Europe's Top 5 Medical Device Companies to Watch in 2023

1. January Issue 04 2023 Industry Insights Understanding The Aspects That Empower Innova?ons In Europe’s Medical Devices Europe's Top Medical Key Approaching Measures Transforma?on Approaching In Leading Medical Device Companies Companies to Watch in 2023 Palliare Taking Healthcare to New Heights

2. Be?er Health and a better way of life.

4. Editor’s Note SHIFTING THE DYNAMICS OF CARE H ow patients receive care, has been shifted from hospitals to the comfort of their homes. Today, a rising number of people prefer to maintain their sense of autonomy and independence by taking greater responsibility for their health, rather than handing it over to doctors. Technological advancements such as the use of medical devices today are proving to support these health-conscious individuals in their journey of health. For instance, instead of waiting long hours at the doctor’s clinic, patients could keep track of their diseases such as diabetes or hypertension which enables them to make lifestyle choices accordingly. Some assistive medical devices are in use for a long time, such as dosing cups for the administration of medications, first aid equipment such as thermometers, heating pads, and prosthetic devices such as artificial arms or legs, and other related. But recently, newer medical devices are starting to migrate there.

5. They are presenting newer opportunities for both healthcare professionals as well as consumers to deliver and seek health in a safe, usable, and cost- effective manner. healthcare to a whole another level, through their innovative services within the medical device industry. If you are enthusiastic about medical devices, then the following companies will not only inspire you but also provide you with meaningful insights that have led them to the position they are in today. The growing sophistication of medical equipment has significantly improved the health of the individual and society. It has improved individual survivability in the face of disease or injury, greatly enhancing patients' life through an accurate diagnosis and therapeutic results. But it is not the only benefit that the advancement has brought. With the climbing costs of healthcare facilities as well as the lack of enough healthcare staff who can attend to every minute concern of the patient, the medical devices act has eased the tension and improved healthcare sustainably for both the patients and healthcare providers. In the following edition of Insights Care, “Europe's Top 5 Medical Device Companies to Watch in 2023,” we present you those companies who have lifted We hope you have an insightful read! Abhishek Joshi

6. C O 08 Cover Sto PALLIARE Taking Healthcare to New Heights

7. N T E N T S 16 24 32 DIVE MEDICAL Transforming Eye-tracking through Artificial Intelligence INJEQ Leading with Precision, Care and Confidence MOWOOT Articles Novelties Ensuring the Quality of Life Industry Insights Understanding the Aspects that Empower Innova?ons in Europe’s Medical Devices 20 Key Approaching Measures Transforma?on Approaching In Leading Medical Device Companies 28

8. Editor-in-Chief Pooja Bansal Senior Editor Anish Miller Managing Editor Abhishek Joshi Assisting Editors Saloni Agrawal Visualiser David King Art & Design Head Mrunalinee Deshmukh Co-designer Paul Belin Art & Picture Editor Sonia Raizada Business Development Manager Amy Jones Marketing Manager John Smith Business Development Executives Sarah Wilson, John Smith, Alex Vincent Sales Executives Kelli, Bill, Anna Technical Consultants David, Robert Assistant Technical Head Prachi Mokashi Technical Head Jacob Smile Digital Marketing Manager Alina Sege Assistant Digital Marketing Manager Renuka Kulkarni SME-SMO Executives Gemson Research Analyst Eric Smith Circulation Manager Tanaji Fartade sales@insightscare.com January, 2023 Contact Us: Insights Success Media Tech LLC 555 Metro Place North, Suite 100, Dublin, OH 43017, United States Phone - 302-319-9947 Email: info@insightscare.com For Subscription: www.insightscare.com Insights Success Media and Technology Pvt. Ltd. Office No. 22, Rainbow Plaza, Shivar Chowk, Pimple Saudagar, Pune, Maharashtra 411017 Phone - India: 7410033802, 74100058552 Email: info@insightscare.com For Subscription: www.insightscare.com https://twitter.com/Insightscare Follow us on : www.facebook.com/InsightsCare/ We are also available on : Copyright © 2022 Insights Success Media and Technology Pvt. Ltd., All rights reserved. The content and images used in this magazine should not be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from Insights success. Reprint rights remain solely with Insights Success Media and Technology Pvt. Ltd. Insights Care is powered by Insights Success Media and Technology Pvt. Ltd.

9. Europe's Top Medical Companies to Watch in 2023 Company Featuring Brief Bredent UK Ltd. supply the dental market with products from a single German manufacturer bredent GmbH & Co located in Senden, south Germany. Bredent UK Ltd Bredent.co.uk Stephen Denman MD DIVE Medical company has been dedicated to enable precise and objective exploration of the visual functions not only in children but in all non- collaborative patients. DIVE-Medical Dive-medical.com Marta Ortin CTO & Co-founder Injeq is a company that founded a solution to to make lumbar punctures safer and more precise through its Injeq IQ-Tip®, a spinal needle that detects gives out an audio alarm to the physician after detecting spinal fluid. Maarit Forsten Clinical Application Manager Injeq Injeq.com MOWOOT Mowoot.com The company is known for its medical device MOWOOT, which is a non-laxative solution against chronic constipation. Dr Markus Wilhelms CEO and Co-founder Palliare, a company that is innovating in the insufflation space, is working toward creating a safer operating environment that provides better physician control and patient outcomes Palliare Palliare.com John O’Dea CEO

10. Palliare Taking Healthcare to New Heights Palliare's vision is to become the world technology leader in advanced insu?ation by innovating to meet the needs of minimally invasive procedures.

12. Europe’s Top 5 Medical Device Companies to Watch in 2023 I mproving patient care with new technologies is critical to continue to improve procedural outcomes and patient quality of care. In recent years, there has been significant evolution in many spaces within the medical field that have benefited both patient outcomes as well as providers’ ability to deliver top care. Many of these advancements have come with a greater focus on integrating technology into medicine. better control for physicians conducting these cases. The company created a compact insufflator tailored to the evolving needs of endoscopic, laparoscopic, and robotic surgery. An engineer by trade, John spent his early career working for Puritan Bennett, where he designed ICU ventilators. Later, in 1998, he Co-founded Caradyne, which developed non-invasive ventilation products for ER and NICU settings. The company was acquired in 2004 by Respironics (NASDAQ: RESP). Palliare, a company that is innovating in the insufflation space, is working toward creating a safer operating environment that provides better physician control and patient outcomes. In 2007, he founded Crospon, which developed a novel diagnostic product called EndoFLIP. This device assesses sphincter performance and motility in the gastrointestinal tract. This company was acquired by Medtronic in 2017 (NYSE: MDT). We had the opportunity to speak with Palliare CEOJohn O’Dea to learn more about this cutting-edge company and the man behind its vision. The Company’s Inception and Efforts John shares, “In 2018, a year after Medtronic acquired Crospon, I founded Palliare. We received FDA clearance for its flagship insufflator device, EVA15, in 2020. We offer two leading solutions: the EVA15 and the EndoTrap, and our vision is to continue to evolve the EVA platform to bring more innovations in surgical and endoscopic insufflation to market.” Palliare is an organization that has been a highlighted name in the healthcare sector. CEO John O’Dea has a legacy and reputation for being a leader in creating solutions to challenges that medical professionals face during surgical and endoscopic procedures. Products, Services, and Their Impacts Before Palliare, John founded a company called Crospon, which operated in the endoscopy space and was later acquired by Medtronic (NYSE: MDT) in 2017. During this period, he spent ample time observing advanced endoscopic procedures. In the last two decades, he observed the shift in endoscopy from being purely diagnostic to providing surgical treatments. The EVA15 insufflator and smoke evacuation system provides best-in-class laparoscopic, robotic, and surgical endoscopic insufflation. It meets AORN guidelines on surgical smoke evacuation, which is important to support the safety of the OR and endoscopy suite staff and adhere to a recent legislative drive to ban surgical smoke in the OR. Insufflation, where gases are injected into the surgical cavity, had been left untouched and was not being evolved to meet the needs of these more complex and longer endoscopic and laparoscopic. During the pandemic, John’s well-known legacy of innovation brought him and Palliare a new opportunity. He shares, “In 2020, during the COVID-19 crisis, we were selected by the European Commission to design devices to reduce potentially contaminated gases emitting from the patient during surgery and endoscopy. The project, called PORSAV (Protecting OR Staff From Aerosolized Virus), was completed in July 2022. Two devices, EndoTrap and LeakTrap, were developed by the project consortium for which Palliare was the technical lead.” Regarding this concern, John says, “In the same period, we have seen the evolution of laparoscopic surgery to robotic surgery. Similarly, insufflators have only started to evolve to meet the emerging needs of these procedures — particularly concerning managing smoke evacuation and leaks from trocars.” EndoTrap was born during COVID-19 but continues to have a strong role beyond it. The device is designed to From this observation, an opportunity was born to innovate in the insufflator space and provide a safer environment and

13. improve staff safety by reducing exposure to airborne particles during upper endoscopy and bronchoscopy procedures. A protective barrier is created around the patient’s nose, mouth, and endoscope using a single-port anesthesia mask and viral filter, along with the EndoTrap, which consists of a T-piece, a valve, and a protective sleeve. EndoTrap is intended to be used during high-risk bronchoscopy and upper GI endoscopy procedures. A key aspect of the EVA15 design is that when smoke is evacuated from the surgical cavity, fresh gas is injected into the cavity so that the surgeon experiences no collapse or reduced visibility. Pressure is sampled 100 times per second so that the response to evacuation is almost instantaneous and there is no perceived change in the pressure. The company’s main product, EVA15, is an insufflator with a built-in smoke evacuation system. Any surgical smoke removed from the patient is filtered through an ultra-low particulate (ULPA) filter, which can trap particles down to 0.04um in diameter. This is important to protect OR staff from smoke produced during these procedures.

14. While talking about the EVA15, John adds, “A key aspect of the EVA15 design is that when smoke is evacuated from the surgical cavity, fresh gas is injected into the cavity so that the surgeon experiences no collapse or reduced visibility. Pressure is sampled 100 times per second so that the response to evacuation is almost instantaneous and there is no perceived change in the pressure.” We o?er two leading solutions: the EVA15 and the EndoTrap, and our vision is to continue to evolve the EVA platform to bring more innovations in surgical and endoscopic insu?ation to the market. Envisioning the Future In the coming years, Palliare is focused on moving the insufflation field forward with exciting developments in intelligent insufflation, such as advisory capabilities to guide surgeons to the optimum insufflation pressure, thus reducing the risks associated with hyper-insufflation. Stating the primary goal of Palliare, John says, “We will be exploring these techniques with the anesthesiologist community, not only for the perioperative phase of a procedure but also with a focus on exploring whether or not smart insufflation can reduce postoperative pain for patients. The company has a lot of exciting innovation goals that will make procedures safer for the medical community and help improve patient outcomes.” It does this by consistently delivering the correct pressure, thus keeping clear visibility during the procedure. John adds, “We have worked with AORN to produce an accredited CE course, Understanding the Challenges of Laparoscopic Insufflation, to educate the OR community on how the smoke evacuation and insufflation systems can be designed to operate to meet the needs of all staff in the OR.” The company is seeking to bring to market the world’s first bi-level insufflator to allow insufflation pressures to be quickly changed intra-procedurally, a feature of central importance in new, emerging endoscopic surgery procedures. Promising Safety Many smoke evacuators operate continuously, regardless of whether or not smoke is being generated. This leads to continuous CO2 being pumped into the OR. Challenging and Changing the Scenario There is a strong legislative agenda, particularly in the U.S., to ban surgical smoke in the operating room. Many insufflators can’t keep the pressure consistent when gas is extracted by standalone smoke evacuation. As a result, surgeons experience a compromised surgical field due to decreased visibility when the gas is removed. As Palliare looks to the future, it is seeking to make this a safer environment for all involved. John adds, “We are working on the way to have a surgical robot or energy system inform the insufflator when it needs to turn on and off smoke evacuation to reduce the unnecessary CO2 produced and emitted during a procedure.” This technical issue has caused major concern in the OR. Everyone agrees surgical smoke is dangerous, but so is forcing surgeons to operate with sub-optimal visibility during a procedure. Using Emerging Technologies “As the company’s founder, it is my focus to continuously develop, innovate, and advance the insufflation space,” John says. As an example, Palliare believes that insufflators should have a layer of communication with other A newer insufflation technology, like EVA15, eliminates this compromise and facilitates both a safer environment for the surgical staff with proper smoke removal and a safer procedural environment for the physician and patient.

15. instruments in the OR and has embedded an API in the EVA15. This allows manufacturers of laparoscopic, endoscopic, and robotic systems to remotely control the insufflator. Over the past decade, there has been li?le innovation in insu?ation technologies designed to inject gas into the surgical cavity. In particular this technology has not evolved to meet the needs of more complex, longer endoscopic procedures. Similar to how we saw laparoscopic insulation needing to evolve to address the needs of laparoscopic robotic surgery, we see a need to move forward insu?ation technology in the emerging fields of endoscopic and robotic endoluminal surgery. We are now working with a number of emerging leaders in both the laparoscopic and endoluminal robotic surgery spaces. Words of Wisdom Palliare has always had the interests of people–both the patients and the clinicians delivering the care–at heart. John’s best advice to any medical technology or device developer is to be “needs-driven” instead of “technology- driven.” He shares “We are excited to have recently obtained a U.S. patent for energy-activated smoke evacuation in continuous pressure insufflators. This is important because it means that CO2 waste is reduced, and less gas is needlessly evacuated from the surgical cavity. With most competitors, smoke evacuation is continuously activated for the entire procedure.”

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19. DI E-Medical V I challenge. The standard visual tests are majorly designed for adult patients with normal cognitive development. It is hardly possible to use the same tests in younger children or patients with developmental issues. n the current times, early detection of visual problems in infants, children below the age of three, and patients with neurocognitive disorder remain a significant From then on, several of the people who had worked in the research of the device within the institutions joined the company, in which we are already seven employees. Please give us a brief overview of your journey in the healthcare niche, highlighting the USPs of DIVE Medical. DIVE is a device that allows us to explore the visual function of any patient, even those with whom doctors cannot communicate (infants, young children, or people with neurocognitive problems) and who are more difficult to examine (such as patients with low vision). It is a great challenge for professionals to explore these patients, and the results they can obtain are often subjective and inaccurate. For this reason, the DIVE Medical Device has been developed to enable precise and objective exploration of the visual functions not only in children but in all non- collaborative patients. With a mission to provide universal, affordable, and effective means to prevent vision impairment, DIVE Medical's Chief Technology Officer and Co-founder, Marta Ortin, believes in the vision of ensuring early vision diagnosis and treatment. DIVE is able to perform a complete visual examination of these patients and provide objective and accurate measures of their visual function. In this way, we help make an earlier and more reliable diagnosis and facilitate the follow-up of pathologies and visual therapies. What are the core values upon which DIVE Medical is built? What is its vision and mission? Our vision is to grow DIVE to become the national and international standard for exploring the visual function in all patients and become a reference in visual test development. Our mission is to universalize eye care by offering new technologies that allow the early detection, diagnosis, and follow-up of visual pathologies in all types of patients. Our values are integrity, effectiveness, accountability, collective talent, and the pursuit of excellence. What is your opinion on the necessity for the healthcare industry to leverage the emerging trends of technology concerning fulfilling your client's requirements in the healthcare industry? The introduction of technology in the healthcare industry brings tremendous potential applications. In particular, in In an interview with Insights Care, Marta talks about DIVE and how the device is helping doctors in the early diagnosis and treatment of visual problems in small children and babies. Below are the excerpts from the interview: Please tell us about DIVE Medical in detail. DIVE began as a collaborative research project between ophthalmologists and opticians from the Aragon Health Research Institute and engineers from the University of Zaragoza (Spain). When we presented our results at congresses, professionals in the field expressed a lot of interest in our project. They often told us that they would like to be able to use our device in their practice and that they thought it was something useful that could benefit many people. Encouraged by the good reception, we started this entrepreneurial adventure and found the company DIVE Medical in early 2020. (17) January | 2023 www.insightscare.com

20. Please give us a few testimonials of your clients/customers and a list of awards/recognitions that accurately highlight DIVE Medical's position as a booming company in the healthcare sector. the ophthalmology field in which we work, without using technology, it is very challenging to explore certain patients (including babies, patients with neurocognitive disorders, or the elderly population), with results being very subjective and non-repeatable, and with some visual functions being impossible to measure. By introducing technology, these challenges can be overcome. In particular, DIVE has a screen on which we display stimuli designed to evaluate different aspects of the visual function. In addition, we incorporate eye-tracking technology, which allows us to know the point on the screen where the patient is looking at any given moment, and deep learning for an automatized analysis of the outcomes. What was your inspiration and commitment behind developing innovative healthcare products to improve people's lives? Testimonials from ophthalmologists with whom we ran a research project: "DIVE is a tool that puts technology at the service of clinical needs. It provides the ophthalmologist with very valuable information because it is capable of analyzing and quantifying visual functions as it had never been achieved before. It is especially useful for pediatric ophthalmology, where explorations can be difficult. DIVE captures children's attention from the beginning, and their collaboration is much better." - Teresa Pérez Roche. Pediatric Ophthalmologist. Hospital Universitario Miguel Servet, Zaragoza (Spain). We started working on this project to solve the need the ophthalmologists of our research team had every day during their clinical practice. As soon as we started working on the development of DIVE, we were able to see the impact of our work in a very close and immediate way. Our biggest motivation is DIVE's tangible beneficial impact on many patients; this is the most gratifying thing for us. As an established industry leader, what would be your advice to the budding entrepreneurs and enthusiasts aspiring to venture into the healthcare industry? "It is a very useful device for decision making. Experience and the subjective impression of the specialist are often needed to make a diagnosis. DIVE facilitates decision- making since it provides objective and quantitative data. It is also useful for patient follow-up, allowing to see their evolution and transmit the results. DIVE makes the office visits easier." - Sandra de Fernando. Ophthalmologist. Hospital Universitario Cruces, Bilbao (Spain). "Interesting device for a deeper analysis of ocular and saccadic movements. In children with neurological problems, it is [traditionally] more complicated to evaluate this function. Exploring contrast sensitivity and color perception is also very interesting for children whose diagnosis is more complex. Traditional tests are more boring, but through games [in DIVE] it is more enjoyable for children. Good experience with children that have syndromes or neurological problems. Useful for young children, with whom doubts arise when making a diagnosis." I would tell them to have a clear objective and high motivation. This is a complex sector that constitutes many paperwork requirements and a prolonged entry process. In turn, it is very rewarding to see how something you have worked on for years helps improve the lives of people. What are your future goals, and how do you envision further strengthening the stronghold of DIVE Medical in the healthcare sector? We are currently focusing on applying our technology for visual exploration, but it has already opened up a lot of exciting opportunities. Besides incorporating new tests into our existing DIVE device, we are also planning on developing visual therapy exercises and systems for the automatic early detection of neurological pathologies that affect vision, such as Parkinson's, Alzheimer's, or autism. - Marta Galdós. Ophthalmologist. Hospital Universitario Cruces, Bilbao (Spain). (18) January | 2023 www.insightscare.com

22. Understanding the ASPECTS that Empower Innovations in Europe’s MEDICAL DEVICES T he implementation of digital health strategies and services has undergone a considerable revolution as a result of the paradigm shift from provider-centered healthcare to patient-centered healthcare. Each nation's healthcare regulatory agencies play a crucial role in creating the best systems, strategies, and procedures to optimize care delivery and provide patients with the best possible treatment. The majority of Western European nations currently have policies or strategies that outline the goals of eHealth implementation, the objectives of eHealth, and a future road map for expanding and introducing additional healthcare services. Next-generation health informatics solutions are being introduced in nations with more developed healthcare ICT infrastructure, such as the United Kingdom, Germany, the Netherlands, Sweden, Denmark, Norway, and Finland, to enhance patient-centered treatment. (20) January | 2023 www.insightscare.com

23. Industry Insights (21) January | 2023 www.insightscare.com

24. care units, the integration of medical device data with patient medical records improves patient monitoring and surveillance. Device connectivity has the ability to decrease human error while boosting operational effectiveness, which is advantageous to both patients and clinicians. Below are some of the aspects that have empowered innovations in Europe’s Medical Device Industry. Healthcare Cloud Technologies More products are being supplied through remotely hosted deployments rather than on-premise dedicated server models as the medical software market evolves. As a result of this inescapable transition to cloud-based digital health services, most providers will no longer need to maintain expensive and unsafe data centers. The industry is anticipated to grow over the next two to three years as providers in Western Europe migrate to cloud-based care management systems like hospital information systems (HIS), ambulatory care management systems, patient management systems (PMS), electronic medical/health records (EMR/EHR), and electronic prescribing. A few providers also provide hybrid cloud models with benefits including remote backup, disaster recovery, high resource availability, and security and support for mobile devices. mHealth & Healthcare Mobility Bring-your-own-device (BYOD) and bring-your-own- application (BYOA) solutions are becoming more and more popular in the healthcare industry as a result of the convergence of mobile solutions and healthcare technologies. The growth of this industry is primarily attributable to the increased adoption of smartphones, connected medical devices, health wearables, mHealth apps for the management of chronic diseases, and robust 3G and 4G network penetration that provides uninterruptible connectivity for digital healthcare services. Conclusion Healthcare System Integration and Interoperability Services The healthcare industry in Western Europe has long been regarded as being unreachable or less desirable as a target for IT advancements. This is unquestionably no longer the case, and the future in the evolving healthcare industry holds many wonderful possibilities for fresh chances. The installation of a safe and inter-institutional networked infrastructure by providers seeking to improve healthcare delivery is the main driver of the enormous development seen in the European healthcare IT sector. By gradually replacing legacy and non-interoperable healthcare IT systems with systems that support open standards-based data interchange, the aim is to further reduce administrative expenses, avoid human errors, optimize the use of medical data, and improve the quality of services. Western Europe is predicted to experience brisk expansion in the market for healthcare systems integration. Many applications, including medical record systems, medical device integration, laboratory integration, radiology integration, hospitals and clinics integration, telehealth portals, home health, and other applications, heavily rely on integration and interoperability services. Fast healthcare Interoperability Resource (FHIR) and SMART on FHIR, the organization's next-generation standard frameworks that make use of the most recent Web standards and place a strong emphasis on implementations, have emerged to address the challenges of clinical and administrative data interoperability in the real world. The best strategy to ensure that Western European countries supply high-quality healthcare to their citizens is to encourage eHealth advances of medical devices in the healthcare industry. The health systems can benefit from increased patient empowerment, workflow optimization through digital means, a more competent workforce, more effective and sustainable health and care systems, and responsive governmental administrations. Medical Device Data Integration Into Care Delivery Process In high acuity care units, the integration of medical device data with patient medical records improves patient monitoring and surveillance. Device connectivity has the ability to decrease human error while boosting operational effectiveness, which is advantageous to both patients and clinicians. Along with device integration, other services like clinical alarms based on Early Warning Scores (EWS), predictive analytics, virtual critical care units, and warning systems for emergency response teams can assist doctors practise preventive care and enhance results.In high acuity - Anish Miller (22) January | 2023 www.insightscare.com

26. Europe's Top 5 Medical Device Companies to Watch in 2023 Leading with Precision, Care and Confidence ealthcare advancements that were mere ideas H enhancing the quality of life. Medical devices have been a vital part of these advancements and can enable technology for its applications to help a better cause, thus is the story of Injeq. performing the procedure cannot see where the tip of the needle is. Until now, the advancement of the needle was based on the haptic feeling in their fingertips and knowledge of the human anatomy. For instance, avoiding nerves and finding cavities like the spinal cavity for cerebrospinal fluid have been based on the professional experience of the medical practitioners so far. decades ago are coming to fruition, proving to be much more valuable to saving human lives and What are your key products and services? How are you revolutionizing the market with them? Injeq was founded when a group of experts in the fields of technology and medicine saw that blind punctures were problematic as they introduced leukemia cells from the blood to the central nervous system. The company found a solution through a medical need: to make lumbar punctures safer and more precise. Its Injeq IQ-Tip® is a spinal needle that facilitates lumber punctures. It gives out an audio alarm to the physician when the needle tip detects spinal fluid based on bioimpedance detection. In a conversation with Maarit Forsten, the Clinical Application Manager of Injeq, she talks more in depth about the organization’s clinically proven product. We are manufacturing bioimpedance spectroscopy-based needles with tissue recognition. Our current solution is a spinal needle that recognizes cerebrospinal fluid on the needle tip. For the last 100 years, nothing particularly new has happened with spinal needles. Now we have this innovative needle that, after detecting cerebrospinal fluid, gives an alarm to the physician performing the lumbar puncture. This has turned out to be very efficient in avoiding the typical and sometimes critical complications related to lumbar punctures. Below are the highlights of the interview: Please brief us on the company’s professional milestones so far. Please brief us about your company and what ideas and developments led to its inception in the medical device niche. The problem of blind punctures and tissue recognition was found by Professor Ritta Seppänen -Kaijansinkko based on all the patient injury reports she had received while working in this patient injury board. Injeq was founded based on the problems of blind punctures, i.e., punctures during which the doctor (24) January | 2023 www.insightscare.com

27. Until now, the advancement of the needle was based on the haptic feeling in their fingertips and knowledge of the human anatomy. But now we have this innovative needle, the Injeq IQ-Tip®, that, after detecting cerebrospinal fluid, gives an alarm to the physician performing the lumbar puncture. This innovation has the potential to improve the safety of all blind punctures and decrease the incidence of related complications, reducing the overall cost of health care in the process. How has technology aided your goal of innovating in the medical device industry? What are your key adaptations of technology in your company? Our current main solution is cerebrospinal fluid detection for challenging and, eventually, for all lumbar punctures. Generally, this innovation has the potential to improve the safety of all blind punctures and decrease the incidence of related complications, this way reducing the overall health care costs also remarkably. What are the challenges that you have faced till now? How have you infused your leadership skills to turn them into opportunities for your company as well as for the industry? The first challenge was to get CE approval for Injeq’s medical device, which represents the highest risk class 3 (25) January | 2023 www.insightscare.com

28. according to the new Medical Device Regulation. CE mark was gained in December 2021. After this marketing approval, the first distributor contracts were signed, and the sales to the biggest European markets were aimed to start. The next challenge was the price of our device, which in the beginning was ten times more expensive compared to the conventional way of making lumbar punctures. However, by improving our manufacturing processes we were able to remarkably reduce the initial prices (almost half of the original). In addition, we have good clinical evidence of the benefits achieved with Injeq IQ Tip system. reactions, or other harm to the user or patient. Lastly, listen to the feedback all the way through. What are the future goals of your company? How do you envision scaling up its growth and operations in 2022 and beyond? We are planning to find other beneficial application areas for bioimpedance-based tissue recognition. The goal is to make the earlier passive needles active to improve safety, efficiency, and patient experience and reduce overall healthcare costs. As an experienced leader, what would be your advice to budding entrepreneurs wishing to enter this industry? First, consult the clinical world about what they need, which means—do not make the innovation first and then go to market, but vice versa. Second, choose the lowest possible risk group for your medical device; choose the indication area not having contact with the central nervous system, heart, or big blood vessels, which automatically makes your device class 3. Third, choose the materials and manufacturing processes so that there are no risky materials like nickel or processed chemicals that cause allergies, toxic (26) January | 2023 www.insightscare.com

30. Key Approaching Measures (28) January | 2023 www.insightscare.com

31. Transformation APPROACHING in Leading Medical Device Companies C ompanies in the medical device business (also known as MedTech), which is under increasing price pressure from healthcare providers and contending with declining returns from mature technologies, must now look for novel methods to boost their bottom lines. For medical equipment to continue to be cost-competitive in the future, supply chains must be digitalized. Business executives continue to express increasing concern about the tough price competition and downstream pressure in the MedTech sector. Less expensive technology, value- and outcome-based payment methods, and stricter regulatory procedures are demanded by payers, providers, and governments. Additionally, in a time of rising out-of-pocket (OOP) expenses, patients have evolved into value-conscious shoppers. Patients are increasingly price sensitive and prone to skipping treatment when faced with high deductibles, even while they are willing to pay out of pocket for high- quality premium services. Prices for MedTech devices have fallen further in the face of these challenges. These players must not only offer exceptional features but also outstanding value to patients and providers while minimising expenses in order to counteract dropping pricing. Below are the transforming approaches adopted within the leading medical device companies. Thinking Big, Starting Small, and Acting Fast We advise a "dream large, start small, act quickly" strategy because disruptive digital medical devices and digital supply (29) January | 2023 www.insightscare.com

32. Conclusion networks may have broad repercussions. The first stage is to create a future-state image of a supply chain that is optimised from suppliers to providers to patients. In order to reduce the risks and show early success to stakeholders, start with small adjustments. In order to gain swift victories, medtech companies should focus on issues that have the potential to unleash value at several stages. Building on early achievements, businesses can continue to create DSNs in areas where doing so makes both strategic and economical sense. MedTech companies can concentrate on new technologies and frameworks as a way of fending off threats and favourably impacting their bottom line, despite the difficulties that may appear insurmountable. Using digital supply networks (DSNs) to improve operational efficiency and give their customers more value would be a good start. Some of the areas where MedTech companies can seek benefits when adopting digital technolgies involve: Inventory management, Logistics and distribution, device maintenance, Product development, and warehouse operations. Developing New Workforce Skills and Capabilities To effectively utilise DSN's potential, MedTech businesses must schedule time and resources, train their workforces, and train themselves. In general, rather of concentrating on department-specific operations, the workforce should become more tech-savvy and able to handle multiple duties. Companies may increase supply chain visibility, lower maintenance and R&D costs, boost customer happiness, and enhance patient experiences by implementing digitalization in these areas. There are three reasons why it's crucial for the workforce to be knowledgeable about digital solutions: - Anish Miller • The users of digital solutions must be able to derive value from them as consumers of the underlying technology. • The workforce needs to be educated on the tools and processes being deployed, the order of new technologies to be adopted, and their expected impact as customers of digital solutions. • Teams need to be ready for a changed working relationship with IT as they implement digital solutions since individual teams may replace IT as the principal owners of technology. Adopting Agile Systems for DNS development and Deployment To achieve significant change across the business, MedTech organizations must adopt an agile strategy to DSN development and deployment. With this method, requirements can be developed incrementally rather than all at once. Adopters can modify development based on constantly changing aims with enhanced confidence in the initiative's ultimate success thanks to adopters' agility in refining and modifying. (30) January | 2023 www.insightscare.com

34. Dr Markus Wilhelms CEO and Co-founder Novelties Ensuring the Quality of Life (32) January | 2023 www.insightscare.com

35. Europe's Top 5 Medical Device Companies to Watch in 2023 T working hand-in-hand with technology, and healthcare workers have to embrace emerging healthcare technologies to stay relevant in the coming years. What are the core values upon which MOWOOT is built, and What is its vision and mission? he future of healthcare is shaping up in front of our very eyes with advances in digital healthcare technology and nanotechnology. This rests in Since the beginning, the MOWOOT team has been guided by direct contact with patients and caregivers to develop and market our solution to solve an unmet need and improve the quality of life in patients with intestinal transit disorders. In medicine and healthcare, digital technology could help transform unsustainable healthcare systems into sustainable ones, equalize the relationship between medical professionals and patients, and provide cheaper, faster, more effective solutions for diseases. Technologies could simply lead to healthier individuals living in healthier communities. What is your opinion on the necessity for the healthcare industry to leverage the emerging trends of technology to fulfil your client's requirements in the healthcare industry? Firstly, I'd state understanding the unmet need, including all relevant stakeholders, and finding the simplest possible solution is crucial. Simplicity is elegance. Innovation does not necessarily need to be complicated. However, if a simple and elegant approach includes an 'emerging trend,' then go for it. Leveraging the latest advancements, MOWOOT,a growth- stage medical device company has developed a medical devicethat stimulates the large intestine in a non-invasive way. It is also marketing a novel, purely physical, non-drug, and non-invasive solution to chronic intestinal transit disorders, such as neurogenic bowel disorders (NBD), opioid-induced constipation (OIC) or chronic idiopathic constipation (CIC). What was your inspiration and commitment behind developing innovative healthcare products to improve people's lives? Under the proficient leadership of Dr Markus Wilhelms, CEO and Co-founder, MOWOOT has received the 'FDA Breakthrough Device Designation' for the critical impact on patients' quality of life, which opens the door to the large US market. Our founder team consists of four people with different professional backgrounds. What we have in common is that we want to have a positive impact on the patients and also on society. In an interview with Insights Care, Dr Markus Wilhelms sheds light on the innovations empowered by MOWOOT in the healthcare industry. Dr Wilhelms, please tell us about MOWOOT, its USPs and what makes it a successful company in the healthcare sector. MOWOOT team has been guided by direct contact with patients and caregivers to develop and market our solution to solve an unmet need and improve the quality of life in patients with intestinal transit disorders. The multidisciplinary founder team of MOWOOT met in 2013 in the dHealth Barcelona program for 'needs-driven innovation,' a European version of Stanford University's Biodesign program. Applying innovation methodologies like design-thinking and based on over 500 patient interviews, the team developed a solution to a significant unmet need in bowel management in collaboration with leading neuro- rehabilitation hospital Institut Guttmann and constituted the company in November 2014. The MOWOOT device is now already available in several European markets and is even recommended in various clinical guidelines. (33) January | 2023 www.insightscare.com

36. Please give us a list of awards/recognitions that accurately highlight your organization's position in the market. Among 23 companies, in an extraordinary all-digital Redefining Early-Stage Investments -RESI- conference edition, MOWOOT was voted as the 'Best Medical Device Company' of the event and achieved second place in the overall rating of the most voted company. MOWOOT received the seal of approval "Impact Business" for start-ups with social impact after a thorough analysis by the Ship2B foundation in the framework of their Tech4Health acceleration program. We firmly believe that to do so, to really reach as many people as possible, you not only need to have an innovative product but also implement it into a viable business model. Innovating in healthcare is one of the most difficult types of entrepreneurship, but we accepted the challenge! MOWOOT is the winner of the Best Overall Company st Award (1 place) as the company with the most votes of all three categories (MedTech, biotech and digital health) of the European Health Catapult at the EIT Health Summit in London. As an established industry leader, what would be your advice to the budding entrepreneurs and enthusiasts aspiring to venture into the healthcare industry? European Health Catapult is an acceleration program and start-up competition. It awards the best-of-the-best innovation concepts from MedTech, biotech, and digital health across Europe.MOWOOT is the winner of the st Audience Award (1 place) in the MedTech category of the European Health Catapult at the EIT Health Summit in London. First, start with understanding the unmet need and its environment/stakeholders and do lots of interviews to learn about this. You will have to develop a quantifiable value proposition for your solution, taking all stakeholders' needs into account (including payors, regulators, etc.) Apply the "scientific method" to business creation: build > measure > learn (repeat) MOWOOT also achieved second place in the Healthcare Professional Jury awards in the MedTech category of the European Health Catapult at the EIT Health Summit in London. Nowadays, there are very well-developed tools available to guide novice entrepreneurs in their healthcare adventure, for example, the GAITS system by CIMIT in Boston. I wish we would have had access to this type of tool when we started—highly recommended! What are your future goals, and how do you envision further strengthening the stronghold of MOWOOT in the healthcare sector? We plan to enter the public healthcare reimbursement in several EU markets regarding business development. Moreover, market entry in the USA is the next natural step for MOWOOT. Regarding products, we are working on a pediatric version of our device to answer a market pulled by many parents and caregivers who contacted us. (34) January | 2023 www.insightscare.com