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RESPINOR general news

Bulletin from the extraordinary general meeting of RESPINOR AB (publ)

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The following resolutions were passed at the extraordinary general meeting (the “EGM”) of RESPINOR AB (publ) (“the Company”) on 21 July 2022. The EGM was carried out through advance voting (postal voting) only.

Directed issue of warrants to lenders

The EGM resolved, in accordance with the Board of Directors’ proposal, to approve the Board of Directors’ resolution, made on 30 June 2022, on a directed issue of warrants to the lenders who have entered into a convertible loan agreement with the Company in July 2022. In short, the resolution includes a directed issue of not more than 1,111,112 warrants. Each warrant entitles the holder, subject to a warrant agreement, to subscribe for one share in the Company meaning that the Company’s share capital may increase by not more than SEK 277,778 and the number of shares may increase by not more than 1,111,112.

Stock option program and associated issue of warrants

The EGM resolved, in accordance with the Board of Directors’ proposal, to approve the Board of Directors’ resolution, made on 30 June 2022, to adopt a new stock option program in the Company for employees in the Company consisting of employee stock options. In short, the new stock option program includes an issue of not more than 490,000 employee stock options to not more than seven (7) participants with otherwise corresponding terms and conditions as for the current stock options in the Company. The EGM furthermore resolved an issue of not more than 543,900 warrants to the Company itself in order to ensure delivery of shares to the participants in the stock option program and to hedge potential costs connected to the program.

Remuneration to the Board of Directors and associated issue of warrants

The EGM resolved, in accordance with a shareholder’s proposal, that remuneration shall be paid to the Board of Directors, with SEK 120,000 to the Chairman of the Board and SEK 80,000 each to the other Board members, for the time period of June 2022 up to the Annual General Meeting 2023.

The EGM further resolved, in accordance with the shareholder’s proposal that the Board members shall be offered to receive all or part of their respective remuneration in the form of warrants through a directed issue of warrants. In short, the resolution includes a directed issue of not more than 656,712 warrants. Each warrant entitles the holder to subscribe for one share in the Company, at a cost of SEK 3,00 per share, during the time period of 1 September 2025 up to and including 12 September 2025, meaning that the Company’s share capital may increase by not more than SEK 164,178 and the number of shares may increase by not more than 656,712.

For further information, please contact:

Trude Tingvoll, CEO, RESPINOR AB
Tel: +47 474 53 313
E-mail: t.tingvoll@respinor.com

RESPINOR AB – Protokoll från Bolagsstämma 21 juli 2022 (utan röstlängd).pdf

RESPINOR AB – Minutes from General Meeting 21 July 2022 (without voting list)

NOTICE OF EXTRAORDINARY GENERAL MEETING IN RESPINOR AB (PUBL)

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The shareholders of RESPINOR AB reg. no. 559348-1806 are hereby given notice of the Extraordinary General Meeting to be held on 21 July 2022.

The EGM will be carried out through advance voting (postal voting) pursuant to temporary legislation. There will be no meeting with the possibility to attend in person or to be represented by a proxy.

See below attached information in both English and Swedish:

RESPINOR AB (publ) – Notice – EGM July 2022 EN

RESPINOR AB (publ) – Kallelse EBS juli 2022

ESPINOR AB (publ) – Notification of attendance and form for advance voting – EGM 2022

RESPINOR AB (publ) – Anmälan och formulär för förhandsröstning – EGM 2022

RESPINOR AB (publ) – Proxy form EGM July 2022

RESPINOR AB (publ) – Fullmaktsformulär EBS juli 2022

RESPINOR AB (publ) – EGM 21 July 2022 EBS 21 juli 2022 – Complete proposal item 6 Fullständigt beslutsförslag punkt 6

RESPINOR AB (publ) – EGM 21 July 2022 EBS 21 juli 2022 – Complete proposal item 7 Fullständigt beslutsförslag punkt 7

RESPINOR AB (publ) – EGM 21 July 2022 EBS 21 juli 2022 – Complete proposal item 8 Fullständigt beslutsförslag punkt 8

 

Stockholm, July 2022

RESPINOR AB (publ)

The Board of Directors

RESPINOR is strengthening the team preparing for commercialization of DXT

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 We are pleased to welcome our new Director of Business Development, Magdalena K. Gjefle, and our new CTO, Tristan Hollande to RESPINOR.

Magdalena K. Gjefle              Tristan Hollande

Magdalena is originally Swedish and has been living in Norway for more than 20 years. She holds a M.Sc in Finance from the London School of Economics and a M.Sc in Business Administration and Economics from the Gothenburg School of Economics.

Magdalena has 30 years of experience from a multitude of roles within business development, strategy, and finance, the past 12 years within the pharma/biotech sector.  She has a proven track record of leading innovation and commercialization teams and processes. Since 2018, Magdalena has held a position as Business Development and Licensing Executive at Inven2, leading negotiations for a large number of licensing agreements with global pharma and biotech corporations. In addition, she has been responsible for new venture creation and led the incubation and initial capitalization of Agiana Pharmaceuticals.

From 2010-to 2018, she was Director of Business Development in Weifa, where she played a key role in executing the company’s ambitious growth plan. Her main responsibilities included international partnering/licensing agreements for drug products and medical devices, development, and implementation of strategies for new market entrance, supply chain management, and various corporate development initiatives.

Magdalena started her career in Investment Banking and has worked in Stockholm, London, New York, and Oslo for Chase, DnB, and First Securities. At DnB and First Securities, she was head of research for the pharma and retail sectors. For more information: LinkedIn

Tristan is originally French and has been living in Norway for more than 18 years. He has a Diplome d’ingenieur en informatique/Master in computer science, Paris-Sud University (Paris XI), and Baccalauréat specialized in Maths and Physics, Lycée, Orsay, France.

Tristan has over 20 years of experience in engineering new products and software mainly related to sensor measurements, maps, and GPS positioning. During the last ten years, he has been engineering manager at Schlumberger and CTO at Think Outside, responsible for the R&D teams. He has experienced all phases of the development process: from proposing a project, setting up the team, conducting feasibility studies, engineering, and manufacturing a product with strict deadlines, then supporting the system in operation. In 2017, he managed a team of 25 specialized engineers in software, electronics, signal processing, and mechanics with a yearly budget of approx. 15M USD.

At Schlumberger, he led projects, including setting up the manufacturing processes to produce a few prototypes to more than 100,000 units and was directly involved in the CE testing and certification of the product.

He was CTO for a start-up company and managed a BIA project that has SINTEF and NGI as research partners. For more information: LinkedIn

RESPINOR AS Successfully completed Private Placement of approx. NOK 20 million (€ 2,0 million)

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The Company’s Board of Directors is pleased to announce that the Private Placement led by our financial advisor Corpura Fondkommission AB has been successfully completed, raising of approx. NOK 20 million (€ 2,0 million) in gross proceeds.

The net proceeds from the Private Placement will enable the completion of the ongoing clinical evidence study DE-RISK WF in France, Italy, and Norway. In addition, the proceeds will be used for the continued DXT product development to reach the design freeze, including CE mark submission to secure product launch by Q4-2022.

RESPINOR is working together with Corpura Fondkommission as our financial advisor and intends to list the Company’s shares at a stock exchange in Sweden during the beginning of 2022.

Trude Tingvoll, CEO of RESPINOR, said: “I am grateful for the commitment to the Company from our existing investors and from new Swedish investors that have joined the Company. We are now accelerating the process towards an IPO after a successful product development, where the clinical utility of RESPINOR DXT is documented. With our breakthrough technology, DXT, we aim to secure patients are liberated from the ventilator at the right time when the breathing muscle/diaphragm is strong enough to enable patients to breathe by themselves. I am proud to help these critically ill patients with an easy-to-use technology that will change respiratory health forever”.

About RESPINOR:

RESPINOR AS was founded in 2015 and is a Norwegian MedTech company. The Company is developing a new, non-invasive, ultrasound-based medical device to monitor the diaphragm, the main respiratory muscle, continuously. This is the first ultrasonic sensor that can be attached directly to the patient’s skin to ensure that they are taken off the respirator at the right time when the diaphragm is strong enough for patients to breathe by themselves. The technology has a wide range of potential benefits in several areas, and the Company’s product, based on this technology, is called RESPINOR DXT. The Company’s technology is, among other things, the winner of Horizon 2020 financing, both in phase I and II, and also won the Nordic Life Science Invest Rising Star Awards in April 2021 in the MedTech/Diagnostics category. RESPINOR has successfully completed clinical feasibility studies in Europe (France, Italy, and Norway) for the first target segment, mechanical ventilation, with technical proof of concept and proof of principle confirmed. RESPINOR has currently an ongoing clinical evidence study, DE-RISK WF, which began in April 2021, where they also include COVID-19 patients and is well underway with recruitment.

 

For further information, please contact:

Trude Tingvoll, CEO of RESPINOR AS

E-mail: t.tingvoll@respinor.com

Cell: +47 474 53 313

RESPINOR has started the last phase of the clinical program, DE-RISK-WF study in Europe, with DXT before regulatory submission (EU and USA)

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A multicenter, multinational clinical evidence study, including COVID-19 patients, to validate RESPINOR DXT’s performance to identify patients at increased risk of weaning failure (ClinicalTrials.gov ID: NCT04696406). RESPINOR has secured NOK 14.2M in soft funding from the Research Council of Norway to perform this study and to support our development to secure that our breakthrough technology, RESPINOR DXT, will be available for critically ill patients on mechanical ventilation worldwide.

The aim is to develop predictive indices to optimize the time patients are on mechanical ventilation (MV) by establishing cut-off values ​​to predict weaning outcome. DXT has the potential to optimize extubation timing, reduce re-intubation rate, improve patient outcomes, and reduce healthcare costs.

COVID-19 is arguably the worst pandemic the world has seen in 100 years and has caused more than 75 million cases and 1.6 million deaths worldwide as of mid-December 2020. It is deeply disrupting our health and socio-economic systems and provoking severe shortages of MV capacity, prompting an urgent need for accelerating the development and spread of technologies that can reduce the strain on these resources.

In 2020, RESPINOR finalized feasibility studies with proof of concept and technical proof of principle confirmed. The results were presented at the American Thoracic Society (ATS) International Conference 2021 (see link for abstract: https://www.atsjournals.org/doi/pdf/10.1164/ajrccm-conference.2021.203.1_MeetingAbstracts.A2766). In the feasibility studies, we identified a threshold value of 1.1 cm for weaning outcome. Now, we will confirm this threshold in the newly started Clinical Evidence Study:

  • Primary endpoint: Difference in the rate of weaning failure between patients with a diaphragm excursion (DE) < 1.1 cm compared to those with a DE > 1.1 cm. Median DE measurements taken during the second minute of the SBT will be used in the analysis to ensure that we identify ventilator-induced diaphragm dysfunction early. The hypothesis is that patients with DE < 1.1 will have a significantly higher rate of weaning failure compared to those with a DE > 1.1. The relative risk (RR) statistic will be used to assess the null hypothesis of equality.

Clinical application: If DE < 1.1 cm at time of weaning, the risk of weaning failure is increased due to the fact that the diaphragm has gotten too weak to enable the patient to breathe on their own. The physicians can now initiate rehabilitation of the diaphragm prior to weaning.

The study is expected to be completed in Q4 2021, following the planned product launch in Q4 2022.

Investigator team at Oslo University Hospital, Rikshospitalet. From the left: Andreas Barratt-Due (assistant head of department), Kine Green Pedersen (ICU nurse), Jon Narum (anesthesiologist), and Ingrid Dannevig Landsverk (anesthesiologist and PI). ICU nurse Siri von Krogh is the patient. Courtesy of OUS by Hedda Holth.

RESPINOR:

RESPINOR is a Norwegian MedTech company developing a novel, non-invasive, ultrasound-based medical device for continuous monitoring of the diaphragm, the main breathing muscle. The technology has a wide range of potential benefits in critical care and respiratory medicine,  and the company’s first product is called RESPINOR DXT (“DXT”). The company’s technology has twice been ranked the winner of Horizon 2020 funding, both in Phase I and II, and won the Nordic Life Science Invest (NLSInvest) Rising Star Awards in the Medtech/Diagnostics category in April 2021. The company has successfully completed clinical feasibility studies in Europe for the first target patient segment on mechanical ventilation (MV) with technical proof of concept, and proof of principle confirmed. RESPINOR has recently started a multicenter, multinational clinical evidence study, including COVID-19 patients.

High medical need:

MV is one of the most common therapies in the intensive care unit (ICU). It is treatment patients only receive in the most life-critical situations. Every extra day a patient is on MV the risk of permanent damage to the breathing abilities increases along with the treatment costs. It is, therefore, vital that patients on MV return to normal breathing as quickly as possible. There is currently a lack of predictive, accurate, and cost-effective solutions to support this process – and the introduction of new technologies is highly warranted. After extubation or liberation from the ventilator, breathing difficulties and respiratory failure can often be directly linked to diaphragm dysfunction.

In today’s clinical practice, diaphragm monitoring is not routinely performed, which means that diaphragm dysfunction often goes unnoticed. The introduction of DXT represents a paradigm shift. Annually, 4.5 million patients are treated with MV in the EU and US, costing the healthcare system €35 billion. The introduction of DXT will provide an objective measure of diaphragm function, to ensure that patients are liberated from the MV at the right time. If 10% of patients can be extubated just 1 day earlier, this represents a cost saving of €727 million per year, while providing significantly improved hospital care.

Problems with current methods: 

There is a significant unmet medical need to improve the weaning or liberation process from MV. And the rapid spread of COVID-19 is provoking severe shortages of MV capacity, prompting an urgent need for solutions that can reduce the strain on these resources. If the patients are too long on MV, the risk of permanent damage to their breathing ability increases. However, if they are extubated too early, they risk reintubation. The risks associated with reintubation are severe, including prolonged length of MV support, increased mortality, and increased costs to both the hospital and society. With today’s standard of care, as many as 30% of patients are re-intubated. The introduction of RESPINOR DXT will provide an objective measure of diaphragm function, to assist the specialists in determining when the patient can be liberated from the MV without complications.

 

Interview: The winners of the NLSInvest Rising Star Award

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Fransisco Rojas, Michael Rutzler and Trude Tingvoll
Photo of Francisco Rojas, Business Development Manager, RetinaRisk, Michael Rutzler, CEO, ApoGlyx and Trude Tingvoll, CEO, Respinor

The three Rising Stars, Swedish ApoGlyx, Norwegian Respinor and Icelandic RetinaRisk, share their companies’ histories and journeys so far and also, their advice to other life science entrepreneurs.

Following a long review of the applications by a pan-Nordic committee of industry leaders, 80 Rising Stars were selected to pitch to investors across three dedicated tracks: biotech/pharmamedtech/diagnostics and digital/e-health. One company from each track was selected as the category winner during the NLSInvest event, April 19th.

The “best of the best” of our entrepreneurs

This year’s NLSInvest Rising Star Awards are sponsored by SwedenBIO and BioInnovation Institute (BII), an international life science entrepreneurship initiative and part of the NLSInvest Committee.

“We believe the Nordic ecosystem has all the ingredients required for success and are happy to see international investor interest in the NLSInvest Rising Star companies. Our view is that high-growth Nordic start-up companies must play on a global playing field, and the Rising Star Award is a step in that direction. We wish the participants and the winners of the competition continued success,” says Bobby Soni, Chief Business Officer at BioInnovation Institute.

“We look upon this as the Olympics of life science innovation, where each Nordic country’s strength in this field is proudly demonstrated by the “best of the best” of our entrepreneurs,” says Helena Strigård, CEO of SwedenBIO, the Swedish Life science Industry organization and host of NLSInvest / NLSDays.

For full Interview profiling RESPINOR, follow the link: https://nordiclifescience.org/interview-the-winners-of-the-nlsinvest-rising-star-award/

RESPINOR Announced Winner at the Nordic Life Science Investment Days

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Over 150 Nordic companies applied to the launch of the first-ever Nordic Life Science Investment Day, NLS Invest. Following a long review of the applications by a pan-Nordic committee of industry leaders, 80 Rising Stars were ultimately selected to pitch to investors across three dedicated tracks: biotech/pharma, medtech/diagnostics and digital/e-health.

From the 80 Rising Stars, one company from each track was selected as the category winner, and RESPINOR was announced winner of the Medtech/Diagnostics tracks. See the full press release in the link below:

https://press.swedenbio.se/posts/pressreleases/apoglyx-respinor-and-retinarisk-announced-as

Kitron and RESPINOR in MedTech partnership

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Kitron and RESPINOR AS have entered into a strategic long-term agreement. Kitron will be providing manufacturing and technical services as RESPINOR is getting ready for commercial manufacturing of its breakthrough technology: RESPINOR DXT. This is the first ultrasound-based sensors that can stick to the skin to provide continuous monitoring of our main breathing muscle, the diaphragm, leading to improved Intensive Care Unit (ICU) patient outcomes and shorter patient stays.

“Kitron and RESPINOR have already cooperated on prototypes, and this new agreement forms a solid platform for industrialization and ramp-up to make RESPINOR DXT available for critically ill patients worldwide,” said Trude Tingvoll, CEO of RESPINOR.

“Kitron has a long track record of helping customers convert ideas into manufacturable technology products, and we specifically look for companies with substantial growth potential. RESPINOR’s products will have an immediate positive impact on patients in ICU’s. This is especially relevant in these Corona fighting days, but also in the long term”, said Israel Losada Salvador, COO & Chief Sales Officer of Kitron.

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RESPINOR awarded 14.2M NOKs from the Research Council of Norway

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Christmas arrived early! We are pleased to announce that RESPINOR has secured 14.2M NOKs in soft funding from the Research Council of Norway to perform our pivotal study (DE-RISK WF) which will commence in Q1-2021! This will take us one step further to secure that our breakthrough technology, RESPINOR DXT, will be available for critically ill patients on mechanical ventilation world wide.

Thank you to the Research Council of Norway for supporting innovation in Norway within MedTech!

https://www.forskningsradet.no/nyheter/2020/forskningsradet-investerer-602-millioner-kroner-i-mer-innovasjon-i-naringslivet/

RESPINOR winner of the European Innovation Councils (EIC) ePitching event for COVID-19 solutions

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COVID-19 is deeply disrupting our health and socio-economic systems and provoking severe shortages of MV capacity, prompting an urgent need for accelerating the development and spread of technologies that can reduce the strain on these resources. The European Innovation Council (EIC) brought together over 50 public and private procurers, five European corporates, and more than 20 EIC-backed SMEs for an EIC ePitching on COVID19-solutions. We are excited to share that RESPINOR was announced the winner of the ePitching session with RESPINOR DXT – That provides an objective and continuous measure of diaphragm function, hence improves clinical decision-making in critically ill patients’ weaning readiness from mechanical ventilation. More information about the event can be found here: https://community-smei.easme-web.eu/articles/eic-epitching-procurers-covid-19-finding-common-solutions-together