News

Oslo, July 21, 2023 -RESPINOR AS, (“RESPINOR ” or the “Company”), a privately held clinical-stage medical device company focused on improving clinical decision-making in critically ill patients in the intensive care unit (ICU), announced the appointment of Anders Wold as Chair of the Board, with immediate effect.

Anders Wold started his career in the field of medical ultrasound in 1984 when he joined the start-up Vingmed which was acquired by GE Healthcare in 1998. He has nearly forty years of leadership experience in the healthcare and ultrasound industry, including President and CEO of GE Healthcare Clinical Care Solutions.

The current Chair of the Board and main shareholder Aage Bryn will assume the Board member role. The rest of the Board will continue in their current roles, Jan Fikkan as Vice Chair and Marco Renoldi, Carl Christian Gilhuus-Moe, and Otto Skolling as Board Members.

Aage Bryn, Chair of the Board, commented: “We are delighted that Anders has accepted the role of Chair of the Board. He is a perfect match for Respinor at this stage of development. He has unique knowledge of the ultrasound business as well as broad international experience and contacts within the MedTech industry. This will be extremely valuable for us when embarking on the next stage to commercialize and launch DXT on the market.”

Anders Wold stated: “I am thrilled to join RESPINOR and chair the Board. RESPINOR is at an exciting stage with an innovative platform technology, a unique ultrasound solution with a product addressing a significant unmet clinical need in the respiratory space. It will be very exciting to take this to market for support of patients undergoing critical ventilation.

In addition, the platform technology is set for several new applications. It is striking to discover the potential and how this may have many familiar similarities to how we created and evolved the global ultrasound industry.“

About RESPINOR:

RESPINOR AS is a privately-owned medical device company founded in Oslo, Norway, in 2015 and established as a holding company RESPINOR AB (publ) in Stockholm, Sweden in 2022. The Company is developing a novel, non-invasive, ultrasound-based medical device, RESPINOR DXT (Diaphragm Excursion Technology) for continuous monitoring of the diaphragm, our main breathing muscle, to improve clinical decision-making in critically ill patients in the intensive care unit (ICU). This is the first ultrasound sensor that can be attached directly to the patient’s skin for early detection of diaphragm dysfunction (DD) and continuous monitoring of diaphragm function. The technology has a wide range of potential benefits in several clinical areas. The Company’s technology is the winner of Horizon 2020 financing, both in phase I and II, and the Nordic Life Science Invest Rising Star Awards in 2021 in the MedTech/Diagnostics category. In 2022, RESPINOR received a Seal of Excellence from the EU Commission. RESPINOR has successfully completed clinical feasibility studies in Europe (France and Norway) for the first target segment, mechanical ventilation, with technical proof of concept and proof of principle confirmed. RESPINOR is currently in the process of finalizing the clinical evidence study, DE-RISK WF II Study in France and Norway, which will be the basis for the regulatory CE mark and FDA submission, with planned DXT launch by Q4-2024. See more on: www.respinor.com

For more information, please contact:

Trude Tingvoll, CEO/VD
RESPINOR AS/RESPINOR AB
Email: t.tingvoll@respinor.com

The shareholders of RESPINOR AB (publ), reg. no. 559348-1806 (the “Company”), are hereby given notice of the Extraordinary General Meeting (the “EGM”) to be held on 14 July 2023 at 14:00 CEST at Fredersen Advokatbyrå’s premises, Birger Jarlsgatan 8 in Stockholm. Registration starts at 13:30 CEST.

See attached information in both English ad Swedish below:

RESPINOR AB (publ) – Kallelse EBS 14 juli 2023

RESPINOR AB (publ) – Notice EGM 14 July 2023

RESPINOR AB (publ) – Fullmaktsformulär

RESPINOR AB (publ) – Proxy form

Anders Wold CV

RESPINOR AB (publ) – Styrelsens redogörelse enligt 13 kap 6 §, 14 kap 8 och 32 §§ aktiebolagslagen The board of directors’ report referred to in Chapter 13, section 6 as well as the Companies Act

RESPINOR AB (publ) – Styrelsens redogörelse enligt 13 kap 7 § aktiebolagslagen The board of directors’ report referred to in Chapter 13, section 7 of the Companies Act

Revisorns yttrande ABL 13_8 över styrelsens redogörelse för kvittning RESPINOR AB_2023-06-30 – blank

Revisorns yttrande enl ABL 13_6, 14_8 och 14_32_RESPINOR AB 2023-06-30 – blank

RESPINOR AB (publ) – EBS23 Fullständigt beslutsförslag (punkt 12), EGM23 Complete proposal (item 12)

RESPINOR AB (publ) – EBS23 Fullständigt beslutsförslag (punkt 13), EGM23 Complete proposal (item 13)

RESPINOR AB (publ) – EBS23 Fullständigt beslutsförslag (punkt 14), EGM23 Complete proposal (item 14)

RESPINOR AB (publ) – EBS23 Fullständigt beslutsförslag (punkt 17), EGM23 Complete proposal (item 17)

RESPINOR AB (publ) – EBS23 Fullständigt beslutsförslag (punkt 18), EGM23 Complete proposal (item 18)

RESPINOR AB (publ) – Bulletin EGM 2023 (FSEN 230713)[3]

The shareholders of RESPINOR AB (publ) reg. no. 559348-1806 (the “Company”) are hereby given notice to attend the Annual General Meeting (the “AGM”) on 3 May 2023 at 14:00 CEST at Fredersen Advokatbyrå’s premises, Birger Jarlsgatan 8 in Stockholm. Registration starts at 13:30 CEST.

See attached information in both English and Swedish below:

RESPINOR AB – Proxy

RESPINOR AB – Kallelse ÅS 2023

RESPINOR AB – Shareholder’s proposal on directed issue to Board members

RESPINOR AB – Notice AGM 2023

RESPINOR AB – Aktieägares förslag till RE till styrelse

RESPINOR AB – FullmaktsformulärRESPINOR AB

ÅR 2021-2022 559348-1806 (2023-03-24) – ENG

ÅR 2021-2022 559348-1806 (2023-03-24)

Revisionsberättelse RESPINOR AB (publ) 2022-12-31

The first patient has been successfully included in the DE-RISK WF II study at the coordinating center, Hôpitaux Universitaires Pitié Salpêtrière, in Paris.

The DE-RISK WF II study is a multicenter, multinational clinical evidence study to validate RESPINOR DXT’s performance to identify patients at increased risk of weaning failure.

RESPINOR DXT is a novel medical device that provides non-invasive, continuous monitoring of the diaphragm, our main breathing muscle.

There is compelling evidence that diaphragm weakness is frequent in critically ill patients and is associated with increased risk of weaning failure from mechanical ventilation (MV): During weaning, evaluating parameters such as respiratory rate, tidal volume, and blood saturation, allow the intensive care clinician to assess the stability of the cardiovascular system and adequate oxygenation and pulmonary function. However, by not having an objective measure of the diaphragm, it is difficult for the physicians to identify whether the patient has ventilator induced diaphragm dysfunction or not. If the diaphragm is too weak at the time of weaning, the accessory respiratory muscles can increase their contribution to compensate for any deficiency of the diaphragm, and consequently all vital signs look acceptable. When the patient is extubated, the accessory respiratory muscles do not have the same endurance as the diaphragm and will consequently fatigue. Thus, delayed weaning failure and reintubation may occur in patients who have unidentified diaphragm dysfunction at the time of weaning.

The risks associated with reintubation are severe and include increased cardiac and respiratory complications, prolonged MV support, prolonged length of ICU and hospital stay, increased mortality, and higher costs. Furthermore, studies show that patients who have prolonged stay on the ventilator have poor prognosis and average treatment costs of €300k per patient per year. Unroe et al. (2010) followed 126 patients weaning from mechanical ventilation, and after one year, 44% of patients on prolonged mechanical ventilation were deceased, and only 9% of the survivors were in good health.

Today, it is well established that diaphragm ultrasound may help diagnose diaphragm dysfunction and predict weaning failure. The literature has documented that monitoring of the diaphragm during weaning can reduce time on mechanical ventilation with 25%. However, standard ultrasound methods require skilled operators and continuous monitoring is not feasible. The introduction of RESPINOR DXT can represent a paradigm shift.

The aim of the DE-RISK WF II study is to develop predictive indices to optimize the time patients are on MV by establishing cut-off values of diaphragm excursion ​​to predict weaning outcome. DXT has the potential to optimize extubation timing, reduce re-intubation rate, improve patient outcomes, and reduce healthcare costs.

The DE-RISK WF II study is a follow-up study in 7 centers in France and Norway with 145 patients with an improved, close-to-the-commercial version of DXT, including a new algorithm for depth selection, a new graphical user interface (GUI), quality control for signal, and a new DXT tape solution.

Primary endpoint: Difference in the rate of weaning failure between patients with a diaphragm excursion (DE) < 1.0 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 < 1.0 cm 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 < 1.0 cm at time of weaning, the risk of weaning failure is increased since 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 Q2 2023.

Figure: RESPINOR DXT in the intensive care unit during training

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)

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

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

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

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

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.

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/pharma, medtech/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/