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10-minute PRESENTERS

AIgnostics GmbH

Aignostics started in 2018 within the walls of Charité Berlin and the Berlin Institute of Health, based on years of research conducted by the pathology department of Charité, TU Berlin and Fraunhofer HHI. Following initial incubation, we spun-out of Charité and BIH in 2020, and are now focusing on pioneering computational pathology for pharmaceutical research, clinical trials and CDx development.

Our strong foundation in pathology and technology, combined with our comprehensive multi-lab data access, enables us to build the best possible solutions for our global client base.

www.aignostics.com

Annaida Technologies SA

IVF success rate still remains around 30% at best for the first attempt, making repeats necessary. This places a growing burden on patients - the family is postponed, costs and stress pile up, discouragement mounts - and even on clinics that see patients renouncing treatment before potential success. Quickly identifying viable embryos is key to releasing this burden and to shortening time to pregnancy. Annaida is developing the solution to this problem through the combination of non-invasive technology and AI powered analysis.

www.annaida.ch

CairnSurgical Europe BV

CairnSurgical, Inc. is an early commercialization growth stage company that has developed a platform technology to improve surgical outcomes with image-derived, 3-D printed surgical guides. Our first product is a breast cancer surgery guide, commercial in EU and clinical stage in US. The Breast Cancer Locator™ System (BCL™) is a proprietary, patient-specific, surgical guidance system designed to achieve clear tumor margins.

www.cairnsurgical.com

EarlySight SA

EarlySight is a medtech startup located in Geneva, Switzerland. The company aims to reduce vision loss by enabling efficient detection and better monitoring of retinal diseases. We are developing a high-performance, cellular-level, eye imaging instrument empowering doctors to see the first impacts of diseases thanks to the combination of advanced optics and AI.

www.earlysight.com/

feops

FEops envisions a future where AI enables physicians to alter the course of heart disease by providing unprecedented insights on the full heart health from any cardiac CT scan.

FEops is on track to install the new standard in personalized treatment planning for structural heart interventions and is uniquely positioned to grasp a part of the coronary CT angiography market, which combined enables unique full heart health predictive analytics.

Recent key milestones:

• Regulatory clearance: CE (MDR) and FDA (de novo)
  
• Strong randomized clinical evidence (PREDICT-LAA)
  
• Selected partner for commercialisation (Abbott)
  

 
FEops wishes to seek a 10M€ Series C financing.

www.feops.com/

Lifespin GmbH

Lifespin is building a diagnostics technology platform based on digitized metabolomic data.

We are merging biology, deep data, artificial intelligence, and cloud technologies to enable digital metabolic insights for a new field of precision diagnostics that will improve the gold standard in numerous indications (e.g., prostate cancer) and will bring about new diagnostic products, where none exist today (e.g., in some neurological diseases); precision drug monitoring for clinical, pharmaceutical and research settings; and precision nutrition for diabetes, obesity, dietary and lifestyle interventions.

We are transforming blood samples into digital samples, making it accessible to data science methods. Our AI-enabled technology is highly scalable and built to provide moderate cost diagnostics to both traditional healthcare and new consumer verticals. Lifespin products are software algorithms and do not require advanced chemical reagents.

We have proven performance against legacy methods in clinical chemistry. Our first regulatory approved product, a health testing software-as-a-service (SaaS), will be for the diagnosis of prostate cancer and is expected in Summer 2023 as a lab developed test (LDT). This will be followed by other tests for the detection of neurological, cancer, and inflammatory diseases. Our cloud-based business model will be built on our proprietary SaaS platform for diagnostics and health information and is globally scalable.

Explainer Video: https://www.youtube.com/watch?v=8qevOlhlcYQ

www.lifespin.health/

Metafora Biosystems

METAFORA is a MedTech developing METAflow, the first digital, clinical-grade flow cytometry platform for Discovery and Clinical applications.

Our data analysis software provides unmatched robustness and a user-friendly interface that yields objective, reproducible, and actionable results from the increasingly large and unwieldy data sets generated by conventional, mass or spectral cytometry. METAflow is currently being launched as a RUO standalone software as a service to flow cytometry departments in academia and industry in Europe and the U.S.

In combination with Metafora’s proprietary reagents METAflow also underpins METAbolism, the company’s IVD activity.

It has yielded already METAglut1, a first IVD test for the early diagnosis of De Vivo disease, a pediatric neurometabolic disorder. The company is exploring a number of oncology diagnostics as well as a solution to increase the clinical efficacy of cell therapies and reduce manufacturing costs.

www.metafora-biosystems.com/

Neurosoft Bioelectronics SA

Neurosoft Bioelectronics is a neurotech spin-off from the Swiss Federal Institute of Technology in Lausanne (EPFL) building the next generation of implantable Brain Computer Interfaces (BCI) to monitor and treat severe neurological disorders.

The startup has developed a unique platform technology of soft and stretchable electrodes that improve the safety and long-term bio-integration of these devices in the human body, while enabling new approaches for minimally invasive surgery.

The company is focused on using its technology to develop the first treatment for severe tinnitus, a debilitating disorder which impacts 50M people worldwide, through closed-loop cortical neuromodulation, as well as developing intra-operative subdural electrodes for brain monitoring during epilepsy and brain tumour resection surgery.

www.neurosoft-bio.com/

Orthox Ltd.

Orthox, a clinical stage Oxford University Company led by a seasoned team of medtech veterans, has developed FibroFix: The only implant platform to provide both tissue regeneration and immediate functional repair of knee cartilage.

The combination of function and regeneration offers significant stakeholder advantages and health economic benefits to patients, surgeons and healthcare providers while offering clear differentiation from competitors in this rapidly growing $2bn+ market opportunity.

Early clinical results in our 75 patient pivotal study are exceptionally promising, with rapid recovery and major reduction in pain.

Orthox will be seeking Series A2 finance of $7.5m in 2023 to build on our $12.5m Series A1, complement our significant grant funding, deepen our clinical data set and further develop our discussions with the FDA and NMPA on the approval route for FibroFix in the US and China.

www.orthox.co.uk/

Pacertool AS

Pacertool is addressing a large unmet need for the more than 200'000 heart failure patients in need of pacing every year: optimal patient selection and optimized lead placement. Currently, 30-40% of heart failure patients who get a bi-ventricular  pacemaker ("CRT") implanted have limited effect of the therapy. Pacertool is solving this problem with the PaCRTool system: a proprietary platform which helps physicians to select patients and to optimize lead placement including avoiding scar tissue in ischemic patients.

The company has established proof-of-principle data in 45 heart failure patients with more than 2 years follow-up. The data indicate differentiation between responders and non-responders. Pacertool is implementing a 510(k) strategy in the US and is initiating the First-in-Patient clinical trial in Europe from 2024.

www.pacertool.com

Pulsify Medical

Pulsify Medical is a Belgian medical device digital health company. We are developing a unique large and flexible ultrasound medical patch, to monitor 24/7 the cardiac output, (and stroke volume, ejection fraction) of patients at risk.

Key applications are in the ICU, in the hospital ward and at home. Patients with for example heart failure and other cardiovascular indications, cardiogenic shock, as well as post-operative patients and patients on chemotheray will benefit from this patch.
Although ultrasound has been around for decades as an intrinsically safe imaging technology, no ultrasound patches exist in the market today with sufficient size to accurately monitor cardiac performance continuously . Pulsify's unique and protected IP enables this new patch format which will transform monitoring of patients at risk.

The benefits of the patch include: better clinical outcomes; cost savings; no need to have scarce and well-trained health care staff at the bedside pof the patient; better quality of life for the patient, and last but not least: peace of mind for both patients and physicians.

www.pulsify-medical.com/

RetinAI

RetinAI is a SaaS digital health company revolutionizing management of health data, decision making and powering digital precision medicine through software. Our solutions accelerate R&D and clinical development of first-in-human drug candidates all the way to commercialisation, optimize clinical trial management and operations, and are used by other stakeholders to enable the right decisions sooner.

With a team of over 40 people, from 20+ nationalities, offices in Switzerland and US, and revenues of $3 million in 2022 (an increase of 500% from 2020, with over 70% of it being recurring revenue and >75% gross margins), we began in ophthalmology but are expanding to neurodegenerative, vascular and rare diseases.

One of the many challenges in healthcare today is data management and the implications for healthcare stakeholders (pharma, clinics, patients). It takes an average of $2-2.5B and 10-12 years to bring a drug to market, and there is a risk of failure due to suboptimal patient/endpoint selection or data management issues, just to name a few. We provide a certified software platform that is FDA & CE cleared and enables data harmonisation, AI-based biomarker analysis and automation at scale connecting devices, stakeholders data sources, and decisions for increased ROI. In one case study we helped a pharma reduce time to decision from 6 months to 6 weeks and cost by 1/10th.

Our AI-powered end-to-end harmonisation, interoperability, operational and analysis capabilities provide pharma R&D, clinical studies and clinics a one stop shop from Phase 1 all the way to RWE and CDSS distribution and creation at scale.

www.retinai.com/

Sensius BV

The Sensius systems offer unparalleled fulfilment in supporting solid tumour treatment by the use of thermotherapy in combination with radiation therapy, immunotherapy or chemotherapy.

Sensius saves cancer patients from the dilemma between treatment and toxicity: improving balance in outcome and quality of life through personalized thermotherapy.

Sensius’ mission is to demonstrate the value of personalized thermotherapy, engaging the medical field to adopt it as adjuvant therapy for a range of different cancer types, starting with head and neck cancer to find the right balance between treatment outcome and quality of life for cancer patients.

www.sensiusthermotherapy.com

Rising stars

aidhere GmbH

aidhere is a digital healthcare company which was founded in 2019 in Hamburg and is now counting more than 150 employees. aidhere develops and sells digital health applications (DiGA) for the holistic treatment of diseases. The therapies developed are based on behavioral psychological and neuroscientific findings as well as current approaches from AI research. The first product from aidhere is zanadio, a digital obesity therapy, which was launched in 2020 as the third DiGA listed on the market. zanadio has already helped more than 30,000 patients lead healthier lives, making it the most prescribed DiGA in Germany.

www.aidhere.com/en/

Deep Breath Intelligence AG

We rethink breath. Deep Breath Intelligence is a MedTech company unleashing the huge potential of analyzing exhaled breath by applying machine learning algorithms. We provide non-invasive solutions for early diagnosis of diseases and therapeutic drug monitoring — enabling better treatment by precision medicine. Our first product, DBI-EPIbreath® is a test for drug monitoring in epilepsy, CE certified under IVDD. We are working hard today on developing a broad range of products in different disease areas to take future precision medicine to the next level and improve people’s health.

dbi.ch/en/home

EarlySight SA

EarlySight is a medtech startup located in Geneva, Switzerland. The company aims to reduce vision loss by enabling efficient detection and better monitoring of retinal diseases. We are developing a high-performance, cellular-level, eye imaging instrument empowering doctors to see the first impacts of diseases thanks to the combination of advanced optics and AI.

www.earlysight.com/

Regenosca SA

Regenosca has a patented implant technology platform to produce regenerative and body friendly implants for soft tissue repair. The implants are off-the-shelf, ready-to-use and 100% natural. Proof-of-concept is validated in an ongoing First-in-Man study where Regenosca’s implants are successfully used to repair urethral strictures. The current gold standard for urethral stricture repair is the use of patient’s own inner mouth tissue.

Regenosca’s implants will render soft tissue repair such as urinary tract reconstruction and esophagus repair less invasive: no second surgical site and shorter operation time. Regenosca’s implants aim to be the body friendly alternative to today’s used patient’s own tissue grafts.

www.regenosca.com/

More tba...

virtual presenter

AOT AG

We are a surgical robotics company located in Basel, Switzerland. After more than a decade of R&D, our Laser Osteotome CARLO® is CE approved for use in operating rooms across Europe. With a comprehensive record of pre-clinical testing, and 110+ successful clinical cases in over 10 European clinics, CARLO® has demonstrated its readiness and unique value. Robotic laser precision, functional cut geometries and healing advantages, all in an easy to adopt, user-friendly system. Our highly differentiated technological innovations are protected by more than 14 patent families globally.

www.aot.swiss