11 March 2021
2021 Presenting Companies
Aelin Therapeutics (BE)
Aelin Therapeutics secured a 27 M€ Series A investment to exploit its proprietary Pept-in™ protein knockdown platform as a novel modality in drug development. Company will exploit its proprietary platform technology to develop a new class of antibiotics and first-in-class therapeutics against high-value undruggable human targets in oncology. The Peptin technology harnesses the power of protein aggregation to specifically induce functional knockdown of a target protein. The technology allows for the rational design of novel biotherapeutics and differentiates itself from any other therapeutic modality through its unique mode of action, its designability and intracellular target space out of reach for other therapeutics.
AM-Pharma is a clinical stage biopharmaceutical company, leading in the development of a treatment for AKI with its innovative recombinant human Alkaline Phosphatase therapeutic (recAP). AKI is a devastating disease with high mortality rate that affects millions of patients worldwide. There is no approved pharmacological treatment for AKI and our biologic, recAP, has the potential to be a life-saving first-in-class medicine.
Amolyt Pharma (FR)
Amolyt Pharma is building on its team’s established expertise in therapeutic peptides to deliver life-changing treatments to patients suffering from rare endocrine and metabolic diseases. Its portfolio includes AZP-3601, a parathyroid hormone analog in Phase I clinical development for the treatment of hypoparathyroidism ; AZP-3404, which is undergoing indication prioritization work ; and AZP-38XX, a small peptide series under evaluation to select a development candidate for the treatment of acromegaly. Amolyt Pharma aims to further expand and develop its portfolio by leveraging its global network in the field of endocrinology and with support from a strong syndicate of international investors. To learn more, visit [www.amolytpharma.com](http://www.amolytpharma.com) or follow us on Twitter at @AmolytPharma.
Atlantic Therapeutics (IE)
Atlantic Therapeutics develops professional and consumer medical devices, related software, apps and connected technologies to treat incontinence and other associated pelvic health disorders by strengthening muscles and modulating nerves. Atlantic Therapeutics is a pioneer of consumer facing healthcare, recently launching a new, cutting-edge wearable technology called INNOVO® that delivers a therapy via a pair of bike shorts. INNOVO® received a DeNovo FDA clearance in 2018, followed by an OTC (direct to consumer) FDA clearance in January 2020, and was approved for reimbursement by CMS in February 2020.
The company vision is to improve the quality of life of millions of people each year by enabling them to restore their pelvic health, and regain the confidence and control to lead full and active lives.
Atlantic Therapeutics’ main offices are located on the Atlantic coast, in Galway and Boston.
Binx health is a first-of-kind population health technology company that brings high quality convenient testing to the places where people live, work, study and shop. We work with large corporate partners and institutions to keep populations healthy and businesses and schools open. Our solutions broaden access to care for millions. Our suite of medically guideline-driven, at-home testing solutions bring high quality testing and population health tools and digital integration capability to large corporate partners and those unable to visit a clinic location. Our FDA cleared io platform is the first ever point-of-care tool for the detection of chlamydia and gonorrhea, two of the most tested for sexually transmitted infections (STIs) globally, that provides central lab performance results in about thirty minutes. Our platform is highly flexible, easy-to-use and rapid, offering molecular point-of-care answers at central-lab quality performance and for the first time enabling single-visit test and treatment. We provide a comprehensive digital program that includes evidence-based testing, counseling, treatment, and follow up in order to increase screening and reduce infections. We are currently expanding the platform which includes development of a rapid point-of-care COVID-19 test by combining our proprietary electrochemical detection with CRISPR methods. We are building solutions designed for the future of healthcare that lies at the nexus of testing convenience, rigorous science, and strong consumer relationships.
BioArctic is a Swedish biopharma company that develops new drugs based on groundbreaking research for patients with central nervous system disorders. For a global market, the aim is to generate transformative medicines that can stop or slow down the progression of diseases, principally Alzheimer’s and Parkinson’s diseases.
The company’s most advanced projects are BAN2401, which is currently in a confirmatory Phase 3 study in early Alzheimer’s disease in partnership with Eisai and, ABBV-0805 aimed at Parkinson’s disease, which is currently in a Phase 1 study in partnership with AbbVie. BioArctic also works in research stages in Alzheimer’s disease, other neurodegenerative disorders, with a technology platform in blood-brain barrier transport, and in diagnostics and biomarkers.
BioArctic was founded in 2003 based on innovative research from Uppsala University, Sweden. BioArctic’s B-share is listed on Nasdaq Stockholm Mid Cap (ticker: BIOA B).
Calliditas Therapeutics is a specialty pharmaceutical company focused on developing high value medical products for patients with significant unmet medical needs in niche indications, where the company can partially or completely participate in the commercialization. Initial focus is in renal and hepatic indications.
Cardiawave was created at the end of 2014 as a result of a partnership of over 6 years between the academic laboratories Physics for Medicine Paris (INSERM/CNRS/ESPCI/PSL) and Langevin Institute (CNRS/INSERM/ESPCI), world leaders in ultrasound imaging and therapy, and the Georges Pompidou European Hospital (HEGP), a leader in the field of valve disease and cardiac ultrasound imaging.
Based at the business incubator of Paris Biotech Santé in Cochin and member of the national research consortium RHU Stop-AS and of the competitiveness cluster MEDICEN Paris Région, Cardiawave employs 26 people and has secured over €22M in funding since its inception.
With a quality management system that is EN ISO 13485:2016 certified since 2019, Cardiawave has developed Valvosoft®, a non-invasive ultrasound therapy medical device for the treatment of calcific aortic stenosis (CAS), the most prevalent heart valve disease in adults and one of the most common causes of cardiovascular mortality worldwide. Valvosoft® is an investigational device. Cardiawave’s mission is to improve the quality of patient care by offering medical devices for non-invasive therapies.
Early 2019, Cardiawave was granted approval to perform a first-in-human feasibility clinical study (FIH‑I) in France and in the Netherlands enrolling 10 patients. Another study (FIH-II) has been approved in Serbia and started at the end of 2019\. In 2020, Cardiawave obtained approval for an extension of its FIH-I increasing the study population up to 30 patients. This study extension is on-going.
A Research Letter presenting the preliminary results of the FIH-I has been published in Circulation on January 25, 2021.
Cardior Pharmaceuticals is a clinical-stage, privately held German biopharmaceutical company pioneering the development of curative and preventive heart failure therapeutics based on noncoding RNAs (ncRNAs).
Cardior’s therapeutic approach is using distinctive ncRNA signatures driving the molecular reprogramming that causes maladaptive remodeling and heart failure. Drug candidates developed by Cardior represent first-in-class ncRNA therapeutics and diagnostics for patients with myocardial infarction and various forms of heart failure.
Founded in 2016 based on the work of cardiologist Prof. Dr. Dr. Thomas Thum of Hannover Medical School, the Company is funded by a consortium of leading investors: LSP, BioMedPartners, Boehringer Ingelheim Venture Fund (BIVF), Bristol-Myers Squibb (BMS) and High-Tech Gründerfonds (HTGF).
Celon Pharma is an integrated biopharmaceutical company which designs, develops, manufactures and distributes pharmaceutical products. It was founded in 2002 by Maciej Wieczorek, PhD. The Company currently has approx. 450 employees. It employs approx. 160 scientists responsible for research and development, half of whom either have a PhD or are in the process of acquiring their PhD. The Company’s pipeline includes more than a dozen projects for the development of innovative drugs with therapeutic groups such as oncology, neuro-psychiatry, autoimmunity and metabolism. The Company has its own research and development laboratories, which allow it to develop its own pharmaceutical technologies by using extensive laboratory equipment resources, as well as the experience and expertise of its staff. It also has a modern manufacturing facility where dry pharmaceutical forms are manufactured. Over the last few years, the Company has introduced products into the market in the following therapeutic areas: oncology, central nervous system diseases, cardiology, HIV treatment, respiratory diseases. The Company has been developing the technology for manufacturing inhalation drugs and several projects of innovative drugs since 2007. It has been listed on the Warsaw Stock Exchange since 2016.
Celyad Oncology (BE)
Celyad Oncology is a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer. We are developing a diversified pipeline of allogeneic and autologous CAR T cell therapy candidates for cancer patients with hematological malignancies and solid tumors.
Cergentis is a privately held genomics company that developed the patented Targeted Locus Amplification (TLA) technology. TLA is a widely published Next Generation Sequencing (NGS) technology that offers unique advantages in the implementation of precision medicine and advanced genetic engineering. Cergentis has established itself as the go-to partner for the characterization of genetically engineered cell lines, cell and gene therapy products and animal models for the global biopharmaceutical industry and leading research institutes worldwide. We develop and sell kits and services for targeted and complete sequencing of (trans)genes and gene editing events and provide services for the support in R&D in these fields. Next to growing revenue from Cergentis’ current business, the company develops additional applications of its core technology. A recent development is the FFPE-TLC (Targeted Locus Capture) technology, with which we can detect all relevant mutations in FFPE tumor biopsy samples in one single test. With this, we strive to overcome limitations of conventional techniques such as FISH as well as to enable physicians to take smaller, minimal invasive biopsies. It is our mission to improve the quality of genetic research: supporting biopharmaceutical R&D will accelerate the development of new treatments with better outcomes for patients all over the world. Cergentis was founded in 2012 as a spin-off from Hubrecht Institute for Development Biology & Stem Cell Research and Royal Netherlands Academy of Arts and Sciences (KNAW).
DNA Script (FR)
DNA Script is a disruptive DNA synthesis company engineering biology to accelerate breakthroughs in life science and human health. That’s why we pioneered SYNTAX, the world’s first benchtop DNA printer powered by a revolutionary enzymatic technology.
With SYNTAX, labs are empowered to print their own synthetic oligos – a dramatically faster and user-friendly alternative to today’s outsourced, chemical-based DNA synthesis model.
SYNTAX puts you in control of your workflows while giving you autonomy over your designs and yielding faster access to results. That means more time to unleash your curiosity and solve tough problems.
We’re helping you get back to doing what you love. It starts with DNA on demand.
EIP Pharma (US)
EIP Pharma is a leading CNS therapeutics-directed clinical stage pharmaceutical company that is led by a top-tier management team that has a track record in developing major, innovative medicines. The company is developing neflamapimod, an oral specific kinase inhibitor that in preclinical studies demonstrated positive effects on both functional and neurodegenerative outcomes. In the clinic, neflamapimod has been evaluated in more than 300 patients and volunteers, with completed phase 2 clinical studies in Alzheimer’s disease and dementia with Lewy bodies (DLB) which demonstrated target engagement and proof-of-concept, respectively. Results of the AscenD-LB Phase 2 clinical study with neflamapimod that demonstrated proof-of-concept for neflamapimod as a treatment for dementia with Lewy bodies (DLB) were presented at a major medical conference (CTAD) in November 2020\. In that study, neflamapimod significantly improved cognition, as assessed by a DLB-specific Neuropsychological Test Battery (NTB) designed to evaluate attention and executive function. In addition, neflamapimod demonstrated a statistically significant on the Timed Up and Go Test, a well validated clinical endpoint that measures walking ability and has been correlated to activities of daily living. The company successfully completed an end-of-phase 2 meeting with the FDA in January 2021 and now has a well-defined clinical path through to approval; including an agreement with the FDA to have the NTB, along with a co-primary endpoint of a global or functional measure, as a primary endpoint in phase 3 to support registration. With financing, the company plans to initiate a pivotal phase 2b study in DLB in Q4 2021 and a phase 3 study in that indication in H1 2022\. Clinical studies under consideration to start thereafter includes POC phase 2 studies in recovery after stroke and Huntington’s disease, and potentially a pivotal study in AD.
Eloxx Pharmaceuticals (IL)
Eloxx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates that are designed to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis from messenger RNA. As a consequence, patients with premature stop codon diseases have short half-life messenger RNA that produce truncated, nonfunctional proteins, accounting for some of the most severe phenotypes in these genetic diseases. These premature stop codons have been identified in over 2,000 rare and ultra-rare diseases. Read-through therapeutic development is focused on extending mRNA half-life and enabling protein synthesis to continue through the premature stop codons to restore protein functionality. Eloxx’s lead product candidate, ELX-02, is a small molecule drug candidate designed to restore full-length functional proteins. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis cystinosis. ELX-02 has not been approved by any global regulatory body. Eloxx is headquartered in Waltham, MA. with R&D operations in Rehovot, Israel.
eTheRNA immunotherapies is a clinical-stage company developing mRNA-based immunotherapies for the treatment of cancer and infectious diseases. The product pipeline is focussed on cancer indications with projects spanning from discovery through to Phase I/II. In addition to its proprietary mRNA platform eTheRNA has developed novel expression and formulation platforms and is establishing a network of research collaborations in non-oncology indications. It secured a EUR 24 million Series A financing in 2016 and is the recipient of several major European research grant awards. It has a GMP manufacturing facility in Niel, Belgium, which conducts both internal and third-party manufacturing services.
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide with more than 2,900 employees. We cover all activities from target-to-clinic (EVT Execute). The Company has substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases and fibrosis. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate).
FoRx Therapeutics (CH)
FoRx Therapeutics is a recently incorporated privately-held company based in Basel, Switzerland. It is backed by a syndicate of investors that include the Novartis Venture Fund, Pfizer Ventures, M Ventures, Omega Funds and LSP Venture Capital. FoRx Therapeutics focuses on drugging key molecular targets involved in DNA Replication Stress, as a new approach towards the development of targeted anticancer drugs.
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Galapagos’ pipeline comprises Phase 3 through to discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. Our target discovery platform has delivered three novel mechanisms showing promising patient results in, respectively, inflammatory diseases, idiopathic fibrosis and atopic dermatitis. Galapagos is focused on the development and commercialization of novel medicines that will improve people’s lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 578 employees, operating from its Mechelen, Belgium headquarters and facilities in the Netherlands, France, and Croatia. More information at [www.glpg.com](http://www.glpg.com).
Heidelberg Pharma (DE)
Heidelberg Pharma (FSE: HPHA) is a listed, biopharmaceutical company focused on oncology. It is the first company to develop the toxin Amanitin into cancer therapies using its proprietary Antibody Targeted Amanitin Conjugate (ATAC) technology and to advance the biological mode of action of the toxin as a novel therapeutic principle. This proprietary and innovative technology platform is being applied to develop the Company’s own therapeutic ATACs, as well as in third-party collaborations, to create a variety of ATAC candidates also for other indication fields. The proprietary lead candidate HDP-101, a BCMA ATAC for multiple myeloma, recently received IND by the FDA for a Phase I/IIa study, which is set to start in Q2.
In addition, Heidelberg Pharma has exclusive multi-target research agreements with biopharmaceutical companies like Takeda (three undisclosed targets) and Magenta Therapeutics (four targets, of which CD117 and CD45 are disclosed) for the joint development of ATACs.
For more information visit www.heidelberg-pharma.com
Hyloris is a specialty biopharma company identifying and unlocking hidden potential in existing medications for the benefit of patients and the healthcare system. Hyloris applies its knowhow and technological innovations to existing pharmaceuticals and has built a broad proprietary pipeline with the potential to offer significant advantages over currently available alternatives. Hyloris currently has two, partnered commercial-stage products, Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid analgesic for the treatment of pain. The Company’s development strategy primarily focuses on the FDA’s 505(b)2 regulatory pathway, which is specifically designed for pharmaceuticals for which safety and efficacy of the molecule has already been established. This pathway can reduce the clinical burden required to bring a product to market, and significantly shorten the development timelines and reduce costs and risks. Hyloris is based in Liège, Belgium.
ImCheck Therapeutics (FR)
ImCheck Therapeutics is a clinical stage biotech company offering unique opportunities for immune modulation by targeting a superfamily of new targets: Butyrophilins (BTNs).
The superfamily of BTNs consists of 14 genes offering separate and distinct mechanisms of action that have not previously been explored in immuno-oncology or autoimmunity including Vγ9Vδ2 T-cells, NK-cells, αβ T-Cells and myeloid cells.
Imcheck Therapeutics is advancing a diverse pipeline of programs against different targets within the BTN family for use in monotherapy or combination with existing drugs to the benefit patients suffering from cancer or autoimmune disorders.
Imcyse develops active targeted immunotherapies to treat and prevent severe chronic diseases caused by disruptions of the immune system. Imcyse’s unique active immunotherapy technology platform, based on the administration of Imotopes™, allows it to locally target immune cells involved in the destruction of the diseased organ. Imcyse has completed its first clinical trial in type 1 diabetes in 7 European countries. Projects which address multiple sclerosis and rheumatoid arthritis, are at preclinical and proof-of-concept research stages, respectively.
Learn more here
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn’s disease, and psoriasis. Immunic is developing three small molecule products: its lead development program, IMU-838, is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based broad-spectrum antiviral effect; IMU-935 is an inverse agonist of RORγt; and IMU-856 targets the restoration of the intestinal barrier function. For further information, please visit: www.imux.com.
ISA Pharma (NL)
ISA develops targeted immuno-activators for the treatment of cancer and infectious diseases. Its best-in-class SLP® technology stimulates the immune system in a highly specific fashion. ISA’s products aim to achieve more, deeper and longer lasting responses and delay or prevent disease recurrence. ISA collaborates with Regeneron around its lead asset, ISA101b targeting HPV16-induced cancers. ISA101b is currently in a randomized, controlled Phase 2 clinical trial for Head and Neck cancer, in combination with cemiplimab (Libtayo®), anti PD-1 antibody. ISA101b is fully funded to approval under the Regeneron partnership. ISA is currently raising funds to bring additional products to the clinic.
iStar Medical (BE)
iSTAR Medical, founded in 2011 and headquartered in Wavre, Belgium, is a clinical-stage, medical technology company focused on the development of novel ophthalmic implants for patients with glaucoma. Glaucoma is the second leading cause of adult blindness globally, affecting more than 90 million people. Micro-invasive glaucoma surgery (MIGS) is the most promising and fastest-growing therapeutic option in the treatment of glaucoma.
iSTAR’s lead product, MINIject ™, has been designed to be a best-in-class MIGS device. Data from its first-in-human STAR-I trial confirms that it is safe and highly effective in achieving significant IOP reduction, as well as easing medication burden in glaucoma patients. Several additional studies are in progress to support iSTAR’s market entry plans into Europe and the United States.
iSTAR has raised €55 million to-date.
Kiadis is developing therapeutics based on Natural Killer cells, or NK-cells. The K-NK immunotherapy platform consists of off-the-shelf uniquely hyperfunctional NK cells, with high dose, low cost industrial production. Kiadis will have 3 products in clinical development in 2020/2021.
Kuros Biosciences is a leader in next generation synthetic bone graft technologies for targeted and controlled bone healing. Kuros’s bone graft substitute, MagnetOs, is commercialized in the US and UK for use in posterolateral spinal fusions. Kuros’s lead product in development, Fibrin PTH, a drug-biologic combination for spinal interbody fusion, has entered a phase 2 clinical trial in the U.S. Kuros is located in Schlieren (Zurich), Switzerland, Bilthoven, The Netherlands and Burlington (MA), U.S.A. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN.
Lumeon Care Pathway Management platform enables healthcare organizations orchestrate and automate systems, processes and teams – uniting patients with care teams: improving patient experience; providing better, more consistent outcomes; ensuring care is efficiently coordinated in real-time. CPM enables digital control of care delivery models, maximizing resource utilization, reducing cost and minimizing variation.
Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific
antibody therapeutics, referred to as Biclonics®. Biclonics®, which are based on the full-length IgG format,
are manufactured using industry standard processes and have been observed in preclinical and clinical
studies to have several of the same features of conventional human monoclonal antibodies, such as long
half-life and low immunogenicity. For additional information on the company and programs, please visit Merus’ website, [www.merus.nl](http://www.merus.nl).
Microsure is a medical device company located in Son – Eindhoven founded by
Tehcnical University of Eindhoven and Maastricht University Medical Center in 2016.
Our focus is to improve people`s lives through developing robotic systems for
microsurgery. Our current product (MUSA) is the world’s first surgical robot with a CE
mark for open microsurgery.
It is designed in close cooperation with microsurgeons and engineers, specifically for
microsurgical applications. MUSA provides superhuman precision for microsurgeons,
enabling new interventions that are currently impossible to perform by hand.
We have strategic collaborations with key clinical opinion leaders, industrial
partnerships, quality and regulatory experts.
Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Its three lead development candidates are built on Mithra’s unique native estrogen platform, Estetrol (E4): Estelle®, a new era in oral contraception, PeriNesta®, the first complete oral treatment for perimenopause and Donesta®, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO. Active in more than 85 countries around the world, Mithra has an approximate headcount of 250 staff members and is headquartered in Liège, Belgium. [www.mithra.com](http://www.mithra.com)
Neurent Medical (IE)
Neurent Medical, founded in 2017, is pioneering innovative treatments for chronic inflammatory sino-nasal diseases by targeting and safely disrupting hyperactive parasympathetic nerves that drive underlying inflammation. The Galway, Ireland-based company has developed NEUROMARK™ Rhinitis Neurolysis Therapy™, an innovative in-office treatment option for chronic rhinitis. Neurent Medical closed a €9.3m Series A in 2018, led by Fountain Healthcare Partners, and a €21m Series B in 2020, led by LSP. Neurent Medical is actively enrolling patients into its pivotal clinical trial of their NEUROMARK™ technology and preparing for its US commercialisation later in 2021.
Founded in 2019, NewAmsterdam Pharma is a clinical-stage company focused on the research and development of transformative therapies for cardio-metabolic diseases. Its mission is to improve patient care in populations where traditional therapies have been unsuccessful or are not tolerated.
Nouscom is an oncology company developing next-generation immunotherapies. Nouscom’s proprietary technology harnesses the full power of the immune response by combining viral vectored genetic vaccines based on neoantigens with other immunomodulators. Nouscom raised 54M EUR to date, and is backed by a strong syndicate of international investors: 5AM, Abingworth, LSP, and Versant Ventures.
Oncopeptides is a rapidly growing biotech company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The company is science driven and committed to bringing innovation to patients with an unmet medical need and improving patient lives.
Despite technological advances, ablation treatment for the millions of patients suffering with AFib is only successful in around half of patients. OneProjects are developing VERAFEYE, a novel endovascular catheter system to increase the efficacy and safety of cardiac ablations. VERAFEYE, utilizing advanced imaging and analytics in conjunction with its innovative catheter-based sensor system, is a connected technology generating unprecedented 4D data during the cardiac ablation procedure. By providing the physician with real-time high resolution anatomical maps of the cardiac structures and beyond, VERAFEYE will aid in therapy planning (cardiac wall thickness/morphology etc.) and also include imaging of ablation lesions as they are created in the heart muscle to increase the efficacy as well as the safety of catheter ablation.
The company vision is to provide data of unparalleled data to physicians to make effective treatment accessible to the growing number of patients worldwide while reducing cost to the healthcare system.
OneProjects offices are located in Dublin, Ireland and Munich, Germany.
ONWARD (formerly GTX Medical) is a medical technology company developing and commercializing innovative therapies to enable functional recovery for people with spinal cord injuries. Driven by its mission to restore movement, independence, and health, ONWARD builds on more than a decade of fundamental science and preclinical research conducted at the world’s leading neuroscience laboratories. ONWARD’s ARC Therapy, delivered by proprietary implantable or external systems, is designed to deliver targeted, programmed stimulation of the spinal cord in order to restore movement and other functions in people with spinal cord injury and improve their quality of life. Both of ONWARD’s technology platforms have been awarded Breakthrough Device Designation by the FDA. ONWARD is headquartered at the High Tech Campus in Eindhoven, the Netherlands and the EPFL Innovation Park in Lausanne, Switzerland, with a growing U.S. presence in Boston, Massachusetts, USA.
Orphazyme’s current clinical programs investigate arimoclomol as a treatment for four protein-misfolding indications: The protein-aggregation diseases Amyotrophic Lateral Sclerosis (ALS) and sporadic Inclusion Body Myositis (sIBM), and the lysosomal storage diseases Niemann-Pick disease Type C (NPC) and Gaucher disease. The new molecular entity (NME) program focuses on the development of new molecules as a treatment for rele- vant protein-misfolding diseases.
Oryzon is a public clinical stage biopharmaceutical company developing epigenetics-based therapeutics. Oryzon is listed on the Spanish Stock Exchange (ORY, ISIN Code: ES0167733015). Oryzon has two compounds in Phase II in CNS and oncology.
OxThera AB is a Swedish biotech company developing a new treatment for primary hyperoxaluria (PH) – a rare genetic and devastating disease with fatal outcomes. Currently pharmaceutical treatment is not available and median age of death is 30, if patients are not transplanted. A phase 3 study of Oxthera’s investigational drug candidate Oxabact is ongoing in patients with PH Type I, II or III not on dialysis, with top-line data expected mid 2021. Oxabact has received orphan drug designation in the US and the EU for the treatment of PH.
Pharming Group (NL)
Pharming is a specialty pharmaceutical company developing innovative products for the safe, effective treatment of rare diseases and unmet medical needs. We are committed to transforming the future for our patients. We develop innovative products for the treatment of unmet medical needs. Pharming’s lead product, RUCONEST® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of acute hereditary angioedema (“HAE”) attacks in patients in Europe, the US, Israel and South Korea. The product is available on a named-patient basis in other territories where it has not yet obtained marketing authorisation.
Pharvaris is a clinical-stage company focused on bringing oral bradykinin B2-receptor antagonists to patients. By targeting this clinically proven therapeutic target with novel small molecules, the Pharvaris team is advancing new alternatives to injected therapies for all sub-types of hereditary angioedema (HAE) and other bradykinin B2-receptor-mediated indications.
PHA121, Pharvaris’ lead drug candidate, is a novel, potent small-molecule bradykinin B2 receptor antagonist. PHA121 is the only oral B2-receptor antagonist in clinical development, currently under Phase 1 clinical study.
Pharvaris was founded in October 2015 by executives with a breadth of expertise across pharmaceutical development and rare disorders, including HAE.
Sequana Medical (CH)
Sequana Medical NV is a commercial stage medical device company developing the alfapump® platform for the treatment of fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a fast growing complication of advanced liver disease driven by NASH (non-alcoholic steatohepatitis) related cirrhosis and a common complication in heart failure with diuretic resistance being widespread in both of these indications.
Both indications leverage Sequana Medical’s alfapump, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally eliminated through urination. The alfapump has been granted FDA breakthrough device designation for recurrent and refractory ascites due to liver cirrhosis with a pivotal study in the U.S. and Canada (POSEIDON) underway, and is approved in Europe for refractory ascites due to liver cirrhosis and malignant ascites. Over 800 alfapump systems have been implanted to date. The alfapump DSR® (Direct Sodium Removal) builds on this experience and is in development as a potential chronic therapy for fluid overload in heart failure. Clinical proof-of-concept was achieved and strong interim results have been published from an ongoing repeated dose alfapump DSR study (RED DESERT) in diuretic-resistant heart failure patients.
Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit [www.sequanamedical.com](http://www.sequanamedical.com).
SafeHeal, based in Paris, France, is working to reshape digestive surgery by developing and commercializing anastomosis protection devices for improved post-operative patient recovery and reduced healthcare costs. SafeHeal develops Colovac™, an innovative endoluminal solution for the protection of colorectal anastomosis, designed to reduce anastomotic complications post-surgery and to obviate the need for diverting ostomies for patients undergoing colectomy. The Colovac device is meant to enable patients to resume their normal life after a colorectal surgery, without having to bear an artificial anus and wear an ostomy pouch.
SNIPR Biome (DK)
SNIPR BIOME: We are the CRISPR microbiome company. Precision killing of bacteria has the impact to revolutionize the management of untreatable and difficult-to-treat infections as well as complex diseases directly impacted by the human microbiota.
Our mission is to develop CRISPR-based medicines that give hope for effective and safe treatment of difficult-to-treat diseases in the future.
uniQure is delivering on the promise of gene therapy — single treatments with potentially curative results. We are leveraging our modular and validated technology platform to rapidly advance a pipeline of proprietary and partnered gene therapies to treat patients with hemophilia, Huntington’s disease and other severe genetic diseases.
We are advancing a focused pipeline of innovative gene therapies. We are currently conducting a pivotal phase 3 trial in our lead indication, hemophilia B, and have initiated a phase 1/2 trial in Huntington’s disease. Our pipeline of adeno-associated virus (AAV)-based gene therapies has been developed using an innovative technology platform, supported by industry-leading proprietary commercial-grade manufacturing capabilities.
Vetex Medical (IRE)
Vetex Medical is a privately-held early stage company based in the strong Med Tech Cluster in Galway Ireland. Established in 2016, the company is focused on making venous clot removal predictable, quick and cost-effective. The company’s first thrombectomy product treats deep vein thrombus by removing large volumes of clot in a single session, without use of thrombolytic drugs.
VAXIMM is a privately held, clinical stage, Swiss/German biotech company developing oral T-cell immunotherapies for patients suffering from cancer. VAXIMM’s plug and play technology is based on a live attenuated, safe, orally available bacterial vaccine strain, which is modified to stimulate patients’ cytotoxic T-cells and that can be readily adapted to target a wide range of cancer-related antigens.
The Company has a pipeline of complementary development candidates targeting different tumor structures. Lead product candidate, oral VXM01, activates killer cells targeting tumor-specific vasculature and certain immune-suppressive cells, thereby increasing immune cell infiltration in solid tumors. VXM01 is currently in clinical development for several tumor types, including brain cancer.
VAXIMM has an ongoing clinical trial evaluating VXM01 in combination with the human anti-PD-L1 antibody, avelumab, as part of a scientific collaboration with Merck KGaA, Darmstadt, Germany.
VAXIMM also has a neoantigen program, which is currently in preclinical development. The Company’s platform allows for fast generation and delivery of personalized T-cell cancer vaccines and may overcome key issues faced by other neoantigen approaches. VAXIMM has a strategic clinical trial collaboration with NEC Corporation for the development of personalized neoantigen cancer vaccines. A clinical Phase I basket study is in preparation.
The Company also has entered into a collaboration agreement with China Medical System Holdings (CMS), granting CMS full rights in China and other Asian countries (excluding Japan) to VAXIMM’s existing programs.
VAXIMM’s investors include BB Biotech Ventures, BCM Europe, BioMed Partners, CMS, M Ventures, NEC and Sunstone Capital.
“We exist to create innovative products that give people more time to enjoy life. We do things differently, but only when that difference is meaningful. Our goal is to be a company people know they can rely on, a friend that’s on their side.”
ViCentra is an innovative medical device company based in Utrecht, The Netherlands, with a ground-breaking product for the management of Type 1 diabetes. Kaleido, the world’s smallest and lightest insulin pump system is designed to help people with diabetes live life on their own terms.
Vico Therapeutics (NL)
Bringing knowledge, experience and science together to discover, develop and deliver therapies for CNS disorders.
Vico was founded in Q4 2019 by the highly experienced entrepreneurs Luc Dochez and Josh Mandel-Brehm and seasoned scientists Dr. Judith van Deutekom and Dr. Gail Mandel with strong academic reputations and vast industry experience.
Together with a team of skilled scientists and drug development professionals, Vico’s focus is on development of RNA modulating therapies for rare neurological disorders, with initial focus on SCA – Spinocerebellar ataxia, HD – Huntington’s disease and RETT syndrome.
Vivasure Medical (IE)
Vivasure Medical Limited (“Vivasure”) is a medical device company developing innovative solutions for unmet clinical needs in cardiology, interventional radiology and vascular surgery. Vivasure’s patented platform technology is designed to close large holes in blood vessels, such as those made to facilitate percutaneous cardiac valve repairs or replacements. Its lead product, PerQseal®, is CE Mark approved and is currently in the early stages of commercialisation in the EU. Vivasure operates a fully integrated, ISO 13485:2016 certified R&D and manufacturing facility. The company is staffed by a widely experienced team of medical device professionals.
Vivoryon Therapeutics (DE)
Vivoryon Therapeutics develops first-in-class drugs targeting post-translational modifying enzymes. Keeping the patient in mind we advance precision intervention medicines derived from our cutting-edge discovery engine into clinical development stages.
Xeltis ETR technology has been tested in various cardiovascular feasibility clinical trials (Fontan, Atrial patch and Pulmonary valve). Xeltis closed a Series B financing and an extension based on these first promising clinical results. In 2017 the company closed a round of 45 M to further expand applications in the cardiovascular space.
XyloCor Therapeutics is focused on improving the lives of people with cardiovascular disease through our commitment to advancing the science of gene therapy.
XyloCor founders Dr. Ronald Crystal and Dr. Todd Rosengart started their collaboration in the 1990s at Weill Cornell Medical College where they combined their expertise in gene therapy and cardiac surgery to develop potential treatments for patients with advanced coronary artery disease. Their work continues to be referenced by the scientific community and is the foundation for the creation of XyloCor and its clinical programs.
XyloCor Therapeutics is focused on the development of novel gene therapy for unmet needs in advanced coronary artery disease. In the United States, coronary artery disease is a leading cause of death and disability. Our lead product candidate, XC001, is in clinical development for patients with refractory angina for which there are no treatment options. XyloCor also has a secondary product, XC002, in discovery stage, for patients with cardiac tissue damage from heart attacks.