Sensodyne Malaysia’s Facebook and Instagram accounts.

*“GlaxoSmithKline Consumer Healthcare Sdn. Bhd. calculation based in part on data reported by NIQ through its Retail Index Service for the Sensitive segment within the Toothpaste category for the 12 months period ending April 2023, for the Total Malaysia Market. (Copyright © 2023, NIQ.)”

About Haleon

Haleon (LSE: HLN) is a global leader in consumer health, with a purpose to deliver better everyday health with humanity. Haleon’s product portfolio spans five major categories – Oral Health, Pain Relief, Respiratory Health, Digestive Health and Other, and Vitamins, Minerals and Supplements (VMS). Its long-standing brands – such as Advil, Sensodyne, Panadol, Voltaren, Theraflu, Otrivin, Polident, parodontax and Centrum – are built on trusted science, innovation and deep human understanding.

For more information, please visit www.haleon.com  

About Haleon Malaysia

Haleon (LSE: HLN) is a global leader in consumer health, with brands trusted by millions of consumers globally. Haleon Malaysia employs over 500 people whose purpose is to deliver better everyday health with humanity. With market leading positions in oral care, pain relief, and wellness, we work closely with pharmacists, physicians, and retailers to increase awareness of everyday health issues and concerns and emphasise the importance of self-care. Haleon’s Hulu Kelang site in Kuala Lumpur also supplies countries around the world with high quality and innovative consumer healthcare products, such as Panadol, ENO and Polident.

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Highlights

• Clarity recently reported that in its diagnostic Phase 1/2 trial, COBRA, ⁶⁴Cu-SAR-bisPSMA was found to be safe and highly effective in detecting prostate cancer (PC) lesions in patients with biochemical recurrence (BCR).
• In trial participants where standard of care (SOC) imaging was unable to detect any lesions, up to approximately 60% had lesions identified by same-day imaging with ⁶⁴Cu-SAR-bisPSMA and up to 80% on next-day imaging, with high specificity on both days. The number of lesions identified by ⁶⁴Cu-SAR-bisPSMA almost doubled from same-day (up to 80) to next-day imaging (up to 153).
• One of the reasons for the higher detection of lesions on next-day imaging was due to the ability of ⁶⁴Cu-SAR-bisPSMA to detect much smaller lesions compared to other prostate specific membrane antigen (PSMA) agents, including a lesion with a diameter of less than 2 mm.
• For all lesions, regardless of their size, ⁶⁴Cu-SAR-bisPSMA lesion uptake increased by more than 80% and lesion contrast increased almost 5 times when comparing same-day to next-day imaging.
• A key observation was the high uptake and contrast observed in lesions of less than 5 mm.
• More lesions and smaller lesions detected on next-day imaging could have a substantial impact on how patients are treated.
• The detection of lesions that are less than 5 mm in size by current PSMA positron emission tomography (PET) imaging agents (including PYLARIFY^® and the generic product ⁶⁸Ga-PSMA-11) is challenging, which possibly contributes to the low sensitivity of these agents.
• The information gathered from the Phase 1/2 COBRA trial, including the size of lesions that are detected by ⁶⁴Cu-SAR-bisPSMA, will be used to inform the design of the registrational Phase 3 trial in patients with BCR of PC.

SYDNEY, March 8, 2024 /PRNewswire/ — Clarity Pharmaceuticals (ASX: CU6) (“Clarity”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to share additional data from its diagnostic ⁶⁴Cu-SAR-bisPSMA trial, COBRA (NCT05249127)^[1].

COBRA was a multi-centre, single-arm, non-randomised, Phase 1/2 diagnostic imaging study of ⁶⁴Cu-SAR-bisPSMA administered to participants with BCR of PC following definitive therapy and who had a negative or equivocal SOC scan at screening. The primary objectives of the trial were to investigate the safety and tolerability of ⁶⁴Cu-SAR-bisPSMA as well as its ability to correctly detect recurrence of PC. Patients underwent PET/computed tomography (CT) scans with ⁶⁴Cu-SAR-bisPSMA on Day 0 and Day 1 (1-4h and 24±6h post-dose, respectively), which were interpreted by three blinded central readers. Following the recent announcement of positive results from the COBRA trial^[2], which began showcasing the many benefits of ⁶⁴Cu-SAR-bisPSMA, further analysis of the data reveals additional advantages of this optimised PSMA product.

⁶⁴Cu-SAR-bisPSMA was able to detect much smaller lesions than anticipated, including a lesion with a diameter of less than 2 mm. This compares favourably against the current SOC PSMA PET imaging agents, including PYLARIFY^® and the generic product ⁶⁸Ga-PSMA-11, with which the detection of lesions smaller than 5 mm is challenging. Sensitivity is a known challenge for the existing PSMA PET agents, particularly for lesions <5 mm^[3]-[6]. This suggests that lesions are missed by current SOC imaging, which can have significant implications on accurate staging and subsequent treatment decisions. For those undergoing initial staging of their disease, missing lesions may lead to unnecessary surgery resulting in long-lasting side effects (e.g. impotence and/or incontinence following the removal of the prostate)^[7]. In patients with BCR of PC, it is also crucial to identify their cancer early to avoid disease progression and the side effects of systemic treatments that accompany such therapies^[8].

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “The cornerstone of better therapy is better diagnosis, and we are incredibly excited about the substantial degree of improvement in detection of lesions with our bisPSMA product compared to SOC imaging. This difference is similar to comparing the old Hubble telescope to the new James Webb telescope, allowing us to visualise with much greater clarity, and to effectively change the paradigm of treatment to considerably improve the outcomes for patients with PC. Innovative products like ⁶⁴Cu-SAR-bisPSMA may prevent many millions of men from receiving inappropriate treatments and suffering substantial debilitating side effects from surgery or other therapies.

“When combining the optimised dual PSMA targeting agent with the ideal half-life of copper-64 (⁶⁴Cu), we continue to observe higher uptake and retention of ⁶⁴Cu-SAR-bisPSMA in PC lesions. We believe the ability of ⁶⁴Cu-SAR-bisPSMA to detect such small lesions is due to the higher uptake and retention of the product over time with high contrast (parameters measured by mean standardised uptake value [SUVmean], maximum standardised uptake value [SUVmax] and tumour-to-background ratio [TBR]). Small lesions become more readily detectable if the uptake of the product in the lesion is high and the background noise on the image is low. This effect enhances the contrast, making the lesion easier to detect, providing clinicians with valuable information on how to best treat their patients.”

The size of the PC lesions detected by ⁶⁴Cu-SAR-bisPSMA was recorded on the same-day (Day 0) and next-day (Day 1) imaging. Lesions with less than 5 mm in size were identified across readers among 14% (7/50) of patients (Figures 1 and 2). These lesions were located in the bone, pelvic and extra-pelvic lymph node regions. The smallest lesion (pelvic lymph node) identified in the study was 2.6 x 1.9 mm (Figure 3).

The SUVmax, SUVmean and TBR were assessed in up to 25 lesions per patient on the same-day and next-day ⁶⁴Cu-SAR-bisPSMA PET imaging. Mean SUVmean and SUVmax increased more than 80% (82% and 87% average increase across all readers, respectively) and TBR increased almost 5 times (4.8x average increase across all readers) comparing same-day with next-day imaging (ranges among readers, Day 0 and Day 1, respectively: SUVmean 6.6-9.9 and 14.7-15.8; SUVmax 13.9-14.0 and 22.2-33.4; TBR 23.2-25.4 and 118.1-181.7) (Graphs 1 and 2). Lesions of less than 5 mm in size had SUVmean, SUVmax and TBR value of 16.3, 16.8 and 90.1, respectively (mean values across all readers).

The ability of ⁶⁴Cu-SAR-bisPSMA to detect lesions less than 5 mm is a result of a few factors unique to the product. ⁶⁴Cu has a longer half-life (12.7 h) than the isotopes used in currently approved PSMA PET agents, such as gallium-68 (⁶⁸Ga) and fluorine-18 (¹⁸F) (<2 h), enabling next-day imaging, which is impossible with ¹⁸F- and ⁶⁸Ga-based agents. Clarity’s SAR Technology holds isotopes of copper securely inside a cage, preventing their leakage when administered to patients. Pre-clinical and clinical evidence has demonstrated that the optimised dual targeting molecule connected to the cage, bisPSMA, ensures increased targeting and retention of the product in PC tumours compared to its single targeting molecule counterpart and approved PSMA agents^[9],[10]. Results from Clarity’s Phase I PROPELLER trial substantiated this hypothesis as ⁶⁴Cu-SAR-bisPSMA showed detection of additional lesions and 2-3 times greater uptake within the same PC lesions compared to the generic SOC imaging agent, ⁶⁸Ga-PSMA-11. Furthermore, the initial positive results from the COBRA study, announced on the 15^th of February 2024^[2], showed that delayed imaging with ⁶⁴Cu-SAR-bisPSMA is able to detect PC lesions in up to 80% of patients with BCR of PC, who demonstrated negative or equivocal SOC imaging at screening. It also showed that the number of lesions detected by ⁶⁴Cu-SAR-bisPSMA almost doubled on delayed imaging compared to same-day imaging.

“The COBRA trial was designed to showcase the true benefits of bisPSMA compared to current SOC imaging, implementing a high standard of study design to validate our findings and utilise an unbiased view of assessment. The results are nothing short of extraordinary, and as we continue to adhere to best practice in clinical development, our science at Clarity is clearly differentiating us from our competitors. Combined with our clinical and pre-clinical evidence to date, this data further validates SAR-bisPSMA as a potential best-in-class PSMA agent for the diagnosis (with ⁶⁴Cu) and subsequent treatment (with copper-67 [⁶⁷Cu]) of PC. The benefits of ⁶⁴Cu-SAR-bisPSMA are now even more evident, given the highest scientific rigour applied to the COBRA study design, and confirmed by clinicians who reported that they would change their treatment plan in response to the ⁶⁴Cu-SAR-bisPSMA scan results in approximately half of their trial patients. Our COBRA trial was an exploratory first-in-human Phase 1/2 trial in BCR to generate information to allow us to meticulously design a Phase 3 registrational trial. Now that we know what we are looking for, including lesions in the 2 mm range, we can structure a Phase 3 trial in the BCR of PC indication to clearly differentiate ourselves from the first-generation PSMA agents as we head towards our ultimate goal of improving treatment outcomes for people with cancer,” Dr Taylor said.

About SAR-bisPSMA

SAR-bisPSMA derives its name from the word “bis”, which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) Technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR Technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or ⁶⁴Cu) for imaging and copper-67 (Cu-67 or ⁶⁷Cu) for therapy.

⁶⁴Cu-SAR-bisPSMA and ⁶⁷Cu-SAR-bisPSMA are unregistered products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA). A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available.

About Prostate Cancer

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide^[11]. The American Cancer Institute estimates in 2024 there will be 299,310 new cases of prostate cancer in the US and around 35,250 deaths from the disease^[12].

About Clarity Pharmaceuticals

Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancer in children and adults.

www.claritypharmaceuticals.com

References

1. Clinicaltrials.gov Identifier: NCT05249127. clinicaltrials.gov/ct2/show/NCT05249127
2. Initial COBRA results announcement. 15 Feb 2024. claritypharmaceuticals.com/news/cobra_results/
3. Pienta et al. A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with ¹⁸F-DCFPyL in Prostate Cancer Patients (OSPREY). Journal of Urology, 2021.
4. Hope et al. Diagnostic Accuracy of ⁶⁸Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection. JAMA Oncol, 2021.
5. Petersen et al. ⁶⁸Ga-PSMA PET/CT compared with MRI/CT and diffusion-weighted MRI for primary lymph node staging prior to definitive radiotherapy in prostate cancer: a prospective diagnostic test accuracy study. World Journal of Urology, 2019.
6. Surasi et al. Diagnostic Performance and Safety of Positron Emission Tomography with ¹⁸F-rhPSMA-7.3 in Patients with Newly Diagnosed Unfavourable Intermediate- to Very-high-risk Prostate Cancer: Results from a Phase 3, Prospective, Multicentre Study (LIGHTHOUSE). European Urology, 2023.
7. Stanford et al. Urinary and Sexual Function After Radical Prostatectomy for Clinically Localized Prostate Cancer. The Prostate Cancer Outcomes Study. JAMA, 2000.
8. Shore et al. Biochemical recurrence in patients with prostate cancer after primary definitive therapy: treatment based on risk stratification. Prostate Cancer and Prostatic Diseases, 2023.
9. Zia et al. A Bivalent Inhibitor of Prostate Specific Membrane Antigen Radiolabeled with Copper-64 with High Tumor Uptake and Retention. Angew Chem Int Ed Engl. 2019.
10. Lengyelova et al. ⁶⁴Cu-SAR-bisPSMA (PROPELLER) positron emission tomography (PET) imaging in patients with confirmed prostate cancer. ASCO, 2023.
11. Global Cancer Statistics 2020. GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660
12. American Cancer Society Key Statistics for Prostate Cancer. cancer.org/cancer/prostate-cancer/about/key-statistics.html 

This announcement has been authorised for release by the Executive Chairperson.

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SEOUL, South Korea, March 8, 2024 /PRNewswire/ — Wellysis, a digital healthcare company spun off from Samsung, has announced the launch of remote cardiac monitoring service in the US in partnership with Artella Solutions (ARTELLA).

This collaboration builds on its FDA-cleared S-Patch electrocardiogram monitoring solution, now featuring the newly FDA-cleared S-Patch ExL device. The ExL model allows for extended testing periods of about 14 days on a single coin battery and received FDA clearance in early February. With this milestone, Wellysis can now expand its reach in the Extended Holter service and Mobile Cardiac Telemetry (MCT) service.

Wellysis is introducing its S-Patch ExL solution to US patients thorough a partnership with ARTELLA, headquartered in Houston, Texas. ARTELLA provides comprehensive remote cardiac monitoring solution across 10 states. By teaming up, Wellysis and ARTELLA aim to deliver an unparalleled end-to-end cardiac monitoring service, commencing in Texas.

The newly launched program includes bundling of Samsung smartphones and smartwatches, seamlessly integrating with the S-Patch ExL device.

Wellysis CEO Young Juhn expressed excitement about this milestone collaboration, stating, “We are thrilled to partner with ARTELLA for our remote cardiac monitoring service in the US, introducing this end-to-end solution using S-Patch to US patients. This collaboration signifies the beginning of an exciting journey, with plans to integrate AI algorithms soon.”

Sepand Moshiri, Co-Founder and CEO of ARTELLA, commented, “This organic journey has led to a dynamic partnership with Wellysis, combining forces to redefine the future of patient care. Together, we are at the forefront of cardiac monitoring innovation, harnessing the power of artificial intelligence and virtual real-time monitoring.”

The groundbreaking collaboration will be unveiled at the upcoming American College of Cardiology (ACC) meeting in April.

In addition to this launch, Wellysis is actively working on obtaining FDA clearance for its AI algorithms, further cementing its commitment to innovation and advancing patient care.

About Artella Solutions Inc.

Artella Solutions Inc. is a forward-thinking digital health care company monitoring patients’ heart rhythms and assisting physicians’ paths from care to cure using the latest patch technology and artificial intelligence to detect and capture abnormal changes in heart rhythms.

The company provides health care providers with one system that meets their real-time diagnostic data needs for immediate viewing while advancing the well-being of their patients with heart rhythm disorders to ensure best clinical outcomes and economic benefits. To learn more, visit artellainc.com

About Wellysis

Wellysis is a digital healthcare company dedicated to revolutionizing patient care through innovative ECG monitoring solutions. The company was founded in 2019 as a spin-off from Samsung SDS’s Digital Health division by a team of experts with extensive experience in the healthcare field. Its flagship product, S-Patch, is a user-friendly, wearable ECG monitor that provides real-time data and advanced analysis, empowering clinicians and patients alike. The company has successfully expanded its business to overseas markets, with over 790 hospitals and clinics using the product worldwide.

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